NEW DELHI: After the American drug regulator USFDA declined to grant emergency use authorisation to Bharat Biotech made Indian Covid jab Covaxin asking it to pursue full approval through a different pathway, the Hyderabad-based firm on Friday said it was pursuing the FDA advice and full approval, when granted to Covaxin, would be the first for any Indian vaccine maker.
Bharat Biotech leaders today said that with good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States and on the sidelines of this development, the USFDA had earlier communicated that no new emergency use authorisation (EUA) would be approved for new Covid-19 vaccines.
“Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for Covaxin, which is full approval. All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for Covaxin,” Biotech said.
This process will extend Covaxin timelines for seeking US approvals.
So far, Covaxin has received EUA from 14 countries with more than 50 countries in the process.
“No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. Thus, it will be a great leap for vaccine innovation and manufacturing from India when approved,” Biotech said.
Covaxin is yet to secure entry to WHO Emergency Use Listing of Covid vaccines.
It has submitted additional data for the purpose.