A World Health Organization expert panel is scheduled to review the clinical trial data of Bharat Biotech’s Covid-19 vaccine Covaxin on October 5, according to the committee’s agenda for the meeting.
Following the review, the Strategic Advisory Group of Experts on Immunization (SAGE) will issue draft recommendations, which will be critical in the process of approving Covaxin for WHO’s Emergency-Use Listing (EUL).
EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the aim of expediting their availability to people affected by a public health emergency.
Inclusion of Covaxin in the WHO list will boost global acceptance of the vaccine, which was developed indigenously.
SAGE will evaluate the vaccine’s safety and efficacy data emerging from Bharat Biotech’s clinical trials (phase 1-3 results and post-marketing), risk-management plans and other implementation considerations. In addition, it will review safety monitoring and assessment of evidence.
SAGE member Hanna Nohynek will present the draft recommendations. According to the SAGE agenda, it has one and half hours for the Covaxin review, including a presentation by the company.
Bharat Biotech was yet to respond to Moneycontrol queries at the time of publishing this story.
Bharat Biotech said last week that Covaxin’s clinical trial data had been fully compiled and became available in June 2021. The information was submitted for EUL application in early July.
“We have responded to clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several WHO prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines. However, we are continuing to work diligently on obtaining WHO EUL at the earliest,” the company said.
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