WHO emergency vaccine use listing procedure for vaccines

Emergency Use Listing (EUL) procedure to streamline the process by which new or unlicensed products can be used during public health emergencies. The EUL replaces the Emergency Use Assessment and Listing (EUAL) procedure, which was used during the West AfricaAfrica Eastern Africa Burundi Comoros Djibouti Eritrea Ethiopia Kenya Madagascar Malawi Mauritius Mayotte Mozambique Réunion Rwanda Seychelles Somalia South Sudan Tanzania Uganda Zambia Zimbabwe Middle Africa Angola Cameroon Central African Republic Chad Congo Democratic Republic of the Congo Equatorial Guinea Gabon São Tomé e Príncipe Northern Africa Algeria Egypt Libya Morocco Sudan Tunisia Western Sahara Southern Africa Botswana Eswatini Lesotho Namibia South Africa Western Africa Benin Burkina Faso Cape Verde Islands Côte d’Ivoire Gambia Ghana Guinea Guinea-Bissau Liberia Mali Mauritania Niger Nigeria Saint Helena Senegal Sierra Leone Togo Ebola outbreak of 2014-2016

Emergency Use Listing Procedure for vaccines

The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.

The procedure is a key tool for companies wishing to submit their products for use during health emergencies.

Eligibility of candidate products

For vaccines to be eligible under the EUL procedure the following criteria must be met:

The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children);
Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines);

The product is manufactured in compliance with current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs; and
The applicant undertakes to complete the development of the product (validation and verification of the product in the case of IVDs) and apply for WHO prequalification once the product is licensed.

Evaluation procedure

Evaluation will determine whether, in light of available WHO/international standards, the submitted data demonstrate a reasonable likelihood that the vaccine quality, safety and effectiveness are acceptable and that the benefits outweigh the foreseeable risks and uncertainties in the context of a PHEIC.

Application for an EUL

The submission for EUL of a vaccine should follow the ICH common technical document (CTD) format. The vaccine manufacturer must apply to WHO with the following information:

• manufacturing quality data
• non-clinical data and clinical data
• a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to WHO as soon as the new data are available
• labelling details.

The contact email for EUL submission and more information is whoeul@who.int