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Federal Democratic Republic of Ethiopia

Ministry of Health

Immunization
Distance Learning Module for the
Health Extension Programme

HEAT
Health Education and Training
HEAT in Africa
Federal Democratic Republic of Ethiopia
Ministry of Health

The Ethiopian Federal Ministry of Health (FMOH) and the Regional Health Bureaus (RHBs)
have developed this innovative Blended Learning Programme in partnership with the HEAT
Team from The Open University UK and a range of medical experts and health science
specialists within Ethiopia. Together, we are producing 13 Modules to upgrade the theoretical
knowledge of the country’s 33,000 rural Health Extension Workers to that of Health Extension
Practitioners, and to train new entrants to the service. Every student learning from these
Modules is supported by a Tutor and a series of Practical Training Mentors who deliver the
parallel Practical Skills Training Programme. This blended approach to workplace learning
ensures that students achieve all the required theoretical and practical competencies while they
continue to provide health services for their communities.
These Blended Learning Modules cover the full range of health promotion, disease prevention,
basic management and essential treatment protocols to improve and protect the health of
rural communities in Ethiopia. A strong focus is on enabling Ethiopia to meet the Millennium
Development Goals to reduce maternal mortality by three-quarters and under-5 child mortality
by two-thirds by the year 2015. The Modules cover antenatal care, labour and delivery,
postnatal care, the integrated management of newborn and childhood illness, communicable
diseases (including HIV/AIDS, malaria, TB, leprosy and other common infectious diseases),
family planning, adolescent and youth reproductive health, nutrition and food safety, hygiene
and environmental health, non-communicable diseases, health education and community
mobilisation, and health planning and professional ethics.
In time, all the Modules will be accessible from the Ethiopian Federal Ministry of Health
website at www.moh.gov.et; online versions will also be available to download from the HEAT
(Health Education and Training) website at www.open.ac.uk/africa/heat as open educational
resources, free to other countries across Africa and anywhere in the world to download and
adapt for their own training programmes.

Dr Kesetebirhan Admasu
State Minister of Health
Ethiopian Federal Ministry of Health

i
Acknowledgements
Immunization is one of the 13 Blended Learning Modules for the Ethiopian Health Extension
Programme. Together with the practical skills training sessions that accompany each of the
supported self-study texts, this programme will upgrade the Health Extension Workers who
complete the curriculum to Health Extension Practitioners at Level-IV of the Ethiopian
Occupational Standards. The upgrading programme is sponsored by the Ethiopian Federal
Ministry of Health (FMOH) and the Regional Health Bureaus (RHBs). The FMOH gratefully
acknowledges the receipt of funding for this programme from the Ethiopian Office of UNICEF
(the United Nations Children’s Emergency Fund), The Open University UK, the Alan and Nesta
Ferguson Foundation Trust UK, and AMREF (the African Medical and Research Foundation).

Immunization was produced by a team of Ethiopian experts, who were trained and supported by
experts in blended learning pedagogy from the HEAT (Health Education and Training) Team for
Africa at The Open University UK. The contributors of original material are:
· Dr Kalid Asrat, FMOH, Ethiopia
· Dr Amha Mekasha (Module Academic Coordinator) Addis Ababa University
· Dr Gavin Grant, WHO/Ethiopia EPI
· Dr Basiro Davey, The Open University
· Dr Janet Haresnape, The Open University

The Academic Editors of Immunization are Dr Basiro Davey, Deputy Director (Ethiopia), HEAT
Team at The Open University UK, and Dr Janet Haresnape, in the Department of Life Sciences
at The Open University UK. The other members of the HEAT Team are:

· Lesley-Anne Long, HEAT Programme Director


· Alison Robinson, HEAT Programme Coordinator
· Dawn Partner, HEAT Senior Production Assistant
· Jessica Aumann, HEAT Programme Assistant
· Ali Wyllie, HEAT Lead eLearning Adviser

We acknowledge the vital contributions of the Programme Coordinators within Ethiopia:

· Ato Mohammed Hussein Abeseko, UNICEF Ethiopia and the Federal Ministry of Health
· Ato Tedla Mulatu, AMREF Ethiopia

The cover design for Immunization is by Chris Hough, Learning and Teaching Solutions, The
Open University UK. The cover photographs are with acknowledgement to hdptcar (large
image). This file is licensed under the Creative Commons Attribution Licence http://
creativecommons.org/licenses/by/2.0. Julien Harnels (small image). This file is licensed under
the Creative Commons Attribution-Share Alike Licence http://creativecommons.org/licenses/
by-sa/2.0

We particularly wish to acknowledge our use in this Module of extracts and illustrations from
the World Health Organization’s series Immunization in Practice: A practical resource guide
for health workers in its various editions (1998, 2001, 2004, 2009), particularly Module 2 ‘The
vaccines’, Module 3 ‘The cold chain’, Module 4 ‘Ensuring safe injections’, Module 5 ‘Planning
immunization sessions to reach every infant’, Module 6 ‘Holding an immunization session’, and
Module 7 ‘Monitoring and using your data’.

The opinions expressed in this Module are those of the authors and do not necessarily reflect
the views of any of the donor organisations whose generous support made the production of
Immunization possible.

ii
Contents
Study
Session

1 Immunity, Vaccines and the Expanded Programme on Immunization

2 Antibacterial Vaccines

3 Antiviral Vaccines

4 Vaccine Preparation and Administration Routes of the EPI Vaccines

5 Vaccine Supply and Stock Management

6 The Cold Chain

7 Immunization Safety

8 Immunization Programme Management

9 Communication for an Effective Immunization Programme

10 Monitoring your Immunization Programme

Notes on the Self-Assessment Questions (SAQs)

iv
Introduction to the Immunization Module
Many serious communicable diseases are easily preventable by immunization. The World
Health Organization estimates that it saves between two to three million lives every year
— the majority in regions with low incomes, under-developed infrastructure and large rural
populations. Immunization (vaccination) can make an enormous difference to the health of
individuals, communities, and nations like Ethiopia. The vaccine-preventable diseases included
in the National Expanded Programme on Immunization (EPI) in Ethiopia are tuberculosis,
poliomyelitis, diphtheria, pertussis (whooping cough), tetanus, measles, pneumonia and
meningitis due to Haemophilus influenzae type b, pneumonia due to pneumococcal bacteria,
diarrhoeal disease due to rotavirus infection, and hepatitis B disease. An efficient and thorough
immunization programme, in which the vaccines are stored and administered correctly, can
prevent these diseases and hence save many lives — particularly of young children.

In this Module, you will learn how immunization can lead to the development of immunity
and is therefore able to protect individuals from many life-threatening communicable diseases.
You will also learn the correct route of administration for each vaccine, and about the rare
contraindications that mean you should not vaccinate a particular child. Immunization is only
effective if vaccine management is good, and if vaccines are administered safely, so we will tell
you how to reduce the risk of adverse effects following immunization (AEFIs), and what to do
if they occur. Vaccines must be kept at the correct temperature right from the time they leave the
factory until the time they are injected into a person, or they lose their potency. How to maintain
vaccines at the correct temperature is explained in the study session on the cold chain. We will
teach you how to predict your community’s requirements for each vaccine, so that you can
order enough doses and minimise wastage. Another important aspect you will learn is how to
dispose safely of potentially hazardous waste materials, such as needles and syringes, after your
immunization sessions.

Immunization campaigns are only successful if they are managed well, and if the community
understands their significance. The importance of communication with parents and community
leaders about the benefits of immunizing infants aged under one year and women of
childbearing age (15 to 49 years) is emphasised throughout this Module. You will also learn
about the effective organisation of immunization activities at your Health Post, in outreach sites,
and in mobile teams. The ability to deliver improved immunization coverage rates and reduced
levels of dropout from immunization programmes also requires excellent record-keeping, and
thorough monitoring and evaluation of the outcomes of your activities.

The ten study sessions in this Module contain clear guidelines on how to conduct all these
important activities. Through these methods, Ethiopia has already had much success in reducing
vaccine-preventable diseases. For example, the number of reported cases of measles was over
10,000 per year in 1980; although the total estimated population has more than doubled since
then, the number of reported cases of measles was less than 1,200 in 2009. There have also been
huge reductions in the reported cases of polio and neonatal tetanus since immunization against
these diseases was introduced. Successes such as these are due to the rapid increase in the
immunization coverage rate among target populations.

Much of the credit for successful immunization campaigns is due to the activities of health
professionals like you. This is why you have such a big part to play in protecting women and
children from vaccine-preventable diseases in your community. We hope that this Module will
help you in this effort.

v
Study Session 1 Immunity, Vaccines and the Expanded Programme on Immunization

Study Session 1
Immunity, Vaccines and the Expanded
Programme on Immunization
Introduction
In the Communicable Diseases Module, Part 1, Study Sessions 3 and 4, you
learned that some diseases are preventable by immunization with vaccines.
Many different types of vaccines are available, and these can be enormously
successful in preventing some of the major communicable diseases
particularly those that affect children if they are used correctly. This Module
teaches you about the concepts and procedures required to deliver an
effective immunization service in your community. In this first study session,
you will learn about how the immune system protects us from infection, the
general principles underlying immunization, the types of immunity and the
types of vaccines available.
We will also explain the main features of the Expanded Programme on
Immunization (EPI) in Ethiopia, and what you as a Health Extension
Practitioner can do to help to make it successful. Immunization benefits the
whole country because it has the following general outcomes:
. It prevents millions of people dying needlessly each year.
. It has led to some diseases being eradicated from the world altogether, for
example smallpox, and others are targets for elimination, e.g. polio and
neonatal tetanus.
. It promotes health and optimal growth and development in children.
. It releases resources for other health interventions.
. It is an investment for a healthy population and a stronger economy.

Learning Outcomes for Study Session 1


When you have studied this session, you should be able to:
1.1 Define and use correctly all of the key words printed in bold.
(SAQs 1.1, 1.2 and 1.3)
1.2 Describe how the human immune system protects the body from
infection, and distinguish between the main types of immunity. (SAQs 1.1,
1.2 and 1.3)
1.3 Describe the main general types of vaccines and what they contain.
(SAQ 1.3)
1.4 Describe the main features of the Expanded Programme on
Immunization (EPI) and how Health Extension Practitioners can help to
achieve its strategies. (SAQ 1.4)

1.1 Immunity and the immune system


Immunity is a state in which the body has sufficient defences to be able to
resist the development of communicable diseases caused by infectious
agents. The main types of infectious agents are bacteria, viruses, fungi,

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protozoa and parasites. They are also often referred to as pathogens, which
means ‘disease-causing organisms’. We will use both terms in this Module.
■ Which of the following are infectious agents: the hepatitis B virus, polio
virus, Mycobacterium tuberculosis, Neisseria gonorrhoeae, Candida
albicans, Giardia intestinalis, and Plasmodium falciparum?

□ All of these are infectious agents. The list includes two viruses (causing
hepatitis and polio), two bacteria (causing tuberculosis and gonorrhoea),
a fungus (Candida causes oral and genital thrush), one protozoan
(Giardia causes diarrhoea), and one parasite (Plasmodium causes
malaria).

The immune system is the name given to the network of cells, proteins,
tissues and organs within the body (Figure 1.1), which act together to protect
us against infectious agents. In addition to the structures shown in Figure 1.1,
the cells of the immune system also circulate in the blood and some of them
migrate through the tissues. These cells are usually known as white blood
cells, which is a confusing name because they are found throughout the body
– not just in the blood. Wherever an infectious agent gets into the body, it
will soon be detected and attacked by the immune system.

Figure 1.1 The sites in the body (in addition to the blood) where the cells and
molecules of the human immune system are concentrated. (Source: The Open
University, SXR376 Preparatory Reading, Figure 1.2)

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Study Session 1 Immunity, Vaccines and the Expanded Programme on Immunization

The immune system of a healthy and well-nourished adult may be able to


fight an infection and stop the disease from developing, or reduce it to mild
symptoms. But in very young or elderly persons, or people who are
malnourished or in bad health – particularly if they already have HIV, TB or
malaria – the immune system is not strong enough to protect them from a
new infection. They can become very ill and even die without medical
treatment.
■ In addition to the immune system, can you think of other ways in which
the human body protects itself from infectious agents?

□ Intact skin covering our bodies acts as a barrier preventing entry of


infectious agents. You may have also thought of the hairs and mucus
inside the nose, which trap bacteria from the air. Coughing and sneezing,
vomiting and diarrhoea rids the body of large numbers of infectious
agents, but also spreads them to other people.

1.1.1 How does the immune system protect us from


infection?
In this section, you will learn about the different ways in which people can
acquire immunity (become immune) to infectious agents. Immunity may be
non-specific or specific.

Non-specific immunity
Non-specific immunity (also known as innate immunity — ‘innate’ means
‘already formed at birth’) includes protection from infectious agents by
mechanical barriers, such as intact skin or the mucus membranes lining the
inside of our nose, mouth, lungs, reproductive system and gut. It also
includes the actions of some kinds of white blood cells that can engulf (‘eat’)
or kill a wide range of infectious agents, without distinguishing between
them.

Specific immunity
In this study session, we will focus on specific immunity, which is the type
generated by immunization. Specific immunity is produced when the immune
system reacts specifically against one particular type of infectious agent in
ways that we will now describe.
When bacteria, viruses or other pathogens get into the body, they are
identified as ‘foreign’ by special white blood cells in the immune system,
known as helper T lymphocytes or helper T cells (Figure 1.2 overleaf).
Infectious agents are recognised as foreign because they have unique proteins
— called antigens — on their surfaces, which the helper T cells can detect.
Each type of infectious agent has its own unique antigens, so the person’s
immune system can tell which type of infectious agent has got into the body,
and direct an attack specifically against that pathogen. Some infectious agents
release antigens into the body fluids of the organism and the helper T cells
detect these too. Thus, a simple definition of an antigen is any substance that
is foreign to the organism that is exposed to it, and which the organism’s
immune system can detect specifically and attack.
You learned about the family of white blood cells called lymphocytes
(pronounced ‘lim-foh-sites’) in the study sessions on HIV/AIDS in Part 3 of
the Communicable Diseases Module.

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HEAT Ethiopia

Figure 1.2 Three types of lymphocytes involved in the immune response against
infectious agents in the human body. (Diagram: Dr Ignacio Romero)
The surface molecules labelled CD8 and CD4 are unique ‘markers’ of these
cells
The helper T cells activate (‘help’) the rest of the immune system to attack
the specific infectious agents they have detected in our bodies. In particular,
they help two other types of lymphocytes shown in Figure 1.2. The cytotoxic
T cells kill our own cells which have become damaged or infected by viruses.
The B lymphocytes or B cells make special proteins called antibodies in
response to infectious agents getting into the body. Antibodies are proteins
made by B cells, which circulate in the blood or body fluids and attach to the
antigens in (or released by) infectious agents. Infectious agents that have
antibodies attached to them are neutralised, or destroyed, by the person’s
immune system.
The helper T cells also cause the production of long-lived memory cells,
which circulate in the body for years, sometimes for the person’s whole life.
These cells ‘remember’ that they have met the infectious agent in the past —
either during an infection, or through immunization — and they direct a rapid
and effective immune attack against it if it ever gets into the body again.

1.1.2 What is immunization?


‘Vaccination’ refers simply to the administration of a vaccine, whereas
‘immunization’ means that the person developed immunity as a result of
being vaccinated (or immunized).
The principle in immunization is to introduce a harmless preparation of the
antigens from an infectious agent into the body of a person, who becomes
immune to the infectious agent as a result. The harmless preparation of
antigens is called a vaccine (pronounced ‘vax-een’). It is made from killed or
weakened viruses or bacteria, or antigens extracted from the infectious
agents. Immunization should happen before the person develops a vaccine-
preventable infection, so vaccines are usually given to babies and young
children, either by injection or swallowing liquid drops. However, you should
note that there are many communicable diseases that cannot be immunized
against at the present time, because a suitable vaccine does not yet exist.
■ Can you think of two very important communicable diseases which do
not yet have a vaccine?

□ You may have thought of malaria and HIV/AIDS.

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Study Session 1 Immunity, Vaccines and the Expanded Programme on Immunization

1.2 Types of specific immunity


Specific immunity can be naturally or artificially acquired, in both cases
through either ‘active’ or ‘passive’ mechanisms. In this section, we will
briefly distinguish between these four types of specific immunity.

1.2.1 Naturally acquired immunity


Naturally acquired immunity occurs ‘naturally’ without any intervention
from a health professional. The difference between the ‘active’ and the
‘passive’ forms depends on whether the immune person makes the antibodies
themselves (actively), or gets them from someone else (passively).

Naturally acquired active immunity


Naturally acquired active immunity occurs after an infection activates the
person’s immune system. For example, non-immunized children who develop
measles and recover from the illness, get better because they have made an
effective immune response against the measles virus. As a result, they acquire
protection from measles for the rest of their lives (i.e. they are immune to
measles). They have naturally acquired active immunity because the
protection developed naturally in their bodies, without a vaccine being given.
The immunity is active because the children produced their own antibodies
and memory cells, which specifically attack any invading measles viruses
they meet in the future.

Naturally acquired passive immunity


Naturally acquired passive immunity occurs when a mother gives her own
antibodies to her baby, transferring them from her blood to the fetal blood
across the placenta, or giving them to the baby in her breastmilk. The
immunity created by these maternal antibodies is naturally acquired from
the mother (without any medical intervention). During the first few months of
a baby’s life, until the mother stops breastfeeding, her antibodies provide
passive protection to the baby against infectious agents that the mother has
encountered during her own life. The term ‘passive’ is used because the baby
didn’t produce the antibodies itself. The active production of antibodies by
the immune system of the baby takes several years to develop properly.
Information about fetal, maternal and placental circulation is given in Box 5.2
in Study Session 5 of the Antenatal Care Module.
Do you know that the tetanus vaccine given to a mother during antenatal care
will also protect the newborn infant from tetanus for the first few weeks or
months of its life? This is because the maternal antibodies against tetanus
bacteria cross the placenta and get into the fetus.

1.2.2 Artificially acquired immunity


In artificially acquired immunity the person must be artificially and
intentionally exposed to foreign antigens (actively), or given someone else’s
antibodies (passively), in order to generate a protective immune response.

Artificially acquired active immunity


Artificially acquired active immunity is protection produced by intentional
exposure of a person to antigens in a vaccine, so as to produce an active and
lasting immune response. The antigens in the vaccine stimulate the immune
system to produce antibodies and memory cells which are specifically

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directed against the antigens in the vaccine. After the immunization, if the
living infectious agents with the same antigens that were in the vaccine get
into the person’s body, the correct antibodies are already present and they
bind to the infectious agents. The memory cells generate a rapid immune
response from the rest of the immune system, and the infectious agents are
quickly attacked and destroyed, often before symptoms of the disease can
develop.

Vaccine doses
Some vaccines are given as a single dose, but others are given as a course of
three doses at intervals of a few weeks. Some vaccines also require a ‘booster
dose’ five to ten years after the original immunization. This is necessary to
increase the immune response and ensure an adequate level of protection.
Once established, the protection provided by immunization usually lasts for
several years, or even for life. This makes immunization a highly effective
method of giving long-lasting immunity.

Artificially acquired passive immunity


Artificially acquired passive immunity is protection acquired by giving a
person an injection or transfusion of antibodies made by someone else. These
antibodies neutralise the infectious agents in the usual way, but the protection
lasts only a few weeks because the antibodies gradually break down and are
not replaced. In artificial passive immunization there is no involvement of the
person’s own immune system.

1.2.3 Summary of types of specific immunity


Table 1.1 gives a summary of the four different types of specific immunity,
with examples to illustrate each of them.
Table 1.1 Summary of different types of specific immunity.

Type of specific immunity Example of how immunity might be


acquired
Naturally acquired immunity Active Infection
Passive Maternal antibodies crossing the placenta,
or in breastmilk
Artificially acquired Active Intentional exposure to antigens in a
immunity vaccine
Passive Injection or transfusion of someone else’s
antibodies

■ You give a polio vaccination containing polio antigens to a baby girl.


What type of immunity will the child develop? Explain your answer.

□ The child will develop artificially acquired active immunity. She was
deliberately exposed to polio antigens in the vaccine, so her immunity is
artificially acquired. She produced her own antibodies and memory cells
directed against the polio antigens, so her immunity is active.

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Study Session 1 Immunity, Vaccines and the Expanded Programme on Immunization

1.2.4 Herd immunity


Herd immunity refers to the level of resistance against a specific
communicable disease in the community as a whole. When a high proportion
of a community is immune to a particular disease that spreads from person to
person (e.g. measles), the infectious agents causing that disease find it
difficult to infect any non-immune (susceptible) people. This could result in
the infection ‘dying out’ in that community, because there are not enough
infected people to act as a reservoir for the infectious agents. A high level of
herd immunity benefits everyone, because it makes it more difficult for a
particular infection to spread from person to person through that community.
■ Suggest two ways in which the level of herd immunity can increase in a
community.

□ If a vaccine exists, immunization of a large proportion of community


members is the best way to increase their herd immunity. If there is no
vaccine, but a large proportion have suffered from a particular infection
in the past and recovered from it, herd immunity increases because many
people have naturally acquired active immunity (Figure 1.3).

Note that herd immunity is not relevant in communicable diseases where the
main reservoir of infectious agents is the environment (e.g. tetanus), or in
other animals (e.g. rabies). Susceptible people can still be exposed to these
infectious agents, even if herd immunity is very high, because they do not
usually spread from person to person.

Figure 1.3 Herd immunity can increase in a community through exposure to


infection or to a vaccine. (Diagram: Basiro Davey)
The aim of a comprehensive immunization programme is to raise the level of
herd immunity so that almost everyone in the population is immune. The
immunization coverage rate is the proportion of the population that has
been immunized. An immunization coverage rate of over 80% can produce
effective herd immunity for some communicable diseases. However, some
infectious agents, such as the measles virus, are so easily spread from
infected to susceptible people that they require much higher immunization
coverage rates — close to 100% — in order to produce effective herd
immunity.

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1.3 Types of vaccines


Let’s now move on to look at the various types of vaccine. You might have
been immunized by injection yourself, or seen children being given
immunization by oral drops. What are the differences between these vaccines,
and what do they contain?
Vaccines are made from weakened or killed bacteria or viruses, or extracts
taken from them, which are intended to produce immunity against a disease.
At present, there are no vaccines in the EPI in Ethiopia to prevent infections
by fungi, protozoa, parasites or many other important bacterial and viral
diseases — but researchers are trying to develop new vaccines, particularly
against malaria and HIV. You will learn about the main antibacterial
vaccines (which protect against bacterial infections) in Study Session 2 and
the main antiviral vaccines (which protect against infections by viruses) in
Study Session 3. Here we describe the five general types of vaccine and how
they are made safe to use in the human body. They are:
. live-attenuated vaccines
. inactivated vaccines
. sub-unit vaccines
. recombinant vaccines
. conjugate vaccines.

1.3.1 Live-attenuated vaccines


Live-attenuated vaccines are prepared from viruses or bacteria that are
whole, active and able to cause infection, but they have been weakened in the
laboratory. The term ‘attenuated’ (pronounced ‘at-ten-you-ay-ted’) means
‘made weak’, so the infectious agents in the vaccine should cause no disease
at all.
Measles vaccine and oral polio vaccine (OPV) are live-attenuated antiviral
vaccines. Bacillus of Calmette and Guerin (BCG) is a live attenuated
antibacterial vaccine (named after its French inventors) that protects infants
and young children against severe forms of tuberculosis (TB).
Live-attenuated vaccines generally activate the immune system very
effectively, because they cause a similar reaction in the body as if to a natural
infection. For example, a single dose of measles vaccine produces lifelong
protection against measles because it is highly immunogenic, i.e. it has a
very high ability to produce immunity.
If a mild fever and small rashes appear in a child you have vaccinated against
measles, tell the mother not to worry. Reassure her that her child will be
protected against the more serious measles disease.
However, live-attenuated vaccines can sometimes produce a weakened
disease pattern in a small proportion of vaccinated children. For example,
measles vaccines can induce fever and an occasional rash, but this is very
unusual and is nothing to worry about. The live-attenuated oral polio vaccine
(OPV) can very rarely cause a type of paralysis, but on average this happens
in only one child in every 1–10 million vaccinated children.

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Study Session 1 Immunity, Vaccines and the Expanded Programme on Immunization

1.3.2 Inactivated vaccines


The pentavalent vaccine used in the EPI in Ethiopia contains five vaccines
and is sometimes referred to as DPT-HepB-Hib vaccine. The letters refer to
diphtheria-pertussis-tetanus-hepatitis B-Haemophilus influenzae type b.
Whole-cell inactivated vaccines are produced by first growing viruses or
bacteria in the laboratory and then inactivating (killing) them with heat or
chemicals. Because they are not alive, they cannot cause the disease. The
pertussis component of the pentavalent vaccine used in the EPI in Ethiopia is
an example. The whole-cell inactivated version of this vaccine contains the
Bordetella pertussis bacteria, which cause whooping cough, but they have
been killed so that they are no longer harmful.
■ Even though they cannot cause infection in the immunized person, the
infectious agents in an inactivated vaccine are still immunogenic. What
does this mean?

□ They are still capable of causing a strong immune reaction in the


immunized person, which usually protects him or her from that particular
infection in the future.

1.3.3 Sub-unit vaccines


Sub-unit vaccines are made from parts of infectious agents, or certain
chemicals produced by bacteria. Because the vaccine does not contain whole
organisms, they cannot cause disease in immunized people. The diphtheria
and tetanus components of the pentavalent vaccine are of the sub-unit type.
Diphtheria and tetanus bacteria each produce special toxins — harmful
chemicals that cause the symptoms of these diseases. The pentavalent vaccine
contains diphtheria and tetanus toxoids — modified versions of the bacterial
toxins, which have been developed in a laboratory. The toxoids don’t cause
disease symptoms, but they do stimulate a protective immune response in
vaccinated people. A sub-unit version of the pertussis vaccine now exists and
is increasingly being used instead of the older whole-cell inactivated version.

1.3.4 Recombinant vaccines


Recombinant vaccines are produced by inserting genetic material from a
disease-causing organism into a harmless cell, which then makes lots of
copies of the antigens of the infectious agent. The antigens are then purified
and used as a vaccine. An example is hepatitis B vaccine (the HepB
component of the pentavalent vaccine used in Ethiopia).

1.3.5 Conjugate vaccines


A conjugate vaccine is made by conjugating (joining together by chemical
bonds) an antigen from an infectious agent and a large ‘carrier’ protein. The
combination makes the antigen more immunogenic than it would be on its
own. An example is the Haemophilus influenzae type b (Hib) vaccine
included in the pentavalent vaccine in Ethiopia.
Now we turn our attention to how these vaccines are used in Ethiopia.

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1.4 The Expanded Programme on Immunization


The Expanded Programme on Immunization (EPI) began in 1974 when
the World Health Assembly pledged to ensure that all children in all
countries receive life-saving vaccines. Each year, immunization now prevents
more than 2.5 million deaths among children worldwide. An additional 2
million lives could be saved if available vaccines reached every child.
Ethiopia started the EPI in 1980 to reduce mortality and morbidity from
vaccine-preventable diseases among children and mothers. The immunization
coverage rate has been increasing since that time, but not as fast as the
original target. The Ethiopian Federal Ministry of Health (FMOH) has
prepared a plan to increase the immunization coverage rate to 80% of the
population in 90% of the woredas (districts) in the country. Health Extension
Practitioners like you can play a major part in the success of this plan.

1.4.1 Vaccine-preventable diseases in the EPI in Ethiopia


The vaccine-preventable diseases included in the EPI in Ethiopia are:
. tuberculosis (TB)
. poliomyelitis (polio)
. diphtheria
. pertussis (whooping cough)
. tetanus
. measles
. pneumonia and meningitis caused by Haemophilus influenzae type b
bacteria
. liver disease caused by hepatitis B viruses
. pneumonia and other infections caused by Streptococcus pneumoniae
bacteria
. diarrhoeal diseases caused by rotaviruses (joining the EPI soon).
In order to achieve the EPI objectives, the FMOH has outlined five strategies
that are applicable throughout the country (see Box 1.1). Next we will
examine each of them in turn and consider what you can do to progress these
strategies.

Box 1.1 EPI strategies

. Increase and sustain high immunization coverage rates


. Increase the quality of immunization services
. Reduce missed vaccination opportunities and trace defaulters
. Improve public awareness and community participation in
immunization programmes
. Ensure prompt reporting and improved control of vaccine-
preventable diseases.

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Study Session 1 Immunity, Vaccines and the Expanded Programme on Immunization

1.4.2 Increase and sustain high immunization coverage rates


The key to increasing and sustaining high immunization coverage rates is to
increase the accessibility of immunization services, particularly by opening
more vaccination delivery sites at times when mothers can bring their infants.
As you know, many children are not immunized because they live far away
from health facilities. These children could be given the opportunity to be
vaccinated through establishing outreach services, supported by mobilisation
teams going from house-to-house identifying children (and mothers) who
need vaccinations.
You might also have seen health workers giving immunizations in your
community in well-publicised campaigns that encourage parents to bring
children to the kebele office or the Health Post for vaccination. The progress
achieved by the Health Extension Workers at one Health Post can be seen in
Figure 1.4. Planning and managing your routine immunization activities are
described in detail in Study Session 8, and communication for an effective
immunization service is in Study Session 9.

Figure 1.4 Increasing immunization coverage rates achieved in one year at Fura
Health Post in the Southern Nations, Nationalities and Peoples Region (SNNPR)
of Ethiopia. (Photo: Janet Haresnape)

1.4.3 Increase the quality of immunization services


A successful immunization service has to be of high quality. This means that
you must use safe injection practices, and all the required vaccines and other
supplies must be available in good condition, and on a regular and timely
basis. Poor quality vaccines will not prevent illness. Therefore, to improve
the EPI, you need to keep the vaccines at the proper temperature, take good
care of the injection equipment and ensure reliable vaccine stock control.
In Study Sessions 5–10, you will learn how to introduce and use quality
assurance methods to improve the efficiency and quality of the immunization
service at your Health Post
You also need to have good interpersonal communication, supportive
supervision and skilled manpower to plan and conduct an effective
immunization programme. By increasing your skills as a Health Extension
Practitioner, you can play an important role in immunizing all the children in
your area. Reaching every child should be your goal.

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1.4.4 Reduce missed vaccination opportunities and trace


defaulters
It is common in Ethiopia to see many children and mothers who have been to
a health facility, but have not been immunized. Thus, another important
strategy is to reduce missed opportunities and trace defaulters.

Reasons for missed immunizations


It is important that you check whether or not children and mothers are
immunized whenever they come into contact with the health service. If they
have missed the opportunity of being immunized during their earlier visits,
then you should immunize them. You will learn how to give immunizations
in Study Session 4.
Sometimes some children are not given the vaccine at the right time because
they have a contraindication — a medical reason for not giving the vaccine
either temporarily or permanently, such as a serious illness or high-grade
fever (38.5ºC or above). Contraindications are described in Study Sessions 2,
3 and 7. However, very few children have genuine reasons for not
vaccinating them at all. Immunization should not be missed if the child has a
mild illness.

Tracing defaulters
Have you come across children who started the immunization programme,
but have not completed the schedule? These children are still at risk of
vaccine-preventable diseases. It is therefore essential to keep a proper
registration system of vaccinations, and to establish a community network for
tracing defaulters — i.e. people who fail to complete a course of
immunization or treatment. You will learn about EPI registration and
defaulter tracing in Study Session 8 and a system for identifying them in
Study Session 10.

1.4.5 Improve public awareness and community participation


in immunization programmes
In the EPI, you are expected to improve public awareness through intensive,
regular social mobilisation and health education campaigns, in order to:
. maximise participation of community members in EPI activities
. increase public demands for immunization and the vitamin A supplements
that are routinely given to infants during the immunization programme.
The techniques for involving the whole community are described in the
Module on Health Education, Advocacy and Community Mobilisation.
It is very important to involve the whole community, including political and
religious leaders, through seminars, public meetings and direct contacts. You
should aim to work with and fully utilise women’s groups, youth associations
and idirs (self-help associations at village level), so that they support and
help to promote the immunization service (see Study Session 9).

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Study Session 1 Immunity, Vaccines and the Expanded Programme on Immunization

1.4.6 Ensure prompt reporting and improved control of


vaccine-preventable diseases
Reporting formats for immediately reportable and weekly reportable cases of
priority diseases are in Study Session 41 of the Communicable Diseases
Module, Part 4.
It is a key part of your role to identify cases of vaccine-preventable diseases,
such as measles, polio, neonatal tetanus and bacterial pneumonia and
meningitis, and report them to your supervising Health Centre, who will
report to the District (woreda) Health Office. Control of these diseases is
largely the result of effective immunization campaigns achieving high
immunization coverage rates, and the isolation and treatment of people who
are infected, to reduce the risk of infection spreading into the susceptible
population.

1.5 Your role in achieving the goals of the EPI


Your role as a Health Extension Practitioner is to lead the following
activities, based on the national EPI recommendations:
. Take every opportunity to identify and immunize all eligible children.
. Ensure all eligible children attending the Health Post are immunized
according to the recommended schedules.
. Make immunization services routinely available at convenient times for
mothers, ideally every day.
. Involve the community in the schedule for outreach immunization
sessions, so that you cover the target population within the target period.
There are five key operations that you need to undertake to run an EPI
service efficiently and effectively, which are summarised in Box 1.2. You will
learn about these key operations in detail in later study sessions in this
Module.

Box 1.2 Five key operations for an effective


immunization service

1 Service delivery: involves strategies and activities in giving safe


and timely vaccinations.
2 Logistics: includes delivery of vaccines and necessary equipment
to the site of use, transport, management of the ‘cold chain’ and
safe waste disposal.
3 Vaccine supply and quality: includes forecasting of vaccine needs,
procurement, monitoring of vaccine usage rates and vaccine safety.
4 Disease surveillance: involves monitoring of disease incidence,
record keeping and reporting (see the Communicable Diseases
Module, Study Sessions 39 to 41).
5 Advocacy and communication: consists of social mobilisation,
advocacy, community education on immunization and vaccination
programme promotion.

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The diagram on the left of Figure 1.5 summarises the five operational
components listed in Box 1.2, and the diagram on the right reminds you that
in order to achieve them there must also be:
. sustainable financing
. management
. strengthening human and institutional resources.

Figure 1.5 (left) The five key immunization operations, and (right) the three
additional requirements for achieving an effective immunization service.
In the next two study sessions, you will learn the details of the antibacterial
and antiviral vaccines used in the EPI in Ethiopia.

Summary of Study Session 1


In Study Session 1, you have learned that:
1 Immunization is beneficial and effective in the prevention of disease,
death and disability from vaccine-preventable diseases. Worldwide, more
than 2.5 million childhood deaths are prevented by immunization each
year.
2 The vaccine activates the immune system to produce antibodies and
memory cells, which identify and attack infectious agents used in making
the vaccine if the live organisms get into the body in the future.
3 Immunity is the state of being resistant to a particular infection; it can be
naturally or artificially acquired, either as active or passive immunity.
4 Immunization of over 80% of the population gives protection to the
susceptible population in a community through herd immunity to vaccine-
preventable diseases that are transmitted from person to person.
5 Vaccines can be prepared as live-attenuated or killed (inactivated)
vaccines, or as sub-unit, recombinant or conjugate vaccines.
6 The vaccine-preventable diseases targeted in the Expanded Programme on
Immunization (EPI) in Ethiopia are: tuberculosis (TB), poliomyelitis
(polio), diphtheria, pertussis (whooping cough), tetanus, measles,
pneumonia and meningitis caused by Haemophilus influenzae type b
bacteria; pneumonia and other infections caused by Streptococcus
pneumoniae bacteria; and hepatitis B diseases of the liver and diarrhoeal
disease caused by rotaviruses.
7 To achieve the objectives of the EPI, you have an important role in
implementing the national strategies to increase and sustain high
immunization coverage, increase the quality of the immunization service,
reduce missed vaccinations and trace defaulters, improve public awareness

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Study Session 1 Immunity, Vaccines and the Expanded Programme on Immunization

and community participation in immunization programmes, and ensure


prompt reporting and improved control of vaccine-preventable diseases.
8 Immunization activities consist of five key operational components:
service delivery, logistics, vaccine supply and quality, disease surveillance,
advocacy and communication. In addition, sustainable financing, effective
management and strong human and institutional resources are also
required.

Self-Assessment Questions for Study Session 1


Now that you have completed this study session, you can assess how well
you have achieved its Learning Outcomes by answering these questions.
Write your answers in your Study Diary and discuss them with your Tutor at
the next Study Support Meeting. You can check your answers with the Notes
on the Self-Assessment Questions at the end of this Module.
SAQ 1.1 (tests Learning Outcomes 1.1 and 1.2)
When the immunization coverage rate is high, the herd immunity of a
community is increased. Explain what this means and how everyone in
the community benefits from it — including people who are not immune
— in the case of a disease like measles, which is transmitted from
person to person.

SAQ 1.2 (tests Learning Outcomes 1.1 and 1.2)


You see a breastfed baby who appears to be immune to measles, even
though he has not been vaccinated. His older brother has measles, but
the baby has not developed the illness. How can this happen, and what
is this type of immunity called?

SAQ 1.3 (tests Learning Outcomes 1.1, 1.2 and 1.3)


(a) What type of vaccine is the diphtheria component of the pentavalent
vaccine?
(b) Explain how immunization with the pentavalent vaccine gives
protection from diphtheria.
(c) What is this type of immunity called?

SAQ 1.4 (tests Learning Outcome 1.4)


The EPI was started many years ago, but it did not reach its original
target of increasing the immunization coverage rate by 10% every year.
The EPI has drawn up strategies to improve the immunization service in
Ethiopia. How can you help to implement these strategies?

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16
Study Session 2 Antibacterial Vaccines

Study Session 2 Antibacterial Vaccines


Introduction
You learned about the main vaccine-preventable bacterial diseases in Study
Session 3 of the Communicable Diseases Module, Part 1.
The most effective way of reducing the major vaccine-preventable diseases is
to maintain a high level of immunization in the whole population, using the
routine Expanded Programme on Immunization (EPI) vaccines. In this study
session, you will learn about the antibacterial vaccines that are approved for
routine use in Ethiopia for preventing some common bacterial diseases, and
the storage, dosages and schedules for immunization with these vaccines.
This study session will also help you to give clear information about
vaccination to the people in your community, including the importance of
giving the vaccines as scheduled to their children – even though it makes
them cry for a short time (Figure 2.1). Reassure parents about the low risk of
adverse events following immunization (AEFIs) and how to manage vaccine
reactions if they occur.
As you learned in Study Session 1, contraindication — in the context of
immunization — means a medical reason for not giving the vaccine, either
temporarily or permanently. Note that children with a mild illness should still
be immunized at the scheduled time. Contraindications, such as a high-grade
Figure 2.1 Immunization saves
fever (38.5oC or above), mean you should refer the child to a health centre
millions of children’s lives.
and wait until they recover before giving the missed vaccine dose. Specific (Photo: AMREF Ethiopia/
contraindications for each vaccine are given in the sections that follow. Demissew Bizuwork)

Learning Outcomes for Study Session 2


When you have studied this session, you should be able to:
2.1 Define and use correctly all of the key words printed in bold.
(SAQs 2.1 and 2.5)
2.2 Describe the antibacterial vaccines included in the Expanded
Programme on Immunization (EPI) in Ethiopia. (SAQs 2.1, 2.2 and 2.4)
2.3 Describe the storage, dosages and schedules of the antibacterial EPI
vaccines. (SAQs 2.1 and 2.2)
2.4 Describe the possible adverse events following immunization with the
antibacterial EPI vaccines and how you manage them at Health Post level.
(SAQs 2.3 and 2.4)
2.5 Describe the contraindications that mean you should not immunize a
child with one of the antibacterial EPI vaccines. (SAQs 2.3 and 2.5)

2.1 BCG vaccine


2.1.1 What is BCG?
Tuberculosis diagnosis and treatment is fully described in Study Sessions 13
to 17 in the Communicable Diseases Module, Part 2.
You have already learned about the different types of vaccines in Study
Session 1. BCG is a live-attenuated antibacterial vaccine that protects against
severe forms of tuberculosis in infants and young children. Tuberculosis
(TB) is a disease caused by the bacterium Mycobacterium tuberculosis. It

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usually attacks the lungs, but can also affect other parts of the body,
including the bones, joints and brain. The letters, B, C and G stand for
Bacillus of Calmette and Guerin.
Bacillus describes the rod shape of the tuberculosis bacteria; Calmette and
Guerin are the names of the people who developed the vaccine.
■ What does a live-attenuated antibacterial vaccine mean?

□ Bacteria in the vaccine are alive, but they have been weakened
(attenuated) in the laboratory so that they cannot cause the disease.

