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Friday, October 22, 2021

Decision On WHO Emergency Approval For Covaxin Postponed To Next Week

It was earlier expected that the WHO would take a call on Covaxin during its meeting on Tuesday.

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New Delhi: The World Health Organization (WHO) will take the long-awaited decision on the submission of Hyderabad-based vaccine manufacturer Bharat Biotech requesting an Emergency Use List (EUL) for its Covid-19 vaccine Covaxin the next week.

“WHO and a group of independent experts are to meet next week to conduct the risk/benefit assessment and make the final decision whether or not to grant the emergency use list to Covaxin,” said WHO in a tweet.

The WHO was earlier expected to call on Covaxin at its meeting on Tuesday.

The world health body also said Bharat Biotech had submitted data to the WHO on an ongoing basis and submitted additional information earlier on September 27.

“The manufacturer of Covaxin, Bharat Biotech, has submitted data to the WHO on an ongoing basis and submitted additional information at the request of the WHO on September 27. WHO experts are currently reviewing this information and if it answers all the questions raised, the WHO assessment will be finalized next week, ”the WHO said on the microblogging platform.

WHO said the emergency use list focuses on determining the quality, safety, and efficacy of a manufactured product.

“The emergency use listing process – carried out by the WHO and the independent expert technical advisory group – focuses on determining whether a manufactured product (eg a vaccine) is of guaranteed quality, safe and effective.” the world health body said in a series of tweets.

The WHO has so far approved the Covid-19 vaccines manufactured by the US pharmaceutical majors Johnson & Johnson, Pfizer-BioNTech, Moderna and the Chinese Sinopharm and Oxford-AstraZeneca for emergency use.

Earlier in September, Bharat Biotech said it had submitted all data relating to Covaxin to the WHO and was awaiting its comments.

Data from the # COVAXIN® clinical trial were fully compiled and available in June 2021. All data was submitted for an Emergency Use List (EUL) request to the World Health Organization in early July. The Hyderabad-based vaccine maker tweeted.

“We have responded to all clarifications requested by #WHO and are awaiting further comments. As a responsible manufacturer with past approvals for our other #vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines, ”Bharat Biotech said in a series of tweets.


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