Bharat Biotech's Covaxin on the Brink of WHO Approval; Decision on Wednesday

The World Health Organisation, which has sought clarifications from Bharat Biotech on its Covid-19 vaccine — Covaxin — and will meet on Wednesday for a final risk-benefit assessment for its Emergency Use Listing. The WHO Technical Advisory Group for Emergency Use Listing (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, the WHO tweeted.

The Technical Advisory Group had met October 26 and sought additional details from Bharat Biotech. 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.

Last week at the G20 summit, Prime Minister Narendra Modi said India is ready to produce over 5 billion Covid vaccine doses next year to help the world in the fight against the pandemic in a sly nudge to the UN health body as he asserted that it was necessary that the WHO approves Indian vaccines at the earliest. The prime minister in his intervention at the session on “global economy and global health” also flagged the issue of facilitating international travel and talked about the mechanism of mutual recognition of vaccine certification as a means of achieving this, according to the text of his intervention shared by his office.

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 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.

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