Food and Drug Administration: Republic of The Philippines Department of Health

Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
20 August 2021
PHIL. ARCHIPELAGO INTERNATIONAL TRADING CORP.

Limtuaco Bldg. 1830 EDSA
Apolonio Samson Balintawak Quezon City
Emergency Use Authorization (EUA) for Gamaleya National Center of

Epidemiology and Microbiology Sputnik Light COVID-19 Vaccine
This applies to the application for the issuance of Emergency Use Authorization (EUA)
for Gamaleya National Center of Epidemiology and Microbiology Sputnik Light vector
vaccine for the prevention of SARS-CoV-2-induced coronavirus infection (“Gamaleya
Sputnik Light COVID-19 Vaccine”).
The details of the Gamaleya Sputnik Light COVID-19 Vaccine are as follows:
Product Name: Sputnik Light vector vaccine for the prevention of

SARS-CoV-2-induced coronavirus infection
Dosage Strength and Form: Solution for intramuscular administration
Pharmacologic category: Vaccine
Storage: -18 0C to -220C
Shelf Life: 10 months
Packaging: Single dose 0.5 ml ampoule (box of 5’s)
5 dose, 3 ml vial (box of 1’s)
Manufacturer: Gamaleya National Center of Epidemiology and
Microbiology
Indication: For the prevention of COVID-19 (infection
caused by SARS-CoV-2 virus) in individuals 18
years old or older.
After careful consideration of the application, with all its supporting documents and a
review of local experts, the FDA has been satisfied that all the conditions for the issuance
of an EUA exist as provided under Executive Order (EO) No. 121, s. 2020 entitled
“Granting Authority to the Director General of the Food and Drug Administration to
Issue Emergency Use Authorization for COVID-19 Drugs and Vaccines, Prescribing
Conditions Therefor, and for Other Purposes,” particularly:
1. Based on the totality of evidence available to date, including data from adequate
and well- known controlled trials, it is reasonable to believe that the Gamaleya
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: [email protected]
Sputnik Light COVID-19 Vaccine may be effective to prevent, diagnose or treat
COVID-19;
2. The known and potential benefits of the Gamaleya Sputnik Light COVID-19
Vaccine, when used to diagnose, prevent or treat COVID-19, outweigh the known
and potential risks of said Vaccine as of date; and
3. There is currently no adequate, approved and available alternative to the product
for diagnosing, preventing or treating COVID-19.
In issuing this EUA, consideration has been given to the emergency use authorizations
given by counterpart National Regulatory Authorities (NRAs) such as Russia and
Belarus. This was followed by a rigorous and thorough review of all submitted published
and unpublished clinical trial data and product information.
This EUA is not a marketing authorization or a Certificate of Product Registration

(CPR). Hence, this EUA cannot be used as an authorization to market the vaccine
commercially.
While the evaluation process was facilitated, strict conditions on the authorization
granted in this Letter shall be imposed as follows:
I. Scope
The scope of the EUA shall be limited as follows:
A. Phil. Archipelago International Trading Corp. (PAITC) shall supply Gamaleya

Sputnik Light COVID-19 Vaccine only to emergency response stakeholders
consistent with the terms and conditions of this EUA.
“Emergency response stakeholders” shall refer to the Department of Health

(DOH) or the National Task Force Against COVID-19 (NTF) or their designees
authorized to procure or purchase Gamaleya Sputnik Light COVID-19 Vaccine
in line with the COVID-19 vaccination program. Designees may include
hospitals (public and private), health facilities of other National Government
Agencies, Local Government Units (LGUs) and other members of the Private
Sector.
B. The Gamaleya Sputnik Light COVID-19 Vaccine shall be administered only by

vaccination providers, and used only to prevent COVID-19 in individuals ages
18 and older.
“Vaccination providers” shall refer to the facility, organization, or a healthcare

provider, including non-physician healthcare providers such as nurses or
pharmacists, authorized by the DOH or the NTF to administer the Gamaleya
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Sputnik Light COVID-19 Vaccine in accordance with the COVID-19 vaccination
program.
II. Dosage Strength and Form
The pharmaceutical product Sputnik Light vaccine helps prevent the newly discovered
coronavirus infection (COVID-19). It is a vector vaccine for the prevention of
coronavirus infection caused by the SARS-CoV-2 virus. It is a solution for intramuscular
injection single dose vaccine in a 5 dose, 3 ml vial or an ampoule containing 0.5 ml of
the solution.
III. Cold Chain Management
In the absence of agreement with the DOH or NTF, PAITC shall provide appropriate
cold chain requirements for storage, transport and handling until it is delivered to the
inoculation sites, and ensure that a contingency plan is in place.
PAITC shall have a system of monitoring to ensure traceability and that the vaccine is
consistent with the storage requirements from the manufacture and transport to the
inoculation sites.
PAITC shall observe strict compliance with the standards for Good Distribution Practices
(GDP) and Good Storage Practices (GSP) adopted pursuant to Administrative Order No.
2013-0027 including supplements thereto (i.e. WHO Technical Report Series No. 961,
2011, Annex 9 and Technical Report Series No. 992, 2015, Annex 5). PAITC shall allow
FDA Inspectors to conduct inspection of the cold storage sites including the transport
vehicles.
IV. Pharmacovigilance
PAITC shall have a comprehensive pharmacovigilance system for Gamaleya Sputnik

