Vaccine developer Bharat Biotech on Tuesday said it expects approval for its Covid-19 vaccine Covaxin from the World Health Organisation (WHO) for emergency use listing (EUL) by July-September.
The company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil and Hungary among others.
“Application for EUL has been submitted to WHO-Geneva. Regulatory approvals are expected during July-September 2021,” the Hyderabad-based company said in a release.
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— BharatBiotech (@BharatBiotech) May 25, 2021
The release comes a day after Bharat Biotech told Indian government officials that 90 per cent of the documents required for Covaxin’s EUL have been submitted to the WHO and the remaining are expected to be filed in June. The firm had said it is “confident” about obtaining the WHO approval.
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.
However, 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 May-June 2021,” the guidance document said.
The WHO approval holds importance as there is a discussion about granting vaccine passports only to those given WHO-approved vaccines.
About 2 crore Indians, including senior Indian government functionaries, have been administered Covaxin in India so far.
As reported by The Indian Express earlier, senior officials of the MEA, Health ministry and Department of Biotech held a meeting with Bharat Biotech MD Dr V Krishna Mohan and his colleagues on the status of the application for WHO’s EUL of Covaxin.
During the meeting, it was noted that Covaxin had already received regulatory approval from 11 countries. There was also interest from 11 other companies in 7 countries for technology transfer and production of Covaxin, sources said. “Bharat Biotech is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines prequalified by WHO,” a source had said.
