Bharat Biotech submits additional data to WHO, decision on Covaxin EUL likely on November 3

NEW DELHI: The Technical Advisory Group (TAG), an independent advisory panel of the World Health Organisation (WHO), has sought additional clarifications from Bharat Biotech, the manufacturer of Covaxin, in order to conduct a final Emergency Use Listing (EUL) risk-benefit assessment for global use of the vaccine.

The World Health Organisation will meet on Wednesday for a final risk- benefit assessment for its Emergency use listing.

“The TAG met on October 26, 2021, and decided to seek additional clarifications from the Covaxin manufacturers that are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine.” said a WHO official.

The Technical Advisory group had met October 26 and had sought additional details from Bharat Biotech. Covaxin has demonstrated 77.8 percent effectiveness against symptomatic Covid-19 and 65.2 percent protection against the new Delta variant. In June the company had said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Bharat Biotech’s Covaxin and AstraZeneca and Serum Institute’s Covishield are the two widely used vaccines in India.

Last week, the WHO had said that the timeframe for it Emergency Use Listing procedure is dependant on how quickly a manufacturing company producing the desired vaccine is able to provide the data required for WHO to evaluate the vaccine’s efficacy, safety, quality,and its suitable for low and middle-income countries.

Meanwhile, India’s cumulative vaccination coverage crossed 107 crore.

The WHO 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.

(With inputs from agencies)

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