Light COVID-19 Vaccine following system or protocol for a registered drug and biologic
product as stated in the FDA Circular No. 2020-003. Submission of serious and non-
serious adverse reaction reports is mandatory.
PAITC shall ensure compliance with the Risk Management Plan (RMP) along with the
Philippine-specific Annex. Additional pharmacovigilance activities such as
interventional and non-interventional studies (ongoing or new studies, or additional
activities) shall be implemented as stated in the RMP. The RMP must be updated
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whenever there is a significant change which may affect the benefit-risk profile of the
vaccine or when an important milestone is reached.
PAITC shall submit monthly summary safety reports as planned and discussed in the
RMP.
V. Responsibility of Emergency Response Stakeholders and Vaccination

Providers
Under FDA Circular No. 2020-036 or the Guidelines for the Issuance of Emergency Use
Authorization for Drugs and Vaccines for COVID-19, the pharmacovigilance obligations
and post-authorization commitments imposed in the Letter shall be shared to the fullest
extent possible and applicable by the national procurer and health program implementors,
and their designees. Emergency response stakeholders and vaccination providers shall
have the following responsibilities.
A. Emergency response stakeholders shall:
1. Identify inoculation sites to receive the Gamaleya Sputnik Light COVID-

19 Vaccine, and ensure appropriate storage and cold chain management is
maintained in said sites, in the absence of an agreement with PAITC;
2. Ensure administration of the Gamaleya Sputnik Light COVID-19 Vaccine
is consistent with the terms of this Letter, latest product information and the
COVID-19 Vaccination Program; and
3. Ensure that vaccination providers of the procured Gamaleya Sputnik Light
COVID-19 Vaccine are aware of this Letter of Authorization and the terms
herein and any subsequent amendments thereof, instructed about the means
which they are to obtain and administer the Gamaleya Sputnik Light
COVID-19 Vaccine, and provided with approved fact sheets.
B. On the other hand, vaccination providers shall:
1. Administer the Gamaleya Sputnik Light COVID-19 Vaccine, in accordance

with this EUA, and participate and comply with the terms and training
required by the DOH for the COVID-19 Vaccination Program;
2. Provide fact sheets to the recipients and caregivers, and provide necessary
information for receiving their second dose;
3. Obtain written informed consent from the recipient of the Gamaleya
Sputnik Light COVID-19 Vaccine prior to vaccination;
4. Report any Adverse Events Following Immunization on the use of
Gamaleya Sputnik Light COVID-19 Vaccine;
5. Monitor and comply with vaccine management requirements (e.g.
obtaining, tracking and handling vaccine) of the DOH; and
6. Ensure that records associated with this EUA are maintained until notified
by FDA. Such records shall be made available to DOH and FDA for
inspection upon request.
Notwithstanding the foregoing, PAITC has the ultimate responsibility for monitoring the
safety and quality of the Gamaleya Sputnik Light COVID-19 Vaccine.
Page 4 of 5
VI. Validity
Unless otherwise revoked, this EUA shall be valid only within the duration of the
declared public health emergency due to COVID-19, or upon issuance of a marketing
authorization/Certificate of Product Registration.
In the event that the declared public health emergency is lifted, or when a COVID-19
drug or vaccine is registered with the FDA, this EUA shall have a provisional validity
for a period of one (1) year from date of lifting of the declaration or registration of the
drug or vaccine for the sole purpose of exhausting remaining products.
This EUA is subject to revocation, suspension or cancellation due to violations of

pharmacovigilance obligations and post authorization commitments, as well as any
violation of the EO No. 121, and RA 3720 as amended by RA No. 9711, FDA Circular
No. 2020-036, and other rules and regulations issued thereunder.
For strict compliance.
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Republic of the Philippines

PHIL. ARCHIPELAGO INTERNATIONAL TRADING CORP.

Emergency Use Authorization (EUA) for Gamaleya National Center of

Product Name: Sputnik Light vector vaccine for the prevention of

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

This EUA is not a marketing authorization or a Certificate of Product Registration

The scope of the EUA shall be limited as follows:

A. Phil. Archipelago International Trading Corp. (PAITC) shall supply Gamaleya

“Emergency response stakeholders” shall refer to the Department of Health

B. The Gamaleya Sputnik Light COVID-19 Vaccine shall be administered only by

“Vaccination providers” shall refer to the facility, organization, or a healthcare

II. Dosage Strength and Form

III. Cold Chain Management

PAITC shall have a comprehensive pharmacovigilance system for Gamaleya Sputnik

V. Responsibility of Emergency Response Stakeholders and Vaccination

A. Emergency response stakeholders shall:

1. Identify inoculation sites to receive the Gamaleya Sputnik Light COVID-

B. On the other hand, vaccination providers shall:

1. Administer the Gamaleya Sputnik Light COVID-19 Vaccine, in accordance

This EUA is subject to revocation, suspension or cancellation due to violations of

For strict compliance.

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