Responding to the US Food and Drug Administration (FDA) denied emergency use approval to India’s indigenously produced COVID-19 vaccine, Covaxin, the government said that the decision has “no bearing” and the country would continue the use of the jab. As per news agency ANI, during the Health Ministry briefing on Friday, NITI Aayog’s member-Health Dr. VK Paul said India ‘respects’ every nation’s framework of issuing an approval but the government is still expecting that its manufacturers would work on complying with whatever is asked for them to do.
As per ANI, VK Paul said, "Every country's regulatory system might have some things in common with others and some things different. We respect it. The Scientific framework is the same but its nuancing is as per context.”
“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.”
The NITI Aayog Health Member also said that the FDA decision as “no impact on our own program. Our regulator has approved it. We have so much data on the safety & phase 3 trial. I'm being told that publication of their phase 3 trial will be done sometime in 7-8 days.” Covaxin is developed by Bharat Biotech and the US FDA “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation.
Ocugen said in a statement, “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 a EUA application for its vaccine candidate and requested additional information and data.” It added that the development might cause a delay to Covaxin launch in the United States. Ocugen is reportedly in talks with the FDA to acquire the needed additional information to support the BLA submission.
"Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US," Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said.
Bharat Biotech also reacted to FDA denial saying, “With good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States. The USFDA had earlier communicated that no new EUA’s will be approved for covid vaccines. All applications have to follow the biological license application process, with is the standard process for vaccines."
"Data from an additional clinical trial will be required to support the marketing application submission for Covaxin. Covaxin has received EUA’s from 14 countries with more than 50 countries in the process. 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," they added.