WHO to take final decision next week on approval to Bharat Biotech’s 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, it said in another tweet.

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The World Health Organization said on Tuesday that it will make a decision on granting emergency use listing (EUL) to Bharat Biotech‘s Covid-19 vaccine next week.

WHO and an independent group of experts are scheduled to meet next week to carry out the risk, benefit assessment and come to a final decision whether to grant EUL to Covaxin,” the global health body tweeted, after the Hyderabad-based company made a presentation of the safety and efficacy data on its vaccine to the strategic advisory group of experts on immunization (SAGE), an expert body that advises the WHO.

The WHO said Bharat Biotech has been submitting data to it on a rolling basis and provided additional information at its request on September 27.

“WHO experts are currently reviewing this information and if it addresses all questions raised, WHO assessment will be finalised next week,” it said. In a meeting held on Tuesday, the company made a presentation of clinical data from Covaxin’s phase 1, 2, 3 and post-marketing studies on safety, immunogenicity, efficacy and effectiveness to the SAGE.

“The company has shared about the wide acceptability of the vaccine. It also informed the experts that the vaccine has been approved in 14 countries and over 70 million doses have been sent to overseas markets,” a person in the know told ET.

The details of ongoing and planned studies on safety and effectiveness have also been submitted to the expert body, the person said.

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