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Final Decision On Approval To Bharat Biotech's Covaxin To Be Taken Next Week: WHO
Bharat Biotech’s COVAXIN, India’s first indigenous vaccine against coronavirus.
The World Health Organisation (WHO) on Tuesday (5 October) said that it will take a decision on granting Emergency Use Listing (EUL) to Bharat Biotech's Covaxin 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 Emergency Use Listing to Covaxin," the global health body said in a tweet.
The WHO added that Bharat Biotech has been submitting data to it on a rolling basis and provided additional information at its request on 27 September.
"WHO experts are currently reviewing this info and if it addresses all questions raised, WHO assessment will be finalised next week," the global health body said.
It further added that 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".
Hyderabad-based Bharat Biotech had recently 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, reports Economic Times.
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