WHO adds LC16m8 mpox vaccine to Emergency Use Listing
November 19, 2024
The World Health Organization (WHO) has approved the LC16m8 mpox vaccine for emergency use, marking it as the second vaccine supported amid the ongoing global mpox outbreak. Developed by KM Biologics in Japan, LC16m8 is a single-dose vaccine recommended for individuals over one year of age, excluding pregnant and immunocompromised individuals. Japan will donate 3.05 million doses, along with specialized needles, to the Democratic Republic of Congo, which remains the hardest-hit nation. WHO emphasized this milestone as part of a broader response strategy, including testing, diagnosis, and education, to control outbreaks in over 80 countries reported this year.
The World Health Organization (WHO) has granted Emergency Use Listing (EUL) to the LC16m8 mpox vaccine, marking a critical milestone in the fight against the ongoing global mpox outbreak. This makes LC16m8, developed by KM Biologics in Japan, the second vaccine to receive WHO approval after the declaration of mpox as a Public Health Emergency of International Concern in August 2024.
LC16m8 is a single-dose vaccine administered via bifurcated needles and is recommended for individuals over one year of age, excluding pregnant and immunocompromised individuals. Japan has announced a generous donation of 3.05 million doses and specialized inoculation needles to the Democratic Republic of Congo (DRC), the hardest-hit country, which has reported over 39,000 suspected cases and more than 1,000 deaths this year. This donation is the largest to date, signifying global collaboration to address mpox outbreaks in vulnerable regions.
The WHO emphasized the importance of integrating vaccines into a comprehensive response strategy that includes improved testing, diagnosis, treatment, infection prevention, and public education. The LC16m8 vaccine has been proven safe and effective during previous outbreaks in Japan, including for individuals with well-controlled HIV.
WHO’s prequalification of LC16m8 follows extensive reviews by global regulatory bodies, including Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Training healthcare workers on safe administration techniques using bifurcated needles is also a priority, ensuring optimal use of this life-saving intervention.
As mpox cases continue across 80 countries, WHO and its partners remain committed to expanding vaccine availability while monitoring evolving epidemiological trends. The approval and deployment of LC16m8 provide new hope for controlling mpox outbreaks globally and protecting high-risk populations, marking a significant step forward in global health security.