Bharat Biotech’s proposal for emergency use authorisation (EUA) of Covaxin has been declined by the US Food and Drug Administration (FDA). FDA has asked Ocugen, the US partner of Bharat Bio, to launch an additional trial so that it can file for full approval.
“The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of a EUA application for its vaccine candidate and requested additional information and data,” Ocugen said to NYSE. Furthermore, it was added that the company is in a discussion with FDA about the additional documents required.
Besides, Bharat Biotech’s vaccines are declined in many other countries. In some countries, people vaccinated with both the doses of Covaxin have been treated as unvaccinated. According to a report, disapproval of Bharat Biotech’s vaccine is caused by the company’s late submission of partial data from the Covaxin trial.
USFDA last month came out with a revised guideline for covid vaccine approval that said it will no longer grant emergency authorization to new applications. Despite this revised guideline from FDA, Ocugen in a statement to investors on 26 May said that the company will be eligible to submit its EUA in June.
Now the global status of Bharat Biotech’s Covaxin sets many questions among millions of Indians.