The World Health Organization (WHO) has granted Emergency Use Listing (EUL) to the LC16m8 mpox vaccine, making it the second mpox vaccine endorsed by the organization following the Director-General’s declaration of mpox as a Public Health Emergency of International Concern (PHEIC) on August 14, 2024.
This decision will accelerate vaccine access in regions facing surging mpox outbreaks. As of October 31, 2024, mpox cases have been reported in 80 countries, including 19 in Africa. The Democratic Republic of the Congo (DRC), the most severely affected, has recorded over 39,000 suspected cases and more than 1,000 deaths.
In a significant development, the Japanese government has pledged to donate 3.05 million doses of the LC16m8 vaccine, along with specialized inoculation needles, to the DRC. This donation marks the largest response package for the ongoing mpox emergency.
About the LC16m8 vaccine
Developed and manufactured by KM Biologics in Japan, the LC16m8 vaccine is recommended for individuals over one year old and is administered as a single dose using a bifurcated needle. The WHO Technical Advisory Group (TAG) for EUL reviewed its safety and programmatic suitability, leading to its endorsement.
“WHO’s Emergency Use Listing of the LC16m8 vaccine against mpox represents a crucial step in combating the current outbreak,” stated Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Vaccines are vital in containing the outbreak alongside improved testing, treatment, infection prevention, and community engagement.”
The LC16m8 vaccine has been previously used in Japan during mpox outbreaks and has demonstrated safety and effectiveness, including among individuals with well-controlled HIV. However, it is not recommended for use during pregnancy or in immunocompromised individuals, such as those with active cancer, transplant recipients, or individuals with HIV and a CD4 cell count below 200 cells/μl.
Safety and training
The Global Advisory Committee on Vaccine Safety (GACVS) reviewed updated data on LC16m8 on September 20, 2024, and emphasized the need for healthcare workers to be trained in using bifurcated needles to avoid injuries and adverse effects. WHO also underscored the importance of ongoing data collection on vaccine safety and effectiveness in various settings.
Broader vaccine efforts
In parallel with the LC16m8 approval, WHO prequalified the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine on September 13, 2024, expanding its use to individuals aged 12 years and older on October 8, 2024.
WHO continues to collaborate with manufacturers, global partners, and countries to ensure the availability and distribution of safe, effective, and life-saving vaccines as part of a comprehensive response to the mpox emergency.
