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WHO seeks further clarification from Bharat Biotech on Covaxin

The World Health Organisation (WHO) has said that additional clarifications from manufacturer are needed to conduct a final Emergency Use Listing (EUL) risk-benefit assessment for global use of Bharat Biotech’s Covaxin. The technical advisory group will now meet on November 3 for a final 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.

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

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

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. Mint