India's indigenously manufactured Covid vaccine Covaxin, developed by Hyderabad-based Bharat Biotech (BB), will be delayed in its launch in the US market as the US Food and Drug Administration (FDA) asked Ocugen Inc, the US partner of BB, to pursue a biological Applications (BLA) path that would require additional clinical trials for the vaccine.

Bharat Biotech had earlier said it and Ocugen Inc, a US-based biopharmaceutical company, have entered into a definitive agreement to co-develop, supply, and commercialise, the Indian vaccine  Covaxin for the US market. Ocugen, which is working towards the submission of the emergency use application (EUA) in the US, will simultaneously seek authorisation under interim order for emergency use in Canada.

According to Hyderabad-based vaccine maker quoted by IBNS, "Our US partner, Ocugen, has received a ‘recommendation ‘from the FDA to pursue a 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", it said.

Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN®, the company said.

Covaxin has so far received EUA’s from 14 countries with more than 50 countries in the process.

No vaccine manufactured or developed from India has ever received EUA or full license from USFDA, the company said. It will be a "Great Leap Forward" for vaccine innovation and manufacturing from India when approved, it added.

With good herd immunity and a significant percentage of the population vaccinated, the USFDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines. (SAM)