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healthcare | IST

Covaxin EUL approval: WHO holds emergency use recommendation, says can’t cut corners

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WHO has said it must evaluate coronavirus vaccine Covaxin thoroughly to make sure it is safe and effective before it is included in the COVID-19 emergency use listing.

As people await a nod for Bharat Biotech’s coronavirus vaccine Covaxin to be included in the COVID-19 emergency use listing (EUL), the World Health Organization (WHO) on Monday held the recommendation and said it first needs to evaluate the jab thoroughly to ensure its safety and effectiveness.
“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 said.
In a series of tweets, WHO said that Covaxin manufacturer Bharat Biotech has been submitting data on a rolling basis and experts have reviewed it. WHO is expecting one additional piece of information from the company today, it said.
Commenting on when Covaxin may get approval, WHO said, the timeframe for the EUL procedure is dependent on how quickly a company producing the vaccine is able to provide the data required 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 tweeted.
WHO’s comment on the developments comes a day after its chief scientist Soumya Swaminathan said the technical advisory group is scheduled to meet on October 26 to consider EUL for Covaxin.
She said WHO has been working closely with Bharat Biotech to complete the dossier and the goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere.
The indigenously developed Bharat Biotech's Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator and is being used in the nationwide anti-COVID-19 inoculation programme along with Covishield and Sputnik V.