FDA Won’t Grant Bharat Biotech an EUA for COVID-19 Vaccine

June 16, 2021

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 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.

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