India / US' FDA delays use of India's Covaxin, asks to file for 'full approval'

New Delhi: Covaxin, Bharat Biotech's India-made vaccine against the coronavirus disease (Covid-19), was not given approval for emergency use in the United States by the country's top public health regulator -- the Food and Drug Administration (FDA). Rejecting Covaxin's application for emergency use authorisation in the US, the FDA sought more data on the clinical trials for the vaccine, the complete extent of which is still lacking. The FDA rejection would normally indicate a delay in Covaxin's launch in the US, but Bharat Biotech's US partner Ocugen Inc said on Thursday that it would instead push for a full US approval of the indigenous vaccine candidate Covaxin, without pursuing an emergency use authorisation.

Why was Covaxin rejected by the Food and Drug Administration (FDA)?

The FDA requested additional information and data on Bharat Biotech's Covaxin, explained a statement by the Hyderabad-based pharma company's US partner Ocugen. Covaxin has been facing criticism back home in India for not sharing its Phase-3 trial data, despite being approved by India's top drug regulator, the Drugs Controller General of India (DCGI) six months ago.

The FDA rejected Bharat Biotech's proposal for emergency use approval of Covaxin, the Covid-19 vaccine, in the US because the company submitted partial trial data from March this year. According to an official statement, the FDA has asked Ocugen to submit additional trial data so that it can file for a Biologics Licence Application (BLA), which is a full approval, instead of the emergency use approval.

Revising its guidelines for emergency use authorisation, the US FDA earlier said that it will entertain no such new requests. Despite this, Ocugen remained hopeful last month that its Covaxin proposal would be considered by the FDA due to a series of discussions since late last year, the company informed its investors in a May 26 statement. "We believe that the FDA's new guidance confirms that Ocugen continues to meet all criteria for the submission of a EUA," the statement read.

Covaxin's lack of Phase-3 trial data

Bharat Biotech, which is currently carrying out the Phase-3 clinical trials for Covaxin, informed news agency ANI on Wednesday that it will make the data public during July, following which the company will be applying for full licensure of the Covid-19 vaccine. "Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin,” Bharat Biotech told the news agency.

Bharat Biotech added that Phase-4 trials are also being done to check the "real-world effectiveness" of the vaccines" and to meet scientifically approved standards for safety and efficacy.

Covaxin's faces hurdle with foreign approval

Bharat Biotech's Covaxin Covid-19 vaccine has been facing hurdles gaining foreign approvals since the Phase 3 trial data is essential for validation from the World Health Organization (WHO), which will allow the Hyderabad-based pharmaceutical company to export its Covid-19 vaccine and make it a part of the much-coveted "vaccine passport".

However, without the Phase 3 trial data, Covaxin has been facing remains unapproved in several countries, where it is failing to gain access in strictly regulated markets. At a time when authorisation from top health regulators at the US, the European Union, or the WHO is needed for a vaccine to cross borders, the India-made Covid-19 vaccine Covaxin remains unrecognised, as some foreign countries are even considering Indian students vaccinated with Covaxin as "unvaccinated". "We are aware that Bharat Biotech has sought the WHO emergency-use listing for Covaxin. We hope that the process of getting this approval is completed at an early date," said MEA spokesperson Arindam Bagchi at an online briefing on Thursday, speaking on the matter.