The Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation (WHO), has recommended Emergency Use Listing (EUL) status for Bharat Biotech's COVID-19 vaccine, Covaxin. "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," the World Health Organisation said in a tweet.
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. Covaxin has demonstrated 77.8% effectiveness against symptomatic COVID-19 and 65.2% protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
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) November 3, 2021
However, the WHO said more data is needed to assess vaccine safety in pregnant women. "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 WHO said.
Hyderabad-based Bharat Biotech had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for the vaccine's Emergency Use Listing (EUL). The WHO has so far approved COVID-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.
Bharat Biotech on Wednesday also issued a statement saying that Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of its COVID-19 vaccine, Covaxin, to up to 12 months from the date of manufacture. This move will help hospitals, especially private hospitals, use up their stock of the vaccine.
"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," Bharat Biotech said in a tweet.
The shelf life extension has been communicated to "our stakeholders," it added.