The launch comes as the country battles a major outbreak of the virus, which remains a continental public health emergency.

Health experts say the ongoing vaccination campaign in DRC offers a rare chance to gather real-world evidence about the vaccine’s performance. The study will look at how effective the vaccine is at preventing Mpox, including among children.

The Coalition for Epidemic Preparedness Innovations (CEPI) is funding the project with up to 10.4 million US dollars, a statement issued on September 11, 2025, said. The International Vaccine Institute (IVI) will serve as the study sponsor, while the Institut National pour la Recherche Biomédicale (INRB) in the DRC will co-sponsor and also lead the research and the Japan Institute for Health Security (JIHS) will act as a co-investigator.

The study is supported by the DRC Ministry of Health and the Institut National de Santé Publique (INSP) and is expected to begin this Autumn once regulatory and ethics approvals are completed.

Researchers will monitor vaccinated people in hotspot health zones in Équateur Province. They will track how many still get infected and also collect safety data from a subset of participants.

The findings are expected to guide vaccination strategies in the DRC and other Mpox-endemic regions. They could also help decide which age groups should be prioritized for vaccination.

Japan has donated three million doses of LC16m8 to DRC to protect at-risk populations. The vaccine, developed by KM Biologics, has been licensed in Japan for decades as a smallpox vaccine. It is safe and effective, including in people with well-controlled HIV.

The DRC Health Minister, Samuel Roger Kamba, said the country will be the first in Africa to collect real-world field data on the vaccine.

“The epidemiological data on Mpox have enabled us to support the response with vaccination of the populations. With this collaborative research, the DRC will be the first African country to collect essential field data on the use of the LC16m8 vaccine against Mpox.”

Dr. Manabu Sumi of Japan’s Health Ministry said LC16m8 is the only Mpox vaccine currently approved for children and could protect people of all ages.

“Building on the findings of this trial and Japan’s accumulated experience, the Ministry looks forward to working with international partners to further enhance LC16m8’s contribution to global preparedness and response efforts against Mpox.”

Africa CDC Director-General, Dr. Jean Kaseya, described the study as “a vital step in protecting Africa’s most vulnerable, especially children.”

“By turning science into action, we are building the evidence needed to guide vaccination and strengthen health security across the continent.”

Other partners, including INRB and JIHS, stressed that the project will also strengthen Africa’s ability to respond to future health emergencies.

Director-General of INRB and Principal Investigator, Prof. Jean-Jacques Muyembe, said scientific collaboration is key.

“The results generated by this study will serve as an effective guide for future Mpox outbreaks,” he said.

Dr. Norio Ohmagari of JIHS said the trial will provide rigorous real-world evidence, while Dr. Mugen Ujiie of the same institute highlighted Japan’s commitment to protecting communities from Mpox.

“The findings will help inform equitable and effective vaccination strategies across affected regions,” Dr Ujiie said.

The International Vaccine Institute’s Deputy Director General, Dr. Florian Marks, added that the study will also help build local research capacity.

“In close partnership with INRB, JIHS, CEPI, and local health teams, we are also working to strengthen local research capacity so that communities are better equipped to respond to future health emergencies,” he said.

General Director of INSP, Dr. Dieudonné Mwamba, said vaccination remains a key pillar in responding to epidemics.

Mpox, formerly known as monkeypox, causes fever, headache, muscle aches, swollen lymph nodes and skin rashes with blisters. The disease can be deadly in severe cases.

WHO and Africa CDC declared the ongoing outbreak a global and continental emergency in August 2024. As of September 2025, Mpox remains a continental health emergency in Africa.

Source: Mahmud Mohammed-Nurudeen  

The European Centre for Disease Prevention and Control (ECDC) has updated its recommendations in response to outbreaks of a new strain of the virus. Other continents, including Europe, can expect some cases too, it says.

ECDC says the risk of it spreading everywhere is low, despite the World Health Organization recently declaring the mpox situation a global emergency.

The disease – formally known as monkeypox – can be passed on by close contact with anyone with the infection.

Those who have been vaccinated against mpox in the past might only need one-top up dose, rather than two shots.

Booster vaccine doses are typically recommended every two to 10 years if a person remains at continued risk for exposure.

Mpox has killed at least 450 people in the DRC in recent months, linked to a new type or Clade called 1b.

What’s known about mpox

Mpox can be passed on from person to person through:

• any close physical contact with mpox blisters or scabs (including during sexual contact, kissing, cuddling or holding hands)
• touching clothing, bedding or towels used by someone with mpox
• the coughs or sneezes of a person with mpox when they’re close to you

It causes flu-like symptoms, skin lesions and can be fatal for some.

Experts say there is still a lot to learn about 1b, but it may be spreading more easily, causing more serious disease.

Pamela Rendi-Wagner from the ECDC said: “As a result of the rapid spread of this outbreak in Africa, ECDC has increasd the level of risk for the general population in the EU/EEA and travellers to affected areas. Due to the close links between Europe and Africa we must be prepared for more imported Clade 1 cases.”

Currently, there are no cases of Clade 1b mpox confirmed in the UK but experts say cases can spread if international action is not taken.

A case of mpox has also been detected in Sweden after a person became infected during a stay in an area of Africa where the disease is spreading.

The ECDC recommends that public health authorities plan and prepare for quick detection of any more cases that may reach Europe.

A previous mpox public health emergency, declared in 2022, was caused by a different, milder strain called Clade 2.

Despite having effective vaccines against mpox, too few doses are currently getting to where they are needed most.

Source: BBC

ALSO READ:

• Mpox outbreak: GHS to begin screening for travellers [Audio]

• 15 African countries record Mpox cases; here’s all you need to know