India reported 1,96,427 new coronavirus cases and 3,511 deaths in the last 24 hours, according to the Health Ministry. Meanwhile, the World Health Organisation has said that ‘more information’ is ‘required’ from Bharat Biotech, which is seeking emergency use listing 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. The 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.