2.1.2 Effectiveness of BCG vaccine


The effectiveness of a vaccine means its capability to protect vaccinated
people from the disease that immunization aims to prevent. In the case of
BCG vaccine, the effectiveness is highly variable — protection from TB
ranges from 0–80% of those who are vaccinated. This means that some
vaccinated individuals may not be protected against TB at all, and up to 80%
of the others will receive some protection. The strongest reason for
vaccinating with BCG is that it protects young children against developing
the more serious forms of tuberculosis, such as TB meningitis (affecting the
brain), TB in both lungs and extra-pulmonary TB (affecting other organs).

2.1.3 BCG vaccine storage, dosage and immunization


schedule
BCG vaccine is a freeze-dried powder, supplied in small glass bottles called
ampoules. Vaccines that come as powders must be mixed with a liquid called
a diluent. This process is known as reconstitution, which means thoroughly
mixing the powder with the diluent to activate the vaccine before it can be
administered. Before use, you must reconstitute BCG vaccine powder with
the appropriate diluent supplied for this purpose, using a mixing syringe to
mix the diluent with the powder in the ampoule. You will learn how to do
this in Study Session 4.

BCG storage
BCG vaccine can be also affected and damaged by heat and light, so it
should be stored between +2°C and +8°C. The vaccine powder may be frozen
for long-term storage, but the diluent and the reconstituted vaccine must
never be frozen. Since BCG vaccine is easily destroyed by sunlight, the vials
containing the vaccine powder are mostly made from black or brown glass.
Some other vaccines which are supplied as powders can stay in good
condition for a long time in a refrigerator and are not spoiled as long as they
remain dry. But BCG vaccine can be spoiled and lose its strength in a very
short time. Also, since other harmful bacteria can grow in the reconstituted
BCG vaccine, it should be used within six hours of mixing the powder with
the diluent. If there is any leftover reconstituted BCG vaccine, it should be
thrown away in the correct medical waste container at the end of the
immunization session.

BCG dosage and schedule


The recommended injection dose for newborns and infants under one year is
0.05 ml, containing 0.05 mg of BCG vaccine powder which has been
reconstituted with 0.05 ml of the specific diluent supplied with the vaccine.

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Study Session 2 Antibacterial Vaccines

For children aged over one year, the dose is twice this amount — 0.1 ml
containing 0.1 mg of BCG vaccine powder.
How to give an intradermal injection and other vaccination routes are
described in detail in Study Session 4 of this Module.
BCG vaccine is given at birth or as soon as possible thereafter. The vaccine
is given intradermally (into the top layer of the skin) in the right upper arm
in Ethiopia. This is so the injection site can be inspected later.
Table 2.1 summarises the characteristics of the BCG vaccine. The only
reason for not giving the BCG vaccine is if the newborn has symptoms of
HIV-disease, which may include a high-grade fever. You will learn more
about routes of administration and cold storage of all the common vaccines,
including BCG, in Study Sessions 4 and 6 of this Module.
Table 2.1 Summary of BCG vaccine characteristics.

Category Description
Type of vaccine Live-attenuated antibacterial vaccine
Number of doses One
Schedule At birth, or as soon as possible after birth. If not given at birth, it is
better to give within the first three months, when the infant is at greatest
risk of developing the most severe forms of TB, such as TB meningitis.
Immunization is generally ineffective at older ages.
Booster (additional dose) None
Contraindications Babies or infants showing symptoms of HIV infection
Adverse events Study Session 7 discusses AEFIs, adverse events following immunization,
more generally.

Mild normal reaction (swelling, small sore). Rarely, severe reaction,


e.g. local abscess, or swelling of glands (lymph nodes)
Special precautions Correct intradermal administration is essential. A special syringe and
needle is used for the administration of BCG vaccine (described in Study
Session 4)
Dosage BCG vaccine is given in the right arm in Ethiopia, but in the left arm in
some other countries.

Infants aged under one year, give 0.05 mg of BCG vaccine powder
reconstituted in 0.05 ml of diluent; over one year, give 0.1 mg in 0.1 ml
of diluent
Injection site Outer upper right arm or shoulder. Routes of administration are described
in Study Session 4
Injection type Intradermal (into the top layer of skin). Types of injection are described
in Study Session 4
Storage Store between +2°C and +8°C. BCG vaccine powder may be frozen for
long-term storage, but the diluent and reconstituted vaccine must never be
frozen. Discard any reconstituted vaccine after no more than six hours.
Vaccine storage is described in Study Session 6

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2.1.4 Adverse events following BCG immunization and how


to treat them
Adverse events may occasionally occur after immunization, in addition to the
desired protective effect. They can include swelling and tenderness at the
injection site. For BCG immunization, the normal reaction is a small raised
swelling, which immediately appears at the injection site (Figure 2.2). This
usually disappears within 30 minutes.

Figure 2.2 A small raised swelling can be seen at the site of an intradermal
BCG injection. (Photo: AMREF Ethiopia/Demissew Bizuwork)
After approximately two weeks, a small red sore normally develops at the
injection site, which is about 10 mm in diameter (the size of the unsharpened
end of a pencil). The sore remains for about another two weeks and then
heals, leaving a small scar about 5 mm across (Figure 2.3). This is a sign that
the child has been effectively immunized. If there is no scar at the injection
site six weeks after a BCG immunization, the injection must be repeated. If
there is still no skin reaction to the second injection, the child should be
referred to a higher-level health facility.

Figure 2.3 (a) The small sore at the injection site is a sign that the child has
been effectively immunized with BCG vaccine. (b) A healed BCG vaccination
scar on the arm of an adult. (Photos: supplied by Dr Kalid Asrat and Dr Basiro
Davey)
Occasionally, there is an abnormal adverse event following BCG
immunization, such as swelling of glands in the armpit, or rarely the
formation of an abscess at the injection site (Figure 2.4).
An abscess is a collection of pus and inflamed tissue at the site of bacterial
infection. It can be due to bacterial causes other than BCG.

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Study Session 2 Antibacterial Vaccines

Figure 2.4 An abscess is a rare adverse event following BCG immunization.


This one is about 1.5 cm in diameter, but they can be larger. (Photo: supplied by
Dr Kalid Asrat)
Abnormal adverse events following BCG vaccination may occur because:
. an unsterile needle or syringe was used
. too much vaccine was injected
. the vaccine was injected too deeply under the skin, instead of into its top
layer.
Table 2.2 summarises the adverse events that may occur following BCG
immunization and how you can treat them at Health Post level.
Table 2.2 Adverse events following BCG immunization and their management.

Adverse events Management Comments


Small sore at the site of Keep dry and clean (do Will heal naturally to
injection after two weeks, not put any ointment on leave a small scar
which may last two weeks the sore or give the child
any medicine)
Swollen glands (lymph Surgical or drug treatment Refer the child to a health
nodes) in the armpit may occasionally be centre
required at a health centre
Abscess at the injection Amoxicillin syrup is an Refer the child urgently to
site antibiotic preparation used the next higher health
to treat bacterial facility
infections, which is
available at Health Post
level.

Amoxicillin syrup orally


three times daily.

2.1.5 Who should not get BCG vaccine?


The only contraindications for BCG immunization are symptoms of HIV
infection. These include chronic lung infection, tuberculosis, persistent
diarrhoea and other serious symptoms of HIV-related diseases, as described in
the Communicable Diseases Module, Part 3.

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2.2 Pentavalent vaccine


2.2.1 What is pentavalent vaccine?
A vaccine that contains five different antigens in one combined preparation is
called a pentavalent vaccine (‘penta’ comes from the Greek word for five).
You do not need to remember these details, but the pentavalent vaccine in
common use in Ethiopia is a combination of one inactivated whole-cell
vaccine (against pertussis bacteria), two sub-unit vaccines (the diphtheria and
tetanus toxoids), one conjugate vaccine (against Haemophilus influenza type
b bacteria) and one recombinant vaccine (against hepatitis B virus). Thus, the
pentavalent vaccine used in Ethiopia in the EPI combines five different
vaccines in one injection to protect against four bacterial diseases: diphtheria,
tetanus, pertussis and Haemophilus influenzae type b (often abbreviated to
Hib), and one viral disease caused by hepatitis B viruses. It is a fully liquid
vaccine, which comes in a single dose vial.
Sometimes you will see the pentavalent vaccine used in Ethiopia described as
DPT-HepB-Hib vaccine. This is the term used in the IMNCI Module in this
curriculum.
■ What is an inactivated antibacterial vaccine?

□ It consists of bacteria that have been killed so that they cannot cause the
disease.

■ What is a toxoid?

□ It is a modified version of the toxin (harmful protein) produced by


certain bacteria, including those causing diphtheria and tetanus. The
toxoid is used in vaccines to immunize against the disease.

2.2.2 The anti-bacterial components of pentavalent vaccine


Three of the antibacterial components in the pentavalent vaccine used
routinely in the EPI in Ethiopia are known as DPT (diphtheria-pertussis-
tetanus), referring to the three bacterial diseases they prevent. In Ethiopia,
DPT is only given in the pentavalent vaccine, but some other countries give
DPT as a separate injection. The fourth antibacterial component of the
Ethiopian pentavalent vaccine is called Hib, which stands for Haemophilus
influenzae type b. These four components are described below.

Diphtheria toxoid
Diphtheria toxoid is a sub-unit antibacterial vaccine, made from the modified
toxin (poison) produced by the bacteria Corynebacterium diphtheriae. The
vaccine protects against diphtheria, a serious bacterial infection causing a
sore throat, high fever and serious complications which can be fatal. It has
become rare in Ethiopia and most other countries where infants are routinely
vaccinated against it.

Pertussis vaccine
Pertussis vaccine is an inactivated antibacterial vaccine, which contains killed
whole bacterial cells. It protects against pertussis (also known as whooping
cough), a highly contagious, acute respiratory infection caused by the bacteria
Bordetella pertussis.

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Study Session 2 Antibacterial Vaccines

Tetanus toxoid (TT)


Tetanus toxoid (TT) is a sub-unit antibacterial vaccine, made from the
modified toxin produced by the bacteria Clostridium tetani. Tetanus is a
disease that is acquired through exposure to the spores of these bacteria,
which are universally present in the soil. TT vaccine is also given on its own
as a ‘booster’ to women of childbearing age, and we will say more about this
in Section 2.4.

Haemophilus influenzae type b (Hib)


Hib vaccine is a conjugate antibacterial vaccine, which protects against
pneumonia and meningitis caused by the bacteria Haemophilus influenzae
type b. These bacteria are the most common cause of bacterial meningitis in
children under five years of age in countries where Hib vaccine is not
routinely given to all infants. Meningitis refers to severe infection of the
membranes surrounding the brain and spinal cord, which can rapidly lead to
high fever, paralysis and death. Haemophilus influenzae type b bacteria are
also the second most common cause of bacterial pneumonia in children. (In
Section 2.3 you will learn about the vaccine that protects against
Streptococcus pneumoniae, the most common cause of bacterial pneumonia in
children.) Pneumonia is a severe infection in the lungs, which causes the air
sacs to fill with fluid and pus; this makes breathing painful and difficult, and
reduces the oxygen getting into the body. Note that Hib vaccine only
protects against diseases caused by type b Haemophilus influenzae bacteria
(there are other types), and it does not prevent pneumonia or meningitis
caused by other infectious agents.
The fifth component of the pentavalent vaccine used in the EPI in Ethiopia
protects against the viruses that cause hepatitis B liver disease; we will
describe it in Study Session 3, together with the other antiviral vaccines in
the Ethiopian EPI.

2.2.3 Storage, dosage and schedule of pentavalent vaccine


Pentavalent vaccine comes in single-dose glass bottles called vials, which
should be stored at between +2°C and +8°C. It should never be frozen, or
allowed to become warmer than +8°C, as this will destroy its effectiveness.
If it is allowed to stand for a long time, fine particles settle to the bottom of
the vial leaving a cloudy liquid above them. This is normal. Shake the vial to
mix the vaccine with the liquid before using it.
Three doses of 0.5 ml each are given intramuscularly (IM, into the muscle) of
the upper outer part of the left thigh, before injecting pneumococcal vaccine
(PCV10) in the right thigh (see Section 2.3.1). The injections are given to
infants at the age of 6, 10 and 14 weeks. If an infant misses a scheduled
dose, give it as soon as possible and complete the series of three doses —
there is no need to start the series of doses over again. Pentavalent vaccine is
usually not given after 6 years of age because there is an increased risk of
adverse reactions in older children.
The characteristics of immunization with pentavalent vaccine are summarised
in Table 2.3.

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Table 2.3 Summary of pentavalent immunization characteristics in the Ethiopian EPI.

Category Description
Type of vaccine Five different antigens combined, including one inactivated whole-cell
vaccine, two sub-unit vaccines (toxoids), one conjugate vaccine and one
recombinant vaccine
Number of doses Three (referred to as Penta1, Penta2 and Penta3)
Schedule At 6, 10 and 14 weeks of age
Booster None in males; boosters of tetanus toxoid vaccine are given to women of
(additional doses) childbearing age
Contraindications Severe allergic reaction or encephalopathy to a previous pentavalent
immunization (see Section 2.2.5)
Adverse events Mild local reactions are common (see Section 2.2.5); rarely, injection-site
abscess
Special precautions Usually not given after six years of age because of the increased risk of
serious adverse reactions
Dosage 0.5 ml
Injection site Upper outer left thigh. Injection sites are described in Study Session 4
Injection type Intramuscular (IM). Types of injection are described in Study Session 4
Storage Store between +2°C and +8°C. Never freeze. Storage of vaccines is
described in Study Session 6

2.2.4 Effectiveness of pentavalent vaccine


On average, 78–95% of individuals who have received three vaccine doses
will normally be protected against all five diseases covered by the pentavalent
vaccine. This means that in every 100 people who receive three doses, on
average, between 78–95 of these individuals will be protected against all five
diseases.

2.2.5 Adverse events following pentavalent immunization


and how to treat them
The possible adverse events following immunization with pentavalent vaccine
are generally mild: serious reactions are very rare (see Section 2.2.6). The
mild reactions are:
. Soreness. Some children may develop mild soreness, redness, or swelling
at the injection site, but this will go away within 1–3 days.
. Fever. Some children may develop a mild fever (a temperature of around
37.3oC to 38.4oC, measured with a thermometer in the child’s armpit, is
termed a low-grade fever). It should disappear within a day. Fever that
begins more than 24 hours after a pentavalent injection is unlikely to be a
reaction to the vaccine and should be investigated.
. Crying for more than three hours, mostly because of pain, occurs in up to
1% of infants.
A serious but rare adverse event is an abscess, which may develop a week or
more after immunization (Figure 2.5), usually because an unsterile needle or
syringe was used, or the vaccine was not correctly injected into the muscle.
The management of these adverse events at Health Post level is summarised
in Table 2.4.

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Study Session 2 Antibacterial Vaccines

Table 2.4 Management of adverse events following immunization with pentavalent


vaccine at Health Post level.

Adverse event Management Comments


Low-grade fever Paracetamol syrup, 5 ml as Will usually disappear
(37.3oC to 38.4oC) required, up to a maximum within a day
of four doses
Pain and soreness at the Paracetamol as above; Will usually disappear
injection site warm compress (a warm within a day
cloth or another warm Figure 2.5 An abscess caused
material) applied under by an unsterile needle or
pressure to the sore area of syringe, or incorrectly
skin and held in place for administered pentavalent
some time vaccination. (Source: WHO,
1998, Immunization in Practice,
Abscess at the injection Amoxicillin syrup orally Refer the child urgently to
Module 2, EPI Vaccines,
site three times daily the next higher health
Figure 2-C, p.8)
facility

2.2.6 Who should not get pentavalent vaccine?


Do not give another dose of the pentavalent vaccine if a child develops any
of these severe reactions to the first dose:
. Severe allergic reaction (doctors call it anaphylaxis), which includes
severe rash, breathing difficulty, signs of shock, weak and rapid pulse,
dizziness or fainting. A child who develops a severe
reaction to the first vaccination
. Encephalopathy, (Enchephalopathy is pronounced ‘en-seff-ah-lopp-ah- should be referred to a higher
thee’) which is a disease of the brain that presents with coma, decreased level health facility immediately.
level of consciousness and/or prolonged convulsions, occuring within
seven days of a pentavalent vaccination, and where the symptoms are not
due to another identifiable cause.

2.3 Pneumococcal vaccine (PCV10)


Next we describe a new antibacterial vaccine that is being introduced into the
routine EPI in Ethiopia.
Pneumococcal infections are described in the Communicable Diseases
Module, Part 4, Study Session 35.
Pneumococcal vaccines (PCVs) protect against pneumonia and other
pneumococcal infections caused by Streptococcus pneumoniae bacteria. These
bacteria can attack different parts of the body, causing serious infections in
the lungs (pneumonia), the inner ear (acute otitis media), the bloodstream
(bacteraemia), and the membranes covering the brain and spinal cord
(meningitis). The WHO estimates that up to one million children die of
pneumococcal infections every year, mainly in sub-Saharan Africa and South
East Asia. In Ethiopia, pneumonia is the leading cause of death among
children under five years, accounting for 28% of all deaths in this age group.
The Streptococcus pneumoniae bacteria exist in many different ‘strains’.
Several different conjugate pneumococcal vaccines have been developed to
give protection against different subsets of these strains. The vaccine that is
being introduced in Ethiopia as part of the EPI is called PCV10, also known
by its brand name Synflorix. PCV10 is highly effective at preventing

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infections caused by the strains of Streptococcus pneumoniae bacteria


included in the vaccine preparation.

2.3.1 Storage, dosage and schedule of PCV10


PCV10 is a freeze-sensitive vaccine, which must be stored in the refrigerator
between +2oC to +8oC. You should keep the vials on the same shelf of the
refrigerator as the vials of pentavalent vaccine because they are given to
infants at the same immunization session. The liquid PCV10 does not contain
any preservative, so once you have opened a vial, any unused vaccine should
be discarded after six hours and not returned to the refrigerator.
The vaccination schedule for PCV10 (Synflorix) is the same as for the
pentavalent vaccine: three doses are given at 6, 10 and 14 weeks of age by
intramuscular (IM) injection into the right outer upper thigh muscle (the
opposite thigh to the pentavalent vaccine). The dosage for each vaccination
with PCV10 is 0.5 ml. The vaccine is a liquid that comes in two-dose vials.
Any child who presents to a health facility for vaccination who is aged less
than one year old is eligible to receive PCV10 vaccine if they missed the
primary series of doses at 6, 10 and 14 weeks. Children should receive all
three doses of PCV10 by their first birthday, but if a child starts their first
dose of PCV10 at the age of 11 months, they should complete the remaining
two doses at intervals of four weeks. Table 2.5 shows the schedule for
PCV10 immunizations for children who have already started the series of
pentavalent vaccine doses.
Table 2.5 PCV10 vaccination schedule for children who have received 0 or 1-3 pentavalent vaccine doses. (FMOH,
June 2011, Introduction of Pneumococcal Conjugate Vaccine in Ethiopia: A Reference Handbook for Health Extension
Workers, p.8)

Vaccination status if infant aged less than At first contact Subsequent contact – Subsequent contact –
one year at time of PCV10 introduction after 4 weeks after 4 more weeks
Never received any Penta Penta1 + PCV1 Penta2 + PCV2 Penta3 + PCV3
Already received Penta1 Penta2 + PCV1 Penta3 + PCV2 PCV3
Already received Penta2 Penta3 + PCV1 PCV2 PCV3
Already received Penta3 PCV1 PCV2 PCV3

2.3.2 Adverse events and contraindications of PCV10


Mild local reactions (redness, pain and slight swelling at the injection site)
and/or mild fever and irritability of the child may occur in one-third to
one-half of the infants vaccinated with PCV10, but these reactions usually
disappear within 24 hours. Manage these mild reactions as described earlier
Refer all cases of severe vaccine in Table 2.4 for pentavalent vaccine. Rare severe reactions to the vaccine
reactions urgently. include convulsions, severe allergic reaction (anaphylaxis), swollen lymph
glands and encephalitis.
The contraindications for PCV10 are the same as for pentavalent vaccine: do
not give PCV10 to an infant who comes to you with a high-grade fever, or
who developed a severe vaccine reaction after a previous dose. However, you
should vaccinate infants with PCV10 if they only have a mild illness, such as
a common cold or low-grade fever.

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Study Session 2 Antibacterial Vaccines

2.4 Tetanus toxoid (TT) vaccine


2.4.1 What is tetanus toxoid vaccine?
The same tetanus toxoid (TT) vaccine that is given to infants in the
pentavalent vaccine is also given on its own, as a single vaccine, to women
of childbearing age (Figure 2.6). The vaccine is a cloudy liquid, and the
powder can settle to the bottom of the vial if it is left to stand for a long
time. Shake the vial to mix the vaccine powder and liquid before use.

Figure 2.6 These women are of childbearing age and should be immunized with
TT vaccine to protect them and their babies from tetanus. (Photo: AMREF
Ethiopia)
■ From your reading of Study Session 1, how do you think immunizing
women against tetanus also prevents tetanus in their newborn babies?

□ Neonatal tetanus is a major cause of death in newborns; it is described


in detail in Study Session 3 of the Communicable Diseases Module, Part
1. The antibodies that form in the mother’s body in response to the
vaccine pass across the placenta and get into the fetus; they give
‘passive’ protection against tetanus to the baby during the birth and for
the first few months of life.

2.4.2 Schedule, dosage, storage and effectiveness of


TT vaccine
If given as a separate vaccine to pregnant and non-pregnant women of
childbearing age, at least two doses of 0.5 ml of TT vaccine are given
intramuscularly (IM) into the upper arm (Figure 2.7 on the next page); but
for maximum long-lasting protection throughout the childbearing years
women should receive more than two doses (TT2+), and the ideal is to give
five doses. It should be stored at between +2oC and +8oC and never frozen.
Table 2.6 summarises the characteristics of TT vaccine; the periods of
protection after each dose are given in Table 2.7.

Figure 2.7 Make sure all pregnant women are immunized against tetanus.

Table 2.6 Summary of tetanus toxoid (TT) vaccine characteristics in women.

Category Description
Type of vaccine Toxoid (sub-unit vaccine)

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Number of doses Women: at least two doses – ideally five (see


Table 2.7)
Schedule Women: first dose at first contact during childbearing
years, or as early as possible in pregnancy (then see
Table 2.7)
Booster Every 10 years during childbearing years
Contraindications Severe allergic reaction to a previous dose, or
encephalopathy
Adverse events Paracetamol can be given to treat mild reactions, but
avoid giving any medication to pregnant women.

Mild reactions, e.g. low-grade fever, soreness, redness


and pain at the injection site: usually disappears after
1–3 days.
Dosage 0.5 ml
Injection site Women: outer upper arm
Injection type Intramuscular (IM)
Storage Store between +2°C and +8°C. Never freeze

Table 2.7 Duration of protection in women following 1–5 doses of TT vaccine.

Dose When given Duration of protection


(0.5ml)
TT1 At first contact with women of childbearing age, or as early as No protection
possible in the pregnancy
TT2 At least 4 weeks after TT1 3 years
TT3 At least 6 months after TT2 5 years
TT4 At least 1 year after TT3 10 years
TT5 At least 1 year after TT4 All childbearing years

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Study Session 2 Antibacterial Vaccines

2.4.3 Adverse events and contraindications of TT vaccine


The possible adverse events following immunization of women with TT
vaccine are usually mild: low-grade fever, and soreness/pain at the injection
site (see Table 2.6 above), which can be treated with paracetamol in women
who are not already pregnant. Women of child-bearing age who developed a
severe allergic reaction or encephalopathy to a previous dose of TT vaccine
should not be given TT again.

2.5 Meningococcal vaccines


Finally, we refer to the meningococcal vaccines which are in common use in
some countries. Although not yet routinely available in the EPI in Ethiopia,
these vaccines are used to control outbreaks of meningitis caused by the
Neisseria meningitides bacteria, which occur in at least six different types.
Types A, B, C, Y, W135 and X cause most cases of meningococcal
meningitis. Quadrivalent vaccines (containing the antigens of four of these
types) are available in the USA, and a vaccine specifically designed for
Africa is being used in the countries with the highest burden of
meningococcal meningitis.

2.6 In conclusion
Table 2.8 summarises the antibacterial vaccines in the Expanded Programme
on Immunization (EPI) in Ethiopia. In Study Session 3, we will turn our
attention to the antiviral vaccines in the EPI.
Table 2.8 Summary of antibacterial vaccines in the current EPI in Ethiopia.

Vaccine Protects against Doses/when Route


BCG Tuberculosis One: at or soon after birth Intradermal, outer upper right
arm
Pentavalent Diphtheria, pertussis, tetanus, Hib Three: at 6, 10 and 14 weeks Intramuscular, outer upper
vaccine disease and hepatitis B left thigh
TT Tetanus At least two: ideally three to five Intramuscular, outer upper
in women of childbearing age arm
PCV10 Pneumonia caused by some Three: at 6, 10 and 14 weeks Intramuscular, outer upper
Streptococcus pneumoniae strains right thigh

Summary of Study Session 2


In Study Session 2, you have learned that:
1 The most effective way to protect people from the common vaccine-
preventable diseases is to maintain a high level of immunization with the
vaccines in the routine Expanded Programme on Immunization (EPI).
2 The common EPI antibacterial vaccines used in Ethiopia are: BCG, which
protects children against the most serious effects of tuberculosis (TB); a
pentavalent vaccine, which protects against diphtheria, pertussis, tetanus,
cases of meningitis and pneumonia caused by Haemophilus influenzae
type b, and hepatitis B liver disease; and PCV10, which protects against
pneumonia and some other infections caused by specific strains of
Streptococcus pneumoniae bacteria.

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3 At least two doses of TT vaccine (and ideally five) should also be given
to pregnant women and women of childbearing age to protect them and
their newborns from tetanus.
4 A meningococcal vaccine is available to control outbreaks of meningitis
caused by Neisseria meningitides bacteria; it is not a routine EPI vaccine.
5 To guarantee long-term protection, all doses of the routine antibacterial
vaccines in the EPI should be given. A child who misses a vaccination
should be given the missed dose as soon as possible and complete any
remaining doses at the scheduled time.
6 The EPI antibacterial vaccines are very effective and safe for infants, and
TT vaccine is safe for women of childbearing age and during pregnancy.
Adverse events following immunization are usually mild, e.g. low-grade
fever and soreness at the injection site, which can easily be managed;
serious adverse events are extremely rare.
7 Infants with minor illnesses may be immunized safely. But if they are
suffering from a high fever (38.5oC or above), they should be referred to
a health centre; delay the immunization until after they recover. Other
contraindications are HIV disease, severe allergic reaction or
encephalopathy following a previous dose of a vaccine.

Self-Assessment Questions (SAQs) for Study


Session 2
Now that you have completed this study session, you can assess how well
you have achieved its Learning Outcomes by answering these questions.
Write your answers in your Study Diary and discuss them with your Tutor at
the next Study Support Meeting. You can check your answers with the Notes
on the Self-Assessment Questions at the end of this Module.
SAQ 2.1 (tests Learning Outcomes 2.1, 2.2 and 2.3)
Which of the following statements is false? In each case, say what is
incorrect.
A All the antibacterial vaccines in the EPI in Ethiopia are injected
intramuscularly in the outer upper arm.
B All of the antibacterial EPI vaccines will lose their effectiveness
if they become frozen.
C If five doses of TT vaccine are given to a woman of childbearing
age at the correct intervals, she will receive the fifth dose at least 2
years and 7 months after the first dose.
D Most infants who are immunized with three doses of pentavalent
vaccine at the correct intervals will be protected against diphtheria,
pertussis and tetanus.
E BCG vaccine is supplied as a powder which has to be mixed with
a special diluent to activate the vaccine before use.
F If a vial of pentavalent vaccine has a deposit like fine sand at the
bottom, you should throw it away.

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Study Session 2 Antibacterial Vaccines

SAQ 2.2 (tests Learning Outcomes 2.2 and 2.3)


Read Case Study 2.1 and then answer the question that follows it.

Case Study 2.1 Birke’s story


Birke is two months’ pregnant with her first baby. She is at the antenatal
clinic and hears Nurse Ayele telling a group of women about neonatal
tetanus, a disease that causes death in newborn babies. Nurse Ayele
talks about the injection that women can get to protect themselves and
their babies. Birke asks for the injection.
‘I am sorry,’ says Nurse Ayele, ‘I can’t give you tetanus toxoid now. It’s
too early in your pregnancy and it might harm the baby.’
Birke is surprised. She says: ‘My friend told me that the health workers
in Dembi Health Post give these injections to every woman the first
time she goes to the antenatal care clinic, even if she is only one month
pregnant. They say it is not dangerous.’

. Who is following the correct procedure: Nurse Ayele or the health


workers in Dembi Health Post?

SAQ 2.3 (tests Learning Outcomes 2.4 and 2.5)


Complete Table 2.9 by filling in the management of the adverse events
listed.
Table 2.9 Adverse events following immunization with antibacterial vaccines and
their management at Health Post level.

Adverse event Managment


Low-grade fever
Soreness at the injection site
Abscess at the injection site
Swollen lymph glands
Severe allergic reaction (rash, breathing difficulty, rapid
pulse, dizziness or fainting)
Coma and/or convulsions

SAQ 2.4 (tests Learning Outcomes 2.2 and 2.4)


The mother of a 10-day-old infant visited your Health Post. She told
you that her baby has a small sore on her right upper arm following a
vaccination given immediately after the birth. What would you tell the
mother?

SAQ 2.5 (tests Learning Outcomes 2.1 and 2.5)


What should you do if an infant is brought to you for routine EPI
immunization at 14 weeks and you find that he or she has a temperature
of 39oC? Is this a contraindication for vaccination?

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Study Session 3 Antiviral Vaccines

Study Session 3 Antiviral Vaccines


Introduction
In this study session, you will learn about the antiviral vaccines that are in
common use for preventing viral diseases in most developing countries,
including Ethiopia, and the recommended dosages and schedules for
immunization with these vaccines. There are many other antiviral vaccines
available in the world that are not widely used in developing countries, so we
will concentrate here on the common antiviral vaccines available for the
Expanded Programme on Immunization (EPI) in Ethiopia. These are hepatitis
B (HepB) vaccine, oral polio vaccine (OPV) and measles vaccine. You will
also be reminded about the need to give vitamin A supplements at the same
time as the measles vaccine, and to children who present to you with
measles. Then we describe one of the newer antiviral vaccines against
rotavirus, which is being added to the EPI. Finally, we mention yellow fever
vaccine, which is not in the EPI but may be required for travel abroad.
Studying this session will enable you to give clear information to the people
in your community about the value of immunizing their children with these
vaccines, which prevent long-term disability and save many millions of lives.
You will be able to tell parents that these vaccines are very safe, and any
adverse events following immunization are almost always very mild and
easily treated. We will also describe the contraindications that mean you
should not immunize a child, either temporarily or permanently.
To guarantee long-term protection, all doses of the antiviral EPI vaccines
should be given. If a child misses the scheduled date for an immunization, he
or she should be given the missed dose as soon as possible. There is no need
to re-start the immunization schedule.

Learning Outcomes for Study Session 3


When you have studied this session, you should be able to:
3.1 Define and use correctly all of the key words printed in bold.
(SAQ 3.1)
3.2 Describe the common antiviral vaccines available in the Expanded
Programme on Immunization (EPI) in Ethiopia, and the new rotavirus
vaccine that will become available soon. (SAQ 3.2)
3.3 Describe the storage, dosages and schedules of the common antiviral
EPI vaccines, and the dosage of vitamin A given routinely with measles
vaccine or to children with measles. (SAQs 3.2, 3.3 and 3.4)
3.4 Describe the possible adverse events following immunization with the
antiviral EPI vaccines and how you manage them at Health Post level.
(SAQ 3.3)
3.5 Describe the contraindications for the antiviral EPI vaccines.
(SAQ 3.5)

3.1 Hepatitis B vaccine (HepB)


3.1.1 What is HepB vaccine?
Hepatitis B diseases are discussed in Study Session 4 of the Communicable
Diseases Module, Part 1.

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Hepatitis B (HepB) vaccine protects against the hepatitis B diseases, which


affect the liver and are caused by hepatitis B viruses. If a child is infected
with hepatitis B viruses, liver disease may develop many years later in adult
life. In Ethiopia, HepB vaccine is routinely given to infants as one of the five
vaccines combined in the pentavalent vaccine (which also protects against
diphtheria, pertussis, tetanus and Haemophilus influenzae type b). The four
antibacterial vaccines in the pentavalent vaccine used in Ethiopia were
described in Study Session 2.
■ HepB vaccine is a recombinant vaccine. What does this mean?

□ A recombinant vaccine is produced by inserting genetic material from a


disease-causing infectious agent into harmless cells in the laboratory.
The cells with the new genes begin to manufacture the unique antigens
that identify the infectious agent. These antigens are then purified and
used in the vaccine.

HepB vaccine is also available on its own as a single vaccine, which may be
given to healthworkers as a ‘booster’ to increase their protection against
infection by bloodborne hepatitis B viruses from patients. The vaccination
schedule in adults is not the same as the schedule you already know for
infants, who receive HepB vaccine as part of the pentavalent vaccine in the
Ethiopian EPI.
■ How many doses and at what ages should infants receive pentavalent
vaccine containing HepB vaccine? What is the route of administration?

□ They should receive three doses of pentavalent vaccine at the age of 6,


10 and 14 weeks, as you learned in Study Session 2. The route of
administration is by intramuscular injection into the left outer upper
thigh muscle.

The HepB component of the pentavalent vaccine is very safe and effective:
up to 95% of infants who receive all three doses of pentavalent vaccine are
protected against hepatitis B virus infection. The contraindications are the
same as already described for pentavalent vaccine: infants with a high-grade
fever should not be vaccinated until they recover. An infant who develops a
severe allergic reaction, swollen lymph glands or encephalopathy to a
previous dose of pentavalent vaccine should not be given another dose.
■ Do you remember the storage conditions for pentavalent vaccine
containing HepB vaccine and the four antibacterial vaccines?

□ The vaccine vials should be stored in a refrigerator at between +2oC and


+8oC, and never frozen.

3.2 Oral polio vaccine (OPV)


3.2.1 What is OPV?
You will learn more about the oral administration of vaccines in Study
Session 4.
Oral polio vaccine (OPV) is made from live-attenuated polioviruses (note
that ‘poliovirus’ is all one word). OPV is a light red or light yellow liquid
supplied in vials that either have droppers as caps, or they come with
separate glass droppers. The vaccine is given by putting two drops into the
child’s mouth (Figure 3.1).

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Study Session 3 Antiviral Vaccines

Poliomyelitis is described in Study Session 4 of the Communicable


Diseases Module, Part 1. It has been eliminated by vaccination in
many countries and the WHO aims to eradicate it from the world.
OPV gives protection against the three types of polioviruses (types
1, 2 and 3) that cause poliomyelitis (polio) — a crippling disease of
the brain and spinal cord.
■ What is the crippling effect of polio called? And what does this
mean?

□ It is called acute flaccid paralysis (AFP), which is the sudden


onset of severe weakening or loss of muscle tone in the legs, Figure 3.1 A child receiving oral polio
arms or hands. vaccine drops. (Photo: UNICEF Ethiopia/
Indrias Getachew)
Note that the vaccine used for routine immunizations in the EPI is
not the only type of OPV available. Other types may be issued to
control outbreaks of polio if they occur, but are not used for routine
protection of infants; these vaccines should be returned to the central store
after the supplementary immunization campaign.

3.2.2 Storage, dosage, schedule and effectiveness of OPV


Store OPV between +2°C and +8°C; but it may be frozen for long-term
storage.
Four doses are given, each of two drops. OPV should be given at birth,
6 weeks, 10 weeks and 14 weeks of age. The interval between all doses must
be at least four weeks. The birth dose is known as OPV0; the subsequent
doses are referred to as OPV1 (at 6 weeks), OPV2 (at 10 weeks), and OPV3
(at 14 weeks).
You should not give OPV0 (the birth dose) to an infant who is more than 14
days old. If this dose has not been given by 14 days, miss this dose and wait
until the child is six weeks old, and then give OPV1. You should also give
the first doses of the other routine EPI vaccines, including PCV10, at six
weeks. The remaining doses should be given as scheduled at 10 and 14
weeks.
If a child spits out the vaccine drops, or vomits immediately after a dose of
OPV, it is quite safe to repeat the dose. You should still give the scheduled
dose even if a child has diarrhoea at the time; give OPV as usual, but
administer an extra (fifth) dose at least four weeks after he or she has
received the final dose in the schedule. Ninety-nine per cent of those who are
vaccinated with four doses of OPV are protected from polio for life, but
during campaigns children are often given additional boosters of OPV to
ensure high herd immunity.

3.2.3 Contraindications of OPV and adverse events


OPV is a very safe vaccine and there is no contraindication to prevent giving
it. Serious adverse reactions to OPV are very rare: acute flaccid paralysis has
been reported in approximately one child in every 1–10 million children who
have been vaccinated with OPV. Table 3.1 summarises what you should know
about OPV.

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Table 3.1 Summary of oral polio vaccine (OPV) immunization characteristics.

Category Description
Type of vaccine Live-attenuated antiviral vaccine
Number of doses Four (referred to as OPV0, OPV1, OPV2 and
OPV3), plus campaign doses
Schedule At birth, 6, 10 and 14 weeks
Additional dose If the child spits or vomits after OPV, repeat the
dose immediately; if the child has diarrhoea, give a
fifth dose at least 4 weeks after the scheduled fourth
dose
Contraindications None
Adverse events Very rarely AFP; refer immediately to a health
centre
Special precautions None
Dosage 2 drops
Administration route Into the mouth (oral)
Storage Store between +2°C and +8°C (may be frozen for
long-term storage)

■ What should you do if a baby vomits immediately after being given the
oral polio vaccine?

□ You should repeat the dose immediately; it is quite safe to give the baby
an extra dose of OPV.

3.3 Measles vaccine


3.3.1 What is measles vaccine?
Measles is discussed in Study Session 4 of the Communicable Diseases
Module, Part 1.
Measles vaccine is made from live-attenuated virus and is supplied as a
powder that has to be reconstituted with (dissolved in) the special diluent
provided to use with it. You will learn about vaccine reconstitution in detail
in Study Session 4.
Measles is a highly infectious disease caused by a virus that weakens the
immune system, leaving children susceptible to other dangerous childhood
infections. The common signs and symptoms of measles are a red skin rash,
runny nose and conjunctivitis (Figure 3.2).

Figure 3.2 (a) Measles rash covering the whole body of a child; (b)
Conjunctivitis (red, watery eyes) caused by measles. (Photos: WHO and
Ethiopian Federal Ministry of Health, 2005, Case Definition of Measles)

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Study Session 3 Antiviral Vaccines

■ Measles vaccine is a live-attenuated vaccine. What does this mean?

□ You learnt about different types of vaccine in Study Session 1,


Section 1.3.
It means it has been made from measles viruses that have been
weakened in the laboratory so that they cannot cause the disease. But
they are still immunogenic, which means they activate the immune
system of the vaccinated person to produce immunity against measles
viruses if encountered in the future.

3.3.2 Storage, dosage and schedule of measles vaccine


The vials containing the dry measles vaccine powder can be frozen for long-
term storage, but after reconstitution with the correct diluent, measles vaccine
should be kept at between +2°C and +8°C, and never frozen. Any remaining
reconstituted vaccine must be thrown away after six hours, or at the end of
the immunization session, whichever comes first.
One dose of 0.5 ml of measles vaccine is injected subcutaneously (into the
fatty layer below the skin and above the muscle) in the outer upper arm as
soon as possible after nine months of age. Waiting this long is advisable
because the maternal antibodies against measles that are transferred to the
unborn baby before birth last longer in the blood of the baby than other
antibodies. As a result, immunization with measles vaccine is often not
effective before nine months of age. The aim in the EPI in Ethiopia is to give
measles vaccine to all children at nine months of age. To achieve high-level
population immunity, a second dose is ideally given after 12 months of age
during supplementary immunization activities.
■ What are antibodies and how can maternal antibodies help in combating
measles?

□ You learnt about antibodies in Study Session 1.


Antibodies are specialized proteins that circulate in the blood and other
body fluids. They are produced by B cells in the immune system. They
identify foreign antigens, such as those found on infectious agents
(e.g. the measles virus), and neutralise them so they are unable to cause
disease. Maternal antibodies are those produced by the mother when she
is vaccinated, which are transmitted passively to the fetus across the
placenta, or to her baby in her breastmilk. Maternal antibodies directed
against measles viruses will protect the infant from measles in the first
few months of his or her life.

In special situations, for instance in measles outbreaks, in emergencies such


as in refugee camps with high measles transmission, or among HIV-infected
children, an ‘early’ extra dose of measles vaccine may be given at six
months. If a child has received measles vaccine before nine months of age, a
second dose should be administered at nine months, or as soon as possible
afterwards. All children should ideally receive a supplementary dose of
measles vaccine after 12 months of age as part of measles elimination
campaigns.

