Covaxin has not yet been approved, and the WHO is seeking additional clarifications

The World Health Organization (WHO) requested “additional clarifications” from Bharat Biotech on Tuesday for its COVID-19 vaccine Covaxin in order to conduct a final “risk-benefit assessment” for the vaccine’s Emergency Use Listing.

“The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are required to conduct a final EUL risk-benefit assessment for global use of the vaccine,” the WHO said in an email response to a question from PTI about the decision regarding Covaxin’s Emergency Use Listing.”

“The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” it added.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.

Covaxin will not be considered an accepted vaccine by most countries without the Emergency Use Approval, making international travel difficult for Indians.

Submissions for pre-qualification or listing under the emergency use procedure are confidential, according to the WHO. If a product submitted for evaluation is found to meet the criteria for listing, the WHO will widely publicise the results. According to the WHO, the duration of the emergency use listing process is determined by the quality of the data submitted by the vaccine manufacturer and whether the data meets the WHO’s criteria.

Covaxin, developed in India by Bharat Biotech, is one of six vaccines that have received emergency use authorization from India’s Drug Regulator and is being used in the nationwide anti-COVID-19 inoculation programme alongside Covishield and Sputnik V. Bharat Biotech recently stated that it has submitted all Covaxin data to the WHO for EUL and is awaiting feedback from the global health watchdog.

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