Biomedical Advanced Research and Development Authority

The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services office responsible for the procurement and development of medical countermeasures created in 2006. Together with its industry partners, BARDA promotes the advanced development of medical countermeasures.

The Biomedical Advanced Research and Development Authority (BARDA) provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear CBRN accidents, incidents and attacks; pandemic influenza (PI), and emerging infectious diseases (EID).

Together with its industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats.¹⁾

Vaccine 'whistleblower' accuses HHS secretary of ongoing retaliation

June 25, 2020 / 7:10 PM / CBS News

Ousted Health and Human Services scientist Rick Bright is accusing HHS Secretary Alex Azar of continuing to retaliate against him in his new position at the National Institutes of Health. In early May, Bright filed a whistleblower complaint alleging he was removed from his original role after he pushed to vet and to limit drug treatments often touted by President Trump.

In an amended whistleblower complaint, Bright claimed that Dr. Gary Disbrow, who replaced Bright in an acting capacity as head of the Biomedical Advanced Research and Development Authority (BARDA), told an HHS employee that Azar said “if anyone were to help Dr. Bright be successful, 'there would be hell to pay.'”²⁾

Director, Biomedical Advanced Research and Development Authority Deputy Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services

Dr. Gary Disbrow is the Director of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.³⁾

BARDA has a proven track record of responding to pandemics and developing lifesaving medical countermeasures. We are rapidly executing new partnerships and building a robust COVID-19 MCM Portfolio because Americans deserve to have safe, effective medical products.⁴⁾

This page is updated regularly, but may not include all awards

All (98) Vaccines (7) Diagnostics (55) Therapeutics (16) Rapidly Deployable Capabilities (15) Other (5)

