WHO Invites Mpox Vaccine Manufacturers to Apply for Emergency Use Listing

The EUL procedure is designed to expedite the availability of unlicensed medical products, such as vaccines, needed during public health emergencies.

The World Health Organization (WHO) has issued a call for manufacturers of mpox vaccines to submit Expressions of Interest for Emergency Use Listing (EUL), in response to alarming trends in the spread of the disease.

On August 7, 2024, WHO Director-General announced the activation of the EUL process due to a severe and expanding outbreak of mpox in the Democratic Republic of the Congo (DRC), which has now spread beyond the country's borders. The outbreak has been exacerbated by a new viral strain, first identified in September 2023, which has recently been detected outside the DRC.

The EUL procedure is designed to expedite the availability of unlicensed medical products, such as vaccines, needed during public health emergencies. This time-limited recommendation is based on an evaluation of the risks and benefits associated with the vaccines.

WHO is requesting manufacturers to provide data demonstrating that their vaccines are safe, effective, of high quality, and appropriate for the intended populations. The EUL process will facilitate faster vaccine access, especially for lower-income countries that may not yet have national regulatory approval for the vaccines. Additionally, the EUL will enable organizations like Gavi and UNICEF to procure and distribute the vaccines more effectively.

Mpox, caused by the monkeypox virus, is a viral illness that can spread to humans through contact with infected individuals, contaminated materials, or infected animals. Currently, two vaccines have been recommended by the WHO Strategic Advisory Group of Experts on Immunization (SAGE) for use against mpox.

The WHO’s call for vaccine submissions is a critical step in addressing the ongoing mpox outbreak and ensuring that effective preventive measures are accessible to the affected regions.