Scientific framework same but its nuancing as per context: VK Paul on USFDA rejecting Covaxin

Updated:1 week, 6 days ago

New Delhi, June 11 (ANI): After US Food and Drug Administration (USFDA) revoked the use of Bharat Biotech’s Covaxin under emergency situation, Member of NITI Aayog, Dr VK Paul on June 11 informed that Covaxin has the same scientific framework but its nuancing is as per the context. “Every country's regulatory system might have some things in common with others and some things different. We respect it. Scientific framework is same but its nuancing is as per context. Keeping these scientific considerations 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,” Paul told media persons. “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 and phase 3 trials. I'm being told that publication of their phase 3 trial will be done sometime in 7-8 days,” Paul added.

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