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WHO To Decide On Approval For Covaxin Next Week After Risk/benefit Analysis

WHO and an independent committee of specialists will meet next week to do a risk/benefit analysis and make a final decision on approval for Covaxin vaccine

WHO

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The World Health Organization (WHO) and an independent committee of specialists will meet next week to do a risk/benefit analysis and make a final decision on whether to issue Covaxin the Emergency Use Listing, according to ANI. The caption of the tweet read, "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 whether to grant EUL to Covaxin: World Health Organization."

In a second tweet, ANI stated that, according to WHO, Covaxin maker Bharat Biotech has been supplying data to WHO on a rolling basis and supplied further information at WHO's request on September 27. This information is currently being reviewed by WHO experts, and if it resolves all of the concerns, the WHO evaluation will be completed next week.

In the third consecutive tweet, ANI stated, referencing WHO that the Technical Advisory Group of independent experts and WHO use the Emergency Use Listing process to determine whether a manufactured product (such as a vaccination) is quality-assured, safe, and effective: WHO is the United Nations' World Health Organization.

In clinical trials, Covaxin, which has been developed by Bharat Biotech in collaboration with the National Institute of Virology and the ICMR, showed a roughly 78% efficacy. While the Indian government approved it for emergency use in January of this year, it has yet to receive WHO approval for emergency usage. Pfizer-BioNTech jab, Astrazeneca vaccine developed by SK Bio and Serum Institute of India (SII), AstraZeneca EU, Janssen, Moderna, and Sinopharm are the six Covid-19 vaccines that have received emergency use authorization from the WHO.

Following allegations of a delay, Bharat Biotech issued an official statement last week clarifying that it is working with the WHO to obtain an emergency use authorisation (EUA) for Covaxin. The EUA for Covaxin, if approved, would allow recipients to travel overseas without being subjected to mandatory quarantine.

Image: PTI/Shutterstock

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