The Technical Advisory Group (TAG) on October 26 had sought 'additional clarifications' from the company for Covaxin to conduct a final 'risk-benefit assessment' for Emergency Use Listing of the vaccine.
World Health Organisation's (WHO) independent advisory committee Technical Advisory Group (TAG) on Wednesday has recommended Emergency Use Listing (EUL) status for Bharat Biotech COVID-19 vaccine Covaxin, accoeding to the sources in the know of the development.
The WHO is in the process of evaluating Covaxin's clinical trial data for use of EUL.
"WHO has granted emergency use listing (EUL) to #COVAXIN (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19," the global health body said in a tweet.
Dr Poonam Khetarpal Singh, Regional Director of WHO South East Asia, in a tweet, said, "Congratulations India for Emergency Use Listing of its indigenously produced COVID-19 vaccine Covaxin."
The TAG on October 26 had sought "additional clarifications" from the company for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
The 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.
Prime Minister Narendra Modi met WHO Director General Dr Tedros Adhanom Ghebreyesus at the G20 summit recently.
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.
Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.
(With PTI Inputs)