WHO to take call on Covaxin's EUL on October 26th
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WHO to take call on Covaxin's EUL on October 26th

The WHO chief scientist Soumya Swaminathan tweeted on Oct. 17

  • By IPP Bureau | October 18, 2021

The technical advisory group of the World Health Organisation (WHO), is scheduled to meet on October 26th to consider Emergency Use Listing (EUL), for Bharat Biotech’s Covaxin. WHO’s chief scientist Soumya Swaminathan tweeted on Sunday.

“WHO has been working closely with Bharat Biotech to complete the dossier,” she tweeted.

“The technical advisory group will meet on Oct 26th to consider EUL for Covaxin,” she tweeted.

Bharat Biotech has been submitting data to the WHO on a rolling basis and submitted additional information at WHO’s request on September 27th 2021.

The Emergency Use Listing process - done by WHO and the Technical Advisory Group of independent experts - is centred on determining if a manufactured product (e.g. a vaccine) is quality-assured, safe and effective.

The WHO Strategic Advisory Group of Experts on Immunization (SAGE) is centred on issuing evidence-based policy recommendations for the best use of vaccines against Covid-19, said WHO.

“SAGE held its regular meeting from October 4th to 8th  during which it examined the latest evidence in preparation of policy recommendations for the best use of Covaxin, to be issued once the EUL process has been completed,” WHO had stated.

In a meeting held on October 5, the company made a presentation of all the clinical data from the vaccine’s phase 1, 2, 3 and post-marketing studies on safety, immunogenicity, efficacy and effectiveness to the SAGE.

 

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