WHO team to meet on October 26 to consider EUL for Covaxin
Covaxin
The technical advisory group of the World Health Organisation will meet on October 26 to consider the Emergency use listing for Covaxin, Chief Scientist at the WHO Soumya Swaminathan said on Sunday.
The approval for Bharat Biotech’s made-in-India vaccine is much awaited.
Bharat Biotech had submitted all the necessary documents required for the EUL on July 9.
“We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines,” said Bharat Biotech in a statement.
Suchitra Ella, the company’s co-founder and joint managing director said that the approval is not expected to be a “long-drawn process”.
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“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,” she said in a tweet.
Meanwhile, the pharma regulator's Subject Expert Committee (SEC) has recommended that Bharat Biotech's Covaxin be approved for emergency use in children aged 2 to 18.
The SEC has submitted its proposal for final clearance to the Drugs Controller General of India (DCGI).
"After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation," the expert panel said in a statement.