Image Credits: Bharat Biotech
Bharat Biotech’s Covaxin has been denied by the FDA for emergency use in the United States of America. The US FDA has asked Ocugen, Bharat Biotech’s partner in the US, to conduct supplementary trials in the country before applying for full approval of the vaccine. Covaxin is an inactivated virus-based COVID-19 vaccine developed indigenously by Indian pharma company Bharat Biotech.
VK Paul, a Niti Aayog member has said on Friday that the denial from the FDA for emergency use of Covaxin will have no effect on India. To add to that he mentioned that every country has a benchmark of its own that it follows for approval but as India’s drug regulator was content with the data that the Hyderabad-based vaccine maker presented, the FDA’s decision does not affect them. This decision however does delay Bharat Biotech’s plan to export its vaccine to the United States. Bharat Biotech has said that it would also ensure that Covaxin gets recognized as a ‘vaccine passport’, which may be needed in the future for traveling to other countries.
“The scientific framework might be the same but nuances change depending on the context. They have their own parameters which we respect,” said Dr. Paul. He also mentioned that India also has regulatory authorities which have separate parameters than that of the USA. Lastly, he said that vaccines may have different outcomes on different cohorts of people.