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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 (preprint)
medrxiv; 2021.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2021.05.03.21256509
ABSTRACT
OBJECTIVE To 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 SETTING This is a nation-wide cohort study in the Republic of San Marino to monitor any Adverse Events Following Immunisation (AEFI) with the Sputnik V. PARTICIPANTS Adults 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 MEASURES Rates 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. RESULT The 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. CONCLUSION The 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).
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Full text: Available Collection: Preprints Database: medRxiv Main subject: Pain / Asthenia / Arthralgia / COVID-19 / Headache Language: English Year: 2021 Document Type: Preprint

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Full text: Available Collection: Preprints Database: medRxiv Main subject: Pain / Asthenia / Arthralgia / COVID-19 / Headache Language: English Year: 2021 Document Type: Preprint