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.

New Delhi: The World Health Organisation (WHO) will take the much-anticipated decision on Hyderabad-based vaccine manufacturer Bharat Biotech’s submission seeking Emergency Use Listing (EUL) for its Covid-19 vaccine Covaxin next week.

“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 Emergency Use Listing to Covaxin,” the WHO said in a tweet.

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

The global health body also said that Bharat Biotech has been submitting data to the WHO on a rolling basis and submitted additional information earlier on September 27.

“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,” the WHO said on the micro-blogging platform.

The WHO said the Emergency Use Listing is centred on determining if a manufactured product is quality-assured, safe and effective.

“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,” the global health body said in a series of tweets.

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

Earlier in September, Bharat Biotech had said it has submitted all the data pertaining to Covaxin to the WHO and is awaiting its feedback.

#COVAXIN® clinical trial data was fully Compiled  & available in June 2021. All Data submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July,” the Hyderabad-based vaccine manufacturer tweeted.

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