1 s2.0 S0264410X24010570 Main
1 s2.0 S0264410X24010570 Main
1 s2.0 S0264410X24010570 Main
Vaccine
journal homepage: www.elsevier.com/locate/vaccine
Short communication
A R T I C L E I N F O A B S T R A C T
Keywords: We assessed the impact of the 2023/2024 COVID-19 vaccination campaign in Italy by estimating the number of
COVID-19 averted COVID-19 severe cases (i.e. COVID-19 associated hospitalisations or deaths) between October 2023 and
Vaccination impact March 2024, in those aged ≥60 years. We estimated that 565 (95 % CI: 497–625) cases, corresponding to 2.1 %
Elderly population
(95 % CI: 1.8–2.3) of the expected cases without a vaccination campaign, were averted. We simulated three
SARS-CoV-2
vaccination coverage scenarios: 50 %, 75 %, 90 % (versus the observed 10.7 %), finding that 9.7 % (95 % CI:
Monovalent XBB-adapted vaccines
8.5–10.7); 14.5 % (95 % CI: 12.8–16.1); and 17.4 % (95 % CI: 15.3–19.3) of the expected cases would have been
averted, respectively.
1. Introduction vaccine adapted to Omicron XBB 1.5 (i.e. Comirnaty Omicron XBB 1.5
and, since December, Nuvaxovid XBB 1.5) [3,4]. This additional dose
By 2023, many countries shifted from universal COVID-19 vaccina- was recommended to be administered at least 6 months after the last
tion campaigns to delivering booster doses to high-risk groups, aiming to received dose of any COVID-19 vaccine or the last SARS-CoV-2 infection
prevent severe COVID-19 disease. In June 2023, the European Centre for (i.e. date of positive diagnostic test) [3]. As of the beginning of the
Disease Prevention and Control (ECDC) and the European Medicines vaccination campaign, Sars-Cov-2 variant EG.5 was the most prevalent
Agency (EMA) recommended the use of monovalent XBB-adapted vac- variant up until week 50 (2023), when JN.1 variant became dominant
cines for the 2023/24 autumn-winter vaccination campaigns, based on [5].
surveillance and sequencing data showing the global predominance of Generating evidence on the impact of the 2023/2024 seasonal
XBB.1 descendent lineages [1]. vaccination campaign is crucial to support vaccination program evalu-
The Italian 2023–2024 seasonal vaccination campaign started on 1st ation and the planning of future vaccination programs. We aimed to
October 2023 targeting high risk groups (i.e. those aged ≥60 years and estimate the number of COVID-19 associated hospitalizations and deaths
those with high-risk comorbidities (full list in Supplementary Table 1)) prevented by the 2023/24 autumn-winter COVID-19 seasonal booster
[2,3]. Vaccines administered included a single dose of a COVID-19 campaign in Italy, in those aged ≥60 years.
* Corresponding author at: Department of Infectious Diseases, Istituto Superiore Di Sanità, Rome, Italy.
E-mail address: [email protected] (E.A. Fotakis).
1
These authors contributed equally to this work and share first authorship.
2
The members of the group are listed under Acknowledgements.
https://doi.org/10.1016/j.vaccine.2024.126375
Received 10 June 2024; Received in revised form 9 September 2024; Accepted 13 September 2024
Available online 18 September 2024
0264-410X/© 2024 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-
nc-nd/4.0/).
E.A. Fotakis et al. Vaccine 42 (2024) 126375
2. Methods 3. Results
2.1. Study design and data sources We included in the analysis 15,558,829 (99 %) of the 15,719,063
eligible individuals, who, at the starting date of the vaccination
We conducted a nationwide retrospective cohort analysis between campaign, were alive (Supplementary Methods 2), had received a
October 2023–March 2024 among individuals ≥60 years of age, who minimum of one booster dose, and had no prior infections nor had
were eligible to receive the seasonal vaccine on 1st October 2023 (i.e. received booster doses in the previous 180 days. We excluded 160,234
had possible previous doses and SARS-CoV-2 infections more than 180 (1 %) individuals through a set of selection criteria described in Sup-
days before 1st October 2023) [3], from which we selected those who plementary Fig. 1.
