WHO needs more information about Covaxin from Bharat Biotech

A pre-submission meeting is expected “to be planned May-June 2021,” the guidance document said.

The World Health Organization (WHO) has said, “more information” is “required” from Bharat Biotech, which is seeking Emergency Use Listing (EUL) for its COVAXIN vaccine for C-19.

The latest ‘Status of C-19 Vaccines within WHO EUL/PQ evaluation process’ guidance document dated 18th May on the WHO website said Bharat Biotech submitted the Expression of Interest (EOI) on 19th April and that “More information required.”

A pre-submission meeting is expected “to be planned May-June 2021,” the guidance document said. According to 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, Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 per cent of documents to WHO for obtaining EUL for the COVAXIN vaccine, sources said yesterday.

The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech told the Central government during a discussion on obtaining the World Health Organisation’s authorisation for EUL 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 US Food and Drug Administration (FDA) for conducting small-scale phase-III clinical trials of COVAXIN in the US, 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 and Family Welfare (MoH&FW), Department of Biotechnology (DBT) and Ministry of External Affairs (MEA).


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