Applied For Licence In US, Says Bharat Biotech’s American Partner

Home ยป Applied For Licence In US, Says Bharat Biotech’s American Partner

Applied For Licence In US, Says Bharat Biotech's American Partner

“Covaxin is the only product to have any data on emerging variants,” Bharat Biotech said. (File)

New Delhi:

India’s first indigenous COVID-19 vaccine manufacturer Bharat Biotech on Saturday said that it will be carrying out clinical trials in the US to support the marketing application for Covaxin in the country.

On Thursday, Ocugen, the US partner for Bharat Biotech’s COVID-19 vaccine said, it has submitted for a Biologics License Application (BLA) for the jab, instead of seeking Emergency Use Authorisation (EUA) as originally planned.

On Phase 3 clinical trial data, Bharat Biotech said it has shared comprehensive data of all research studies of Covaxin to the regulators in India.

As per the company release studies of Covaxin, “The complete data for Phase I and II, and partial data for Phase III trials of COVAXIN(r) have been thoroughly scrutinized by the regulators in India. In a timely approach to peer review, the company has already published as many as nine research studies on the safety and efficacy of COVAXIN(r) in five globally reputed peer-reviewed journals in a span of just twelve months.”

“COVAXIN(r), a whole-virion inactivated coronavirus vaccine, has many firsts to its credit in data transparency. It is the first and only product to have published any data from human clinical trials in India. It is the only product to have any data on emerging variants. It is also the first and only COVID-19 vaccine to have efficacy data in Indian populations,” Bharat Biotech said.


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