• Pfizer Inc.
• Paxlovid
• EUA Issued
• Learn More
• GlaxoSmithKline
• sotrovimab
• EUA Issued
• Learn More
• Molnupiravir
• EUA Issued
• Learn More
• Eli Lilly and Company
• Bamlanivimab and etesevimab administered together
• EUA Issued
• Learn More
• Commercial Scale Manufacturing
• Pfizer Inc.
• COMIRNATY (COVID-19 Vaccine, mRNA)
• Licensed
• Learn More
• BD (Becton Dickinson and Company)
• BD COR System Respiratory Panel
•  
• Learn More
• BD (Becton Dickinson and Company)
• BD MAX System Respiratory Panel plus Pan-Coronavirus
•  
• Learn More
• BD (Becton Dickinson and Company)
• BD COR System Respiratory Panel plus Pan-Coronavirus
•  
• Learn More
• BD (Becton Dickinson and Company)
• BD Veritor Plus System Respiratory Panel
•  
• Learn More
• BD (Becton Dickinson and Company)
• BD MAX System Respiratory Panel
•  
• Learn More
• OraSure Technologies, Inc
• SARS-CoV-2 Antibody ELISA for use with OraSure® Oral Antibody Collection Device
•  
• Learn More
• OraSure Technologies, Inc
• InteliSwab™ COVID-19 Rapid Test
• EUA Issued
• Learn More
• OraSure Technologies, Inc
• InteliSwab™ COVID-19 Rapid Test Rx
• EUA Issued
• Learn More
• OraSure Technologies, Inc
• InteliSwab™ COVID-19 Rapid Test Pro
• EUA Issued
• Learn More
• SAb Biotherapeutics, Inc.
• SAB-185 (anti-SARS-CoV-2 human immunoglobulin)
• Phase 3
• Learn More
• [Manufacturing Demonstration Project]
• Sanofi Pasteur and GSK GlaxoSmithKline
• Recombinant SARS-CoV-2 Protein Antigen + AS03 Adjuvant
• Phase 3
• Learn More
• Cepheid
• Xpert  Xpress SARS-CoV-2/Flu/RSV test 
• EUA Issued
• Learn More
• Cepheid
• Xpert Pan-Coronavirus test panel
•  
• Learn More
• Cepheid
• Xpert Xpress SARS-CoV-2 test
• EUA Issued
• Learn More
• [Commercial Scale Manufacturing]
• LightDeck Diagnostics
• LightDeck® COVID-19 Antigen Test
•  
• Learn More
• [Commercial Scale Manufacturing]
• LightDeck Diagnostics
• LightDeck® COVID-19 Total Antibody Test
•  
• Learn More
• [Commercial Scale Manufacturing]
• ModernaTX, Inc.
• SARS-CoV-2 mRNA-1273 vaccine
• EUA Issued
• Learn More
• Dascena Inc.
• COViage™: Machine Learning Software for COVID-19 Severity Predictions
• EUA Issued
• Learn More
• [Commercial Scale Manufacturing]
• DiaSorin Inc.
• LIAISON SARS-CoV-2 TrimericS IgG Assay
• EUA Issued
• Learn More
• DiaSorin Inc.
• LIAISON SARS-CoV-2 IgM Test
• EUA Issued
• Learn More
• DiaSorin Inc.
• LIAISON SARS-CoV-2 S1/S2 IgG
• EUA Issued
• Learn More
• AgileMD
• eCART
•  
• Learn More
• [Commercial Scale Manufacturing]
• Siemens Healthineers
• ADVIA Centaur® SARS-CoV-2 Antigen (CoV2Ag) Test
•  
• Learn More
• [Commercial Scale Manufacturing]
• Siemens Healthineers
• Atellica® IM SARS-CoV-2 Antigen (CoV2Ag) Test
•  
• Learn More
• Siemens Healthineers
• Atellica® IM SARS-CoV-2 Total (COV2T) assay
• EUA Issued
• Learn More
• [Commercial Scale Manufacturing]
• Ortho Clinical Diagnostics
• VITROS® SARS-CoV-2 Ag (Antigen) Test
• EUA Issued
• Learn More
• [Commercial Scale Manufacturing]
• Ortho Clinical Diagnostics
• VITROS® Anti-SARS-CoV-2 IgG Test (Improved)
•  
• Learn More
• [Commercial Scale Manufacturing]
• Ortho Clinical Diagnostics
• VITROS® Anti-SARS-CoV-2 Total Test (Improved)
•  
• Learn More
• Siemens Healthineers
• ADVIA Centaur® SARS-CoV-2 Total (COV2T) assay
• EUA Issued
• Learn More
• PeraHealth Inc.
• Rothman Index Risk Triage Tool
•  
• Learn More
• Philips North America
• Philips Lumify Ultrasound
•  
• Learn More
• CIADM at Emergent Biosolutions
• Human immune Globulin for COVID-19 (COVID-19 HIG)
• Phase 3
• Learn More
• [Manufacturing Demonstration Project]
• Janssen Pharmaceuticals, Inc.
• AD26.COV2.S - Viral Vector Vaccine for COVID-19
• EUA Issued
• Learn More
• DiaSorin SpA
• DiaSorin LIAISON SARS-CoV-2 Antigen
• EUA Issued
• Learn More
• [Manufacturing Demonstration Project]
• AstraZeneca
• Evusheld (tixagevimab co-packaged with cilgavimab and administered together)
• EUA Issued
• Learn More
• Luminex Corporation
• Combined ARIES® Flu A/B/RSV + SARS-CoV-2 Assay
•  
• Learn More
• Luminex Corporation
• NxTAG® RPP v2 with SARS-CoV-2
•  
• Learn More
• Luminex Corporation
• xMAP® SARS-CoV-2 IgG Neutralizing Antibody Assay
•  
• Learn More
• Luminex Corporation
• ARIES® SARS-CoV-2 Assay
• EUA Issued
• Learn More
• Luminex Corporation
• NxTAG® CoV Extended Panel
• EUA Issued
• Learn More
• Visby Medical Inc.
• Visby Medical Flu & COVID-19 test
•  
• Learn More
• [Commercial Scale Manufacturing]
• Hologic, Inc.
• Panther Fusion SARS-CoV-2/Flu/RSV assay
•  
• Learn More
• [Commercial Scale Manufacturing]
