Covaxin's lack of USFDA approval a roadblock in getting WHO green flag

G. Naga Sridhar Hyderabad | Updated on October 28, 2021

WHO experts to reconvene for final risk-benefit study on November 3

Despite almost 12 crore people in India having been administered Bharat Biotech’s Covaxin, the absence of an approval from the US drug regulator could have come in the way of the vaccine’s speedy processing by the World Health Organization (WHO), for an emergency use tag.

Bharat Biotech had begun the regulatory process for an Emergency Use Listing (EUL) in June and a decision was expected by September. But the company has since been fielding a series of questions, clarifications and requests for additional data submission.

Two-part process

This time too, additional clarifications were sought by the Technical Advisory Group (TAG) that reviewed the vaccine-linked data at a meeting on Tuesday. In a late night response to BusinessLine, the WHO had said that clarifications were sought to conduct a final risk-benefit assessment for global use of the vaccine. Response from Bharat Biotech was expected by the end of this week, after which the WHO would reconvene for the final risk-benefit assessment on November 3, the agency said. Recommendations from TAG, an independent advisory group, completes the WHO’s two-part EUL process.

Bharat Biotech has submitted to the WHO piles of efficacy studies conducted on over 26,000 volunteers. The company, though, is silent on the nature of information sought by the WHO. Instead, it maintains that the approval process involved a constant dialogue between the manufacturer and WHO committees.

The Indian Council of Medical Research (ICMR), a collaborator on Covaxin, is working with the company to provide the additional data to the WHO, a government source said.

Mutual recognition

Pointing to Pfizer’s Covid-19 vaccine, an industry-insider said an approval from the US Food and Drug Administration would have worked in Covaxin’s favour in getting a speedy EUL from the WHO. The WHO relies on approvals from SRAs (Stringent Regulatory Authorities) and National Regulatory Authorities. Bharat Biotech is in the process of obtaining a US regulatory nod through its US-based partner, Ocugen.

Covaxin is, however, on the US Centres for Disease Control (CDC)’s list of Covid-19 vaccines. In fact, vaccine industry representatives urge more countries to adopt a “mutual recognition of vaccines” approach to ensure that people taking one vaccine are not stranded in another country, waiting for a WHO listing.

Though an EUL is not required for countries to source vaccines from a company, a WHO ratification facilitates easier travel.

While industry-watchers express concern on the EUL “delay” due to data documentation or possible quality manufacturing or sustained supply issues, company insiders said there was no delay. In pre-pandemic times, an approval used to take 12 to 24 months; this has been just four, they add. “Even if one goes by timelines of approvals after pandemic, the Chinese Covid vaccine also took about four is not appropriate to see a delay in the process,” the source said.


Bharat Biotech is gearing up to export Covaxin, possibly by next month. It is producing 55 million doses per month.


(With inputs from Monika Yadav, Delhi.)

Published on October 27, 2021

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