Japan's Mpox Vaccine Listed by the WHO

The World Health Organization (WHO) today announced it has granted Emergency Use Listing (EUL) for the LC16m8 smallpox / mpox vaccine, making it the second mpox vaccine to be supported by WHO.

LC16m8 is a vaccine developed and manufactured by KM Biologics in Japan.

It is recommended by the WHO for use in individuals over one year of age as a single-dose vaccine via a multiple puncture technique using 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,” commented Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, in a press release on November 19, 2024. 

“Vaccines are one of the important tools to help contain the outbreak as part of a comprehensive response strategy that also includes improved testing and diagnosis, treatment and care, infection prevention control, and engagement and education within affected communities.”

This decision is expected to facilitate increased and timely vaccine access in communities where mpox outbreaks are surging.

Today’s move is particularly relevant as the Government of Japan has announced that it will donate 3.05 million doses of the LC16m8 vaccine and specialized inoculation needles to the Democratic Republic of the Congo. This is the most extensive vaccine donation package announced to date in response to the current mpox emergency.

Previously, the WHO has LIsted Bavarian Nordic A/S JYNNEOS® (MVA-BN®) smallpox / mpox vaccine.