WHO Wants “More Information” Before Listing Covaxin in ‘EUL’
Manas Dasgupta
NEW DELHI, May 25: Among the anxiety of the Indian recipients who have taken two shots of Bharat Biotech-made “Covaxin,” the World Health Organisation (WHO) has said “more information” was required from its manufacturer before giving approval for its Emergency Use Listing (EUL).
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 was expected to be “planned in May-June 2021,” the guidance document said.
The WHO listing of a vaccine in the “EUL” is currently mandatory for anyone with two vaccine shots intending to travel to various countries, particularly the European countries. These countries are refusing to issue visas unless the applicants have received two shots of a vaccine approved by the WHO under the EUL list.
Of the two vaccines widely being used in India, “Covishield” manufactured by the Pune-based Serum Institute of India under license from AstraZeneca-Oxford University, is already listed under the EUL by the Who while Covaxin is yet to get the nod causing anxiety among its recipients who intended to make a trip abroad. Incidentally, the prime minister Narendra Modi is among those who have received two shots of the indigenously developed Covaxin.
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 on Monday.
The remaining documents are expected to be submitted by June, the company told the Central government during a discussion on obtaining WHO’s authorisation for EUL listing of Covaxin.
“BBIL is confident about obtaining WHO’s emergency use listing,” official sources said. 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 Hyderabad-based 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.
The Foreign Secretary Harsh Vardhan Shringla was also among those who attended the meeting.
