The Indian Covid vaccine Covaxin, developed by Hyderabad-based Bharat Biotech (BB), will be delayed until it reaches the US market, as the US Food and Drug Administration (FDA) asked Ocugen Inc. BB’s partner advised to follow the biological application path (BLA) for Covaxin, which is full approval.
Bharat Biotech previously reported this and US biopharmaceutical company Ocugen Inc entered into a definitive agreement to jointly develop, supply and commercialize Indian manufacturers of Covaxin vaccine for the US market.
Ocugen, which is working on an Emergency Use Application (EUA) in the United States, will simultaneously request a Temporary Order Authorization for Emergency Use in Canada.
According to a statement from the Hyderabad-based vaccine manufacturer on Friday, “Our US partner, Ocugen, has received a ‘recommendation’ from the FDA to continue the Biological License (BLA) application path for COVAXIN®, which is full approval.
All applications must comply with the BLA process, which is standard for vaccines, he said.
Therefore, BLA will require additional clinical trial data to support the marketing application for COVAXIN®, the company said “this process will extend our timeline.”
COVAXIN has received EUA certificates from 14 countries, more than 50 countries.
The company said that no vaccine manufactured or developed in India has ever received an EUA or full license from the USFDA.
He added that once approved, this will be a big step forward for innovation and vaccine production in India.
Pharma also said that with good herd immunity and a sizable percentage of the vaccinated population, the USFDA previously reported that a new Emergency Use Authorization (EUA) would not be approved for new Covid-19 vaccines.