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WHO Approves Bharat Biotech's Covaxin COVID Vaccine For Emergency Use

In a big development, the Technical Advisory Group (TAG) on Wednesday recommended Emergency Use Listing (EUL) status for Bharat Biotech COVID-19 vaccine Covaxin

Covaxin

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In a big development, the Technical Advisory Group (TAG) on Wednesday recommended Emergency Use Listing (EUL) status for Bharat Biotech COVID-19 vaccine Covaxin to the World Health Organisation (WHO). The WHO has subsequently approved Covaxin for emergency use.

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 Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin," a source told PTI.

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.

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. 

Dr Poonam Khetarpal Singh, Regional Director, WHO South East Asia, congratulated India for Emergency Use Listing of its indigenously produced COVID-19 vaccine COVAXIN

Why WHO's approval is important for Covaxin

The WHO's approval for Covaxin would facilitate international travel for those inoculated with it to countries where a vaccination certificate for WHO-approved vaccines is mandatory. It also opens avenues for Bharat Biotech to export Covaxin

Covaxin's overall efficacy at 77.8%

Developed by Bharat Biotech in collaboration with ICMR and the National Institute of Virology, Covaxin is a Whole Virion Inactivated Coronavirus vaccine. In the phase 3 trials, which included over 25,000 participants between 19-98 age group, the vaccine showed overall 77.8% efficacy and 93.4% efficacy against severe coronavirus disease as per final results. Moreover, it has proven to neutralise COVID-19 variants such as B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta) and B.1.617 (Kappa).

Meanwhile, recently, India's Subject Expert Committee (SEC) approved Covaxin for children aged 2-18 years of age. The trials are taking place on more than 500 subjects at various sites including AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur with two doses administered in an interval of 28 days. Sources had stated that SEC found COVID trial results compatible with safety protocols.

(With PTI inputs)

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