WHO's decision on Bharat Biotech's Covaxin likely today
2 min read 03 Nov 2021, 07:32 AM ISTBharat Biotech had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine's Emergency Use ListingThe company has been submitting data on the EUL of Covaxin regularly and very quickly to a technical committee
PremiumThe World Health Organization (WHO), which has sought additional clarifications from Covid-19 vaccine manufacturer Bharat Biotech, will be meeting today, that is November 3, to conduct a final Emergency Use Listing (EUL) risk-benefit assessment for global use of the company's Covaxin vaccine.
The Technical Advisory Group (TAG) of the WHO met on October 26, 2021, and decided to seek additional clarifications from the Covaxin manufacturers that are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine.
TAG is an independent advisory group that provides recommendations to WHO on whether a Covid19 vaccine can be listed for emergency use under the EUL procedure.
Which countries have approved Covaxin so far?
On November 1, Australia recognised Bharat Biotech's Covaxin. This recognition is for travellers aged 12 and over who have been vaccinated with Covaxin. Besides, countries like Nepal, Sri Lanka, Zimbabwe, Oman, Mauritius, the Philippines, Estonia, Greece, and Iran are the countries that have recognised Covaxin.
Why WHO's approval is important for Bharat Biotech?
The WHO's approval, if granted, will hold importance for citizens vaccinated with Covaxin as it would facilitate international travel. Until now, the delay has impacted students and businessmen who want to travel to countries where a vaccination certificate for WHO-approved vaccines is mandatory.
WHO has recognised only Pfizer-BioNTech, AstraZeneca, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.
What is the Emergency Use Listing (EUL)
The WHO EUL is a procedure for assessing unlicensed vaccines, therapeutics, and in vitro diagnostics during public health emergencies with the ultimate goal of expediting the availability of these products to people who need them.
How soon can a vaccine against Covid-19 be assessed under the EUL?
For a vaccine to be considered fit for use in a public health emergency, the manufacturer's data should demonstrate that there is a benefit in the target population that outweighs the risk of its use.
Hyderabad-based Bharat Biotech had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine's Emergency Use Listing.
The company has been submitting data on the EUL of Covaxin regularly and very quickly to a technical committee that hopes to have a final recommendation to the WHO this week.
About Covaxin:
- The vaccine is developed using Whole-Virion Inactivated Vero Cell-derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead viruses, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.
- Covaxin demonstrated 77.8% vaccine efficacy against symptomatic Covid-19 infection.
- The efficacy against severe symptomatic coronavirus infection is shown to be 93.4%. The efficacy data demonstrates 63.6% protection against asymptomatic Covid-19.
- It is a 2-dose vaccination regimen given 28 days apart
