WHO seeks ‘additional clarification’ from Bharat Biotech to conduct final ‘risk-benefit assessment’ for Covaxin – Times of India

United Nations/Geneva: The Technical Advisory Group of the World Health Organization on Tuesday called for “additional the explanation” From Bharat Biotech for its covid-19 vaccine covaxin To perform a final “risk-benefit assessment” for the emergency use list of vaccines.
Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted the EOI (Expression of Interest). WHO On April 19 for the Emergency Use List (EUL) of the vaccine.
The Technical Advisory Group met on Tuesday to review data on Covaxin for the Emergency Use List of India’s indigenously manufactured vaccine.
“TAG met today (26 October 2021) and decided that the global use of the vaccine requires additional clarification from the manufacturer to conduct a final EUL risk-benefit assessment,” WHO said in an email to a query by PTI. said in response. Decision regarding the emergency use list of Covaxin.
“Tag expects to receive these clarifications from the manufacturer by the end of this week, and aims to regroup for a final risk-benefit assessment on Wednesday, November 3rd,” it added.
The Technical Advisory Group for Emergency Use List (TAG-EUL) is an independent advisory group that provides recommendations to WHO as to whether a covid As many as 19 vaccines can be listed for emergency use under the EUL process.
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 said it had finished the final analysis of Covaxin efficacy from Phase 3 trials.
Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are two widely used vaccines in India.
WHO has so far approved Covid-19 vaccines from Pfizer-BioNtech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna and Sinopharm for emergency use.
Last week, the WHO said it was expecting an additional information about Covaxin from Bharat Biotech and stressed that the vaccines are safe and “corners to be cut” before recommending the vaccine for emergency use. Can’t” would have to be thoroughly evaluated to be sure.

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