Merck will provide the investigational vaccine based on a proven platform technology
NEW YORK – OCTOBER 25, 2022 – IAVI, a nonprofit scientific research organization, and Merck, known as MSD outside the United States and Canada, intend to enter into an agreement that could enable IAVI to accelerate the entry of a promising Sudan ebolavirus (SUDV) vaccine candidate that IAVI is developing into clinical evaluation in response to the rapidly spreading outbreak of SUDV disease in Uganda.
Merck plans to produce and provide to IAVI vials of candidate vaccine from existing investigational drug substance to supplement IAVI’s ongoing SUDV vaccine development program. The investigational vaccine being produced is based on the same vesicular stomatitis virus (VSV) viral vector platform that is used in ERVEBO®, Merck’s efficacious, single-dose Zaire ebolavirus (EBOV) vaccine that has achieved regulatory approval by the U.S. FDA, the European Medicines Agency (EMA), and a number of regulatory authorities in Africa.
IAVI and Merck have been in discussions with the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), and other stakeholders regarding the potential production and supply of doses of investigational SUDV vaccine to help support the WHO’s efforts to conduct a clinical trial of vaccine candidates in Uganda, in partnership with the Government of Uganda.
Mark Feinberg, M.D., Ph.D., president and CEO of IAVI, said, “We are grateful to Merck for producing and supplying the vaccine candidate, and we look forward to the opportunity to demonstrate vaccine effectiveness and safety so that we are prepared for future outbreaks of SUDV, as well as the SUDV outbreak in Uganda should it not be promptly contained by public health measures alone. Outbreak response is more effective at containing disease spread when countermeasures work quickly, and we are hopeful that this one-dose vaccine, which is likely to generate a rapid immune response, will be a critical part of Sudan virus containment efforts in the future.”
“We are proud to work together with IAVI in support of the World Health Organization’s response to address the Sudan Ebola outbreak in Uganda,” said Beth-Ann Coller, executive director, Global Clinical Development Vaccines, Merck Research Laboratories. “We are moving with urgency to prepare these vials and donate them to IAVI as quickly as possible to help support the efforts of the WHO and the people of Uganda as they grapple with this outbreak.”
Production schedules and quantities are still being defined. Based on the quantities of available bulk drug substance and current plans, Merck hopes to be able to deliver approximately 50,000 doses by the end of the year. IAVI is actively working to accelerate the manufacture of additional doses of IAVI’s VSV-SUDV vaccine should they be needed. The number of doses provided by Merck should be sufficient for conducting Phase I and efficacy studies as well as for public health response if the outbreak in Uganda continues or spreads and should the vaccine be shown to be safe and efficacious.
IAVI will act as developer and regulatory sponsor and will be responsible for all aspects of future development of the vaccine candidate.
No SUDV vaccines have been approved to date, and existing EBOV vaccines and treatments are not effective against SUDV. In the midst of the ongoing SUDV disease outbreak, ensuring that all promising vaccine candidates are evaluated for safety and efficacy could enable vaccine stockpiles to be established for use in future outbreaks.
Vesicular stomatitis virus is the vector that underpins ERVEBO® as well as IAVI’s portfolio of emerging infectious disease vaccine candidates. These include the SUDV vaccine candidate supported by the Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services; a Lassa fever virus vaccine candidate currently in a Phase I trial and supported by the Coalition for Epidemic Preparedness Innovations (CEPI) and the European & Developing Countries Clinical Trials Partnership (EDCTP); a Marburg virus vaccine candidate supported by the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DOD) and BARDA; and an intranasal SARS-CoV-2 vaccine candidate supported by the Japan Ministry of Finance. VSV is a harmless animal virus; in the vaccine platform, it is engineered to encode a surface protein from a target pathogen — in this case, SUDV — that stimulates an immune response.
IAVI holds a nonexclusive license to the VSV vaccine candidates from the Public Health Agency of Canada (PHAC). The vector was developed by scientists at PHAC’s National Microbiology Laboratory.
Funders who have made the development of IAVI’s VSV-vectored vaccine candidates possible include the Bill & Melinda Gates Foundation; the Government of Canada; the Danish Ministry of Foreign Affairs; the Government of Japan; the Irish Department of Foreign Affairs and Trade; the Netherlands Ministry of Foreign Affairs; the Norwegian Agency for Development Cooperation; the U.K Department for International Development; the U.S. National Institutes of Health (NIH); and through the generous support of the American people from the United States Agency for International Development (USAID).