Covaxin representative files for regulatory approval

Representatives of the Indian-made Covaxin immunizer filed a request to Brazilian health regulators for the vaccine’s emergency approval in the country.

Corruption allegations involving a USD 300-million federal government contract to purchase 20 million Covaxin doses have been at the center of the Brazilian political storm since last week. Among the main suspicions regarding the deal was that the government appeared to spare no expense in going after a vaccine that was not even close to obtaining regulatory approval in Brazil — contradicting the administration’s own argument to ignore Pfizer vaccine purchases last year.

Health regulator Anvisa will take 24 hours to analyze whether the representatives have submitted sufficient documentation. If so, the agency will have between seven and 30 days to issue its decision on the vaccine. 

On Friday, a senior Health Ministry official told the Senate’s Covid hearings committee that he was coerced into greenlighting the deal, despite multiple red flags around payments and vaccine efficacy. The pressure allegedly came from Congressman Ricardo Barros, the government’s House whip.

• #corruption
• #regulation
• #vaccine