• Hologic, Inc.
• Aptima® SARS-CoV-2/Flu Assay
• EUA Issued
• Learn More
• [Commercial Scale Manufacturing]
• Hologic, Inc.
• Aptima® SARS-CoV-2 assay
• EUA Issued
• Learn More
• [Commercial Scale Manufacturing]
• Hologic, Inc.
• Panther Fusion SARS-CoV-2 Assay
• EUA Issued
• Learn More
• [Manufacturing Demonstration Project]
• Regeneron Pharmaceuticals, Inc
• Casirivimab & Imdevimab (SARS-CoV-2 specific monoclonal antibodies)
• EUA Issued
• Learn More
• DiaSorin Molecular LLC
• Simplexa™ COVID-19 and Flu A/B Direct Assay
•  
• Learn More
• DiaSorin Molecular LLC
• Simplexa™ COVID-19 Direct Assay
• EUA Issued
• Learn More
• Chembio Diagnostics Inc.
• DPP® Respiratory Panel Antigen Test System
•  
• Learn More
• Chembio Diagnostics Inc.
• DPP® SARS-CoV-2 Antigen
•  
• Learn More
• Mesa Biotech, Inc.
• Accula® Flu A/B and SARS-CoV-2 Integrated Test
•  
• Learn More
• Mesa Biotech, Inc.
• Accula® SARS-CoV-2 Diagnostic Test
• EUA Issued
• Learn More
• Humanigen
• Lenzilumab
• Phase 3
• Learn More
• [Commercial Scale Manufacturing]
• InBios International, Inc.
• SCoV-2 Detect™ IgG Rapid Test
• EUA Issued
• Learn More
• [Commercial Scale Manufacturing]
• InBios International, Inc.
• SCoV-2 Ag Detect™ Rapid Test
• EUA Issued
• Learn More
• [Commercial Scale Manufacturing]
• AstraZeneca
• AZD1222 (formerly ChAdOx1 nCoV-19 vaccine)
• Phase 3
• Learn More
• Beckman Coulter
• Monocyte Distribution Width (MDW) hematology-based biomarker
•  
• Learn More
• Current Health
• Continuous Monitoring Platform & Algorithm for COVID-19 Severity
•  
• Learn More
• 98point6
• Text-based virtual care to assess, diagnose and treat COVID-19
•  
• Learn More
• NOWDiagnostics Inc.
• ADEXUSDx® COVID-19 Serology Test
• EUA Issued
• Learn More
• University of Connecticut
• Single-Administration Microneedle Skin Patch for Pandemic Vaccine
•  
• Learn More
• Vaxess Technologies, Inc.
• MIMIX-COVID Pre-fusion Spike Protein Micro Array Patch
•  
• Learn More
• Esperovax, Inc.
• Egress RD mRNA Oral Cellular Vaccine Delivery Technology
•  
• Learn More
• Verndari, Inc.
• VaxiPatch™ Complete Vaccination Kit
•  
• Learn More
• [Manufacturing Demonstration Project]
• Novavax Inc.
• NVX-CoV-2373 Vaccine for SARS-CoV-2
• Phase 3
• Learn More
• Sonica Health
• Sonica's Bio-Integrated, Wireless Sensor System (ADAM) System
•  
• Learn More
• Empatica, Inc.
• Aura
•  
• Learn More
• Immunexpress Inc.
• SeptiCyte RAPID Host-Based Sepsis In Vitro Diagnostic
•  
• Learn More
• Sepsis Alliance
• Sepsis COVID-19 webinars
•  
• Learn More
• Quidel Corporation
• Point of Care SARS-CoV-2 Sofia 2 Antigen Assay
•  
• Learn More
• Genentech USA, Inc.
• MSTT1041A (anti-ST2) and UTTR1147A (IL-22Fc)
• Phase 2
• Learn More
• VitalConnect
• Vista Solution
•  
• Learn More
• Beckman Coulter
• Monocyte Distribution Width (MDW) and Algorithms for Sepsis Detection
•  
• Learn More
• Cerus Corporation
• INTERCEPT Blood System
•  
• Learn More
• Evidation Health
• COVID-19 Detection & Forecasting Model Pilot
•  
• Learn More
• Tangen Biosciences
• Tangen SARS-CoV-2 Assay
•  
• Learn More
• Cytovale Inc.
• Rapid Sepsis Diagnostic
•  
• Learn More
• Grifols Shared Services North America, Inc. (Grifols)
• Convalescent plasma and hyperimmune globulin
• Phase 3
• Learn More
• Nanomix
• Nanomix eLab® COVID-19 Rapid IgG/IgM Antibody Panel
•  
• Learn More
• Nanomix
• Nanomix eLab® COVID-19 Rapid Antigen Panel
•  
• Learn More
• Genentech USA, Inc.
• ACTEMRA (tocilizumab)
• EUA Issued
• Learn More
• Vela Diagnostics USA, Inc.
• ViroKey™ SARS-CoV-2 RT-PCR Test (Manual)
• EUA Issued
• Learn More
• Vela Diagnostics USA, Inc.
• ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 (Automated)
• EUA Issued
• Learn More
• Cue Health Inc.
• Point-of-Care COVID-19 Cue Health Monitoring System & Mobile App
• EUA Issued
• Learn More
• GenMark Diagnostics, Inc.
• ePlex Respiratory Pathogen v2 Panel
• EUA Issued
• Learn More
• Qiagen, LLC
• QIAstat-Dx Respiratory SARS-CoV-2 Panel
• EUA Issued
• Learn More
• Janssen Research & Development, LLC
• SARS-CoV-2 Therapeutic Drug Screening Efforts
•  
• Learn More
• Merck Sharp & Dohme Corp.
• MK-7110
•  
• Learn More
• Eli Lilly and Company
• Bamlanivimab (LY-CoV555)
•  
• Learn More
• Merck and IAVI
• rVSVΔG-CoV2 
•  
• Learn More
• Hememics
• Rapid SARS-CoV-2 Antibody Test for HemBox™ Biosensor System
•  
• Learn More
• Hememics
• Rapid SARS-CoV-2 Antigen Test for HemBox™ Biosensor System
•  
• Learn More
• Regeneron Pharmaceuticals, Inc
• Sarilumab
• Phase 2/3
• Learn More ⁵⁾

