IJCM_273A: Severe adverse events following Covid 19 vaccination immunisation in India: Retrospective Study.

Abstract

Background: Coronavirus disease 2019 is a newly emerged viral infection reported in India on 30th Jan 2020. Because of high transmissibility rate it spread rapidly and become a pandemic in the year 2020. Though it was a new disease, there were no specific treatment measures for the same. COVISHIELD is the vaccine manufactured from serum institute of India and give approval for emergency use from 30th Dec 2020 without conducting phase trials, Because of numerous infective cases, complications and deaths. There is no separate AEFI surveillance system for COVID 19 vaccines. All the AEFIs were reported via immunization division of Ministry of Health and Family welfare. Objective: 1. To identify the type of AEFI following COVID 19 vaccination. 2. To detail the outcome of AEFI following COVID 19 vaccination Methodology: An observational study on AEFI following COVID 19 vaccination in India, the secondary data during 2020 to 2022 was collected from the open access government data http://surl.li/npkmb from 1st to 20th Oct 2023. The causality assessment results, 254 reported serious AEFI cases were approved by National AEFI Committee on 3rd May 2022.2 The data analysed by using SPSS Statistics. Results: A total of 125 million COVID 19 vaccine doses were administered all over India till 2nd Feb 2022. Out of which 254 reported serious AEFI. Among this 20.1% were =60 years of age. Serious AEFI with hospitalization was 57.9% and death was 42.1%. Around 30.7% cases were found to have a consistent causal association to vaccination. Among this 60.26 %were anxiety related and 39.74 % were vaccine product related. 8 deaths per 1 lakh COVID 19 vaccinations. Only 24.4% of the people with severe AEFI have comorbidities. Conclusion: Benefits of COVID 19 vaccination are enormous. However, as a measure of utmost precaution, all emerging AEFI are being constantly tracked and reviewed periodically.