`More information required': WHO asks Bharat Biotech before approving `Covaxin'

According to the latest status of the COVID-19 vaccine EUL/PQ evaluation process, Bharat Biotech has submitted its EOI (Expression of Interest) on April 19. WHO has asked it to furnish more information before granting EUL.

A pre-submission meeting is expected to be planned May-June 2021, the guidance document said. According to the WHO, submissions 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. The 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 percent of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin, sources said.

The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech Ltd told the Central government during a discussion.

"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.