The World Health Organisation’s Technical Advisory Group for Emergency Use Listing expects to receive some additional clarifications on Covaxin from the manufacturer, Bharat Biotech, by the end of this week and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November 2021.
“The Technical Advisory Group for Emergency Use Listing (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,” a WHO report said.
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The TAG met on October 26 and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine. Last week, the WHO had said it is expecting one “additional piece” of information from Bharat Biotech regarding Covaxin.The WHO had said that there needed to be a thorough evaluation to ensure vaccines are safe and “cannot cut corners” before they are recommended for emergency use.
Hyderabad-based Bharat Biotech, which has developed Covaxin, submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine’s Emergency Use Listing (EUL).
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India’s first indigenous Covid-19 vaccine, Covaxin, demonstrated 77.8 per cent efficacy in its Phase 3 clinical trial.
In June, Bharat Biotech said it concluded the final analysis of Covaxin efficacy from Phase 3 trials. The Covaxin jab has been approved in 14 countries and 70 million doses have been distributed overseas, Bharat Biotech told WHO.
Chief scientist of World Health Organisation Soumya Swaminathan on Wednesday said that the WHO- International Health Regulations Emergency Committee has called upon countries to recognise all vaccines that have received the WHO Emergency Use Listing and to not use vaccine certificates as the only criterion for international travel. She said such policies were affecting global travel for education and business.Internet Explorer Channel Network