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3.3.3 Effectiveness of measles vaccine


Measles vaccine is highly effective at preventing measles; 85% of infants
who are immunized at 9 months are protected from measles for the rest of
their lives; vaccine efficacy rises to 95% after a second dose after 12 months
of age. In the year 2000 there were an estimated 750,000 deaths from
measles worldwide. By 2008, vaccination campaigns had succeeded in
reducing this number by 75%. The World Health Organization (WHO)
estimated that in 2008 around 83% of the world’s children were receiving one
dose of measles vaccine by their first birthday.

3.3.4 Contraindications for measles vaccine, adverse events


and how to manage them
In around 20% of children, a mild fever lasting one to three days may occur
approximately one week after immunization. A few children (less than 5%)
develop a mild rash. Injection-site abscess or severe allergic reactions
including rash, breathing difficulty and fainting occur very rarely. Table 3.2
Children who develop a severe gives a summary of the possible adverse events following measles
allergic reaction should be vaccination and how to manage them.
referred immediately to a health
centre, and should not be given Table 3.2 Management of adverse events following immunization with measles
measles vaccine again. vaccine.

Adverse event Management Comments


Low-grade fever Give paracetamol syrup Usually lasts 1 to 3 days
Slight rash (5 ml) up to 4 doses
Abscess at injection site Amoxicillin syrup orally Refer urgently to a higher
three times daily health facility
Severe rash, breathing Do not give measles Refer the child to a health
difficulty, loss of vaccine again centre immediately
consciousness

Table 3.3 summarises what you should know about measles vaccine.
Table 3.3 Summary of measles vaccine immunization characteristics.

Category Description
Type of vaccine Live-attenuated antiviral vaccine
Number of doses One in routine EPI schedule, plus one in
supplementary campaigns
Schedule At 9 months in the EPI; after 12 months in
campaigns
Additional early dose At 6 months in some circumstances (see
Section 3.3.2)
Contraindications Severe allergic reaction to previous dose
Adverse events Fever, rash and (rarely) severe allergic reaction or
abscess (see Section 3.3.4)
Special precautions None
Dosage 0.5 ml
Injection site Outer upper arm
Injection type Subcutaneous
Storage Store between +2°C and +8°C (Note: the vaccine
powder may be frozen for long-term storage, but not
the diluent or the reconstituted vaccine)

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Study Session 3 Antiviral Vaccines

3.3.5 Vitamin A supplements and measles prevention


It is important to know that in countries such as Ethiopia where vitamin A
deficiency frequently occurs among children, vitamin A should be given
routinely every six months. If a child has not previously received a vitamin A
supplement, it should be given at the same time as the measles vaccine. This
is because measles increases the risk of blindness due to vitamin A
deficiency. Signs of vitamin A deficiency are white spots on the sclera (white
part of the eye) and clouding of the cornea (the thin tissue covering the black
centre of the eye and the coloured parts around it). In severe cases, blindness
results.
Vitamin A is supplied in capsules of 100,000 IU (international units, which is
the standard measurement for vitamin doses). Each capsule has a nipple at
one end. The drops are given by cutting across the middle of the nipple with
scissors and immediately squeezing the drops into the child’s mouth
(Figure 3.3). Vitamin A drops are also given in Child Health Days to ensure Do not put the vitamin A capsule
the dose is repeated every six months, until the child reaches five years. into the child’s mouth, or allow
the child to swallow the capsule.

Figure 3.3 A child receiving vitamin A drops at a scheduled immunization clinic


where he will also receive measles vaccine. (Photo: UNICEF Ethiopia/Indrias
Getachew)

The routine dose of vitamin A for a child aged 6–11 months is the drops
from one capsule (100,000 IU); the drops from two capsules (200,000 IU) are
given to children aged 12–59 months at regular intervals, every six months.
This ensures that all children are fully protected from the harmful effects of
vitamin A deficiency.

Vitamin A for children with measles


What should you do if you see a child who has already developed measles?
Do not give vitamin A drops if the child has received a dose within the last
month. But if a child with measles has not recently received a vitamin A
supplement, give the vitamin A treatment dosages summarised in Table 3.4
on the next page. The second dose should be given 24 hours after the first
dose.

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Table 3.4 Vitamin A treatment dosages for children with measles in different age-
groups.

Age Immediately on After 24 Follow-up


diagnosis hours
Infants less than 6 50,000 IU 50,000 IU Third dose given two to
months old four weeks later if there are
Infants aged 6–11 100,000 IU 100,000 still signs of vitamin A
months IU deficiency
Children aged 12 200,000 IU 200,000
months and over IU

3.4 Rotavirus vaccine


Rotavirus vaccine is one of the new antiviral vaccines that should soon
become available as part of the routine EPI in Ethiopia. Rotaviruses are the
leading cause of severe diarrhoeal disease and dehydration among children in
many developed and developing countries. The WHO estimates that 20% of
child deaths under five years from diarrhoeal diseases worldwide are due to
rotavirus infection — most of them in countries like Ethiopia. Globally, more
than 125 million cases and up to 610,000 deaths annually are due to rotavirus
diarrhoea.

3.4.1 Dosage and schedule of rotavirus vaccine (RotarixTM)


Two new live-attenuated rotavirus vaccines have been licensed for use in
routine immunization programmes. They are both given orally to infants as
drops into the mouth. The vaccine chosen for the EPI in Ethiopia is known
by its brand name RotarixTM. It is a liquid suspension vaccine, supplied in
single-dose ‘squeeze-tube’ vials.
RotarixTM is given in two oral doses, each of 1.5 ml, at the following time
intervals:
. First dose at 6 weeks of age, but no later than 12 weeks
. Second dose at least 4 weeks after the first dose
. The two-dose schedule should be completed by 16 weeks, but no later
than by 24 weeks of age.
Note that the ideal schedule is to give the first dose of RotarixTM to all
infants at 6 weeks of age at the same time as giving Penta1 and OPV1, and
give the second dose at 10 weeks at the same time as Penta2 and OPV2.

3.4.2 Storage and effectiveness of RotarixTM


RotarixTM is a freeze-sensitive vaccine that must be stored in the refrigerator
at a temperature of between +2oC to +8oC. It is a very safe vaccine, which
provides 90–100% protection from severe rotavirus disease to fully
immunized infants, and 74–85% protection against rotavirus diarrhoea of any
severity.
You will receive instructions on the contraindications for giving rotavirus
vaccine, and the management of possible adverse events following
immunization, when RotarixTM is introduced into the EPI in Ethiopia.

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Study Session 3 Antiviral Vaccines

3.5 Yellow fever vaccine


Finally, we will briefly mention an antiviral vaccine that is not part of the
routine EPI in Ethiopia, but is given in certain circumstances. Yellow fever
vaccine is a live-attenuated antiviral vaccine, supplied as a powder which
must be reconstituted with the appropriate diluent before use. It is not
included in the national EPI in Ethiopia because the risk is very low, but it is
given to people who want to travel abroad to countries like Kenya and
Uganda where yellow fever is endemic. Some countries (like the USA and
South Africa) require a current yellow fever vaccination certificate as a
condition of entry from Ethiopia. Yellow fever is a viral vector-borne disease,
transmitted by certain species of mosquitoes when they take a blood meal.
Infection can result in a high fever, nausea and internal bleeding leading to
shock, and in extreme cases, death.
■ Yellow fever vaccine is a live-attenuated vaccine. Which other antiviral
vaccines of this type have you already learnt about in this study session?

□ Measles vaccine and OPV are also live-attenuated vaccines.

Mild reactions to yellow fever vaccine occur occasionally and include


headache, muscle pain or low-grade fever.

3.6 In conclusion
Table 3.5 summarises the current and forthcoming antiviral EPI vaccines in
Ethiopia.
Table 3.5 Summary of antiviral vaccines in the EPI in Ethiopia.

Vaccine Protects Doses/when Route


against
HepB Hepatitis B Three: at 6, 10 and 14 weeks, Intramuscular, upper
in the pentavalent vaccine outer left thigh
OPV Poliomyelitis Four: at birth, then at 6, 10 Oral (drops into the
and 14 weeks (additional mouth)
campaign doses may be given)
Measles Measles One: at 9 months, or as soon Subcutaneous, outer
as possible thereafter (plus one upper arm
additional campaign dose)
Rotavirus Rotavirus Two: at 6 and 10 weeks (but Oral (drops into the
diarrhoea first dose no later than 12 mouth)
weeks, second dose no later
than 24 weeks, with an
interval of at least 4 weeks
between doses)

Summary of Study Session 3


In Study Session 3, you have learned that:
1 The common antiviral vaccines in the EPI in Ethiopia are hepatitis B
(HepB) vaccine, which is given in the pentavalent vaccine, oral polio
vaccine (OPV) and measles vaccine. A rotavirus vaccine (RotarixTM) to
protect against diarrhoea and dehydration caused by rotaviruses will
become part of the EPI soon.

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2 To guarantee long-term protection, all recommended doses of the antiviral


vaccines should be given. If a child misses the scheduled date for an
immunization, the child should be given the missed dose as soon as
possible. There is no need to restart the immunization schedule.
3 The antiviral EPI vaccines are very effective and safe for children, and
any adverse events following immunization are usually mild and easily
managed; serious adverse events are extremely rare.
4 There are no contraindications to prevent giving the oral polio vaccine; if
a child vomits a dose, give a replacement dose immediately; if the child
has diarrhoea at the time of vaccination, give a fifth dose at least 4 weeks
after the scheduled fourth dose.
5 Contraindications for the other antiviral vaccines are high-grade fever, or
a severe allergic reaction or encephalopathy following a previous dose.
6 Vitamin A drops should be routinely given at the same time as measles
vaccine, or if a child presents with measles, to reduce the risk of eye
damage which can be serious enough to cause blindness.
7 Yellow fever vaccine is not part of the EPI in Ethiopia, but may be
required by travellers going abroad to certain countries.

Self-Assessment Questions (SAQs) for Study


Session 3
Now that you have completed this study session you can assess how well you
have achieved its Learning Outcomes by answering the following questions.
Some of the question test the Learning Outcomes for Study Session 2, as
well as those for Study Session 3. Write your answers in your Study Diary
and discuss them with your Tutor at the next Study Support Meeting. You
can check your answers with the notes on the Self-Assessment Questions at
the end of this Module.
SAQ 3.1 (tests Learning Outcomes 2.1, 2.2, 3.1 and 3.2)
Classify each of the following vaccines as either antibacterial or
antiviral (or both) by putting crosses in the appropriate columns of
Table 3.6. Write the name of the diseases or conditions that each
vaccine prevents in the last column of the table.
Table 3.6 Antibacterial and antiviral vaccine characteristics.

Vaccine Antibacterial Antiviral Protects against


BCG vaccine
Measles vaccine
Pentavalent vaccine
Yellow fever vaccine
Pneumococcal vaccine (PCV10)
OPV
TT vaccine
Meningococcal vaccine
Rotavirus vaccine

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Study Session 3 Antiviral Vaccines

SAQ 3.2 (tests Learning Outcome 3.3)


Summarise the dosage, route of administration and schedule for each of
the current antiviral EPI vaccines used in Ethiopia by completing
Table 3.7.
Table 3.7 Summary of dosage, route and schedule for antiviral EPI vaccines.

Vaccine Dosage and route Schedule


HepB (as part of pentavalent vaccine)

OPV

Measles

SAQ 3.3 (tests Learning Outcome 3.4)


Complete Table 3.8 to indicate the possible adverse events following
immunization with OPV and measles vaccines, and their management at
Health Post level.
Table 3.8 Adverse events following OPV and measles immunization, and their
management.

Vaccine Adverse events Management


OPV

Measles

SAQ 3.4 (tests Learning Outcomes 2.3 and 3.3)


What immunizations (if any) should the following children be given?
Assume that rotavirus vaccine has not yet been introduced.
(a) A newborn baby.
(b) A ten-month-old child who has had BCG, OPV3, PCV3 and Penta3.
(c) An eight-month-old child who has had BCG, OPV3, PCV3 and
Penta3.
(d) A six-week-old child who has had BCG and OPV0.

SAQ 3.5 (tests Learning Outcomes 2.5 and 3.5)


Fatima’s grandmother brings her to your Health Post when she is ten
weeks old for OPV2, PCV2 and Penta2. Three days later, Fatima
becomes very ill and develops a severe allergic reaction. After a brief
period of hospitalisation, she recovers fully. When Fatima is 14 weeks
old, her grandmother brings her to see you at an immunization clinic.
She has a mild episode of diarrhoea at the time.
(a) What vaccines (if any) should you give Fatima?
(b) What should you explain to Fatima’s grandmother?

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Study Session 4 Vaccine Preparation and Administration Routes of the EPI Vaccines

Study Session 4 Vaccine Preparation and


Administration Routes of the EPI Vaccines
Introduction
In this study session you will learn how to prepare the EPI vaccines used in
Ethiopia, which were described in Study Sessions 2 and 3. Some vaccines
come as fully prepared liquids for injection or administering by drops into the
mouth. Other vaccines comes as powders that have to be reconstituted —
mixed with a special liquid (a diluent) before they can be used. We will teach
you how to do this and about the safe handling of needles and syringes for
injecting vaccines.
Appropriate vaccine administration and safe vaccination practices are both
very important for vaccine effectiveness. The recommended site, route and
dosage for each vaccine are based on research and practical experience. In
the final sections of this study session you will learn about the correct routes
of administration for each of the EPI vaccines, together with instructions for
positioning the child or adult client. The four administration routes are:
. Intradermal (ID): the vaccine is injected into the top layers of the skin.
. Subcutaneous (SC): the vaccine is injected into the fatty tissue below the
skin and above the muscle.
. Intramuscular (IM): the vaccine is injected into the muscle.
. Oral: the vaccine is given by drops into the mouth.

Learning Outcomes for Study Session 4


When you have studied this session, you should be able to:
4.1 Define and use correctly all of the key words printed in bold.
(SAQs 4.1 and 4.3)
4.2 Summarise the standard precautions to minimise the risk of infection
or injury when handling vaccines, diluents and injection equipment.
(SAQs 4.2 and 4.3)
4.3 Describe how to reconstitute BCG and measles vaccines with the
correct diluent before administration. (SAQs 4.1 and 4.3)
4.4 Describe the correct route of administration for each of the injectable
EPI vaccines. (SAQs 4.1 and 4.3)
4.5 Describe the correct preparation and administration of oral polio
vaccine (OPV). (SAQ 4.5)

4.1 Preparing to give injectable vaccines


In this section, you will learn about the necessary steps before administration
of the injectable EPI vaccines in routine use in Ethiopia.

4.1.1 Standard procedures for giving safe injections


First, you should always follow the standard procedures (also known as
universal precautions) for preventing infection and injury when you are
giving an injection.

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■ What standard procedures should you take before giving an injection?


Standard procedures are described in several parts of this curriculum,
including the Antenatal Care, Labour and Delivery Care, and
Communicable Diseases Modules.

□ You should:

. Wash your hands thoroughly with soap and water, and allow them to ‘air
dry’.
. Prepare all the equipment you need and lay it out on a clean tray that has
been swabbed with antiseptic solution.
. Organise your equipment to minimise the risk of injury from needles and
broken glass.
. Make sure there is a safety box nearby for the safe disposal of used
syringes and needles (Figure 4.1).
Figure 4.1 A standard safety . Make sure that children are securely held by someone they know and
box. (Photo: Basiro Davey) trust, in the correct position to enable you to give the injection
(Figure 4.2). You cannot hold the child because you need both hands to
give the injection.

Figure 4.2 The mother or another caregiver should hold the child securely like
this. (Source: WHO, 2004, Immunization in Practice, Manual 4, Ensuring Safe
Injections, Figure 4-D)
. The skin at the site of the injection should be swabbed clean with an
appropriate antiseptic solution. After giving the injection, press a clean
cotton swab onto the site until all bleeding stops.
You will learn about these and other immunization safety issues in more
detail in Study Session 7.

4.1.2 Preparing injection equipment


Careful preparation before giving an immunization is very important, and
includes selection of the correct syringes and needles.

Syringe selection
A separate syringe should be used for each injection. BCG vaccine should be
injected using a 0.1 ml syringe; for all other EPI vaccines, use a 1 ml
syringe. Disposable syringes are supplied in sterile plastic packages and are

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Study Session 4 Vaccine Preparation and Administration Routes of the EPI Vaccines

designed to be used once only and then put into a safety box. The safest type
recommended by the World Health Organization is the auto-disable (AD)
syringe (Figure 4.3). This has the needle already attached and a plunger
mechanism that prevents the syringe from being used a second time. If the
syringe and needle are supplied separately, when you remove a syringe from
its package, take care not to touch the syringe adapter shown in Figure 4.4.

Figure 4.3 Auto-disable 1 ml syringes, supplied with


needles already attached. (Photo: Basiro Davey)

Needle selection
The needle used should be of the appropriate diameter for the vaccine.
Typically, vaccines are not very thick liquids, and therefore a fine needle size
of 22–26 gauge (outer diameter) can be used. A new needle and syringe is
used for each injection. Note that for vaccines that need to be reconstituted
with diluent before use, you should use a separate ‘mixing’ syringe and
needle (like those shown in Figure 4.4) for reconstitution. Use a new auto-
disable (AD) syringe and needle to inject the client.

Figure 4.4 Parts of a syringe and a hollow needle, showing the areas that should
not be touched. (Source: Adapted from WHO, 2004, Immunization in Practice,
Module 4, Ensuring Safe Injections, Figures 4-B and 4-C)
Figure 4.4 shows the parts of a needle — none of which should be touched.
Open the protective wrapping around the needle and remove it without
touching the adaptor. The needle is inside a plastic outer case. Holding the
needle by the outer case, push the needle adapter onto the syringe adapter
until they ‘lock’ together firmly.
Vaccine reconstitution is taught in the next section. Diluents were introduced
in Study Session 2.

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4.1.3 Inspecting vials and ampoules of vaccines and diluents


Vaccines and diluents are supplied in either a vial or an ampoule. A vial is a
glass bottle with a thin rubber membrane across the top, which is held in
place by a metal or plastic cap (Figure 4.5a). An ampoule is a sealed sterile
glass or plastic bottle with a thin ‘neck’ (Figure 4.5b). The ampoule has to be
broken open at the neck before the vaccine (or diluent) can be withdrawn.
Note that some injectable vaccines are supplied in single-dose vials, and
some contain more than one dose. You will learn how to use multi-dose vials
in Study Session 7.
Vaccines (e.g. BCG) that are sensitive to light are supplied in dark glass vials
or ampoules.

Figure 4.5 (a) Vials. (b) Ampoules, with a metal file to ‘scratch and break’ the
neck of the ampoule. (Source: WHO, 1998, Immunization in Practice, Module 7,
During a Session: Preparing Vaccines, Figures 7-M and 7-I)
Vials and ampoules should be carefully inspected for damage or
contamination prior to use. The expiry date printed on the vial or ampoule,
or the box they came in, should be checked. The expiry date gives the last
day of the month that the vaccine or diluent can be used, unless otherwise
stated on the package labelling. Expired vaccines and diluents should never
be used. You will learn more about stock control to avoid wastage in Study
Session 5.
Check the vaccine vial monitor (VVM), which is a label that changes colour
when the vaccine vial has been exposed to heat over a period of time. The
VVM enables you to check if the vaccine has not passed the discard point
due to heat exposure. It cannot tell you if the vaccine has been damaged by
freezing. You will learn more about this, and other components of the ‘cold
chain’ for preserving vaccines, in Study Session 6.
■ What is the correct temperature for storing vaccines supplied as liquids?

□ It is between +2oC and +8oC, as you learned in Study Sessions 2 and 3.

4.1.4 Reconstituting BCG and measles vaccines with diluent


Reconstitution is the process of mixing vaccines that come as powders with
the diluent provided with the vaccine. This section will also explain how to
open vials and ampoules. BCG and measles vaccines are the two routine EPI
vaccines that require reconstitution, following the steps below:
It is very important to
reconstitute a powder vaccine
using only the diluent provided by
1 Wash your hands and organise your equipment and work area
the manufacturer specifically for Wash your hands with clean water and soap and follow the standard
that vaccine procedures outlined in Section 4.1. Your aim is to minimise the risk of
infection or injury to yourself, your clients and their caregivers.

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Study Session 4 Vaccine Preparation and Administration Routes of the EPI Vaccines

2 Inspect the vaccine vial or ampoule


Measles vaccine powder (and most fully liquid vaccines) come in vials, but
BCG vaccine powder comes in ampoules. Check that the vial or ampoule is
not cracked. Check the vaccine vial monitor (VVM) and the expiry date as
described above, and discard any vaccines that are no longer safe to use.

3 Tap the vial or ampoule


To make sure that all of the vaccine powder is at the bottom of the vial or
ampoule, tap it with your finger. Figure 4.6 (left arrow) The
centre of the metal cap has
4 Open the vaccine vial been bent back and removed;
(right arrow) the plastic stopper
The centre of the metal cap on a vaccine vial is pre-cut so that it can be has been removed. (Source:
removed easily. Lift the centre of the metal cap and bend it back, using a WHO, 1998, Immunization in
metal file. Some vials have plastic stoppers instead of metal caps. Flip off the Practice, Module 8, During a
stopper with your thumb. When the cap or stopper is removed, it reveals the Session: Giving Immunizations,
rubber membrane on top of the vial, protecting the vaccine (Figure 4.6). How p.4)
to open an ampoule of BCG vaccine is described in step 6.

5 Inspect the diluent


Most diluents for reconstituting vaccines come in sealed ampoules, which you
open by breaking off their pointed tops. Check that the ampoule is not
cracked and that it has been chilled to between +2ºC and +8ºC before use.
Make sure that you are using the diluent the manufacturer sent with the
vaccine, and that the expiry date has not passed. Each vaccine has its own
diluent and must not be reconstituted with anything else. Deaths have
resulted when vaccines were incorrectly mixed with liquids other than the
specific diluent approved by the manufacturer for use with the vaccine.
Even if the main ingredient of the diluent is sterile normal saline or sterile
water, you must never use normal saline or water instead of the correct
diluent.

6 Open the ampoule of diluent


The process for opening an ampoule of BCG vaccine is exactly the same as
for opening an ampoule of diluent.
Hold the ampoule between your thumb and middle finger, and use your index
finger to support the top (Figure 4.7a on the next page). Use the metal file
packed with the ampoules to scratch hard around the neck of the ampoule.
Wrap the ampoule in a piece of clean cloth and gently break off the top. It
breaks where you made the scratch (Figure 4.7b on the next page). If you
injure your hand while doing this, discard the ampoule because the diluent
may have become contaminated. Cover the wound before opening a new
ampoule.

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Figure 4.7 (a) Scratching and (b) breaking the neck of an ampoule.
(Source: WHO, 2004, Immunization in Practice, Module 6, Holding an
Immunization Session, p.16)

7 Draw diluent into the mixing syringe


Use a new disposable mixing syringe (0.1 ml for BCG and 1 ml for other
vaccines) attached to an appropriate-sized needle. Hold the ampoule at an
angle (as shown in Figure 4.8), and put the needle into the open top. Pull
back the plunger to draw all the diluent from the ampoule into the syringe.

Figure 4.8 Withdrawing diluent from an ampoule. (Source: WHO, 2004, as in


Figure 4.7, p.16)

8 Reconstitute the vaccine


Insert the needle of the mixing syringe through the rubber membrane on top
of the vaccine vial, or (for BCG) into the open neck of the vaccine ampoule
(Figure 4.9). Push the syringe plunger in with your thumb to empty the
diluent into the vaccine vial or ampoule, where it begins to mix with the
vaccine powder. Draw them both up slowly into the syringe and inject them
back slowly into the vial or ampoule. Repeat this mixing step several times
until the vaccine powder is thoroughly mixed with the diluent.
Discard the mixing syringe and needle in a safety box and use new ones for
the immunization. Ideally, you should use an auto-disable (AD) syringe for
the immunization.

9 Keep reconstituted vaccines cold


Place the vial or ampoule of reconstituted vaccine into the spaces in the foam
pad (a piece of soft foam that fits on top of the ice-packs; Figure 4.10) to
keep it cold during your immunization session. You will learn more about the
Figure 4.9 Adding diluent to a use of foam pads and ice-packs in Study Session 6.
vaccine ampoule. (Source:
WHO, 2004, as in Figure 4.7,
p.17)

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Study Session 4 Vaccine Preparation and Administration Routes of the EPI Vaccines

Figure 4.10 The foam pad on top of the ice-packs in a vaccine carrier.
(Photo: Janet Haresnape)

10 Do not keep unused reconstituted vaccine


Unused reconstituted vaccine must be administered within the time limit
stated by the manufacturer (usually six hours). Any unused vaccine should be
thrown away after six hours, or at the end of the immunization session if you
finish before the time limit has passed.
■ Why should you throw away reconstituted vaccines after an
immunization session is completed?

□ Reconstituted vaccines lose their potency (strength) quickly. As you


learned in Study Sessions 2 and 3, reconstituted BCG vaccine is quickly
damaged by sunlight and heat, and reconstituted measles vaccine is also
damaged by heat.

4.2 Routes of immunization for injectable


vaccines
In this section you will learn about the routes of administration for the
injectable EPI vaccines. The injection routes are either intradermal (ID),
subcutaneous (SC) or intramuscular (IM). Figure 4.11 shows the correct
needle position for each of these routes. In all cases, you should follow the
standard procedures for reducing the risk of infection and injury
(Section 4.1).

Figure 4.11 Needle positions for intradermal, subcutaneous and intramuscular


injections. (Source: WHO, 2001, Immunization in Practice, Module 2, EPI
Vaccines, Figure 2-G, p.21)

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4.2.1 Intradermal immunization with BCG vaccine


Intradermal (ID) means within or between the layers of the skin (dermis).
BCG vaccine is the only EPI vaccine which is given intradermally. BCG
vaccine should be reconstituted with the appropriate diluent before
administration, as described in Section 4.2 above.
Swab the outer surface of the child’s outer upper right arm with antiseptic
solution and allow it to dry. Select a sterile 0.1 ml syringe with a 26 gauge
needle (Figure 4.12) and draw 0.05 ml of the reconstituted BCG vaccine into
the syringe. Hold the syringe with the needle pointing upwards and tap the
syringe so any air bubbles float to the top of the barrel. Gently push the
plunger just enough to expel the air through the needle — you should see a
tiny drop of vaccine emerging from the tip of the needle. This ensures that
you do not inject air into the child’s skin. Make sure the vaccine dose is
exactly 0.05 ml by checking the scale on the barrel of the syringe.

Figure 4.12 The 0.1 ml syringe and 26 gauge needle used for BCG
immunizations. (Source: WHO, 1998, Immunization in Practice, Module 8,
During a Session: Giving Immunizations, Figure 8-A)
Ideally you should use auto-disable (AD) syringes with needles attached.
■ Why should you use a 0.1 ml syringe to inject BCG vaccine and a 1 ml
syringe for all other injected EPI vaccines?

□ The dose of BCG vaccine is very small – only 0.05 ml. In order to
measure and inject such a small dose accurately you must use a 0.1 ml
syringe. All other injected vaccines are given in doses of 0.5 ml, so you
should use a 1 ml syringe.

Inject the recommended dose of 0.05 ml of reconstituted BCG vaccine into


the most superficial layers of the skin (intradermally) in the upper right arm.
You should insert the tip of the needle just under the skin by inserting the
bevel and a little bit more of the needle into the skin, while keeping the bevel
facing upwards (Figures 4.13). The syringe should be lying along the child’s
arm (Figure 4.14.)

Figure 4.13 Needle position for intradermal injection of BCG vaccine. (Source:
WHO, 2001, Immunization in Practice, Module 2, EPI Vaccines, Figure 2-A)

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Study Session 4 Vaccine Preparation and Administration Routes of the EPI Vaccines

Figure 4.14 Correct position of the 0.1 ml syringe and needle for BCG
immunization. (Photo: AMREF Ethiopia/Demissew Bizuwork)
The reason for injecting the vaccine in the same place (upper right arm) for
each child is to make it easy to find the BCG scar subsequently. This enables
you to check that the immunization has been effective. If the child does not
develop a sore at the injection site, which heals to form a small scar (see
Figure 2.3a in Study Session 2), the BCG vaccination should be repeated.

4.2.2 Subcutaneous immunization with measles vaccine


Where vitamin A deficiency is common among children, as in Ethiopia,
vitamin A drops are given at the same time as measles vaccine, as described
in Study Session 3.
Subcutaneous (SC) injections are given into the fatty tissue below the skin
and above the muscle. Measles vaccine is the only routine EPI vaccine which
is administered subcutaneously. The vaccine comes in powder form and must
be reconstituted before use with the approved diluent (as described in
Section 4.1.4), and used within six hours of reconstitution.
For the immunization, select a sterile 1 ml auto-disable (AD) syringe or a
sterile syringe attached to a 23 gauge needle, and draw 0.5 ml of the
reconstituted measles vaccine into the syringe. Expel any air bubbles as
described above for BCG immunization (Section 4.2.1). Swab the skin of the
child’s outer upper arm with antiseptic solution and let it air dry. Hold the The child shown in Figure 4.15
child’s arm from below, and pinch the skin with your fingers and thumb (as should be held securely by a
shown in Figure 4.15 on the next page), to push up a fold of skin on top of caregiver to prevent sudden
movements
the arm. Push the needle a little way under the pinched-up skin. The needle
should go in at a sloping angle (Figure 4.16), not straight down. Inject 0.5 ml
of the vaccine into the fatty subcutaneous layer below the skin, but above the
muscle.

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Figure 4.15 Subcutaneous injection of measles vaccine. (Source: WHO, 1998,


Immunization in Practice, Module 8, During a session: giving immunizations,
Figure 8-N)

Figure 4.16 Needle position for subcutaneous injection of measles and yellow
fever vaccines. (Source: WHO, 2001, as Figure 4.13, but Figure 2-B)

4.2.3 Subcutaneous immunization with yellow fever vaccine


Yellow fever vaccine is not currently used routinely in the EPI in Ethiopia,
but may be required by travellers going abroad to countries where the disease
is common. It is the only other vaccine, apart from measles vaccine, which is
injected subcutaneously, and is also given into the outer upper arm.

4.2.4 Intramuscular immunization with all other EPI vaccines


All the other EPI vaccines in routine use in Ethiopia are injected
intramuscularly. Intramuscular (IM) injections are administered into the
muscle layer below the skin and subcutaneous tissue, using a 1 ml syringe
with a 26 gauge needle pointing straight down into the muscle (Figure 4.17).

Pentavalent and pneumococcal vaccines


Pentavalent vaccine and the new pneumococcal vaccine (PCV10) are injected
intramuscularly into the opposite thighs. Swab the thigh area with antiseptic
solution and let it air dry, then inject 0.5 ml of vaccine as shown in
Figure 4.18. Make sure the child is held securely.

Figure 4.17 Needle position


for intramuscular injections.
(Source: WHO, 2001, as
Figure 4.13, but Figure 2-C)

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Study Session 4 Vaccine Preparation and Administration Routes of the EPI Vaccines

Figure 4.18 Holding a child for immunization by intramuscular injection into the
outer upper thigh. (Photo: Dr Kalid Asrat)

Tetanus toxoid (TT) vaccine


Tetanus toxoid is commonly given separately on its own to pregnant women
and non-pregnant women of childbearing age. Before giving TT vaccine, you
should shake the vial so that any particles of vaccine that have settled to the
bottom of the vial are mixed completely with the liquid. If the tetanus toxoid Note that pentavalent vaccine
is not well mixed, the correct dose may not be given. and PCV10 must be given as two
separate injections into opposite
Inject 0.5 ml of TT vaccine intramuscularly (IM) using a sterile 1 ml syringe thighs (pentavalent on the left
and a sterile 22 gauge needle into the muscle of the upper left or right arm, and PCV10 on the right).
depending on the woman’s preference (Figure 4.19). At least two doses, and
ideally five doses, should be given for maximum protection of women and
their newborns from tetanus.

Figure 4.19 Intramuscular injection of tetanus toxoid into a woman of


childbearing age. (Source: WHO, 2004, Immunization in Practice, Module 6,
Holding an Immunization Session, p.22)
You learned about the effectiveness of different numbers of TT vaccine doses
in Study Session 2, Table 2.7.

The shake test


Pentavalent, PCV10 and TT vaccines are all damaged by freezing. After
freezing, the vaccine tends to form flakes that quickly settle at the bottom of
the vial after shaking. If you suspect the vaccine has been accidentally
frozen, you should check for damage by conducting a shake test before you
use it. (You will learn how to do the shake test in Study Session 6.)

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4.3 Oral administration of vaccines


The oral route of administration is used for polio vaccine (OPV) and will
also be used for the rotavirus vaccine (RotarixTM) when it becomes available
in the EPI in Ethiopia.

4.3.1 Oral administration of OPV


OPV is a clear red or yellow liquid vaccine that may come in either of two
types of containers:
. Small plastic bottles that work like droppers – the drops are given directly
from the dropper into the baby’s mouth.
. Glass vials with a dropper (also made of glass) supplied in a separate
plastic bag. Remove the metal or plastic cap from the vial of OPV. Then
cut open the plastic bag containing the dropper and fit it onto the top of
the OPV vial (Figure 4.20) before use.

Figure 4.20 (a) Removing a dropper from its plastic bag, and (b) fitting it on top
of a vial of OPV. (Source: WHO, 1998, Immunization in Practice, Module 8,
During a Session: Giving Immunizations, Figure 8-E)
Ask the parent or carer to hold the child firmly with the child lying on its
back. Then open the child’s mouth by squeezing the cheeks gently between
your fingers to make the child’s lips point outward. Hold the dropper over the
child’s mouth at an angle of 45 degrees (Figure 4.21) and let two drops of
the vaccine fall from the dropper onto the child’s tongue. If the child spits
out the vaccine or vomits, give another dose immediately.

Figure 4.21 OPV drops being administered to a newborn baby. (Photo: Dr Kalid
Asrat)

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Study Session 4 Vaccine Preparation and Administration Routes of the EPI Vaccines

4.3.2 Oral rotavirus vaccine


Rotavirus vaccine is also administered orally in a similar way as described
for OPV, but RotarixTM is supplied in single-dose ‘squeeze-tube’ vials. Each
vial contains 1.5 ml of vaccine which is squeezed slowly — drop by drop —
into the infant’s open mouth. You will be given more detailed instructions
when the vaccine is introduced into the EPI in Ethiopia.

4.4 In conclusion
Table 4.1 summarises what you should know about the routes and sites of
administration of the EPI antibacterial and antiviral vaccines.
Table 4.1 Summary of routes of administration and injection sites of the EPI
vaccines.

Vaccine Route of Injection site


administration
OPV and rotavirus vaccine Oral None (given by
(RotarixTM) mouth)
BCG Intradermal (ID) Outer upper right
arm
Measles Subcutaneous (SC) Outer upper arm
Pentavalent (DPT-HepB-Hib) Intramuscular (IM) Outer left upper
thigh
Tetanus toxoid (TT) for women of Intramuscular (IM) Outer upper arm
childbearing age
Pneumococcal vaccine (PCV10) Intramuscular (IM) Outer right upper
thigh

Summary of Study Session 4


In Study Session 4, you have learned that:
1 Correct preparation before giving an immunization is very important to
minimise the risk of infection or injury to yourself, your clients or their
caregivers, and to maintain the effectiveness of the vaccine during transfer
from the manufacturer’s vial to the syringe and finally to the client.
2 Correct vaccine preparation includes using standard procedures (hand
washing, skin preparation using antiseptics, etc.), selection of an
appropriate syringe and needle, inspection of vials and ampoules to check
the expiry date and vaccine vial monitors (VVMs) to ensure that vaccines
and diluents are in good condition, vaccine reconstitution for those
vaccines that require it, and keeping vaccines cold during the
immunization session.
3 Always use the appropriate diluents provided specifically for the
reconstitution of BCG or measles vaccines before use. Never use sterile
normal saline or sterile water as a substitute for the correct diluent.

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4 The injectable EPI vaccines are each given by a specific route and site:
BCG vaccine is injected intradermally into the upper right arm; measles
vaccine is injected subcutaneously into the upper arm; pentavalent vaccine
and pneumococcal vaccine (PCV10) are injected intramuscularly into
opposite upper thigh muscles; tetanus toxoid vaccine is injected
intramuscularly into the woman’s upper arm.
5 Oral polio vaccine (OPV) is given by two drops into the infant’s mouth.
Rotavirus vaccine (RotarixTM) is given as 1.5 ml of drops into the infant’s
mouth.

Self-Assessment Questions (SAQs) for Study


Session 4
Now that you have completed Study Session 4, you can assess how well you
have achieved its Learning Outcomes by answering the following questions.
Some questions test your understanding of some Learning Outcomes for
previous study sessions, as well as those in this one. Write your answers in
your Study Diary and discuss them with your Tutor at the next Study Support
Meeting. You can check your answers with the Notes on the Self-Assessment
Questions at the end of this Module.
SAQ 4.1 (tests Learning Outcomes 4.1, 4.3 and 4.4)
Place a cross in the appropriate boxes in Table 4.2 to indicate the
correct route of administration for each vaccine, and whether it is
supplied as a liquid or if it has to be reconstituted with diluent before
use.
Table 4.2 Vaccine administration and reconstitution summary.

Route of administration Reconstitution?

Vaccine ID SC IM Oral Yes No


BCG
Pentavalent
Measles
Polio (OPV)
Pneumococcal (PCV10)
Rotavirus (RotarixTM)
TT (in women)

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Study Session 4 Vaccine Preparation and Administration Routes of the EPI Vaccines

SAQ 4.2 (tests Learning Outcomes 2.4, 3.4 and 4.2)


Read Case Study 4.1 and then answer the questions that follow it.

Case Study 4.1 Bekelech’s immunization clinic


Three worried mothers have brought their sick babies to the Health Post
one week after the babies received their scheduled EPI vaccines at six
weeks of age. When Bekelech, the Health Extension Practitioner, checks
the babies, she finds that they each have red and painful swellings on
the left upper thigh and moderate fever. When they were immunized at
the Health Post a week previously it had been a very busy day. Over 25
parents brought their children for immunizations, five pregnant women
needed TT vaccine, and several people arrived with other health
problems. Bekelech remembered that things kept going wrong that day
and she had to rush to finish immunizing all the clients before nightfall.

(a) What is the swelling in the thighs of the three sick babies, and what
could have caused it?
(b) What should Bekelech do about this problem?

SAQ 4.3 (tests Learning Outcomes 4.1, 4.2, 4.3 and 4.4)
Read Case Study 4.2 and then answer the question that follows it.

Case Study 4.2 Fatuma’s immunization clinic


Fatuma is preparing to give BCG vaccinations to a number of babies.
Before giving the vaccination, she washes her hands, checks that the
expiry date on the vaccine ampoule has not passed, she taps the
ampoule to make sure all the vaccine powder is at the bottom, and
opens the ampoule. She inspects the diluent and uses it to reconstitute
the vaccine. She places the reconstituted vaccine on a foam pad placed
on top of conditioned ice-packs in a vaccine carrier, and administers it
intradermally to each baby in the upper right arm.

. What two things has Fatuma forgotten to do? In each case, explain
why this is important and what could happen as a result of it being
forgotten.

SAQ 4.4 (tests Learning Outcome 4.5)


What is incorrect in the following statement?
. OPV is given to babies by first withdrawing the liquid vaccine into a
sterile syringe, and then pushing the plunger just enough to let 2
drops of vaccine drip from the syringe into the baby’s mouth.

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60
Study Session 5 Vaccine Supply and Stock Management

Study Session 5 Vaccine Supply and Stock


Management
Introduction
This study session deals with how to determine vaccine needs and how to
keep your stock of vaccines in a reliable way, so that your immunization
programme will not be interrupted as a result of shortage of supply. We also
explain how to avoid wastage of vaccines by reducing the risk that the stock
will pass its expiry date. The study session involves a lot of calculations
using basic mathematics (addition, subtraction, multiplication and division)
and using letters to represent values that you will need to measure or
estimate. You are advised to apply your own data after each of the examples
given here, to help you understand how the calculations apply in your setting.

Learning Outcomes for Study Session 5


When you have studied this session, you should be able to:
5.1 Define and use correctly all of the key words printed in bold. (SAQs
5.1, 5.3 and 5.4)
5.2 Calculate the size of the target population in your community and
forecast their vaccine needs, using three different methods. (SAQs 5.1 and
5.2)
5.3 Calculate vaccine wastage rates and wastage factors and apply them
to orders of vaccine stocks to minimise wastage. (SAQs 5.1 and 5.3)
5.4 Calculate the minimum and maximum quantities of vaccines required
for a stated supply period and manage the critical stock level effectively.
(SAQ 5.4)

5.1 Estimating vaccine needs


Vaccine management involves estimating the number of vaccine doses,
diluents and injection equipment (e.g. syringes, needles) needed for a
particular population over a stated supply period. In order to run an efficient
and effective immunization session you need to have an adequate supply of
vaccines of acceptable quality. This is essentially dependent on reliable
planning and monitoring. You might have heard from mothers in the
community that the health facility ran out of vaccines and their child could
not be immunized. On the other hand, health facilities may have an excess
stock of vaccine that has passed its expiry date and has to be thrown away.
You should try to ensure that these situations do not arise in your Health Post
(Figure 5.1).

