Active Surveillance of the Sputnik v Vaccine in Health Workers

Abstract

Introduction The World Health Organization (WHO) recommends vaccination against Sars Cov-2 coronavirus to mitigate COVID-19 pandemic. On December 29th, the Argentine Ministry of Health started a vaccination plan with the Sputnik V vaccine emphasizing the registration of the Events Supposedly Attributed to Vaccines and Immunizations (ESAVI) in the National Surveillance System. The aim of this study is to determine the safety of this vaccine. Methods In an ongoing cohort study, health professionals from Hospital Italiano de Buenos Aires vaccinated with the first component of the Sputnik V vaccine (a rAd26 vector-based) were followed up. Safety at 72 hs was analysed from a self-report form. Local and systemic reactions were characterized as mild, moderate and severe. Incident rates were calculated per 1000 person-hours by age groups and gender. Adjusted hazard ratio and 95% Confidence Interval (HR; 95%CI) is obtained by Cox Regression Model. Results 707 health professionals (mean age 35, 67% female) were vaccinated, response rate was 96,6% and 71,3% reported at least one ESAVI. Rate was 6.3 per 1.000 person-hours. Among local reactions, 54% reported pain at the injection site, 11% redness and swelling. Among systemic reactions 40% reported fever, 5% diarrhea and 68% new or worsened muscle pain. Five percent had serious adverse events that required medical evaluation and one inpatient. ESAVI rate was higher among females (65.4% vs 50%; HR 1.38, 95%CI 1.13-5.38) and in younger than 55 years-old (72.8% vs 32%; HR 2.66, 95%CI 1.32-1.68). Conclusion Active surveillance on safety for vaccines with emergency approval is mandatory. This study shows high rates of local and systemic reactions however early serious events were rare. Short term safety is supported by these preliminary findings. Studies on long term safety and efficacy, accoding sex and age, are needed.

COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines’ Side Effects

“…The phase III trials displayed the same pattern; therefore, the post-marketing studies only came to confirm this preliminary finding [38,39]. Female gender was consistently associated with an increased risk of side effects following different types of COVID-19 vaccines; interestingly, the genderbased differences were reported by manufacturers [21][22][23]25,28].…”

“…Independent (non-sponsored) studies with rigorous methods can successfully lead the unbiased pharmacovigilance efforts of COVID-19 vaccines globally [21][22][23][24][25][26][27][28]. Thus, in view of their independent nature and transparent design, these studies can play a key role in suppressing VH levels by enhancing public confidence in the vaccines.…”

The Implementation of Mass-Vaccination against SARS-CoV-2: A Systematic Review of Existing Strategies and Guidelines

“…The included research articles in this systematic review, confirms the overall safety of vaccines available. Anaphylaxis is rare, indicated by an incidence of <0.001% in large, vaccinated populations in the United States [49,53]. However, when reviewing electronic records of reports of adverse events by individuals presenting to clinicians post-vaccination, the frequency of adverse events was found to be much lower compared to systems that use active surveillance, such as in clinical trials [45].…”

Vaccine against COVID-19

“…Esperamos los datos completos de la fase 3 [178,179], con los correspondientes estudios de vigilancia de seguridad y eficacia [180], y la eventual aprobación de las Agencias Regulatorias.…”