WHO seeks 'additional clarifications' from Bharat Biotech for Covaxin’s emergency approval

The World Health Organisation (WHO) has asked for additional clarifications from Bharat Biotech to conduct a final Emergency Use Listing (EUL) risk-benefit assessment for global use of Bharat Biotech's Covaxin.

The WHO technical advisory group will 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.

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

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 Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to the 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.

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.

Earlier on Tuesday, WHO spokesperson Dr Margaret Harris had said that on COVAXIN, the technical advisory group that reviews all the data for a potential emergency use listing was reviewing that data.

"Now if all is in place, and all goes well, and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so," she had said during a press meeting on Tuesday.

World Health Organization (WHO) stated Monday that it is aware that many people are waiting for the organisation's recommendation for Bharat Biotech's Covaxin to be included in the Covid-19 Emergency Use Listing (EUL) but it cannot cut any corners and that before recommending a product for emergency use, the organisation must "evaluate it thoroughly to make sure it is safe and effective".  

The organisation explained that the timeframe for the WHO EUL 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," noted WHO.

Also Read: COVID-19: Moderna says its vaccine safe for 6-11 years old children

Also Read: Russia, EU countries see spurt in Covid-19 cases in new wave of infections