had previously received at least one booster dose, comprising the vast
majority of the elderly population in Italy. We linked the Italian COVID- 3.1. Demographic and clinical characteristics of the study population
19 vaccination registry data, held by the Ministry of Health, containing
individual information on each COVID-19 vaccination dose adminis- The demographic and clinical characteristics of persons included in
tered in the country [6], with data from the SARS-CoV-2 integrated the study are presented in Table 1. A total of 1,659,448 individuals
surveillance system in Italy [7], including information on every labo- (10.7 %) received a booster dose with XBB.1 adapted vaccines during
ratory confirmed case of SARS-CoV-2 followed up until recovery or the seasonal vaccination campaign (of which >99 % received a Com-
death associated to COVID-19. irnaty Omicron XBB 1.5 booster). A total of 13,899,381 individuals
These databases were deterministically linked using a unique iden- (89.3 %) did not receive a booster dose.
tifier (universal tax code).
We also used the latest available information on the levels of ur- 3.2. Trends in booster vaccination coverage and severe COVID-19 cases
banization and socioeconomic deprivation (SED) of the Italian munici-
palities, which was linked to individual records through the The start of the vaccination campaign coincided with an increase in
municipality's code where the vaccination took place [8]. the trend of severe cases, which lasted until weeks 48–50 of 2023
(Fig. 1). Incidence decreased steeply afterwards until the end of the
2.2. Estimation of relative vaccine effectiveness of the COVID-19 seasonal season, whilst cumulative vaccine coverage among those aged ≥60
vaccination campaign years reached its maximum (10.7 %) at around week 7 of 2024.
We compared the time to SARS-CoV-2 infection leading to severe 3.3. Vaccine effectiveness of the COVID-19 vaccination campaign and
COVID-19 (i.e. hospitalization or death occurring within 28 days since severe events averted
testing positive) between individuals who received a booster dose with
XBB.1 adapted vaccines during the seasonal vaccination campaign and We estimated that rVE peaked at 60 % (95 % CI, 51–67) in Octo-
those who did not receive the booster. ber–November and then progressively declined to 47 % (95 % CI, 43–51
We conducted a Cox proportional hazard regression analysis to es- %) in December–January, and 36 % (95 % CI, 21–47 %) in
timate the adjusted hazard ratio (HR) of severe COVID-19 between the February–March.
two groups, using calendar time measured in days as the underlying time We estimated that the 2023/24 autumn winter COVID-19 vaccina-
scale and vaccination as a time-dependent exposure for different tion campaign averted 565 (95 % CI: 497–625) severe COVID-19 cases
observation periods (i.e., two-month calendar intervals as of 1st October in Italy, corresponding to 2.1 % (95 % CI: 1.8–2.3) of those expected
2023). Individual follow-up started at the beginning of the vaccination without a vaccination campaign. Based on our analysis, under scenarios
campaign on the 1st October 2023 and ended on the first of the with cumulative vaccination coverage rates of 50 %, 75 %, and 90 % at
following dates: the date of testing positive for SARS-CoV-2 infection the study end, a total of 2636 (95 % CI: 2320–2914); 3953 (95 % CI:
subsequently leading to severe COVID-19, the imputed date of death for 3480–4371); and 4744 (95 % CI: 4176–5245) severe cases would have
causes unrelated to COVID-19 (Supplementary Method 2), the end of the been averted respectively, accounting for 9.7 % (95 % CI: 8.5–10.7);
study period on 31st March 2023 or the date of vaccination if any of the 14.5 % (95 % CI: 12.8–16.1); and 17.4 % (95 % CI: 15.3–19.3) of the
prior three events occurred within the first two weeks post vaccination. expected cases in each respective scenario (Table 2). Fig. 2 shows the
Estimates were adjusted for sex, age (5-year age groups), country of number of averted severe cases by calendar month, both observed and
birth (born in Italy or abroad), geographical area where the last vacci- under different scenarios, most of them estimated in December.
