Bharat Biotech's Covaxin gets go-ahead from WHO team for emergency use listing

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 COVID-19 vaccine Covaxin.

The WHO tweeted:

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

This comes after Prime Minister Narendra Modi had pushed for Covaxin approval at G20 with WHO director-general Dr Tedros Adhanom Ghebreyesus, sources told News18.

Also read: Covaxin recommended by expert panel for kids: All you need to know about children's COVID-19 shot

The TAG on 26 October 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.

Covaxin has demonstrated 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 percent 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.

This comes on the same day that Covaxin was granted an extension of shelf life for up to 12 months from the date of manufacture, as per a statement from Bharat Biotech. The approval of extension of shelf life by the Central Drugs Standard Control Organisation (CDSCO) was based on the "additional stability data", Bharat Biotech said in a tweet.

The shelf life extension has been communicated to "our stakeholders," it added. The development comes after several Indians complained of travel difficulties due to Covaxin not being recognised for international travel by several countries.

Recently at the G-20 Summit in Rome, Prime Minister Narendra Modi said India will be able to produce over 5 billion vaccine doses next year to help the world in the fight against the pandemic. Earlier this year, Bharat Biotech had written to the Drugs Controller General of India (DCGI) seeking extension of the shelf life of the indigenously developed vaccine from six to 24 months.

Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.