The Hyderabad-based vaccine maker will now be applying for a full license from the US FDA
Reacting to the United States Food and Drug Administration (FDA)'s rejection of Bharat Biotech's Covaxin jab for emergency use authorization, the Union Health Ministry on Friday said that it respects the decision taken by the authority but it will not have any impact on India's vaccine plan.
"Every country's regulatory system might have some things in common with others and some things different. We respect it. The scientific framework is the same but its nuancing is as per the context. All of these are scientific considerations and keeping those in mind, the nuancing might be different, especially in those countries where science is strong. Our manufacturing is strong. They have decided this. We respect it," Member-Health, Niti Aayog Dr VK Paul said.
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Dr VK Paul, also expressed hope that the vaccine maker will comply with what the FDA has wanted. "We expect that our manufacturers will be able to comply with it. It has no impact on our own program. Our regulator has approved it," he added. Dr Paul also mentioned that the publication of Covaxin's phase 3 trial will be done sometime in 7-8 days.
"A vaccine manufactured in India may not be equally effective in Argentina," Paul said, citing the example of the Rota Virus for Children. "The nutrition level, the gut flora of the population make a difference in the effect of the Rota Virus. This may lead to some differences especially in countries where science is strong, and our manufacturing is strong," Dr Paul said.
Bharat Biotech's application for approval of indigenous COVID-19 vaccine, Covaxin, has been rejected by the US FDA that cited a lack of sufficient data. The Hyderabad-based vaccine maker will now be applying for a full license from the US FDA and a statement put out today says the US FDA has stopped all Emergency Use Approvals for COVID-19 vaccines.
