WHO to decide on Covaxin's approval request in October

The World Health Organisation has informed that the decision on Bharat Biotech's submission seeking emergency use listing (EUL) for its Covid-19 vaccine Covaxin will be made in October. The vaccine manufacturer had submitted its Expression of Interest(EoI) on April 19. However, the status of assessment of Covaxin is "ongoing".

As per the 'Status of COVID-19 vaccines within WHO EUL/PQ evaluation process' document on the WHO website, dated September 29, the decision date for Covaxin is October 2021. The WHO began rolling data of the vaccine on July 6. It enables the WHO to start the review process immediately as data continues to arrive, thereby accelerating the review process.

The submissions made to the WHO for prequalification or emergency use listing procedures are confidential. But, if approved, the WHO will publish the results. The duration of the listing process depends on the quality of the data submitted by the vaccine manufacturer and if those data meet WHO criteria.

Regarding the submissions made for approval, Bharat Biotech had 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."

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