No nod for Covaxin yet, WHO seeks additional clarifications

New Delhi, Oct 26: The World Health Organization (WHO) on Tuesday sought "additional clarifications" from Bharat Biotech for its COVID-19 vaccine Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.

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

"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.

Without the Emergency Use Approval, Covaxin will not be considered an accepted vaccine by most countries around the world, making it difficult for Indians to travel internationally.

According to the WHO, submissions for pre-qualification or listing under the emergency use procedure are confidential. If a product submitted for assessment is found to meet the criteria for listing, the WHO will publish the results widely. Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on the data meeting the WHO's criteria, according to the agency.

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. Bharat Biotech recently said it submitted all data pertaining to Covaxin to the WHO for EUL and is awaiting feedback from the global health watchdog.

with PTI inputs