"More Information" Required: WHO On Emergency Use Listing Of Bharat Biotech's Covaxin

According to the WHO, submissions to it for prequalification or listing under the emergency use procedure are confidential.

The World Health Organisation (WHO) has said that 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.