USFDA rejection of Covaxin not to impact India’s Covid-19 vaccination drive

Bharat Biotech Phase-III data has been screened by the Indian regulators and would be published in the next 7-8 days, Paul said.

The USFDA rejecting Bharat Biotech’s emergency use authorisation for the COVAXIN vaccine will not have any impact on the country’s Covid-19 vaccination drive.

Their decision has no bearing on our programme, VK Paul, member, health, Niti Aayog, said at a media briefing on Friday. The country’s regulators are satisfied and have approved the vaccine with lot of data on safety and Phase-III trials, Paul said.

Bharat Biotech Phase-III data has been screened by the Indian regulators and would be published in the next 7-8 days, Paul said. This data was beyond what they had already shared with the Indian regulators to get emergency use license as there have been follow-up studies and reviews since then, he said. Bharat Biotech was also expected to go in for peer reviews by journals soon. So the company had done well on the Indian regulatory front, he said.

“The USFDA has their own parameters and we respect their decision,” Paul said. He expected that Bharat Biotech would be able to comply with whatever is required to be done. The scientific framework for all the regulators were same but there would be differences depending on the context, genetic background and cohort of people, he pointed out.

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