USFDA’s rejection of Covaxin won’t have any impact on our own programme : Health Ministry


New Delhi: The Union Health Ministry on Friday said that the US drug regulator USFDA’s denial for emergency use authorization to Covaxin will not have any impact on its vaccination programme in India.

“Every country’s regulatory system might have some things in common with others & some things different. Scientific framework is same, but its nuancing is as per context: Dr VK Paul, Member-Health, Niti Aayog.

“All of these are scientific considerations & 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.  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. We have so much data on safety & phase 3 trial. I’m being informed that publication of their phase 3 trial will be done sometime in the next 7-8 days” he said.

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