Vial of Covaxin (File image)
The technical advisory group of experts will meet on October 26 to consider Emergency Use Listing for Bharat Biotech’s Covaxin, said WHO’s chief scientist Dr Soumya Swaminathan on October 17.
“Our goal is to have a broad portfolio of vaccines approved for emergency use to expand access to populations everywhere,” she added.
The EUL process conducted by WHO and the Technical Advisory Group of independent experts is centred on determining if a manufactured product (COVID vaccine in this case) is quality-assured, safe and effective.
Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine.
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 to expand access to populations everywhere https://t.co/lqQIyqItF9
— Soumya Swaminathan (@doctorsoumya) October 17, 2021
Earlier this month WHO tweeted, “Bharat Biotech, has been submitting data on a rolling basis and submitted additional info at WHO’s request on September 27.”
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.
Meanwhile, Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for emergency use authorisation in children and adolescents in the two to 18 years age group.
If approved by the drugs regulator, it will be the second COVID-19 vaccine after Zydus Cadila’s needle-free ZyCoV-D to receive EUA for use in those below 18 years.