WHO today published the 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 Africa Ebola outbreak of 2014-2016.
The 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. It 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
The EUL concerns three product streams (vaccines, therapeutics and in vitro diagnostics), each of which has specific requirements for products to be eligible for evaluation 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.
Looking forward: Roadmap for evaluation of
novel oral polio vaccine type 2
One of the first applications of the EUL is likely to be for the novel oral polio vaccine type 2, for which WHO has developed a roadmap. Novel oral polio vaccine type 2 is expected to become a key tool in addressing type-2 vaccine derived polio and could significantly impact on progress in polio eradication.
Type 2 vaccine derived polio is currently affecting a number of countries, notably in Africa but also in some parts of the Middle East and Asia (including Somalia, Pakistan and the Philippines). Over the past five years, a total of 423 cases have been detected in 19 countries. It occurs when routine immunization coverage is low or when supplementary immunization activities are poorly conducted and not enough children are reached with the vaccine. As a result, a population is left under-immunized and the vaccine virus is able to circulate among unvaccinated children and undergo genetic changes. Hence, the main risk factor is low vaccination coverage. A fully immunized population is protected against both vaccine-derived and wild polioviruses.
The best measure against vaccine-derived poliovirus is to ensure high-quality outbreak response. If a population is fully immunized against polio, it will be protected against both wild polio and vaccine-derived polio.
One of the key actions to address the current vaccine-derived polio emergency is to roll out the novel OPV type 2 (nOPV2). The vaccine is currently in Phase II clinical trials. With the streamlining of the WHO emergency use procedure and the roadmap published today, access to the vaccine could become possible as early as the second quarter of 2020.
Source: World Health Organization