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Expecting 'one' additional information on Covaxin, decision on emergency use listing after complete assessment: WHO

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Geneva | October 18, 2021 8:17:21 PM IST
World Health Organisation (WHO), which is reviewing the data provided by Bharat Biotech for Emergency Use Listing of COVID-19 vaccine Covaxin, said on Monday that it is "expecting one additional piece of information from the company today".

The WHO, which made a series of tweets, said a vaccine recommended by it for emergency use must be evaluated thoroughly.

"Bharat Biotech - the manufacturer of Covaxin - has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data. WHO is expecting one additional piece of information from the company today," it said.

"We are aware that many people are waiting for WHO's recommendation for Covaxin to be included in the COVID19 Emergency Use Listing, but we cannot cut corners - before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective," it added.

WHO chief scientist Dr Soumya Swaminathan had said on Sunday that WHO's technical advisory group will meet on October 26 to consider emergency use listing (EUL) for Covaxin.

"The technical advisory group will meet on Oct 26th to consider EUL for Covaxin. WHO has been working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere," Dr Swaminathan had said in a tweet.

The WHO today said on Monday that the timeframe for the WHO Emergency Use Listing procedure depends on how quickly a company producing the vaccine is able to provide the required data.

"The timeframe for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine's quality, safety, efficacy and its suitability for low- and middle-income countries," it said.

"When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine," it added.

Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional information at WHO's request on September 27.

Covaxin, India's first indigenous COVID-19 vaccine, has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). (ANI)

 
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