Hours after Covaxin was denied emergency-use approval, the Central government on Friday stressed that the US Food and Drug Administration’s (FDA) decision has “no bearing” on India’s continued use of the COVID-19 vaccine.
During a Health Ministry press briefing in New Delhi, Niti Aayog’s Member-Health Dr VK Paul said every country’s framework is different but the government still expects its manufacturers to comply with whatever they have been asked to do.
“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,” he said.
He continued saying, “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.”
Dr VK Paul went on to add that the Central government still expects that its manufacturers will be able to comply with the US FDA’s standards.
“It has no impact on our own program. Our regulator has approved it. We have so much data on the 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 added.
Earlier in the day, the US FDA denied approval for emergency use of Covaxin, developed by Hyderabad-based Bharat Biotech, and asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker said.
The FDA recommended Ocugen to “pursue a Biologics Licence Application (BLA) submission instead of an EUA application” and “requested additional information and data”.
During the press conference, the Niti Aayog member also confirmed that the preparation for national serosurvey is done and the Indian Council for Medical Research (ICMR) will begin work for next serosurvey this month.
“But if we want to protect our geographies, we won’t have to depend on national serosurvey alone, we will have to encourage states for serosurveys too,” said Dr Paul.
