WHO approves Bharat Biotech’s Covaxin for emergency use after a long wait

• WHO gives green signal to home-grown Covaxin for emergency use.
• WHO’s advisory committee had sought more clarity on additional information from Bharat Biotech to conduct the ‘risk benefit assessment’ for emergency use listing of the vaccine.
• Bharat Biotech had submitted ‘Expression of Interest’ to WHO on April 19.

The World Health Organisation’s (WHO) advisory technical group on Wednesday has given a green signal to Hyderabad-based Bharat Biotech’s COVID-19 vaccine Covaxin for emergency use.


The WHO, in a tweet, said: "WHO has granted emergency use listing (EUL) to Covaxin, developed by Bharat Biotech, adding to a growing portfolio of vaccines validated by WHO for the prevention of Covid 19".

The source said that Prime Minister Narendra Modi had pushed for Covaxin approval at G20 meet with WHO Director General Dr Tedros Adhanom Ghebreyesus.

Earlier, on October 26, WHO’s advisory committee had sought more clarity on additional information from Bharat Biotech to conduct the ‘risk benefit assessment’ for emergency use listing of the vaccine.

Bharat Biotech had already submitted ‘Expression of Interest’ to WHO on April 19. The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that guides and recommends WHO on whether COVID-19 vaccine can be listed under emergency use or not.

“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," WHO had told PTI in an email interaction.

"The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November," WHO had added at the time.

Covaxin, which was co-developed by Hyderabad-based Bharat Biotech, in collaboration with the government's Indian Council of Medical Research (ICMR), was granted emergency authorisation in the country in January.

It has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. Bharat Biotech said that it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

The global health body has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson 7 Johnson - Janssen, Moderna, and Sinopharm for emergency use against Covid-19.

(With inputs from IANS and PTI)

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