WHO’s technical advisory group to assess safety, quality of Covaxin for EUL on October 26

The WHO’s EUL process is aimed at determining quality-assurance, safety and effectiveness of a manufactured product like Bharat Biotech's Covid Vaccine Covaxin in this case.

By:Updated: Oct 18, 2021 12:45 PM
WHO, EUL, Bharat Biotech, Covaxin, Dr Soumya Swaminathan, DCGI, EUAAccording to the WHO, submissions to WHO for prequalification or listing under the EUA procedure are confidential. If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely.

To consider Emergency Use Listing (EUL) for Bharat Biotech’s Covid Vaccine Covaxin, the World Health Organisation (WHO) technical advisory group will meet on October 26, stated WHO’s chief scientist Dr Soumya Swaminathan recently.

The WHO’s EUL process is aimed at determining quality-assurance, safety and effectiveness of a manufactured product like Bharat Biotech’s Covid Vaccine Covaxin in this case.

“Our goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere,” Dr Soumya Swaminathan stated.

Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for emergency use authorisation (EUA) in children and adolescents in the two to 18 years age group.

WHO had this month 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 EUA procedure are confidential. If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely.

 

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