US FDA denies India’s Covaxin emergency use approval; seeks additional clinical trial data

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 India vaccine makers Covaxin for the USA 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 on Friday, ‘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 ‘this process will extend our timelines’.

COVAXIN has 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.

The Pharma company also said 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.