Decision on Bharat Biotech’s Covaxin EUL in October: WHO

PTI, Sep 30, 2021, 10:34 AM IST

United Nations/Geneva: A decision on Bharat Biotech’s submission seeking emergency use listing (EUL) for its Covaxin COVID-19 vaccine will be made in October, the World Health Organisation has said.

The status of assessment for Covaxin is “ongoing”. Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine.

The latest ‘Status of COVID-19 vaccines within WHO EUL/PQ evaluation process’ guidance document dated September 29 on the WHO website said that the decision date for Bharat Biotech’s Covaxin is “October 2021”.

The WHO said it began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.

According to the WHO, submissions to WHO for prequalification or listing under the emergency use procedure are confidential.

If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely.

Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

Bharat Biotech recently said it submitted all data pertaining to Covaxin to the WHO for EUL and is awaiting feedback from the global health watchdog.

“#COVAXIN clinical trial data was fully compiled & available in June 2021.

All Data submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback,” Bharat Biotech had tweeted earlier this month.

“We are diligently working with the WHO to obtain EUL at the earliest,” the company had said on Tuesday.