Covishield India: Demystifying Myths Through an Early Multicenter Safety Study

ABSTRACT

Objectives: Nationwide COVID-19 vaccination was initiated in India on January 16, 2021, in a phased manner with vaccines including Covishield. This vaccine was indigenously prepared by Serum Institute of India in line with the Oxford-AstraZeneca ChAdOx1 vaccine developed at the University of Oxford. This is the first multicenter study to assess the safety of the indigenously prepared Covishield vaccine in India. Study Design: Multicenter observational descriptive study. Methods: This was a multicenter study carried out in northern and eastern India. Individuals who received the first dose of the Covishield vaccine were followed up for 7 days to check for any adverse effects or systemic effects post vaccination. The data were collected by the authors with a participant-administered questionnaire. The primary end point was the incidence of adverse or systemic effects within 7 days post vaccination. Results: No serious adverse or systemic effects were noted in 7 days of follow-up. Nonserious systemic effects were seen in 42.0% of individuals post vaccination. Myalgia and/or fatigue was the most common effect of vaccination in 25.7%, followed by fever in 22.0% of individuals. In most individuals, the systemic effects started 6 to 12 hours post vaccination. There were no reports of fresh onset of systemic effects of any kind beyond 48 hours of vaccination. Women and older adults tolerated the vaccination better. Conclusions: The absence of serious adverse effects in our study will help allay fears around vaccine acceptance and give a boost to the vaccination campaign worldwide.