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

Zeno Di Valerio; Giusy La Fauci; Giorgia Soldà; Marco Montalti; Jacopo Lenzi; Marcello Forcellini; Edoardo Barvas; Susanna Guttmann; Elisabetta Poluzzi; Emanuel Raschi; Rossano Riccardi; Maria Pia Fantini; Aurelia Salussolia; Davide Gori

doi:10.1016/j.eclinm.2022.101468

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

EClinicalMedicine. 2022 Jul:49:101468. doi: 10.1016/j.eclinm.2022.101468. Epub 2022 May 20.

Affiliations

¹ School of Hygiene and Preventive Medicine, Department of Biomedical and Neuromotor Sciences, Public Health and Medical Statistics, University of Bologna, Via San Giacomo 12, 40126 Bologna, Italy.
² Unit of Hygiene, Department of Biomedical and Neuromotor Sciences, Public Health and Medical Statistics, University of Bologna, Via San Giacomo 12, 40126 Bologna, Italy.
³ Department of Finance (PhD Student), CASS Business School London, London, United Kingdom.
⁴ San Marino Neurological Unit, State Hospital of the Republic of San Marino, Via Scialoja, 20, 47893 Cailungo, Republic of San Marino.
⁵ Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126 Bologna, Italy.
⁶ San Marino Central Pharmacy, San Marino Hospital, Via Scialoja, 20, 47893 Cailungo, Republic of San Marino.

Abstract

Background: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up on the ROCCA study, focused on the older population, by describing adverse effects following immunisation (AEFIs) rates and characteristics in all age groups for the first time in a real-world context.

Methods: An active surveillance study on recipients of at least one dose of the Gam-COVID-Vac vaccine was conducted. Participants were administered online questionnaires through live/phone interviews with physicians, by e-mail or by scanning a QR code at different points in time after the first dose: one week (Q1) one month (Q2), and three months (Q3) between March and August 2021.

Findings: Overall, 6190 vaccine recipients were recruited. Mean age was 52·4 ± 18·2 years. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at injection site and myalgia. Grade 3 or 4 AEFIs were reported by 2·7% and 1·1% of the participants, respectively. Multivariate analysis showed younger age, being a woman and food allergies are risk factors for more severe AEFIs.

Interpretation: Our results confirm a good tolerability profile for the population aged 18 and over providing useful data for vaccination campaigns ongoing in countries planning to use Gam-COVID-Vac.

Funding: None.

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