nation took place (19 regions and two autonomous provinces of Italy),
high-risk conditions (presence/absence of at least one condition among 4. Discussion
those listed in Supplementary Table 1), post-primary cycle number of
booster doses received before the starting date of the study (1, 2, or ≥3), We found that less than 3 % of expected severe COVID-19 events
urbanization level (high, medium, low) and SED level (1st quintile-least were averted by the 2023/24 seasonal booster campaign in Italy. The
deprived to 5th). low number of severe averted events can be partially explained by the
We then calculated relative vaccine effectiveness (rVE) against se- moderate rVE of XBB.1.5 vaccines we found, the overall low uptake of
vere COVID-19 as [(1 − HR) * 100]. the booster, and the increasing incidence trend of severe cases preceding
considerable vaccine uptake among the elderly population. Indicatively,
2.3. Estimation of severe events averted by the vaccination campaign our simulated scenarios suggested that increasing VC to 50 %, 75 %, and
90 % could have potentially averted a substantially larger proportion of
We estimated the number of averted severe cases by adapting the severe COVID-19 cases.
formula proposed by Machado et al. [9], using the bi-monthly adjusted Other countries have investigated VE of XBB.1.5 vaccines. Pre-
rVE estimates, the weekly vaccine uptake and the weekly number of liminary studies conducted in Denmark [10] and the Netherlands [11] in
observed events. In addition, we estimated the expected number of the first weeks of the campaign reported higher levels of protection
averted cases based on scenarios in which the weekly rates of vaccine compared to our study, with VE around 70 % against hospitalization in
uptake were re-proportioned, following the observed weekly coverage older adults. Later studies, with observation periods ending in the first
curve, to simulate different cumulative vaccination coverage. We eval- weeks of January, estimated VE against severe COVID-19 comparable to
uated three scenarios with cumulative vaccination coverage rates of 50 our results [12,13], suggesting that the seasonal vaccines were moder-
%, 75 %, and 90 % at the study end. ately effective in preventing severe disease. One of the reasons could be
2
E.A. Fotakis et al. Vaccine 42 (2024) 126375
Table 1
Baseline characteristics of the individuals included in the analysis, as eligible to receive a seasonal booster at the beginning of the study. (Italy, 1st October 2023–31st
March 2024).
Did not receive seasonal booster1 n = 13,899,381 Received seasonal booster1 n = 1,659,448 Total n = 15,558,829
n % n % n %
Sex
Male 6,327,472 45.5 808,547 48.7 7,136,019 45.9
Female 7,571,909 54.5 850,901 51.3 8,422,810 54.1
Age Group
60–64 3,142,155 22.6 155,235 9.4 3,297,390 21.2
65–69 2,679,721 19.3 241,075 14.5 2,920,796 18.8
70–74 2,381,214 17.1 298,131 18 2,679,345 17.2
75–79 2,155,305 15.5 325,341 19.6 2,480,646 15.9
80–84 1,670,828 12 291,944 17.6 1,962,772 12.6
85–89 1,156,928 8.3 213,334 12.9 1,370,262 8.8
90–94 540,212 3.9 102,511 6.2 642,723 4.1
95+ 173,018 1.2 31,877 1.9 204,895 1.3
Country of birth
Other 632,010 4.5 46,224 2.8 678,234 4.4
Italy 13,267,371 95.5 1,613,224 97.2 14,880,595 95.6
Geographical macroarea
North-East (ITH) 2,619,488 18.8 430,869 26 3,050,357 19.6
North-West (ITC) 3,768,252 27.1 574,867 34.6 4,343,119 27.9
Centre (ITI) 2,822,147 20.3 441,327 26.6 3,263,474 21
Islands (ITG) 1,518,307 10.9 55,443 3.3 1,573,750 10.1
South (ITF) 3,171,187 22.8 156,942 9.5 3,328,129 21.4
High-risk group
None reported 9,556,985 68.8 853,627 51.4 10,410,612 66.9
Immunocompromised 83,873 0.6 18,196 1.1 102,069 0.7
RLTCF 170,180 1.2 51,820 3.1 222,000 1.4
