A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis.

ABSTRACT:

Introduction

The BBV152 coronavirus disease 2019 (COVID-19) vaccine (COVAXIN) has recently been approved for adolescents.

Objective

We provide the first real-world safety data of COVAXIN use in adolescents and compare with adults.

Methods

A prospective observational study was initiated in January 2022. Enrolled adolescents and adults were contacted by telephone after 14 days of receiving the BBV152 vaccine. The primary outcome was vaccine safety assessed as rate of adverse events following immunization (AEFIs). Severity grading of AEFIs was done using the Food and Drug Administration (FDA) scale. Interim results are presented.

Results

A total of 698 adolescents and 326 adults were enrolled. AEFIs after the first dose developed in 243 out of 670 adolescents (36.

SUBMITTER: Kaur U 

PROVIDER: S-EPMC9419918 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature