In a blow for Bharat Biotech and the ICMR, the US Food and Drugs Food and Drug Administration has denied emergency usage approval to Covaxin. According to reports, the makers of India's first homegrown COVID-19 vaccine have been asked to apply for a full license approval instead. This will however delay the launch of the vaccine in the western country.
While it has been used in India for several months, the vaccine is yet to be granted global recognition. Bharat Biotech is also seeking emergency use listing for Covaxin from the World Health Organization. According to reports that quoted a statement by the company's US partner, Ocugen, it is in discussions with the FDA to understand what additional information will be required to support an application for a full license.
While third phase interim data for Covaxin had been released some time ago, the final data is yet to be made available. According to the company, this is expected in July. Peer review will take another 2-4 months.
Raches Ella, who leads the COVID-19 projects at Bharat Biotech, tweeted recently that after submitting efficacy and 2-months of safety to Central Drugs Standard Control Organisation (CDSCO) in July, it is expected to instantly reach pre-print server.
Ella made a series of tweets on the status of the long awaited results from third phase and this comes amid a raging debate on a recent pre-print study which said that while both Covaxin and Covishield showed a good immune response after two doses, Covishield produced more antibodies than Covaxin.
(With inputs from agencies)