WHO Seeks ‘Additional Clarifications’ From Bharat Biotech, Covaxin Waits For Nod

World Health Organisation’s technical advisory group has sought “additional clarifications” from Bharat Biotech for its Covid-19 vaccine Covaxin to conduct a final risk-benefit assessment for Emergency Use Listing of the vaccine. 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 technical advisory group met  as reported by PTI  to review data on Covaxin for the emergency use listing of India’s indigenously-made vaccine. “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 .

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.