Brazil's ANSIVA raises safety issues in Covaxin production

Brazil’s medicines regulator has rejected an application from India’s Bharat Biotech for a certificate of Good Manufacturing Practices for its COVID-19 vaccine Covaxin, following an inspection of the company’s site in Hyderabad earlier this month.

The move, which does not affect Bharat Biotech’s application for emergency use authorization of the vaccine in Brazil, could potentially still delay its ability to supply doses of the COVID-19 vaccine to the country until the issue is resolved.

An inspection by the Agencia Nacional de Vigilancia Sanitari (ANVISA) from March 1-5 revealed issues related to Bharat Biotech’s manufacturing processes. According to the regulator, these issues could potentially risk the quality of the vaccine, and the action plan it sent was not sufficient to mitigate the risks.