The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the LC16m8 mpox vaccine, marking a significant development in the global response to the mpox public health emergency of international concern (PHEIC) declared by the WHO Director-General on August 14, 2024. This approval makes LC16m8 the second mpox vaccine endorsed by the WHO, facilitating swifter access to critical vaccination in areas facing surging outbreaks.
In 2024, mpox cases have been reported in 80 countries, with 19 located in Africa. This includes the Democratic Republic of the Congo, which has borne the brunt of the outbreak with more than 39,000 suspected cases and over 1,000 fatalities. Today’s ratification of the LC16m8 vaccine by the WHO is particularly crucial as Japan has committed to donating 3.05 million doses, accompanied by specialized needles, to the Democratic Republic of the Congo—an unprecedented contribution in the ongoing mpox crisis.
Developed by KM Biologics in Japan, the LC16m8 vaccine underwent rigorous review by the Technical Advisory Group (TAG) for EUL, which assessed its suitability and effectiveness. The vaccine is recommended as a single dose for individuals aged over one year, utilizing a multiple puncture technique administered with a bifurcated needle.
“WHO emergency use listing of the LC16m8 vaccine against mpox marks a significant step in our response to the current emergency, providing a new option to protect all populations, including children,” stated Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. She emphasized the vaccine's role as part of a holistic strategy encompassing testing, diagnosis, treatment, prevention, and community education.
The LC16m8 vaccine, previously used in Japan with positive results, has demonstrated safety and efficacy, even among individuals with well-controlled HIV. The Strategic Advisory Group of Experts (SAGE) on Immunization reviewed the evidence and endorsed its use in outbreak settings, especially for high-risk groups. However, it advised against usage during pregnancy or in immunocompromised individuals, including those with HIV with a CD4 count under 200 cells/µl.
The Global Advisory Committee on Vaccine Safety has urged healthcare workers to be trained in using bifurcated needles to minimize risks of injury. As mpox continues to evolve, WHO focuses on gathering comprehensive data regarding vaccine safety and effectiveness, aiming to collaborate closely with manufacturers and global entities to make life-saving products accessible.
Notably, on September 13, 2024, WHO prequalified the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, broadening its application to individuals aged 12 and above as of October 8, 2024. This advocacy underscores WHO's continued commitment to using advanced scientific evaluations like PQ and EUL to guide international procurement decisions and safeguard public health.
