NEW YORK, NY, SINGAPORE, SG INCHEON, SOUTH KOREA, AND DESSAU-ROSSLAU, DE / ACCESS Newswire / October 28, 2026 / Today 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.[1]

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.

This ASPR-BARDA-supported program complements ongoing development activities by IAVI and Hilleman, funded by the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI's funding supports activities intended to accelerate the development and manufacturing of BDBV vaccine candidate doses for BDBV outbreak control and response. The BARDA award, in addition to bolstering outbreak response, focuses on manufacturing readiness and stockpile supply. Both investments seek to strengthen longer-term preparedness, for Bundibugyo virus outbreaks.

"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," said Dr. Mark Feinberg, president and CEO of IAVI. "IAVI is bringing together organizations with highly complementary capabilities to accelerate development of our vaccine candidate, which 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."

"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," said Dr. Raman Rao, CEO of Hilleman Laboratories.

"Proactively preparing for infectious disease threats requires sustained efforts to strengthen vaccine development and manufacturing capabilities," said Jaeyong Ahn, CEO of SK bioscience. "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."

"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," says Dr. Antje Ksienzyk, Head of Global Portfolio & Strategy, IDT Biologika.

The rVSV platform underlying this vaccine candidate has been successfully applied in MSD's licensed and World Health Organization-prequalified vaccine for prevention of disease caused by Ebola virus. IAVI's expanding rVSV-based emerging infectious disease vaccine portfolio also includes vaccine candidates targeting Sudan virus, Lassa virus, Marburg virus, and Crimean-Congo hemorrhagic fever virus.

The World Health Organization previously identified IAVI's one-dose rVSV-based BDBV vaccine candidate as the most promising Bundibugyo vaccine in development. The rVSV-BDBV vaccine candidate being developed by IAVI has demonstrated high-level protective efficacy that manifests within days of vaccination in nonhuman primate studies and has not yet been evaluated in humans.[2, 3, 4]

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005.

About the vaccine candidate

The rVSV-based BDBV vaccine candidate originates in research by Andrea Marzi, Ph.D., and Heinz Feldmann, M.D., Ph.D., and their teams at the Laboratory of Virology, National Institute of Allergy and Infectious Diseases, and was first tested in non-human primates by Thomas Geisbert, Ph.D., of The University of Texas Medical Branch. The candidate has demonstrated protective efficacy in nonhuman primate studies, including in pre-exposure and post-exposure research.

The candidate is designed to be administered in a single dose. Single-dose vaccines may offer practical advantages during outbreaks by allowing rapid vaccination without the logistical requirements of a multidose regimen.

Key points for journalists:

BARDA awards IAVI US $36 million of a contract valued up to US $99 million to advance development, manufacturing, and preparedness activities for IAVI's rVSV-based BDBV vaccine candidate.

IAVI leads the program and is responsible for clinical development, regulatory strategy, FDA engagement, outbreak preparedness, and stockpile readiness.

The award brings together IAVI, Hilleman Laboratories, SK bioscience, and IDT Biologika, combining complementary expertise in vaccine development and manufacturing.

The partners will advance updated manufacturing approaches designed to improve scalability, cost efficiency, and preparedness for future outbreaks.

Initial manufacturing activities will support clinical evaluation and outbreak response, with options for expanded production to support future preparedness requirements as well as development of a vaccine candidate based on the 2026 Bundibugyo outbreak viral variant.

The BARDA-supported program complements ongoing CEPI-funded activities focused on accelerating the development of Bundibugyo virus vaccines in response to the outbreak in the DRC and preparing for future epidemics.

Notes

[1] The BDBV vaccine currently in early-stage development is based on the virus strain identified in the 2007 BDBV outbreak. The new BARDA funding will also support the development of an updated version of the vaccine designed to match the viral variant responsible for the 2026 outbreak. CEPI and the Government of the Netherlands supported the laboratory construction of a rVSV-BDBV vaccine that incorporates the BDBV glycoprotein from the 2026 virus for use in immunologic assays that will be used to characterize vaccine-elicited neutralizing antibody responses.

[2] Mire CE, Geisbert JB, Marzi A, Agans KN, Feldmann H, Geisbert TW. Vesicular stomatitis virus-based vaccines protect nonhuman primates against Bundibugyo ebolavirus. PLoS Neglected Tropical Diseases. 2013 Dec 19;7(12):e2600.

[3] O'Donnell KL, Haase JA, Henderson CW, Gathright BR, Fletcher P, Rhoderick JF, et al. A single-dose Bundibugyo virus vaccine protects macaques within 3 days [preprint]. bioRxiv. 2026 Jun 15. doi:10.64898/2026.06.14.732188.

[4] Woolsey et al. A recombinant vesicular stomatitis virus-based vaccine provides postexposure protection against Bundibugyo ebolavirus infection. J Infect Dis. 2023 Nov 15;228(Suppl 7):S712-S720.

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About IAVI

IAVI is a global nonprofit biomedical research organization dedicated to translating scientific discoveries into vaccines, antibodies, and other interventions that address urgent global health challenges. IAVI works with partners in Africa, India, Europe, and the U.S. to advance research and development for HIV, tuberculosis, and emerging infectious diseases, and to strengthen the scientific and clinical capabilities needed to make biomedical innovation accessible to the people and communities who need it most. For more information, visit www.iavi.org.

About Hilleman Laboratories
Hilleman Laboratories was established in 2009 as a joint venture between MSD, a global research-driven biopharmaceutical company, and Wellcome, a global charitable foundation dedicated to human and animal health. Hilleman Laboratories' mission is to develop affordable vaccines and biologics against infectious diseases that affect low- and middle-income countries.

The company's expertise in end-to-end product development is targeted at creating novel vaccines and biologics in areas of high unmet need as well as adapting existing vaccines and biologics with more effective delivery tools to meet challenging environments in developing countries. Hilleman Laboratories also seeks to collaborate with local, regional, and global partners and stakeholders, including policymakers and governments, to facilitate wider, affordable access to life-saving vaccines and biologics.

About SK bioscience
SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions.

About IDT Biologika
IDT Biologika was founded in 1921 and is one of the world's leading contract development and manufacturing organizations (CDMOs), specializing in the development and manufacture of vaccines and complex biologics. The company's extensive expertise encompasses viral vector technologies, live and recombinant vaccines, and other biologics with high safety requirements, making IDT a preferred partner for global vaccine programs and public health initiatives. Over the past two decades, IDT Biologika has played a central role in addressing international health emergencies and vaccine shortages.

IAVI media contact
Karie Youngdahl
Head, Global Communications
kyoungdahl@iavi.org

Hilleman Laboratories media contact
communications@hilleman-labs.org
marcher@globalhealthstrategies.com

SK bioscience media contacts
Changhyun Jin
jin99@sk.com
Tae-Gyun Kim
taegyunkim@sk.com
Moonchel Kim
mc_kim@sk.com

IDT Biologika media contact
communications@idt-biologika.de

SOURCE: IAVI

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