2 min read.Updated: 11 Jun 2021, 06:00 PM ISTLivemint
Centre said, every country's regulatory system might have some things in common with others and some things different
All of these are scientific considerations and keeping those in mind, the nuancing might be different, especially in those countries where science is strong, it said
The day after US Food and Drug Administration (FDA) rejected the emergency use authorization for Bharat Biotech's COVAXIN, the Centre stated \it respects the decision saying 'every country's regulatory system might have some things in common with others and some things different."
During a regular press briefing regarding the coronavirus situation in India, Dr VK Paul, Member-Health, Niti Aayog, said, "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."
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.
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, he also said.
Bharat Biotech has not shared data from its phase 3 clinical trials almost six months after the company’s vaccine was included in India’s immunization programme.
Will now be seeking a full approval of Covaxin: Ocugen
After the EUA for COVXIN was rejected by the FDA on Thursday, Ocugen, the US partner of Bharat Biotech, said that it will seek a full approval for the COVID-19 vaccine. The statement comes in connection to FDA asking the company to launch an additional trial in order file for a Biologics Licence Application (BLA), which is a full approval.
Ocugen said in a statement, "Ocugen Inc today announced that upon recommendation from the U.S. Food and Drug Administration (FDA), it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN. 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."
The company is in discussions with the FDA on the additional documents required to clear its application.
It is a great leap forward: Bharat Biotech
Touching upon the issue, Bharat Biotech said, "With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the sidelines of this, the USFDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines."
It further said Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval. "All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN. This process will extend our timelines."
It also added, No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. Thus, it will be a Great Leap Forward for vaccine innovation and manufacturing from India when approved.
(With inputs from agencies)
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