Bharat Biotech's US partner Ocugen to file for BLA

Bharat Biotech's US partner Ocugen will file for Biologics License Applications (BLA) for Covaxin. Bharat Biotech's Covaxin has received emergency use authorization from 14 countries so far.

Hyderabad: With good herd immunity and a significant percentage of the population vaccinated, the Covid pandemic is reducing in the United States of America. On the sidelines of this, the United States Food and Drug Administration (USFDA) had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines.

Bharat Biotech's US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for Covaxin, which is a full approval license. 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 the timelines.

C️ovaxin has received EUA's from 14 countries with more than 50 countries in the process. No vaccine manufactured or developed in India has ever received EUA or full license from USFDA. Thus, it will be a great leap forward for vaccine innovation and manufacturing from India when Covaxin is approved.