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Figure 5.1 Fura kebele Health Post, in the Southern Nations, Nationalities and
Peoples Region (SNNPR) of Ethiopia, has been commended for meeting high
performance targets. (Photo: Janet Haresnape)
Before we move on, remind yourself of the meaning of some key terms from
previous study sessions.
■ What is the expiry date?

□ The expiry date is the (international calendar) date after which a


vaccine, diluent or other consumable item should not be used for the
purpose of immunization, because of possible loss of potency (vaccines;
diluents) or durability (syringes, needles and other items).
Potency refers to the ‘strength’ or ‘effectiveness’ of a vaccine;
durability refers to the time period that equipment such as syringes or
needles remain in good condition (how long they last).

■ What is a diluent?

□ A diluent is a liquid used to reconstitute a freeze-dried vaccine. Each


vaccine has its own diluent which should not be used to reconstitute any
other vaccine.

Determining your vaccine needs accurately is important because it allows you


to manage your immunization programme efficiently. Good vaccine
management:
. enables you to use vaccines efficiently, and reduce wastage
. avoids shortages or excess accumulation of vaccines.
If the vaccine needs for your Health Post are not estimated correctly, and the
wrong amounts are supplied by the health centre, this may result in shortage
of vaccines or excess stock.
■ What is the problem if you order excess stock?

□ There is the risk that the vaccines will pass their expiry date before you
need to use them, so they will be wasted.

We now consider how you can determine the vaccine needs for your Health
Post. There are three methods based on:
. size of the target population for immunization
. previous vaccine consumption data
. size of the scheduled immunization sessions.
You will learn about each of these methods in the sections that follow. But
you should note that vaccine requirements are likely to vary a lot from one

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Study Session 5 Vaccine Supply and Stock Management

kebele to another; the stocks required for your immunization programme may
be very different from the examples used in this study session.

5.2 Estimating vaccine needs based on the size of


the target population
5.2.1 What is the target population?
The target population is the number of people who are eligible for
vaccination with a particular vaccine. We use the letters ‘pt’ to represent the
target population in calculations.
. For tetanus toxoid (TT) vaccine the target population is the total number You learnt about tetanus toxoid
of pregnant and non-pregnant women in the childbearing age-group (TT) vaccine and all the other the
(15–49 years). (Children will usually be protected from tetanus by vaccines available in the EPI in
Ethiopia in Study Sessions 2
receiving three doses of pentavalent vaccine at 6, 10 and 14 weeks of and 3.
age.)
. For BCG vaccine, the target population is all live births (i.e. complete
expulsion from the mother, regardless of duration of pregnancy, showing
any evidence of life).
. For all other vaccines in the Expanded Programme on Immunization
(EPI) in Ethiopia, the target population is all surviving infants
(i.e. survive to their first birthday).
To calculate vaccine needs based on the target population, you need to know
the size of the target population, the number of doses required according to
the EPI schedule, and the percentage immunization coverage rate you have
been given as the target in your annual activity plan (Figure 5.2).

Figure 5.2 Annual activity plan performance for immunizations in Fura kebele
with a total population of 6,348 people in 2003 E.C. (Ethiopian calendar, or 2010
in the European calendar). (Photo: Janet Haresnape)
In Figure 5.2, the column headed ‘eligible’ gives the number in the target
population for each vaccine. You can see that the health workers in this
Health Post planned to immunize 100% of the eligible children and 100% of
the pregnant women (TT+2 PW, pregnant women receiving more than 2
doses of TT vaccine). Columns headed P refer to ‘planned’ numbers for
immunization, and A are the ‘actual’ numbers immunized — in the first
quarter of the year, they exceeded their targets for all categories except

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TT+2 NPW (non-pregnant women of childbearing age receiving more than 2


doses of TT).
Next, we will show you how to use data from an area similar to that of your
kebele to calculate the target population for vaccination, so you can construct
an annual activity plan for immunization like the one shown in Figure 5.2.

5.2.2 Calculating numbers in the target population


Table 5.1 shows an estimate of the target population for immunization in a
kebele with a total population of 5,000. A figure of 4% of the Ethiopian
population is usually taken to estimate the coverage required for all live
births and surviving infants. You can assume that (on average) about 23% of
the Ethiopian population will be women of childbearing age, of whom about
4% will be pregnant in a typical year.
Table 5.1 Estimating the target population for immunization in a kebele with a total
population of 5,000.

Category % of total Estimated number in target


population population
Live births 3.6 180
Surviving infants 3.4 170
Women of childbearing age 23 1,150
(pregnant and non-pregnant)

You estimate the target population by multiplying the total population by the
percentage in a particular category; for example in Table 5.1:
Expressing a percentage as a decimal number is easy, e.g.
90% is the same as 0.9; 23% is the same as 0.23, and 4% is the same as
0.04.
. The estimated number of women eligible for TT vaccination (Figure 5.3)
is 5,000 × 23% (or 0.23) = 1,150
. The estimated number of children eligible for all other EPI vaccines is
5,000 × 4% (or 0.04) = 200, if you take the simple average of 4%. If you
use the Ministry of Health indicators of live births (3.6%) and surviving
infants (3.4%), the numbers will be 170 and 180 respectively.

Figure 5.3 About 23% of the Ethiopian population are women of childbearing
age (pregnant and non-pregnant combined). (Photo: Ali Wyllie)

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Study Session 5 Vaccine Supply and Stock Management

■ Look back at Figure 5.2. What was the estimated target population
eligible for TT immunization in Fura kebele in the year shown?

□ The estimated eligible population for TT vaccination was 1,478 women


of childbearing age (247 pregnant and 1,231 non-pregnant) in Fura that
year; this is 23% of the total population of 6,348 in the kebele.

5.2.3 Calculating required doses based on the immunization


schedule
In addition to calculating the number of people in the target population, you
also need to know the number of doses required in the EPI schedule in order
to immunize everyone (total coverage). You learned about the EPI schedule
in Study Sessions 2 and 3, but we repeat the key points in Table 5.2. We use
the letters ‘dn’ to represent the number of doses in calculations.
Table 5.2 Vaccine schedule by age and number of doses.

Vaccines Schedule by age Number of doses in


schedule (dn)
BCG At birth 1
Pentavalent At 6, 10 and 14 weeks 3
Polio (OPV) At birth, 6, 10 and 14 weeks 4
PCV10 At 6, 10 and 14 weeks 3
Measles At 9 months 1
Tetanus On reaching childbearing age At least 2
toxoid Ideally all women of childbearing age
should receive five doses of tetanus
toxoid.

■ If you have an estimated 200 surviving infants in your kebele, how many
doses of pentavalent vaccine would be needed to complete the EPI
schedule for all these children? Use the data on % of total population in
Table 5.1.

□ The target population is 170 surviving infants, so you would need 510
doses to complete the EPI schedule for all of them, because each
surviving infant should have three doses of pentavalent vaccine.

5.2.4 Immunization coverage targets


You now know how to calculate the annual vaccine needs for immunization
of everyone in the target population. The EPI policy is to immunize 100% of
the target population, but you may not be able to reach everyone in the target
population in one year (for example, if your kebele includes very remote
areas). Your annual action plan will include a percentage target from the
woreda health office for the immunization coverage rate — the percentage
of the eligible population that has been agreed as your objective for
immunization with each of the EPI vaccines this year. The performance of
your Health Post will be measured against this target.

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If the annual target is less than 100% for a particular vaccine, you can
estimate the number of vaccine doses you will actually need as follows. Start
with the number of doses required to immunize everyone in the target
population (i.e. total coverage), and multiply that number by the agreed
(lower) percentage target for immunization coverage in your setting. We use
the letters ‘ic’ to represent the percentage target for immunization coverage in
calculations. Now look at the example in Table 5.3. (Your targets will be
different.)
Table 5.3 Estimate of actual vaccine doses needed for various percentage targets for immunization coverage in an
imaginary population of 5,000. (ic stands for immunization coverage target)

Vaccine Number of doses for 100% % coverage target Actual number of doses
coverage (ic) needed
BCG (1 dose) 200 90 180
Polio (4 doses) 800 90 720
Pentavalent (3 doses) 600 100 600
PCV10 (3 doses) 600 90 540
Measles (1 dose) 200 80 160
Tetanus toxoid (2 doses) 2,300 65 1,495

■ How many doses of TT vaccine would you need to immunize the


eligible women in Table 5.3 with three doses per woman, if you
increased the percentage coverage target to 70%?

□ Total 100% coverage with three doses would require 3,450 doses. If the
coverage target is 70%, the actual doses required would be
3,450 × 0.7 = 2,415 doses.

Note that you can use the same method of calculation to estimate the number
of ampoules of specific diluents required to reconstitute the freeze-dried
vaccines (BCG and measles), and your requirement for injection equipment.

5.2.5 Vaccine wastage rates and wastage factors


Using calculations like the one in Table 5.3 enables you to determine the
number of vaccine doses you need. However, some vaccine doses may be
wasted during the year for various reasons (Box 5.1 on the next page). The
wastage rate is the percentage of vaccine doses that are wasted. The general
guideline on the amount of vaccine wastage that is considered acceptable for
different types of vaccines is also shown in Box 5.1.

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Study Session 5 Vaccine Supply and Stock Management

Box 5.1 Vaccine wastage

Some reasons for vaccine wastage:


. Some unused doses may have to be thrown away, e.g. because they
have passed their expiry date or lost their labels.
. Some doses may be spoilt for one reason or another (e.g. vaccines
damaged by storage at the wrong temperature).
. Some vials or ampoules may be broken during transport and
handling.
Acceptable vaccine wastage rates:
. For liquid vaccines supplied in single or two-dose vials
(e.g. pentavalent vaccine and PCV10), a wastage rate of 5% is
acceptable.
. For OPV, a wastage rate of 10% is considered acceptable.
. For liquid vaccines supplied in multi-dose vials of 10 or more doses,
a wastage rate of 15% is acceptable.
. For reconstituted vaccines, wastage rates of 50% for BCG and 25%
for measles vaccine are considered acceptable.

Calculating the wastage factor


The wastage factor is the factor (number) that you multiply your estimated
vaccine needs by, in order to allow for some doses being wasted. We use the
letters ‘wf’ to represent the wastage factor in the following equation:
wastage factor (wf) = 100 ÷ (100 minus the % wastage rate)
where the wastage rate is the number of doses wasted, expressed as a
percentage.
Note the ‘brackets first’ rule. In equations that include brackets around some
of the numbers, you always calculate the answer to whatever is inside the
brackets first, before you do anything else.
■ If the wastage rate is 30%, what is the wastage factor?


Wastage factor = 100 ÷ (100 – 30)
= 100 ÷ 70
= 1.43

Therefore, if 30% of the doses are wasted, the wastage factor will be
1.43.

Now you have learned how to calculate the basic values you need to estimate
your vaccine needs for the target population. These values are the target
population (pt), the number of doses in the schedule (dn), the immunization
coverage target (ic) and the wastage factor (wf).

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5.2.6 Calculating annual vaccine needs from the size of the


target population
To calculate the annual vaccine needs for your immunization programme
from the size of the target population, you need to multiply together the four
values explained in Sections 5.2.1 to 5.2.4 of this study session. The
calculation can be summarised using the equation shown below:
Annual vaccine needs = pt × dn × ic × wf
The equation uses the following values:
. target population (pt)
. number of doses in the schedule (dn)
. target immunization coverage (ic) expressed as a decimal number (not a
percentage)
. wastage factor (wf) expressed as a decimal number.
■ Calculate the annual vaccine needs for pentavalent vaccine for a target
population of 200 surviving infants, using the equation given above.
Remember that three doses of this vaccine per child are needed for full
immunization. Assume the target coverage rate is 90% and the wastage
factor is 1.33 in this example.

□ The calculation is as follows:


. number of surviving infants (pt) = 200
. number of pentavalent doses in the EPI schedule (dn) = 3
. target coverage rate (ic) expressed as a decimal number = 0.9 (90%)
. wastage factor (wf) = 1.33

Annual pentavalent vaccine = pt × dn × ic × wf


needs
= 200 × 3 × 0.9 ×
1.33
= 178

In this example, 718 doses of pentavalent vaccine would be needed


annually. Remember that the requirement in your own kebele may be
different.

Now we turn to the second method of calculating vaccine needs.

5.3 Estimating vaccine needs on the basis of


previous consumption
This method is based on the consumption of vaccines during the previous
reporting period (usually the previous year). Some adjustment may be
necessary if you believe that there has been any increase in the population
size since the previous vaccine consumption was recorded. This method is
useful for a Health Post where the stock management is good, but there is
insufficient information on immunization objectives and targets for the next
action plan. It is also useful when placing short-term orders.

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Study Session 5 Vaccine Supply and Stock Management

In a kebele where stock management is efficient, there is likely to be good


information on previous vaccine consumption. For example, you can probably
see from the red bars in Figure 5.4 that 97 babies were immunized at birth
with BCG in this kebele in 2001 (Ethiopian calendar). So this number could
be used to predict the BCG vaccine requirement in the following year.

Figure 5.4 EPI coverage for infants aged under one year during a five year
period at Fura kebele, SNNPR, Ethiopia; years are in the Ethiopian
calendar (E.C.). (Photo: Janet Haresnape)

5.3.1 Calculating annual vaccine needs from previous


consumption
For this calculation, we use an equation based on the stock of vaccine at the
beginning and end of a particular period, the vaccines received during that
period, and the vaccines lost, destroyed or thrown away during that period.
The equation is given below:
Annual vaccine needs (in doses) = (i+r) – (f+l)
Remember the ‘brackets first’ rule; calculate the sums inside the brackets
first, before you do anything else.
The equation includes the following numbers of doses:
. initial vaccine stock at the beginning of the period (i)
. vaccines received during the period (r)
. stock remaining at the end of the period (f)
. lost, destroyed or expired doses (l).

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■ Use the above equation to calculate the annual vaccine needs (in doses)
for pentavalent vaccine in a particular kebele, in which the initial stock
at the beginning of the year was 250 doses, and the quantity received
during the year was 1,250 doses. At the end of the year there were 500
doses remaining in stock. The quantity lost during the year was 125
doses.

□ The answer is calculated as follows:

Annual = (i+r) – (f+1)


vaccine
needs
= (250 + 1,250) – (500 + 125) doses
= 1,500 – 625 doses
= 750 doses

In this example, the estimated annual pentavalent vaccine need based on


previous consumption is 750 doses.

■ In the example given in Section 5.2.5, the estimated annual pentavalent


vaccine need, based on the size of the target population, was 718 doses.
However, the estimate based on the previous year’s consumption (see
above) was 750 doses. If both these imaginary examples had come from
the same Health Post, what explanations could you suggest for the
difference between the two estimates?

□ Clearly the Health Post staff used more vaccine doses (750) in the
previous year than was predicted from the size of the target population
(718). There are several possible reasons for this, including:
. There were more surviving infants in the kebele than the 200
estimated from calculating 4% of the total population size
of 5,000.
. The Health Post staff achieved a higher immunization coverage rate
in the previous year than the 80% target they were asked to deliver.
. They wasted more doses of vaccine than expected.

5.4 Estimating vaccine needs based on the size of


immunization sessions
Now we show you how to calculate vaccine needs based on the size of
immunization sessions. This method is appropriate if you cannot determine
the rates of vaccine wastage, or vaccine stock management is not good. The
equation you should use to estimate the annual vaccine needs by this method
is given below:
Annual vaccine needs = posts × weeks × sessions × vials × doses, where:
. posts = number of immunization sites
. weeks = number of weeks the service is delivered during the year
. sessions = number of immunization sessions per week
. vials = number of vials opened per immunization session
. doses = number of doses per vial.

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Study Session 5 Vaccine Supply and Stock Management

Table 5.4 shows how to calculate vaccine needs based on the size of
immunization sessions in an imaginary example, using a vaccine supplied in
multi-dose vials containing 10 doses per vial.
Table 5.4 Calculation of annual vaccine needs based on the size of immunization sessions.

immunization weeks sessions per vials per doses per total


posts delivered week session vial doses
1 × 48 × 2 × 1 × 10 = 960

So the vaccine needs for this particular multi-dose vaccine, based on the size
and number of vaccination sessions = 960 doses per year.
■ Why do you think an estimate based on the size of the immunization
sessions is likely to be higher than one based on previous consumption?

□ An estimate based on the size of the immunization sessions assumes that


all of the scheduled immunization sessions will actually be held for each
of the scheduled weeks in the year. But if some sessions cannot be held
(for example, if there was a shortage of vaccine, or if the health worker
was ill), then the actual number of vaccine doses given would be lower
than estimated using the method illustrated in Table 5.4.

5.5 Ordering vaccines


In the previous section you learnt how to estimate vaccine needs. Vaccines
are very expensive, so it is important to ensure that the ordered vaccines will
be used and not spoiled. The World Health Organization (WHO) recommends
that every order for vaccines should take into account the considerations in
Box 5.2. There are some new terms in this box which are explained on the
next page.

Box 5.2 Considerations for vaccine ordering

Health facility staff should always use an EPI Vaccine and Injection
Materials Stock Record (see Figure 5.5 on the next page) to help them
to:
. Avoid stock shortages, especially when mass immunization
campaigns are planned.
. Avoid stock excesses, by not ordering excess stock, or exceeding the
recommended storage periods.
. Avoid situations where vaccines expire during their storage period.
. Ensure that the other necessary stocks (e.g. diluents, syringes,
needles; wick and paraffin or kerosene for refrigerators, etc.) are
ordered at the same time as the vaccines.
. Organise stock using the principle of ‘bundling’ for all supplies
required delivering an immunization session.
. Ensure that there are adequate cold chain storage facilities (both in
capacity and temperature; see Study Session 6).

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Figure 5.5 This stock record should be kept up to date at all times to ensure that
stock shortages and stock excesses are avoided.
Bundling refers to the practise of organising related stock all together in
‘bundles’ consisting of the correct numbers of all the items you need during
an immunization session:
. good quality vaccines and diluents
. auto-disable (AD) syringes (or single-use disposable syringes and needles,
if these are still used)
. safety boxes, etc.
Auto-disable (AD) syringes were mentioned in Study Session 4, and are
specially modified disposable syringes with a fixed needle; an AD syringe is
automatically disabled after it has been used once, because the plunger
cannot be pulled back a second time. The WHO recommends that
immunization programmes use AD syringes for all vaccinations, to prevent
re-use of contaminated injection equipment.
The cold chain is fully described in Study Session 6, and refers to the
network of refrigerators, cold stores, freezers, cold boxes and vaccine
carriers, and their efficient organisation and maintenance, so that vaccines are
kept at the right temperature at all times. This ensures that vaccines keep
their potency during their transportation and storage at all stages, from
leaving the factory to the point of administration to the target population.
Storage of vaccines is a major challenge. Vaccines are easily damaged during
storage if the cold chain is not maintained. Therefore it is important to divide
the vaccine supply into manageable periods for the purpose of ordering
stocks. A Health Post will usually have a shorter supply period (four weeks)
than a health centre. The next section explains how to calculate the quantities
of vaccine needed for a specific supply period.

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Study Session 5 Vaccine Supply and Stock Management

5.5.1 Calculating quantities of vaccine for a particular supply


period
The vaccine needs for a specific storage or supply period (in this case,
12 months or 48 working weeks) can be calculated using the following
equation:
qperiod = (qyear ÷ 12) × psupply when the supply period is given in months, or
qperiod = (qyear ÷ 48) × psupply when the supply period is given in working
weeks.

where:
qperiod = vaccine needs for the period
qyear = annual vaccine needs
psupply = supply period (in months or weeks).
You can see an example of vaccine needs calculated in weeks in the
following question.
■ If the number of doses of vaccine required for one year in an imaginary
kebele is 2,000, how many doses would be needed for a two-week
period?

□ In this example, the annual vaccine needs qyear = 2,000 and the supply
period psupply is 2 weeks.
The vaccine needs for one week would be 2,000 doses ÷ 48 working
weeks.
So the vaccine needs for the period (qperiod) of 2 weeks is
(2,000 ÷ 48) × 2 = 83 doses.
Therefore, 83 doses would be required for a two-week period in this
example.

5.5.2 Calculating the minimum stock level


The time between the date of ordering vaccines and the date when you
collect them may not be as soon as you would wish it to be. There may be an
increase in vaccine demand that you want to respond to quickly, but you may
find there are unexpected delays in restocking. Therefore, you should always
aim to keep a minimum amount of vaccine in stock. The minimum stock
level is the minimum number of vaccine doses that should be in the
refrigerator when the next supply of vaccines is collected. Usually, the
minimum stock is taken as 25% of the total vaccine needs for the supply
period.
The minimum stock level can be calculated using the following equation:
smini = qperiod × 25% (or 0.25)
where smini is the minimum stock level and qperiod is the vaccine needs for
the period.
■ Imagine that at a particular Health Post, the number of doses of oral
polio vaccine (OPV) required for a 2-week supply period is 80. If the
minimum stock should be 25% of the total vaccine needs for the supply
period, what should the minimum stock level be at this Health Post
when the next supply of vaccine is collected from the health centre?
(Remember that 25% is expressed as 0.25 in calculations.)

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□ The number of doses of OPV required for 2-weeks is 80.


The percentage required as minimum stock is 25% (0.25).
So the minimum stock is 80 × 0.25 doses, or 20 doses.
This means that there should be at least 20 doses of OPV in stock at this
Health Post when the next supply of vaccine is collected.

5.5.3 Calculating the maximum stock level


You have learned that vaccines are easily damaged and that they are very
expensive. It is not good practice to keep an unnecessary amount of vaccine
in stock. The maximum stock level is the maximum number of vaccine
doses that should be present in the refrigerator immediately after a new
supply has been collected from the health centre.
The maximum stock level can be calculated using the following equation:
smaxi = qperiod + smini
where smaxi is the maximum stock level, qperiod is the vaccine needs for the
period, and smini is the minimum stock level.
■ Think again about the Health Post where the number of doses of OPV
needed for a 2-week supply period is 80 and the minimum stock level is
20 doses. What should the maximum stock level of OPV be in this
Health Post?

□ The number of OPV doses needed at this Health Post for a 2-week
period is 80, and the minimum stock level is 20 doses, so the maximum
stock level is (80 + 20) = 100 doses. So there should be no more than
100 doses of OPV in stock when the next supply of this vaccine is
collected.

If your supplies of vaccine exceed your maximum stock level, it may be wise
to consider returning some vials to the higher level facility.

5.5.4 Calculating the critical stock level (or ‘time to order’)


It is important to be aware of your vaccine stock, and to place your next
order at the right time. The critical stock level (or ‘time to order’ level) is
the number of vaccine doses in stock at the time when it is absolutely
necessary to place a new order. ‘Time to order’ calculations take into account
the level of vaccine consumption while waiting for the new supply. This
precaution is necessary to prevent the vaccine stock from dropping below the
minimum stock level before the new order can be collected. The delivery
time is the time interval between the day the vaccines are ordered and the
day that you collect them from the health centre.

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Study Session 5 Vaccine Supply and Stock Management

The critical stock level can be calculated using the following equation:
scritical = qdelivery + smini , where:
. scritical is the critical stock level
. qdelivery is the number of doses needed during the delivery time, and
. smini is the minimum stock level.
qdelivery = (qperiod × tdelivery) ÷ n , where:
The number of doses required during the delivery time (qdelivery) can be
calculated using the following equation:
. tdelivery is the number of days between placing the order and collecting
new vaccines
. n is the number of days in the supply period (i.e. the period that the
health facility maintains its vaccine stocks at, or above, the minimum
level).
Now attempt Activity 5.1 to calculate the critical stock level for an imaginary
Health Post. You will need paper and a pen or pencil to help you make the
calculations.

Activity 5.1 Calculating the critical stock level


At a particular Health Post, it often takes 2 working days for the HEW to
collect her new supply of vaccines after ordering them from the health centre,
which is 15 km away along difficult tracks. The number of doses of OPV she
needs for a supply period of 2 weeks is 80 doses.
What is the critical stock level (or ‘time to order’ level) for OPV at this
Health Post? Assume that the minimum stock level is 25% of the number of
doses needed for the 2-week supply period (10 working days).
Write down all your calculations so that it is clear how you reached your
answers. Do this before you check our answer below.

Answer
The calculation of the critical stock (or ‘time to order’) level can be done
using the equations given above Activity 5.1. First, calculate the number of
doses you will need during the delivery time (qdelivery) by using the equation:
qdelivery = (qperiod × tdelivery) ÷ n
In this Health Post, qperiod is 80 doses of OPV, tdelivery is 2 days, and the
supply period is 10 working days (2 weeks) so n is 10.
qdelivery = (80 × 2) ÷ 10 = 16 doses
The minimum stock level (smini) is 25% of 80 doses, which is 20 doses. The
critical stock level (scritical) is calculated using the equation:
scritical = qdelivery + smini
In this Health Post, qdelivery is 16 doses and smini is 20 doses, so:
scritical = (16 + 20) = 36 doses.
So the staff at this Health Post should place an order for OPV when the
critical stock level is reached at 36 doses.

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In the next study session you will learn about keeping vaccines and diluents
safe and effective by maintaining the cold chain. This is vitally important in
reducing wastage, as well as maintaining the potency of the vaccines.

Summary of Study Session 5


In Study Session 5, you have learned that:
1 Vaccine management is important because vaccines are easily damaged
and they are very expensive.
2 Accurate estimation of all stock requirements avoids shortages and
prevents wastage from excessive orders; good vaccine stock management
is essential to the smooth running of immunization sessions.
3 There are three methods of estimating annual vaccine needs, based on:
◦ size of the target population
◦ previous consumption levels
◦ size of immunization sessions.
4 These methods can also be applied to estimates of other immunization
supplies, such as diluents and injection equipment.
5 It is essential to keep the EPI Vaccine and Injection Materials Stock
Record up to date; this will help you to avoid stock shortages and stock
wastage.
6 It is good practise to organise stocks of vaccines, diluents, syringes,
needles and safety boxes together in bundles.
7 It is important to ensure that vaccine stocks do not fall below the
recommended minimum level, or rise above the recommended maximum
level, and that you order new supplies when the stock falls to the critical
level.

Self-Assessment Questions (SAQs) for Study


Session 5
SAQ 5.1 (tests Learning Outcomes 5.1, 5.2 and 5.3)
Imagine that you are working in a kebele with a total population of
5,700, and that 5% of the total population are children aged 0 to 11
months. There is only one immunization site — your Health Post. You
have been given a target of 90% immunization coverage for pentavalent
vaccine for the year. The wastage rate has been agreed as 5%.
. Based on the national EPI schedule for this vaccine, calculate the
annual pentavalent vaccine needs, based on the size of the target
population in this kebele.

SAQ 5.2 (tests Learning Outcomes 5.2)


Imagine that in your kebele you plan to deliver two sessions of
immunization per week for 45 weeks of the year. Your Health Post is
provided with PCV10 (Synflorix) vaccine in multi-dose vials of 2 doses
per vial, and at each immunization session 5 vials are used.
. Estimate the annual PCV10 vaccine needs for the Health Post, based
on the size of the immunization sessions.

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Study Session 5 Vaccine Supply and Stock Management

SAQ 5.3 (tests Learning Outcomes 5.1 and 5.3)


If the wastage rate for oral polio vaccine (OPV) is 10%, what wastage
factor would you need to use when calculating the annual OPV needs,
based on the size of the target population?

SAQ 5.4 (tests Learning Outcomes 5.1 and 5.4)


(a) How much PCV10 vaccine would be required by the Health Post
mentioned in SAQ 5.2 for a 2-week period?
(b) What is the minimum stock level for PCV10 vaccine for a 2-week
period for this Health Post?
(c) What is the maximum stock level for PCV10 vaccine in the same
period?

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Study Session 6 The Cold Chain

Study Session 6 The Cold Chain


Introduction
In this study session you will learn about the cold chain — the equipment
and procedures that you will use to keep vaccines within the correct
temperature range (between +2oC and +8oC), so that they remain in good
condition. Vaccines should be stored carefully at all times, beginning at the
factory where they are manufactured and at every stage until the moment
they are given to children and mothers. Excess heat or cold will reduce the
vaccine potency (strength), increasing the risk that recipients will not be
protected against vaccine-preventable diseases.
The cold chain has three main components: equipment for vaccine transport
and storage, well-trained personnel, and efficient management procedures. In
this study session, and the next two sessions, you will learn how all three
components are required to ensure that vaccines are transported and stored
safely.

Learning Outcomes for Study Session 6


6.1 Define and use correctly all of the key words printed in bold. (SAQs
6.1 and 6.2)
6.2 Describe the common types of cold chain equipment and their uses in
your Health Post. (SAQs 6.1, 6.2, 6.5 and 6.6)
6.3 Describe how you can monitor the effectiveness of the cold chain for
vaccines at your Health Post and when you are transporting vaccines.
(SAQs 6.1, 6.2, 6.5 and 6.7)
6.4 Describe how vaccines can be spoiled and how to prevent this from
happening. (SAQs 6.4, 6.6 and 6.7)
6.5 Describe how to load vaccines and diluents correctly into cold chain
equipment. (SAQ 6.3, 6.4 and 6.6)
6.6 Briefly describe how to maintain cold chain equipment (undertake
minor repairs). (SAQs 6.5 and 6.7)

6.1 Components of the cold chain


The cold chain has three main components, each of which must combine to
ensure safe vaccine transport and storage:
. transport and storage equipment
. trained personnel
. efficient management procedures.
This study session is about the first of these components. You can see the
cold chain equipment in Figure 6.1 on the next page, together with the
storage temperatures required at each storage place, from arrival in the
country to the storage in your Health Post. Next we will describe the
common cold chain equipment you will use when you collect vaccines from
the health centre and in your practice at the Health Post and in the
community.

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Vaccine Manufacturer

Vaccines International Transport

Transit storage facility at Bole


Bole International Airport
International Airport (+2° to +8°C)

Transportation with refrigerated trucks and/or cold


National Vaccine Store Cold rooms (+2° to +8°C) and
(PFSA) freezer rooms (-15° to -25°C)
boxes (vaccine carriers for outreach)
Regional Vaccine Stores Cold rooms (+2° to +8°C) and
(RHBs) freezers (-15° to -25°C)

Zonal Vaccine Stores Cold rooms and refrigerators (+2° to


+8°C) and freezers (-15° to -25°C)

Woreda Vaccine Stores Refrigerators (+2° to +8°C)

Health Centre Refrigerators (+2° to +8°C)


and cold boxes

Health Post Refrigerators (+2° to +8°C) cold


boxes and vaccine carriers

Child and Mother

Figure 6.1 The cold chain. (Adapted from: WHO, 2004, Immunization in
Practice, Module 3, The Cold Chain, Figure 3A, p.2)

6.2 Cold chain equipment in Health Posts


The common cold chain equipment used in Health Posts are refrigerators,
cold boxes, vaccine carriers, ice-packs and foam pads. In this section, the
correct use of each of these will be described.

6.2.1 Refrigerators
A refrigerator is a cooling apparatus. Health facility refrigerators may be
powered by electricity, kerosene, paraffin, bottled gas or solar energy. Electric
refrigerators are usually the least costly to run and the easiest to maintain, but
they must have a reliable electricity supply, which is not often possible in
rural Health Posts in Ethiopia. Different refrigerators have different capacities
for storing vaccines and for freezing and storing ice-packs (Figure 6.2).

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Study Session 6 The Cold Chain

Figure 6.2 A Health Extension Worker with a kerosene-powered refrigerator in a


rural Health Post in SNNPR, Ethiopia. This refrigerator has a freezer
compartment on top, and plenty of space for the vaccines, diluents and other
supplies that must be kept cold. (Photos: Janet Haresnape)
A refrigerator in a Health Post should be able to hold:
. One month’s supply of vaccines and diluents in the refrigerator
compartment.
. A minimum stock of one to two weeks’ supply of vaccines and diluents
(i.e. an additional 25% of the standard stock).
. Frozen ice-packs (strong, specially made plastic bottles containing frozen
water) standing in the freezer compartment for at least 24 hours to
become fully frozen.
. Unfrozen chilled ice-packs in the refrigerator compartment (Figure 6.3);
they help to keep the refrigerator cold for a while if there is a power
failure. You can also keep ordinary plastic bottles filled with chilled water
in the refrigerator for the same purpose.

Figure 6.3 These unfrozen (chilled water) ice-packs help to keep the refrigerator
cold during a power failure. They should always be stored vertically to avoid
possible leaks. (Photo: Basiro Davey)

6.2.2 Cold boxes and vaccine carriers


A cold box is an insulated container that can be lined with ‘conditioned’ ice-
packs to keep vaccines and diluents cold — but not frozen — during
transportation of vaccine supplies from the health centre, or to outreach sites.
(We will explain what ‘conditioning’ ice-packs means in the next section.)
Cold boxes can also be used for short periods of vaccine storage (from two Do not put frozen ice-packs into
to seven days, depending on the manufacturer) when the refrigerator is out of the main refrigerator
order or being defrosted, or if vaccines are being transported in a vehicle for compartment! They could cause
the temperature to drop too low
a few days by mobile immunization teams. and destroy the freeze-sensitive
vaccines.

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Cold boxes are quite large. At Health Post level you may instead use a
smaller insulated container called a vaccine carrier (Figure 6.4). Vaccine
carriers are also lined with conditioned ice-packs to keep vaccines and
diluents cold during transportation from the collection store at the health
centre, or on journeys to outreach sites, and for temporary storage during
Health Post immunization sessions. They are smaller than cold boxes and are
easier to carry if walking, but they do not stay cold for as long — at most
36–48 hours with the lid closed (depending on the type).

Figure 6.4 (a) A vaccine carrier lined with conditioned ice-packs. (b) This type of
vaccine carrier stays cold for a maximum of 36 hours if the lid remains closed.
(Photo: Basiro Davey)

6.2.3 Ice-packs
Ice-packs are flat, rectangular plastic bottles filled with water and then either
kept at refrigerator temperature (Figure 6.3 on the previous page), or frozen
and then conditioned for use in vaccine carriers and cold boxes (Figure 6.4a).
The number of ice-packs required for a cold box or vaccine carrier varies.
Every Health Post should have a minimum of two sets of ice-packs for each
of their cold boxes and vaccine carriers, one in the process of being frozen or
refrigerated, and the other conditioned for use in a cold box or vaccine
carrier.

Freezing ice-packs
The proper freezing and conditioning of ice-packs is essential for maintaining
the potency of vaccines. To freeze ice-packs, follow the steps in Box 6.1.

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Study Session 6 The Cold Chain

Box 6.1 Freezing ice-packs

. Fill the ice-packs with water, leaving about 20% air space at the top,
and put the cap on tightly.
. Hold each ice-pack upside down and squeeze it to make sure it does
not leak.
. Put the ice-packs upright in the freezer compartment of the
refrigerator, so that the surface of each ice-pack is touching the
evaporator plate, and close the door.
. Leave ice-packs in the freezer for at least 24 hours to freeze solid.
After 24 hours they should be ready to use.
. After each vaccination session put the melted ice-packs back in the
freezer as soon as possible.

Keep extra unfrozen ice-packs that do not fit in the freezer in the bottom part
of the main refrigerator compartment (look back at Figure 6.3). This helps
the water in these chilled ice-packs to freeze relatively quickly when you put
them into the freezer, and it also helps to keep this section of the refrigerator
cold in case of a power failure.

Conditioned ice-packs and chilled water packs


Conditioned ice-packs have first been fully frozen, and then removed from
the freezer and left at room temperature for a short time (it may take over 30
minutes if the room is cold). Allow the frozen ice-packs to sit at room
temperature until the ice begins to melt and water starts to form. Check to
see if each ice-pack has been conditioned properly by shaking it and listening
for the sound of water moving inside. This prevents the ice-packs from
freezing the vaccines inside a cold box or vaccine carrier, and damaging the
freeze-sensitive vaccines.
Studies conducted in many countries on cold chain temperatures have
revealed that many vaccines are damaged more severely by freezing than by
heat. So it is crucial to use properly conditioned ice-packs or chilled water
packs when transporting freeze-sensitive vaccines like pentavalent, PCV10
and TT. Chilled water packs can be made by almost filling the ice-pack
containers or ordinary plastic water bottles with water and placing them in
the main compartment of the refrigerator for about 24 hours. Using chilled
water packs may be more efficient than using conditioned ice-packs, because
it takes more electricity, gas or kerosene, and more time, to freeze ice-packs
and then condition them. Also, there is a risk that if frozen ice-packs are not
conditioned properly, they may expose freeze-sensitive vaccines to damage
from freezing during transport in vaccine carriers or cold boxes.

6.2.4 Foam pads


A foam pad is a piece of soft foam that fits on top of the conditioned ice-
packs in a cold box or a vaccine carrier (Figure 6.5). There are some cuts in
the foam to allow vaccine vials to be inserted in the pad.

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During immunization sessions, the foam pad can be used as a temporary lid
to keep unopened vaccines inside the carrier cool, while providing a surface
to hold and protect opened vaccine vials and keep them cool (Figure 6.6).
Vaccines are protected from heat damage during an immunization session if
they are inserted in the foam pad above the ice-packs in the vaccine carrier.

Figure 6.5 The foam pad in a vaccine carrier has cuts to hold vials and vaccines
during an immunization session. (Photo: Janet Haresnape)

Figure 6.6 Foam pad with vaccine vials inserted. (Source: WHO, 2004, as in
Figure 6.1, p.8)

6.3 Cold chain monitoring equipment in your


Health Post
It is important to know about the common cold chain monitoring equipment
for keeping a record of the temperature that vaccines and diluents are
exposed to during transportation and storage. The items of equipment used
are vaccine vial monitors, freeze indicators and thermometers.

6.3.1 Vaccine vial monitors


A vaccine vial monitor (VVM) is a label that changes colour when the
vaccine vial or ampoule has been exposed to temperatures above 8ºC over a
period of time. Before opening a vaccine container, the status of the VVM
must be checked to see whether the vaccine has been damaged by heat.
Manufacturers attach VVMs to vials and ampoules of most vaccines. The
VVM is printed on the label or cap, or the neck of ampoules of freeze-dried
vaccines (Figure 6.7). It looks like a square inside a circle. As the vaccine
vial is exposed to more heat, the square becomes darker.

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Study Session 6 The Cold Chain

Figure 6.7 (a) Vaccine Vial Monitors (VVMs) on the neck of an ampoule, or on
the label or cap of a vaccine vial (Source: WHO, 2004, as in Figure 6.1, p.10).
(b) A vial of liquid PCV10 vaccine (Synflorix) with the VVM on the cap (Photo:
WHO).
You should only use vaccines where the inner square in the VVM is lighter
in colour than the outside circle (Figure 6.8, top row). Vials with VVMs in
which the inner square has begun to darken, but is still lighter than the outer
circle (Figure 6.8, second row), should be used first, i.e. before vials where
the VVM square has not begun to darken. Vials with VVMs in which the Do not use vaccines that have
inner square matches the colour of the outer square, or in which the inner reached the discard point, even if
square is darker than the outer circle, have reached or gone beyond the they have not passed their expiry
date!
discard point and should not be used (Figure 6.8, bottom two rows).

Figure 6.8 How to read a vaccine vial monitor (VVM). (Source: WHO, 2004, as
in Figure 6.1, p.11)

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VVMs respond to heat — but not to freezing!


VVMs respond to heat — they do not measure exposure to freezing
temperatures. A vaccine may have been frozen and have lost its potency, but
the VVM cannot tell you this. So even if the VVM indicates that the vaccine
has not been exposed to heat, the vaccine may still have been frozen.
Therefore, for freeze-sensitive vaccines, it is important to establish that they
have not been frozen before using them. Inspect the freeze indicator, as
described next.

6.3.2 Freeze indicators


Freeze indicators are devices used to monitor the exposure of vaccines to
freezing. Freeze indicators are packed with batches of freeze-sensitive EPI
vaccines (pentavalent, PCV10 and TT), as well as with other freeze-sensitive
vaccines such as HepB, which may be used to protect healthcare workers.
The most commonly used type of freeze indicator is the freeze-tag
(Figure 6.9). This is an irreversible temperature indicator that shows if a
product, such as a vaccine, has been exposed to freezing. It consists of an
electronic temperature measuring circuit with a liquid crystal display (LCD).
A small blinking dot of light in the corner of the display shows that the
freeze-tag is functioning correctly.

Figure 6.9 Freeze-tags showing: (a) ‘good status’ display; (b) ‘alarm status’
display. (Photo: WHO)
If the freeze-tag is exposed to a temperature below 0oC (with a range
between +0.3 oC and –0.3 oC) for more than 60 minutes (with a range of
between 57 to 63 minutes), the display will change from the ‘good status’
(Figure 6.9a) to the ‘alarm status’ (Figure 6.9b).
Vaccines that have been exposed to freezing may have been damaged and
should be checked by using the shake test, as described below.

