ROCCA study protocol and interim analysis on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino: an observational study using active surveillance

Abstract

AbstractOBJECTIVETo assess the safety of the Sputnik V (Gam-COVID-Vac) COVID-19 vaccine through participant-based active surveillance from the Republic of San Marino vaccination campaign.DESIGN AND SETTINGThis is a nation-wide cohort study in the Republic of San Marino to monitor any Adverse Events Following Immunisation (AEFI) with the Sputnik V.PARTICIPANTSAdults aged 18-89 years who had at least one dose of Sputnik V administered and who responded or accessed to an e-questionnaire sent via email, QR-code or were live/phone interviewed about the 7 days after the first vaccine dose (n=2,558) and 7 days after the second dose (n=1,288). Exclusion criteria were inability to understand nor to answer the questionnaire properly.MAIN OUTCOME MEASURESRates of overall AEFI short-term and long-term (3 months). Secondary outcomes focus on subgroups of the population presenting specific comorbidities. Being this an interim analysis, long-term data (3 months) is still being collected, especially for vulnerable populations, including subjects with comorbidities and the youngest age groups.RESULTThe median age of participants was 68 years. 56% were females. After the first dose, vaccine recipients described both local and systemic reactions in 16.4% of cases, 25.8% reported systemic reactions only, and 10.2% reported local symptoms only. After the second dose, both local and systemic reactions were reported in 31.9% of cases, 18.5% reported systemic reactions only, and 16.1% reported local symptoms only. Main symptoms were local pain (24.8% for first dose and 43.8% for the second), asthenia (23.8% and 31.9%), headache (18.5% and 21.0%), and joint pain (16.5% and 21.9%). In the population over 60, recipients having reported AEFI after the first dose could be a predictor of AEFI recurrence after the second dose (p<0.001). 81.8% of those reporting second-dose AEFI, reported AEFI after the first dose, while amongst those not having reported any AEFI after the first dose, 18.2% reported AEFI after the second dose.CONCLUSIONThe ROCCA interim analysis confirmed a good tolerability profile in the over 60 years age group after both doses regarding short-term solicited AEFI to Sputnik V (Gam-COVID-Vac).