By Bunmi Yekini
The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the LC16m8 mpox vaccine, developed by Japan’s KM Biologics. This milestone makes it the second mpox vaccine endorsed by WHO since the declaration of a global public health emergency in August 2024.
The move is expected to enhance timely vaccine access in areas battling surging mpox outbreaks. According to WHO, over 80 countries, including 19 in Africa, have reported cases in 2024. The Democratic Republic of the Congo (DRC) has been hardest hit, with over 39,000 suspected cases and more than 1,000 deaths as of October 31, 2024.
Adding to the momentum, Japan has pledged a donation of 3.05 million LC16m8 doses, along with specialized inoculation needles, to the DRC. This donation marks the largest contribution to date in response to the current mpox crisis.
“WHO’s emergency use listing of the LC16m8 vaccine against mpox marks a significant step in our response to the current emergency,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “It provides a new option to protect all populations, including children. Vaccines are one of the important tools to help contain the outbreak as part of a comprehensive response strategy.”
The LC16m8 vaccine, approved for individuals aged one year and older, is administered via a single dose using a bifurcated needle. However, it is not recommended for use during pregnancy or in individuals who are immunocompromised. WHO emphasizes the need for healthcare workers to receive proper training to ensure safe administration.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization supports the vaccine’s use in high-risk groups, while urging the collection of safety and effectiveness data, especially in light of evolving mpox strains.
The LC16m8 vaccine joins the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, which WHO prequalified earlier this year for use in individuals aged 12 and older.