United Nations/Geneva: The World Health Organisation’s technical advisory group 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 technical advisory group will now meet on November 3 for a final assessment.
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).
The technical advisory group met on Tuesday to review data on Covaxin for the emergency use listing of India”s indigenously-made 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.
Update: The @WHO independent TAG met today & asked for addnl clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data received soon
Update: The @WHO independent TAG met today & asked for addnl clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data received soon
— Soumya Swaminathan (@doctorsoumya) October 26, 2021
“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.
Earlier Tuesday, WHO spokesperson Dr Margaret Harris had said that on COVAXIN, the technical advisory group that reviews all the data for a potential emergency use listing was reviewing that data.
“Now if all is in place, and all goes well, and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so,” she had said during a press briefing.
