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| - | ===== BARDA - Biomedical Advanced Research and Development Authority ===== | ||
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| - | The Biomedical Advanced Research and Development Authority 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. | ||
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| - | 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, | ||
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| - | Together with its industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats.((https:// | ||
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| - | ==== BARDA Director ==== | ||
| - | Director, Biomedical Advanced Research and Development Authority | ||
| - | Deputy Assistant Secretary for Preparedness and Response | ||
| - | U.S. Department of Health and Human Services | ||
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| - | 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.((https:// | ||
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| - | {{:: | ||
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| - | ==== BARDA’s Expanding COVID-19 Medical Countermeasure Portfolio ==== | ||
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| - | 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 [[: | ||
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| - | This page is updated regularly, but may not include all awards | ||
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| - | All (98) Vaccines (7) Diagnostics (55) Therapeutics (16) Rapidly Deployable Capabilities (15) Other (5) | ||
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| - | * [[:Pfizer]] Inc. | ||
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| - | * EUA Issued | ||
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| - | * EUA Issued | ||
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| - | * BD ([[:Becton Dickinson]] and Company) | ||
| - | * BD COR System Respiratory Panel | ||
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| - | * Learn More | ||
| - | * BD ([[:Becton Dickinson]] and Company) | ||
| - | * BD MAX System Respiratory Panel plus Pan-Coronavirus | ||
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| - | * Learn More | ||
| - | * BD ([[:Becton Dickinson]] and Company) | ||
| - | * BD COR System Respiratory Panel plus Pan-Coronavirus | ||
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| - | * Learn More | ||
| - | * BD ([[:Becton Dickinson]] and Company) | ||
| - | * BD Veritor Plus System Respiratory Panel | ||
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| - | * Learn More | ||
| - | * BD ([[:Becton Dickinson]] and Company) | ||
| - | * BD MAX System Respiratory Panel | ||
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| - | * EUA Issued | ||
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| - | * Phase 3 | ||
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| - | * Phase 3 | ||
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| - | * Xpert Xpress SARS-CoV-2/ | ||
| - | * EUA Issued | ||
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| - | * Xpert Pan-Coronavirus test panel | ||
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| - | * Xpert Xpress SARS-CoV-2 test | ||
| - | * EUA Issued | ||
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| - | * EUA Issued | ||
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| - | * eCART | ||
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| - | * ADVIA Centaur® [[: | ||
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| - | * EUA Issued | ||
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| - | * EUA Issued | ||
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| - | * Ortho Clinical Diagnostics | ||
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| - | * Ortho Clinical Diagnostics | ||
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| - | * ADVIA Centaur® SARS-CoV-2 Total (COV2T) assay | ||
| - | * EUA Issued | ||
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| - | * Phase 3 | ||
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| - | * EUA Issued | ||
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| - | * EUA Issued | ||
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| - | * Visby Medical Flu & COVID-19 test | ||
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| - | * EUA Issued | ||
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| - | * EUA Issued | ||
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| - | * DPP® Respiratory Panel Antigen Test System | ||
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| - | * DPP® SARS-CoV-2 Antigen | ||
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| - | * Mesa Biotech, Inc. | ||
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| - | * EUA Issued | ||
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| - | * Phase 3 | ||
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| - | * EUA Issued | ||
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| - | * EUA Issued | ||
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| - | * Phase 3 | ||
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| - | * EUA Issued | ||
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| - | * ** Single-Administration Microneedle Skin Patch for Pandemic Vaccine** | ||
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| - | * Phase 3 | ||
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| - | * Aura | ||
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| - | * Point of Care SARS-CoV-2 Sofia 2 Antigen Assay | ||
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| - | * Phase 2 | ||
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| - | * Rapid Sepsis Diagnostic | ||
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| - | * Phase 3 | ||
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| - | * EUA Issued | ||
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| - | * EUA Issued | ||
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| - | * Vela Diagnostics USA, Inc. | ||
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| - | * EUA Issued | ||
| - | * Learn More | ||
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| - | * EUA Issued | ||
| - | * Learn More | ||
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| - | * ePlex Respiratory Pathogen v2 Panel | ||
| - | * EUA Issued | ||
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| - | * EUA Issued | ||
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| - | * Rapid SARS-CoV-2 Antibody Test for HemBox™ Biosensor System | ||
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| - | * Learn More | ||
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| - | * Rapid SARS-CoV-2 Antigen Test for HemBox™ Biosensor System | ||
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| - | * Phase 2/3 | ||
| - | * Learn More ((https:// | ||
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| - | ==== BARDA 2022-2026 Strategic Plan ==== | ||
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| - | STATEMENT FROM THE BARDA DIRECTOR, [[:GARY DISBROW]], PhD | ||
| - | {{:: | ||
| - | On the release of BARDA' | ||
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| - | ==== Strategic Plan pdf ==== | ||
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| - | Table of Contents ((https:// | ||
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| - | Preface from the BARDA Director.............. 1 | ||
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| - | 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 widely accessible to all Americans. | ||
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| - | BARDA understands the importance of delivering lifesaving medical countermeasures quickly, which requires a sustainable, | ||
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| - | 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. | ||
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| - | 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, | ||
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| - | 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. | ||
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| - | In addition to supporting nearly 100 products as part of the [[:COVID-19 portfolio]], | ||
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| - | 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]]. | ||
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| - | 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 [[: | ||
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| - | Consistent with the [[:American Pandemic Preparedness Plan]] and other policies, BARDA scientists, technical experts, and contracting professionals leverage unique authorities granted by [[: | ||
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| - | 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. | ||
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| - | BARDA will fortify the nation’s health security with our partners, stakeholders, | ||
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| - | Introduction.................................. 3 | ||
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| - | Biomedical Advanced Research and Development Authority......... 4 | ||
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| - | BARDA’s Five-Year Strategic Plan............ 5 | ||
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| - | 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. | ||
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| - | 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. | ||
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| - | 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. | ||
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| - | **Goal 1: Preparedness**: | ||
| - | accessible to all Americans ............ 7 | ||
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| - | Objective 1.1: Accelerate the development of agile MCMs that can pivot and be brought | ||
| - | to scale in response to new threats.............. 7 | ||
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| - | Objective 1.2: Catalyze innovation across the MCM development pipeline............................................. 9 | ||
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| - | Objective 1.3: Embrace end-user needs and promote interventions across the continuum of care.... 10 | ||
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| - | Objective 1.4: Protect all members of our communities against an evolving threat landscape.. 11 | ||
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| - | **Goal 2: Response**: Enhance and maintain a sustainable, | ||
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| - | Objective 2.1: Enhance BARDA’s response posture by leveraging a diverse MCM portfolio | ||
| - | of proven technologies..... 13 | ||
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| - | Objective 2.2: Build a resilient, surge-capable, | ||
| - | prioritizes increased domestic capacity...... 15 | ||
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| - | Objective 2.3: Enhance and sustain response-ready support services............ 16 | ||
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| - | Objective 2.4: Leverage acquisition vehicles that enable rapid response....... 17 | ||
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| - | Objective 2.5: Ensure BARDA’s response posture accounts for the needs of all segments | ||
| - | of the population..... 18 | ||
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| - | **Goal 3: Partnerships**: | ||
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| - | Objective 3.1: Advance new, adaptable partnership models............ 19 | ||
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| - | Objective 3.2: Foster existing and establish new partnerships........... 20 | ||
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| - | Objective 3.3: Enhance sustainability by supporting development and repurposing of products | ||
| - | and technologies with commercial value..... 21 | ||
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| - | Objective 3.4: Expand partnerships with socially and economically disadvantaged businesses 22 | ||
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| - | **Goal 4: Workforce**: | ||
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| - | Objective 4.1: Recruit and retain leading experts across the BARDA enterprise..... 23 | ||
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| - | Objective 4.2: Promote diversity across BARDA ........... 24 | ||
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| - | Objective 4.3: Expand career development and mentorship opportunities... 25 | ||
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| - | Objective 4.4: Adopt modern business, analytics, and communications tools to enhance efficiency. 25 | ||
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| - | Appendices............. 27 | ||
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| - | Appendix 1: | ||
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| - | BARDA’s Contributions to the COVID-19 Pandemic Response.... 27 | ||
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| - | COVID-19 Accomplishments............ 27 | ||
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| - | 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. | ||
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| - | BARDA has and continues to play a critical role in the COVID-19 response. | ||
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| - | 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. | ||
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| - | **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. | ||
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| - | These **initial investments were made with annual appropriations, | ||
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| - | 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. | ||
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| - | BARDA established a COVID-19 Market Research Portal (“[[: | ||
| - | centralized, | ||
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| - | 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 [[: | ||
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| - | BARDA has coordinated activities closely within the Department of [[:Health and Human Services]] (HHS) and [[: | ||
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| - | The success in development, | ||
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| - | These programs allowed **BARDA to immediately launch and execute an MCM development pl**an when the pandemic began. Subsequent acceleration efforts supported manufacturing expansion and EUA of vaccines, | ||
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| - | 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. | ||
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| - | **BARDA COVID-19 Vaccine Investments**...... 28 | ||
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| - | BARDA invested in a portfolio of **vaccine candidates** that showed potential to be: (1) **safe and effective**, | ||
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| - | 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. | ||
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| - | **Previous investments made by BARDA on three vaccine platforms** (Ad26-vectors, | ||
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| - | Investments in multiple candidates served as the basis for [[: | ||
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| - | BARDA also secured manufacturing scale-out and scale-up, fill/finish capacity, and ancillary supplies (e.g., | ||
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| - | 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; | ||
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| - | BARDA is also supporting novel vaccine approaches and platforms to accelerate vaccine | ||
| - | availability, | ||
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| - | **BARDA COVID-19 Therapeutic Investments**............ 29 | ||
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| - | Addressing the COVID-19 pandemic requires developing and procuring therapeutics for individuals | ||
| - | across the continuum of disease, from mild infections to the severely ill. | ||
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| - | 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. | ||
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| - | BARDA supported screening existing [[: | ||
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| - | In addition, BARDA supported the collection, distribution, | ||
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| - | **BARDA COVID-19 Diagnostic Investments**.... 29 | ||
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| - | 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. | ||
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| - | 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 [[: | ||
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| - | 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]]. | ||
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| - | In parallel, BARDA invested in **rapidly deployable capabilities** that augment current diagnostic technologies, | ||
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| - | These included exploring the capability of non-invasive, | ||
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| - | Such technologies could aid in identifying at-risk individuals, | ||
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| - | In addition, **BARDA supported technologies** that included [[: | ||
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| - | Appendix 2: Overview of Key Legislation............. 31((https:// | ||
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