No nod for Bharat Bio’s Covaxin yet, WHO seeks ‘additional clarifications’

The World Health Organisation’s technical advisory group on Tuesday 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 on Tuesday 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.

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. The UN health agency 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.

When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine, it said. Earlier, WHO Chief Scientist Soumya Swaminathan had said that the technical advisory group at the WHO will meet on October 26 to consider the Emergency Use Listing for Covaxin.

“The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere, she said. News18