A pilot study of “adverse events following immunization” surveillance with COVID-19 vaccination among adolescents: A prospective observational study based on single-center experience from a tertiary care hospital

Abstract

Abstract BACKGROUND: COVID-19 vaccination was started on January 3, 2022, among children aged 15–-18 years with Covaxin vaccination. Subsequently, Corbevax was approved for age groups up to 12 years of age since March 16, 2022. OBJECTIVES: To know the incidence and spectrum of adverse effects following immunization (AEFI) for this newly approved COVID-19 vaccine for children. DESIGN: This was a prospective observational pilot study undertaken in a tertiary-level care hospital. MATERIALS AND METHODS: All children vaccinated at our tertiary care center in South India were enrolled after informed consent. AEFI at 30 min, up to 24 h, and 1–7 days postvaccination are noted. The causality assessment was done. RESULTS: A total of 36 participants were studied, out of which 24 received Covaxin and 12 received Corbevax. No immediate AEFI was noted with any vaccine. Up to 24 h, 22/36 (61%) AEFI noted where 12/24 (50%) with Covaxin and 10/12 (83.3%) with Corbevax. Postvaccination within 1–7 days, only 1 (2.8%) side effects were present with Covaxin. Fever was reported statistically more in the Corbevax vaccine (P = 0.03). CONCLUSION: Corbevax and Covaxin both are safer vaccines for children. None of the vaccines had any major side effects. Maximum AEFI noted were up to 24 h postvaccination.