Bharat Biotech is asked to provide ‘more information' by the WHO in order for Covaxin to be listed as an emergency use vaccine.
25th May, 2021
Bharat Biotech, which is seeking an emergency use listing (EUL) for its Covaxin vaccine for COVID-19, has been told by the WHO that “more information” is needed.
Bharat Biotech submitted an EOI (Expression of Interest) on April 19, according to the latest ‘Status of COVID-19 Vaccines inside WHO EUL/PQ evaluation procedure' guidance document on the WHO website dated May 18, adding that “More information required.” According to the guidance document, a pre-submission meeting would be held “in May-June 2021.”
Submissions to the WHO for pre-qualification or listing under the emergency use procedure are confidential, according to the WHO.
If a product is deemed to fit the requirements for listing, WHO will make the findings widely available.
The agency stated that the length of the emergency use listing procedure is determined by the quality of the vaccine manufacturer's data and whether or not it meets WHO requirements.