WHO approves Bharat Biotech's Covaxin for emergency use against Covid-19
03 Nov 2021
In a big boost to India’s fight against the Wuhan virus (Covid-19), the World Health Organisation (WHO) on Wednesday granted Emergency Use Listing (EUL) to Bharat Biotech's SARS-CoV 2 vaccine Covaxin after its Technical Advisory Group (TAG) recommended that the India-made vaccine is eligible for emergency use listing for 18 years and above.
"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 on Wednesday, 3 November.
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 COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used, the WHO said on Wednesday.
With validation from WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin. UNICEF, Pan-American Health Organisation (PAHO), GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide."
ICMR Director General Balram Bhargava said that with this development, "the whole world opens up for us."
"With this, the whole world opens up for us, for sending this vaccine. Now that we have administered a large number of vaccine doses, we will be able to send this absolutely indigenous vaccine to the rest of the world."
Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above, it added.
Reacting to the development, Covaxin maker Bharat Biotech said the Emergency Use Listing approval by WHO "validates the international safety and quality standards of Covaxin".
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".
Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant.
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."
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.
Several countries, including Australia, Nepal, Iran, Oman, Mauritius, Philippines, Sri Lanka, Greece, Mexico, Zimbabwe, have already approved Covaxin for international travel,
Covaxin now joins the list of WHO-approved vaccines against Coronavirus, including Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson - Janssen, Moderna, and Sinopharm.