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Bharat Biotech holds talks with US FDA for phase-3 clinical trial of Covaxin: Report – Mint

Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90% 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 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.

Sources also said that no country has instituted a ‘vaccine passport’ and that countries around the world have their own requirements for approval which, in most cases, involves travel by carrying a COVID-19 negative RT-PCR report.

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 also said that BBIL is in the final stages of submission of required documents for regulatory approvals to Covaxin in Brazil and Hungary.

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. 

Foreign Secretary Harsh Vardhan Shringla was among those who attended the meeting.

This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.

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