STATEMENT FROM THE BARDA DIRECTOR, GARY DISBROW, PhD On the release of BARDA's Strategic Plan 2022-2026 ^{6) 7)}

Table of Contents ⁸⁾

Preface from the BARDA Director………….. 1

As the Biomedical Advanced Research and Development Authority enters its 16th year, we are re- leasing a new Strategic Plan focused on strengthening the health security of the nation, embracing lessons learned from the COVID-19 pandemic, incorporating new avenues of promising research and development, and addressing the imperative for medical countermeasures that are safe, effective, and widely accessible to all Americans.

BARDA understands the importance of delivering lifesaving medical countermeasures quickly, which requires a sustainable, mission-ready response posture with a workforce of scientists and other experts who can readily adapt to protect Americans from emerging threats.

This blueprint creates a framework on which the nation’s preparedness and response is strengthened by a world-class workforce and diverse public-private partnerships.

Although the COVID-19 pandemic spotlighted both new and known challenges in the nation’s pandem- ic preparedness and response strategy, the intrinsic flexibility of BARDA’s comprehensive partnership model and portfolio approach allowed a rapid pivot and acceleration in the development of vaccines, diagnostics, and therapeutics against COVID-19.

These investments also helped to improve the manufacturing and fill-finish capacity for seasonal influenza vaccines, demonstrating that sustained investment in the pandemic influenza strategy will equip BARDA with the ability to rapidly respond to emerging and reemerging pandemic pathogens.

In addition to supporting nearly 100 products as part of the COVID-19 portfolio, BARDA has supported 62 U.S. Food and Drug Administration approvals, licensures or clearances, four products used to halt Ebola outbreaks in western Africa, and more than 18 products in development for antibiotic resistance, one of the top global health threats.