6.3.3 The shake test


The shake test is how you check whether freeze-sensitive vaccines
(pentavalent, PCV10, TT or HepB) have been subjected to freezing
temperatures, which are likely to have damaged them. To perform the shake
test, follow the steps below:
Step 1 — Prepare a frozen control vial: Take a vial of vaccine of the same
type and batch number as the vaccine you want to test, and from the same
manufacturer. Freeze the vial until the contents are solid (at least 10 hours at
–10°C) and then let it thaw. This is the frozen control vial (the middle vial
in Figure 6.10). Mark the vial clearly so that it is easily identifiable and will
not be used by mistake.

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Study Session 6 The Cold Chain

Step 2 — Choose a test vial: Take a vial (or vials) of vaccine from the batch
that you suspect has been frozen. This is the suspected frozen test vial (on
the left in Figure 6.10).
Step 3 — Shake the control and test vials: Hold the frozen control vial and
the suspected frozen test vial together in one hand and shake them vigorously
for 10–15 seconds.
Step 4 — Allow the vials to rest: Leave both vials to rest by placing them on
a table side by side and not moving them further. A freeze-sensitive vaccine
(see the vial on the right in Figure 6.10) that has not been frozen appears as a
uniformly cloudy liquid. After freezing, the vaccine tends to form flakes that
quickly settle at the bottom of the vial to form a sediment when you leave it
to rest after vigorous shaking. The speed at which the flakes settle is called
the sedimentation rate. Note that some vials have large labels that conceal the
vial contents. This makes it difficult to see the sedimentation process. In such
cases, turn the control and test vials upside down and observe sedimentation
taking place in the neck of the vials.
Step 5 — Compare the vials: Observe the difference in sedimentation rates in
the frozen control and suspected frozen test vials for a maximum of 30
minutes. View both vials against the light to compare the sedimentation rate.
If the vaccine in the suspected test vial shows a much slower sedimentation
rate than the vaccine in the frozen control vial, you can conclude that the test
vaccine has most probably not been frozen and can be used.
■ What should you conclude if the sedimentation rate is similar in the
suspected test vial and the frozen control vial?

□ You should conclude that the test vial has probably been damaged by
freezing and the vaccine should not be used.

Figure 6.10 Three vials of liquid freeze-sensitive vaccine viewed with the light
behind them: (left) frozen test vial in which a sediment has settled to the bottom
of the vial after vigorous shaking; (centre) frozen control vial in which the
sedimentation rate can be compared with the rate in a suspected frozen test vial;
(right) non-frozen test vial showing the uniformly cloudy appearance of a vaccine
that has not been damaged by freezing. (Photo: WHO)
The shake test should be conducted for all vaccines with the following
characteristics:
. Vaccines packed in boxes that have a freeze indicator (e.g. freeze tag, see
Figure 6.9), which is found to be activated.
. Refrigerator temperature records that show the temperature has fallen
below +2ºC.

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. Where you suspect that the vaccines may have been frozen by mistake,
for example by placing too close to the freezer plate in the refrigerator, or
touching frozen ice-packs.
If the vaccine fails the ‘shake test’ it must be discarded. There is no need to
conduct a shake test if a liquid vaccine vial is already frozen solid — simply
discard it. Also discard any vials that develop white lumps of sediment
attached to the glass, which cannot be dispersed despite vigorous shaking.
This can happen if pentavalent vaccine is exposed to freezing below 0ºC.

6.3.4 Thermometers
A thermometer is an instrument for monitoring the temperature of your cold
chain equipment — refrigerator, cold box or vaccine carrier. It enables you to
adjust the temperature to the correct range for the storage and transport of
vaccines.
At a Health Post, either a dial or a stem (bulb) thermometer may be used to
monitor the equipment temperature. On a dial thermometer, the needle moves
around the scale, pointing to plus (+) numbers when it is warmer, and to
minus (–) numbers when it is colder (Figure 6.11a). On a stem (or bulb)
thermometer, coloured fluid in the bulb moves up the scale as it becomes
warmer, and down the scale as it becomes colder (Figure 6.11b).
■ What temperature is showing on the thermometers in Figure 6.11? Is this
a safe temperature for the storage of liquid vaccines?

□ Both thermometers are recording a temperature of +5oC. This is safe for


storing liquid vaccines, which should be maintained between +2oC and
+8oC.

6.4 How to load cold chain equipment


Refrigerators, cold boxes and vaccine carriers must be loaded correctly to
keep the temperature of the vaccines and diluents inside within the acceptable
range. All health workers in a Health Post should know how to monitor the
cold chain equipment and what action to take if the temperature is too high
Figure 6.11 or too low.
(a) Dial thermometer, and (b)
stem thermometer. (Source:
WHO, 2004, as in Figure 6.1, 6.4.1 The design of vaccine refrigerators
p.13) All electric powered refrigerators have a thermostat. The thermostat is a
device that automatically responds to temperature changes by activating
switches controlling the cooling equipment to maintain the refrigerator
compartments at the correct temperature. You can alter the setting of the
thermostat if the temperature of the refrigerator is found to be too high or too
low when you check the thermometer. Gas or kerosene refrigerators are
adjusted by altering the size of the flame.
To ensure that the refrigerator is effective for storing your vaccines, there are
a number of guidelines that you should follow (Box 6.2).

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Box 6.2 Guidelines for storing vaccines in a refrigerator

. Do not keep opening and closing the refrigerator door, since this
raises the temperature inside the refrigerator.
. Do not put vaccines on the door shelves. The temperature in this part
of the refrigerator is too warm to store vaccines, and when the door
is opened the door shelves are instantly exposed to room
temperature.
. Discard all expired vaccines (past their expiry date), or vaccines with
VVMs that have reached or are beyond their discard point, or
vaccines that have been reconstituted for more than six hours.
. Do not return reconstituted vaccines (BCG, measles) or opened
PCV10 vials to the refrigerator. They should be discarded at the end
of the immunization session or after six hours, whichever comes
soonest.
. The refrigerator should not be packed too full. Approximately half of
the total space inside should be left empty to allow air to circulate
around the vaccines and diluents and keep them cool.
. Vaccines, diluents and ice-packs should ideally be kept in a separate
refrigerator from other items. However, if your Health Post has only
one refrigerator and you need to store other heat-sensitive supplies in
it, such as drugs, ointments, serum and blood samples, be sure to
label them clearly and keep them on a separate shelf from the
vaccines and diluents.
. Food and drinks should NEVER be stored in a vaccine refrigerator.

There are a number of different types of refrigerator. Some front-loading


refrigerators have one door, with a second freezing compartment inside.
Others have two separate compartments, with different doors (look back at
Figure 6.2, and see the diagram in Figure 6.12).

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Figure 6.12 Front-loading refrigerator with separate freezing compartment on


top. (Source: WHO, 2004, as Figure 6.1, p.18)
The two compartments shown in Figure 6.12 should be used as follows:
. The main compartment (the refrigerator), in which the temperature should
be kept between +2ºC and +8ºC, is used for storing vaccines and diluents.
. The top compartment (the freezer) is used for freezing ice-packs. If the
refrigerator is working properly, this compartment will be between –15ºC
and –20ºC.
Notice the ‘use first’ box, for multi-dose vaccines that have been opened, or
unopened vials that have been taken out for an immunization session but not
used. These vials should be used before other vials.
Boxes containing vials with long expiry dates are stored at the back, and
those with shorter expiry dates are at the front.
Remember that you must not
return opened vials of PCV10
vaccine to the refrigerator; it is a
liquid vaccine without
preservative and once it is
opened any remaining vaccine in
the two-dose vial should be
discarded after six hours or at
the end of the immunization
session, whichever comes
soonest.

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6.4.2 Loading a vaccine refrigerator


A vaccine refrigerator should be loaded as illustrated in Figure 6.12 and as
described in Box 6.3.

Box 6.3 Guidelines for loading a vaccine refrigerator

. Freeze and store ice-packs in the freezer compartment.


. Store all the vaccines and diluents in the refrigerator compartment.
. If there is not enough space, diluents can be stored at room
temperature.
. It is important to chill diluents by putting them in the refrigerator for
several hours before you use them to reconstitute BCG or measles
vaccines.
. Arrange the boxes of vaccine so air can move between them.
. Keep boxes of freeze-sensitive vaccines (pentavalent, PCV10, TT
and HepB) away from the freezing compartment, the refrigeration
plates, and the side or bottom linings of the refrigerator, where they
might become frozen by accident.
. Keep melted ice-packs or ordinary plastic water bottles filled with
chilled water on the bottom shelf of a front-loading refrigerator.
These help to keep the temperature cool in case of a power cut.
. Store vaccines in locations appropriate to the style of refrigerator
you use. For a front-loading refrigerator with the freezing
compartment on the top (Figure 6.12), vaccines should be stored as
follows:
◦ OPV and freeze-dried vaccines (BCG and measles) on the top
shelf
◦ all other vaccines on the middle shelves
◦ diluents on the bottom.
. Some refrigerators have ice-packs lining the freezing compartment.
This type is called an ice-lined refrigerator (Figure 6.13). In this
type, all the vaccines should be stored in the basket provided with
the refrigerator as follows:
◦ measles vaccine, BCG and OPV are stored in the bottom only
◦ freeze-sensitive vaccines (pentavalent, PCV10, TT and HepB)
in the top only.

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Figure 6.13 Storing vaccines in an ice-lined refrigerator. (Source: WHO, 2004,


as in Figure 6.1, p.19).

6.4.3 Loading cold boxes and vaccine carriers


When you are loading vaccines into cold boxes and vaccine carriers before an
immunization session, it is important to follow the steps in Box 6.4.

Box 6.4 Guidelines for loading cold boxes and vaccine


carriers

. At the beginning of the day of the immunization session, take all the
frozen ice-packs you need from the freezer compartment of the
refrigerator and close the door.
. Allow the frozen ice-packs to sit at room temperature until the ice
begins to melt and water starts to form. This is important because if
the ice packs are too cold, freeze-sensitive vaccines may be damaged
by freezing.
. Check to see if each ice-pack has been prepared properly by shaking
it and listening for the sound of water moving around the ice inside.
Ice-packs in which the ice has begun to melt are called conditioned
ice-packs.
. Put conditioned ice-packs against each of the four sides of the cold
box or vaccine carrier, and also on the bottom of the cold box.
Ordinary plastic bottles of chilled water can also be used.
. Put the vaccines and diluents in the middle of the cold box or
carrier.
. In vaccine carriers, place a foam pad on top of the conditioned ice-
packs. In cold boxes, place conditioned ice-packs on top of the
vaccines.
. Close the lid of the cold box or vaccine carrier tightly. It is then
ready to be taken to the immunization session.

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6.5 Maintaining the correct temperature of cold


chain equipment
It is important to maintain the correct temperature in your cold chain
equipment, and to adjust the temperature of your vaccine refrigerator if it is
too high or too low.
■ Why is it important to monitor the temperature of your vaccine
refrigerator?

□ All vaccines are heat-sensitive and most are freeze-sensitive. Therefore it


is important to monitor the temperature of the refrigerator, so that the
vaccines are prevented from becoming too warm or freezing.

6.5.1 Monitoring the temperature of your vaccine


refrigerator
It is important to monitor the temperature of the main section of a
refrigerator, so that you can ensure that it stays within the acceptable range
for storage of vaccines.
■ What is the acceptable temperature range for vaccine storage?

□ It is between +2ºC and +8ºC.

To monitor the temperature of your refrigerator, you will need a thermometer


and a temperature chart (see Figure 6.14), which you should tape to the
outside of the refrigerator door. Then follow the steps in Box 6.5.

Figure 6.14 Temperature chart, showing the safe temperature range and unsafe
temperatures that require adjustment of the thermostat, or checking that the
refrigerator is working properly. (Source: WHO, 2004, as in Figure 6.1, p.23)

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Box 6.5 Guidelines for monitoring the refrigerator


temperature

. Set the refrigerator thermostat during the coldest part of the day to
around +2ºC to +4ºC.
. Measure the temperature of the refrigerator first thing in the morning
and before you leave the Health Post in the evening. If the
temperature is between +2ºC to +8ºC, do not adjust the thermostat.
. Record the temperature at least twice every day (every morning and
every evening, seven days a week) on the refrigerator temperature
chart, as shown in Figure 6.14.

When a temperature monitoring chart has been completed, replace it with a


new one. Keep the completed charts in a record book for future reference.
Action should be taken when the temperature goes out of the safe range, as
illustrated in the example in Figure 6.14.
■ According to Figure 6.14, what was the temperature of the refrigerator
on the 7th day of the month: (a) in the morning, and (b) in the evening?
Would any action have been required to adjust the temperature on that
day, and if so, what should that action be?

□ Based on the temperature chart in Figure 6.14, you should have noticed
that:
(a) In the morning of the 7th day of the month, the temperature of the
refrigerator was about +2ºC, which is within the acceptable
temperature range. No adjustment was needed.
(b) In the evening, the temperature had dropped to below +1ºC, which is
below the acceptable range. The thermostat should have been
adjusted to ‘warmer’, as described in the next section.

6.5.2 Adjusting the temperature of your vaccine refrigerator


The +2ºC to +8ºC safe margin may be difficult to maintain, especially for a
kerosene refrigerator, so you should frequently check the condition of the
vaccines. Here we give some guidelines on what to do if the temperature of
your refrigerator becomes too low or too high.

Kerosene and gas refrigerators


The temperature of a kerosene or gas refrigerator is adjusted by increasing or
decreasing the size of the flame. If the temperature inside the main
refrigerator compartment is too low, you can increase the temperature by
decreasing the flame size. A smaller flame means less cooling, so the
temperature in the refrigerature will rise. If the refrigerator temperature is too
high, you can reduce it by increasing the flame size. A bigger flame means
more cooling, so the temperature in the refrigerature will fall. Monitor the
change in temperature frequently – about every 15 minutes – after adjusting
the flame, until the temperature remains steadily between +2oC to +8oC, to
ensure that it does not rise too high or fall too low.

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Study Session 6 The Cold Chain

Electric refrigerators: if the temperature is too low


If the refrigerator temperature falls too low (below +2°C), you should take
the following actions:
Thermostat dials in most refrigerators are labelled from
1 to 6, where 1 is the warmest and 6 is the coldest setting.
. Adjust the thermostat so that the arrow points to a lower number, e.g. if
the thermostat dial was set at 5, adjust it to 4. This will make the
refrigerator get warmer.
. Check freeze-sensitive vaccines to see whether they have been damaged
by freezing. You can do this by using the shake test, which you learned
about earlier (Section 6.3.3).

Electric refrigerators: if the temperature is too high


If the refrigerator temperature becomes too high (above +8°C), you should
take the following actions:
. Make sure that the refrigerator is working. If not, check if the power
supply is present.
. Check whether the door of the refrigerator or the freezing compartment
closes properly. The seal may be broken, allowing warm air to leak into
the refrigerator. If the seal is broken, it will need to be replaced.
. Adjust the thermostat so that the dial points to a higher number, e.g. if the
dial was set at 3, adjust it to 4. This will make the refrigerator get colder.
. Check whether ice is preventing cold air in the freezing compartment
from entering the refrigerator compartment. If the refrigerator is blocked
with too much ice, it may be necessary to defrost it (remove the ice).
If the temperature cannot be maintained between +2ºC and +8ºC, store
vaccines in another place, such as a vaccine carrier, and try to get the
refrigerator repaired as soon as possible.

6.5.3 Maintaining the correct temperature in cold boxes and


vaccine carriers
It is just as important to maintain the correct temperature in cold boxes and
vaccine carriers as it is in your refrigerator. To do this, you should follow the
steps below:
. Place an adequate number of conditioned (melting) ice-packs or chilled Do not adjust the thermostat to
water bottles in the cold box or vaccine carrier. a colder setting immediately after
a power cut, or just after you
. Always place the cold box or vaccine carrier in the shade – never in a have put a new batch of vaccine
sunny place. into the refrigerator. The
refrigerator could become too
. Avoid opening the lid of your cold box or vaccine carrier except when cold and freeze the vaccines.
you are removing a vaccine, and close it again immediately afterwards.
. Use the foam pad above the conditioned ice-packs to hold vials during
immunization sessions.

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If the ice-packs have completely melted


If you find that the ice-packs inside the cold box or vaccine carrier have
completely melted during an immunization session, you should follow the
steps below:
. Discard all vials of reconstituted vaccines (BCG and measles).
. Check the VVM status of the vaccines, and return those that can still be
used to a refrigerator at the correct temperature as soon as possible.
. Place them in the ‘use first’ box, and use them before other vials at your
next immunization session.

6.6 How to maintain cold chain equipment


In this section we give some basic guidelines on how to maintain your cold
chain equipment.

6.6.1 Maintaining vaccine refrigerators


A refrigerator works well only if it is properly installed, cleaned and
defrosted (ice is removed) regularly. Thick ice in the freezer compartment
does not keep a refrigerator cool. Instead, it makes the refrigerator work
harder and uses more electricity, gas or kerosene. You should defrost the
refrigerator when ice becomes more than 0.5 cm thick, or once a month,
whichever comes first.

What to do when a vaccine refrigerator is out of order


If your vaccine refrigerator stops working, protecting the vaccines is the first
priority. Move them to another cold place until the refrigerator is repaired. If
you think that the problem will last only a short time, you may use a cold
box or vaccine carrier lined with conditioned ice-packs or chilled water
bottles for temporary storage. If the breakdown is likely to last a long time,
you should move the vaccines to another refrigerator as quickly as possible
— for example, by transporting them in a vaccine carrier to the nearest health
centre.
When you have moved your vaccines to a safe place, check the electricity,
gas or kerosene supply that keeps the refrigerator cold. If it is not working
because the gas or kerosene has run out (Figure 6.15), try to get a new
supply delivered as soon as possible. If the breakdown is due to a mechanical
problem, try to repair the refrigerator if you can. If this is not possible, report
the problem to the repair technician and your supervisor at the nearby health
centre. Don’t forget to record the breakdown on the daily temperature
recording chart.

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Study Session 6 The Cold Chain

Figure 6.15 A Health Extension Worker checks the kerosene tank of a kerosene
refrigerator. (Photo: Janet Haresnape)

6.6.2 Maintaining cold boxes and vaccine carriers


. Always dry your vaccine carriers and cold boxes after use. If they are left
wet with the lids closed, they will become mouldy. Mould may affect the
seal of the cold boxes and vaccine carriers.
. Store your cold boxes and vaccine carriers with the lid open if possible,
when they are not being used.
. Avoid placing cold boxes and vaccine carriers in the sun, as sunlight can
cause cracks in their walls and the lids. If a cold box or vaccine carrier
wall has a small crack you may be able to repair it with adhesive tape
until you can get an undamaged one.

Summary of Study Session 6


In Study Session 6, you have learned that:
1 Vaccines should be stored carefully between +2ºC and +8ºC at all times,
from the factory where they are manufactured until they are used. Excess
heat or cold will reduce the vaccine potency (strength), increasing the risk
that recipients will not be protected against vaccine-preventable diseases.
2 Health Posts should have a vaccine refrigerator and enough cold boxes
and vaccine carriers to hold one month’s supply of vaccines and diluents,
and one to two week’s reserve stock, to ensure that routine immunizations
can continue if the refrigerator is temporarily out of working order.
3 Cold chain equipment, including refrigerators, cold boxes and vaccine
carriers, must be loaded correctly to maintain the temperature of the
vaccines and diluents inside. Ice-packs should be conditioned (allowed to
begin to melt) before use in cold boxes and vaccine carriers.
4 Vaccines and diluents should be stored in the refrigerator compartment. If
there is not enough space, diluents can be stored at room temperature, but
they should be chilled to between +2ºC and +8ºC before use.
5 Freeze-sensitive vaccines (pentavalent, PCV10, TT and HepB) should be
kept away from the freezing compartment, refrigeration plates, side linings
or bottom linings of refrigerators, and frozen ice-packs.
6 A vaccine vial monitor (VVM) is a label that changes colour when the
vaccine vial has been exposed to heat over a period of time. Before
opening a vial, the status of the VVM must be checked to see whether the
vaccine has been damaged by heat. Vials which have passed their discard
point should be thrown away.

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7 VVMs do not measure exposure to freezing temperatures. Inspect the


freeze-indicator and use the shake test to make sure that freeze-sensitive
vaccines have not been frozen.
8 A refrigerator works well only if it is properly installed, cleaned and
defrosted (ice is removed) regularly.

Self-Assessment Questions (SAQs) for Study


Session 6
Now that you have completed this study session, you can assess how well
you have achieved its Learning Outcomes by answering the following
questions. Write your answers in your Study Diary and discuss them with
your Tutor at the next Study Support Meeting. You can check your answers
with the Notes on the Self-Assessment Questions at the end of this Module.
SAQ 6.1 (tests Learning Outcomes 6.1, 6.2 and 6.3)
Which of the following statements is false? In each case, explain what
is incorrect.
A Vaccine Vial Monitors (VVMs) measure exposure to freezing
temperatures.
B It is safe to use vaccines that have reached the VVM discard
point if the expiry date has not passed.
C The thermometer is an instrument for measuring the temperature
in a refrigerator.
D Diluents should always be kept in the main refrigerator
compartment.

SAQ 6.2 (tests Learning Outcomes 6.1, 6.2 and 6.3)


Figure 6.16 shows the VVM attached to two different vials of vaccine.
Would you use the vaccines with the VVM shown below in (a) and (b)?
Explain your answer.

Figure 6.16 Vaccine vial monitors (VVMs) for SAQ 6.2.

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Study Session 6 The Cold Chain

SAQ 6.3 (tests Learning Outcome 6.5)


Complete Table 6.1 by putting a cross in the appropriate empty column
for each vaccine to show which shelf it should be stored on in a front-
loading refrigerator.
Table 6.1 Storage of vaccines in a front-loading refrigerator.

Vaccine Top shelf Middle shelf


Measles
Pentavalent or DPT
TT
OPV
BCG
PCV10

SAQ 6.4 (tests Learning Outcomes 6.4 and 6.5)


On Friday, Abeba decides to defrost and clean her refrigerator because a
lot of ice has collected around the freezer compartment. She puts
conditioned ice-packs in a vaccine carrier and then places the vaccines
from the refrigerator in the middle. There is not enough room in the
vaccine carrier for everything, so she puts the diluents on the window
ledge. She thought to herself: ‘The diluents will be safe here until I can
put them back in the refrigerator. Diluent doesn't lose its strength as
vaccine does.’
The following Monday is immunization day at the Health Post and
many children come in for measles immunization. Abeba takes the
measles vaccine out of the refrigerator, but at first she cannot find the
diluent. Eventually she sees it on the window ledge.
(a) Can the diluent be used to reconstitute the measles vaccine?
(b) What should Abeba do before she can immunize the children?

SAQ 6.5 (tests Learning Outcomes 6.2, 6.3, 6.4 and 6.6)
Figure 6.17 shows a dial thermometer used to measure the temperature
of a vaccine refrigerator. Is this temperature safe for storing vaccines?
What actions should be taken?

Figure 6.17 Refrigerator dial. (Photo: Basiro Davey)

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SAQ 6.6 (tests Learning Outcomes 6.2, 6.4 and 6.5)


How do you keep the following vaccines cold during an immunization
session?
(a) Vaccine in opened vials that you are using.
(b) Vaccine in unopened vials.

SAQ 6.7 (tests Learning Outcomes 6.3, 6.4 and 6.6)


Look at the refrigerator temperature chart in Figure 6.14.
(a) What was the temperature on the 11th day of the month, and what
actions should the Health Extension Practitioner have taken on that
day?
(b) What happened on the 12th day of the month, and what actions
should have been taken then?

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Study Session 6 The Cold Chain

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Study Session 7 Immunization Safety


Introduction
Immunization programmes will only be successful if immunization is
practised safely. In this study session, you will first be reminded about how
to keep vaccines safe and give injections safely (already taught earlier in this
Module). You will also learn in more detail how to identify vaccine reactions
and what to do if adverse events following immunization (AEFIs) occur.
Finally, we will explain about methods of safe disposal for used injection
equipment, discarded vaccines, vials and ampoules, and other waste such as
used cotton swabs.

Learning Outcomes for Study Session 7


When you have studied this session, you should be able to:
7.1 Define and use correctly all of the key words printed in bold.
(SAQs 7.1, 7.2, 7.3 and 7.5)
7.2 Explain how to keep vaccines safe and maintain their quality,
including the correct practices for using multi-dose vials.
(SAQs 7.2, 7.3 and 7.4)
7.3 Describe how to deliver safe injections in immunization sessions,
how to treat mild vaccine reactions, and how to avoid adverse events due
to programme errors in your immunization service. (SAQs 7.2 and 7.4)
7.4 Identify clients with contraindications to immunization and describe
the appropriate actions to take if adverse events following immunization
(AEFIs) occur. (SAQs 7.3 and 7.4)
7.5 Describe the equipment and methods used for safe waste disposal
during and after immunization sessions. (SAQs 7.2 and 7.5)

7.1 Importance of immunization safety


Immunization practice that is not safe affects not only the individual
receiving the vaccine, but can also affect you and others in the community.
Immunization injections are safe when the correct and potent vaccine is
properly administered with sterile equipment that is subsequently disposed of
safely.
Immunization safety includes the following components, which will be
described in detail in the following sections of this study session:
. vaccine quality and safety
. injection safety
. avoiding adverse events following immunization (AEFIs)
. safe waste disposal.
The organisation of immunization sessions, good communication with
parents, other caregivers, and the community, and the collection and
monitoring of immunization data, are also crucial requirements for a safe and
effective immunization programme. You will learn about immunization
programme management in Study Session 8, communication and advocacy on
immunization in Study Session 9, and techniques for monitoring your
immunization programme in Study Session 10.

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Study Session 7 Immunization Safety

7.2 Vaccine quality and safety


7.2.1 Vaccine quality
Using vaccines of high quality is very important in order to protect your
community against vaccine-preventable diseases. Using poor quality vaccines
can have an adverse effect on the individual, and is also likely to upset the
community as a whole, for example if there is an outbreak of a disease that
should have been prevented by your immunization programme (Figure 7.1).

Figure 7.1 The confidence of mothers in the safety and quality of the
immunization programme is crucial to its success. (Photo: Steve Evans, accessed
from Wikimedia Commons)
The first check on the quality of vaccines supplied to health facilities in
Ethiopia is made by a national body authorised for this purpose. Other checks
follow on their condition at every stage in the transport to health facilities
around the nation. However, once vaccines are in your care, you are
responsible for maintaining their quality by storing them at an appropriate
temperature until they are used. All vaccines are sensitive to heat, most
cannot be frozen, and some are damaged by bright light; so it is crucially
important to ensure that they are not exposed to heating or freezing, and are
kept out of direct sunlight. Therefore, as you learned in Study Session 6, the
cold chain should be maintained at all times, from the original manufacturer
of the vaccine until the moment of administration to your clients.

7.2.2 Safety of the cold chain


If vaccines are spoiled by incorrect storage conditions, they will not be
effective in preventing the associated disease, and they could also cause
adverse reactions. This is also true for the diluents (ampoules of special
liquid) used to reconstitute the freeze-dried (powder) BCG and measles
vaccines before use. Each of these vaccines has its own specific diluent,
which cannot be used for another vaccine. Diluents can be stored at room
temperature if there is no room for them in the refrigerator, but before use
they must be completely chilled to between +2oC and +8oC, so they reach the
same temperature as the vaccine they are being mixed with.
■ Which vaccines and diluents available for routine use in the EPI in
Ethiopia should not be frozen? What action should you take if freezing
occurs?

□ Pentavalent vaccine, PCV10, TT and OPV should not be frozen. Also,


the diluents for reconstituting BCG and measles vaccines should not be
frozen. If any of these vaccines or diluents becomes frozen, they are no
longer effective and should be discarded.

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■ Which vaccines can be frozen (under exceptional circumstances) for


temporary storage?

□ The only EPI vaccines in Ethiopia that can be frozen are the freeze-dried
powder vaccines (BCG and measles) before reconstitution. Normally, all
vaccines should be stored at between +2ºC and +8 ºC in the main
(chilled) compartment of the vaccine refrigerator.

7.2.3 Multi-dose open vial policy


WHO Policy Statement, 2000, The use of opened multi-dose vials of vaccine
in subsequent immunization sessions.
In order to reduce vaccine wastage, the Ethiopian Federal Ministry of Health
(FMOH) and the World Health Organization (WHO, 2000) have developed
guidelines on how to continue using vials of some types of vaccines once
they have been opened, so they are not discarded unnecessarily at the end of
the immunization session. These vaccines are supplied in multi-dose vials
containing preservatives, so each vial can be used for many doses. Opened
vials that are returned to the refrigerator must be labelled with the date they
were opened, so you know when to discard them.
Opened vials of OPV and TT vaccines are the only EPI vaccines used in
Ethiopia that can be used in subsequent immunization sessions within four
weeks until the vaccines in the vials are fully used, provided that all five
conditions in Box 7.1 are maintained. These conditions must be observed at
every immunization session at the Health Post or at an outreach site.

Box 7.1 Conditions for using opened vials of multi-dose


vaccines

Expiry dates are written in the European calendar (not the Ethiopian
calendar).
. The expiry date has not been passed, i.e. the date after which the
vaccine should not be used for immunization.
. The vaccines have been stored between +2oC and +8oC under
appropriate cold chain conditions at all times.
. The vaccine vial has not been submerged in water (e.g. from leaking
ice-packs in a vaccine carrier).
. The vaccine vial monitor (VVM), if attached, has not reached its
discard point (look back at Figure 6.8 in Study Session 6).
. A new sterile needle and syringe and standard infection-control
procedures have been followed to prevent contamination of vials
when vaccine doses were withdrawn previously.
Standard procedures to reduce the risk of infection, contamination and
injuries were taught in Study Session 4.
(Source: Adapted from WHO, 2004, Immunization in Practice,
Module 3, The Cold Chain, p.16)

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Study Session 7 Immunization Safety

■ Why do you think it is important to prevent opened vials from being


submerged in water?

□ The rubber membrane protecting the top of an opened vial has been
pierced by needles whenever previous doses were withdrawn, so water
could get into the vial if it becomes submerged.

If the conditions in Box 7.1 have been maintained, opened vials of OPV and
TT vaccines may be returned to your refrigerator at a temperature between
+2oC and +8oC after an immunization session. Put them in the ‘use first’ box
to remind you that they should be used first (before unopened vials) the next
time you give immunizations with these vaccines. (Look back at Figure 6.12
and note the position of the ‘use first’ box in the front-loaded refrigerator.)
Vaccines that should not be returned to the refrigerator after an immunization
session are:
. opened vials of reconstituted BCG and measles vaccines
. opened vials of PCV10 vaccine (which does not contain a preservative).
These vaccines must be discarded 6 hours after reconstitution, or at the end
of each immunization session — whichever comes first.
If a PCV10 vial is opened for one child and another is not immediately
available to be vaccinated with the remaining dose in the two-dose vial, you
should:
. write the time that the vial was opened on the vial so you can discard it
after 6 hours if it has not been used
. ensure that the vial is kept cool in the foam pad of the vaccine carrier
. ensure that the vial is kept away from potential contamination.
Any unopened vials of vaccine – including unopened pentavalent vaccine,
which is supplied in single-dose vials – can be returned to the refrigerator at
the end of an immunization session, providing that the expiry date has not
passed, storage under cold chain conditions has been maintained at all times,
and the VVM has not reached the discard point.
However, if the VVM indicates that the vaccine has reached its discard point,
then it should of course be thrown away and not used. Any vaccine which
has passed its expiry date should also be discarded. You will learn how to do
this safely later in this study session.

7.4 Injection safety


Safety in giving injections is essential for both the client and the provider.
Unsafe injections can lead to the transmission of diseases such as HIV and
hepatitis. Unless the waste materials of the injection process are disposed of
safely, they may result in the spread of infection and cause injury.
A safe injection is one that:
. does not harm the recipient
. does not expose the provider to any avoidable risk
. does not result in dangerous waste.

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You learned in detail about the equipment for giving safe injections in Study
Session 4. Here we will remind you of the main types that may be available
at your Health Post:
. Disposable, sterile, single-use syringes and needles, which are used once
only and then disposed of safely. They are commonly used for mixing
freeze-dried vaccines (BCG and measles) with their diluents and should
never be re-used.
. Auto-disable (AD) syringes, which are the preferred type of injection
equipment for administering vaccines and should replace all other
injection equipment if possible. These are used once and cannot be re-
used, because the plunger of the syringe cannot be pulled back again once
it has been pushed forward to inject the vaccine.
. Pre-filled, single-use syringes, which already contain a single dose of the
vaccine, and are made by the manufacturer in such a way that they can
only be used once.
All types of injection equipment must be disposed of safely after use, as
described later in this study session. But first, we remind you of the
circumstances in which immunizations should not be given.

7.4 Contraindication to immunization


The EPI policy recommends that health workers should use every opportunity
to check whether eligible children have been immunized, and to immunize
them if they have not received all scheduled doses of all the EPI vaccines at
the correct age. However, as you already know from Study Sessions 2 and 3,
sometimes a child may be temporarily or permanently unfit to receive a
specific vaccine. This is called a contraindication to immunization.
Minor illnesses such as upper respiratory tract infections or diarrhoea, with
low-grade fever below 38.5oC, are not contraindications for immunizing
children with EPI vaccines. Infants with a moderate or severe fever (above
38.5ºC) should be considered as temporarily unfit for vaccination until their
condition improves. A good rule to follow is that:
. if you are seeing a sick child at the Health Post and he or she is well
enough to go home
. or you have no reason to refer a sick child that you have seen at home
. then the child is well enough to be immunized.
However, there are some absolute contraindications to immunization, which
mean that a child should not be immunized (Box 7.2 on the next page). You
need to be aware of these conditions, because they may seriously affect a
child if he or she is immunized.
The contraindications for individual vaccines were explained in Study
Sessions 2 and 3 of this Module.

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Box 7.2 Absolute contraindications to immunization with


EPI vaccines

. Do not give another dose of pentavalent or PCV10 vaccine to a


child who developed convulsions or a severe allergic reaction soon
after, or within three days, of receiving the previous dose. Severe
acute allergic reactions include generalized skin itching, skin rash,
difficulty in breathing, swelling of the mouth and throat, and signs of
shock (low blood pressure and rapid pulse rate); the symptoms
quickly get worse (this is what ‘acute’ means).
. Do not give any doses of pentavalent PCV10 vaccine to a child with
recurrent convulsions, or another active neurological disease of the
central nervous system (brain and spinal cord).
. Do not give BCG or PCV10 vaccines to HIV-positive infants with
AIDS, or symptoms of HIV infection including chronic lung
infections, tuberculosis and persistent serious diarrhoea.

■ Why do you think symptomatic HIV infection (with symptoms) is an


absolute contraindication for BCG vaccination? Think back to what you
learned about BCG vaccine in Study Session 2, and the effect of HIV on
the immune system (Communicable Diseases Module, Part 3.) Note that HIV-positive
asymptomatic infants (without
□ BCG vaccine contains live-attenuated TB bacteria. The defence against symptoms) should receive all EPI
infection in people with symptomatic HIV infection is very low, because vaccines at the earliest age
possible, according to the
HIV has damaged their immune system. If they are given BCG vaccine,
nationally recommended EPI
they can develop tuberculosis. schedule.

7.5 Adverse events following immunization


(AEFIs)
An adverse event following immunization (AEFI) is the term used to
describe any adverse event that takes place after immunization, which may or
may not be caused by the immunization. There are five categories of AEFIs
defined in Table 7.1 below.

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Table 7.1 Categories of adverse events following immunization (AEFIs).

Adverse events Description


Vaccine reaction Event caused or precipitated by the vaccine when
given correctly, and due to the inherent properties of
the vaccine
Programme error Event caused by an error in vaccine preparation,
handling or administration
Coincidental event Event that happens after immunization but is NOT
caused by the vaccine, i.e. it is a chance association
Injection reaction Event caused by anxiety about, or pain from, the
injection itself rather than the vaccine
Unknown cause Event for which the cause cannot be determined
despite thorough investigation

7.5.1 Mild reactions to vaccines


As you already know from Study Sessions 2 and 3, most immunizations do
not cause any serious health problems. Any vaccine reactions that do occur
are usually mild and last only a day or two. They may include:
. swelling, soreness and redness at the injection site
. a low-grade fever, particularly after pentavalent, DPT or measles
vaccination
. a slight rash, most often after measles vaccination
. some babies may display irritability (they are easily upset), or malaise
(they seem low in energy and not interested in anything), particularly after
pentavalent vaccination.
However, if scheduled doses of vaccines are not given because of mild
reactions to a previous dose, this will lead to delayed immunization, or no
immunization at all. If you allow this to happen, you will miss opportunities
to protect children from vaccine-preventable diseases. Therefore, you should
take every opportunity to immunize children, even if they have experienced a
mild reaction previously.

Managing mild vaccine reactions


Advice on managing the common vaccine reactions should be given to
parents, as well as instructions to return if there are more serious symptoms.
This will help to reassure parents about immunization and prepare them for
these common reactions.
Paracetamol is useful for the common minor reactions. It eases pain and
reduces fever. A feverish child can be cooled with a tepid sponge or bath,
and by wearing cool clothing. Extra fluids need to be given to feverish
children. For a local reaction, a cold cloth applied to the site may ease the
Paracetamol may be needed to pain.
reduce fever. However,
paracetamol should NEVER be
given before vaccination because 7.5.2 Serious vaccine reactions
it reduces the effectiveness of the On rare occasions, a reaction to a particular vaccine can be serious, even so
vaccine, i.e. the vaccine works
less well in children who have serious as to be life-threatening. When serious problems follow an
taken paracetamol. immunization, rumours are likely to circulate in the community that
immunization is not safe, and children may then not be brought by parents

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for immunization. This will have a damaging effect on the spread of


infectious diseases in the community.
■ Can you explain why a measles epidemic is likely to occur in a
community if not enough children receive measles vaccine?


The reason is because the herd immunity in the population will be too You learnt about herd immunity
low to prevent the measles viruses from spreading; it can pass from in Study Session 1.
infected children to the many susceptible children who have not be
immunized.

Table 7.2 summarises the possible serious adverse reactions to different


vaccines that you may very rarely encounter. For example, acute flaccid
paralysis following OPV occurs about once in every 1–10 million children
vaccinated.
Table 7.2 Possible onset of serious vaccine reactions.

Vaccine Serious adverse event Estimated period of onset (time after


immunization)
BCG Abscess (collection of pus) 1–6 weeks
Swollen lymph nodes in the armpit 2–6 months
Bone disease 1–12 months
Pentavalent or DPT Severe acute allergic reaction 0–1 hour
Continuous screaming 0–24 hours
Brain disease, seizures (convulsions, fits) 0–3 days
Abscess 1–6 weeks
HepB Severe acute allergic reaction 0–1 hour
Paralysis 1–6 weeks
Measles Severe acute allergic reaction 0–1 hour
Abscess 1–6 weeks
OPV Acute flaccid paralysis 4–30 days
TT (women) Severe acute allergic reaction 0–1 hour
Nerve damage in the arm 2–28 days

However, most adverse events following immunization are not due to


reactions caused by the vaccine. We will look at the other causes of AEFIs
next.

7.5.3 Other causes of AEFIs


The most common causes of AEFIs are programme errors.

Programme errors
A programme error is the term given to an error caused by improper use of
safety procedures or injection techniques. Common programme errors are
summarized in Box 7.3.

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Box 7.3 Incorrect immunization practices leading to


possible AEFIs

. Failure to store vaccines correctly: inadequate maintenance of the


cold chain at all times, leading to heat-damage or freezing of
vaccines.
. Reconstitution errors: incorrect reconstitution of freeze-dried
vaccines through use of the wrong diluent, the wrong amount of
diluent, inadequate mixing of the vaccine powder with the diluent, or
use of diluents at room temperature (they should be chilled to
between +2ºC and +8ºC, the same temperature as the vaccine before
mixing).
. Administration of vaccine by the wrong injection route:
e.g. subcutaneous injection of BCG (it should be given
intradermally), or subcutaneous or intradermal injection of
pentavalent, PCV10 or TT vaccines (they should all be given
intramuscularly).
. Administration of vaccine into the wrong site: e.g. giving
intramuscular injections to infants in the buttocks, instead of in the
outer thigh muscle; this error can lead to nerve damage.
. Administration of contaminated vaccine or diluent, or using unsterile
injection equipment: this transmits infection and may cause a local
abscess, or a more serious blood-borne infection such as HIV or
hepatitis.
. Re-use of vaccines beyond their discard point or expiry date, or
re-use of reconstituted vaccines or opened vials of PCV10 after more
than 6 hours; these vaccines should be discarded and should never be
returned to the refrigerator after an immunization session.
. Contraindications ignored, e.g. when a child who has had a severe
reaction after a previous dose of a vaccine is immunized with the
same vaccine, or a child with symptomatic HIV infection is given
BCG or PCV10 vaccines.

Programme errors are mostly related to mistakes made by the health worker,
which can be prevented through proper training. They may also be due to
faulty equipment (e.g. a badly functioning refrigerator), or inadequate
supplies of sterile injection equipment and other essential materials.

