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WHO to decide on Covaxin clearance in October

The World Health Organisation (WHO) has recently stated that a decision regarding the approval of the emergency use listing (EUL) of Bharat Biotech’s COVID vaccine, Covaxin, will be issued in October. This is in regard to the submission made by Bharat Biotech recently, seeking the approval for EUL of Covaxin.

Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine shot, Covaxin. WHO has said that the status of assessment of the vaccine is “ongoing.” This statement was made by the WHO yesterday, September 29.

WHO uploaded a guidance document on its website yesterday titled ‘Status of COVID-19 vaccines within WHO EUL/PQ evaluation process’ which stated that the decision date for Bharat Biotech’s Covaxin is “October 2021”. Earlier, WHO had said it began rolling data of the vaccine on July 6.

Earlier this month, Bharat Biotech had tweeted, “COVAXIN clinical trial data was fully compiled & available in June 2021. All Data was 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.”

WHO had informed earlier that the submissions of products for prequalification or listing under the emergency use procedure are confidential. WHO publishes the result of the clearance of a product widely once a product submitted for assessment is found to meet the criteria for the listing.

According to WHO, the duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting organization’s criteria. Bharat Biotech has recently stated that it has submitted all the data regarding the EUL of Covaxin by WHO.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India. Bharat Biotech also stated earlier, “We are diligently working with the WHO to obtain EUL at the earliest.” DNA India

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