Ending a long wait, the World Health Organization (WHO) on November 3 approved Covaxin, the Covid-19 vaccine developed and manufactured by Indian pharmaceutical company Bharat Biotech. The world health body granted the Emergency Use Listing status to Covaxin after the Technical Advisory Group of WHO recommended the same earlier today.
🆕 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) November 3, 2021
In a tweet thread, WHO said the Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation (WHO), has recommended Emergency Use Listing (EUL) status for Covaxin, the Covid-19 vaccine manufactured by India’s Bharat Biotech. It further added, “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 Earth globe Europe-Africa.”
#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) November 3, 2021
WHO further added that its Strategic Advisory Group of Experts on Immunization (SAGE) also reviewed the vaccine and recommended the use of this vaccine in two doses, with a dosing interval of four weeks, in all age groups 18 and above.
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) November 3, 2021
While talking about the vaccine for pregnant women, WHO said, “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.”
The Technical Advisory Group had met on October 26 and sought additional details from Bharat Biotech. They decided to approve the vaccine after receiving the additional details from the company.
WHO had been delaying approval for Covaxin citing the requirement of additional information several times in the past few months. Dr Mariangela Simao, Assistant Director-General, Access to Medicines and Health Products at WHO, had earlier said, “Bharat Biotech has been submitting data regularly and very quickly, but they submitted the last batch of data on the 18th of October.”
What is TAG-EUL?
The TAG-EUL is an independent advisory group that recommends to WHO if a COVID-19 vaccine can be listed for emergency use under the procedure recommended by EUL. Data suggests Covaxin has shown 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.
Covaxin and Covishield by AstraZeneca are the most widely used Covid-19 vaccines in India. On Wednesday Central Drugs Standard Control Organisation (CDSCO) also approved the extention of the shelf life of the vaccine up to 12 months.
In a tweet, Bharat Biotech said, “The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO.”