USFDA Denied EUA Approval for Bharat Biotech’s Covaxin

Story Highlights
  • Covaxin - widely administered COVID-19 Vaccine in India
  • FDA directs Ocugen Inc to conduct an additional trial for BLA
  • BLA is a full approval mechanism by the FDA for drugs and vaccines

New Delhi: Holding a colossal range of vaccine administration, Covaxin manufactured by Bharat Biotech had been denied emergency use approval by USFDA.  It received accelerated approval in India on January 3, 2021, after which it became one of the two major vaccines in the country’s COVID-19 inoculation drive. 

In its announcement on Thursday, the FDA recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data. It has directed Ocugen to conduct local trials based on which FDA would re-evaluate the vaccine.  

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and co-founder of Ocugen said.  

The US partner of the Indian vaccine maker is in dialogue with the FDA to understand the additional information required to support BLA Submission. BLA is a full approval mechanism by the FDA for drugs and vaccines.

So far no vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA.  When approved, it will be a “great leap forward” for vaccines” innovation and manufacturing from India, Bharat Biotech stated.

Pfizer Shot Could be Made Within 100 Days to Tackle Variants if Needed, says CEO Bourla

Related Articles

Back to top button