WHO approves Japanese mpox vaccine for emergency use

The World Health Organisation (WHO) has granted emergency use listing (EUL) for the LC16m8 mpox vaccine.

This would be the second mpox vaccine to be supported by WHO following the declaration of mpox as a public health emergency of international concern (PHEIC) on August 14, 2024.

The 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.

Cases have been reported across 80 countries, including 19 countries in Africa, as of October 31, 2024.

The Democratic Republic of Congo, the hardest-hit country, recorded a majority of suspected cases — over 39,000 — as well as more than 1,000 deaths.

In a statement on Tuesday, the WHO said the move is particularly relevant as the Japanese government has announced that it will donate 3.05 million doses of the LC16m8 vaccine, alongside specialised inoculation needles, to the DRC.

“This is the largest donation package announced to date in response to the current mpox emergency,” the statement reads.

“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.

“WHO’s assessment for EUL is based on information submitted by the manufacturer and review by the Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese regulatory agency of record for this vaccine.

“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.”