WHO invites mpox vaccine manufacturers to submit dossiers for emergency evaluation

WHO has today issued aninvitation for manufacturers of mpox vaccines to submit an Expression of Interest for Emergency Use Listing (EUL).

The WHO Director-Generalannounced on 7 August 2024 that he had triggered the process for EUL of mpox vaccines given worrying trends in the disease's spread. There is a serious and growing outbreak in the Democratic Republic of the Congo (DRC) that has now expanded outside the country. A new viral strain, which first emerged in September 2023, has for the first time been detected outside DRC.

The EUL procedure is an emergency use authorization process, specifically developed to expedite the availability of unlicensed medical products like vaccines that are needed in public health emergency situations. This is a time-limited recommendation, based on a risk-benefit approach.

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

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

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

There are currently two vaccines in use against the disease, both of which have been recommended for use by the WHO Strategic Advisory Group of Experts on Immunization, or SAGE.