In response to the escalating outbreak of MPOX, the World Health Organization (WHO) has invited manufacturers of MPOX vaccines to submit an Expression of Interest for Emergency Use Listing (EUL). This decision comes after the WHO Director-General triggered the EUL process on August 7, 2024, due to the concerning surge in the spread of the disease. The Democratic Republic of the Congo (DRC) is currently experiencing a serious and growing outbreak, which has now extended beyond its borders.

The urgency behind the EUL procedure lies in its ability to fast-track the availability of unlicensed vaccines and other medical products during public health emergencies. This procedure is time-limited and based on a risk-benefit approach to ensure the safety, efficacy, quality, and suitability of the vaccines for the target populations. In order to determine the viability of each vaccine, WHO is requesting manufacturers to submit comprehensive data.

By granting an EUL, WHO aims to expedite vaccine access, particularly for lower-income countries that have not yet granted their own regulatory approval. This will enable partners such as Gavi and UNICEF to procure vaccines for distribution. Currently, there are two MPOX vaccines in use, both of which have been recommended by the WHO Strategic Advisory Group of Experts on Immunization (SAGE).

The renewed call for manufacturers to submit their vaccine dossiers comes as a new viral strain, first detected in September 2023, has been identified in locations outside of the DRC. This development raises further concerns about the potential global impact of the disease and highlights the urgent need for effective prevention measures.

The submission of dossiers for emergency evaluation will play a crucial role in combatting the ongoing MPOX outbreak. WHO's proactive approach aims to ensure that the vaccines approved for emergency use are effective in curbing the spread of the disease and protecting vulnerable populations, especially in regions where the virus continues to pose a significant threat.

As the situation evolves, the WHO will continue to closely monitor the outbreak and work with manufacturers, regulatory bodies, and global partners to accelerate the availability of safe and effective MPOX vaccines.