Day after US Food and Drug Administration (FDA) rejected the emergency use authorization for Bharat Biotech's COVAXIN, the Health Ministry during a regular press briefing said it respects the decision saying 'every country's regulatory system might have some things in common with others and some things different."
Dr VK Paul, Member-Health, Niti Aayog said, "Every country's regulatory system might have some things in common with others & some things different. We respect it. Scientific framework is same but its nuancing is as per context"
He said, "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", he added.
Paul mentioned that the disapproval will have no impact on the country's vaccination program since India's regulator has approved it. "We have so much data on safety & phase 3 trial. I'm being told that publication of their phase 3 trial will be done sometime in 7-8 days", he said.
The United States Food and Drug Administration rejected Bharat Biotech's proposal for emergency use authorisation of its Covid vaccine, delaying the company’s vaccine launch in that country.
The drug regulator has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data instead of EUA (Emergency Use Authorisation) application for its vaccine candidate.
“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 said.