The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the LC16m8 mpox vaccine, making it the second mpox vaccine to be supported by WHO following the Director-General’s declaration of an mpox public health emergency of international concern (PHEIC) on August 14, 2024.
In 2024, cases have been reported across 80 countries, including 19 countries in Africa, based on data as of October 31, 2024. The Democratic Republic of the Congo, the hardest-hit country, recorded a large majority of suspected cases – over 39 000 – as well as more than 1000 deaths.
LC16m8 is a vaccine developed and manufactured by KM Biologics in Japan. The Technical Advisory Group (TAG) for EUL of vaccines convened to discuss the outcome of the LC16m8 vaccine review, including the product and programmatic suitability assessments. The TAG recommended the vaccine for use in individuals over one year of age as a single dose vaccine, via a multiple puncture technique using a bifurcated needle.
The LC16m8 vaccine has been used in Japan during previous mpox outbreaks and was shown to be safe and effective, including in people with well-controlled HIV.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization reviewed available evidence and recommended the use of LC16m8 vaccine in outbreak settings in children and others with a documented high-risk of exposure to mpox.
However, minimally replicating vaccines, such as LC16m8, should not be used during pregnancy and in people who are immunocompromised. Immunocompromised persons include those with active cancer, transplant recipients, immunodeficiency, and active treatment with immunosuppressive agents. They also include people living with HIV with a current CD4 cell count of <200 cells µl.
The Global Advisory Committee on Vaccine Safety reviewed the updated safety data on LC16m8 on September 20, 2024 and recommended that healthcare workers are provided with training on the use of bifurcated needles to prevent injuries and adverse effects.
