FDA Denies Emergency Authorization for Bharat Biotech’s COVID-19 Vaccine

The FDA has declined to authorize Bharat Biotech’s COVID-19 vaccine, Covaxin, for emergency use, prompting the Indian drugmaker’s U.S. partner, Ocugen, to instead seek a full approval of the shot through a Biologics License Application (BLA).

The agency told Ocugen it needs to see results from an additional U.S. trial of the two-dose vaccine and said it will assess the BLA based on data from that study.

Covaxin received emergency approval in India in early January (DID, Jan. 5) but the decision was controversial because the two-dose regimen was authorized before final phase 3 trial results were available.

Bharat Biotech and Ocugen have since released interim phase 3 results showing the vaccine had an overall efficacy of 78 percent, with 100 percent efficacy in preventing severe disease and hospitalizations. The shot was effective against the SARS-CoV-2 variants first identified in Brazil, the UK and India, the companies said.

Ocugen, which has the rights to sell Covaxin in Canada, is seeking authorization from Health Canada. The shot has already received emergency authorizations in 13 countries with 60 additional applications pending. — Jason Scott