Hazards of vaccinating the way out of Covid-19 pandemic: Study of adverse events following immunization (Aefi) in India

ABSTRACT

Context The COVID-19 pandemic burdened the healthcare systems and led to unprecedented impact leading to global economic crisis. In India, the vaccines given emergency use authorization for restricted use were Covishield and Covaxin. The majority of the known adverse effects of COVID vaccine were reported to be mild but there are some serious and severe adverse events reported in COVID-19 vaccine trials including deaths. Aim: To make estimates of the adverse events following immunization (AEFI) burden in India based on Vaccine Adverse Effect Reporting System data model from the USA. Settings and Designs The descriptive study was carried out in March-May 2022. Data were extracted from report of National AEFI Committee, Ministry of Health and Family Welfare (MOHFW), Immunization Division, Government of India. This study made different hypothesis based on assumption of levels of underreporting ranging from 0.1 to 5%. From these hypotheses, projected deaths and those requiring hospitalization because of AEFI were calculated. Results: More than half (51.34%) of adverse events following immunization were classified as coincidental by National AEFI Committee. Actual reported deaths by MOHFW were 387 but estimated deaths may be around 38,700-41,400 or even more. From the total AEFI deaths, 77.78% were labelled as coincidental deaths. A Maximum of 53.82% coincidental death were because of cardiac cause. Conclusion: Deaths reported by MOHFW are likely to represent gross underestimate of the real scenario in India. © Medical Journal of Dr. D.Y. Patil Vidyapeeth 2022.