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.
Meanwhile, Hyderabad-based 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 in New Delhi 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 WHO’s authorisation for emergency use listing for Covaxin, sources said.
“BBIL is confident about obtaining WHO’s emergency use listing,” said a source. Noting that Covaxin has already received regulatory approval from 11 countries, sources said there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.