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No approval for Covaxin yet as WHO seeks further clarifications from Bharat Biotech

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The United Nations health agency said after a meeting on Tuesday that the World Health Organization’s (WHO) expected approval of Covaxin was further postponed after experts requested some clarification from vaccine manufacturer Bharat Biotech.

Millions of Indians and the center have been following this process, and it is expected that the process will reach some conclusion at the end of October. The approval will allow other countries to have greater recognition of Covaxin, so that Indian travelers taking this dose are eligible for vaccine authorization. Conversely, rejection may damage confidence in dosage.

The WHO stated that it is expected to be clarified this weekend and will meet again on November 3 to discuss approval, which is technically called the Emergency Use Listing (EUL). “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. The TAG met today (26 October 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,”

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“TAG expects to receive these clarifications from the manufacturer before this weekend, and plans to reconvene the final risk-benefit assessment meeting on Wednesday, November 3.” The EUL grant will also make the vaccine eligible for distribution to low- and middle-income countries under COVAX facilities. Earlier, at a media conference on Tuesday, Union Health Minister Mansukh Mandaviya said: “WHO has a system under which a technical committee observes the data, and then another technical committee analyzes the data further Data.

The first committee has approved the data, and the approval of Covaxin will be approved based on the recommendations of the second committee.”

News Source : Hindustan Times

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