Bharat Biotech to conduct additional clinical trials for USFDA nod

Timelines will be delayed; firm has received EUSs from 14 other countries

After its US partner Ocugen said that it would follow the biologics license application (BLA) route to seek full licensure of Covaxin, Bharat Biotech said on Friday that they would conduct additional clinical trials. This, however, would delay the timelines.

"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. This process will extend our timelines," the Hyderabad based vaccine maker said.

It further added that with good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). "The USFDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines," Bharat Biotech said.

Bharat Biotech's Covid 19 vaccine Covaxin has  received EUA’s from 14 countries with more than 50 countries in the process.

The company claimed that no vaccine manufactured or developed from India has ever received EUA or full licensure from US FDA.

Ocugen in a statement on Thursday announced that as recommended by the USFDA, it will pursue submission of a BLA for Covaxin.

Biologics Licence Application or BLA, is a "full approval" mechanism by the FDA for drugs and vaccines.

"The company will no longer pursue an Emergency Use Authorisation (EUA) for Covaxin. 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 an EUA application for its vaccine candidate and requested additional information and data," Ocugen said.