In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine. Table of Contents Front Matter Summary 1 Introduction 2 Lessons Learned from Other Allocation Efforts 3 A Framework for Equitable Allocation of COVID-19 Vaccine 4 Applying the Framework for Equitable Allocation of COVID-19 Vaccine in Various Scenarios 5 Administering and Implementing an Effective and Equitable National COVID-19 Vaccination Program 6 Risk Communication and Community Engagement 7 Achieving Acceptance of COVID-19 Vaccine 8 Ensuring Equity in COVID-19 Vaccine Allocation Globally Appendix A: Study Methods Appendix B: Committee and Staff Biosketches

Large catastrophic events, or rare acute events, may cause situations in which a local jurisdiction's medicines and medical supplies are not sufficient to provide care to the population it serves. In these cases of natural or engineered disasters, such as a terrorist attack, influenza pandemic, or earthquake, state or local authorities can request that the federal government provide assets from the Strategic National Stockpile to augment the state and local jurisdictions' resources. The Centers for Disease Control and Prevention's (CDC's) Strategic National Stockpile (SNS) is the nation's repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical materiel designed to supplement and resupply state and local public health agencies in the event of an emergency. The materiel is intended to support national health security and is managed by the Office of Public Health Preparedness and Response's (OPHPR's) Division of Strategic National Stockpile (DSNS). The stated mission of the SNS is to prepare and support partners and provide the right resources at the right time to secure the nation's health. The National Academies of Sciences, Engineering, and Medicine organized a two-day public workshop to explore opportunities to improve the efficiency, effectiveness, and sustainable methods used by the CDC's SNS to distribute medical countermeasures and other supplies during disasters and other public health emergencies, especially those which result in disruption of physical infrastructure such as the electrical grid, central roadways, bridges, and tunnels within the impacted community. Participants explored relevant distribution lessons learned from other federal agency stockpiles and the private sector as well as opportunities to develop public-private collaborations in the purchase, warehousing, management, and distribution of medical countermeasures. This report summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction, Background, and Context 2 The Strategic National Stockpile: Origin, Policy Foundations, and Federal Context 3 Studies and Reports Related to the Strategic National Stockpile 4 Potential Opportunities for Restructuring Strategic National Stockpile Scope, Governance, and Decision Making 5 Reaching the Last Mile: Potential Opportunities to Improve Coordination and Communication Among Local, State, and Federal Agencies 6 Potential Supply-Chain Opportunities and Lessons from the Commercial Sector and Government Partners 7 Wrap-Up References Appendix A: Workshop Agenda Appendix B: Workshop Speaker Biographies

The National Academies of Sciences, Engineering, and Medicine held a workshop on August 22?23, 2018, in Washington, DC, to explore medical and public health preparedness for a nuclear incident. The event brought together experts from government, nongovernmental organizations, academia, and the private sector to explore current assumptions behind the status of medical and public health preparedness for a nuclear incident, examine potential changes in these assumptions in light of increasing concerns about the use of nuclear warfare, and discuss challenges and opportunities for capacity building in the current threat environment. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Federal Planning for Nuclear Incidents 3 Current State of Nuclear Preparedness 4 Updating Planning Assumptions of Nuclear Preparedness 5 Implications of Communication, Education, and Information Challenges 6 Challenges for Building Capacity Within the Health Care System 7 Capability-Building Challenges and Opportunities: Building Response Capability 8 Capability-Building Challenges and Opportunities: Ensuring Workforce Readiness and Response Capacity 9 Building Preparedness and Response Capability: Looking to the Future 10 Reflections on the Workshop and Opportunities for Moving Forward References Appendix A: Workshop Agenda Appendix B: Workshop Speaker Biographies

Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series. Table of Contents Front Matter 1 Introduction 2 Perspectives on Real-World Evidence 3 Learning from Success 4 Barriers and Disincentives to the Use of Real-World Evidence and Real-World Data 5 Getting Unstuck: Mythbusting the Current System 6 When Is a Real-World Data Element Fit for Assessment of Eligibility, Treatment Exposure, or Outcomes? 7 How Tightly Should Investigators Attempt to Control or Restrict Treatment Quality in a Pragmatic or Real-World Trial? 8 Obscuring Intervention Allocation in Trials to Generate Real-World Evidence: Why, Who, and How? 9 Gaining Confidence in Observational Comparisons 10 Looking Ahead References Appendix A: Related Resources Appendix B: Workshop One Agenda Appendix C: Workshop Two Agenda Appendix D: Workshop Three Agenda