USFDA’s decision to ask Bharat Biotech to apply for a full BLA has been welcomed by the NITI Aayog member

Denial of emergency use authorisation to Bharat Biotech made Covaxin by the United States Food and Drug Administration’s (USFDA) has no bearing on the policies in India said NITI Aayog member (Health) Dr. V.K. Paul.

Stating that every country has its own parameter for approval of vaccinations for its population despite the world sharing a common scientific framework for approval, Paul clarified that India also follows its own regulatory process for approval that is tailor-made for its population. The NITI Aayog member said in a press conference on Friday.

“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.

However, he added, “It’s their decision, it should be respected. Our regulator has endorsed this vaccine and there is no impact on use of Covaxin in our national programme.” He said Covaxin phase-3 clinical trial data would be published in the next 7-8 days.

“We expect that the Covaxin manufacturers will be able to comply with the regulators’ requirement. Our regulator has approved this vaccine. We have enough data on safety and efficacy,” the NITI Aayog member

On issue of Amphotericin-B medicine, he said doctors should not prescribe Liposomal Amphotericin-B. Standard Amphotericin-B could be used in otherwise healthy people without a pre-disposed kidney condition to treat mucormycosis.

“This would ensure that we have a robust availability of this drug,” he pointed out.

Earlier this week, the USFDA announced that it will not provide emergency use authorisation (EUA) to Bharat Biotech's COVAXIN COVID-19 vaccine.

On the other hand, the US' top medical regulatory body 'recommended' Ocugen Inc, the American partner of the Hyderabad-based vaccine maker, to seek authorisation through the Biologics License Application (BLA).

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