What Centre said on US rejecting emergency use for Covaxin
New Delhi, June 11: After Food and Drug Administration (FDA) refuses to grant the emergency use authorization for Bharat Biotech's COVAXIN, the Central government has said that it respects US authorities decision but that has "no bearing" on India's continued use of the COVID-19 vaccine.
Addressing a press conference 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 said.
"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 am being told that publication of their phase 3 trial will be done sometime in 7-8 days," he added.
Why has the US FDA declined emergency use nod to Covaxin?
Bharat Biotech's partner for Covaxin the US has said it will no longer pursue an Emergency Use Authorization (EUA) for Covaxin.
The US health agency has asked for additional information to make a decision on an EUA request for this vaccine.
The US FDA has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
Biologics Licence Application or BLA, is a "full approval" mechanism by the FDA for drugs and vaccines.
Does this mean there is something wrong with the vaccine?
No. A recommendation from the FDA to pursue a BLA path will only extend, Ocugen Inc, the US partner of the Indian vaccine maker will only delay bringing Covaxin to the US. This means the US FDA will need to see more information from more human clinical trials to be convinced that the vaccine is safe, prompts an immune response.