Other health-risk conditions 4,088,343 29.4 735,805 44.3 4,824,148 31
Number of prior booster doses
1 dose 10,032,155 72.2 247,088 14.9 10,279,243 66.1
2 doses 3,613,929 26 1,207,762 72.8 4,821,691 31
3 or more doses 253,297 1.8 204,598 12.3 457,895 2.9
Urbanization level2
High 4,713,466 33.9 723,011 43.6 5,436,477 34.9
Medium 6,606,213 47.5 712,401 42.9 7,318,614 47
Low 2,579,702 18.6 224,036 13.5 2,803,738 18
Deprivation level2
1st quintile (least deprived) 5,899,252 42.4 611,410 36.8 6,510,662 41.8
2nd quintile 3,361,316 24.2 445,916 26.9 3,807,232 24.5
3rd quintile 2,068,653 14.9 254,600 15.3 2,323,253 14.9
4th quintile 1,657,280 11.9 220,213 13.3 1,877,493 12.1
5th quintile (most deprived) 912,880 6.6 127,309 7.7 1,040,189 6.7
that, whilst these vaccines were designed to target the XBB 1.5 sub- One strength of our work is that we used data from complete and
variant, this was not the prevalent variant in Italy at any timepoint of the accurate national databases. We also examined a longer period of
seasonal campaign [5]. observation compared to previous studies, allowing for a more thorough
Vaccine coverage of the 2023/24 seasonal booster in Italy in those evaluation of the vaccination campaign. Our study has several limita-
aged ≥60 years (10.7 %) was slightly lower than the median coverage in tions. Firstly, our estimates of rVE was adjusted for several variables, but
the EU/EAA area (12.0 %; country range: 0.01–66.1 %) [14]. Several could not evaluate unmeasured confounders, such as behavioral factors
factors could explain the low booster coverage observed in Italy. General related to vaccine uptake and SARS-CoV-2 infection risk. In addition,
Practitioners (GP) played key roles in the management of the seasonal high rates of self-diagnosis and consequent under-reporting of asymp-
vaccination campaign and the co-administration of vaccination against tomatic/mild cases likely led to an overestimation of eligible individuals
influenza and COVID-19 in Italy [15]. However, as the mRNA XBB.1.5 at the start of the vaccination campaign, especially in those who did not
vaccines require cold chain maintenance [16], vials are stored in uptake the seasonal booster, possibly causing an underestimation of rVE
authorized central pharmacies, and prepared and distributed on demand in the early months. Moreover, the surveillance system may have mis-
[17], likely negatively affecting GP participation in the vaccine pro- classified incidental positive admissions as severe cases, introducing a
gram. Less effective vaccination communication strategies, fear of bias toward underestimating rVE [20]. Finally, we adjusted our esti-
vaccination side effects and current low perception of risks associated mates for the level of socioeconomic deprivation measured at the mu-
with SARS-CoV-2 infection may also underlie the low booster coverage nicipality level, which does not necessarily reflect the individual
we found [18]. socioeconomic status, especially in large municipalities where hetero-
These barriers could partly explain why the uptake of COVID-19 geneity between subareas is likely present.
boosters was significantly lower than the average seasonal influenza
vaccine uptake in Italy, which tends to be between 50 and 60 % in those
aged ≥65 years [19].
3
E.A. Fotakis et al. Vaccine 42 (2024) 126375
Fig. 1. Cumulative weekly number of people vaccinated with the seasonal booster by 14 days post vaccination calendar date (black line), corresponding vaccination
coverage (grey bars), and number of severe COVID-19 cases by calendar week (red line), among those aged ≥60 years; Italy, 1st October 2023– 31st March 2024. (For
interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article.)
