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. 2021 Jul 8:38:101027.
doi: 10.1016/j.eclinm.2021.101027. eCollection 2021 Aug.

ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance

Marco Montalti  1 , Giorgia Soldà  1 , Zeno Di Valerio  1 , Aurelia Salussolia  1 , Jacopo Lenzi  2 , Marcello Forcellini  3 , Edoardo Barvas  4 , Susanna Guttmann  4 , Rossella Messina  2 , Elisabetta Poluzzi  5 , Emanuel Raschi  5 , Rossano Riccardi  6 , Maria Pia Fantini  2 , Giusy La Fauci  1 , Davide Gori  2 ; San Marino Republic COVID ROCCA Group
Affiliations

ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance

Marco Montalti et al. EClinicalMedicine. .

Abstract

Background: In August 2020, Sputnik V was registered as Gam-COVID-Vac by the Russian Ministry of Health, and since December 2020 it has been distributed in 61 countries worldwide. On 25 February 2021, the Republic of San Marino started its vaccination campaign, which includes Sputnik V. Our aim was to describe the adverse events following immunization (AEFIs) with this vaccine through participant-based active surveillance in the country.

Methods: Beginning from 4 March to 8 April 2021, a nationwide study was conducted on San Marino's population aged 18-89 years who received one or two doses of Sputnik V. E-questionnaire dissemination occurred through e-mails, QR-codes or live/phone interviews ~7 days after the first and second vaccine dose. A descriptive analysis was conducted to quantify AEFI incidence on both occasions, stratifying results by type and severity of symptoms.

Findings: Mean age of the 2558 vaccine recipients was 66±14 years. First-dose AEFI incidence was 53.3% (systemic reactions at 42.2%), while second-dose AEFI incidence was 66.8% (systemic reactions at 50.4%) (n = 1288). In general, 76.0% of two-dose recipients reported some AEFIs after either vaccine dose, and 2.1% suffered severe reactions; in 60- to 89-year-olds (n = 1021), AEFI incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache and joint pain.

Interpretation: Our results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs.

Funding: None.

Keywords: Active surveillance; Adverse events following immunisation; Covid-19 vaccine; Gam-COVID-Vac; Safety; San Marino Republic; Sputnik V; Vaccination.

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Conflict of interest statement

The authors have no conflicts of interest to declare. All co-authors have seen and agree with the contents of the manuscript and there is no financial interest to report. We certify that the submission is original work and is not under review at any other publication. The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

Figures

Fig. 1
Fig. 1
Percentage age distribution of the study sample (n = 2558), overall and by sex -Republic of San Marino (2021).
Fig. 2
Fig. 2
Incidence of local and systemic adverse events following immunisation with the first shot of Sputnik V (n = 2558), overall and by age group - Republic of San Marino (2021).
Fig. 3
Fig. 3
Incidence of specific adverse events, both local and systemic, following immunisation with the first shot and second shot of Sputnik V - Republic of San Marino (2021).
Fig. 4
Fig. 4
Incidence of local and systemic adverse events following immunisation with the second shot of Sputnik V (n = 1288), overall and by age group - Republic of San Marino (2021).
Fig. 5
Fig. 5
Incidence of specific adverse events, either local or systemic, following immunisation (AEFI) with the second shot of Sputnik V according to the presence or absence of (AEFI) after the first shot, by age group - Republic of San Marino (2021).
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References

    1. Coronavirus Disease (COVID-19) – World Health Organization. Available online: https://www.who.int/emergencies/diseases/novel-coronavirus-2019 (accessed on 21 April 2021).
    1. San Marino: WHO coronavirus disease (COVID-19) dashboard with vaccination data. Available online: https://covid19.who.int (accessed on 21 April 2021).
    1. Vaccination Plan anti-SARS-CoV-2/COVID-19 of the Republic of San Marino. Available online: https://vaccinocovid.iss.sm/doc/piano-vaccinale-anti-covid-14.1.2021-rev... (accessed on 21 April 2021)
    1. About Vaccine. Available online: http://sputnikvaccine.com/about-vaccine/ (accessed on 21 April 2021).
    1. State Register of Medicines. Available online: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=6c1f7501-7067-... (accessed on 21 April 2021).

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