FDA announcements or press releases

WHO Approves LC16m8 Mpox Vaccine by Japan's KM Biologics for Emergency Use, Second Vaccine Listed

Nov 20, 2024, 03:00 PM

The World Health Organization (WHO) has granted emergency use listing to the LC16m8 mpox vaccine, developed by Japan's KM Biologics, a subsidiary of Meiji Group, on November 19, 2024. This approval marks the second mpox vaccine to receive the WHO's emergency use listing, following the Jynneos vaccine by Bavarian Nordic and the ACAM2000 vaccine by Emergent BioSolutions. The LC16m8 vaccine is particularly aimed at protecting vulnerable populations, including children over one year old, especially in outbreak settings. Japan has pledged to donate 3 million doses of the vaccine to the Democratic Republic of Congo (DRC), where the disease has significantly impacted young children. The vaccine will also facilitate immunization efforts for younger children who are at risk of infections from household contact. The LC16m8 is the first vaccine listed for children. During the 46th week, from November 11 to 16, 2024, the DRC reported 478 suspected cases of mpox, 56 confirmed cases, and 1 death.