Safety profile of BCG revaccination for COVID prevention among elderly individuals in India

Abstract

BCG vaccination is known to be safe in infants and a part of immunization schedule in high tuberculosis (TB) burden countries. In the conquest to bring down the severity of the COVID 19 pandemic, many drugs were repurposed in research mode including BCG vaccination/revaccination in various populations. We did a study among the elderly population (>60 years of age) to assess the role of BCG revaccination in preventing the severity of COVID 19 disease. Live attenuated BCG vaccine was given to the willing participants and were followed up for 6 months to estimate COVID19 incidence, understand severity and immunogenicity profile. A total of 48 serious adverse events (SAE) were reported among 1566 elders, none of them had more than one SAE. None of the SAEs were related to the BCG revaccination. Among the 372 adverse events reported, 96% were local reactions at the vaccine site and resolved on its own. BCG revaccination appeared to be safe and could be explored further if repurposing studies were planned for other diseases.

Keywords: Adverse events; BCG revaccination; COVID 19; Elderly; Safety; Tuberculosis.