Mpox Vaccines May Qualify for Emergency Use Listing

The World Health Organization (WHO) today announced it had invited mpox vaccine manufacturers to submit an Expression of Interest for Emergency Use Listing (EUL).

On August 9, 2024, the WHO stated that the EUL procedure is an emergency use authorization process specifically developed to expedite the availability of unlicensed medical products, such as vaccines, needed in public health emergencies.

This is a time-limited WHO recommendation based on a risk-benefit approach.

WHO requests manufacturers to submit data to ensure that the vaccines are safe, effective, of assured quality, and suitable for the target populations.

Granting an EUL will accelerate vaccine access, particularly for lower-income countries that have not yet issued their national regulatory approval. The EUL also enables partners, including Gavi and UNICEF, to procure vaccines for distribution.

The WHO Director-General announced on August 7, 2024, that he had triggered the process for EUL of mpox vaccines, given worrying trends in the disease's spread.

A severe and growing mpox outbreak in the Democratic Republic of the Congo (DRC) has expanded outside to other countries. A new viral mpox strain, which first emerged in September 2023, has been detected outside DRC for the first time.

Mpox is a viral illness caused by the monkeypox virus, a species of the genus Orthopoxvirus. It can be transmitted between humans through physical contact with an infectious person, contaminated materials, or infected animals.

Two vaccines against the mpox disease are currently in use globally, both of which have been recommended by the WHO Strategic Advisory Group of Experts on Immunization.

These mpox vaccines are JYNNEOS® (MVA-BN, IMVANEX®, IMVAMUNE®) Smallpox and Mpox Vaccine, and K.M. Biologics' LC16 "KMB" freeze-dried smallpox vaccine.

In the United States, JYNNEOS has been offered since May 2022.