New Delhi: NITI Aayog member VK Paul on Friday (June 11) said that the FDA’s refusal to grant emergency use authorisation to Bharat Biotech’s Covaxin will not have any impact on India’s vaccination drive. Paul said that the decision of the FDA is to be respected but it has been already cleared by regulators in India so it will be continued to be used in the vaccination drive.
The statement comes after the FDA asked Ocugen Inc which is the US partner of the Indian vaccine maker to go for the Biologics Licence Application (BLA) route with additional data, nixing hopes of emergency use authorisation.
“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 especially 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 trials that have been screened by them,” Paul added.
The United States has approved Pfizer, Moderna, Johnson & Johnson, and AstraZeneca for emergency use authorisation.
He added that the Phase-III trials of the Covaxin will come in 7-8 days and will be shared with the Drugs Controller General of India (DCGI).
“We are doing very well. We respect their decision but it will have no bearing on our track at this moment,” he added.