WHO decision on Covaxin approval next week
Drug Approval

WHO decision on Covaxin approval next week

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

  • By IPP Bureau | October 06, 2021

The World Health Organization’s (WHO's) Technical Advisory Group (TAG) is expected to convene next week to carry out a risk-benefit assessment and come to a final decision on whether to grant emergency-use listing (EUL) to Bharat Biotech’s Covaxin.

The World Health Organisation (WHO), is expected to decide on granting Emergency Use Listing to Bharat Biotech’s Covaxin, tweeted WHO.

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.

WHO experts are currently reviewing this info & if it addresses all questions raised, the WHO assessment will be finalized next week.  WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision on whether to grant Emergency Use Listing to Covaxin. 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 tasked to issue evidence-based policy recommendations for the best use of vaccines against Covid-19, said WHO.

“SAGE is holding its regular meeting (October 4-8), during which it will examine the latest evidence in preparation of policy recommendations for the best use of Covaxin, to be issued once the EUL process has been completed,” said WHO.

 

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