Hyderabad: The World Health Organization (WHO) tweeted on Tuesday that WHO and an independent group of experts will meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing (EUL) to Covaxin.
Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis and submitted additional information at WHO’s request on 27 September.
“WHO experts are currently reviewing this information and if it addresses all questions raised, WHO assessment will be finalised next week,” WHO said.
The Emergency Use Listing process, done by WHO and the Technical Advisory Group of independent experts, is centred on determining if a manufactured product (a vaccine) is quality-assured, safe and effective.
The EUL is a risk-based procedure that considers each unlicensed vaccine for assessment and listing. The process also includes therapeutics and in-vitro diagnostics to expedite vaccine availability to people affected by a certain public health emergency.
Bharat Biotech is the only company to develop a vaccine indigenously in India and manufacture it on a large scale.
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