The impact of COVID-19 vaccination programme in the Republic of San Marino: Focus on effectiveness of Gam-Covid-Vac.

Autor:	Tonnara G; Istituto per la Sicurezza Sociale, San Marino., Piselli P; Istituto Nazionale per le Malattie Infettive 'L. Spallanzani', IRCCS, Rome, Italy. Electronic address: pierluca.piselli@inmi.it., Cimaglia C; Istituto Nazionale per le Malattie Infettive 'L. Spallanzani', IRCCS, Rome, Italy., Arlotti M; Istituto per la Sicurezza Sociale, San Marino., Sacchini E; Istituto per la Sicurezza Sociale, San Marino., Manoni S; Istituto per la Sicurezza Sociale, San Marino., Zani A; Istituto per la Sicurezza Sociale, San Marino., Muccioli F; Istituto per la Sicurezza Sociale, San Marino., Laderchi A; Istituto per la Sicurezza Sociale, San Marino., Rabini S; Istituto per la Sicurezza Sociale, San Marino., Antinori A; Istituto Nazionale per le Malattie Infettive 'L. Spallanzani', IRCCS, Rome, Italy., Vaia F; Istituto Nazionale per le Malattie Infettive 'L. Spallanzani', IRCCS, Rome, Italy., Nicastri E; Istituto Nazionale per le Malattie Infettive 'L. Spallanzani', IRCCS, Rome, Italy., Girardi E; Istituto Nazionale per le Malattie Infettive 'L. Spallanzani', IRCCS, Rome, Italy.
Jazyk:	angličtina
Zdroj:	Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2022 Dec; Vol. 28 (12), pp. 1636-1643. Date of Electronic Publication: 2022 Jul 04.
DOI:	10.1016/j.cmi.2022.06.026
Abstrakt:	Objective: The adenovirus-based vaccine Gam-COVID-Vac (Sputnik V) showed promising effectiveness in a phase 3 clinical trial; however, data concerning its impact at a population level are scarce. The Republic of San Marino (RSM) conducted a SARS-CoV-2 vaccination programme mainly based (>80%) on Gam-COVID-Vac. Our aims were to investigate the impact of Gam-COVID-Vac vaccination programme and its effectiveness in a retrospective observational study based on the entire RSM population aged ≥12 years. Methods: We calculated the incidence rate and the vaccine effectiveness (VE) in the entire RSM population not previously infected, against SARS-CoV-2 infection and COVID-19-related hospitalization, from 25 February to 1 October 2021, considering any vaccine and separately according to the vaccine used. Vaccine effectiveness was calculated using a multivariable negative binomial regression model as 1-Incidence Rate Ratio. Results: During the study period, 21 568/28 791 (74.9%) not previously infected subjects received at least one dose of the Gam-COVID-Vac (84%) or BNT162b2, vaccines with 98% completing the vaccination schedule. Overall, 1634 SARS-CoV-2 infections and 166 COVID-19-related hospitalizations were observed with 17 COVID-19-related deaths reported. Incidence rates of SARS-CoV-2 infection and COVID-19-related hospitalization were 7.11 and 0.49/100 000 person-days in the fully vaccinated population, respectively. The adjusted overall VE was 67.6% (95% CI: 61.8-72.5) against SARS-CoV-2 infection and 87.9% (95% CI: 77.4-93.5) against COVID-19-related hospitalizations. Gam-COVID-Vac against SARS-CoV-2 infection VE peaked 91.8% (95% CI: 86.3-95.1) in the first bimester from the second dose, declining to 57.8% (95% CI: 42.2-69.2) at 6 months. Protection against hospitalization with COVID-19 was overall 91.6% (95% CI: 81.5-96.2), with no relevant waning trend over time. Discussion: Our study demonstrated the effectiveness of overall vaccination (Gam-COVID-Vac [84%] and BNT162b2 [16%]) in the prevention SARS-CoV-2 infection (pre-Omicron variant), waning over time but still with sustainable effectiveness against COVID-19-related hospitalization in the Republic of San Marino. (Copyright © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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