FDA move will not hit vaccination policy: Govt

Bharat Biotech International’s application for emergency use authorization (EUA) of Covaxin before the US Food and Drug Administration (USFDA) was rejected due to lack of sufficient data on the covid-19 vaccine’s safety and efficacy.

The government on Friday said it respects the USFDA’s decision, but that will not impact India’s covid-19 vaccination programme. “Each country has its own regulatory system. Some parameters may be common, while some might be different which we respect,” said Vinod Paul, member (health), NITI Aayog, and chair, National Expert Group on Vaccine Administration for covid-19.

The Hyderabad-based company, which is yet to publish its Phase 3 results for the indigenously developed vaccine, however, on Friday came out in defence of its product saying that Covaxin has received EUAs from 14 countries and more than 50 countries are in the process of considering its applications.

“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 marketing application submission for Covaxin. This process will extend our timelines,” said the vaccine maker in a statement.

The firm said the US has reported good herd immunity with a significant percentage of its population vaccinated and, therefore the USFDA had communicated that new EUAs will not be approved for new covid-19 vaccines. “No vaccine manufactured or developed from India has ever received an EUA or full licensure from the USFDA. Thus, it will be a great leap forward for vaccine innovation and manufacturing from India when approved,” it said.

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