WHO To Decide On Bharat Biotech’s Covaxin Emergence Use Listing In October
Bharat Biotech has responded to clarifications sought by WHO and is awaiting further feedback.
Mumbai: The World Health Organization (WHO) informed that the final decision on Bharat Biotech’s submission for its Covaxin Covid-19 vaccine on emergency use listing (EUL) will be made in October 2021.
Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine. On the WHO website, the decision date for Bharat Biotech’s Covaxin is October 2021.
As of now, the status of assessment for Covaxin is “ongoing”, as per a WHO document citing the status of Covid-19 vaccines.
The WHO has also asked for additional data from Biotech for Covaxin, as reported by ANI. The duration of the emergency use listing process depends on the quality of the data which is submitted by the vaccine manufacturer.
“There is a procedure of submitting the documents for approval, WHO’s emergency use authorization to Covaxin is expected soon,” Dr Bharati Pravin Pawar, Mos, Health.
According to Bharat Biotech Covaxin Phase3, clinical trials of Covaxin demonstrated an efficacy rate of 77.8%.
Bharat Biotech had also informed that the company has responded to clarifications sought by WHO and is awaiting further feedback.
A statement from Biotech said, “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.”
Speaking to ANI, Chairman of the National Expert Committee on Vaccine Administration and Member of Health for NITI Aayog Dr VK Paul had also said that the WHO’s approval for Bharat Biotech’s Covid-19 vaccine, Covaxin, is likely to come before the end of this month.
The strategic advisory group of experts on Immunization (SAGE) of WHO will be meeting in October to make its recommendation on Bharat Biotech’s Covaxin on EUL.
SAGE is authorized with advising WHO on overall global policy and strategies ranging in vaccines, technology, research, and other health interventions.
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