ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance
| Autor: | Rossella Messina, Giusy La Fauci, Marco Montalti, Edoardo Barvas, Elisabetta Poluzzi, Marcello Forcellini, Rossano Riccardi, Giorgia Solda, Emanuel Raschi, Jacopo Lenzi, Maria Pia Fantini, Zeno Di Valerio, Davide Gori, Aurelia Salussolia, Susanna Guttmann |
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| Přispěvatelé: | Montalti M., Solda' G., Di Valerio Z., Salussolia A., Lenzi J., Forcellini M., Barvas E., Guttmann S., Messina R., Poluzzi E., Raschi E., Riccardi R., Fantini M.P., La Fauci G., Gori D. |
| Rok vydání: | 2021 |
| Předmět: |
Medicine (General)
Pediatrics medicine.medical_specialty Population Active surveillance Sputnik V R5-920 Adverse events following immunisation San Marino Medicine Adverse effect education San Marino Republic Covid-19 vaccine education.field_of_study business.industry Incidence (epidemiology) Vaccination General Medicine Early results Tolerability Observational study Safety Gam-COVID-Vac business Research Paper |
| Zdroj: | EClinicalMedicine, Vol 38, Iss, Pp 101027-(2021) EClinicalMedicine |
| ISSN: | 2589-5370 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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