Coincidental events
An adverse event that follows an immunization may not have any association
with the vaccine or the vaccination procedure – it may simply be due to
coincidence. For example, a child may already be in the latent period of an
infection, i.e. already infected but not yet showing any symptoms. When the
symptoms appear a day or two after the immunization, the parents may
conclude — incorrectly — that the vaccine has caused the infection. It is
important that you investigate all AEFIs and explain to parents and the
community why and how adverse events may follow an immunization simply
as a chance effect.

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Injection reactions
Sometimes the fear of being injected with a needle or the pain from the
injection may cause a child to become very upset, perhaps even fainting or
vomiting. This may also occur occasionally in women given TT vaccine.
Take care to reassure the vaccinated person and any caregiver who is with
them that the vaccine itself is harmless and their symptoms are due to
anxiety, which will rapidly disappear.

AEFIs of unknown cause


Very rarely an adverse event occurs following immunization that cannot be
attributed to any known cause, despite thorough investigation. You need to be
alert to the possibility that unfounded rumours about a vaccine may start to
circulate in the community. Be honest about the situation and explain that the
cause is unknown but it is very unlikely to be due to the vaccine. You must
report the AEFI so that the health authorities with responsibility for vaccine
safety can record the event in case another similar event occurs following this
vaccine, for example in another part of the country.

7.5.4 How to avoid AEFIs


In order to avoid AEFIs as much as possible, you should follow these
guidelines:
. Fulfil the five requirements for using opened multi-dose vials (see
Box 7.1).
. Do not vaccinate clients with absolute contraindications to immunization
(see Box 7.2).
. Always reconstitute vaccines with the diluent supplied by the
manufacturer. Never use another diluent.
. Discard reconstituted vaccines and PCV10 six hours after reconstitution,
or at the end of the immunization session, whichever comes first.
. Do not keep other drugs in vaccine refrigerators if at all possible. If you
have to keep other injectable drugs in the same refrigerator, put them on a
separate shelf. AEFIs are likely to occur if you give an injection of a drug
instead of the vaccine by mistake, or use a drug instead of the correct
diluent.
. Prepare immunizations in a clean area where contact with blood and body
fluids is unlikely.
. Use a sterile needle and syringe to prepare every injection dose
immediately before administering it. Do not prepare several syringes in
advance and do not re-use injection equipment.
. Do not touch the needle and never leave it in the top of the vaccine vial.
. The child should be held firmly, so that there cannot be a sudden
movement during the injection.
. If you use auto-disable (AD) syringes, AEFIs due to contamination should
not occur.

Do not leave the


needle in the vial!

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7.5.5 Detecting and responding to AEFIs


In your immunization activities, you should monitor, investigate, treat, refer
and report the following AEFIs:
. all injection site abscesses
. all swelling in the armpit, particularly after BCG immunization
. all hospitalizations following immunization that occur within one month
. any other severe or unusual medical incident following immunization
within one month
. all deaths that occur within one month of an immunization
. all medical events believed to be caused by immunization and about
which people are concerned.
If you come across a suspected case of AEFI you should treat the affected
person within your professional capacity, as described in Study Sessions 2
and 3, and refer him or her urgently to a higher health facility for further
investigation and treatment. The patient should be accompanied by a
responsible caregiver who has a clearly written referral note from you,
explaining all relevant details.
If the AEFI is related to a known programme error, you must take immediate
action to correct the cause. Liaise with the parents and community leaders to
explain the cause of the AEFI, if it is known. You will learn more about
communication in immunization programmes in Study Session 9.
■ A mother brings you an infant who has a large abscess on his arm. The
abscess is at the site where you gave him an immunization against BCG
ten days previously. What action should you take?

□ Keep the site of the abscess clean. Give amoxicillin syrup three times
daily and refer the child urgently to a higher health facility.

All AEFIs, including those reported immediately during the month, should be
counted in routine, written, monthly surveillance reports. (You will learn how
to do this in Study Session 10.)

7.6 Safe waste disposal


The immunization programme should not put the community in any danger.
Proper disposal of waste is an important issue and should always be planned
from the very beginning. In particular, you need to plan how you will dispose
of the used vials, ampoules, syringes and needles after an immunization
session.
Disposal of medical waste is also taught in the Hygiene and Environmental
Health Module, Part 2.
■ What other waste will need to be disposed of?

□ There will also be contaminated cotton swabs for cleaning the skin with
alcohol or antiseptic before giving an injection, and pressed onto the
injection site afterwards.

In this final section, you will learn about possible methods of disposing of
waste safely. You may not have access to the best waste disposal method, so
you may need to think about what innovations could be made to ensure that

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you keep the environment safe for the local community. You will need to
select the most appropriate disposal method and site for the particular
circumstances in your area.

7.6.1 Safety boxes


In order to avoid anyone being pricked by used needles and other ‘sharps’
(e.g. lancets), they should always be discarded with care. Immediately after
injecting a vaccine, the syringe and needle should be placed in a nearby
Safety Box (Figure 7.2).
Needle-stick injuries can transmit
blood-borne infections! Do not
try to recap the needle, because
in doing this you could easily
prick your finger.

Figure 7.2 (a) Safety box in an immunization clinic. (Photo: Basiro Davey); (b)
Do not overfill the safety box!
A five-litre safety box can hold about 100 needles and syringes. It is
important not to wait until the safety box is completely full before disposing
of it. It should be closed when it is about three-quarters full.
■ Can you explain why safety boxes should not be overfilled?

□ If the safety box is full, you could injure yourself on something sharp
near the top of the box when you try to add more injection equipment.

7.6.2 Incineration and other methods of burning waste


Incineration means burning at very high temperatures under controlled
conditions in an incinerator designed for this purpose. Incineration is a good
way of disposing of waste, because it completely destroys needles, syringes,
glass vials, and infectious agents by burning at very high temperatures. Figure 7.3:
However, you may not have an incinerator (also known as a ‘protected An incinerator used for burning
hearth’) within reach of your Health Post. You could discuss the need for a healthcare waste. (Photo:
proper facility for waste disposal with others in your community, such as Muluken Azage)
Agricultural Extension Workers and kebele leaders. It might be possible to
build an incinerator for you all to use (Figure 7.3).

Burning in a metal drum (container burning)


If you can get a suitable container such as a metallic drum with both ends
removed (Figure 7.4), you can burn your medical waste in it. The drum
should be placed in a fenced area that has been cleared for this purpose.
Place four bricks on the ground, with spaces between them and a metal
screen or grate on top. Place the open base of the drum on the metal screen
and put another screen on top. The metal screens are to allow air to flow
around the burning waste so the fire gets hotter, and to reduce the amount of
ash flying out of the top. Put the safety boxes and some paper, dry leaves, or
small sticks into the drum, sprinkle them with a small amount of kerosene (if

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available). Put paper under the drum, between the bricks, and set light to it so
the flames rise through the metal screen.
When the waste has completely burned and everything has cooled, put on
heavy protective gloves and carefully scrape out any tiny pieces remaining in
the bottom of the drum. Put them in a box and carry it to the Health Post
waste pit for burial (see below).

Open pit burning


Open pit burning of waste is a common practice in many rural communities
(Figure 7.5). The pit should be dug at least 2 metres deep in a fenced area.
The waste should be placed in a closed and sealed box, such as a safety box,
Figure 7.4 Burning a to be burnt. However, the problem with this method is that unburnt pieces
safety box in a metallic may be blown by the wind and scattered around the pit, or the fire may go
drum. (Source: WHO, out and not destroy some of the waste. Ideally, you should watch while the
2004, Immunization in waste is burning until you can see that everything in the box has been
Practice, Module 4, completely burnt. When the pit is three-quarters full of burnt waste, it should
Ensuring safe injections,
be covered with a deep layer of soil and (if possible) topped with concrete. It
Figure 4I, p.17)
should be clearly marked so that everyone is aware that they must not dig up
the contents.

Figure 7.5 Open pit burning of healthcare waste. Note the fence around the area.
(Photo: Muluken Azage)

7.6.3 Burying without burning


This method of disposing of medical waste involves digging a deep hole
(known as a sharps pit) in a fenced area and burying the waste in the safety
box, or another sealed container. If possible, the pit should be constructed
with cement walls and a water-tight cover. It may be difficult to find a large
Do not bury used injection enough space for repeated disposal of waste by this method. If the hole is not
equipment in an open cardboard deep enough, the waste might become exposed when the top soil is washed
box. away by rain or wind. Children or animals may dig up the waste unless the
pit is protected by a secure fence. For these reasons, this method should be
regarded as a last resort as the primary method of waste disposal. However, a
pit should be constructed for burial of any small fragments remaining after
waste has been burnt in an incinerator or metal container.
In the next study session we turn to other aspects of immunization
programme management, in particular how you can increase the coverage rate
in your catchment area.

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Summary of Study Session 7


In Study Session 7, you have learned that:
1 Safe immunization is essential in order to have a successful immunization
programme.
2 Immunization safety should include everyone involved: the client, the
health worker and the community as a whole.
3 You should follow standard infection-control procedures, and the
guidelines on vaccine preparation and the re-use of open multi-dose vials,
to ensure that vaccines and immunizations are safe and effective.
4 Most vaccine reactions are mild and should not prevent the child from
being immunized again. Serious adverse events following immunization
(AEFIs) are rare, and are often due to programme errors by health
workers. They may also be due to anxiety about the pain of an injection,
or they may be coincidental events or due to unknown causes.
5 Children with a minor illness (e.g. low-grade fever, respiratory infection,
diarrhoea) should still be immunized according to the routine EPI
schedule. Manage their symptoms and reassure their parents.
6 Absolute contraindications to immunization are convulsions or a severe
acute allergic reaction soon after a previous dose, or existing neurological
disease. Infants with symptomatic HIV/AIDS should not be given BCG or
PCV10 vaccines.
7 Serious AEFIs should be reported immediately. All AEFIs should be
reported in monthly written surveillance reports.
8 Immunization waste must be disposed of safely to ensure that there is no
danger to the community. If an incinerator or protected hearth is not
available locally, safe waste disposal can be achieved by container burning
or open pit burning in a protected area, or (if there is no other alternative)
burial in a sharps pit protected by a fence.

Self-Assessment Questions (SAQs) for Study


Session 7
Now that you have completed this study session, you can assess how well
you have achieved its Learning Outcomes by answering the following
questions. Write your answers in your Study Diary and discuss them with
your Tutor at the next Study Support Meeting. You can check your answers
with the Notes on the Self-Assessment Questions at the end of this Module.
SAQ 7.1 (tests Learning Outcomes 7.1 and 7.3)
(a) What is meant by a safe injection?
(b) Give three examples of possible programme errors in vaccine
preparation or administration.

SAQ 7.2 (tests Learning Outcomes 7.1, 7.2, 7.3 and 7.5)
Which of the following actions could result in an infection being
transmitted to your clients when you inject them with a vaccine? In each
case, explain why or why not.
A Allowing a freeze-sensitive vaccine to become colder than +1oC
for a short time.
B Allowing opened multi-dose vials of vaccine to become
submerged in melted water in a vaccine carrier.

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C Using auto-disable syringes for every immunization.


D Removing the cap from a disposable needle and holding it by the
adaptor before you fit it onto the syringe.
E Attempting to replace the cap on a used needle before you place it
in the safety box.

SAQ 7.3 (tests Learning Outcomes 7.1, 7.2 and 7.4)


Five minutes after you immunized a 6-week-old baby with her first dose
of pentavalent vaccine, she became short of breath and developed a
widespread rash. Her pulse became rapid and her blood pressure
dropped.
(a) What is the name for this condition?
(b) What action should you take? (You will need to think back to earlier
Modules in this curriculum to answer this part of the question fully.)

SAQ 7.4 (tests Learning Outcomes 7.2, 7.3 and 7.4)


Which of the following children should not be given an immunization
and why?
(a) A healthy-looking one-week-old baby girl who you know is
probably HIV-positive.
(b) A 10-week-old boy who developed a low-grade fever soon after the
first pentavalent immunization, which lasted about 24 hours.
(c) A 10-week-old boy who had a convulsion soon after the first
pentavalent immunization.

SAQ 7.5 (tests Learning Outcomes 7.1 and 7.5)


List one potential disadvantage of each of the following methods of
disposal of a safety box containing used needles and syringes after an
immunization session:
(a) An incinerator at a health centre.
(b) Burning in a metal container.
(c) Burning in an open pit.
(d) Burying without burning in a sharps pit.

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Study Session 8 Immunization Programme


Management
Introduction
For more details of health planning, see Study Sessions 12 to 16 of the
Health Education, Advocacy and Community Mobilisation Module, Part 2.
This study session is on the effective management of the immunization
programme in your catchment area. We will show you how to plan,
implement, monitor and evaluate your immunization activities, with the
overall goal of increasing the immunization coverage rate in your community
and sustaining the increase over time. First, you will learn how to prepare an
annual plan of the immunization programme for your Health Post and
measure progress towards meeting your objectives. Then, we show you how
to prepare for your actual immunization sessions, either in a fixed facility
(such as your Health Post), or in outreach activities or mobile delivery teams.
You have already learned how to calculate the resources you will need in
Study Session 5, and you may need to refer back to those calculations as you
read this study session.

Learning Outcomes for Study Session 8


When you have studied this session, you should be able to:
8.1 Define and use correctly all of the key words printed in bold.
(SAQs 8.1, 8.2 and 8.3)
8.2 Describe the principles and concepts of planning an efficient
immunization programme, and summarise the six steps in the planning
process. (SAQs 8.1, 8.2 and 8.3)
8.3 List some common indicators of progress in monitoring and
evaluating an immunization programme. (SAQ 8.3)
8.4 Explain how you would determine the immunization eligibility of an
infant or woman who does not have an immunization record card. (SAQs
8.3 and 8.4)
8.5 Describe how to set up before an immunization session and what you
should do after it has ended. (SAQs 8.4 and 8.5)
8.6 Describe how an immunization session should be managed at a fixed
site, an outreach site and a mobile delivery service. (SAQ 8.5)

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8.1 Planning your immunization programme


For any activity to improve the health and wellbeing of your community, you
need to have a plan. It is often said that if you fail to plan, you plan to fail.
As a Health Extension Practitioner you will be expected to develop an annual
immunization action plan that can reach all the children and women in your
catchment area. Thus, careful planning is an important activity that every
Health Extension Practitioner must undertake.

8.1.1 Collecting basic information about the community


Before you can begin to make an effective plan for any health intervention,
you must first collect some basic information about the community you serve.
For example:
. The size of the total population of your kebele, and the size of the target
population — in this case, clients for immunization.
. A map of your kebele showing the location of homes, health facilities and
other buildings, and geographical features such as paths, ponds, rivers or
forests. (Figure 8.1)

Figure 8.1 Map of a rural kebele around Fura Health Post in the Southern
Nations, Nationalities and Peoples Region (SNNPR) of Ethiopia. (Photo: Basiro
Davey)
. The distances (in kilometres, or travel time by walking) between the
health centre and your Health Post, and between the Health Post and the
furthest members of the community (Figure 8.2).

Figure 8.2 Routes that local people can take to reach the Health Post are visible
in this map from a rural kebele near Butajira in the Oromia region of Ethiopia.
(Photo: Ali Wyllie)

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. Details of transport and communication networks in the area, e.g. roads,


and the availability of telephone, radio or TV coverage.
. Knowledge of available energy sources in the area, e.g. electricity
generators and supplies of gas, diesel or kerosene.
. The location of potential partners who could assist you, e.g. community
associations, employers, private institutions, charitable organisations, etc.
Information like this will help you to anticipate possible problems that could
affect your planned activities. Information such as the geography,
socioeconomic situation and the health profile of the community you are
working in will help you to establish the current situation and work out what
problems or challenges are to be expected. If you can identify the possible
problems and their causes and their effects in advance, then you may be able
to work out potential solutions before the problem becomes serious.

8.1.2 Steps in the planning process


When you know a lot about your community, you can begin to make a plan
of action. The planning process should follow the six steps outlined in
Figure 8.3. We have briefly summarised each step in Box 8.1 on the next
page, and in the rest of this section we will look at each of them in more
detail.

Figure 8.3 Six steps in planning health interventions. (Diagram: Henk von
Stokkom)

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Box 8.1 Steps in the health planning process

Step 1 Assess need: identify the problems and clarify the situation you
want to improve.
Step 2 Identify and prioritise: select your priorities for action — what
are the most important issues to tackle?
Step 3 Set goals and objectives: what is the overall goal of your
activities, what are your specific objectives (targets) and in what
timescale do you aim to achieve them?
Step 4 Develop strategy: What is your action plan? What activities,
resources (people, equipment) and finances will be needed to achieve
your objectives? How will you explain your action plan and gain
community support for it?
Step 5 Implementation: How will you deliver your plan? Do you have
everything you need to make it successful?
Step 6 Monitor and evaluate: What data will you collect and how will
you evaluate the impact and outcomes of your activities? How will you
measure progress towards meeting your objectives? Notice that in
Figure 8.3, the results of Step 6 help you improve the next cycle of
planning, beginning at Step 1.
Resource Management at Health Post level is covered in detail in the
Health Management, Ethics and Research Module.

8.1.3 Immunization needs assessment


A health needs assessment is the process of identifying and understanding
the health needs of your community. It includes identifying any problems and
their possible causes that make it harder to meet those needs. In relation to
immunization, the key questions that you need to address are:
. Has the immunization coverage rate reached the targets that were planned
in the previous year? If not, what were the problems?
. If there were outbreaks of vaccine-preventable diseases in your kebele,
what does this imply about the effectiveness of your immunization
service? For example, has it been difficult for people to get to the Health
Post or attend outreach events?
. Have there been many defaulters — clients who began a series of routine
immunizations but ‘dropped out’ before the EPI schedule was completed?
What are the possible reasons for dropouts?

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■ Make a list of possible problems that might need to be addressed in your


community if your goal is to increase the immunization coverage rates.

□ You may have thought of other problems in addition to those below:


. The target population is large and very widespread; people who live
a long way from the Health Post find it difficult to get to
immunization sessions
. The roads to the Health Post are flooded in the rainy season
. Immunization is only available on certain days; some people cannot
attend on those days
. Communicating about immunization sessions is difficult; some people
come on days when immunization is not available
. Vaccine supplies are sometimes not enough to immunize all the
children and mothers who come
. The refrigerator is unreliable and vaccines have to be moved to the
health centre for safety
. There is a high dropout rate, possibly because a child had a severe
allergic reaction after an immunization last year, and negative
rumours spread; some parents refused to bring children for
immunization.
If you have identified problems that contribute to low immunization
coverage rates in your area, discuss them with your supervisor and local
health officials, and make a list of possible solutions. For example, if the
problem is low immunization coverage, then the solution might be one
(or more) of those listed in Box 8.2.

Box 8.2 Some ways to address low immunization


coverage rates

. Improved communication with the local community about the huge


benefits and very low risks of immunization
. More in-service training, updating or supportive supervision for you
and other health workers, including community volunteers
. Mobilisation of additional people, equipment, finances or other
resources to improve delivery of the immunization programme
. Change of immunization strategy, e.g. increased use of outreach or
local immunization days
. Focus group discussions with community members to find out why
immunization coverage is low
. Regular review meetings with kebele leaders and local health
officials to assess progress
. Partnerships with other organisations (e.g. community associations,
charities, private sector) to assist in delivering the programme.

Remember that some solutions may not be appropriate to your setting, or


may not be feasible in your kebele. For example, additional in-service
training may not be affordable in the short term, or there may not be a
suitable local organisation willing to assist with your immunization activities.

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8.1.4 Identify and prioritise problems


Prioritisation is the process of informed decision-making about what to do
first, second, third and so on, when there are competing claims on human and
other resources. It is impossible to solve all problems at once because there
are always many resource constraints. In order to select your priority
activities — in this case, with the aim of reducing vaccine-preventable
diseases through delivery of an effective immunization programme — you
should consider the criteria below for each of the problems you have
identified:
. magnitude of the problem — what percentage of the population is at
high risk of developing the disease, or is already affected by it?
. severity of the problem — how serious is the disease in question, in
terms of its impact on health and the risk of death?
. socioeconomic impact of solving the problem — how will the social and
economic circumstances of individuals, families and the community
benefit if immunization coverage increases?
. feasibility of tackling the problem — do solutions exist, and is it
realistic to increase immunization coverage with the available technical
resources, personnel and organisational capabilities?
. affordability of tackling the problem — is the financial support
adequate for an improved immunization programme?
. acceptability to the beneficiaries of tackling the problem in the ways
suggested — does it meet community and government concerns?
■ Consider two diseases: pneumonia and the common cold. Which of these
has the greatest magnitude and which has the greatest severity?

□ The number of people who suffer from a common cold is much higher
than the number with pneumonia, but pneumonia is a much more serious
disease than the common cold. So the magnitude of the problem is
greater for the common cold, but the severity of the problem is greater
for pneumonia.

A simple scoring chart, like the one in Table 8.1, can help you to rank
priorities for each of the health problems identified in your needs assessment.
For each problem, you decide on a score from 1 to 5 for each column, where:
1 = concern about this criterion is very low
5 = concern about this criterion is very high.
Table 8.1 A simple chart for scoring and ranking priorities for health problems.

Problem Magnitude Severity Impact Feasibility Affordability Acceptability Total score Rank
Neonatal tetanus
Measles

■ In the example in Table 8.1, neonatal tetanus and measles are listed as
health problems that can be reduced by immunization. How would you
score each of these conditions based on your knowledge of these
diseases and their impact in your community?

□ We can’t guess what scores you wrote in Table 8.1, because local
circumstances will vary in different communities. But you should have

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given a lower ‘magnitude’ score and a higher ‘severity’ score to neonatal


tetanus than you did to measles. More children suffer from measles than
tetanus, and measles kills a higher number of children than any other
vaccine-preventable disease worldwide (higher magnitude). But the
majority of children infected with measles recover, whereas over 70% of
babies with neonatal tetanus will die (higher severity). To take another
example, you may have decided that the feasibility of vaccinating
children once against measles is greater than the feasibility of
vaccinating pregnant women, and all women of childbearing age at least
twice (preferably three to five times) with tetanus toxoid.

When you have given a score to each problem in your priority chart, you add
up the scores and enter this figure in the ‘Total score’ column. You then
assign a rank to each problem according to its total score. The highest
scoring problem has a rank of 1; the next highest scoring problem has a rank
of 2, etc. Conducting an assessment like this will help to clarify your
thinking about which problems to tackle first. This will also enable you to
explain the reasons for your priorities to community members, so they
understand why you have prioritised certain activities.

8.1.5 Setting goals and objectives


Once you have identified problems with feasible solutions and ranked your
priorities, then you must set clear objectives (or targets) for each problem in
your priority list in order to make progress towards your overall goal. In this
case, the goal is to increase the immunization coverage rate in your
community. The objectives for delivering your goal must be specific and
measurable, and state exactly what you want to achieve, where the activities
will take place, which target group will be addressed and when the target
should be achieved. For example, some possible objectives of an improved
immunization programme might be:
. To reach 95% coverage of all eligible children in the catchment area with
the third dose of pentavalent vaccine (Penta3) by the end of the year.
. To conduct immunization sessions at the Health Post twice every week for
48 weeks of the year.
. To update the registration of newborns in your catchment area once a
month for the whole year.
■ What objective could you set for tetanus toxoid (TT) coverage?

□ You may have thought of other objectives, but one might be to increase
by 20% the number of women of childbearing age who receive more
than two doses of TT this year (Figure 8.4).

Notice that in all the examples above, a timescale is given for achieving the
objective, and the outcome (success or failure to meet the objective) can
easily be measured if accurate records are kept. Record keeping is covered in
Study Session 10.

Figure 8.4 Immunizing all 8.1.6 Developing strategies and activities in your action plan
women of childbearing age
After agreeing your objectives, the next task is to decide on the strategies and
with more than two doses of
activities for achieving them. This means working out the methods you will
TT vaccine protects them and
their babies. (Photo: Basiro use and the activities you will undertake, and writing a clearly stated action
Davey) plan. The action plan should include every activity to be performed during
the year, the time when that activity is to be done, who will do it, how that

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person (or people) will do it, and what resources will be needed. In
developing your action plan, you should ensure that your strategy and
activities are relevant to resolving the identified problems, and that they are
technically feasible, financially affordable and acceptable to the community.
■ What activities might you undertake in order to meet the objective of
updating registration of newborns in your community every month?

□ Here are some suggestions. You may have thought of others.


. Ask about recent births in each family whenever you visit a
household for any reason.
. Ask kebele leaders, traditional birth attendants and other influential
people what recent births have occurred in each village.
. Ask each mother who visits the Health Post when she (or any other
women in her family) last had a baby, and check that you have
recorded the birth.

8.1.7 Estimating resource needs


You have already learnt how to estimate the size of your target population
and your resource needs in Study Session 5.
Your action plan should also include an estimate of your resource needs.
Resources include people, materials, time, finance and information, and these
should be determined in advance for each of the planned activities. The first
and most important estimate is the total size of the population and the
number in the target population for your activities.
■ What is the target population for the Expanded Programme on
Immunization (EPI)?

□ It is the number of children aged 0–11 months and women of


childbearing age (15–49 years).

You can then determine the resources required (vaccines, diluents, infection
equipment, etc.) for delivering an effective immunization programme for this
target population. The next step in the action plan is to allocate people
(e.g. community volunteers), materials, time and finance to each of the
activities in your plan.

8.1.8 Implementing your action plan and maintaining


community support
Community communication about immunization is described in more detail in
Study Session 9.
Once the action plan for the year is complete, it should be communicated to
all stakeholders at community level, your supervisor and the woreda health
office. You should arrange a meeting with local government administration
officials, community leaders and community volunteers to discuss your plan
and gain their approval and support (Figure 8.5). Once approved, it is your
responsibility to implement the plan. You have to keep all stakeholders well
informed about progress during the year, so that you can agree on a solution
to any problems you encounter during the implementation period.

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Figure 8.5 Discuss your action plan with local officials and community leaders
to ensure community support.

8.1.9 Monitoring and evaluation indicators


Monitoring and evaluation are crucially important parts of any health plan.
Monitoring refers to the continuous observation and collection of relevant
data, and evaluation means analysing the data to see if you are meeting your
objectives. Therefore, you need to select reliable indicators of progress for
each of the objectives in your action plan. Collecting and analysing data
from these indicators is an essential activity during the implementation of
your immunization programme.

Indicators of progress in immunization programmes


Some of the main EPI indicators of progress that are commonly used to
monitor and evaluate immunization programmes are given below:
. Immunization coverage rate for each vaccine, i.e. the percentage of all
eligible children who have received all doses of a vaccine under one year
of age, according to the EPI schedule.
. Percentage of fully immunized children aged under one year, who have
received all recommended doses of all vaccines (including measles
vaccine at age 9 to 11 months), according to the EPI schedule
(Figure 8.6).

Figure 8.6 Chart showing immunization coverage rates during five years at Fura
kebele, SNNPR, Ethiopia. The black bar to the right of each year shows the
number of fully immunized children. Years are given in the Ethiopian calendar
(E.C.), and correspond to 2005–2010 in the European calendar. (Photo: Basiro
Davey)

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. Percentage of pregnant women with adequate TT doses, defined as


receiving any of TT3, TT4 or TT5. This indicator is often abbreviated to
TT2+ (because more than two doses of TT vaccine have been given).
. Percentage of children protected at birth (PAB) from neonatal tetanus,
because their mother received a valid dose of TT2+ vaccination at least
two weeks before delivery (Figure 8.7).

Figure 8.7 Percent of babies protected at birth from neonatal tetanus, and the
pentavalent 3 and measles vaccine coverage rates in Shera Dibandibe kebele,
Oromia region, Ethiopia. (Photo: Basiro Davey)
. Dropout rates: the percentage of children and mothers not completing all
the scheduled EPI immunizations.
. Reported new cases in the community of:
◦ neonatal tetanus
◦ acute flaccid paralysis (AFP)
◦ measles in children under five years of age
◦ all vaccine-preventable diseases.
. Number of reports of adverse events following immunization (AEFIs).
. Vaccine wastage factors
. Reporting completeness, accuracy and timeliness.
You learned how to calculate vaccine wastage factors in Study Session 5.
Monitoring and reporting procedures are taught in Study Session 10.
The collection of data on your EPI progress indicators during the year will
help you to assess how well you are meeting the objectives of your action
plan. You may need to revise your activities if monitoring and evaluation
suggests that more needs to be done in order to achieve your objectives.

8.2 Immunization delivery at various sites


The second part of this study session describes how to implement your action
plan depending on where you will be conducting the immunization session.
Immunization can be delivered at various sites, each of which has some
differences in terms of preparation and delivery. To increase immunization
coverage, a combination of these three approaches should be used:
. Fixed-site service is delivered at your Health Post. Ideally, immunization
should be routinely available on a daily basis, but this may not be
possible in your setting. In order to increase attendance, the regular days
should be fixed after discussion with community members.

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. Outreach service involves Health Post staff and volunteers giving


immunizations in the community on well-publicised dates and at well-
known locations. Establishing an outreach immunization service on a
regular basis, in addition to the service at your Health Post, is a key part
of the approach in Ethiopia called ‘Reaching Every Infant/Child’.
. Mobile service involves a team going to remote or hard-to-reach parts of
an area and staying there for more than one day to deliver immunizations,
for example to pastoral or nomadic communities.
As part of your planning procedure, you should have determined the size of
the target population in your kebele, and made a map of your area. This will
help you determine which parts of the community can best be served by
fixed-site immunization, and which by an outreach or mobile delivery service.
The main difference between these three ways of delivering the immunization
service is the method of maintaining the cold chain. We start by considering
an immunization session at your Health Post, and then briefly describe the
additional requirements for an outreach or mobile delivery service.

8.2.1 Setting up an immunization session at a fixed site


First, you need to prepare the area where you can give the immunizations and
record what you have done, and you need a waiting area for children and
their caregivers. The workplace should be in the shade so that you can keep
your vaccines away from direct sunlight. It is also important to keep yourself
and your clients from direct sunshine, dust and rain. You have to keep the
working area clean and quiet to make it conducive for your work. For
efficient immunization, you need to avoid the workplace becoming crowded.
The example in Figure 8.8 shows the flow of people through a Health Post
during an immunization session. Arrange the flow so that it can be in one
direction only, to avoid clients who have already been vaccinated mixing with
clients who are waiting for their turn.

Figure 8.8 The workplace flow through a Health Post (walls and roof not
shown) during an immunization session.
You need a table for registration and recording and another table to put
vaccines and accessories on. Ideally, there should be enough seats for carers
to sit on while waiting for their turn. While they are waiting, this area can
also be used to deliver information about immunization and to check the
infant immunization record cards (Figure 8.9).

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Figure 8.9 Women and babies waiting for immunizations; the health worker is
showing the vaccination certificate they will receive when their babies have been
immunized. (Photo: UNICEF Ethiopia)

What resources do you need for a fixed-site immunization session?


Determine the number of vials you will need to take out of the refrigerator
and place them in a vaccine carrier with the correct number of conditioned
ice-packs. You should aim to open the refrigerator as few times as possible,
preferably just once at the beginning and once at the end of the session. This
is why it is important to estimate how many people you expect to come for
vaccination at each session, so you can remove the right number of vaccine
vials. Some multi-dose vials may have been opened and used in the previous
session, so take them out of the ‘use first’ box and place them on the foam
pad in a vaccine carrier above the conditioned ice-packs or chilled water
packs.
You learned about the cold chain in Study Session 6, and about the multi-
dose open vial policy in Study Session 7.
Check the quality of all vaccines and diluents as described in Study
Session 6. Discard any vials or ampoules if the expiry date has passed, or if
the vaccine vial monitor (VVM) has changed to the discard point, or any
freeze-sensitive vaccines that have accidentally been frozen. Also discard
any vaccine vial or diluent which has lost its label, because you cannot be
sure what it is.
The other materials you will need for the immunization session include:
. source of water and soap for handwashing
. auto-disable (AD) syringes for immunizations and single-use disposable
syringes and needles for mixing diluent with freeze-dried vaccines
. cotton swabs and antiseptic or alcohol for cleaning the skin at the
injection site
. metal file to open ampoules
. stationery, including the immunization tally sheet, EPI Registration Book,
pencils or pens
. new immunization cards for infants and women who have not come for
immunization before
. safety boxes for syringes, needles and other sharp instruments, and
another container for non-medical rubbish.
you will learn about registration and how to use the tally sheet to create your
Summary Report in Study Session 10.

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Deciding which vaccines to give an infant


Check which of the vaccines the infant has received before by looking at the
information on the infant’s immunization card. If the carer has forgotten or
lost the card, you should look for any entry for the infant in the EPI
Registration Book. You can also look for a BCG scar on the upper left arm to
If the infant has any establish if the infant has had the BCG vaccination. If the immunization card
contraindications to is lost, you should issue a new one. If you cannot establish whether or not
immunization, DO NOT the infant has been vaccinated before, it is advisable to give all the vaccines
immunize. You learned about
according to the national EPI schedule — unless there are contraindications.
contraindications in Study
Sessions 2, 3 and 7. An extra dose of vaccine does not hurt most children.

Deciding whether to give a woman a TT dose


Check the immunization card of every woman of childbearing age who
attends the clinic and give her the appropriate dose according to the TT
schedule. If she does not have an immunization card, ask whether she has
had any previous TT vaccinations, and whether she knows how many doses
she has received in the past. Give her the next dose in the series. Take into
account any dose given during an earlier campaign that might have taken
place in your kebele. If she cannot remember or does not know, you should
give her a dose of TT and advise her when to come for the next one. If she is
pregnant, and has not received a TT dose in the past month, immunize her
with TT vaccine.

8.2.2 Recording immunizations


Record keeping is an important part of every immunization session, whether
it occurs at a fixed site or during outreach or mobile services. Study
Session 10 describes the records in detail, so here we will briefly mention
only the main points.
The Family Folder is not only for recording immunizations, but for all vital
events (e.g. births, deaths, cause of death, etc.)
Before you immunize an infant or a woman you must enter all the required
information into the EPI Registration Book, the Family Folder and the
Immunization Tally Sheet. You should check that the infant is the correct age
for immunization, and that the infant’s age on the immunization card is
correct. (You will see examples of the EPI Registration Book, immunization
card and tally sheet in Study Session 10.) Also, record the doses of vaccine
given at each session in the Vaccine Stock Register shown in Study
Session 5.
If this is the first time the infant has been brought for immunization, ask the
age of the infant, and if the carer does not know the exact date of birth, try
to find out the date by relating it to a historical event or national holiday,
such as Easter or Eid Al Fetir.
The EPI Registration Book is an important record of your activity and the
number of vaccine doses used. It also enables you to trace which vaccinations
the infant has had if the carer fails to bring the immunization card on a future
occasion. Record all vaccines and vitamin A supplements given on the tally
sheet by counting the number of doses of each type of vaccine given during
the session. Complete the tally sheet and the infant’s immunization card.
On the immunization card you should write:
. the date for each vaccine administered or vitamin A supplement given

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. the date when the next immunization is due.


You should return the card to the carer, and before she leaves the Health
Post, you should explain that:
. The immunization card is an important document about the health of the
infant. She should keep it in good condition and bring it with her
whenever the child is brought to the Health Post for any reason – not just
when she comes for another immunization.
. The infant should complete the full course of vaccinations. Give the carer
the date when the infant should be brought back for the next dose of
vaccine.
. Occasionally there are adverse reactions to the immunization, but usually
these are very mild and get better quickly. Make sure the carer knows
what to do if they occur, and explain that the infant should be brought
back if the symptoms get worse or the reaction continues for more than a
day or two.

8.2.3 Immunization delivery at an outreach site


There are very few differences between delivery of an immunization service
at an outreach site, and the details already described for a fixed site such as
your Health Post. The key point is that the dates, times and sites for regular
outreach sessions should be planned carefully, with the goal of covering the
target population within the target period. It is very important to work with
the community in selecting the most suitable sites and the most appropriate
days for outreach immunization sessions. The site should be readily
accessible, such as a school or kebele office, or in the shade of a large tree
(Figure 8.10).

Figure 8.10 A large shady tree can be a good place for people to wait for an
outreach session. (Photo: Basiro Davey)
Training, assistance and supportive supervision should be provided regularly
for you and the community volunteers in outreach sites, to ensure the
delivery of safe and high-quality immunization services for the local
community. Monitoring and evaluation of the outreach service, with
community input, is crucially important for its success. Regular meetings
should be organised to discuss ways of increasing the immunization coverage
locally, for example by changing the location to a more convenient site or
adding new outreach sites.

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What resources do you need for an outreach immunization session?


Human and financial resources for outreach sessions require very careful
management in order to reach every district in a sustainable manner. In
addition to the resources already described for a fixed-site session, the
community should help by providing chairs and tables, and local volunteers
Make sure that your vaccine to assist you. When you arrive, inspect the site to check that it has been
carrier or cold box is shaded arranged correctly to ensure a good workflow (look back at Figure 8.8), and
from the sun!
that all surfaces have been properly cleaned. Swab the table where the
injections will be given with alcohol before you set out your equipment.
■ What additional resources will you need to take to an outreach session,
compared to a fixed-site session?

□ You will need to pack all your equipment safely to transport it over the
required distance, while maintaining the vaccines and diluents under cold
chain conditions at all times. This may mean that you need a cold box,
which stays cold for longer than a vaccine carrier.

When you leave the outreach site, you should collect all the safety boxes and
any other waste, and take them back to your Health Post, where you can
dispose of them in a safe way (see Study Session 7). Do not leave any waste
at the site. You started your work in a clean area and it is important to leave
the site as clean as when you began. Make sure that you thank all the
community volunteers who helped you deliver a successful immunization
session that day.

8.2.4 Mobile delivery


During a mobile immunization programme, it is important to plan other
health intervention activities, such as malaria control and antenatal visits, at
the same time.
A mobile immunization service is likely to be most appropriate for pastoral
and hard-to-reach areas. The key difference with other ways of delivering
immunization is that it requires a mobile team to travel from place to place,
carrying all the immunization equipment and maintaining absolute cold chain
conditions for several days. The organisation of a mobile team requires
careful planning.
Decisions about where to conduct the immunizations should be discussed and
agreed with local government officials, community leaders and other
stakeholders. Once the area is identified, you should use all possible ways to
get information on the eligible target population in the area, so you can
estimate what resources you will need for the number of sessions planned
during this trip. Make sure that news reaches every community well in
advance of the dates when your mobile service will be coming, and advertise
where local people should go to meet you and your team. The setting-up and
delivery of each session is exactly as already described for an outreach
session.
In the next study session we turn to communication about the immunization
service in more detail. Good communication is essential to ensure its success,
wherever immunization sessions occur.

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Summary of Study Session 8


In Study Session 8, you have learned that:
1 Proper planning is a crucial step in all your immunization activities. If
you do not plan properly, you are likely to fail in reaching your targets.
2 Planning consists of six steps: assessing the community’s health needs,
identifying and prioritising problems to be addressed, setting goals and
objectives, agreeing strategies and activites in the annual action plan
(including resource requirements), implementing the service, and
monitoring and evaluating progress towards meeting the targets.
3 Planning should be carried out in consultation with the district health team
and kebele leaders, agreed with all relevant stakeholders and reviewed
regularly.
4 There are three types of immunization service delivery: fixed site,
outreach and mobile services. Resource planning requires additional
community participation at outreach or mobile delivery sites to set up the
immunization workplace. The cold chain must be maintained at all times.
5 At every immunization session, all required information must be entered
into the EPI Registration Book, the clients’ immunization record cards,
the Family Folder, the tally sheet and the Vaccine Stock Register.
6 The mother or carer of each child brought for immunization should be
given a clear explanation of the importance of the immunization record
card, when next to bring the child and any possible adverse events
following immunization, how to treat them and what to do if a reaction is
serious.

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Self-Assessment Questions (SAQs) for Study


Session 8
Now that you have completed this study session, you can assess how well
you have achieved its Learning Outcomes by answering the following
questions. Write your answers in your Study Diary and discuss them with
your Tutor at the next Study Support Meeting. You can check your answers
with the Notes on the Self-Assessment Questions at the end of this Module.
SAQ 8.1 (tests Learning Outcomes 8.1 and 8.2)
Rearrange the following steps in the planning process into the correct
sequence and number them 1–6:
. setting goals and objectives
. assessing the community’s health needs
. agreeing strategies and activities in the annual action plan, including
resource requirements
. implementing the immunization service
. monitoring and evaluating progress towards meeting the targets
. identifying and prioritising problems to be addressed.

SAQ 8.2 (tests Learning Outcomes 8.1 and 8.2)


Imagine you identify a number of problems in your catchment area
which you think might prevent you from implementing your
immunization programme effectively. You have considered the
magnitude and severity of each of the problems you have identified.
. What else should you consider in attempting to prioritise these
problems?

