The World Health Organization (WHO) has approved Emergency Use Listing (EUL) for the LC16m8 mpox vaccine. This marks it as the second vaccine endorsement by WHO after the August 14, 2024, declaration of an mpox international public health emergency by the Director-General.
The approval is anticipated to enhance vaccine accessibility in areas facing mpox outbreaks. Reports from 2024 show the virus affecting 80 nations, including 19 African countries, according to data from October 31, 2024. The Democratic Republic of the Congo remains severely affected, recording over 39,000 suspected cases and more than 1,000 fatalities.
The significance of this announcement is underscored by Japan’s decision to donate 3.05 million doses of the LC16m8 vaccine and specialized needles to the Democratic Republic of the Congo, marking the largest aid package amidst the mpox crisis.
Developed by KM Biologics in Japan, LC16m8 was reviewed by the Technical Advisory Group (TAG) for EUL, which evaluated the vaccine’s programmatic and product suitability. The vaccine is recommended for individuals over one year old as a single-dose vaccine, utilizing a bifurcated needle for administration.
“The WHO emergency use listing of the LC16m8 vaccine significantly bolsters our response to the ongoing crisis, offering children and others a new protective measure,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Vaccines form a critical element of our strategy, which also includes enhanced testing, diagnosis, care, and public engagement.”
The WHO’s EUL assessment depends on manufacturer-submitted information and review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The LC16m8 vaccine has been previously used in Japan, proving its safety and efficacy, even among individuals with well-managed HIV.
WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization examined the data and endorsed the LC16m8 vaccine’s use in outbreak settings for children and high-risk individuals.
Nonetheless, LC16m8, a minimally replicating vaccine, is advised against use during pregnancy and among immunocompromised individuals, including those with active cancer, transplants, immunodeficiency, undergoing immunosuppressive treatment, or with HIV and a CD4 count under 200 cells µl.
The Global Advisory Committee on Vaccine Safety reviewed the updated LC16m8 safety data on September 20, 2024, and emphasized training for healthcare workers on bifurcated needle use to prevent injuries. As viral patterns shift, it’s crucial to continually gather safety and effectiveness data across diverse situations.
WHO remains committed to collaborating with manufacturers, partners, and nations to guarantee the delivery of safe, effective, essential resources.
Previously, on September 13, 2024, WHO had prequalified the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, later extending its use to individuals 12 years and older on October 8, 2024.
WHO’s Prequalification and Emergency Use Listing are crucial processes for evaluating medical products’ quality, safety, and efficacy, specifically in low- and middle-income countries. These processes guide international and regional procurement strategies executed by UN agencies, partners, and Member States during health emergencies.