On Nov. 19, 2024, the World Health Organization (WHO) announced it had granted Emergency Use Listing (EUL) to Japan-based KM Biologics for the LC16m8 mpox vaccine, making it the second mpox vaccine to be supported by WHO following the Director-General’s declaration of an mpox public health emergency of international concern (PHEIC) on August 14, 2024.

The Government of Japan will donate 3.05 million doses of the vaccine, along with certain specialized needles, to Congo. The vaccine has been used in Japan during previous mpox outbreaks and was shown to be safe and effective, including in people with well-controlled HIV. The WHO reported there have been more than 50,500 confirmed and suspected cases of mpox in Africa to date, and more than 1,100 deaths in the continent due to the illness.