Additional Clarifications Needed For Emergency Use Listing Of COVAXIN, Assessment To Reconvene On Nov 3: WHO

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The World Health Organisation (WHO) has said that additional clarifications from manufacturer are needed to conduct a final Emergency Use Listing (EUL) risk-benefit assessment for global use of India-made COVAXIN.

“Technical Advisory Group (TAG) for Emergency Use Listing has decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” the WHO said in response to ANI on a decision regarding the Emergency Use Listing of Covaxin. The vaccine is India’s indigenous COVID-19 vaccine by Bharat Biotech. The UN health body said that the TAG expects to reconvene for the final risk-benefit assessment on November 3.

“TAG expects to receive these clarifications from the manufacturer by end of this week and aims to reconvene for the final risk-benefit assessment on Wednesday, November 3,” the WHO added.

Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional information at the UN health body’s request on September 27.

Earlier this month, WHO chief scientist Dr Soumya Swaminathan had said that the UN health body’s technical advisory group will meet on October 26 to consider Emergency Use Listing (EUL) for Covaxin.Last week, WHO had said a vaccine recommended by it for emergency use must be evaluated thoroughly.

“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the COVID19 Emergency Use Listing, 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,” the UN health body had said.

Covaxin, India’s first indigenous COVID-19 vaccine, is developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research.

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