WHO seeks more information from Bharat Biotech for Covaxin emergency use listing
New York/Geneva: 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 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. 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.
The company is in the final stages of negotiations with the Food and Drug Administration of the US for conducting small-scale phase-III clinical trials of Covaxin in the United States, sources said.
Sources said the meeting with BBIL on the EUL was attended by the company''s managing director V Krishna Mohan and his colleagues besides senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs.
Foreign Secretary Harsh Vardhan Shringla was among those who attended the meeting.
Read also: Bharat Biotech Covaxin production ramped up by additional 200 million
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.