Biomedical Advanced Research and Development Authority (BARDA)

What Biomedical Advanced Research and Development Authority (BARDA) does

BARDA (Biomedical Advanced Research and Development Authority) is a U.S. federal government agency within the Department of Health and Human Services, operating under the Administration for Strategic Preparedness and Response (ASPR). Established by the Project BioShield Act of 2004, BARDA's mandate is to fund and coordinate the advanced research, development, regulatory approval, procurement, and stockpiling of medical countermeasures (MCMs) — vaccines, therapeutics, diagnostics, and medical devices — against chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. The agency operates through four primary divisions (CBRN, Influenza & Emerging Infectious Diseases, Detection/Diagnostics/Devices Infrastructure, and Regulatory & Quality Affairs) plus special initiatives including Project BioShield, Project NextGen (a $5B COVID-19 successor program with NIAID), the BioMaP-Consortium for domestic biomanufacturing, DRIVe for transformative technology acceleration, and FASTx for flexible therapeutics platforms.

BARDA funds external partners — large pharmaceutical manufacturers (Moderna, GSK, Sanofi, CSL Seqirus), specialty biotechs (Mapp Biopharmaceutical, Cidara, Paratek, Basilea), diagnostics developers (Pattern Bioscience, Prenosis, Spectral AI, RIVANNA, GE HealthCare), and biomanufacturing firms (Ginkgo Bioworks, Just–Evotec, SCHOTT Pharma) — through contract mechanisms including the Broad Agency Announcement (BAA), Easy BAA, TechWatch meetings, and Other Transaction Authorities. Its business model is federal procurement rather than commercial sales: BARDA does not sell products but funds development and acquires countermeasures for the Strategic National Stockpile (SNS), Vendor Managed Inventory (VMI), and Other Designated Storage Spaces (ODSS) for emergency deployment to state and local health departments, healthcare providers, and first responders.

The agency has facilitated 115 FDA Approvals, Licensures, and Clearances for supported products since inception. It coordinates regulatory pathways through a formal BARDA-FDA Memorandum of Understanding, operates a Clinical Studies Network (CSN) supporting 60+ FDA applications and 19 quality audits in 2025, and integrates with HHS, DHS, and DOD through the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) governance structure. Customers are fundamentally U.S. federal, state, and local government entities and the healthcare/first-responder workforce that administers MCMs during declared public health emergencies.

Name

Biomedical Advanced Research and Development Authority (BARDA)

Legal name

Biomedical Advanced Research and Development Authority (BARDA)

Website

http://www.medicalcountermeasures.gov

Company type

Public

Founded year

2006

Operating status

Operating

Headcount range

501–1,000 employees

Short description

BARDA is a U.S. federal agency within HHS/ASPR that funds, develops, and procures medical countermeasures — vaccines, therapeutics, diagnostics, and devices — against CBRN threats, pandemic influenza, and emerging infectious diseases for national stockpiles and emergency deployment.

Ownership category

akta.pro rank

Product category

Government Health and Medical Countermeasures

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Federal & Federally-Sponsored Credit Agencies (6111)

akta.pro primary industry

Public Health Laboratories & Diagnostic Oversight (BPAIAJAF)

akta.pro secondary industries

National Development Banks & State Development Finance Institutions (DFIs) (BPADACAC), National Public Health Reference Laboratories (HLAJAIAA)

Keywords

• Medical countermeasures
• Biodefense research
• Public health preparedness
• Vaccine development
• Therapeutic development

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Others

Distribution channels4 records

Marketing channels6 records

Core offering

BARDA is a U.S. federal government agency that funds and accelerates the development, manufacture, and procurement of medical countermeasures (MCMs) — including vaccines, therapeutics, diagnostics, and devices — to protect the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. It partners with industry, academia, and other government agencies through contracts, grants, and other transaction authorities to advance MCMs from early research through advanced development and FDA approval.

Product overview

BARDA is a U.S. government agency within HHS that develops and funds medical countermeasures (MCMs) against public health threats. The organization operates through multiple interconnected programs: CBRN programs address chemical, biological, radiological, and nuclear threats; IEID focuses on influenza and emerging infectious diseases; DDDI develops diagnostics and devices; and special initiatives like Project BioShield, Project NextGen, and the BioMaP-Consortium accelerate MCM development and domestic manufacturing. BARDA funds external partners through mechanisms including the Broad Agency Announcement (BAA), Easy BAA, and TechWatch program. The Clinical Studies Network and Regulatory & Quality Affairs division provide operational support for product development through FDA approval.

Differentiator

Problem solved

Functional benefit

Brands

• Project BioShield: A program to accelerate research, development, procurement, and availability of effective medical countermeasures against CBRN threats.
• Project NextGen
• FASTx (Flexible and Strategic Therapeutics)
• PRISM
• DRIVe (Division of Research, Innovation & Ventures)
• BioMaP-Consortium

Products and services

• Medical Countermeasure Development Funding Funding and partnership programs that support the advanced research, development, and manufacturing of vaccines, therapeutics, diagnostics, and medical devices to address public health emergencies and CBRN threats. Customers are biopharmaceutical companies, research institutions, and product developers.
• Medical Countermeasure Procurement Procurement and stockpiling of approved medical countermeasures for inclusion in the Strategic National Stockpile and other federal reserves, providing guaranteed offtake to manufacturers.
• Other Transaction Authority (OTA) Agreements Flexible contracting mechanism used to enter into prototype, research, and production agreements with industry and academic partners outside of traditional FAR-based procurement, enabling faster partnership formation.

Quantifiable outcome

• 115 FDA approvals, licensures, and clearances for BARDA-supported products
• +1 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability9 records

Feature5 records

Partnerships

36 partnerships are on record, tiered core and minor.

• Mapp BiopharmaceuticalcoreStrategic or Co-development Partner · 29 June 2026BARDA is seeking vaccine candidates based on the platform used in Merck's Ervebo, while supporting the transfer of MBP134, an experimental monoclonal antibody therapy developed with Mapp Biopharmaceutical, for compassionate use and clinical trials during the Ebola Bundibugyo outbreak response.
• University of OxfordminorStrategic or Co-development Partner · 29 June 2026Global coordination partner in Ebola Bundibugyo outbreak response alongside BARDA, UNICEF, and CEPI for vaccine development efforts.
• Coalition for Epidemic Preparedness Innovations (CEPI)coreStrategic or Co-development Partner · 29 June 2026Global health partner committing over $61 million in initial funding across Ebola Bundibugyo vaccine candidates during the 2026 outbreak response.
• SCHOTT PharmacoreStrategic or Co-development Partner · 4 June 2026Over $60 million investment largely funded by BARDA to strengthen U.S. pharmaceutical supply chain through expanded vial production in Lebanon, Pennsylvania. Significantly increases annual production capacity for core vials while tripling local capacity for RTU vials and specialty containers for biologics, vaccines, and targeted cancer treatments.
• RIVANNAcoreStrategic or Co-development Partner · 22 April 2026Nearly $9.92 million from BARDA to develop AI module for Accuro XV ultrasound platform. Expanded clinical studies from 2 to 8 sites nationwide following BARDA exercise of funding option. Study aims to develop first automated fracture detection algorithm from volumetric ultrasound imaging.
• Shionogi Inc.coreStrategic or Co-development Partner · 8 April 2026BARDA awarded Shionogi a Project BioShield contract for Fetroja (cefiderocol) as a countermeasure against drug-resistant bacterial infections and biothreat pathogens. Contract initially funded at $119 million with multiyear options up to $482 million total. Will establish U.S. drug product manufacturing, support procurement, and advance treatments for melioidosis and plague infections.
• Avita MedicalcoreStrategic or Co-development Partner · 8 April 202610-year agreement worth up to $25.5 million with BARDA to supply RECELL products for burn mass casualty incidents. Provides 3,000 units of FDA-approved wound care treatments along with logistics support, quality assurance, and deployment readiness services.
• Vericel CorporationcoreStrategic or Co-development Partner · 2 April 2026$197 million contract from BARDA to support procurement, development, and clinical testing of cell therapy products. Funding aims to accelerate Vericel's pipeline of regenerative medicine solutions and scale up manufacturing.
• Just - Evotec BiologicscoreStrategic or Co-development Partner · 23 March 2026Selected by BARDA's Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium) for a multi-year program to optimize biomanufacturing of monoclonal antibody therapeutics targeting Ebola and Sudan filovirus diseases. Agreement valued at up to $10 million if all options are activated.
• Spectral AIcoreStrategic or Co-development Partner · 19 March 2026$31.7 million non-dilutive funding award from BARDA to accelerate development of DeepView System burn wound imaging platform. Supplements $54.9 million already committed under existing BARDA contract with total potential value up to $150 million. Supports additional features, FDA clearance efforts, and Phase II initiatives.
• Pattern BiosciencecoreStrategic or Co-development Partner · 19 March 2026BARDA contract valued at up to $40.9 million for Pattern Pneumonia ID/AST Panel pivotal trial. First culture-free, rapid phenotypic susceptibility testing panel for critically ill pneumonia patients, delivering results in hours rather than 2-4 days. Holds FDA Breakthrough Device Designation.
• GE HealthCarecoreStrategic or Co-development Partner · 16 March 2026$35 million contract expansion with BARDA for AI-powered ultrasound solutions. Building on existing relationship for advanced medical imaging technologies.
• Basilea PharmaceuticacoreStrategic or Co-development Partner · 25 February 2026Multi-year collaboration with BARDA to advance clinical antifungal candidates including fosmanogepix and BAL2062 toward regulatory approval. Received USD 6 million payment, with potential for up to USD 147 million in additional non-dilutive funding upon milestone completion including phase 3 clinical studies.
• Paratek PharmaceuticalscoreStrategic or Co-development Partner · 24 February 2026BARDA Project BioShield contract valued at up to approximately $304 million for NUZYRA in pulmonary anthrax. Positive Animal Rule study results triggered additional oral NUZYRA procurement under the contract, supporting U.S. onshoring initiative.
• ASPRcoreStrategic or Co-development Partner · 12 February 2026ASPR has launched $100 million Small Molecule Approaches for Rapid and Robust Treatment Prize coordinated by BARDA. Competition supports development of antiviral drug therapies targeting Togaviridae and Flaviviridae families including dengue, Zika, West Nile, and Chikungunya.
• PrenosiscoreStrategic or Co-development Partner · 29 January 2026$20 million BARDA contract for developing integrated diagnostics and therapeutics for critical care conditions including sepsis. Supports commercial delivery of FDA-authorized Sepsis ImmunoScore and pivotal randomized controlled trial of AI-driven corticosteroid companion diagnostics in approximately 800 patients.
• Cidara TherapeuticscoreStrategic or Co-development Partner · 6 November 2025Received $339.2 million BARDA award to support manufacturing and clinical development of CD388, an influenza preventative. CD388 received Breakthrough Therapy designation from the FDA. Company enrolled first patients in Phase 3 ANCHOR study.
• Ginkgo BioworkscoreStrategic or Co-development Partner · 4 November 2025Awarded contract up to $22.2 million through BARDA's BioMaP-Consortium to develop and strengthen domestic biomanufacturing of monoclonal antibodies targeting Ebola and Sudan viruses. Leading a multi-partner team including Advanced BioScience Laboratories, Isolere Bio by Donaldson, NeuImmune, and ProteoNic BV to scale production of Emory University's 1C3 and 1C11 mAbs cocktail.
• Advanced BioScience LaboratoriesminorStrategic or Co-development Partner · 4 November 2025Partner in Ginkgo-led multi-organization team for BARDA BioMaP-Consortium anti-filovirus mAb manufacturing project.
• Isolere Bio by DonaldsonminorStrategic or Co-development Partner · 4 November 2025Partner in Ginkgo-led multi-organization team for BARDA BioMaP-Consortium anti-filovirus mAb manufacturing project.
• NeuImmuneminorStrategic or Co-development Partner · 4 November 2025Partner in Ginkgo-led multi-organization team for BARDA BioMaP-Consortium anti-filovirus mAb manufacturing project.
• ProteoNic BVminorStrategic or Co-development Partner · 4 November 2025Licensed its 2G UNic vector technology to Ginkgo Bioworks for use in BARDA-funded anti-filovirus mAb manufacturing project through BioMaP-Consortium.
• Start2 GroupcoreStrategic or Co-development Partner · 3 November 2025BARDA partnership to launch $100 million antiviral prize competition aimed at developing broad-spectrum antivirals. Multi-year, tiered competition expected to start in early 2026 focusing on dengue and West Nile virus.
• True DiagnosticscoreStrategic or Co-development Partner · 20 October 2025Approximately $11 million BARDA project to develop rapid diagnostic test capable of detecting Ebola and Marburg viruses, focusing on accelerating biothreat response for future outbreak preparedness.
• ModernacoreStrategic or Co-development Partner · 21 January 2025$590 million award from HHS through BARDA-funded Rapid Response Partnership Vehicle (RRPV) Consortium to accelerate mRNA-based pandemic influenza vaccine development. Supporting late-stage development, licensure of pre-pandemic vaccines, and expansion of clinical studies for up to five additional subtypes of pandemic influenza.
• Advanced Technology International (ATI)coreStrategic or Co-development Partner · 1 October 2023BARDA awarded agreement to ATI to serve as consortium management firm (CMF) for BioMaP-Consortium. ATI manages day-to-day operations including releasing, managing, and streamlining solicitations under the Consortium.
• FDAcoreStrategic or Co-development PartnerBARDA-FDA Memorandum of Understanding for coordinated regulatory pathways, enhanced collaboration, and exchange of information and expertise on medical countermeasure development and approval.
• Department of Homeland SecuritycoreStrategic or Co-development PartnerKey interagency partner in PHEMCE governance structure coordinating research, development, regulation, procurement, stockpiling, and deployment of medical countermeasures.
• Department of DefensecoreStrategic or Co-development PartnerKey interagency partner in PHEMCE governance structure and coordinated medical countermeasure development. DoD has been briefed on BARDA programs including radiation/nuclear countermeasures.
• GSKcoreStrategic or Co-development PartnerLong-standing BARDA partnership for pandemic influenza vaccine development and National Pre-Pandemic Influenza Vaccine Stockpile sustainment and modernization.
• SanoficoreStrategic or Co-development PartnerLong-standing BARDA partnership for pandemic influenza vaccine development and National Pre-Pandemic Influenza Vaccine Stockpile sustainment and modernization.
• CSL SeqiruscoreStrategic or Co-development PartnerLong-standing BARDA partnership for pandemic influenza vaccine development and National Pre-Pandemic Influenza Vaccine Stockpile sustainment and modernization.
• NIH/NIAIDcoreStrategic or Co-development PartnerBARDA collaborates with NIAID on Project NextGen for next-generation COVID-19 vaccines and therapeutics. NIAID provides Phase I/IIa safety and immunogenicity trial infrastructure through its network sites.
• VaxxascoreStrategic or Co-development PartnerHHS BARDA awarded $22 million to Vaxxas for needle-free vaccine administration technology using High-Density Microarray Patch (HD-MAP) platform to improve pandemic vaccine deployment.
• ModeX TherapeuticscoreStrategic or Co-development PartnerExpanding partnership under Project NextGen to develop multispecific antibody (mAb) and RNA-expressed multispecific mAb for SARS-CoV-2.
• VaxartcoreStrategic or Co-development PartnerProject NextGen partnership supporting Vaxart's oral vaccine candidate Phase 2b clinical trial for COVID-19.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• National Institutes of Health (NIH) / NIAID: The U.S. federal health research agency that co-leads Project NextGen with BARDA and provides Phase I/IIa clinical trial infrastructure. Comparable as a federal R&D funding authority operating in infectious disease, vaccine, and therapeutic development.
• Centers for Disease Control and Prevention (CDC): U.S. federal public health agency coordinating disease response and stockpiling policy. Comparable to BARDA as a federal public health preparedness actor with overlapping interests in CBRN, influenza, and emerging infectious disease response.
• Defense Advanced Research Projects Agency (DARPA): U.S. federal R&D agency funding high-risk, high-impact technology development including biodefense and pandemic response. Comparable as a government program funding breakthrough biomedical research with non-dilutive contracts.
• Food and Drug Administration (FDA): U.S. federal regulator with which BARDA holds a formal MOU for coordinated medical countermeasure regulatory pathways. Comparable as a federal health agency deeply entangled with BARDA's development and approval processes.
• Administration for Strategic Preparedness and Response (ASPR): BARDA's direct parent organization within HHS, coordinating federal medical and public health emergency preparedness. Comparable as the immediate federal counterpart exercising oversight over BARDA's program portfolio.

Direct peers

• Coalition for Epidemic Preparedness Innovations (CEPI): International coalition funding vaccine development against epidemic threats. Comparable as a public-sector countermeasure funding entity that co-funds Ebola and pandemic influenza vaccine development alongside BARDA.

Others

• Biomedical Advanced Research and Development Authority (BARDA) DRIVe: BARDA's internal Division of Research, Innovation & Ventures focused on transformative health security technologies. Listed as an internal adjacent unit demonstrating the agency's own R&D venture-style funding arm.
• Biomedical Advanced Research and Development Authority — Project BioShield (sub-brand): BARDA's $5.6B special procurement program for CBRN medical countermeasures. Listed as an internal program equivalent that operates as a dedicated countermeasure acquisition vehicle.

Regional players

• European Health Emergency Preparedness and Response Authority (HERA): EU-level agency established to strengthen health emergency preparedness and countermeasure development. Comparable as a regional peer to BARDA with a similar mandate around CBRN and pandemic preparedness.
• UK Health Security Agency (UKHSA): UK government agency responsible for public health protection including pandemic preparedness. Comparable as a national-level public health security counterpart to BARDA in a different geography.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/BARDA

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments84 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biomedical Advanced Research and Development Authority (BARDA)