The World Health Organization (WHO) has authorized the emergency use of the Lc16m8 mpox vaccine, marking the first time a vaccine has been approved for children aged one year and older to combat the surging mpox outbreak. This decision is expected to facilitate increased and timely access to vaccines in communities where mpox outbreaks are rapidly escalating, particularly in regions like the Democratic Republic of Congo (DRC).
The Lc16m8 vaccine, developed by KM Biologics in Japan, is recommended as a single dose for individuals one year of age and older. This approval follows the WHO's previous authorization of Bavarian Nordic's mpox vaccine in September, which was later expanded to include individuals aged 12 years and older.
Mpox in Africa
According to the Africa Centres for Disease Control and Prevention (Africa CDC), there have been over 53,000 cases of mpox and 1,100 deaths reported across 19 African countries this year. The DRC has been particularly affected, with Save the Children reporting a 130% increase in mpox cases among children.
Mpox is characterized by symptoms such as fever, fatigue, and a painful rash. Transmission occurs through close skin-to-skin contact with an infected individual or contact with contaminated objects.
Global Health Emergency
The WHO declared mpox a global health emergency in August, with the virus reported in 80 countries in 2024. The authorization of the Lc16m8 mpox vaccine represents a significant step in addressing this emergency.
Dr. Yukiko Nakatani, WHO's assistant director-general for access to medicines and health products, stated that the vaccine's approval "marks a significant step in our response to the current emergency, providing a new option to protect all populations, including children.” She further emphasized that vaccines are a crucial tool in containing the outbreak, alongside improved testing, diagnosis, treatment, and community engagement.
As part of international efforts to combat the outbreak, the government of Japan will donate 3.05 million doses of the Lc16m8 vaccine with specialized needles to the DRC.
