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New Delhi: In a significant development, the Food and Drug Administration has “recommended” Ocugen Inc, the US partner of Bharat Biotech, to go for Biologics Licence Application (BLA) route for Covaxin with additional data, nixing hopes of Emergency Use Authorisation (EUA) in the USA.
Ocugen confirmed this is in a statement adding that it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA is a “full approval” mechanism by the FDA for drugs and vaccines.
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“The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” Ocugen informed.
Ocugen is in discussions with the FDA to find out the additional information required to support a BLA submission. The company anticipates data pertaining to additional clinical trial to be required to support the submission.
Reacting to the FDA’s “recommendation”, Bharat Biotech stated that the US regulator had earlier communicated that no new EUAs will be approved for Covid-19 vaccines.
“All applications have to follow the biological license application process, which is the standard process for vaccines. Data from an additional clinical trial will be required to support the marketing application submission for Covaxin,” the vaccine maker said.
No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. When approved, it will be a “great leap forward” for vaccines” innovation and manufacturing from India, Bharat Biotech added.
Speaking about the same, Dr. VK Paul, Niti Aayog Member (Health), said that every country’s regulatory system might have some things in common and some differences as well. “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,” he added.
He also talked about the awaited Phase-3 trial data, saying: “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 trial. I’m being told that publication of their phase 3 trial will be done sometime in 7-8 days”.
(With inputs from agencies)
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