Covaxin approval delayed as WHO asks for additional data from Bharat Biotech

The TAG will now reconvene on November 3 for the final EUL assessment if the data asked of Bharat Biotech is provided by them soon. 

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World Health Organisation’s Technical Advisory Group (TAG) on Tuesday, October 26 sought additional clarification from Hyderabad-based vaccine maker Bharat Biotech to evaluate a final risk-benefit assessment of its domestically developed COVID-19 vaccine Covaxin. 

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India. However, Covaxin has yet to receive the recommendation of WHO for its Emergency Use Listing (EUL). 

Additional data from the vaccine maker by the Technical Advisory Group was necessitated just hours after WHO official Dr Margaret Harris had claimed that Covaxin’s recommendation was expected under 24 hours on accounts of all assessments going well. 

“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 stated earlier on Tuesday. The TAG will now reconvene on November 3 for the final EUL assessment if the data asked of Bharat Biotech is provided by them soon.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides guidance to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.

Bharat Biotech had submitted an Expression of Interest (EOI) to the World Health Organisation on April 19 to be granted approval for Covaxin to be administered under Emergency Use Listing. 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.

Covaxin has so far proved 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 percent protection against the new Delta variant. In June, Bharat Biotech had confirmed that it had concluded the final analysis of Covaxin efficacy from Phase 3 trials.

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