While adults in the capital of the Democratic Republic of Congo began receiving mpox vaccinations this week, children—who represent the most vulnerable group—remain without access to life-saving shots. The delay follows a legal challenge surrounding a key vaccine donation, which was initially held up over issues of liability.
In September, Japan pledged to donate three million doses of the LC16m8 vaccine, produced by local firm KM Biologics and originally developed for smallpox. This vaccine is the only one approved for use in children to protect against mpox and represents the largest single donation to date aimed at combating the disease. However, negotiations between Congo and Japan were delayed due to concerns over who would bear responsibility for any side effects caused by the vaccine.
Congo’s health minister, Samuel Roger Kamba Mulamba, confirmed that the issue has now been resolved, but experts stress that the delay underscores the urgent need for an improved global framework to handle such issues efficiently during public health emergencies. In many cases, poorer nations are reluctant to assume liability for vaccine side effects, while donor countries are hesitant to shoulder the financial burden themselves. This stalemate has led to similar delays in global health responses, including the COVID-19 vaccination rollout.
Japan’s government clarified earlier this month that the liability issue had been resolved, though discussions over vaccine delivery logistics are still ongoing. Despite this, global health experts argue that a more streamlined, pre-established system for managing such risks should be in place to prevent further setbacks in responding to outbreaks.
The LC16m8 vaccine, which received emergency use approval from both the World Health Organization and the Congolese government, cannot be covered by insurance for any side effects due to the nature of its expedited approval process. In contrast, the Bavarian Nordic vaccine, which has received full regulatory approval, has not faced the same liability concerns. However, while governments, including the United States, have pledged around three million doses of the Bavarian Nordic vaccine to Congo, only a fraction—about 375,000—have arrived in the country, hampering vaccination efforts.
Vaccination campaigns in Congo have been slow, with some communities unaware of the available protection against the virus. Health officials have raised concerns over the lack of widespread awareness, especially given that children account for the majority of the more than 1,100 suspected mpox-related deaths in Africa this year. Experts emphasize that timely vaccine deployment is critical, but they also note the importance of adequate training for health workers in administering the LC16m8 vaccine, which requires a bifurcated needle technique.
Japan has acknowledged the ongoing challenges, with officials stating they are working to resolve the remaining logistical issues but have not provided a specific timeline for the vaccines’ arrival in Congo.
