WHO requires additional information to list Covaxin

WHO requires additional information to list Covaxin
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WHO requires additional information to list Covaxin

Highlights

The World Health Organisation (WHO) has said "more information" is "required" from Bharat Biotech, which is seeking emergency use listing (EUL) for its Covaxin vaccine for Covid-19

New York/Geneva: The World Health Organisation (WHO) has said "more information" is "required" from Bharat Biotech, which is seeking emergency use listing (EUL) for its Covaxin vaccine for Covid-19.

The latest 'Status of Covid-19 Vaccines within WHO EUL/PQ evaluation process' guidance document dated May 18 on the WHO website said Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that "more information required". A pre-submission meeting is expected "to be planned May-June 2021," the guidance document said.

According to the WHO, submissions to it for prequalification or listing under the emergency use procedure are confidential. If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely.

Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.

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