Need more info for emergency use listing of Covaxin: WHO

BHARAT BIOTECH HAS CONVEYED TO THE GOVT THAT IT HAS ALREADY SUBMITTED 90%OF DOCUMENTS TO WHO FOR EUL

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 MayJune 2021,” the guidance document said.

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, Hyderabadbased Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90%of documents to WHO for obtaining EUL for the Covaxin vaccine, people aware of the development said in New Delhi on Monday. The remaining documents are expected to be submitted by June, Bharat Biotech Ltd told the Central government during a discussion on obtaining the WHO’s authorisation for emergency use listing for Covaxin, people familiar with the matter said. “BBIL is confident about obtaining WHO’s emergency use listing,” said a person familiar with the development. Noting that Covaxin has already received regulatory approval from 11 countries, people familiar with the matter 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 US, people familiar with the matter said.

They 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.