WHO expands Mpox vaccine options with LC16m8 Emergency Use Listing

SWITZERLAND— The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the LC16m8 mpox vaccine, marking it as the second such vaccine to receive this designation.

This follows another WHO prequalification of the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine on 13 September 2024, expanding its use to individuals aged 12 years and older by 8 October 2024.

The addition of the LC16m8 vaccine is expected to increase vaccine access in regions where pox outbreaks are rapidly spreading.

As of 31 October 2024, mpox cases have been reported across 80 countries, including 19 in Africa.

The Democratic Republic of the Congo (DRC) remains the hardest-hit nation, with more than 39,000 suspected cases and over 1,000 deaths.

In response, the Government of Japan has announced a donation of 3.05 million doses of the LC16m8 vaccine, along with specialized needles for vaccination, to the DRC.

This donation marks the largest contribution to date aimed at combating the current mpox crisis.

Developed and manufactured by KM Biologics in Japan, the LC16m8 vaccine underwent rigorous assessments by the WHO’s Technical Advisory Group (TAG) for Emergency Use Listing.

The TAG recommended the vaccine for individuals over one year of age as a single-dose treatment administered through a multiple puncture technique with a bifurcated needle.

Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, highlighted the significance of the LC16m8 vaccine’s inclusion in the global response to mpox.

She emphasized that vaccines play a crucial role in containing the outbreak, alongside other efforts such as improved testing, diagnosis, treatment, and community engagement.

The vaccine’s EUL status is based on data provided by the manufacturer, reviewed by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The LC16m8 vaccine has been previously used in Japan during mpox outbreaks, where it proved safe and effective, even for individuals with well-controlled HIV.

However, it is not recommended for pregnant women or immunocompromised individuals, including those with active cancer, transplant recipients, and those undergoing immunosuppressive treatments.

The WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization has also endorsed the LC16m8 vaccine for use in outbreak settings, particularly for children and individuals at high risk of exposure to the virus.

Additionally, the Global Advisory Committee on Vaccine Safety has urged healthcare workers to receive proper training on the use of bifurcated needles to avoid injuries and ensure safety.

As new strains of the virus emerge and the epidemiology of mpox evolves, WHO continues to monitor vaccine safety and effectiveness, working with manufacturers, global partners, and governments to ensure the availability of life-saving products in affected regions.

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