WHO Approves Bharat Biotech's Covaxin For Emergency Use Listing

WHO's technical advisory group had sought "additional clarifications" from the company for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.

New Delhi: The World Health Organization (WHO) on Wednesday granted Emergency Use Listing (EUL) to Bharat Biotech's Covid-19 vaccine Covaxin soon after the Technical Advisory Group (TAG) recommended the India-made vaccine for emergency use listing for 18 years and above.

The development comes as a massive boost to India's vaccination drive against Coronavirus.

"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," WHO said in a tweet. 

The emergency listing of Covaxin got delayed by a month as the TAG sought some additional information from vaccines manufacturers for final risk assessment.

According to reports, an independent advisory committee of the WHO recommended Emergency Use Listing for the Indian vaccine almost a month after it sought "additional clarifications" from the company for Covaxin to conduct a final "risk-benefit assessment".

So far, Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.

In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Reacting to WHO's approval, Dr Poonam Khetarpal Singh, Regional Director, WHO South East Asia said, "Congratulations India for Emergency Use Listing of its indigenously produced COVID-19 vaccine COVAXIN."

A source close to news agency IANS said that Prime Minister Narendra Modi had pushed for Covaxin approval at G20 meet with WHO Director-General Dr Tedros Adhanom Ghebreyesus.

Co-developed by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research (ICMR), Covaxin was granted emergency authorisation in the country in January.

So far, WHO has approved several vaccines against Coronavirus including Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson 7 Johnson - Janssen, Moderna, and Sinopharm.