The World Health Organization (WHO) has approved the LC16m8 mpox vaccine for emergency use, marking it as the second vaccine to receive this status since the disease was declared a global health emergency in August 2024.Â
This development comes as cases of mpox continue to rise across 80 countries, with the Democratic Republic of Congo (DRC) bearing the brunt of the outbreak.
The LC16m8 vaccine, produced by KM Biologics in Japan, has been recognized for its safety and effectiveness, including its use in previous mpox outbreaks.
As part of a global response, Japan has pledged 3.05 million doses of the vaccine to the DRC, alongside specialized needles for administration.
This is currently the largest donation aimed at curbing the spread of the disease.
The WHO’s approval followed a thorough review process by its technical advisory group, which evaluated the vaccine’s suitability for emergency deployment.
 The vaccine is recommended for individuals older than one year and is administered using a multiple puncture technique.
However, it is not advised for pregnant individuals or those with compromised immune systems.
Mpox remains a major concern in Africa, with over 39,000 suspected cases and more than 1,000 deaths reported in the DRC alone.
The global health community views the approval of the LC16m8 vaccine as a critical step in addressing the ongoing crisis.