SAQ 8.3 (tests Learning Outcomes 8.1, 8.2, 8.3 and 8.4)
Which of the following statements is false? In each case, explain what
is incorrect.
A Community discussion and approval is essential during the
development of your annual immunization action plan.
B If a mother has lost the immunization card for her child, you
should send her home to find it before you agree to immunize the
child.
C The percent of newborns protected at birth from neonatal tetanus
is a good indicator of progress towards achieving adequate TT doses
for their mothers during pregnancy.
D A fully immunized child has received all doses of all the EPI
vaccines scheduled for routine immunization by the age of 14 weeks.
E Accurate entries in your EPI Registration Book during each
immunization session will help you to estimate the number of doses
of vaccine needed for future sessions.

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SAQ 8.4 (tests Learning Outcomes 8.4 and 8.5)


After vaccinating a 6-week-old baby with BCG, OPV1, Penta1 and
PCV10, you explain to the mother that she should look after her
immunization card carefully, and bring it with her next time she brings
her baby for immunization. You also explain the importance of
completing the full course of immunizations.
. What else should you tell the mother before she leaves the Health
Post?

SAQ 8.5 (tests Learning Outcomes 8.5 and 8.6)


(a) What should community volunteers prepare for an outreach
immunization session before you arrive at the site?
(b) What should be provided to support the community volunteers at
this site?
(c) What should you do before leaving the site at the end of the
outreach session?

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Study Session 9 Communication for an


Effective Immunization Programme
Introduction
The Health Education, Advocacy and Social Mobilisation Module describes
in depth the importance of communication in the health service and methods
of achieving good communication. As you already know from earlier study
sessions, a key part of a successful immunization programme is effective
communication. Communication plays a major role in achieving the overall
goal of increasing immunization coverage rates and reducing the number of
infants and mothers who drop out of the programme (default) before
completing all their vaccinations. This study session will deal with
communication in the immunization programme in more detail.

Learning Outcomes for Study Session 9


When you have studied this session, you should be able to:
9.1 Define and use correctly all of the key words printed in bold.
(SAQ 9.1)
9.2 Describe how you would plan and choose appropriate communication
strategies to promote immunization activities and remove barriers to
accessing the service. (SAQ 9.2)
9.3 Describe effective communication techniques to use with carers,
members of the community and other stakeholders. (SAQs 9.1 and 9.3)
9.4 Explain how you would manage negative rumours about
immunization in your community. (SAQ 9.4)

9.1 Why is communication crucial for an


effective immunization programme?
Advocacy and communication form one of the five key EPI operations
(Figure 9.1), which you saw first in Study Session 1. Advocacy refers to
ways of delivering an argument effectively, so that you gain the support and
commitment of policy-makers, community members and other stakeholders,
and are able to ‘put the case’ successfully for increasing immunization
coverage. Communication is the transmission of information from one
person to another, or from a source to a destination.

Figure 9.1 The five key EPI operations.

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Immunization programmes may be unsuccessful if incorrect or inadequate


information is transmitted to the community. Sometimes, even though correct
information may be communicated, it may be ineffective in achieving the
desired outcome. It is important that you, as a Health Extension Practitioner,
use terms that are readily understood when you talk to members of the
community, ensuring that you appreciate local problems and show respect for
local customs and culture. One way to improve communication with members
of your community would be to organise a committee to look into reasons
why people do not come to be vaccinated, or do not complete their
vaccinations. This would help you to:
. improve relations between you as a Health Extension Practitioner and the
community
. promote participatory decision-making to improve community
involvement in the EPI
. support the community to develop strategies for identifying and tracing
immunization defaulters
. improve the quality of the immunization service
. encourage the community to identify and report outbreaks of
communicable diseases.
■ What do you hope this would achieve in the long term?

□ The hope is that this would increase immunization coverage in your


kebele and help high immunization coverage rates to be maintained. If
more infants and mothers are fully immunized, then disease and deaths
from vaccine-preventable diseases will be reduced.

9.2 Planning a communication activity


A communication strategy should be included in your annual EPI action
plans. There are likely to be many possible barriers to effective
communication between Health Extension Practitioners like you, carers, the
community and stakeholders. It is important that you identify these barriers
and do your best to eliminate them. The aim is that your messages will be
understood and will result in changes in behaviour, which will increase EPI
coverage rates and decrease dropout rates.
The planning process involved in communication for improving immunization
coverage can be summarised in a series of four steps as outlined in
Figure 9.2; this is a simplified version of the six-step diagram you have
already seen in Study Session 8 (Figure 8.3).

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Figure 9.2 Planning process for effective communication.

9.2.1 Conduct a communication needs assessment


First, it is important to talk to people to find out about attitudes to
immunization in the community, in particular whether there is opposition to
it. If there is some resistance to immunization, you need to ask why this has
occurred. Discussion with members of women’s groups and youth groups in
your kebele may help you to find answers to your concerns. You may be able
to identify specific behaviour or attitudes that are creating a barrier to
immunization in the community. Has there been an adverse incident in the
past that has worried parents? Is there an opinion leader in the community
who is opposed to immunization and has persuaded others to resist it? This
communication needs assessment will help you to assess what strategies and
activities to plan for this community.

9.2.2 Define communication objectives, strategies and


activities
If you can identify specific barriers to immunization, you will need to decide
which of these might be targeted in order to look for a solution. Which of
these barriers might it be possible to remove? How might this help to
increase immunization coverage and decrease dropout rates? Why are so
many children not brought for immunization? Table 9.1 on the next page lists
some commonly reported reasons.

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Table 9.1 Top ten reasons reported by caregivers to explain why their children were
not fully immunized in Ethiopia. (Source: WHO, 2006, EPI National Survey in
Ethiopia)

Reason why child not fully immunized Caregivers giving this as the main
reason (%)
Unaware of need for immunization 22.8
Unaware of need to return for next dose 12.8
Vaccine not available 12.5
Mother too busy 6.3
Vaccinator absent 6.1
Place and time of immunization 6.0
unknown
Immunization site too far away 5.7
Family problems and/or mother ill 5.3
Fear of adverse effects following 4.0
immunization
Time of session not convenient 2.6

Stop reading for a moment and think about which of the reasons in
Table 9.1 are the most likely reasons for children not being brought for
immunization in your catchment area.
These are the issues that you should concentrate your communication
efforts on, and that should form the basis of your communication
objectives.

■ Which of the reasons listed in Table 9.1 do you think could be best
addressed by improved communication? How might you hope to address
these barriers to an effective immunization service?

□ Many of the reasons given in the table could be addressed by improved


communication, but in particular you might have suggested:
. Unaware of the need for immunization: You could arrange a
community meeting to explain the advantages of immunization, and
the seriousness of the diseases it protects against.
. Unaware of the need to return for the next dose: You could ensure
that all those bringing their children for immunization are clearly told
when they should return and why.
. Place and time of immunization unknown: You can make sure there
are notices clearly visible at your Health Post and in the kebele office
announcing when and where immunization is available. You can also
make every effort to remind people of these dates and places
whenever you visit families, and ask your volunteers to tell everyone
they visit.
. Fear of adverse effects: Whenever you are telling people about the
advantages of immunization and the seriousness of the diseases it
protects against, you could also explain that there may be mild side-
effects, but that these are very rarely serious.

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Setting objectives
You will recall from Study Session 8 that objectives always have to be
specific and the outcomes must be measurable. A well-constructed objective
identifies what will be done in order to achieve it, who will do it and where,
what resources will be used, and the timescale in which the target should be
achieved. You will also need to work out what resources are available in the
community that can be used for the communication activities that you may
wish to organise.
Having set your communication objectives, you next need to decide what
activities would be the most appropriate to help you to achieve them. You
should address the following questions:
. What message is it that you want to communicate?
. What media will be most suitable for communicating it?
. Will you be able to get the resources required?

Strategies and activities


There are a number of possible strategies or activities you can use to get your
message across to the community. These might include a community
conversation (Figure 9.3 and see Section 9.3.4 later in this study session) or a
community mobilisation or advocacy programme. The work plan for
conducting these activities should be realistic. You will need to think about
what it is that you want to do, when you hope to do it, how many people you
will need to help you and who these people might be.

Figure 9.3 A Health Extension Practitioner engaged in a community


conversation. (Photo: AMREF Ethiopia)

Assessment, monitoring and evaluation


You will also need to find ways to check whether your strategy or activity is
working. For example, you might have held a meeting or conducted a
community conversation to explain the advantages of immunization, and the
seriousness of the diseases it protects against. You hope that this might
increase immunization coverage by encouraging caregivers to bring their
children to the Health Post for immunization.

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■ How could you evaluate whether your message was understood and
whether it has made a difference to people’s behaviour?

□ There are many possible ways you might try to evaluate the
effectiveness of your activities. Here are some suggestions (you might
have thought of others):
. You could record how many people attended the meeting or
community conversation, and who they were. You could then monitor
how many of these people have shown a change in behaviour. You
could see if these people brought their children for immunization, or
brought them more regularly than before.
. If someone who is not known to you brings their children for
immunization for the first time, you could ask how they knew the
immunization was available. This might help you to establish
whether those who were present at the meeting or community
conversation spread the message to others.
If you look back at Figure 9.1, you will see that the five key operators are
connected to one another. This is because the results of your monitoring and
evaluation help you to determine which strategies and activities are making
progress towards achieving your objectives. This information should be fed
back into your next communication analysis (Figure 9.2), so communication
improves when you find out about people’s attitudes and behaviour next time.

9.3 Behaviour change communication (BCC)


You will probably be aware that firmly held views do not change fast. It
takes time for people to change their attitudes. The aim is to increase
immunization coverage, so the goal of communication about immunization is
to bring about positive behaviour change. When you deliver messages to
people they may understand what you are saying and acquire knowledge
about immunization, but they may not take this knowledge and apply it. They
still may not bring their children for immunization. They may not actually
change their behaviour.
Behaviour change communication (BCC) is a process of developing
communication strategies to promote a positive change in health-related
behaviours in a community, appropriate to local circumstances. This can only
be done by sustained work with individuals and communities to explain the
issues and implications involved and support people as they try to understand
them.

9.3.1 Common methods of BCC in immunization


When you want to communicate a message, for example about the advantages
of having your child immunized, you should first identify or decide who the
message is intended to influence. The message to be sent to a group of school
teachers, a women’s group, a youth group, or a group of religious leaders is
not the same, even though the aims of all these messages might be to
increase immunization coverage. Their level of understanding of the issues
involved is likely to be quite different. Therefore in preparing a BCC
message, the first step should be to decide who you intend to address. This is
your target audience.

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■ Suppose the message you want to communicate is that there are many
diseases that are serious and may lead to death, but they can be
prevented by immunization; therefore, bringing babies and children for
immunization from an early age is beneficial. Who would your target
audience be? (Who would you want to communicate this message to?)

□ You would want to communicate this message to all mothers of babies


and children (Figure 9.4), and any other caregivers in the kebele who are
responsible for looking after babies and children.

Figure 9.4 Mothers and other caregivers are the main target audience for
behaviour change communication about immunizing babies. (Photo: Basiro
Davey)
Once you have identified your target audience, the next step is to think about
your objective. What change in behaviour do you want your target audience
to make? This could be based on the problems you have identified in your
communication needs analysis. There are several strategies and activities that
you can use, including advocacy, community mobilisation, community
conversations and interpersonal communication — all of which are explained
in detail in the Health Education, Advocacy and Community Mobilisation
Module, Part 2. We will remind you of the main points below.

9.3.2 Advocacy
Advocacy is a process or activity that aims to influences politicians, policy-
makers and opinion leaders. In the context of EPI activities, this could refer
to an activity that aims to gain the support of stakeholders, community
leaders and local politicians, and to encourage community acceptance of and
commitment to the EPI. There are many activities and strategies that can be
used in advocacy. Here are some of them:
. lobbying
. meetings
. negotiation
. project visits
. use of information and education resources.

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■ Imagine that a new vaccine is being added to the routine EPI schedule,
but no decision has yet been reached about when it will be available for
your kebele. You may need to undertake some advocacy activities in
order to speed up the decision to make it available locally. What do you
think the most appropriate activities might be in this situation?

□ Appropriate advocacy activities might include negotiation with local


political and community leaders, as well as women’s and youth groups.
You will need to provide them with information on the new vaccine, its
safety, the diseases it can prevent and the particular needs of your
community to receive its protection.

9.3.3 Community mobilisation


Community mobilisation is a process of gaining the involvement of
everyone in the community for an action towards a particular goal.
■ Can you remember some of the advantages of the community
mobilisation process?

□ You may not have remembered all of the advantages, but your answer
should have included some of the following.
Community mobilisation:
. helps motivate the people in the community through participation and
involvement of everyone in a shared goal
. builds community capacity to identify and address community needs
. helps mobilise and release local resources
. promotes long-term commitment to sustained behaviour change and
hence sustainability of health improvements
. motivates communities to campaign for policy changes to respond
better to their health needs
. links members of the community to the available health services
. leads to a feeling of local ownership, which ultimately leads to a
more sustainable immunization programme.
In the EPI, mobilising the community is likely to enhance the programme and
hence make it much more effective. In order to mobilise the community you
will need to interact with your target audience members in person. You
should prepare your message in a clear and simple way. You can have the
interaction in community meetings, in religious places, market places, etc.
Loudspeaker messages for large community meetings may be appropriate.
You may need to use written materials — for example, you could put up
posters and distribute leaflets. Drama shows and local community radio
broadcasts may also help your communication messages to be heard and
understood.

9.3.4 Community conversation


One of the ways in which it is possible to influence behaviour is through a
community conversation (Figure 9.5). This is a collective discussion of a
particular issue, such as the causes of high dropout rate in the immunization
programme, and can lead to a way of finding solutions to particular problems.

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Figure 9.5 A Community conversation in progress. (Photo: Janet Haresnape)


Such a conversation will be successful when everyone is given the
opportunity to be heard. Many will not participate fully in a meeting unless
they feel at ease and believe their opinions will be heard. Therefore in
organising a successful community conversation, you should consider the
following points:
. Decide on the purpose of the conversation and advertise it widely.
. Decide who should attend or be invited.
. Prepare an agenda for the meeting.
. Decide on the date and time; make sure that everyone you want to attend
is informed about when and where the meeting will take place.
. Choose a meeting place where there is little interference, so that everyone
will be able to hear one another’s views.
. Facilitate the conversation in an open and non-judgemental way, so
everyone feels included and respected.

9.3.5 Interpersonal communication


Interpersonal communication is a term for face-to-face interaction with an
individual, or a small group of people, for the exchange of information.
Because it is a face-to-face interaction, the people involved have eye contact,
they hear each other, and they can respond to each other’s ideas. Note that
interpersonal communication is a two-way process, where everyone learns
from each other — including you!
Interpersonal communication is vitally important in supporting the behaviour
change process. In particular it is very good for:
. Persuading and convincing individuals and target audiences about the
value of the proposed behaviour change, by explaining and responding to
questions and doubts about immunization.
. Addressing rumours about adverse effects of immunization.
. Addressing any personal issues the caregivers may express.
. Helping to mobilise resources from the community to enhance the
immunization programme, through advocacy efforts.
. Building consensus for a concerted effort, for example to bring all eligible
children for immunization.
. Explaining to caregivers about the immunization status of the child.

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. Telling the caregivers about the next immunization(s) that the child will
need.

Interpersonal communication skills


Here is a reminder of the important interpersonal communication skills you
learned about in the Health Education, Advocacy and Community
Mobilisation Module.
. Welcome the client warmly and offer a seat.
. Empathise with the client.
. Speak in simple terms, using easy language; give examples that the
caregiver is likely to understand.
. Motivate by praising the caregiver for bringing the child for immunization
and encouraging them to return for the next dose.
. Listen actively. Active listening is very different from just hearing. It is
listening to another person during a conversation in a way that shows
your understanding and interest. It encourages the other person to be more
involved in the conversation. You can show that you are actively listening
by using gestures, saying ‘Aha!’, or repeating what the client has said
(Figure 9.6).

Figure 9.6 Active listening encourages the client to trust you and express her
concerns. (Photo: Basiro Davey)
. Use appropriate visual aids. The pictures you use should be relevant to
the message you want to transmit, and appropriate to the local customs.
. Summarise what has been discussed at the end of the conversation. You
should check and confirm areas of agreement and disagreement.

Asking questions sensitively


It is important to give your client a chance to ask questions. This will help
you to see how much she has understood and accepted what you have
discussed. You can also ask her questions that enable you to assess her
attitudes and the likelihood of positive behaviour change. But questioning
must be done sensitively!
■ What questions might you ask a mother in one-to-one interpersonal
communication if you think she may drop out of the immunization
programme?

□ There are many questions you might ask, for example the ones suggested
below. You may have thought of others.

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. Ask specific questions such as ‘Which immunizations did your child


have last time? How was his health afterwards? Did you have any
concerns about the vaccination?
These questions help you to establish whether the mother understands
which immunizations the child has had, and which ones remain to be
completed.
. Ask ‘Is there anything that makes you feel unsure if you will bring
your child back for the next immunization?’ If she says she is unsure,
gently ask about her worries and try to reassure her.
Asking about a caregiver’s worries about immunization is an example of an
open question, i.e. a question that encourages the client to answer in her own
way and share her concerns with you. You should avoid asking closed
questions where the caregiver can simply answer ‘Yes’ or ‘No’. A closed
question does not allow you to check whether the client has really understood
the question, or really knows the answer.
■ Here is an example of a closed question: ‘Did your child complete all
her immunizations?’ Change this into an open question on the same
topic.

□ You could ask ‘Which immunizations has your child been given, and
what age was she when she got them?’

When asking questions, always give time for the client to think and answer.
Let the client answer freely and do not interrupt while the client is
answering.

9.4 Meeting with target audiences to promote


EPI activities
In your efforts to increase immunization coverage and decrease dropout rates,
you are likely to come across various interested groups of people and
organisations. These may include health staff at various levels, politicians and
policy-makers, community leaders, representatives from the private sector and
from the NGOs (non-governmental organisations, such as UNICEF, AMREF
and others), parents, and journalists. You may also particularly want to meet
people from those parts of the population that have not yet been reached by
the immunization programme. In this section, you will learn ways to promote
immunization campaigns when you contact representatives from these target
groups.

9.4.1 Meeting with community leaders


Community leaders may include kebele leaders, clan leaders, religious
leaders, elders and school leaders, and the leaders of women’s and youth
groups. You should try to gather information about the community you are
working in before you meet such community leaders. To increase the
effectiveness of your meeting, you should identify who the relevant
participants will be, decide on an agenda and what issues to discuss, and
make sure that all those you want to attend the meeting are aware of the
agenda, and where and when to meet. To gain the maximum benefit from the
meeting, try to find out beforehand what the participants already know about
immunization. It is based on this background that you can introduce the topic
and build up useful discussions.

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■ What issues might you want to discuss with community leaders?

□ Some possible issues are listed below. You may have thought of others:
. any concerns the leaders and families may have about immunization
. any religious or traditional beliefs about disease or immunization
. barriers that may prevent people from accessing immunization
services, e.g. distance, seasonal work commitments, traditional
festivals or customs, lack of money for transport, and inconvenient
days, times or sites for immunization sessions
. the most appropriate times and locations for immunization sessions
. possible ways of reaching more children in the community
. whether immunization could be promoted by being mentioned
regularly at religious or other gatherings.

9.4.2 Meeting with parents


One of the most effective ways to get a range of opinions in a short space of
time might be to arrange small focus groups, with clear guidelines from you
about the topic that the discussion should ‘focus’ on. The ideal number of
participants in a focus group is between six and ten, with a facilitator who
keeps the discussion focused on the agreed topic (in this case, immunization)
and makes sure that everyone’s views are heard. You could select particular
participants, such as parents you think may be unlikely to bring their children
for immunization.
You may also talk to parents one-to-one when they visit the Health Post and
find out about their experiences (good and bad) with the immunization
services provided. In particular, you should try to reach those parents in the
community who, for one reason or another, do not visit the Health Post.
Interview the mothers who do attend the Health Post first, since they are
readily accessible and are often willing to talk about their experience of the
services. In addition they may suggest ways of reaching those who do not use
the Health Post facilities.
■ When meeting with parents, what might you want to find out?

□ There are many things you might want to find out from parents, but here
are some things you may have suggested:
. what they already know about immunization
. what concerns they may have about immunization
. their traditional beliefs about disease or immunization
. any barriers to accessing existing services
. if the times and locations of immunization sessions are appropriate
. what they think about the quality of the service provided
. how they think the service could be improved.

9.4.3 Meeting with NGOs and other partners


Try to meet with any other partners or institutions who you think might be
able to help improve the immunization service. Who these might be will
depend on your community, but could include traditional birth attendants
(TBAs), traditional healers, private health practitioners, volunteer groups and
representatives of NGOs that focus on health — particularly the health of
children.

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9.4.4 Meetings with special groups


In your community you may be aware of some special groups who have been
largely unreached by immunization services, or have chosen not to participate
in them. You should try to include such people or groups in your meetings
and planning process right from the start. Some examples of special groups
include:
. pastoralist groups
. migrant workers
. ethnic or other minority groups
. groups in geographically remote areas, who may find it difficult to reach
the site of the immunization services
. people who are injured, sick or disabled, who may find it difficult to get
to where immunizations are taking place
. religious or traditional sects that refuse immunization
. refugees
. homeless families.
You should always try to ensure that your messages are concise and to-the-
point, and also that they are memorable. This is particularly important in
meetings with representatives from any of the special groups mentioned in
this section. In the final part of this study session, we turn to some of the
negative rumours about immunization that might influence people against the
service in your community.

9.5 Negative rumours about immunization


Rumours about bad consequences of immunization often circulate in
communities. If such negative rumours are not dealt with appropriately, they
can cause serious problems for the effective delivery of immunization
services.
■ Can you think of any rumours about immunization in your kebele? If so,
what are they?

□ Examples of some rumours that may be circulating are that:


. vaccines are a contraceptive to control births in the population, or to
limit the size of a certain ethnic group
. children are dying after receiving vaccines.
You may have come across other rumours, which could be equally
damaging to the success of an immunization programme.

What can you do about negative rumours? Any negative rumours about
immunization that you hear are circulating should be communicated to your
supervisor as soon as possible. The following suggested actions cannot be
carried out by you alone, as the local Health Extension Practitioner; you will
need the full involvement of health centre officials and the district Health
Office. Immediate reporting is important and advice should be sought before
you take action.
With their approval, these are the steps you should take if you come across a
potentially damaging rumour about immunization:

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. First, try to find out what the rumour is, who was the original source of
the rumour and who is spreading the rumour now. Try to establish
whether there is any reason for the rumour spreading — there might be a
political or religious reason, or it might simply have arisen from lack of
information or incorrect information about the immunization programme.
. Once you have gathered this information, arrange a meeting with opinion
leaders such as local government officials, traditional and religious
leaders, community leaders and other health workers. In the meeting,
begin by providing information about the immunization programme and
the diseases it can prevent. Try to ensure that those present are free to ask
questions and express concerns. Discuss and reach agreement on
collective ways to correct the negative rumour and the wrong information
about the immunization service.
. Train your community volunteers on how to give the correct information
about vaccines and how to deal with the rumour.
. Distribute posters and printed materials which give correct information
about immunization to the public. Such materials may be made available
by your local health centre or to support regional or national campaigns.
In the final study session in this Module, we turn to a crucial aspect of your
immunization programme — monitoring and evaluating the outcomes.

Summary of Study Session 9


In Study Session 9, you have learned that:
1 Barriers to accessing the immunization service include issues that can be
resolved by better communication. These barriers include lack of
knowledge about the need for immunization or the need to return for
further doses, or about the time and location of immunization sessions;
fear of adverse reactions is another barrier that good communication can
overcome.
2 Immunization coverage rates can be increased and dropout rates reduced
by effective advocacy and communication activities; inadequate
communication with local people, in particular parents, can seriously
affect the success of the immunization programme.
3 Behaviour change communication (BCC) activities should be an integral
part of your planned immunization strategy; the planning process involves
a communication needs assessment, the definition of communication
objectives, strategies and activities, implementation, and assessment of
outcomes through monitoring and evaluation.
4 You should select BCC strategies and activities appropriate to the target
audience, local culture and context, such as advocacy, community
mobilisation, community conversations, interpersonal communication and
focus group meetings, e.g. with community leaders, parents, women’s
groups, youth groups, NGOs and other partners, and special groups —
particularly those who have not yet been reached by the immunization
service, or are reluctant to access it.
5 You should seek guidance from your supervisor and district health
officials on how best to address negative rumours about immunization if
they circulate in your community.

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Self Assessment Questions (SAQs) for Study


Session 9
Now that you have completed this study session, you can assess how well
you have achieved its Learning Outcomes by answering these questions.
Write your answers in your Study Diary and discuss them with your Tutor at
the next Study Support Meeting. You can check your answers with the Notes
on the Self-Assessment Questions at the end of this Module.
SAQ 9.1 (tests Learning Outcomes 9.1 and 9.3)
(a) What is meant by a community conversation?
(b) In what circumstances might you arrange a community conversation
about your immunization programme?
(c) Who would you invite?

SAQ 9.2 (tests Learning Outcome 9.2)


Supposing you wanted to increase the low immunization coverage rate
in one particular group of parents in your kebele. What steps would you
take in the planning process to address this problem?

SAQ 9.3 (tests Learning Outcome 9.3)


Suppose that you find the main reason given for high dropout from the
immunization programme is a lack of awareness of when or where
immunizations take place. What measures might you take to improve the
situation?

SAQ 9.4 (tests Learning Outcome 9.4)


Imagine that you discover there is a rumour circulating in your kebele
that measles vaccination causes deafness. What would you do?

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Study Session 10 Monitoring your Immunization Programme

Study Session 10 Monitoring your


Immunization Programme
Introduction
In this study session you will learn about how to monitor your own
immunization programme. Monitoring is the routine ongoing collection of
data and the assessment of activities, in order to enable the targets you agreed
in your action plan to be compared with what you have actually achieved.
Monitoring an immunization programme includes the proper use of EPI
recording tools to collect reliable data, which can be evaluated to improve the
planning and management of the immunization service in the future. So, in
this study session, we will teach you about the main recording tools used to
collect and report the data from your immunization programme, so you can
monitor and evaluate your performance.
The aim of this study session is to teach you how to improve your
immunization service by identifying problems and their causes, developing
solutions, and incorporating these solutions as activities in your work plan.
Your overall goal is to increase immunization coverage rates and reduce
dropout, so that babies like the one pictured in Figure 10.1 can be protected
from all the vaccine-preventable diseases covered by the EPI.

Figure 10.1 Immunization protects thousands of Ethiopian babies every year.


(Photo: Sacca, accessed from Wikimedia Commons)

Learning Outcomes for Study Session 10


10.1 Define and use correctly all of the key words printed in bold. (SAQs
10.1 to 10.5)
10.2 Describe how to use the basic EPI recording tools: immunization
cards, the EPI Registration Book and the tally sheet. (SAQ 10.1)
10.3 Explain how you calculate immunization coverage and dropout rates
and use them to monitor the success of your immunization programme.
(SAQs 10.2, 10.3 and 10.4)
10.4 Explain the possible causes of low immunization coverage rates,
and/or high dropout rates, and suggest ways to improve these EPI
indicators, including systems for tracing defaulters. (SAQs 10.3 and 10.4)
10.5 Describe how you make accurate, timely and complete immunization
Summary Reports from your Health Post. (SAQ 10.5)

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10.1 EPI recording tools


We begin by teaching you about the basic EPI recording tools used in
immunization programmes: these are the infant immunization card, the EPI
Registration Book, the tally sheet and the Summary Report Form. Already
described in earlier study sessions are the Vaccine Stock Register and Family
Folder, which are not covered again here.

10.1.1 Infant immunization card


The infant immunization card (or vaccination card) is a small card that
contains relevant information about the child and his or her immunization
history. It is kept by the mother or other principle caregiver of the infant. It
shows:
. a unique identification number (card number)
. name of the infant
. its birth date
. its sex
. name and address of mother/parent
. date that infant was protected at birth (PAB) from neonatal tetanus
. date of each subsequent immunization and vitamin A supplement given
. date when the next immunization is due.
The cards may vary slightly, and some may show additional information,
such as the age of the mother and dates of her TT immunizations
(Figure 10.2).

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Figure 10.2 Sample infant immunization card used in some parts of Ethiopia. Note that DPT-HepB-Hib vaccine is
referred to as pentavalent vaccine on some cards. (Federal Ministry of Health, supplied by Dr Amha Mekasha)
We now consider how you should complete the infant immunization card.
You should write down the date for each vaccine administered, or vitamin A
supplement given. Include doses of TT given to the mother if she is eligible
for a dose. Mark the next appointment date on the card and tell the mother
when and where to return for the next dose of the vaccine. Make sure that
the appointment date corresponds to a planned immunization session. Remind
the mother verbally as well as by writing on the card. Always return the card
to the mother or caregiver.

10.1.2 The EPI Registration Book


The EPI Registration Book (or Immunization Register) is a book for entering
immunization data. It helps you keep a record of the immunization services
you offer to each infant and to women of childbearing age, particularly all
those who are pregnant (Figure 10.3 on the next page). Your Health Post can
either have two separate EPI Registration Books, one for recording infant
immunizations and another for recording TT given to women, or one book to
record both. The Immunization Register can also be used like a birth register.
As soon as an infant is born in the community, its name can be entered in the
register even before the infant has received any immunizations. This will help
you to follow up all infants in the community.

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Figure 10.3 All women of childbearing age should be entered in your EPI
Registration Book the first time they come to your Health Post, or outreach site.
Their records should also be entered in the Family Folder. (Photo: Basiro Davey)

What information is entered in the Registration Book?


The EPI Registration Book should include the following information:
. a unique identification number (registration number)
. registration date (usually the date of the first visit)
. full name of infant
. infant’s birth date
. infant’s sex
. immunizations (vaccine lot number and dose) and vitamin A supplements
given
. whether the infant was protected at birth (PAB) from neonatal tetanus
. additional remarks (e.g. growth monitoring).
The following information about TT doses given to women may be recorded
in a separate book, or in your EPI Registration Book:
. name and address of mother
. TT immunization provided to pregnant and non-pregnant women in the
target age group (15–49 years) by dose.

Using the Registration Book


You must register infants, and women in the 15–49 age group (whether they
are pregnant or not), as soon as they arrive at the Health Post or outreach
site. Fill in all the required information, except the space provided for
immunizations, which should only be completed after the immunization has
actually been given. It is important to enter a unique registration number for
each infant, which is the same number as the one on the immunization card.
This way, for the next immunization, it will be easy to locate the infant’s
entry in the Registration Book.
Do not create a new entry in the register each time the mother brings the
infant for immunization. Ask the mother for the immunization card and look
for a corresponding entry in the register. If the immunization card is not

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available, ask the mother the age of her infant and details of the first
immunization to help you locate the infant’s entry in the Registration Book.
For every new infant who has never been immunized, create a new entry in
the register and complete a new immunization card. For an infant who has
come to your Health Post for the first time, but has received immunizations
in another health facility, create a new entry in the register, ask for the
immunization card and mark on the register the immunizations that the infant
has already received.
Remember to record the vaccine dose and lot number in your Vaccine Stock
Register (see Study Session 5).

10.1.3 Immunization tally sheets


Tally sheets are forms on which health workers make a mark every time they
administer a dose of vaccine. These are used as the basis for monitoring and
making regular summary reports of vaccine use. Use a new tally sheet for
each immunization session (Figure 10.4). The same tally sheet can be used to
mark vaccines given to infants, and vaccines given to pregnant and non-
pregnant women in the childbearing age group.
After you have immunized an infant, record the immunization in the EPI
Registration Book and on the infant’s immunization card, and inform the
mother which doses were given. On the tally sheet, place a mark next to the
dose you have just given. Mark each vaccine dose given on the tally sheet
immediately after giving it.

Figure 10.4 Sample tally sheet for recording immunizations. (Source: as in Figure 10.2)

After immunizing any woman, whether she is pregnant or not, record the
immunization in the EPI Registration Book and on the woman’s
immunization card, and mark it in the correct column of the tally sheet and
the Vaccine Stock Register. If no card is available, rely on the woman’s
history to tally the dose. For example, if a woman says she has received three
doses in the past, tally the new dose as TT4, issue a new card for the woman
and mark the card with the date.
Check that the tally sheet is complete at the end of a session. Add up the
number of doses of each vaccine that you have given during the session, and
check that the number of doses given ‘tallies’ (matches) the number recorded
in your EPI Registration Book. You will use this information to monitor your
performance and to prepare your monthly Summary Report (described in
Section 10.6) to your supervisor and the woreda health office. Keep the tally
sheets so that your supervisor can check the data quality (accuracy of
reporting).

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Common mistakes during tallying


The common mistakes that can occur on tally sheets are summarized in
Table 10.1.
Table 10.1 Common mistakes during tallying an immunization session.

Possible mistake Possible problem that may occur Correct practice


Tallying before the vaccine is The child or woman may not receive Give the dose first, then mark on the
administered the vaccine tally sheet
Tallying at the end of a session ‘Wasted’ doses may be counted as Tally each dose as it is given
according to the number of doses being given
remaining in the opened vials
Tallying all vaccines under one age Inaccurate immunization coverage data Tally separately for infants under one
group (including those outside the year and those over one year old
targeted age)

10.2 Monitoring EPI indicators


For immunization to be effective in reducing cases of vaccine-preventable
diseases and deaths, every child should be fully immunized by the age of one
Sometimes you will see this year. A fully immunized child (FIC) has received all doses of all EPI
statistic referred to as ‘fully vaccines, including measles vaccine, before the age of one year. In this
immunized infant’ (FII). section, we show you the two main ways to monitor whether your
immunization service has the potential to reduce the target EPI vaccine-
preventable diseases. You do this by measuring the:
. immunization coverage rate for each vaccine
. dropout rates from completion of scheduled immunizations.
These are the two main EPI indicators that are used internationally to
analyse the performance of EPI programmes.

10.2.1 How to measure immunization coverage rates


Immunization coverage is the percentage of eligible fully-immunized infants
compared to the total number of surviving infants in the target population.
The immunization coverage rate is measured by comparing the number of
doses actually given and the number in the target population of surviving
infants under one year of age (these are the eligible infants). The result is
expressed as a percentage. The equation below shows you how to calculate
immunization coverage rate in your kebele.
Immunization coverage rate (for a particular vaccine) =
number receiving all doses ÷ number in the target population x 100%, where:
. number receiving all doses is the number of surviving infants under one
year of age receiving all the required doses during the previous 12 months
for the selected vaccine.
. target population is the total number of eligible infants under one year of
age (or total number of surviving infants) at the start of that reporting
period.
■ If the total number of fully immunized infants aged under one year in a
particular kebele was 192 during the annual reporting period, and the

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total number of eligible infants in this age group was 205, what was the
immunization coverage rate in that period?

□ The calculation is (192 ÷ 205) × 100% = 93.6%. In other words, in this


example, 93.6% of the eligible infants were fully immunized during that
reporting period.

If the number of fully immunized infants appears to be greater than the


number in the target population, this indicates that some of the recorded
information must be incorrect. The reason for this problem should be
identified.
■ Can you suggest some possible reasons for this problem with the
coverage data?

□ The target population data may be incorrect; there could have been more
surviving infants aged under one year than the number counted. The
number of fully immunized infants recorded may include some children
aged over one year. Children from other areas (not counted in your
target population) may have come to your Health Post for immunization.

10.2.2 How to measure dropout rates


The dropout rate is found by comparing the number of infants who start the
immunization schedule with the number who complete it. Two measures of
dropout rate are routinely used:
In this section, we refer to pentavalent vaccine, which is also known as DPT-
HepB-Hib vaccine.
. the dropout rate between infants receiving the first dose of pentavalent
vaccine (Penta1) and the third dose (Penta3)
. the dropout rate between receiving the first dose of pentavalent vaccine
(Penta1) and the single dose of measles vaccine.

Pentavalent 1 to pentavalent 3 dropout rate


■ What should the interval be between receiving pentavalent 1 and
pentavalent 3 vaccines?

□ The interval should be 8 weeks: pentavalent 1 is given at 6 weeks of


age, and pentavalent 3 is given at 14 weeks.

If an infant fails to complete the schedule of three doses of pentavalent


vaccine, it indicates that there is an access problem for the parents, i.e. they
have difficulty in getting to (accessing) the immunization sessions for the
second or third doses.
The pentavalent 1 to pentavalent 3 dropout rate is calculated using the
following equation:
Brackets in an equation mean that you should calculate the answer to
whatever is inside the brackets first.
Penta1 to Penta3 dropout rate = (Penta1 – Penta3) ÷ Penta1 × 100%, where:
. Penta1 is the number (or percentage) receiving the first pentavalent
vaccine dose
. Penta3 is the number (or percentage) receiving the third dose.

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■ Imagine that 156 infants received the first dose of pentavalent vaccine at
your Health Post last year. The number brought back for the second dose
was 140 and the number who received the third dose was 132. What was
the Penta1 to Penta3 dropout rate for your Health Post last year?

□ In this example, Penta1 is 156 and Penta3 is 132.


So the Penta1 to Penta3 dropout rate in this example is:
(156 – 132) ÷ 156 × 100%, or
24 ÷ 156 × 100% = 15.4%.

Another way of analysing dropout rates is to start with the percentage of the
target population that attends for pentavalent 1, and compare this with the
percentage that attends for pentavalent 3. For example, imagine that 70% of
the eligible infants in a kebele are brought to you for pentavalent 1
immunization. However, you find that only 61% of the target population
complete the three-dose series of pentavalent vaccine.
■ What is the Penta1 to Penta3 dropout rate in the above example?

□ Penta1 is 70% and Penta3 is 61%.


So the Penta1 to Penta3 dropout rate = (70 – 61) ÷ 70 × 100%, or
9 ÷ 70 × 100% = 12.8%

Pentavalent 1 to measles vaccine dropout rate


There is a very long interval in the EPI schedule in Ethiopia between an
infant receiving the first pentavalent immunization at six weeks old, and
completing the ‘fully immunized’ schedule with the single dose of measles
vaccine at 9 months of age (Figure 10.5). It is very important to complete all
the immunizations in order to protect children from all the EPI target
diseases.

Figure 10.5 All children in Ethiopia should be fully immunized according to the
EPI schedule before their first birthday. (Photo: Lesley-Anne Long)
The pentavalent 1 to measles vaccine dropout rate is calculated using the
following equation:
Penta1 to measles vaccine dropout rate =
(Penta1 – measles) ÷ Penta1 × 100%, where:
. Penta1 is the number (or percentage) of infants receiving the first
pentavalent 1 dose
. measles is the number (or percentage) of infants receiving the measles
vaccine.

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If there is a high dropout rate between Penta1 and the measles immunization,
it suggests that there is a problem for parents of utilising (making use of) the
health services generally. A dropout rate of more than 10% indicates that the
particular Health Post has a utilisation problem — i.e. many people are not
using the services on offer.

10.2.3 Calculating the number of un-immunized infants


You should also calculate the annual number of un-immunized infants —
i.e. eligible infants who have not completed any of the scheduled
immunizations. You do this using the following equation:
number of un-immunized infants = target population – (minus) fully-
immunized infants, where:
. target population is the total number of eligible infants in the target age-
group for immunization (under one year)
. fully-immunized infants is the number in the target age-group who have
received all doses of all the EPI vaccines.

10.3 Analysing and interpreting immunization


data
After determining the immunization coverage and dropout rates, you need to
analyse and interpret the data in relation to your planned targets.

10.3.1 What data should you analyse?


You should analyse your data in terms of the categories listed in Box 10.1 for
each reporting period (monthly or quarterly).

Box 10.1 Data analysis to evaluate performance of


immunization programmes

. Compare the percentage immunization coverage rate with the


objectives (targets) set for the immunization programme in the
annual action plan.
. Compare the percentage immunization coverage rate with the
equivalent data for the previous year.
. Compare the percentage immunization coverage rate of different
vaccines given at the same time.
. Evaluate whether there is an access problem for the Health Post by
calculating the Penta1 to Penta3 dropout rate.
. Evaluate whether there is a utilisation of health services problem for
the Health Post by calculating the Penta1 to measles vaccine dropout
rate; this also tells you the percentage of fully immunized children
compared to the target population.
. Evaluate whether there is a problem in delivering TT+2 (more than
two doses of TT vaccine) to pregnant and non-pregnant women of
childbearing age.

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For continuous self-monitoring at Health Post level, we suggest you use wall
charts to record such indicators as actual immunization coverage rates for
each quarter of the year, compared with the planned targets for that period
(Figure 10.6).

Figure 10.6 Wall chart showing actual immunization coverage (number and
percentage) for the first quarter of the year, and the planned targets for the
remaining quarters at Fura Health Post in SNNPR. (Photo: Janet Haresnape)
Figure 10.7 illustrates how to enter data into an immunization monitoring
chart, in order to assess your monthly progress in meeting a 100%
immunization coverage target.

Figure 10.7 Immunization monitoring chart with examples of data for a Health
Post with a monthly target of 13 eligible infants (out of the total of 156)
immunized with Penta1 and Penta3. The bottom two rows calculate the number
and the percentage who dropped out between Penta1 and Penta3.

