Decision on EUL of COVAXIN in October, says WHO
A decision on Bharat Biotech's submission seeking emergency use listing (EUL) for its COVID-19 vaccine COVAXIN will be made in October, the World Health Organization has said. The latest status of COVID-19 vaccines within the 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.
WHO began rolling data of COVAXIN on July 6
The status of the assessment for COVAXIN is ongoing. Notably, Bharat Biotech had submitted EOI (Expression of Interest) on April 19 this year for its COVID-19 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.
WHO publishes results widely if product meets criteria for listing
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 EUL process depends on quality of data submitted
The duration of the EUL process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency. Notably, Bharat Biotech's COVAXIN and AstraZeneca and Oxford University's Covishield, which is manufactured by the Pune-based Serum Institute of India (SII) are the two most widely used COVID-19 vaccines in India.
We are awaiting feedback from WHO: Bharat Biotech
Bharat Biotech recently said it submitted all data pertaining to COVAXIN to the WHO for EUL. It had tweeted earlier this month, "#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."
Here is what the tweet said
#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. (1/3) pic.twitter.com/r4CnROpUfP
— BharatBiotech (@BharatBiotech) September 17, 2021
Trial data of COVAXIN looks promising: Dr. Paul
Notably, the company had said on Tuesday, "We are diligently working with the WHO to obtain EUL at the earliest." Meanwhile, NITI Aayog member Dr. VK Paul had earlier said that the trial data of India's indigenous COVID-19 vaccine COVAXIN looked promising. Earlier this month, Bharat Biotech had also said that they were expecting to get WHO's approval by September end.
COVAXIN is 77.8% effective against COVID-19: Bharat Biotech
Notably, releasing the Phase III trial data of COVAXIN in July this year, Bharat Biotech had said that the vaccine is 77.8% against "mild, moderate and severe COVID-19 disease." The company also said that the jab provides 65% protection from the highly infectious Delta variant.
