Abstract

PROSPECTIVE OBSERVATIONAL STUDY ON ASSESSMENT OF ADVERSE EVENTS AND EFFECTIVENESS FOLLOWING COVISHIELD VACCINATION

Sharon Susan Raj*, Simran Shrestha, Raksha Chetry and Balakeshwa Ramaiah

ABSTRACT

Background: Enhancing immunity was one of the options to hold back the invasion of the uninvited guest - SARS COV-2. Vaccines replaced the position of drugs in pharmaceutical stores, and it is salient to analyze the post-immunisation effects. Objectives: Assessment of post-vaccination reactions with covishield was the primary objective, whereas the effectiveness of the latter was analysed along the study as the secondary objective. Methods: It was a prospective observational study in which 326 individuals were studied for the early(< 30 minutes) and delayed post-vaccination reactions(> 30 minutes) of COVISHIELD. The latter’s effectiveness was also analysed in the sample population with a regular follow-up of 3 months for a study period of 9 months. Results: People of the age group 18 to 44 became the highest vaccinated population with 60.12%. Around 56.44% of the population were females and 69.01% of individuals were back – line workers. In the first dose,357 AEFI were reported as delayed and 140 AEFI were reported as immediate reactions. While in the second dose, 48 were delayed and no immediate reactions were observed. Meanwhile, covid occurrence in the vaccinated population after the first and second dose was assessed to be 1 and 9 individuals, respectively, giving the effect of COVISHIELD as 96.93%. Conclusions: The study on post-vaccination effects of COVISHIELD against SARs Cov 2 has been studied along with the probability of covid occurrence in the vaccinated individuals. The study saw various COVISHIELD associated AEFI and will help pharmacovigilance to have a bird’s eye on post-immunisation reactions.

Keywords: Covishield, SARS-Cov 2, Adverse Event Following Immunisation, Microbial Evolution Proof Vaccine.