Decision on Bharat Biotech’s Covaxin EUL in October, says WHO

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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Dear Reader,

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor