eul: Cannot cut corners, need to thoroughly evaluate product before recommending emergency use: WHO on Covaxin | India News – Times of India

HYDERABAD: “We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the Covid-19 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,” WHO tweeted on Monday evening.

The WHO said while Covaxin’s manufacturer Bharat Biotech has been submitting data on a rolling basis and its experts have reviewed these data, it is “expecting one additional piece of information from the company today”.
However, neither WHO nor Bharat Biotech pecified what information has been sought.
The WHO had on October 5, after a meeting of its Strategic Advisory Group of Experts (SAGE) on Covaxin’s EUL application, stated that it, along with an independent group of experts, was “scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant EUL to Covaxin” after the company had submitted additional information 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,” WHO had tweeted on October 5.
However, on Monday, WHO said: “The timeframe for the WHO EUL 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.”
“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,” WHO added.
Late on Sunday night, WHO’s chief scientist Soumya Swaminathan had said that WHO’s TAG would be meeting on October 26 to consider EUL for Covaxin.
“WHO has been working closely with Bharat Biotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use to expand access to populations everywhere,” Swaminathan had said in her tweet.

India Today

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