‘USFDA decision not to affect Covaxin use in India’

Our Bureaus Delhi/Hyderabad | Updated on June 12, 2021

US regulator tells Ocugen, Bharat Bio partner, to apply for a full licence instead

The Centre has said that the US Food and Drug Administration turning down EUA for Covaxin will not disrupt India’s inoculation programme as the Drug Controller General is satisfied with data on the vaccine.

Bharat Biotech’s application for Emergency Use Authorisation (EUA) for Covaxin was turned down by the USFDA. The FDA has asked Ocugen, Bharat Biotech’s partner in the US, to apply for a full licence for Covaxin, instead of seeking EUA. According to Ocugen, it will now work towards this. Hyderabad-based Bharat Biotech has already announced that complete data on Phase-3 trials will be out in July and Phase-4 trials will also be conducted.

Responding to questions on this issue at the Health Ministry’s media briefing here on Friday, VK Paul, Member-Health of NITI Aayog, said: “All of these are scientific considerations and keeping those in mind, the nuancing might be different, especially in those countries where science is strong. Our manufacturing is strong. They have decided this, we respect it.”

Phase-3 data soon

“Certain vaccines vary taking into account the scientific consideration like nutrition, genetic dynamic consideration. We respect their (the FDA) decision and we expect that our manufacturers will be able to comply with whatever it requires to be done,” he said adding that the Phase-3 trial data of the vaccine will be published soon in a peer-reviewed journal, he added.

Separately, in a statement, Bharat Biotech said: “With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the US... the USFDA had communicated that no new EUA would be approved for new Covid-19 vaccines. Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications path for Covaxin, which is full approval instead of EUA.”

Timeline extended

“... 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,” it said adding that Covaxin has received EUA’s from 14 countries with the process on in more than 50 nations.

“No vaccine manufactured or developed from India has ever received EUA or full licensure from the USFDA. Thus, it will be a Great Leap Forward for vaccine innovation and manufacturing from India when approved,” the company statement added.

Published on June 11, 2021

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