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 (JPM CBRN Medical) entered into a Letter of Agreement for Materials and Information Transfer with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical companies of Johnson & Johnson on October 2, 2019. The Agreement defines assay validation submission protocol and reporting processes to the European Medicines Agency, and potentially other foreign regulatory agencies and authorities, to expedite its review of Janssen’s vaccine.
The Department of the Army, Surgeon General, developed these assays to support the nonclinical and clinical evaluation of immunogenicity of a vaccine protecting against Ebola Virus Disease (EVD). JPEO-CBRND entered into a similar agreement with Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co., Inc., to support regulatory submissions for their vaccine, and works with other partners to end the outbreak. Due to the world's second largest outbreak of EVD, currently ongoing in the Democratic Republic of Congo (DRC), there is an urgent medical need to accelerate review and approval of the Janssen Ebola vaccine and other medical countermeasures against EVD.
JPM CBRN Medical has a similar agreement in place with Merck to cross reference the Army Surgeon General's index on assays that evaluate the immunogenicity of vaccines in support of regulatory submissions. While Merck’s vaccine is the current standard vaccine used against the Ebola outbreak in the DRC, both the DRC and Rwanda are piloting the use of the Janssen vaccine as a secondary source of protection. JPEO-CBRND is also supporting Janssen’s Phase II clinical trial of the vaccine under a separate contract.
Under the Agreement, Janssen will share communications from regulatory authorities to aid DOD in ongoing Ebola vaccine and treatment development efforts. In addition to this Agreement, the JPM CBRN Medical supports efforts countering EVD through a broad spectrum antiviral meeting U.S. military requirements, developing vaccines for biodefense, and supporting interagency efforts through collaboration on other vaccines and treatments.
“This Agreement is a step forward towards licensing critical vaccines to address the global threat of Ebola,” said Col. Ryan R. Eckmeier, Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical. “The JPM CBRN Medical collaborates with like-minded agencies and industry partners to streamline development efforts and reduce timelines, putting safe and efficacious medical products into the hands of the warfighter.”
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, WE PUT 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