Topic Collection Cover Page

Medical Countermeasure Commercialization
Topic Collection
May 12, 2023

Medical Countermeasure Commercialization

The COVID-19 pandemic required unprecedented coordination and cooperation between the U.S. government and the pharmaceutical industry to bring vaccines to the public in record time. The U.S. government is also committed to enhancing the nation’s public health security and emergency preparedness by facilitating innovative products and solutions between federal agencies and public stakeholders.

While the U.S. government was initially the exclusive purchaser and distributer of COVID-19 vaccines and therapeutics, COVID-19 medical countermeasures will increasingly shift away from US government purchasing and distribution to more traditional pathways for procurement, distribution, and payment. COVID-19 vaccines and therapeutics are the first products to make this transition, but may not be the last. This page provides resources on the shift of products from government purchasing and distribution to commercial channels.

The resources in this Topic Collection highlight these considerations, factors, and research from a variety of sources to provide guidance for stakeholders who are interested in the commercialization of vaccines, therapeutics, and other products developed with the support of the U.S. government and later transitioned to commercial channels. Stakeholders may also wish to access the following related ASPR TRACIE collections: COVID-19 and Minority/Vulnerable Populations: Resources for Outreach and Protection of At-Risk Individuals in a COVID-19 Environment; and COVID-19 Information and Peer-Reviewed Resources. 

