The Technical Advisory Group (TAG) for Emergency Use Listing (EUL) is seeking additional clarifications from Bharat Biotech for global use of Covaxin. The TAG-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 Covaxin has so far demonstrated 77.8% effectiveness against symptomatic COVID-19 and 65.2% protection against the new Delta variant. In June, Bharat Biotech said it had concluded the final analysis of Covaxin efficacy from Phase III trials. It should be noted that Bharat Biotech’s Covaxin and AstraZeneca, and Oxford University’s Covishield are the widely used vaccines in India.
WHO told Indian Express that 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 November 3. “The TAG met on October 26, 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 World Health Organization has said in a series of tweets that it could not cut corners and that the timeframe for its Emergency Use Listing was dependent on how quickly vaccine manufacturers were able to provide the required data. “We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID-19 EUL but we cannot cut corners before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” it explained.
Dr Margaret Harris, WHO spokesperson, during a press briefing said that if all is in place, and all goes well, and if the committee is satisfied, they would expect a recommendation within the next 24 hours or so.
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The WHO has so far approved COVID-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson&Johnson’s Janssen, Moderna and Sinopharma for emergency use.
