The World Health Organisation (WHO) on Wednesday informed that the final decision on Bharat Biotech's submission on emergency use listing (EUL) for its Covaxin COVID-19 vaccine will be made in October 2021.
The status of assessment for Covaxin is "ongoing" as of now, the WHO informed in a document citing the status of COVID vaccines.
On the WHO website, the decision date for Bharat Biotech's Covaxin is October 2021. Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine.
The duration of the emergency use listing process depends on the quality of the data which is submitted by the vaccine manufacturer.
The WHO has also asked for additional data from Bharat Biotech for Covaxin, sources from the WHO informed ANI.
"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 had informed ANI.
According to Bharat Biotech Covaxin Phase 3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent.
Bharat Biotech had also informed that the company has responded to clarifications sought by WHO and is 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," a statement from Bharat Biotech informed.
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 the WHO will be meeting in October to make its recommendations on Bharat Biotech's COVID-19 vaccine Covaxin on EUL.
SAGE is authorised with advising WHO on overall global policies and strategies ranging in vaccines, technology, research and other health interventions.
(With ANI inputs)
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