The U.S. Department of Health and Human Services (HHS) will support the simultaneous development of individual vaccine candidates against Marburg virus and Sudan ebolavirus infections. Both diseases are caused by potentially deadly filoviruses, the same family of viruses that includes the Ebola virus currently affecting communities in the Democratic Republic of the Congo.
To help the United States prepare for and respond to these potential health security threats, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), initially will provide The Albert B. Sabin Vaccine Institute Inc. of Washington, D.C., with approximately $20.5 million and technical expertise to develop the vaccine candidates.
“The Sabin Vaccine Institute’s use of a single well-established platform for the Sudan ebolavirus and Marburg vaccines will help to expedite the clinical development process so that the vaccines are available more rapidly,” said BARDA Director Rick Bright, Ph.D. “In addition, by supporting development of both vaccines simultaneously, BARDA is taking critical steps forward in protecting Americans from these potentially deadly viruses that could emerge and cause outbreaks at any time.”
Under the contract, the Sabin Vaccine Institute (Sabin) will conduct nonclinical studies and complete manufacturing activities to advance the development of both vaccines. BARDA has the option to provide additional funding to advance both vaccine candidates through Phase 2 clinical development.
Developing the vaccines simultaneously allows Sabin to use the same manufacturing platform, which could speed development and be more cost effective than developing one vaccine and then the other independently. The manufacturing platform was used by GlaxoSmithKline (GSK), in partnership with National Institute for Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to develop a vaccine for Ebola Zaire during the 2014-16 West Africa Ebola outbreak. Prior to that outbreak, NIAID also sponsored vaccine studies through early stage clinical evaluation. GSK recently licensed the platform to Sabin for development of the Sudan ebolavirus and Marburg vaccines .
The Sudan ebolavirus vaccine candidate is the first for this virus strain to receive BARDA support, and the Marburg vaccine candidate is the second to receive BARDA support. Together, they will represent key enhancements in the U.S. preparedness posture for the threats posed by Marburg virus and Sudan ebolavirus.
The most recent outbreaks of Marburg occurred in 2012, 2014 and 2017 in Uganda, Africa, where more than 25% of people infected died. The last Sudan ebolavirus outbreak also took place in Uganda in 2012, killing 57% of people infected. The viruses continue to pose potential public health and biodefense threats.
In addition to these two development projects, BARDA is supporting the development and procurement of vaccines, therapeutics, and diagnostics against the Ebola virus strain currently circulating in the Democratic Republic of the Congo.
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, devices, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. For more about ASPR and BARDA, visit www.phe.gov/aspr, and to learn more about partnering with BARDA, visit www.medicalcountermeasures.gov.