Bharat Biotech submitted an EOI (Expression of Interest) for its vaccine on 19 April. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer.
New Delhi: on the World Health Organization (WHO) Wednesday Informed that a final decision on emergency use of Bharat Biotech’s Covaxin COVID-19 vaccine will be taken in October.
WHO informed that the evaluation status of Covaxin was “ongoing”
Bharat Biotech had submitted EOI (Expression of Interest) to April 19 for its commentary. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer.
The report said that the WHO has also sought additional data for Covaxin from Bharat Biotech.
Dr Bharti Praveen Pawar, Minister of State for Health, said, “There is a process to submit documents for approval, WHO’s emergency use authorization to Covaxin is expected soon.”
Covaxin Phase 3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 percent, according to Bharat Biotech.
Bharat Biotech had also informed that the company has responded to the clarification sought by WHO and is awaiting further response.
Meanwhile, Bharat Biotech issued a statement: “As a responsible manufacturer with many pre-qualified vaccines, we do not consider it appropriate to speculate or comment on the approval process and its timeline.”
First published:September 30, 2021, 1:14 pm