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New York/Geneva, May 25
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.
(Photo by AFP)
The regulatory approvals for Bharat Biotech s COVID-19 vaccine Covaxin are in process in over 60 countries, including the United States and Brazil, the Hyderabad-based company said on Tuesday. Emergency Use Authorization (EUA) have been obtained in 13 countries with more to follow, it added.
Bharat Biotech further said it has submitted an application for emergency use listing to World Health Organization (WHO)-Geneva, and regulatory approvals are expected in July-September 2021.
Bharat Biotech s statement comes after the WHO said more information is required from the company, which is seeking emergency use listing (EUL) for its COVID-19 vaccine for Covaxin .
The 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 is required . A pre-submission meeting is expected to be planned May-June 2021, t
WHO says ‘more information’ required from Bharat Biotech for emergency use listing of Covaxin
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A pre-submission meeting is expected “to be planned May-June 2021,” the guidance document said.
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A health worker displays vials of Covaxin at a vaccination centre in Jammu. File
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A pre-submission meeting is expected “to be planned May-June 2021,” the guidance document said.
The World Health Organisation (WHO) 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.
Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 per cent of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin vaccine, sources said on Monday. The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech Ltd told the Central government during a discussion on obtaining the World Health Organisation s authorisation for emergency use listing for Covaxin, sources said. BBIL is confident about obtaining WHO s emergency use listing, said a source. Sources also said that no country has instituted a vaccine passport and that countries around the world have their own requirements for approval which, in most cases, involves travel by carrying a COVID-19 negative RT-PCR report.
The World Health Organisation (WHO) 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.