In a critical move to combat a deadly outbreak, the Sabin Vaccine Institute has dispatched more than 640 doses of its investigational Marburg virus vaccine to Ethiopia. The delivery, confirmed on December 4, 2025, supports the country's first-ever response to Marburg virus disease, a severe and often fatal illness.
Responding to a High-Stakes Outbreak
The Ethiopian Ministry of Health confirmed Marburg as the cause of a hemorrhagic fever outbreak in the country's southern region. Marburg virus disease is highly contagious and can have a case fatality rate as high as 88%. Currently, there are no approved vaccines or specific treatments available globally, heightening the urgency of the response.
Following the confirmation, Ethiopian health officials directly engaged with Sabin and the U.S. government to request access to the investigational vaccine, known as cAd3-Marburg. This request received approval from U.S. authorities, enabling the rapid shipment.
A Coordinated Clinical Trial Effort
Sabin and the Ethiopia Ministry of Health have established a clinical trial agreement to evaluate the vaccine candidate. The effort is funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.
The trial will be a Phase 2, rapid-response, open-label, and randomized study designed to assess the vaccine's safety, efficacy, and immunogenicity. It will involve two cohorts:
- Cohort A: Limited to high-risk individuals, including healthcare workers, frontline responders, and people who had direct contact with an infected person within the 21-day incubation period.
- Cohort B: Will include other healthcare workers and contacts, who will be randomized to receive the vaccine either on the first day of the trial or on day 22.
"We've built on our previous outbreak response experience to quickly assist our Ethiopian colleagues as requested," stated Sabin Chief Executive Officer Amy Finan, highlighting the partnership with Ethiopian Health Minister Dr. Mekdes Daba.
Building on Past Experience and Current Concerns
This response mirrors a similar effort in 2024, when Sabin, with authorization from the U.S. Administration for Strategic Preparedness and Response (ASPR), provided its vaccine candidate to Rwanda during an outbreak. The current operation involves the same coalition of partners, including manufacturer ReiThera, clinical research organization IQVIA, and the Coalition for Epidemic Preparedness Innovations (CEPI).
As of the latest update, Ethiopian authorities have confirmed 13 Marburg infections and eight deaths. An additional three deaths are suspected to be linked to the virus but are not yet confirmed. A significant concern for officials is the outbreak's proximity to neighbouring countries with fragile health systems, including Kenya and South Sudan, raising the stakes for containing the virus quickly.
The delivery of these investigational vaccine doses represents a pivotal step in using cutting-edge, yet unlicensed, medical tools during a public health emergency, underscoring the global collaboration required to tackle rare but devastating diseases.
