Corbevax vaccine side effects in children of age group 12–14 years: A prospective observational study

Abstract

Introduction: Corbevax was introduced by the Government of India in March 2022 for the vaccination of children between 12 and 14 years, however, there is a dearth of literature providing side effect profiles of Corbevax in the real-world/community. Hence, this study was conducted to assess the incidence and types of adverse events following immunization (AEFI) of Corbevax vaccine. Materials and Methods: A prospective observational study was conducted among 358 children between 12 and 14 years of age who had received Corbevax vaccine at a tertiary care center in western Maharashtra from March 16 to May 31, 2022. The participants were followed-up telephonically for side effects at 24 h, 72 h, and 7 days following the first dose and second doses of vaccinations. Results: Out of 358 children of age 12–14 years who received Corbevax vaccine, almost 80% of vaccines developed mild AEFI. Overall, reactogenicity was higher after the second dose and the most common AEFI was pain in the abdomen, followed by headache and pain at the site of injection. Occurrence of AEFI after the first dose (odds ratio: 158.87, 95% confidence interval 46.58–528.28, P < 0.005) was found to be a risk factor for the development of AEFI after the second dose. Conclusion: Corbevax was introduced in India for children between 12 and 14 years, but to the best of our knowledge, till date, there is no study specifically focused of AEFI due to Corbevax in the community setting. The study findings indicate that Corbevax is a safe vaccine with few mild side effects, thus reinforcing faith in the safety profile of the vaccine.