Study on adverse events in Health care workers receiving Covid Vaccine - An Observational study

Abstract

Background: Vaccines used in vaccination program are considered safe and effective but immunization safety has become as important as the efficacy of vaccination program. The objective of the study was to detect Adverse Events Following Immunization (AEFIs) to inactivated COVID vaccine administered to a Health Care worker in Karnataka.

Methods: The prospective active vaccine safety surveillance study enrolled eligible Health Care workers (HCWs) in the age group 18–60 years receiving vaccination from the immunization centre at HIMS Hospital, Hassan. Study participants were monitored at the site for 30min following vaccination and a telephonic survey was made till 7 days to identify all AEFIs. Causality assessments of the AEFIs were done using a new algorithm developed by the safety and vigilance department of the World Health Organization (WHO).

Results: The incidence of reported AEFIs was 11.4% The most frequently reported AEFI within 1^st 30minutes was vomiting [33%] and after 30 minutes waspain at injection site (n=26) with an incidence of 20.4% of vaccine administered, followed by fever (n=25, 19.6% of vaccine), headache (n=21) and giddiness (n=23 of vaccine). Consistent causal association to vaccination was observed in 93.4% of cases.

Conclusions: AEFIs observed among Health Care Workers (HCWs) were non-serious. Hence, inactivated COVID vaccine used in the Vaccine program were found to be safe. Similarly, active multi-centric studies will help to generate more safety data about the inactivated COVID vaccine. Understanding vaccine safety issues among HCWs provide feedback to concerns of vaccine safety, which will enable them to communicate effectively with the public to maintain their confidence/trust in vaccines.