IAVI awarded $36 million from BARDA for Bundibugyo virus vaccine development

, , ,

On Oct. 28, 2026, IAVI, a global nonprofit biomedical research organization, together with partners Hilleman Laboratories, SK bioscience, and IDT Biologika announced that IAVI has been awarded US $36 million of a contract valued up to US $99 million from the Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to advance development, manufacturing, and clinical evaluation of its one-dose vaccine candidate against Bundibugyo virus (BDBV), the cause of the ongoing Ebola epidemic in the Democratic Republic of the Congo (DRC).

The award supports manufacturing of vaccine doses for clinical evaluation and outbreak response, clinical and regulatory activities including a Phase 1 trial, and options for expanded manufacturing to support future preparedness needs, as well as development of an updated vaccine candidate based on the viral variant causing the 2026 Bundibugyo outbreak.

With 10,060 confirmed cases and 4,887 deaths as of October 25, 2026, the current epidemic in the DRC is the second largest Ebola outbreak on record and is likely to become the largest ever. There are currently no approved vaccines or specific treatments for disease caused by BDBV, and development of a one-dose vaccine with rapid onset of immunity is a major unmet need. The goal is to provide the BDBV vaccine for use in a planned ring vaccination trial in the DRC after Phase 1 evaluation.  

Under IAVI’s leadership, the ASPR/BARDA-funded program aims to bring together four organizations to leverage their complementary capabilities across product development, manufacturing innovation, and large-scale vaccine production. IAVI will lead overall program development, clinical development, regulatory strategy, U.S. Food & Drug Administration (FDA) engagement, and preparedness planning. Hilleman Laboratories, a Singapore-based joint venture of biopharmaceutical company MSD and charitable foundation Wellcome, is set to produce initial vaccine doses for clinical evaluation, adapting the updated manufacturing process currently in development for MSD’s WHO-prequalified Ebola virus (formerly Zaire ebolavirus) vaccine. Hilleman would also facilitate technology transfer to enable larger-scale manufacturing, if BARDA exercises that option. SK bioscience, an innovative Korean vaccine and biotech company, would lead manufacturing scale-up activities to generate a  supply of the investigational vaccine. IDT Biologika, a Germany-based CDMO and subsidiary of SK bioscience, would carry out fill-finish of doses to be stockpiled. MSD will provide technical assistance in support of vaccine manufacturing efforts.

The collaboration will build on IAVI’s extensive experience advancing recombinant vesicular stomatitis virus (rVSV)-based vaccine candidates for epidemic-prone diseases and the expertise of Hilleman, SK bioscience, and IDT in vaccine process development, commercial manufacturing, and global vaccine supply. Together, the organizations aim to advance updated manufacturing approaches designed to increase scalability, reduce production costs, and support improved access to vaccines for outbreak response and preparedness.

Tags:


Source: IAVI
Credit:

Advertise in our E-history sent to 5,000 plus company decision makers twice per month for only $300 per month. Reserve your space now! E-mail: info@LifeScienceHistory.com.