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Every Health Post should display a chart like Figure 10.7 where it can be
seen by all staff every day. The diagonal line from zero to the top right-hand
corner (labelled 100%) shows the ideal rate of progress if every eligible
infant is immunized on time.
■ What is your evaluation of the progress in meeting the Penta1 and
Penta3 immunization targets in the (fictional) Health Post in Figure 10.7?

□ The Health Extension Practitioners have not improved their


immunization coverage between January and August. Penta1 coverage
has remained at about 85% of the target population, and Penta3 coverage
has not exceeded 75%.

Next we discuss how to analyse immunization coverage and dropout data to


shed light on what may be causing low coverage and/or high dropout.

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10.3.2 Analysis of access and utilisation problems


The commonly used immunization coverage and dropout rate indicators, and
what they may indicate, are summarised in Table 10.2.
Table 10.2 Immunization coverage and dropout indicators and their interpretation.

Indicator (%) What it may indicate


Penta1 coverage Availability of, access to, and initial use
of immunization services by parents or
caregivers
Penta3 coverage Continuity of use by parents or
caregivers
Measles coverage Protection against a disease of major
public health importance
Penta1 to Penta3 dropout Access to the service by parents or
caregivers, and quality of
communication by health workers —
this is an international dropout indicator
Penta1 to measles dropout Utilisation of health services by parents
or caregivers, and the perceived quality
of the service in the community — this
is an international dropout indicator
TT1 coverage during pregnancy Availability of, access to, and use of
immunization services by pregnant
women
TT2 (TT3, TT4 or TT5 coverage) Continuity of use, client satisfaction and
TT2+ (or TT+2 as in Figure 10.6) capability of the system to deliver a
means the women received more than series of immunizations to women
two doses of TT vaccine.
Fully-immunized children (FIC) Capability of the system to provide all
vaccines in the childhood schedule at
the appropriate age, and at the
appropriate interval between doses in
the first year of life; also measures
public demand and perceived quality of
services

Table 10.3 shows you how to assess whether low immunization coverage or
high dropout rates are due to a problem of access (coming to the
immunization services) or to a problem of utilisation (usage of immunization
services). You should use the results of your assessment to identify and
prioritise problems in your immunization programme, and work out possible
solutions, as described in Section 10.4.

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Table 10.3 Example of immunization problem analysis.

Observation at Health Post level Problems identified


High Penta1 coverage and low dropout rate No problem
High Penta1 coverage and high dropout rate Utilisation problem
Low Penta1 coverage and low dropout rate Access problem
Low Penta1 coverage and high dropout rate Access and utilisation problems

10.4 What could be causing immunization


problems?
Some possible local causes of low immunization uptake or high dropout rates
are summarised in this section, which includes two new key terms (in bold).
Service organisation problems:
. Community not clearly informed of dates/times of immunization sessions
at the Health Post, at outreach sites, or via mobile teams
. Immunization sessions not frequent enough, or at inconvenient sites
. Immunization session dates/times conflict with farming or family duties
. Poor vaccine quality, e.g. due to cold chain breakdown or usage after the
expiry date
. Vaccine or other equipment shortages.
Staffing problems:
. Inadequate staffing levels to provide enough immunization sessions
. Inadequate training or supportive supervision for a high quality
immunization service
. Health staff perceived as hostile or poor communicators by parents
. Incorrect contraindication practices, e.g. not immunizing children with
minor illnesses, low grade fever, etc. which should not prevent them from
receiving vaccines
. Missed opportunities to immunize, e.g. not immunizing children who
visit the Health Post for another reason, unrelated to immunization.
Data collection and reporting problems:
. Incomplete or inaccurate data collection and analysis
. Failure to report monitoring data regularly
. No active follow-up of defaulters.
■ Can you suggest some possible solutions for the problems identified
above?

□ You may have thought of these (and other) examples:


. Improved communication with the community (see Study Session 9)
. Better in-service training for health staff and adequate supportive
supervision

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. Mobilisation of additional resources, e.g. increased staffing levels,


more reliable cold-chain equipment, better delivery times for vaccines
and other supplies, etc.
. Apply other immunization strategies, e.g. sustainable outreach
delivery, local immunization days, partnership with private and other
sectors (see Study Session 8)
. Apply an effective system for tracing defaulters (see Section 10.5
below)
. Make timely, accurate reports to the higher level, so problems can be
addressed collectively at the earliest opportunity.
We conclude this study session by explaining how the last two solutions in
the above list should be implemented.

10.5 Systems for tracing defaulters


In this section you will learn how you trace (track) defaulters. Defaulters are
those infants who started the routine EPI immunizations but failed to
complete the schedule for whatever reason. If you trace defaulters regularly
every month, it will make the task of follow-up much easier. You may be
able to contact the mothers directly, or ask other members of the community
to help you to find them. Try to ensure that every infant receives the
immunizations that are overdue. There are many ways to monitor and follow-
up on defaulters. Here we describe two tracking systems that can easily be
used.

Using the EPI Registration Book


At the end of each month, review the EPI Registration Book to identify
infants and mothers who have not received doses of vaccine at the
appropriate time, according to the recommended EPI schedule.

Using reminder cards


Make reminder cards, which are copies of the infant’s immunization cards.
File them in a box behind the divider for the month when the infant’s next
immunization is due (Figure 10.8). Refer to these every month to identify the
defaulters.

Figure 10.8 Box for storing immunization reminder cards. (Source: WHO 2001,
Immunization in Practice, Module 7, Monitoring and Using your Data,
Figure 7F, p.11)

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10.6 Making immunization Summary Reports


The monitoring data you have collected on your immunization programme
has to be organized into a Summary Report for transmission from the
Health Post to the Health Centre that supervises you. The Health Centre
collects data from all the satellite Health Posts and transmits it to the woreda
(district) health office. The woreda compiles data from health facilities in the
district for transmission to the higher level, and eventually to the Federal
Ministry of Health. At each level the data should be analysed and used to
improve the immunization programme.

10.6.1 What data should the Summary Report contain?


The Summary Report from your Health Post should include the following
information:
. Vaccinations and vitamin A supplements given to infants and women.
Data collected on the tally sheets should be organised clearly (see the
sample monthly report forms shown in Appendix 10.1 and 10.2 at the end
of this study session).
. Vaccine-preventable diseases in your area. State the number of cases of
each vaccine-preventable disease and the immunization status of each
case. Even if there are no cases of a disease during the reporting period,
you should still provide a ‘zero’ report.
. Adverse events following immunization (AEFI). If there have been any
adverse events during the month, the details of any that are life-
threatening, resulted in hospitalisation, disability (or have the potential to
result in disability), or resulted in death should be reported. If there are no
cases, provide a ‘zero’report.
. Vaccine usage and wastage patterns. The usage and wastage of vaccines
will vary from one session to another. However it is useful to monitor
wastage and usage patterns regularly at all immunization sessions, in
order to improve supply and avoid stock shortages. This can be done by
recording the number of vaccine vials at the start and end of every
session, and the number of vials received or wasted each month.
Vaccine supply and stock management were described in detail in Study
Session 5.
. Any specific problems encountered during the reporting period (e.g. stock
shortages, transportation problems, cold chain failure, etc.).

10.6.2 Preparing good Summary Reports


You should ensure that the Summary Reports you prepare on your
immunization service are:
. Complete: Ensure all the sections of the reports have been completed; no
parts have been left blank and all reports due from outreach sites or
mobile teams have been received.
. Timely: When reports are sent and received on time, there is a greater
possibility of a prompt and effective response to any problems you have
identified.
. Accurate: Before sending the reports, check the totals and all calculations
to make sure that the reported figures correspond to the actual figures in
the tally sheets, the EPI Registration Book and the immunization cards.

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This helps you to evaluate the accuracy of your recorded data and identify
and resolve any discrepancies. The district, provincial and national levels
should keep track of the completeness and timeliness of reporting at your
level, and remind you about any missing or late reports.

10.7 In conclusion
Now that you have completed this Module, you should be well prepared for
the practical skills training that accompanies it. Be proud that you have the
opportunity to improve the health of your community and save many young
lives by delivering a well-managed and effective immunization service.

Summary of Study Session 10


In Study Session 10, you have learned that:
1 Monitoring of immunization programmes is very important for the
planning and management of the EPI. It is the process of continuous
observation and data collection, with the aim of comparing what you have
achieved with your planning targets.
2 Monitoring your immunization programme includes proper use of EPI
recording tools: the infant immunization cards, the EPI Registration Book
(Immunization Register) and the tally sheets for each immunization
session.
3 The Immunization Register helps you record the immunization services
offered to each client. You must register infants and pregnant women as
soon as they arrive at your Health Post or outreach site, before giving any
immunizations or vitamin A supplements.
4 Tally sheets are used as the basis of your monthly or quarterly Summary
Reports.
5 EPI indicators include Penta1 to Penta3 coverage, Penta1 to measles
vaccine coverage, percentage of fully immunized children, percentage of
women in the childbearing age-group (pregnant and non-pregnant)
receiving more than two doses of TT vaccine, and protection at birth
(PAB) against neonatal tetanus.
6 Estimates of whether implementation of the immunization service will (or
has the potential to) reduce the target EPI diseases are obtained through
measuring immunization coverage rates and dropout rates for each
vaccine.
7 Pentavalent 1 coverage (and Penta1 to Penta3 dropout) is an
internationally accepted measure of accessibility to the health facility;
pentavalent 3 coverage (and Penta3 to measles vaccine dropout) is a
measure of utilisation of health services.
8 It is important to trace defaulters by using the immunization register or
reminder cards.
9 The immunization data collected should be organised into a complete,
timely and accurate summary form. These reports enable you, your
supervisor and the woreda health office to monitor the performance of
your immunization service and quickly address any problems.

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Self-Assessment Questions (SAQs) for Study


Session 10
Now that you have completed this study session, you can assess how well
you have achieved its Learning Outcomes by answering the following
questions. Write your answers in your Study Diary and discuss them with
your Tutor at the next Study Support Meeting. You can check your answers
with the Notes on the Self-Assessment Questions at the end of this Module.
SAQ 10.1 (tests Learning Outcomes 10.1, 10.2 and 10.5)
In your Health Post, you use infant immunization cards to record
immunizations given to each individual infant, and an EPI Registration
Book to record the immunizations you have given.
. What other basic EPI recording tool should you be using and what
two things does it enable you to do?

SAQ 10.2 (tests Learning Outcomes 10.1 and 10.3)


The percentage of children in the target population who receive the first
dose of pentavalent vaccine (Penta1), and the percentage who receive
measles vaccine, are commonly used EPI indicators for monitoring an
immunization programme. Name two other EPI indicators and, in each
case, explain why they are particularly useful.

SAQ 10.3 (tests Learning Outcomes 10.1, 10.3 and 10.4)


Figure 10.9 shows the percentage immunization coverage for Penta1 and
Penta3 in two districts, labelled A and B. Based on the information in
this figure, answer the following questions:
(a) Calculate the pentavalent dropout rate for the two districts A and B.

(b) Do the dropout rates suggest that access or utilisation is the major
problem for the immunization service in each district? Explain how
you reached your answer.

(c) What are the possible solutions for the problems in each district?

Figure 10.9 Percentage immunization coverage rates for pentavalent 1 and


pentavalent 3 vaccine doses in two districts, A and B.

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SAQ 10.4 (tests Learning Outcomes 10.1, 10.3 and 10.4)


In a kebele with a total population of 5,000, an estimated 3.6% are
surviving infants under 12 months old. In September, nine infants aged
under one year and two children aged between 12 and 23 months old
were immunized against measles.
(a) What was the measles immunization coverage rate for infants aged
under one year in September? Is it lower or higher than the
estimated total population of eligible infants in that month? (You
can assume that approximately the same number of babies is born
alive each month.) Show how you reached your answers.
(b) List some possible reasons for the measles immunization coverage
rate in this kebele.
(c) What actions would you take to improve the coverage with measles
vaccine?

SAQ 10.5 (tests Learning Outcomes 10.1 and 10.5)


Meseret completed the Summary Report of the immunization service
delivered from her Health Post for the previous month. She carefully
recorded the number of doses of vaccines and vitamin A supplements
given to infants and women in her catchment area during the reporting
period. There were no cases of vaccine-preventable diseases and no
serious adverse events following any of the immunizations, so she left
this part of the report form blank. She recorded the number of vaccine
vials she used during the month and the number wasted. Then she sent
the report form to her supervisor.
(a) What mistake did Meseret make when she entered her data in the
Summary Report?
(b) What other types of data did she forget to include in the Summary
Report?

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Appendix 10.1 Example of a Summary Report


Form for infants

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Appendix 10.2 Example of a Summary Report


Form for women

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Notes on the Self-Assessment Questions (SAQs) for Immunization

Notes on the Self-Assessment Questions


(SAQs) for Immunization
Study Session 1
SAQ 1.1
When the immunization coverage rate is high, a large proportion of the
members of a community will be immune to the disease caused by the
particular infectious agent in the vaccine. This is called herd immunity.
Therefore, in a disease like measles, which is transmitted from person to
person, there will be a very small reservoir of infection restricted to a
few infected people in the community. Transmission of infection from
infected to susceptible people will very rarely occur, so the infectious
agent will not be able to spread through that community and it may
even ‘die out’. This protects the susceptible people even though they are
not immune.

SAQ 1.2
Some immunity can be acquired without vaccination. This infant has
become temporarily immune to measles because he has received
maternal antibodies in his mother’s breastmilk (and possibly also across
the placenta before he was born). This type of immunity is called
naturally acquired passive immunity (‘passive’ because the antibodies
protecting the baby were made by his mother, not by his own immune
system).

SAQ 1.3
(a) The diphtheria component of the pentavalent vaccine is made from
the toxin (poison) produced by the bacteria that cause the disease;
the modified toxin is called diphtheria toxoid. This is an example of
a sub-unit vaccine.
(b) The diphtheria toxoid in the vaccine has antigens in its structure
which are unique to the diphtheria bacteria. Helper T cells in the
immune system of the immunized person recognise these antigens as
foreign. They activate other parts of the immune system to make
antibodies and memory cells, which remain circulating in the body
for a long time. If live diphtheria bacteria get into the body, the
person’s immune system is already prepared to attack them and
prevent the disease from developing.
(c) This type of immunity is called artificially acquired active immunity,
where a vaccine is used to develop active immunity against an
infection (‘active’ because the antibodies and memory cells were
made by the person’s own immune system).

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SAQ 1.4
There are many ways in which you can help to implement the EPI
services. You may have thought of the following:
. Help to increase immunization coverage rates by using every
opportunity to immunize eligible children, for example, when they
are brought to the Health Post for another reason; and by making
immunization routinely available at convenient times, preferably on a
daily basis.
. Ensuring the community is made aware of when immunizations are
available. Use any strategies you can to sustain high immunization
coverage, e.g. reminders, posters, meetings, etc.
. Increase the quality of immunization services through good
management, stock control and safe storage of vaccines and other
supplies, and using safe injection practices and disposal of waste.
. Help to reduce missed opportunities for immunization by checking if
all eligible children that you see are immunized, and tracing
defaulters (children who have not completed all the vaccinations in
the schedule).
. Help to improve public awareness and community participation in
the immunization service by involving community leaders and
groups in planning outreach sessions, so as to cover as much of the
target population as possible.
. Keep an accurate register of immunizations and report any cases of
vaccine-preventable diseases to the District Health Office.

Study Session 2
SAQ 2.1 (tests Learning Outcomes 2.1, 2.2 and 2.3)
A is false. BCG is injected intradermally (into the top layer of the
skin). The other antibacterial vaccines in the EPI are injected
intramuscularly, but only BCG and TT vaccine are injected in the
upper arm. Pentavalent vaccine and PCV10 are injected in the upper
outer thigh.
B is false. BCG vaccine is a powder which can be frozen before it is
reconstituted with diluent. The BCG diluent and all the other
antibacterial EPI vaccines will not be effective if they become
frozen.
C is true. If five doses of TT vaccine are given to a woman of
childbearing age at the correct intervals, she will receive the fifth
dose at least 2 years and 7 months after the first dose. The intervals
are TT1, then at least 4 weeks to TT2, then at least 6 months to TT3,
then at least 1 year to TT4, and then at least one more year to TT5.
D is true. Between 78% and 95% of infants who are immunized with
three doses of pentavalent vaccine at the correct intervals will be
protected against pertussis, diphtheria and tetanus. (They will also be
protected against hepatitis B and Hib diseases.)
E is true. BCG vaccine is supplied as a powder which has to be
mixed with a special diluent to activate the vaccine before use.
F is false. If a vial of pentavalent vaccine has a deposit like fine sand
at the bottom, it does not need to be thrown away; you should shake
the vial to mix the vaccine with the liquid before use.

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Notes on the Self-Assessment Questions (SAQs) for Immunization

SAQ 2.2
The health workers in Dembi Health Post are correct. TT vaccine should
be given to all pregnant women during their first contact with a health
facility, regardless of the gestational age of their pregnancy. So Nurse
Ayele should give Birke the TT immunization.

SAQ 2.3
The completed version of Table 2.9 appears below.
Table 2.9 Adverse events following immunization with antibacterial vaccines and
their management at Health Post level.

Adverse event Management


Low-grade fever Paracetamol syrup, 5 ml as required, up
to a maximum of
four doses
Soreness at the injection site Paracetamol (as above); warm compress
applied to the affected area
Abscess at the injection site Amoxicillin syrup orally three times
daily and urgent referral to a health
centre
Swollen lymph glands Refer the child to a health centre
Severe allergic reaction (rash, breathing Do not give another dose of this
difficulty, rapid pulse, dizziness or vaccine; refer the child to a health
fainting) centre immediately
Coma and/or convulsions Do not give another dose of this
vaccine; refer the child to a health
centre immediately

SAQ 2.4
You should tell the mother that the sore is a result of BCG vaccination,
which will protect her baby from tuberculosis. Reassure her that this is a
normal reaction to the vaccine and that the small sore is a good sign
that the vaccine is working effectively. Tell her the sore will heal in
about two weeks and leave a small scar, which is harmless.

SAQ 2.5
This child has a high-grade fever. Give paracetamol syrup (5 ml) and
refer the child to a health centre; do not vaccinate until the child
recovers.

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Study Session 3
SAQ 3.1
The completed version of Table 3.6 appears below.
Table 3.7 Antibacterial and antiviral vaccine characteristics.

Vaccine Antibacterial Antiviral Protects against


BCG vaccine X Tuberculosis
Measles vaccine X Measles
Pentavalent vaccine X (four X (one Diphtheria, pertussis,
components) component) tetanus, Haemophilus
influenzae type b meningitis
and pneumonia, hepatitis B
liver diseases
Yellow fever vaccine X Yellow fever
Pneumococcal X Pneumococcal diseases
vaccine (PCV10) (including pneumonia)
OPV X Poliomyelitis
TT vaccine X Neonatal tetanus (and
tetanus in women)
Meningococcal X Meningococcal meningitis
vaccine
Rotavirus vaccine X Diarrhoea and dehydration
caused by rotaviruses

SAQ 3.2
The completed version of Table 3.7 appears below.
Table 3.7 Summary of dosage, route and schedule for the antiviral EPI vaccines.

Vaccine Dosage and route Schedule


HepB (as part of 0.5 ml, three intramuscular At 6, 10 and 14 weeks
pentavalent vaccine) injections
OPV 2 drops, four oral doses At birth, and 6, 10 and 14
weeks
Measles 0.5 ml, one subcutaneous At 9 months of age in the
injection in the EPI, plus EPI; campaign dose after
one campaign dose 12 months

SAQ 3.3
The completed version of Table 3.8 appears below.
Table 3.8 Adverse events following OPV and measles immunization, and their
management

Vaccine Adverse events Management


OPV None None required
Measles Mild rash None required
Mild fever Paracetamol syrup

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SAQ 3.4
The immunizations (if any) that these individuals should receive are as
follows:
(a) A newborn baby should be given BCG and OPV0.
(b) A ten-month-old child who has had BCG, OPV3, PCV3 and Penta3
should be given measles vaccine.
(c) An eight-month-old child who has had BCG, OPV3, PCV3 and
Penta3 should not be given any further vaccinations until he or she
is 9 months old, when measles vaccine should be given.
(d) A six-week-old child who has had BCG and OPV0 should be given
OPV1, PCV1 and Penta1.

SAQ 3.5
(a) Immunize Fatima with OPV3; it is safe to give this vaccine even
though she has mild diarrhoea. But do not give her PCV3 or Penta3
because she developed a severe allergic reaction three days after the
earlier immunization, which may have been an adverse vaccine
reaction following immunization with one of these vaccines. It is
very unlikely to have been due to the previous dose of OPV.
(b) Explain to the grandmother that it is safe for Fatima to have another
dose of OPV, and why you are not giving the child another dose of
the other two vaccines. Tell the grandmother to come back after
another four weeks; because of the diarrhoea Fatima has today, she
will need an extra (fifth) dose of OPV in four weeks’ time.

Study Session 4
SAQ 4.1
Table 4.2 Completed vaccine administration and reconstitution summary.

Route of administration Reconstitution?


Vaccine ID SC IM Oral Yes No
BCG X X
Pentavalent X X
Measles X X
Polio (OPV) X X
Pneumococcal (PCV10) X X
Rotavirus (RotarixTM) X X
TT (in women) X X

SAQ 4.2
(a) The red and tender swelling on the babies’ left thighs is likely to be
an abscess at the site where they received the pentavalent vaccine by
intramuscular injection the previous week. An abscess at an injection
site is usually caused by a contaminated needle or syringe, or incorrect
vaccine preparation, or incorrect injection technique. The fact that
Bekelech was so busy that day last week may have resulted in poor
adherence to standard procedures when she immunized the babies. For
example, she may have:
. used the same needle and syringe for more than one injection

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. touched the needle with unclean hands before giving the injection
. placed the needle and syringe on a table top or other unclean surface
. failed to keep the vaccine cold during the long immunization session.
(b) Bekelech should:
. Treat the abscesses by giving the babies amoxicillin syrup three
times daily and placing clean, warm compresses on the affected area.
She should ensure that the mothers take their babies to a health
centre urgently for further assessment.
. Take care in future to ensure that standard procedures are followed
when giving immunizations.

SAQ 4.3
Fatuma forgot to check the VVM on the vaccine ampoule. She checked
the expiry date of the vaccine, but this will not tell her if the vaccine
has been exposed to heat and lost its potency. She should check the
VVM and if it has passed the discard point she should discard it.
Fatuma also forgot to clean the injection site. She should clean the skin
with antiseptic solution and leave it to dry before giving the vaccination.
Pushing a needle through dirty skin could introduce an infection into the
baby’s body.

SAQ 4.4
OPV is never given to babies using a syringe as a substitute for the
glass dropper supplied with the vaccine or the dropper incorporated into
the vaccine vial. Using the correct dropper ensures that the correct dose
of OPV is given in two drops of vaccine.

Study Session 5
SAQ 5.1
The equation for calculating the annual vaccine needs, based on the size
of the target population, is:
Annual vaccine needs = pt × dn × ic × wf where:
. pt is the target population – for pentavalent vaccine this is the
number of children aged 0–11 months (calculated below)
. dn is the number of doses of vaccine in the recommended schedule
— this is 3 for pentavalent vaccine
. ic is the target immunization coverage rate — in this example it is
90%
. wf is the wastage factor (calculated below)
The number of children aged between 0–11 months is 5% (0.05) of the
total population of 5,700, which is:
5,700 × 0.05 = 285 children in this age group (5% expressed as a
decimal number is 0.05)
The wastage factor is calculated from the wastage rate of 5% using the
equation:
Wastage factor (wf) = 100 ÷ (100 – % wastage rate)
So for a wastage rate of 5%:
wf = 100 ÷ (100 – 5) = 100 ÷ 95 = 1.05

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Notes on the Self-Assessment Questions (SAQs) for Immunization

Using the equation below to calculate the annual vaccine needs based on
the target population size:
pt × dn × ic × wf = 285 × 3 × 0.9 × 1.05 = 808 doses
So the annual pentavalent vaccine needs, based on the size of the target
population in this kebele, is 808 doses.

SAQ 5.2
The equation for calculating annual vaccine needs based on the size of
the immunization sessions is as follows:
Annual vaccine needs = posts × weeks × sessions × vials × doses;
where (for PCV10 vaccine in this example):
. posts is the number of immunization sites, which is 1
. weeks is how many weeks the immunization site operates, which is
45 in this example
. sessions is the number of sessions per week, which is 2
. vials is the number of vials used per session, which is 5
. doses is the number of doses per vial, which is 2.
So the annual vaccine needs for DPT in this example is:
1 × 45 × 2 × 5 × 2 = 900 doses.

SAQ 5.3
The wastage factor (expressed as a decimal number) is calculated from
the wastage rate (expressed as a percentage), using the following
equation:
Wastage factor (wf) = 100 ÷ (100 – % wastage rate)
In this example, the wastage rate for OPV has been set at 10%. So the
wastage factor is:
wf = 100 ÷ (100 – 10) = 100 ÷ 90 = 1.11
Therefore, the wastage factor is 1.11.

SAQ 5.4
(a) In the example given in SAQ 5.2, there are two immunization
sessions per week. Five multi-dose vials of PCV10 each containing
2 doses are used per session, so 20 doses are needed per week.
Therefore the number of doses required for a 2-week supply period
in this kebele is 40 doses.

(b) The minimum stock level is generally taken to be 25% (or 0.25) of
the requirement for the supply period, which in this example is 2
weeks. The equation needed to calculate the minimum stock level
for a 2-week period is:
smini = qperiod × 0.25 (25% expressed as a decimal number is 0.25)
where qperiod is the number of doses required for the supply period,
which in this example is 40 doses.
smini = 40 × 0.25 = 10 doses.
So the minimum stock level for PCV10 vaccine for a 2-week
period in this kebele is 10 doses.

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(c)
The maximum stock level for PCV10 for a 2-week period in this
kebele is calculated from the following equation:
smaxi = qperiod + smini

smaxi = 40 + 10 = 50 doses
(d) So the maximum stock level for PCV10 vaccine for a 2-week period
in this kebele is 50 doses.

Study Session 6
SAQ 6.1
A is false. The VVM records exposure of vaccines to heat over a
period of time, but it does not record exposure to freezing
temperatures.
B is false. Even if the expiry date has not passed, it is unsafe to use
vaccines that have reached the discard point indicated by the VVM.
C is true. A thermometer measures the temperature in a refrigerator.
D is false. Diluents can be kept at room temperature if there is not
enough space in the refrigerator, but should be chilled thoroughly
before use.

SAQ 6.2
(a) The vaccine can be used because the inner square of the VVM is
lighter than the outer circle. This means that the vaccine has not
been damaged by excessive heat.
(b) This vaccine should not be used because the inner square of the
VVM is almost as dark as the outer circle. This means that the
vaccine has been damaged by excessive heat and should be
discarded.

SAQ 6.3
The completed version of Table 6.1 appears below, with the correct
shelf for storing each vaccine marked with a cross.
Table 6.1 Storage of vaccines in a front-loading refrigerator.

Vaccine Top shelf Middle shelf


Measles X
Pentavalent X
TT X
OPV X
BCG X
PCV10 X

SAQ 6.4
(a) Abeba must not reconstitute the vaccine using the diluent which has
been on the window ledge for several days because it will be warm.
Warm diluent damages the vaccine.
(b) Abeba should put the diluent back into the refrigerator and only use
it when it is cold again (between +2ºC and +8 ºC). She should
apologise to the parents and explain that they can either wait for

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Notes on the Self-Assessment Questions (SAQs) for Immunization

several hours for the diluent to reach the correct temperature, or


come back for the next immunization session.

SAQ 6.5
The thermometer shows a temperature of +22oC. This is much too high
a temperature for storing vaccines! They have to be stored between
+2oC and +8oC. This refrigerator is not working at all and must be
repaired, or the power may have been cut off. Check the gas, electricity
or kerosene supply, and call your supervisor to report the problem.
Move the vaccines and diluents into cold boxes and transport them
quickly to the nearest health centre for cold storage.

SAQ 6.6
(a) Opened vials that you are using should be put on the foam pad that
rests above the conditioned ice-packs on top of the vaccine carrier.
Make sure that the vaccine carrier is in a shady place, not in
sunshine.
(b) Unopened vials should be put inside the vaccine carrier with
conditioned ice-packs or chilled water bottles and the lid closed
until you need them.

SAQ 6.7
(a) On the morning of the 11th day of the month, the temperature of the
refrigerator had risen to above +8ºC, which is above the acceptable
temperature range. The refrigerator should have been checked on
that day. The thermostat should have been adjusted to ‘colder’. If
this action was taken, and the temperature still continued to rise, the
vaccines should have been moved into a vaccine carrier and
attempts made to repair the refrigerator or restore the power supply
(e.g. the kerosene may have run out).
(b) Figure 6.14 shows that the temperature continued to rise, and
reached about +18ºC by the morning of the 12th of the month. This
is much too high for safe storage of vaccines. It would be important
to check the VVM on any vaccines which had remained in the
refrigerator during this time, and throw away any which had reached
their discard point.

Study Session 7
SAQ 7.1
(a) A safe injection is one that does not harm the client, does not
expose the provider to any avoidable risk and does not result in
dangerous waste.
(b) Look back at Box 7.3 for descriptions of programme errors, i.e. due
to incorrect immunization practices.

SAQ 7.2
The actions that could expose your clients to infection when you
immunize them are:
B Allowing opened multi-dose vials of vaccine to become
submerged in melted water in a vaccine carrier. Contaminated water
can infect the vaccine if it leaks into the vial through the tiny holes
made by the needles used to withdraw vaccine previously.

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D Removing the cap from a disposable needle and holding it by the


adaptor before you fit it onto the syringe. Infection could be
transferred from your hands to the needle.
Actions A, C and D do not pose in infection risk to your clients, but
you should know that:
A Allowing a freeze-sensitive vaccine to become too cold will
reduce its effectiveness.
C Using auto-disable syringes for all immunizations is the best way
to avoid any infection risk to your clients.
E Attempting to replace the cap on a used needle poses an infection
risk to you!

SAQ 7.3
(a) These are the symptoms of a severe acute allergic reaction, with
signs of shock (fast pulse and low blood pressure).
(b) You should refer the child immediately to the nearest health facility
– this is a potentially life-threatening reaction to the vaccine. As you
should know from earlier Modules, you should keep the baby warm
at all times, tell the mother to continue breastfeeding if the child
will suckle and go with them if you can. If you cannot go you
should send a clearly written referral note listing all the relevant
details.

SAQ 7.4
(a) This HIV-positive infant is well, so she can receive the birth dose of
BCG vaccine and all the routine EPI immunizations according to the
normal schedule at the age of 6 weeks.
(b) Immunization with pentavalent vaccine can result in low-grade
fever, which usually resolves within 24 hours. This is not a
contraindication, so the child should be immunized with the second
dose of pentavalent and the other routine EPI vaccines scheduled at
10 weeks.
(c) This child should not be given another pentavalent immunization.
Convulsions soon after immunization are an absolute
contraindication to further immunization with the same vaccine.

SAQ 7.5
The potential disadvantages of disposing of a safety box containing used
needles and syringes after an immunization session, using one of the
following methods, are:
(a) An incinerator at a health centre may be too far away to be a
realistic method of regular waste disposal.
(b) Burning in a metal container will leave fragments of waste that must
be scraped out of the drum and buried safely.
(c) Burning in an open pit may result in fragments being blown about
by the wind and scattered around the pit, or not being completely
burnt if the fire goes out too soon.
(d) Burying without burning in a sharps pit could result in waste being
exposed by soil being washed away, or children or animals digging
it up.

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Study Session 8
SAQ 8.1
The six planning steps in the correct sequence are:
1 assessing the community’s health needs
2 identifying and prioritising problems to be addressed
3 setting goals and objectives
4 agreeing strategies and activities in the annual action plan, including
resource requirements
5 implementing the service
6 monitoring and evaluating progress towards meeting the targets.

SAQ 8.2
You should also consider the socioeconomic impact of reducing each
problem, the feasibility of available solutions to each problem (are the
required actions realistically deliverable, and do you have adequate
resources?), and whether they are likely to be affordable within existing
budgets. Another consideration in prioritising your activities is whether
the beneficiaries in the community will find your solutions acceptable,
and whether they meet local and government concerns.

SAQ 8.3
A is true. Community discussion and approval is essential during the
development of your annual immunization action plan.
B is false. If a mother has lost the immunization card for her child,
you should not send her home. You should question her carefully to
see if she remembers what vaccines her child has received and the
date of the last immunization. Check your EPI Registration Book to
see if you can find an entry for her child’s previous immunizations
and give the next dose accordingly. If there are no available records
and there are no contraindications, give the child the appropriate EPI
vaccines based on its age.
C is true. The percentage of newborns protected at birth (PAB) from
neonatal tetanus is a good indicator of progress towards achieving
adequate TT doses for their mothers during pregnancy. The maternal
antibodies developed by women who have had TT2+ within 2 weeks
of delivery will protect their newborns from tetanus.
D is false. A fully immunized child has received all doses of all the
EPI vaccines scheduled for routine immunization — including
measles vaccine — by its first birthday.
E is true. Accurate entries in your EPI Registration Book during each
immunization session will help you to estimate the number of doses
of vaccine needed for future sessions.

SAQ 8.4
You should also tell her to bring her baby for her next dose of these
vaccines in 4 weeks’ time, at 10 weeks old, and explain that possible
side-effects of the vaccines her baby received are mild swelling and
soreness at the sites of vaccination and a slight fever, but these are
nothing to worry about.

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SAQ 8.5
(a) Before you arrive at an outreach site, the community volunteers
should prepare the area for the immunization session by setting out
a registration table and a table at which immunizations can be given,
and some chairs or other places for clients to wait for their turn. The
tables should be clean and the area should be tidy and well shaded,
so that everyone is protected from sun and rain, and the vaccines are
not exposed to heat or sunlight.
(b) Support for the community volunteers at the outreach site should be
provided in the form of adequate training and supportive
supervision, to enable you to deliver a safe and effective
immunization service with their help.
(c) Before leaving the site at the end of the outreach session you should
collect all waste and safety boxes for safe disposal back at your
Health Post, and leave the area clean and tidy — just as you found
it. Don’t forget to thank all the volunteers!

Study Session 9
SAQ 9.1
(a) A community conversation is a process of discussion with a
community group. It looks into an issue that is causing problems
locally and seeks to find collective solutions to these problems.
(b) There are many situations where you might decide to arrange a
community conversation about your immunization programme; for
example:
◦ If you have large numbers of families who do not bring their
children for immunization
◦ If you have a high dropout rate from the immunization
programme in parts of your kebele
◦ If children have had serious adverse reactions after
immunization
◦ If you believe there are negative rumours circulating in the
community about immunization.
(c) The appropriate people to invite will depend on the situation:
◦ If you have large numbers of families who do not bring their
children for immunization, you could invite representatives
of those families and also any of their neighbours who do
bring their children for immunization.
◦ If you have a high dropout rate from the immunization
programme in parts of your kebele, you could invite parents
from families whose children started their vaccinations, but
did not complete them.
◦ If children have had serious adverse reactions after
immunization, you might invite the parents of those
particular children, together with other parents whose
children were not adversely affected.
◦ If you believe there are negative rumours circulating in the
community about immunization, you might invite those who
you believe are being influenced by the rumours, together
with community leaders and other influential people in your
local community who support immunization.

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SAQ 9.2
The steps you should undertake in planning your strategy are:
1 Communication needs assessment — try to find out which parents
are not accessing the immunization programme and why this might
be.
2 Set specific and measurable objectives — identify what barriers need
to be removed in order to improve coverage rates, and what
communication activities might support this goal. Establish what
community resources you might have available to address the
problem.
3 Plan appropriate strategies or activities, e.g. a focus group with
parents, a community conversation, a meeting with opinion leaders,
etc.
4 Prepare your action plan — decide when and where the
communication activities will take place, who will lead them, who
will be invited, how you will advertise the event and ensure the right
people attend it.
5 Implement your plan.
6 Monitor and evaluate the outcomes of your communication activity
— record how many people took part, and whether they changed
their behaviour afterwards and brought their children for
immunization.

SAQ 9.3
Lack of accurate knowledge about the immunization service could be
improved by better communication. You should make sure that you
communicate the times and places for the immunization sessions
effectively, so that they are known to everyone. You could do this by
posting notices where they will easily be seen, telling all your clients
when you see them at the Health Post, or in their homes, at the market,
etc., and asking your community volunteers to tell everyone they visit.
You could ask community or religious leaders to announce the dates and
locations of immunization sessions during their own meetings.

SAQ 9.4
If you discover such a rumour, you should do the following:
. Report the rumour and seek advice from your supervisor and health
centre officials about how to deal with it.
. Collect information about the rumour — who has started it? Why do
they think that measles vaccination causes deafness? Has the rumour
started because of incorrect information, or is there some other
reason?
. Meet with opinion leaders — give them an opportunity to ask
questions, and provide clear information about the dangers of
measles and how vaccination can prevent it.
. Train community volunteers to give correct information about the
measles vaccine and how to deal with the rumour.
. Arrange meetings with concerned parents to communicate correct
information about measles vaccination.

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. Prepare posters and print materials and distribute them around your
kebele explaining in simple local language about the benefits of
measles vaccination and that it very rarely causes any bad effects.

Study Session 10
SAQ 10.1
Tally sheets should also be used to record the number of doses and the
lot number of each vaccine given during each immunization session.
This enables you to check that the number of doses given tallies
(matches) the number recorded in your Registration Book. It also acts as
a way of monitoring the number of doses given, and enables you to
complete your monthly Summary Report to the higher level. You may
also have mentioned your Vaccine Stock Register (see Study Session 5).

SAQ 10.2
The percentage of children in the target population who receive the third
dose of pentavalent vaccine (Penta3) is particularly useful, because it
indicates the continuity of use of the immunization service by parents
and caregivers. A low dropout between Penta1 and Penta3 indicates that
parents and caregivers are able to access the service.
The percentage of fully immunized children (FIC) is another particularly
useful indicator, as it demonstrates the capability of the system to
provide all the vaccines in the schedule at the appropriate times. It also
gives an indication of the public demand for the service. Low dropout
between Penta1 and measles immunization demonstrates satisfaction
with the perceived quality of the service in the community, and also that
there is not a general problem of utilisation of health services locally.

SAQ 10.3
(a) Calculation of dropout rates.
District A:
Figure 10.10 shows that 50% of infants received pentavalent 1 vaccine,
and 42% completed the three-dose schedule (using pentavalent 3
coverage as the indicator). The dropout rate is calculated using the
equation:
Penta1 to Penta3 dropout rate = (Penta1 – Penta3) ÷ Penta1 × 100%
The dropout rate in District A is therefore (50 – 42) ÷ 50 × 100 % =
16%.
District B:
Figure 10.10 shows that 85% of infants received pentavalent 1 vaccine,
but only 58% completed the three-dose schedule (received
pentavalent 3). The dropout rate in District B is therefore:
(85 – 58) ÷ 85 × 100% = 32%.
(b) In District A, the major problem is low coverage, as only 50% of
children received the first pentavalent dose, which indicates an access
problem for parents or caregivers. In District B, the major problem is
the high dropout rate of 32%, which indicates a general problem of
utilisation of health services.

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Notes on the Self-Assessment Questions (SAQs) for Immunization

c) In District A, priority should be given to raising the pentavalent 1


coverage rate, by aiming to immunize the 50% of children who have
never been reached by the immunization service. In District B, the
priority should be given to following up on defaulters and persuading
them to complete the schedule of immunization, so the pentavalent 3
coverage rate rises from 58% to closer to the 85% who received
pentavalent 1.

SAQ 10.4
(a) An estimated 3.6% of the population of 5,000 in the catchment area
are under one year of age and therefore eligible for measles
immunization. The total eligible population of infants in this age-
group is calculated as follows:

5,000 × 0.036 (or 3.6%) = 180 infants


You would expect about 15 of these infants to have been born each
month of the year (180 ÷ 12 = 15). However, only nine infants
received measles vaccine during September, so the measles vaccine
coverage for September was (9 ÷ 15) × 100% or 60%.

(b) The measles immunization coverage rate of only 60% is low, and
indicates a problem with utilisation of health services for parents or
caregivers.

(c) Possible actions you could take to try to reach more infants in the
target age group could include:
. more house-to-house visits in remote areas (using mobile teams)
. more outreach immunization sessions
. ensuring that no opportunities are missed to immunize eligible
infants with measles vaccine, e.g. if they are brought to the Health
Post for another reason, or when you are visiting the family
. more effective tracing of defaulters by checking entries in the EPI
Registration Book every month, and using reminder cards to tell you
which infants are due for their next immunization in which month.

SAQ 10.5
(a) Meseret’s mistake was leaving the Summary Report blank where she
should have recorded ‘zero’ for cases of vaccine-preventable
diseases and any serious adverse events following immunization.
(b) Meseret’s Summary Report should also have included:
. the number of vaccine vials she received as new stock during the
month
. any specific problems encountered during the reporting period,
e.g. stock shortages, transportation problems, cold chain failures, etc.

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