The World Health Organization has approved the emergency use of the Lc16m8 mpox vaccine, the first such authorization for children aged one year and older. The development comes after this approval was announced on 19 November 2024 as part of an effort to continue the war against the mpox outbreaks that, devastatingly, are happening in different parts of the world, especially in areas where the virus is spreading. KM Biologics of Japan developed the vaccine, which is administered as a single dose for people aged one year and older.
Mpox cases are increasing astronomically in some areas. Save the Children reported a dramatic 130% increase among children in the Democratic Republic of Congo. According to Save the Children, the WHO approved the Lc16m8 vaccine, seen as a key move in controlling infection, particularly among those at risk. The vaccine’s emergency use listing is expected to enhance access to immunization, thereby protecting vulnerable groups, including children, in areas experiencing a surge in cases.
The WHO had already cleared another mpox vaccine from Denmark-based manufacturer Bavarian Nordic in September 2024, which was initially recommended to be used in infants, children, and adolescents during outbreaks. That vaccine also was authorized for wider use among persons aged 12 years and older in October. What is unique, though, is the Lc16m8 vaccination approval because of its expansion of vaccine use among younger populations, who have increasingly been affected by the disease.
Mpox is a viral disease that features fever, chills, fatigue, as well as several painful rashes. It is primarily spread through intimate contact with the skin of an infected person or through contact with objects contaminated with the virus. Mpox cases have been reported in over 53,000 cases in 19 African countries so far this year. According to latest statistics provided by Africa CDC, there are more than 1,100 deaths associated with the virus.
In response to the deepening crisis, Japan promised to provide 3.05 million doses of Lc16m8 vaccines, together with specific injection needles, to the DRC. That’s the global effort underway to contain the outbreak. WHO’s assistant director-general for access to medicines and health products, Dr. Yukiko Nakatani, described the approval as a significant step in the battle against mpox, highlighting that vaccines are vital components of a comprehensive strategy to control the virus, in addition to enhancing testing, treatment, and community engagement efforts.
