SK bioscience Joins U.S.-Backed Bundibugyo Ebola Vaccine Development and Production

Partners with IAVI and Hilleman Laboratories; receives up to $99 million in BARDA funding
SK bioscience to scale up production and manufacture at scale
German subsidiary IDT to handle fill-finish process

With support from the U.S. government, SK bioscience will work with global partners to develop and manufacture a vaccine against Bundibugyo ebolavirus.

SK bioscience said on the 29th that it will participate in a vaccine development project supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) under the U.S. Department of Health and Human Services (HHS), together with the International AIDS Vaccine Initiative (IAVI) and Hilleman Laboratories. The project could receive up to $99 million (approximately 131 billion won), including an initial allocation of $36 million (approximately 47.7 billion won).

The project aims to develop a vaccine against Bundibugyo virus and establish a stable global supply system. The funding will go toward clinical and regulatory activities, including Phase 1 clinical trials; production of vaccines for pandemic response; and supply for health security. The project will also pursue the development of vaccines against variant strains.

SK bioscience's headquarters in Songdo. SK bioscience.

Bundibugyo virus is a type of ebolavirus. According to the source, the Democratic Republic of the Congo (DRC) had recorded a cumulative 10,060 confirmed cases and 4,887 deaths as of late October. As there is currently no vaccine or specific treatment for Bundibugyo virus, the participating organizations aim to develop a vaccine that can trigger a rapid immune response with a single dose.

Each organization will have a role based on its area of expertise. IAVI will oversee the overall program and lead clinical development, engagement with regulatory authorities such as the U.S. Food and Drug Administration (FDA), and pandemic preparedness strategies. Hilleman Laboratories will produce vaccines for early-stage clinical trials and handle technology transfer.

SK bioscience will lead the scale-up of the vaccine production process and large-scale manufacturing. Its German contract development and manufacturing organization (CDMO) subsidiary, IDT Biologika, will handle the fill-finish process, from aseptic filling through final product manufacturing. SK bioscience plans to strengthen its vaccine production capabilities by leveraging its subsidiary's manufacturing expertise.

The project will complement and expand on vaccine development efforts led by IAVI and Hilleman Laboratories with support from the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI has supported the accelerated development and production of vaccine candidates to enable a rapid response and curb the spread of Bundibugyo ebolavirus outbreaks.

The participating organizations plan to accelerate development using the same recombinant vesicular stomatitis virus (rVSV) platform technology as the Zaire ebolavirus vaccine that received prequalification (PQ) from the World Health Organization (WHO). SK bioscience has been working with Merck (MSD) in the United States, Hilleman Laboratories, CEPI and others to develop next-generation Zaire ebolavirus vaccines and improve manufacturing processes.

IAVI President and Chief Executive Officer (CEO) Mark Feinberg said, "This BARDA funding reflects deep confidence in the potential of the vaccine candidate and in the capabilities, technology and commitment of our partners. By combining IAVI's expertise in rVSV vaccine development, clinical trials and regulatory engagement with our partners' manufacturing capabilities, we will strengthen preparedness for future Bundibugyo virus pandemics."

Hilleman Laboratories CEO Raman Rao said, "Close collaboration among organizations is essential to vaccine development and production. Working with our partners, we will arrange the supply of vaccines for clinical trials and transfer technology for large-scale manufacturing, contributing to the development of vaccines that can enable a rapid response to infectious disease outbreaks."

IDT Biologika CEO Sally Choi said, "Through collaboration with our partners, we will help strengthen global preparedness for Ebola outbreaks and improve access to life-saving vaccines."

SK bioscience CEO Ahn Jae-yong said, "To proactively respond to infectious disease threats, it is critically important to continuously secure the foundations for vaccine development and production. Our participation in this project demonstrates that the combined capabilities of SK bioscience and IDT are recognized in the global market." He added, "We will work closely with global partners to accelerate vaccine development and establish a stable supply chain."

SK bioscience is expanding its portfolio of vaccines for infectious disease response through partnerships with global pharmaceutical companies and public institutions. It is conducting a global Phase 3 clinical trial of a 21-valent pneumococcal conjugate vaccine being co-developed with Sanofi and has signed a technology transfer agreement for an injectable rotavirus vaccine candidate developed by the U.S. Centers for Disease Control and Prevention (CDC). It is also working with the Gates Foundation, CEPI, the Korea Disease Control and Prevention Agency (KDCA) and others to develop respiratory syncytial virus (RSV) preventive antibodies and a universal coronavirus vaccine.

This content was produced with the assistance of AI translation services.