WHO seeks 'additional clarifications' from Bharat Biotech for Covaxin to conduct final 'risk-benefit assessment'
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 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.
''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.
The Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
Last week, the WHO had said it is expecting one additional piece of information from Bharat Biotech regarding Covaxin and emphasised that it has to thoroughly evaluate to ensure vaccines are safe and "cannot cut corners" before recommending a vaccine for emergency use.
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