Brazil Regulator Denies Certificate To Bharat Biotech, Flags Safety Issues In Covaxin Production – Three Concerns Highlighted

Brazil’s health regulator has rejected an application to give Bharat Biotech’s Covaxin a certificate of Good Manufacturing Practices. This comes post 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 authorisation 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 Agencia Nacional de Vigilancia Sanitari (ANVISA) from March 1-5 revealed issues related to the Hyderabad-headquartered vaccine maker’s manufacturing processes. As per 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. The company has an agreement to supply 20 million doses of Covaxin to the Brazilian government through Precisa Medicamentos, its partner in the country. Watch the video to know more.