With the US FDA rejecting emergency use authorisation to Bharat Biotech’s Covaxin, the government Friday said it respects the decision but asserted it will have no impact whatsoever on India’s vaccination programme. In what could potentially delay the launch of Covaxin in the US, the Food and Drug Administration there has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of emergency use authorisation.
Responding to a question on the denial to Covaxin, NITI Aayog member (Health) V K Paul said each country has its own regulatory system which India respects and hoped that the manufacturer will be able to comply with it by doing whatever requires to be done. “Each country has its own regulatory system. Some parameters might be common while some might be different which we respect. Our country’s regulatory system also takes decisions in a similar manner. The scientific framework is the same but nuancing is on context… These are scientific considerations specially in those countries where science is strong and for us manufacturing is strong,” he said.
“We expect that our manufacturer will be able to comply with it by doing whatever requires to be done. It will have no impact whatsoever on our programme clearly. We are satisfied our regulator has approved it. We have so much data on safety and so much data on phase-3 trial that has been screened by them,” Paul added.
He further said that the phase 3 publication of Covaxin will also come in 7-8 days which is beyond data shared with DCGI. “We are doing very well. We respect their decision but it will have no bearing on our track at this moment,” he added.
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