Bharat Biotech’s Covaxin being denied of emergency use approval by the United States’ Food and Drug Administration will have no bearing on India, Niti Aayog (health) member VK Paul said on Friday during the press briefing of the Union health ministry. Welcoming their decision, Dr Paul said that every country has its own benchmark for such approval. But as India’s drug regulator was satisfied with the data that the Hyderbad-based vaccine maker produced, the FDA’s decision will have no bearing in India. “We are happy as we have gone through their safety data,” Dr Paul said.
A vaccine manufactured in India may not be equally effective in Argentina, Dr Paul said, citing the example of the Rota Virus for Children. The nutrition level, the gut flora of the population make a difference in the effect of the Rota Virus. “This may lead to some differences especially in countries where science is strong, and our manufacturing is strong,” Dr Paul said.
The FDA has not given emergency use approval to Covaxin and sought more data on the clinical trials. Bharat Biotech’s American partner Ocugen has now decided to go for full approval, with complete data.
Dr Paul also expressed hope that the vaccine maker will comply with what the FDA has wanted.
“Every country has a different regulatory system. The scientific framework might be the same but nuances change depending on the context. They have their own parameters which we respect. Our regulatory authorities too have separate parameters. When our vaccine makers make vaccines for our children, the nutritional status, the genetic background are taken into account to find out whether the vaccine will be fully effective. If one vaccine is effective on our children, it may not work in Argentina. That is a different cohort of people,” Dr Paul said.
Bharat Biotech’s application before the World Health Organization for emergency use approval is also pending. But the company is not seeing FDA’s disapproval as a setback as no vaccine manufactured or developed in India has ever received emergency use approval or full licensure from FDA.