Approval to Covaxin: WHO technical group to meet on Oct 26

The World Health Organisation’s technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech protecting against COVID-19, the global health agency’s chief scientist said on Sunday.

‘The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere,’ World Health Organisation Chief Scientist Soumya Swaminathan said in a tweet on Sunday.

Earlier this month, the WHO said Bharat Biotech ‘has been submitting data to WHO on a rolling basis and submitted additional information at the WHO’s request on September 27. The WHO experts are currently reviewing this information and if it addresses all questions raised, the WHO assessment will be finalised next week’.

Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine.

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 for pre-qualification 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 the data meeting the WHO’s criteria, according to the agency.

The indigenously developed Bharat Biotech’s Covaxin is one of the six vaccines that have received emergency use authorisation from India’s Drug Regulator and is being used in the nationwide anti-COVID-19 inoculation programme along with Covishield and Sputnik V.

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 and 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 last month.

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

According to Johns Hopkins University, the coronavirus has claimed 4,897,386 lives along with 240,559,605 confirmed cases across the world so far.

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