Virendra Pandit
New Delhi: After the US Food and Drug Administration (USFDA) asking Bharat Biotech to provide more data for approval of Covaxin, the Hyderabad-based company has said that with herd immunity developed and successful mass vaccination, the US is no longer giving the emergency use approval (EUA) to any new vaccine.
So far, Covaxin, already administered to millions of Indians, has received EUA from 14 countries with more than 50 countries in the process to do so.
“No vaccine manufactured or developed from India has ever received EUA or full licensure from the USFDA. Thus, it will be a great leap for vaccine innovation and manufacturing from India when approved,” Bharat Biotech said, according to media reports.
Covaxin is yet to secure entry into the WHO’s Emergency Use Listing of Covid-19 vaccines.
Prime Minister Narendra Modi was the first Indian to get himself the India-made Covaxin dose on March 1 when he launched the nationwide vaccination drive for people, other than frontline workers whose inoculation had commenced on January 14.
After the USFDA declining to grant EUA for Covaxin to Bharat Biotech and asking it to pursue full approval through a different pathway, the company said it was pursuing the advice expeditiously.
The Indian vaccine-maker said that with good herd immunity and a significant percentage of the American population vaccinated, the pandemic’s impact is declining in the United States. That was why the USFDA had communicated that no new EUA would be approved for 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,” Bharat Biotech said.