New Mpox vaccine study to launch in outbreak-affected DRC
September 10, 2025
The Democratic Republic of the Congo is set to launch groundbreaking research on the LC16m8 mpox vaccine, supported by CEPI and international partners. This study will provide the first real-world African data on vaccine safety and effectiveness, including in children, amid the ongoing public health emergency. Three million LC16m8 doses donated by Japan will be deployed, with monitoring in hotspot health zones of Équateur province. The trial represents a milestone for Africa in building evidence-based vaccination strategies and strengthening research capacity. Its findings could inform global policy, ensuring better protection for vulnerable populations and reinforcing preparedness against future outbreaks.
The Democratic Republic of the Congo (DRC) is preparing to launch an important study of the LC16m8 vaccine, marking a critical step in Africa’s response to the mpox emergency. Backed by the Coalition for Epidemic Preparedness Innovations (CEPI), the International Vaccine Institute (IVI), Japan Institute for Health Security, and the Institut National pour la Recherche Biomédicale (INRB), the research will assess vaccine performance in real-world African settings where transmission remains high.
LC16m8, a live-attenuated vaccine licensed in Japan for decades against smallpox, has demonstrated safety and efficacy, including in people with well-controlled HIV. Japan is donating three million doses to the DRC, with rollout targeting vulnerable populations. The observational study will evaluate infection rates among vaccinated individuals and gather safety data, focusing on health zones in Équateur province, one of the country’s hardest-hit regions. Importantly, the vaccine is the only mpox product currently approved for use in children, positioning this trial to fill a critical evidence gap for pediatric protection.
International leaders emphasized that the research will both inform outbreak management now and build long-term resilience. Dr. Richard Hatchett of CEPI highlighted that the study will strengthen Africa’s ability to generate rapid outbreak data, supporting faster, evidence-based responses to future threats. Africa CDC Director-General Dr. Jean Kaseya called the trial vital for protecting Africa’s most vulnerable, especially children. Japanese health officials noted that the results will support global preparedness, reinforcing LC16m8’s potential role in pandemic response.
As mpox continues to spread across Africa, with WHO and Africa CDC maintaining its designation as a continental and global emergency, the DRC’s leadership in advancing vaccine evidence is timely. This study not only promises to guide vaccination strategies in Africa but also sets a precedent for global collaboration in epidemic preparedness.