Covaxin: WHO to consider emergency listing at today’s meeting

The World Health Organization (WHO) will meet on Tuesday to consider granting Covaxin, India’s indigenous coronavirus vaccine, emergency use approval (Covid-19). According to WHO chief scientist Soumya Swaminathan, the global health organization’s technical advisory group will meet on October 26 to discuss the emergency use listing (EUL) for Covaxin, which is already being used nationwide in the pandemic inoculation campaign.

The World Health Oragnisation(WHO) will meet today to consider giving the emergency use approval to Covaxin. According to WHO chief scientist Soumya Swaminathan, the technical advisory group will meet on to grant emergency use listing(EUL) for Covaxin.

The global health agency also emphasized that it must evaluate a vaccine thoroughly to make sure it is “safe and effective”.

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine’s Emergency Use Listing (EUL).

In a series of tweets, WHO said, “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.”

It also said that Bharat Biotech 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.

“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 EUL to the vaccine,” 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 EUL to the vaccine,” it said.

WHO said the timeframe for its 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 suitability for low- and middle-income countries.

Covaxin is one of the two anti-COVID vaccines used by India in its vaccination drive across the country.

Earlier this month, WHO had said in a tweet that Bharat Biotech “has been submitting data to WHO on a rolling basis & submitted additional info,..on 27 September. WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalized next week.”

Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.

According to WHO, submissions for pre-qualification or listing under the EUL procedure are confidential and if a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely.

 

 

Medically Speaking

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