Emergency Use Listing (EUL)

In news- Bharat Biotech International will hold a preliminary meeting with the World Health Organization (WHO) before applying for an emergency-use listing (EUL) for its covid vaccine, Covaxin.

About emergency-use listing (EUL)-

The World Health Organization (WHO) developed the Emergency Use Assessment and Listing (EUAL) mechanism in response to the 2014 – 2016 Ebola Virus Disease (EVD) outbreak.
The EUAL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics (IVDs) for use primarily during public health emergencies of international concern (PHEIC).
Later the EUL procedure replaced the Emergency Use Assessment and Listing (EUAL) procedure.
The EUL is a special procedure intended to provide a time-limited listing for unlicensed products in an emergency context when limited data are available and the products are not yet ready for application for prequalification.
The manufacturer will complete the development of the product and submit for licensure and WHO prequalification.
The EUL is not intended to interfere with ongoing clinical trials.
Bharat Biotech officials, on 19 April, 2021 had submitted an expression of interest for EUL with WHO.
After the company submits its final proposal for Covaxin’s EUL, WHO’s product evaluation group comprising regulatory experts from around the world and a technical advisory group will conduct a review.
The process may include on-site inspections of the company’s facilities.
The company had recently issued a statement saying that the second interim data from its phase 3 trial of nearly 26,000 participants showed that the vaccine has an efficacy of 78% in preventing covid-19.
This efficacy is partially lower than the 80.6% found in the first interim data in March, 2021.
WHO’s cutoff for efficacy of covid-19 vaccines is 50%, the same as the lower limit set by regulators in India, the US and other countries.
A WHO EUL will make those inoculated with Covaxin eligible to enter regions such as the European Union.
While WHO and European Medicines Agency (EMA) have authorized vaccines from Pfizer, Moderna, AstraZeneca and Johnson & Johnson, WHO has also included jabs from China’s Sinopharm in its list.