The development of a vaccine to prevent Ebola virus disease will be accelerated with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
Under a one-year contract with Profectus BioSciences Inc., headquartered in Baltimore, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide approximately $5.8 million in funding, in addition to subject matter expertise and technical assistance, to further develop an experimental Ebola vaccine. The company will manufacture vaccine for use in animal safety studies and future clinical trials and conduct animal studies to test safety. The contract can be extended to a total of 13 months and $8.6 million.
Upon successful completion of this work, the company is expected to submit an investigational new drug application to the U.S. Food and Drug Administration (FDA). This application, once accepted by the FDA, would allow the vaccine to begin the first clinical trials for safety in humans.
“We are pushing hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease,” said BARDA Director Robin Robinson, Ph.D. “Our goal is to close the global gap in vaccines and therapeutics needed to protect the public health from Ebola as highlighted by the epidemic in West Africa.”
The project builds on early research of this experimental vaccine supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and animal studies supported by the Department of Defense. In the DoD-supported studies, a single dose of the experimental Ebola vaccine provided 100 percent protection in non-human primates. BARDA will support further development of the vaccine against the Ebola virus strain responsible for the current epidemic.
Clinical trials are under way with other experimental vaccines. NIAID currently is supporting Phase 1 clinical trials that examine an investigational Ebola vaccine developed by GlaxoSmithKline and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. Phase 2 clinical efficacy trials for these vaccine candidates are expected in 2015.
BARDA also continues to explore how its Centers for Innovation in Advanced Development and Manufacturing, its Fill Finish Manufacturing Network, or other measures can accelerate the manufacturing time for Ebola therapeutics and vaccines.
The agency is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever. Program requirements are described in BARDA’s Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 at https://www.fbo.gov.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
Within ASPR, BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.