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EMA, AMA, and national regulatory authorities in Africa are working on potential clinical trial designs and medical treatments for the Ebola outbreak in the DRC and Uganda.
The European Medicines Agency (EMA) announced on June 3, 2026 that the agency’s Emergency Task Force (ETF) is discussing clinical trial designs and medical countermeasures to the Ebola outbreak in the Democratic Republic of the Congo (DRC) and Uganda with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs).1 The organizations are leveraging expertise from the World Health Organization (WHO)-AFRO African Vaccines Regulatory Forum (AVAREF) to address the Ebola outbreak caused by the Bundibugyo virus. The collaboration, the first since the AMA was started, will support “efficient, coordinated and timely regulatory responses to the outbreak”1 that will build on experience gained from previous Ebola outbreaks, joint reviews conducted by the AVAREF, and EMA operations.
WHO declared the Ebola outbreak caused by the Bundibugyo virus an international public health emergency on May 17, 2026.2 No authorized vaccines or treatments currently exist for Bundibugyo virus disease, and existing countermeasures that target the Zaire Ebola virus might not be effective, according to EMA.1 The agency says there are antivirals and investigational pan-filovirus monoclonal antibodies (mAbs) in development that may be effective against Bundibugyo and should be advanced into clinical trials. “Vaccine candidates should also be rapidly developed and could then be progressed into late-stage clinical trials by establishing regulatory criteria that would ensure both scientific rigor and speed,” the agency stated in the press release.
EMA’s ETF has been investigating potential treatment candidates, alongside treatment developers and WHO, and has identified 3 possible vaccine candidates, 3 possible treatment candidates, and 1 potential post-exposure prophylaxis (antiviral obeldesivir).
The 3 vaccine candidates include a recombinant vesicular stomatitis virus (rVSV)-based Bundibugyo vaccine, a Bundibugyo virus vaccine using the ChAdOx1 modified adenovirus platform, and a messenger RNA vaccine. The treatment candidates are MBP-134, a combination of 2 mAbs active against different ebolaviruses including Bundibugyo virus, the antiviral remdesivir, and the mAb maftivimab.
Discussions with developers, academia, and funders to advance these medical countermeasures have already begun. The organizations involved are looking at the aspects of development and critical trial design to demonstrate safety and efficacy of the potential treatments and vaccines. These discussions include the potential for different uses of the products, including prophylaxis and post-exposure prophylaxis. “Prompt and flexible regulatory decisions that are anchored on solid scientific evidence are key to ensure an effective public health response in the context of this emergency,” EMA stated in the release.
The European Centre for Disease Prevention and Control (ECDC) stated on its website that the outbreak continues to impact the DRC and Uganda. The DRC Ministry of Health reported that there is a total of 344 confirmed cases that include 60 deaths, and 116 suspected cases as of June 1, 2026. The most affected province is Ituri, with 322 confirmed cases. Uganda has reported 15 confirmed cases and one death. The ECDC stresses that the risk of cases in the EU/EEA is “very low”.3
“National authorities, in collaboration with WHO and partners, are implementing response measures including deployment of rapid response teams, delivery of medical supplies, strengthened surveillance, laboratory confirmation, infection prevention and control, the set-up of safe and optimized treatment centers, and community engagement,” WHO states on its website.4