WHO to Finalise Nod to Covaxin Next Week, Health Body Currently ‘Reviewing Additional Data’

The World Health Organisation on Tuesday said a decision on the Emergency Use Listing (EUL) of India’s home-grown coronavirus vaccine, Covaxin, will be finalised next week when the health watchdog and an independent group of experts will meet to carry out an assessment of the risks and benefits of the jab.

In a tweet, WHO said: “WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin.”

WHO further wrote that Hyderabad-based Bharat Biotech, which manufactured Covaxin, had submitted additional information on its request on September 27, which is being currently reviewed.

“Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis and submitted additional info at WHO’s request on 27 September. WHO experts are currently reviewing this info and if it addresses all questions raised, WHO assessment will be finalised next week,” it said.

Sources told CNN-News18 that the Strategic Advisory Group of Experts (SAGE) has submitted its recommendations to WHO with regard to Covaxin. There were no objections from any of the SAGE members, sources said, adding that the expert group had full consensus on around 20 parameters.

News18 had on September 28 reported that the approval for Covaxin may take a few more weeks because WHO had raised some more questions on the vaccine and the queries were sent to Bharat Biotech for further clarification.

Bharat Biotech had submitted all the necessary documents required for the EUL on July 9. “All documents required for EUL of Covaxin have been submitted to WHO as of July 9. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest,” Dr Krishna Ella, chairman and managing director of Bharat Biotech, had said in a statement.

This statement, in July, was released days after Suchitra Ella, the company’s co-founder and joint managing director, said that the approval from the world health body is not expected to be a “long-drawn process”. “We are working closely with the World Health Organisation for the inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” Suchitra Ella had tweeted.

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