WHO expert panel seeks additional info to clear Covaxin for emergency use

The World Health Organisation has said that its technical advisory group that recommends it on the clearance of vaccines, has sought more clarifications from Covaxin manufacturer Bharat Biotech to conduct a final risk-benefit assessment for the emergency use listing of the vaccine.

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 TAG met today (October 26, 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 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, November 3,” WHO told PTI.

Covaxin, India’s indigenous COVID-19 vaccine is developed by Hyderabad-based pharmaceutical company Bharat Biotech and the Indian Council of Medical Research (ICMR).

Bharat Biotech had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine’s Emergency Use Listing (EUL).

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 had said that the timeframe for its EUL procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for the health agency to evaluate a vaccine’s quality, safety, efficacy and its suitability for low and middle income countries.

During trials 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, marketed in India by Serum Institute of India, are the two widely used vaccines in the country.

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.

(With inputs from agencies)