Table 2
Cumulative number (and %) of severe COVID-19 cases averted by the seasonal vaccination campaign, also by scenarios with vaccine uptake set at different levels, in
those aged ≥60; Italy, 1 October 2024–31 March 2024.
VCmax = 10.7 % VCmax = 50 % VCmax = 75 % VCmax = 90 %
(observed) (simulated) (simulated) (simulated)
n. observed 27,062 – – –
n. adjusted1 (95 % CI) 26,653 (26,593–26,721) 24,582 (24,304–24,898) 23,265 (22,847–23,738) 22,474 (21,973–23,042)
n. averted
565 (497–625) 2636 (2320–2914) 3953 (3480–4371) 4744 (4176–5245)
(95 % CI)
% averted
2.1 (1.8–2.3) 9.7 (8.5–10.7) 14.5 (12.8–16.1) 17.4 (15.3–19.3)
(95 % CI)
Adjusted incidence per 100,000 (95 % CI) 171.3 (170.9–171.7) 158.0 (156.2–160.0) 149.5 (146.8–152.6) 144.4 (141.2–148.1)
4
E.A. Fotakis et al. Vaccine 42 (2024) 126375
Fig. 2. Monthly number of severe COVID-19 cases averted through the seasonal vaccination campaign and according to scenarios with cumulative vaccine coverage
(VC) at the end of the campaign set at different levels, in those aged ≥60; Italy, 1 October 2023–1 March 2024.
EAF, AM-U, EP, AO, MF and CS designed the study, which was Declaration of competing interest
further refined with the input of PP and DP. CS, AB, MDM, MT and AC
extracted data from the different databases and linked them. EAF, AM-U, The authors declare that they have no known competing financial
and EP reviewed the current epidemiological, immunological, and interests or personal relationships that could have appeared to influence
microbiological literature. EAF carried out the analysis. The first draft the work reported in this paper.
was written by EP, AM-U and MF, with the contribution of EAF and PP.
The draft was then circulated, reviewed, and modified by all mentioned Data availability
authors. All listed authors reviewed and approved the final version, and
had final responsibility for the decision to submit for publication. The data that has been used is confidential.
E.A. Fotakis: Writing – review & editing, Visualization, Methodol- Italian Integrated Surveillance of COVID-19 group:
ogy, Investigation, Formal analysis, Conceptualization. E. Picasso: ISS coordination team: Antonino Bella, Stefano Boros, Marco Bressi,
Writing – original draft, Methodology, Investigation, Conceptualization. Emiliano Ceccarelli, Fortunato (Paolo) D'Ancona, Martina Del Manso,
C. Sacco: Writing – review & editing, Methodology, Data curation, Corrado Di Benedetto, Massimo Fabiani, Antonietta Filia, Alberto Mateo
Conceptualization. D. Petrone: Writing – review & editing, Methodol- Urdiales, Daniele Petrone, Patrizio Pezzotti, Flavia Riccardo, Maria
ogy. M. Del Manso: Writing – review & editing, Data curation. A. Bella: Cristina Rota, Chiara Sacco, Paola Stefanelli, Marco Tallon, Maria
Writing – review & editing, Data curation. F. Riccardo: Writing – review Fenicia Vescio.
& editing. A. Odone: Writing – review & editing, Methodology. A. Regional representatives: Antonia Petrucci (Abruzzo); Michele La
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– review & editing, Software, Data curation. L. De Angelis: Writing – (Campania); Erika Massimiliani (Emilia-Romagna); Fabio Barbone
review & editing. A. Sciurti: Writing – review & editing. D. Cescutti: (Friuli Venezia Giulia); Francesco Vairo (Lazio); Camilla Sticchi (Ligu-
Writing – review & editing. P. Pezzotti: Writing – review & editing, ria); Danilo Cereda (Lombardia); Marco Pompili (Marche); Francesco
5
E.A. Fotakis et al. Vaccine 42 (2024) 126375
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