The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the LC16m8 mpox vaccine, marking it as the second mpox vaccine supported by the WHO following the declaration of an mpox public health emergency on 14 August 2024. This decision is expected to enhance timely access to vaccines, particularly in communities facing surging outbreaks. As of 31 October 2024, mpox cases have been reported in 80 countries, including 19 in Africa, with the Democratic Republic of the Congo (DRC) being the hardest-hit, accounting for over 39,000 suspected cases and more than 1,000 deaths.
In response, Japan has announced a donation of 3.05 million doses of the LC16m8 vaccine, along with specialized needles, to the DRC—this is the largest donation made thus far. Developed by KM Biologics in Japan, LC16m8 is recommended for individuals over one year old as a single-dose vaccine using a bifurcated needle. The WHO’s approval follows rigorous assessments of both the product and its suitability for programmatic use.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized that the LC16m8 vaccine represents a crucial tool in controlling the outbreak, providing protection for all populations, including children. The vaccine has been previously used in Japan during outbreaks, showing safety and efficacy, including in individuals with well-controlled HIV.
While the vaccine is suitable for most individuals, it should not be used during pregnancy or in immunocompromised persons, including those with active cancer, transplant recipients, and individuals with low CD4 cell counts. The WHO continues to monitor vaccine safety and effectiveness and collaborates with global partners to ensure broad access to these vital resources.
