Highlights

  • WHO experts group has sought additional clarifications on Covaxin
  • WHO experts will meet for final assessment on November 3
  • Bharat Biotech had applied for Covaxin approval on April 19

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The technical advisory group will now meet on November 3 for a final assessment of Covaxin

Nod to Covaxin delayed further as WHO has more questions for Bharat Biotech

India made Covid vaccine Covaxin's wait for the WHO nod just got longer.

The World Health Organisation's technical advisory group on Tuesday sought "additional clarifications" from Covaxin maker Bharat Biotech to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.

Also watch: 'Cannot cut corners': WHO on approving India's Covaxin shot

The technical advisory group will now meet on November 3 for a final assessment.

Hyderabad-based Bharat Biotech had submitted Expression of Interest to the WHO on April 19 for the vaccine's Emergency Use Listing.

"The TAG met on October 26 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 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.

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