Updated November 3rd, 2021 at 18:13 IST
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
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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.
🆕 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 #COVID19. pic.twitter.com/dp2A1knGtT
— World Health Organization (WHO) (@WHO)
The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the #Covaxin vaccine meets WHO standards for protection against #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used 🌍.
— World Health Organization (WHO) (@WHO)
#Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. #COVID19
— World Health Organization (WHO) (@WHO)
Available data on vaccination of pregnant women with the #Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry. #COVID19
— World Health Organization (WHO) (@WHO)
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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Published November 3rd, 2021 at 17:27 IST