WHO calls for Emergency Use Listing of Mpox vaccines amid rising outbreaks across Africa

AFRICA—The World Health Organization (WHO) has invited manufacturers of Mpox vaccines to submit an Expression of Interest (EOI) for Emergency Use Listing (EUL).

This move is in response to growing concerns over the spread of Mpox across Africa, a situation that has prompted the Africa Centres for Disease Control and Prevention (Africa CDC) to intensify efforts to declare Mpox a continental priority

The situation has become particularly alarming due to a severe and escalating outbreak in the Democratic Republic of the Congo (DRC), which has now extended beyond its borders.

As of this year, fifteen African countries have reported Mpox outbreaks, resulting in 2,030 confirmed cases and 13 deaths. This marks a significant increase compared to the 1,145 cases and seven deaths recorded throughout 2023.

Furthermore, four countries—Burundi, Kenya, Rwanda, and Uganda—previously unaffected by Mpox, have reported cases since mid-July 2024, highlighting the growing reach of the virus.

Adding to the outbreak’s complexity is the first detection of a new viral strain outside the DRC, known as clade 1b, which first emerged in September 2023.

According to WHO Africa, clade 1b, which originated in eastern DRC, has been linked to transmission through sexual contact and high population movement.

 In South Africa, most of the cases have been reported among men who identify as having sex with men, raising additional public health concerns.

The EUL procedure, which is the focus of WHO’s recent call to vaccine manufacturers, is an emergency use authorization process designed to expedite the availability of unlicensed medical products, such as vaccines, during public health emergencies.

This process provides a time-limited recommendation based on a careful assessment of the medical product’s risk-benefit profile.

In their invitation, WHO has urged manufacturers to submit comprehensive data to ensure that the vaccines meet the necessary criteria for safety, efficacy, quality, and suitability for the targeted populations.

Granting an EUL would significantly accelerate access to vaccines, especially in lower-income countries that have yet to secure their own national regulatory approval for these vaccines.

Additionally, the EUL would enable global partners, including Gavi and UNICEF, to procure vaccines for distribution, thereby enhancing the global response to the Mpox outbreak.

Two vaccines against Mpox are currently in use, both of which have been recommended by the WHO Strategic Advisory Group of Experts on Immunization (SAGE).

The swift implementation of the EUL process will be crucial in ensuring that these vaccines are made widely available to those who need them most, particularly in the regions hardest hit by the outbreak.