No impact of USFDA move on Covaxin in India: VK Paul

The United States Food and Drug Administrations’s denial of an Emergency Use Authorisation (EUA) to Bharat Biotech's Covaxin will have no bearing on India, Niti Aayog (health) member VK Paul said on Friday.

Paul said that every country has its own benchmarks, and welcomed the USFDA’s decision to ask Bharat Biotech to apply for a full Biologics License Application (BLA) instead of an EUA. “India's drug regulator was satisfied with the data that the Hyderbad-based vaccine maker produced. We are happy as we have gone through their safety data,” Paul added.

Bharat Biotech has not shared data from its phase 3 clinical trials yet, but Paul said that the company’s Phase III data will be published in the next 7-8 days.


In March 2021, the USFDA had said that it would not issue further EUAs for Covid-19 vaccines as the USA had enough vaccines approved and available for its population.

Paul pointed out that each country’s regulatory system works with different 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,” he said.