A prospective observational safety study on ChAdOx1 nCoV-19 corona virus vaccine (recombinant) use in healthcare workers- first results from India.

ABSTRACT:

Background

We provide the first post-approval safety analysis of COVISHIELD in health care workers (HCWs) in northern India.

Methods

This continuing prospective observational study (February 2021 to May 2022) enrolled participants ≥18 years receiving COVISHIELD vaccination. Primary outcome was safety and reactogenicity. Categories (FDA toxicity grading) and outcomes of adverse events following immunization (AEFIs) were recorded, causality assessment performed, and risk factors analysed.

Findings

We present the results of an interim analysis of 804 participants. AEFIs following first dose were reported in 321 (40%; systemic involvement in 248). Among 730 participants who completed a 7-day follow-up post second dose, AEFIs occurred in 115 (15.7%; systemic in 99). Majori

SUBMITTER: Kaur U 

PROVIDER: S-EPMC8413251 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature