Biomedical Advanced Research and Development Authority

The office manages Project BioShield, which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (CBRN) attacks.[1]: 267 BARDA works with the biomedical industry, using grants and other assistance, to promote advanced research, innovation and the development of medical devices, tests, vaccines and therapeutics.BARDA plays a unique and unusual role within the structure of the US Federal Government, assisting in getting drugs, deemed essential during public health emergencies including attacks compromising US national security, to market.Such assistance ranges from direct funding, procuring and stockpiling medical countermeasures (MCM’s), to helping obtain US FDA approvals, including Emergency Use Authorization (EUA) if needed.Its goal is to provide multiple product candidates in each program to both account for attrition in medical countermeasure deployment and to establish multi-product/multi-manufacturer portfolios for sustainability and redundancy.[21] This program aims to support the advanced development of vaccines, therapeutic and diagnostic medical countermeasures that address emerging infectious disease threats.[22] Research into substitute medical countermeasures (MCM) against nerve agents conducted by BARDA has shown the utility of current atropine solutions used in limited quantities in the treatment of cholinergic pathologies, to promote dilation of the eye, or organophosphate poisoning.Noting the lack of sufficient stocks in the case of mass-casualty situations, citing the 1995 Tokyo subway sarin attack, the study proposed alternate routes of administration (ROI) for atropine.[27] The Pandemic and All-Hazards Preparedness Act (PAHPA) established BARDA as the focal point within HHS for the advanced development and acquisition of medical countermeasures to protect the American civilian population against Chemical, Biological, Radiological, and Nuclear (CBRN) and naturally occurring threats to public health.six-year contract to Sanofi Pasteur, a global pharmaceutical company with U.S. headquarters in Bridgewater, New Jersey, to increase production capacity for an influenza vaccine.When state, local, tribal, and/or territorial responders request federal assistance to support their response efforts, the stockpile is used to ensure that supplies are available when and where needed.[36] [37] PAHPA charges BARDA to support innovation to reduce the time and cost of medical countermeasures and product advanced research and development.BARDA has taken this innovation mandate as an opportunity to work with its partners (including NIH, DoD, CDC, industry, and academia) to create new ways to “make medical countermeasure better.” Examples of this approach to innovation could include the development of animal models to support efficacy testing, immune modulation and other broad-spectrum approaches, immunity assessment, and analytical (potency) assays.The division “focuses on contract development & manufacturing for biologics.”[39] Fujifilm Diosynth Biotechnologies, with help from a BARDA grant, invested around $93 million to build a production facility in the US state of Texas.[50] In June 2020, BARDA and the U.S. Department of Defenses signed a $143 million contract with SiO2 Materials Science to ramp up production of vials and syringes used for COVID drugs and vaccines.While the US discontinued immunization in 1972, and it was declared eradicated [55] [56] by the World Health Organization (WHO) in 1980 (the last known naturally occurring case was seen in 1977, in Somalia), it is still considered a potent bioterrorism threat.However BARDA has an announced (general) four-part Zika strategy [62] (such as VX) Table source:[22] The Department of Defense (DoD) and HHS each identify medical countermeasure requirements to address their different missions and focus.On April 20, 2020, during the COVID-19 pandemic in the United States, in an action that led to the filing of a US whistleblower complaint and testimony before the US House of Representatives,[64][65] Rick Bright was asked to step down as Director of BARDA.On January 27, 2021, the U.S. Office of Special Counsel transmitted an investigative report to President Biden confirming whistleblower allegations that ASPR “misappropriated millions of dollars that Congress appropriated for [BARDA] to respond to public health emergencies like outbreaks of Ebola, Zika, and—now—COVID-19.”[67][68] The investigation by the HHS Office of Inspector General (OIG) substantiated whistleblower claims that “ASPR did not always comply with Federal fiscal law when managing BARDA appropriations.”[69] In his transmittal letter, Special Counsel Henry Kerner wrote the President that he was “deeply concerned about ASPR’s apparent misuse of millions of dollars in funding meant for public health emergencies like the one our country is currently facing with the COVID-19 pandemic.
Federal Government of the United StatesHubert H. Humphrey BuildingOffice of the Assistant Secretary for Preparedness and ResponseU.S. Department of Health and Human Servicesmedical countermeasuresbioterrorismchemical, biological, radiological and nuclear (CBRN) threatsPandemic and All-Hazards Preparedness ActProject BioShieldpublic health emergencies U.S. federal governmentbiomedicalPublic Health Emergency Medical Countermeasures EnterpriseStrategic National StockpilePublic Health Service ActAssistant Secretary for Preparedness and ResponsePublic Health Security and Bioterrorism Preparedness and Response Act2001 anthrax attacksSeptember 11, 2001Pandemic and All-Hazards Preparedness Reauthorization Act of 2013Rick BrightCOVID-19 pandemic in the United Statesbusiness acceleratorEmergency Use Authorizationventure capitalistsPHEMCEcongressionalantibiotic-resistant bacteriaAnthrax vaccineVX gasNorth KoreanKim Jong-unmidazolamMeridian Medical Technologiesatropine1995 Tokyo subway sarin attackSanofi Pasteurexecutive orderPublic Health Security and Bioterrorism Preparedness ActHealth and Human ServicesEmergent BioSolutionsBioThraxFujifilm CorporationBasilea PharmaceuticaFood and Drug AdministrationceftobiproleStaphylococcus aureuspoint-of-care diagnostic testanthraxplasmaemergency roomsintensive care unitsTara O'TooleXERAVAZEMDRIGepotidacinGlaxoSmithKlineSPR994Defense Threat Reduction Agencymulti-drug resistantAnthrasilCangeneAnthimElusys TherapeuticsBotulismbotulinum toxinOperation Warp SpeedJanssen PharmaceuticalAstraZenecaUniversity of OxfordPfizerModernaVaxartInovioU.S. Department of DefensesWest Africa Ebola virus epidemicKivu Ebola epidemicERVEBOZaire ebola virusDemocratic Republic of the CongoSmallpoxVariola virusWorld Health OrganizationSIGA TechnologiesZika virusCytokineNational Institute of Allergy and Infectious DiseasesNational Institutes of HealthUS whistleblowerCOVID-19Robert KadlecU.S. Office of Special CounselHHS Office of Inspector General (OIG)Advanced Research Projects Agency for HealthWayback MachineUnited States biological defense programDHS Chemical and Biological Defense DivisionDHS Office of Health AffairsBioWatchNational Biodefense Analysis and Countermeasures CenterNational Bio and Agro-Defense FacilityNational Counterproliferation CenterDivision of Select Agents and ToxinsNational Science Advisory Board for BiosecurityAssistant SECDEF for NCB Defense ProgramsJoint Program Executive Office of Chemical and Biological DefenseNational Center for Medical IntelligenceNational Interagency Confederation for Biological ResearchNational Interagency Biodefense CampusFort DetrickU.S. Army Medical Research Institute of Infectious DiseasesDefense Advanced Research Projects AgencyEdgewood Chemical Biological CenterDugway Proving GroundGalveston National LaboratoryPlum Island Animal Disease CenterForeign Disease Weed Science Research UnitLocal Health DepartmentsState Health DepartmentsNational Medical Response Team/National Pharmacy Response TeamChemical Biological Incident Response ForceEpidemic Intelligence ServiceAeromedical Biological Containment SystemJohns Hopkins Center for Health Security (formerly Center for Biosecurity)Henry L. Stimson CenterBrown UniversityMiddle-Atlantic Regional Center of Excellence for Biodefense and Emerging Infectious Diseases ResearchUniversity of RochesterJohns Hopkins Center for Civilian Biodefense StrategiesGeorge Mason Univ.GovernmentcontractorsBattelle Memorial InstituteSRI InternationalPhoenix AirNunn–Lugar Cooperative Threat Reduction ProgramProject BacchusProject Clear VisionProject JeffersonBiosurveillanceNational Biosurveillance StrategyLaboratory Response NetworkESSENCEBiosecuritySelect Agent ProgramPersonnel Reliability ProgramMedical intelligenceNational Intelligence Assessments on Infectious DiseasesDisaster responseNational Response FrameworkNational Strategy for Homeland SecurityNational Disaster Medical SystemProtectionNBC suitRespiratorsCell CANARYAutonomous Pathogen Detection SystemBiocontainmentBiosafety levelBiosafety cabinetPositive pressure personnel suitGeneva ProtocolStatement on Chemical and Biological Defense Policies and ProgramsBiological Weapons ConventionBiological Weapons Anti-Terrorism Act of 1989Soviet Nuclear Threat Reduction Act of 1991Executive Order 13139Patriot ActPublic Health Security and Bioterrorism Preparedness Response ActProject Bioshield ActBiodefense and Pandemic Vaccine and Drug Development Act of 2005Public Readiness and Emergency Preparedness ActGlobal Health Security InitiativeGlobal Partnership Against the Spread of Weapons and Materials of Mass DestructionUnited Nations Security Council Resolution 15401984 Rajneeshee bioterror attack1989 California medfly attackWood Green ricin plot2003 ricin letters2013 ricin lettersUnited States Army Medical UnitUnited States biological weapons programSunshine ProjectAeromedical Isolation TeamAgro-terrorismBiodefenseBiosecurity in the United StatesBiological agentBiological hazardBiological warfare (BW)CBRN defenseDecontaminationEntomological warfareIsolation (health care)Select agentSmallpox virus retention debateresearch and development agenciesNational Science FoundationNational Aeronautics and Space AdministrationEnvironmental Protection AgencyIntelligence Advanced Research Projects ActivityAgricultureAgricultural Research ServiceNational Institute of Food and AgricultureEconomic Research ServiceCommerceNational Institute of Standards and TechnologyNational Oceanic and Atmospheric AdministrationDefenseArmy Combat Capabilities Development CommandArmy Research LaboratoryCombat Capabilities Development Command Soldier CenterCCDC Armaments CenterPicatinny ArsenalBenét LaboratoriesWatervliet ArsenalTest and Evaluation CommandUnited States Army Medical Research and Development CommandEngineer Research and Development CenterMarine Corps Combat Development CommandMarine Corps Warfighting LaboratoryMarine Corps Operational Test and Evaluation ActivityOffice of Naval ResearchNaval Research LaboratoryNaval Medical Research CenterSurfaceUnderseaCommand, Control and Ocean SurveillanceNaval Air Weapons Station China LakeNaval Postgraduate SchoolOperational Test and Evaluation ForceAir Force Materiel CommandAir Armament CenterAir Force Research LaboratoryAir Force Life Cycle Management CenterAir Force Nuclear Weapons CenterAir Force Institute of TechnologyAir Force Operational Test and Evaluation CenterSpace ForceSpace Systems CommandUniformed Services University of the Health SciencesEducationInstitute of Education SciencesNational Institute on Disability, Independent Living, and Rehabilitation ResearchEnergyOffice of ScienceAdvanced Research Projects Agency–EnergyNational LaboratoriesHealth andHuman ServicesNational Institute for Occupational Safety and HealthAgency for Healthcare Research and QualityCenter for Medicare and Medicaid InnovationHomeland SecurityScience and Technology DirectorateCoast Guard Research and Development Center InteriorUnited States Geological SurveyJusticeNational Institute of JusticeFBI Science and Technology BranchTransportationResearch and Innovative Technology AdministrationFederal Aviation AdministrationFederal Highway AdministrationTreasuryOffice of Financial ResearchVeterans AffairsVeterans Health Administration Office of Research and DevelopmentExecutive Officeof the PresidentOffice of Science and Technology PolicyU.S. Global Change Research ProgramNetworking and Information Technology Research and DevelopmentNational Nanotechnology InitiativeLegislative branchHouse Committee on Science, Space, and TechnologySenate Committee on Commerce, Science, and TransportationOffice of Technology AssessmentJudicial branchFederal Judicial Center