Bharat Biotech says working with WHO to obtain clearance, no word on approval delays
Bharat Biotech has said it doesn't 'find it appropriate to speculate or comment on the regulatory approval process and its timelines' after reports emerged of a possible delay in WHO approval
September 28, 2021 / 03:41 PM IST
Bharat Biotech on September 28 said it was working with the World Health Organisation to get the emergency use listing for Covaxin at the earliest, as reports talked of a delay with the UN body asking for more data on the Indian pharma firm's COVID jab.
"As a responsible manufacturer with past approvals for our other vaccines, we don’t find it appropriate to speculate or comment on the regulatory approval process and its timelines," Bharat Biotech said in a statement.
"At appropriate times, we will make announcements to indicate the availability of regulatory approvals."
EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics to expedite their availability to people affected by a public health emergency.
The inclusion of Covaxin, one of the six jabs approved by India, in the WHO list will boost global acceptance of the vaccine, making it easier for beneficiaries to travel abroad.
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The Hyderabad-based company’s statement comes amid reports of a likely delay in the approval by several weeks.
As reported by Moneycontrol, the Strategic Advisory Group of Experts on Immunization (SAGE), which advices WHO, will meet on October 5 to review Covaxin's safety and efficacy data emerging from clinical trials (phase 1-3 results and post-marketing), risk-management plans and other implementation considerations.
Covaxin’s clinical trial data had been compiled and was available in June 2021, Bharat Biotech said early this month. The information was submitted for EUL in early July.