Washington: Bharat Biotech’s COVID-19 vaccine is once again in the news. Covaxin has not been approved by the US for emergency use. This is a big setback for India because the vaccine is completely indigenous and India has also applied for its recognition from the World Health Organization. The US Food and Drug Administration (FDA) has turned down a request for its emergency use.
However, Dr Fauchi, Principal Medical Adviser to US President Joe Biden, acknowledged the effectiveness of the vaccine. It is feared that this stand of America may also give a setback to India’s campaign, under which it is engaged in getting the vaccine recognized by the World Health Organization.
Bharat Biotech’s US partner Ocugen had applied for Emergency Use Authorization (EUA) of the vaccine with the FDA. Ocugen said on Thursday that it will no longer seek emergency approval for the vaccine, but will seek full approval for its anti-Covid shot. Ocugen said that this decision has been taken on a recommendation given by the US FDA.
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The FDA had asked Bharat Biotech to conduct another clinical trial so that it can file for a Biologics License Application (BLA), which is required for full approval. In a statement to the NYSE, Ocugen said, “The FDA has provided feedback to Ocugen regarding the company’s master file. The FDA advised Ocugen to apply for BLA instead of emergency use authorization for its vaccine candidate. The FDA has also sought additional information and data on the vaccine.
