WHO to take finalise decision on Covaxin next week, examining 'additional information'
By Team Newsable | First Published Oct 6, 2021, 9:43 AM ISTWHO stated in a tweet, "WHO and an independent panel of experts are set to meet next week to conduct out the risk/benefit evaluation and make a final decision on whether to award Covaxin Emergency Use Listing."
The World Health Organization said on Tuesday that a decision on the Emergency Use Listing (EUL) of Covaxin, India's home-grown coronavirus vaccine, will be made next week when the health watchdog and an independent committee of specialists meet to examine the risks and advantages of the vaccine. WHO stated in a tweet, "WHO and an independent panel of experts are set to meet next week to conduct out the risk/benefit evaluation and make a final decision on whether to award Covaxin Emergency Use Listing."
Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional info at WHO’s request on 27 September.
WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalized next week https://t.co/s2vadrdePS
The decision might significantly impact how other nations handle patients who have been vaccinated with Covaxin. Experts from WHO and a panel of independent experts review data and are expected to do a risk-benefit analysis before reaching a judgment.
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WHO also stated that on September 27, Hyderabad-based Bharat Biotech, which created Covaxin, filed more material on its request, which is now being examined. "WHO specialists are presently examining this information, and if it answers all of the issues raised, the WHO evaluation will be completed next week," it added.
Experts will look at presenting clinical data on Covaxin from phase 1, 2, 3, and postmarketing trials on safety, immunogenicity, efficacy, and effectiveness as part of the analysis.
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According to sources, the Strategic Advisory Group of Experts (SAGE) has presented its recommendations to WHO on Covaxin. According to reports, none of the SAGE members objected, and the expert panel reached a complete agreement on around 20 factors. Bharat Biotech said on July 12 that it had submitted the essential papers to WHO to initiate the EUL process. In India, at least 105, 984,630 doses of Covaxin have been administered. On July 6, 2021, the WHO launched a continuous assessment of Covaxin. Covishield received EUL in February of this year, making Covaxin suitable for usage in low and middle income countries through the COVAX facility.
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