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Home Science & Tech

Emergency Use Listing (EUL)

May 26, 2021
in Science & Tech
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Emergency Use Listing (EUL)
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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.
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Source: LiveMint
Tags: LiveMintPrelims

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