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The government says the US’s refusal to EUA to Covaxin will not affect India’s vaccine program

Given that the US FDA has denied an emergency use authorization for Bharat Biotech’s Covaxin, the government said it would respect the decision on Friday, but claimed it would have no effect on India’s vaccination program. The U.S. Food and Drug Administration has selected a Biopharmacy Approval Application (BLA) route with additional data for Ocugen Inc, a U.S. partner of Indian vaccine manufacturers, as it may delay the launch of Covaxin in the U.S. “Recommended” to do. Request for emergency use permission.

NITIAayog member (Health) VK Paul responded to a question about Covaxin’s refusal, stating that each country has its own regulatory system that India respects, and that manufacturers can comply with whatever they need to do. I want

“Each country has its own regulatory system. Some parameters may be common or different. Some may be respected by us. Our country’s regulatory system is similar. Make a decision. The scientific framework is the same, but the subtle differences vary from situation to situation … these are scientific considerations, especially in countries where science is strong and manufacturing is strong for us. ” He said.

“Our manufacturers expect to comply with this by doing whatever they need to do. It does not have a clear impact on the program. We are pleased with the regulatory approvals. Safety There is plenty of data on things like that, and a lot of data on Phase 3 trials screened by them, “Paul added.

He further stated that the issuance of Phase 3 of Covaxin will also take place in 7-8 days beyond the data shared with the DCGI.

“We’re doing very well. We respect their decisions, but at this point it won’t have anything to do with our trajectory,” he added.

The government says the US’s refusal to EUA to Covaxin will not affect India’s vaccine program

Source link The government says the US’s refusal to EUA to Covaxin will not affect India’s vaccine program

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