DEPARTMENT OF THE ARMY, THE SURGEON GENERAL (DA-TSG)-SPONSORED ASSAY SUPPORTS FIRST-EVER FDA-APPROVED EBOLA VACCINE IN U.S.
Posted by: Press Release |
Dec 23, 2019 |
JPM CBRN Medical’s filovirus program plays key role in Ebola vaccine’s FDA approval
FORT DETRICK, Md. – The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical’s (JPM CBRN Medical) involvement with today’s U.S. Food and Drug Administration (FDA)-approval of the world’s first Ebola vaccine contributed to a leap forward in protecting both the warfighter and civilian populations from the deadly, naturally-occurring Ebola virus.
On Dec. 20, 2019, pharmaceutical company Merck Sharp & Dohme received FDA-approval of their Ebola vaccine, Ervebo, known in the U.S. as “V920.” This FDA approval follows closely behind the Nov. 10, 2019 marketing authorization granted by the European Commission. Ervebo has been in development since the Ebola outbreak in West Africa in 2014.
The JPM CBRN Medical’s filovirus program played a key role in filling the gap between two regulatory agencies by providing access to the contents of the Filovirus Animal Non-Clinical Group (FANG) Zaire Ebolavirus (EBOV) Enyzme-Linked Immunosorbent Assay (ELISA) DOD-led Master File 16537. In 2016, the FDA found the FANG EBOV ELISA was adequate for its intended use of testing human samples. Two years later, the FDA concurred that the same FANG EBOV ELISA was adequate for testing of non-human primate (NHP) samples. Analysis of both human and NHP samples in the same assay permitted immunobridging comparisons between NHPs and humans, a critical component for licensure of vaccines under the FDA’s Animal Rule.
The JPEO-CBRND’s JPM CBRN Medical worked closely with several key partners in leading this effort, including the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Walter Reed Army Institute of Research (WRAIR), and the Defense Threat Reduction Agency (DTRA). JPM CBRN Medical's ability to respond quickly to the outbreak in 2014, and its ongoing collaborative efforts with the U.S. Department of Health and Human Services (HHS), the Biomedical Advanced Research and Development Authority (BARDA), and Merck to see this product receive both European Union and U.S. approval, highlights the value of the CBRN defense enterprise as a whole. About the JPM CBRN Medical: The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability.
About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological, and nuclear defense equipment and medical countermeasures. As an effective acquisition program, JPEO-CBRND puts capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force, enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment, championed by innovative and state-of-the-art solutions.