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Decision on Bharat Biotech’s Covaxin Emergency Use Nod to be Made in October: WHO

New Delhi: A decision on Hyderabad-based pharma major Bharat Biotech’s submission seeking emergency use listing (EUL) of its COVID-19 vaccine — Covaxin will be made in October, said the World Health Organisation (WHO). The WHO’s statement came a day after reports of the EUL to be further delayed surfaced. At present, 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.

On Tuesday, the pharma company said that it is diligently working with the WHO to obtain EUL at the earliest. Earlier this month, the company tweeted, “#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.”

(With PTI inputs)



source https://www.india.com/news/india/decision-on-bharat-biotechs-covaxin-emergency-use-nod-to-be-made-in-october-who-4995592/

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