SK bioscience has secured a key role in a major US-backed initiative to develop a vaccine against the deadly Bundibugyo strain of Ebola, joining a global partnership supported by $36 million in funding from the US Biomedical Advanced Research and Development Authority (BARDA).

 

The project, involving global biomedical research organisation IAVI, Hilleman Laboratories and Germany-based IDT Biologika, is part of a contract valued at up to $99 million (approximately KRW 130 billion) awarded by the US Department of Health and Human Services (HHS).

 

The partnership will accelerate vaccine development, manufacturing and clinical evaluation, with the goal of producing a single-dose vaccine capable of rapidly triggering immunity against Bundibugyo virus (BDBV).

 

The urgency is underscored by the scale of the latest outbreak, which has been spreading primarily in the Democratic Republic of the Congo (DRC). As of October 25, the outbreak had recorded 10,060 confirmed cases and 4,887 deaths, translating into a case fatality rate of 48%.

 

It is the second-largest Ebola outbreak on record and the largest ever involving the Bundibugyo strain. Despite the mounting threat, no approved vaccine or specific treatment is currently available for BDBV infection.

 

Under the partnership, each organisation will bring specialised expertise to accelerate the vaccine programme and establish a reliable global supply network.

 

IAVI will oversee the overall programme, clinical development, regulatory engagement with agencies including the US Food and Drug Administration (FDA), and outbreak preparedness strategy.

 

Hilleman Laboratories will manufacture the initial clinical vaccine supplies using an advanced manufacturing process before leading the subsequent technology transfer.

 

SK bioscience will take charge of process scale-up and large-scale manufacturing of investigational vaccine doses, while its German subsidiary, IDT Biologika, will handle fill-and-finish operations.

 

IDT will draw on its established expertise in aseptic filling, processing and final product manufacturing to support the programme, strengthening manufacturing synergies across SK bioscience's global contract development and manufacturing organisation (CDMO) network.

 

BARDA funding will support clinical and regulatory activities, including a Phase 1 clinical trial, alongside vaccine production for outbreak response and broader health security preparedness. The programme will also support the development of an updated vaccine targeting a 2026 variant strain.

 

The BARDA-backed initiative builds on ongoing vaccine development efforts by IAVI and Hilleman Laboratories, supported by the Coalition for Epidemic Preparedness Innovations (CEPI).

 

While CEPI funding is focused on accelerating development and manufacturing of vaccine candidate doses for outbreak control and response, the BARDA award adds a broader emphasis on strengthening long-term preparedness and ensuring supply capacity for future emergencies.

 

The partners will leverage the recombinant vesicular stomatitis virus (rVSV) platform, the same technology used in the Zaire ebolavirus vaccine, which has demonstrated safety and efficacy and received World Health Organization (WHO) prequalification.

 

SK bioscience is also collaborating with MSD, Hilleman Laboratories, CEPI and other international partners to develop a next-generation Zaire Ebola vaccine and improve its manufacturing processes.

 

Mark Feinberg, president and CEO of IAVI, said, “By supporting efforts to address the current Bundibugyo virus epidemic and strengthen preparedness for future outbreaks, this BARDA award strengthens partnerships, capabilities, and this vaccine candidate. 

 

"IAVI is bringing together organizations with highly complementary capabilities to accelerate development of a vaccine candidate that addresses a critical unmet public health need. By combining IAVI´s expertise in rVSV vaccine development, clinical advancement, regulatory engagement, and outbreak preparedness with our partners´ manufacturing capabilities, we are working to strengthen preparedness for future Bundibugyo virus outbreaks.”

 

Raman Rao, CEO of Hilleman Laboratories, said, “Vaccine manufacturing is incredibly complex, and it takes a village to make the entire value chain work. Working closely with IAVI, SK bioscience, IDT Biologika, and MSD, Hilleman Laboratories is focused on supplying clinical trial material and advancing technology transfer for manufacturing at scale. The strength of this partnership lies in the diversity of expertise each organization brings, united by the commitment to delivering an effective single-dose vaccine for outbreak response.”

 

Sally Choe, CEO of IDT Biologika, said, “IDT Biologika is proud to be part of this important initiative. Together with our partners, we are helping to strengthen global preparedness for Ebola outbreaks and ensure access to potentially life-saving vaccines.”

 

Jaeyong Ahn, President and CEO of SK bioscience, said, “Proactively preparing for infectious disease threats requires sustained efforts to strengthen vaccine development and manufacturing capabilities. This project brings together SK bioscience’s vaccine development expertise and IDT’s manufacturing capabilities with the complementary strengths of our global partners. By working closely with our partners to accelerate vaccine development and strengthen reliable supply capacity, we aim to contribute to global preparedness for future infectious disease outbreaks.”

 

The latest partnership adds momentum to SK bioscience's broader push to expand its infectious disease response portfolio through collaborations with international organisations and pharmaceutical companies.

 

The company's global Phase 3 clinical trial of a 21-valent pneumococcal conjugate vaccine, being jointly developed with Sanofi, is progressing as planned.

 

SK bioscience has also secured a technology licence agreement for an injectable rotavirus vaccine candidate developed by the US Centers for Disease Control and Prevention (CDC), with subsequent clinical development and commercialisation now advancing.

 

In addition, the company is working with the Gates Foundation, CEPI, the Korea Disease Control and Prevention Agency (KDCA) and other partners on next-generation public health programmes, including an RSV preventive antibody and a broadly protective coronavirus vaccine.

 

Through these initiatives, SK bioscience is seeking to expand its vaccine development and manufacturing capabilities while strengthening its position in the global infectious disease preparedness landscape.