The World Health Organization (WHO) has approved the emergency use of the M-Pox (monkeypox) vaccine, LC16, developed by Japan’s KM Biologics.
This marks the second vaccine to gain WHO approval, following Bavarian Nordic’s vaccine, which was authorized earlier this year.
The approval comes amid ongoing efforts to combat M-pox outbreaks, particularly in Africa, where over 50,000 cases and 1,100 deaths have been reported in 2024.
The decision follows successful trials of LC16 in Japan, where it demonstrated safety and effectiveness, especially in individuals with well-managed HIV.
The WHO’s approval is a response to the spread of the Clade IB variant, first reported in the Republic of Congo, which has since affected neighboring regions.
In addition to the vaccine approval, the WHO has pledged to donate 3.05 million doses of the vaccine, along with specialized injection needles, to support Congo’s vaccination efforts.
KM Biologics, a subsidiary of Meiji Holdings, specializes in producing vaccines for humans and animals. The LC16 vaccine has been previously used in Japan during M-pox outbreaks and is now poised to play a critical role in global health efforts.
The WHO’s action reflects its commitment to accelerating vaccine access and addressing criticism about the slow rollout of preventive measures against M-pox.
The organization had previously declared the virus a global health emergency and is now intensifying its efforts to curb its spread through vaccination and international collaboration.
