The international initiative for the COVID vaccination drive, Covax, has requested WHO to allow Bharat Biotech’s Covaxin for emergency usage as the vaccine supply runs dry. Meanwhile, Indian pharma giant Bharat Biotech said that 90 per cent of the required documents have been sent to WHO for its vaccine approval.
Bharat Biotech International Limited (BBIL) told Indian government officials on Monday that it is “confident” about obtaining the WHO approval.
In a meeting held on Friday, Covax facility experts from India and other nations recommended the approval of Covaxin and Russia's Sputnik V. This gains significance as WHO’s approval is a prerequisite for any COVID-19 vaccine to be included under the Covax for distribution.
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However, a guidance book dated May 18th posted on WHO’s an official website named ‘latest status of COVID19 vaccines within WHO EUL/PQ’ suggests that the Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that more information was required. A pre-submission meeting is expected “to be planned May-June 2021,” the guidance document said.
According to the agency, the duration of the emergency use listing process depends on the quality of the documents shared by the vaccine manufacturer. This means that the better the documents of the vaccine, the easier it is to give it emergency usage approval.
Dr Krishna Ella led company had submitted its expression of interest for an emergency use listing (EUL) of Covaxin to WHO in April. Following this, the WHO had asked Bharat Biotech for additional details. The company is expected to submit its final dossier of details soon.
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The approval is key since about 2 crore Indians, including senior Indian government functionaries, have been administered Covaxin and there is a discussion about granting vaccine passports only to those given WHO-approved vaccines.
Senior officials from the MEA, Health Ministry and Bharat Biotech held a meeting to discuss the status of the application for WHO’s EUL for 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,” the Indian Express reported.
