Bharat Biotech submits ‘90% of documents’ for WHO nod

Ninety per cent of the documents required for Emergency Use Listing of Covaxin have been submitted to the WHO and the remaining are expected to be filed in June, the vaccine's developer Bharat Biotech International Limited (BBIL) told Indian government officials on Monday. The firm said it is "confident" about obtaining the WHO approval.

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, reports The Indian Express.

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.

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.

The approval is key since about 2 crore Indians, including senior Indian government functionaries, have been administered Covaxin and there is discussion about granting vaccine passports only to those given WHO-approved vaccines.

Meanwhile, senior officials of the MEA, Health ministry and Department of Biotech held a meeting with BBIL MD Dr V Krishna Mohan and his colleagues on the status of 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. "BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines prequalified by WHO," a source said.

BBIL is also in the final stages of negotiations with FDA of the USA for conducting small-scale phase-III clinical trials in the US, sources said. They clarified that all regulatory approvals have both retrospective and prospective effects. BBIL is in the final stages of submission of required documents for Covaxin's regulatory approvals in Brazil and Hungary, they informed. They have held extensive bilateral consultations with both the countries. The company is in regular touch with regulatory authorities in these countries.