The World Health Organization (WHO) has added another mpox vaccine, LC16m8, to the list of available vaccines through its Emergency Use Listing (EUL). LC16m8 was developed and manufactured by KM Biologics in Japan.¹

“WHO emergency use listing of the LC16m8 vaccine against mpox marks a significant step in our response to the current emergency, providing a new option to protect all populations, including children,” Yukiko Nakatani, MD, PhD, WHO assistant director-general for Access to Medicines and Health Products, said in a statement. “Vaccines are one of the important tools to help contain the outbreak as part of a comprehensive response strategy that also includes improved testing and diagnosis, treatment and care, infection prevention control, and engagement and education within affected communities.”¹

The WHO’s Technical Advisory Group (TAG) for Emergency Use Listing (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 1 year of age as a single dose vaccine, via a multiple puncture technique using a bifurcated needle.¹

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.¹

This recent announcement coincides with the Government of Japan announcing it was going to donate 3.05 million doses of the LC16m8 vaccine, along with specialized inoculation needles, to the Democratic Republic of the Congo, which is one of the hardest hit countries of the recent ongoing outbreaks in Africa. 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.¹

Last August, the Africa Centers for Disease Control and Prevention (Africa CDC) declared the ongoing mpox outbreak a Public Health Emergency of Continental Security, and during that same time period, the World Health Organization declared the mpox outbreaks in Congo and elsewhere in Africa a global emergency. ^2-3

In previous reporting by Contagion, the first case in the US was confirmed last month. The person infected with mpox had traveled to areas where transmission had been ongoing.

In terms of the person’s condition, the individual had been receiving care in the US and was isolating from others. The patient, who has no underlying health conditions, has not had any severe manifestations of disease, and symptoms are improving, according to a Centers for Disease Control and Prevention statement. The federal agency said it is working closely with the local and state health authorities to investigate the circumstances surrounding this case and to prevent spread of the virus.⁴

Back in October, WHO prequalified another mpox immunization, the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine and expanded its indication to include use in individuals aged 12 years and older.¹

References
1.WHO adds LC16m8 mpox vaccine to Emergency Use Listing. WHO press release. November 19, 2024. Accessed December 2, 2024. https://www.who.int/news/item/19-11-2024-who-adds-lc16m8-mpox-vaccine-to-emergency-use-listing
2. Africa CDC Declares Mpox A Public Health Emergency of Continental Security, Mobilizing Resources Across the Continent. Africa CDC. August 13, 2024. August 14, 2024.
https://africacdc.org/news-item/africa-cdc-declares-mpox-a-public-health-emergency-of-continental-security-mobilizing-resources-across-the-continent
3. Cheng M. WHO declares mpox outbreaks in Africa a global health emergency as a new form of the virus spreads. AP News. August 14, 2024. Accessed August 14, 2024. https://apnews.com/article/who-mpox-africa-health-emergency-cc9bdf31b49d06bec5efd44fb55d5e42
4.First Case of Clade I Mpox Diagnosed in the United States. CDC. November 18, 2024. Accessed December 2, 2024.
https://emergency.cdc.gov/han/2024/han00519.asp