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

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 18À89 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.

Common Side Effects of COVID-19 Vaccines Used in Iran: A Review

“…However, the duration of experiencing the side effects of the vaccine in most of the participants was less than 3 days (42). According to the findings of Montalti et al's study (43), the severity of local and systemic side effects after the second dose of the Sputnik V vaccine was higher than the first dose. Pagotto et al (44) acknowledged that the side effects of the Sputnik V vaccine are more common in women and younger individuals, often occur 24 hours after injection and resolve in less than 3 days.…”

Mild Adverse Events of Sputnik V Vaccine in Russia: Social Media Content Analysis of Telegram via Deep Learning

“…The safety profile of the Sputnik V vaccine includes mild AEs that are more similar to vector vaccines than to mRNA anti-COVID-19 vaccines, which was quantified by the Euclidean distance between AE frequencies ( Figure 4 ). The Sputnik V safety profile also showed a high fever-to-fatigue ratio ( Table 6 ) and a stronger reaction to the first dose than to the second one ( Table 3 ), which was also analyzed in a retrospective observational study in San Marino [ 65 ].…”

COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety

“…The lack of pre-marketing evidence concerning the four COVID-19 vaccines authorised in Europe makes the role of spontaneous reporting of suspected adverse reactions to vaccines even more important to better understand the actual benefit/risk profile in a broader range of vaccinees. Active surveillance is pivotal to fully appreciate the tolerability profile in the real world [140]. In fact, numerous post-marketing surveillance programmes for COVID-19 vaccines have been funded both nationally and internationally.…”