This plan sets out how BARDA will continue to work with our partners to further secure the nation during public health emergencies including expanding the domestic supply chain for production of sterile injectables.

The COVID-19 pandemic has highlighted that new and innovative approaches are required to appropriately respond during a large-scale public health emergency. BARDA will emphasize innovation across all sectors of our portfolio. BARDA has established an ecosystem of innovation to include CARB-X, BARDA Ventures, an Accelerator Network, and the Blue Knight program.

Consistent with the American Pandemic Preparedness Plan and other policies, BARDA scientists, technical experts, and contracting professionals leverage unique authorities granted by Congress to promote innovation, support advanced research and development, and facilitate procurement of medical countermeasures.

Effectively preparing for future pandemics and other health security threats, we must embrace ideas and creativity from private-sector partners both large and small so that the resulting medical countermeasures serve the needs of the diverse populations we serve. Building and supporting a more inclusive, diverse workforce further enhances this capability and capacity and enables BARDA’s decision-making to reflect a broader and deeper understanding of real-world application of medical countermeasures.

BARDA will fortify the nation’s health security with our partners, stakeholders, and workforce. This Strategic Plan establishes how this will be achieved in BARDA’s next five years. Gary Disbrow, Ph.D.

Introduction……………………………. 3

Biomedical Advanced Research and Development Authority……… 4

BARDA’s Five-Year Strategic Plan………… 5

This strategic plan is built on four strategic goals to fortify and strengthen BARDA: 1. Enhancing PREPAREDNESS by investing in development of a robust pipeline of innovative MCMs 2. Embracing our role as an agile RESPONSE organization 3. Expanding and sustaining public-private PARTNERSHIPS 4. Continuing to invest in the organization’s WORKFORCE.

Each goal is supported by objectives that are critical to achieving the goal. Each objective identifies new activities and associated key milestones to achieve by 2026. Each of these milestones are ambitious targets that may be challenging to achieve. But when they are interwoven together, BARDA will be able to continually provide a solid foundation that protects our nation’s health security.

Activities and milestones in this plan may be contingent upon additional legislative authorities and budgetary resources beyond those currently available. However, the price of pursuing these activities is small compared to the cost and consequences of waiting to respond to health security threats after they occur.

Goal 1: Preparedness: Rapidly develop safe, effective medical countermeasures accessible to all Americans ………… 7

Objective 1.1: Accelerate the development of agile MCMs that can pivot and be brought to scale in response to new threats………….. 7

Objective 1.2: Catalyze innovation across the MCM development pipeline……………………………………… 9

Objective 1.3: Embrace end-user needs and promote interventions across the continuum of care…. 10

Objective 1.4: Protect all members of our communities against an evolving threat landscape.. 11

Goal 2: Response: Enhance and maintain a sustainable, mission-ready response posture …. 13

Objective 2.1: Enhance BARDA’s response posture by leveraging a diverse MCM portfolio of proven technologies….. 13

Objective 2.2: Build a resilient, surge-capable, flexible manufacturing ecosystem that prioritizes increased domestic capacity…… 15

Objective 2.3: Enhance and sustain response-ready support services………… 16

Objective 2.4: Leverage acquisition vehicles that enable rapid response……. 17

Objective 2.5: Ensure BARDA’s response posture accounts for the needs of all segments of the population….. 18

Goal 3: Partnerships: Leverage mechanisms to foster flexible partnerships……… 19

Objective 3.1: Advance new, adaptable partnership models………… 19

Objective 3.2: Foster existing and establish new partnerships……….. 20

Objective 3.3: Enhance sustainability by supporting development and repurposing of products and technologies with commercial value….. 21

Objective 3.4: Expand partnerships with socially and economically disadvantaged businesses 22

Goal 4: Workforce: Build and support a world class workforce …….. 23

Objective 4.1: Recruit and retain leading experts across the BARDA enterprise….. 23

Objective 4.2: Promote diversity across BARDA ……….. 24

Objective 4.3: Expand career development and mentorship opportunities… 25

Objective 4.4: Adopt modern business, analytics, and communications tools to enhance efficiency. 25

Appendices…………. 27

Appendix 1:

BARDA’s Contributions to the COVID-19 Pandemic Response…. 27

COVID-19 Accomplishments………… 27

The COVID-19 pandemic represents one of the greatest threats to public health the world has faced in more than 100 years.

Public-private partnerships to develop and produce MCMs have been critical in responding to the pandemic. BARDA has and continues to play a critical role in the COVID-19 response.

Early in the COVID-19 pandemic response, BARDA assessed its portfolio of existing partners for technologies that could support development of MCMs against COVID-19, and quickly pivoted to initiate development of COVID-19 products.

Less than one month after the SARS-CoV-2 sequence was shared, BARDA leveraged existing public-private partnerships that included options to support pandemic preparedness and response activities. BARDA also pivoted rapidly to develop an array of MCMs to address COVID-19.

These initial investments were made with annual appropriations, prior to the availability of supplemental funding.

On January 30, 2020, ASPR/BARDA hosted an industry stakeholder engagement session, with broad participation across relevant U.S. Government agencies, to communicate MCM needs and challenges with developers.

BARDA established a COVID-19 Market Research Portal (“CoronaWatch”) to facilitate a centralized, all-of-government portal for submission and review of potential MCMs to diagnose, treat, or prevent COVID-19, leveraging BARDA’s TechWatch program. Submissions were reviewed by subject-matter experts from across the USG, and promising candidates were selected for further discussions with interagency partners.

By the end of 2021, BARDA received 4,569 submissions to the CoronaWatch portal and held 688 meetings with developers. In March 2020, BARDA received supplemental funding that enabled accelerated efforts to rapidly develop and gain Emergency Use Authorizations (EUAs) for MCMs

BARDA has coordinated activities closely within the Department of Health and Human Services (HHS) and Department of Defense (DoD) agencies to ensure a whole-of-government approach.

The success in development, regulatory approval, and production of COVID-19 diagnostics, therapeutics, and vaccines is rooted in the previous 15 years of BARDA investments in MCM preparedness.

These programs allowed BARDA to immediately launch and execute an MCM development plan when the pandemic began. Subsequent acceleration efforts supported manufacturing expansion and EUA of vaccines,therapeutics, and diagnostics in record time.

Throughout the COVID-19 response process, BARDA identified potential risks that have been addressed (e.g. limited supply of needles and syringes) or are subject of actions under this strategic plan.

BARDA COVID-19 Vaccine Investments…… 28

BARDA invested in a portfolio of vaccine candidates that showed potential to be: (1) safe and effective,(2) rapidly developed for addressing the pandemic in a relevant timeframe, and (3) in parallel with clinical trials, manufactured at a scale sufficient to meaningfully contribute to a national vaccination campaign.

BARDA supported advanced development of five vaccine candidates and an advanced purchase agreement for one candidate that de-risked the development of the candidate. Less than 12 months from receiving COVID-19 supplemental funds, three vaccine candidates received EUA from the FDA.

Previous investments made by BARDA on three vaccine platforms (Ad26-vectors, recombinant baculovirus expression systems, and mRNA) facilitated the rapid development, manufacturing, and scale-up of several candidates.

Investments in multiple candidates served as the basis for Operation Warp Speed, and subsequently the Countermeasures Acceleration Group, portfolio.

BARDA also secured manufacturing scale-out and scale-up, fill/finish capacity, and ancillary supplies (e.g.,needles and syringes). These capabilities included substantial investments in U.S.-based manufacturing.

BARDA product development contracts funded and supported in-house technical assistance across all phases of product development and manufacturing for the vaccine candidates, including phase 1, 2, and 3 clinical trials; manufacturing; validation and scale-up; quality oversight; nonclinical support; and regulatory support.

BARDA is also supporting novel vaccine approaches and platforms to accelerate vaccine availability, delivery, and administration. These included alternative vaccine administration approaches for addressing a potential shortage of needles and syringes as well as needleless vaccine administration technologies.

BARDA COVID-19 Therapeutic Investments………… 29

Addressing the COVID-19 pandemic requires developing and procuring therapeutics for individuals across the continuum of disease, from mild infections to the severely ill.

BARDA invested COVID-19 supplemental funds to accelerate the clinical development and manufacturing scale-up of therapeutic candidates most likely to have a broad public health impact.

BARDA supported screening existing monoclonal antibodies and small molecule compounds with existing clinical or preclinical data for activity against SARS-CoV-2. An existing partnership was expanded by BARDA to develop new targeted monoclonal antibodies using a proven technology that was licensed for another indication.

In addition, BARDA supported the collection, distribution, and EUA of COVID-19 convalescent plasma, which was used to treat approximately 400,000 patients.

BARDA COVID-19 Diagnostic Investments…. 29

BARDA supported multiple assays for SARS-CoV-2 infection that spanned over 40 diagnostic products. From May to June 2020, approximately 40% of the COVID-19 diagnostics available for Americans were the result of BARDA investments.

These included high-throughput devices in commercial clinical labs and hospitals, point-of-care tests for use in provider offices and limited testing resource settings (such as nursing homes), and over-the-counter tests for home use. Tests supported also included multiplex molecular diagnostic tests that detect SARS-CoV-2, in addition to influenza A and B viruses, and, in some cases, respiratory syncytial virus (RSV).

BARDA’s first supported diagnostic was authorized for emergency use in March 2020. BARDA also supported the development of diagnostics to distinguish specific SARS-CoV-2 variants when needed to inform therapeutic usage. BARDA also collaborated with NIH, providing both financial support and subject-matter expertise to facilitate rapid launch of the RAD-X program.

In parallel, BARDA invested in rapidly deployable capabilities that augment current diagnostic technologies, leveraging the physiological, host biomarkers, and vital sign data from patients.

These included exploring the capability of non-invasive, wearable physiological sensors, remote monitors, and telemedicine tools to empower individuals and health care providers to better inform on infection status (including those that may be asymptomatic or pre-symptomatic) or infection severity.

Such technologies could aid in identifying at-risk individuals, reducing further transmission by providing early indication of infection and monitoring mildly ill patients that may be progressing to more severe illness.

In addition, BARDA supported technologies that included electronic health records – integrated algorithms, apps, and blood biomarker-based in vitro diagnostics.

Appendix 2: Overview of Key Legislation…………. 31⁹⁾

ASPR and BARDA’s legal authorities for preparing and responding to public health emergencies are based in the Public Health Service Act (42 USC 247d). The relevant impact for BARDA’s mission from various amendments to the act are highlighted below.

• • Project BioShield Act of 2004: - Project BioShield provided incentives to industry to develop MCMs for which traditional markets were not sufficient to promote private investment. This act also established a fund that may be used to procure MCMs for the SNS, prior to licensure, if they may be made available under an EUA during a public health emergency.
• • Public Readiness and Emergency Preparedness (PREP) Act of 2005: The PREP Act authorizes
• the HHS Secretary to issue a declaration that provides some immunity from liability to individuals and organizations involved in the development and use of certain FDA-regulated MCMs. It does not exempt liability for willful misconduct.
• • Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA): PAHPA established the ASPR organization, including BARDA as a part of ASPR. The act also provided new authorities for
• advanced development and acquisitions of MCMs.
• • Pandemic and All-Hazards Preparedness Reauthorization Act - (PAHPRA) of 2013:
• PAHPRA reauthorized BARDA and the funds for procurement of MCMs through 2018. PAHPRA
• also increased the flexibility of Project BioShield to support advanced research and development of potential MCMs.
• • 21st Century Cures Act of 2016: This act clarified BARDA contracting authorities. In addition, it provided to BARDA the authorities related to the use venture capital methods and practices.
• • Pandemic and All Hazards Preparedness and Advancing Innovation Act - (PAHPAIA) of 2019:
• PAHPAIA reauthorized BARDA and the funds for procurement of MCMs through 2023