WHO panel to decide on Covaxin EUL today

New Delhi, Nov 03: The World Health Organisation's technical advisory group is set to meet on Wednesday for a closely watched decision on giving an emergency use listing (EUL) to Covaxin.

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine's Emergency Use Listing (EUL).

The Who's technical group is taking longer to analyse the data that previously disclosed timelines.

The panel, WHO's Technical Advisory Group for Emergency Use Listing (TAG-EUL), sought more clarification from the vaccine maker on October 26.

"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 on the decision regarding the Emergency Use Listing of Covaxin.

"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 (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.

The Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.

The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.

Last week, the WHO had said it is expecting one additional piece of information from Bharat Biotech regarding Covaxin and emphasised that it has to thoroughly evaluate to ensure vaccines are safe and "cannot cut corners" before recommending a vaccine for emergency use.

WHO has said the timeframe for its Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine's quality, safety, efficacy and its suitability for low- and middle-income countries.