India / No approval for Covaxin yet as WHO seeks further clarifications from Bharat Biotech

New Delhi: The World Health Organization (WHO) has yet again delayed granting Emergency Use Listing (EUL) to India’s indigenous COVID-19 vaccine Covaxin seeking more technical details to conduct a final 'risk-benefit assessment'.

The WHO met on Tuesday to take a final decision on giving clearance to Bharat Biotech's Covaxin. Notably, the world health body’s technical committee has already approved Covaxin, and now another committee is evaluating to grant the final approval.

The technical advisory group be meeting on November 3 for the final assessment on Covaxin.

"The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine," the WHO said in an email response to a question by PTI.

"The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November," it added.

The Technical Advisory Group for Emergency Use Listing is an independent advisory group that provides recommendations to WHO on whether a particular vaccine can be used under EUL procedure.

Bharat Biotech had submitted EOI (Expression of Interest) to the WHO on April 19, 2021 for Covaxin's Emergency Use Listing (EUL).

Earlier, Reuters quoted Margaret Harris saying that if all goes well then Covaxin may get the WHO approval within the next 24 hours.

"If all is in place and all goes well and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so," Reuters quoted Harris as saying at a UN press briefing.

Union Health Minister Mansukh Mandaviya on Tuesday said that the WHO has a system and the approval for Covaxin will be given on the basis of the meeting which will be convened the global health body today.

The WHO has so far listed the Pfizer/BioNTech vaccine, two AstraZeneca/Oxford vaccines,  AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India, COVID-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) and China's Sinopharm for emergency use.

It may be noted that India had approved Covaxin and Covishield in January 2021. The Bharat Biotech's Covaxin recently got the emergency use approval for children in the age group of 2 to 18 years from the Drugs Controller General of India (DCGA).