Need additional clarifications on `Covaxin' before EUL: WHO to Hyd-based Bharat Biotech

The technical advisory group will now meet on November 3 for a final risk-benefit assessment.

"The @WHO independent Technical Advisory Group (TAG) met today & asked for additional clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data is received soon," WHO chief scientist Dr. Soumya Swaminathan said in a tweet.

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.

Last week, the WHO had said it is expecting one additional piece of information from Bharat Biotech regarding Covaxin. The WHO said there needs to be a thorough evaluation to ensure vaccines are safe and "cannot cut corners" before it is recommended for emergency use.

Bharat Biotech has been submitting data to WHO on a rolling basis. It submitted additional information at the UN health body's request on September 27.

Covaxin, India's first indigenous COVID-19 vaccine, has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research.

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

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.