Administration for Community Living. (2023). Unwinding Guidance to State Units on Aging Older Americans Act Formula Grants – PHE for COVID-19 & MDD for COVID-19.
This document addresses the unwinding of flexibilities for Older Americans Act formula grants to State Units on Aging associated with the conclusion of the COVID-19 public health emergency and related major disaster declaration.
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Administration for Strategic Preparedness and Response. (n.d.). COVID-19 Therapeutics. (Accessed 5/8/2023.) U.S. Department of Health and Human Services.
The Administration for Strategic Preparedness and Response (ASPR) therapeutics landing page will be updated with relevant changes to COVID-19 therapeutics as therapeutic products transition to the commercial market.
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Administration for Strategic Preparedness and Response. (2023). PREP Act Questions and Answers. U.S. Department of Health and Human Services.
This page provides an overview of the PREP Act and responses to frequently asked questions from the manufacturing industry, the healthcare community, and state and local government officials.
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Beleche, T., Bush, L., and Finegold, K. (2022). Understanding Coverage Considerations for COVID-19 Vaccines and Treatments. U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE).
This report was initially released in August 2022 and subsequently updated in May 2023 to reflect recent legislative changes to Medicare Part D, the planned expiration of the COVID-19 Public Health Emergency Declaration on May 11, 2023, and the announcement that the monoclonal antibody Evusheld is no longer authorized for emergency use by the FDA as of January 23, 2023.
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Centers for Disease Control and Prevention. (2023). COVID-19 Vaccination Program Operational Guidance. U.S. Department of Health and Human Services.
The U.S. Centers for Disease Control and Prevention (CDC) released a guidance document on vaccine simplification, aiming to streamline the process of COVID-19 vaccinations for healthcare providers and the public. This page provides guidance and helpful resources for COVID-19 vaccine operations including: CDC Fall Vaccination Operational Planning Guides; Single-Dose Vials - Pfizer (12+) Updated COVID-19 Vaccine; CDC Novavax COVID-19 Vaccination Operational Planning Guide; The COVID-19 Vaccination Program Interim Operational Guidance for Jurisdictions Playbook; Interim Jurisdiction COVID-19 Vaccination Playbook Draft Executive Summaries; COVID-19 Vaccination Eligibility Guidance; Key Operational Considerations for Jurisdictions Planning to Operate COVID-19 Vaccination Clinics; and Key Operational Considerations for Jurisdictions Planning to Operate COVID-19 Vaccination Clinics.
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Centers for Medicare & Medicaid Services (n.d.). CMS Guidance. (Accessed 5/8/2023.)
The CMS website will be updated with relevant changes to the CMS COVID-19 payment rates as the vaccine commercializes.
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Centers for Medicare & Medicaid Services. (n.d.). Medicare COVID-19 Vaccine Shot Payment Rates. (Accessed 5/8/2023.)
The CMS website will be updated with relevant changes to the CMS COVID-19 payment rates as the vaccine commercializes.
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Centers for Medicare & Medicaid Services. (2023). CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency. U.S. Department of Health and Human Services.
This fact sheet highlights what individuals can expect at the end of the PHE as it relates to healthcare. The following topics are covered: COVID-19 vaccines, testing, and treatments; telehealth services; healthcare access/continuing flexibilities for healthcare professionals; and inpatient hospital care at home.
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Centers for Medicare & Medicaid Services. (2023). Coding for COVID-19 Vaccine Shots.
This page provides information about Medicare coding for administering COVID-19 vaccines during and after the COVID-19 public health emergency.
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Centers for Medicare & Medicaid Services. (2023). Coronavirus Waivers and Flexibilities.
This fact sheet can help health care providers better understand the coronavirus waivers and flexibilities.
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Centers for Medicare & Medicaid Services. (2023). Current Emergencies.
This page provides routine updates on current emergencies and links to information on the CMS-related impacts of those emergencies.
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Centers for Medicare & Medicaid Services. (2023). Frequently Asked Questions: CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.
This resource serves as a helpful guide to understanding frequently asked questions about the impact of the end of the COVID-19 public health emergency on programs such as Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and private insurance.
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Health Resources & Services Administration. (2021). Coronavirus (COVID-19) Information.
The Health Resources & Services Administration (HRSA) will publish guidance relevant to commercialization for stakeholders.
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Holtkamp, N., Marus, J., and Ross, T. (2022). Trends in COVID-19 Vaccination Intentions. U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation.
This report uses the U.S. Census Bureau Household Pulse Survey to examine trends in COVID-19 vaccination intentions of unvaccinated adults and implications for projected population vaccine uptake over time. This report can inform anticipated demand for COVID-19 vaccines.
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Kaiser Family Foundation. (2022). What Happens When COVID-19 Emergency Declarations End? Implications for Coverage, Costs, and Access.
This article provides an overview of the major COVID-19 federal emergency declarations that have been made, summarizes the flexibilities triggered by each, and identifies the implications for their ending across several areas. This resource can be used to understand potential implications for COVID-19 vaccine cost, coverage, and access after emergency declarations end.
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Murphy, S., Samson, L., and Sommers, B. (2022). COVID-19 Antivirals Utilization: Geographic and Demographic Patterns of Treatment in 2022. Office of the Assistant Secretary for Planning and Evaluation.
This report examines the utilization of oral antiviral medications, Paxlovid and Lagevrio, for the treatment of COVID-19. The analyses include an examination of time trends of COVID-19 antiviral use as well as breakdowns by age cohorts and gender, and find wide variation in COVID-19 antiviral medication use by state. Analysis on antiviral utilization can inform which populations may be most impacted by the shift of COVID-19 antiviral medications to the commercial market.
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O'Connell, D. (2022). COVID-19 Medical Countermeasures and the Commercial Marketplace. U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response.
This blog outlines the U.S. Department of Health and Human Services’ commercialization planning considerations. It also summarized key themes from a meeting HHS convened in August 2022 to discuss the pathway to commercialization for COVID-19 vaccines and therapeutics.
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O’Connell, D. (2023). Working with Partners to Transition COVID-19 Medical Products to the Commercial Markets. Administration for Strategic Preparedness and Response.
This blog outlines the Department of Health and Human Services’ commercialization planning considerations. It also summarized key themes from a meeting HHS convened in February 2023 to discuss the pathway to commercialization for COVID-19 vaccines and therapeutics.
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Office of the Federal Register, National Archives and Records Administration. (2020). Families First Coronavirus Response Act (FFCRA).
A provision in the Families First Coronavirus Response Act (FFCRA) eliminated beneficiary cost sharing for COVID-19 testing-related services, including the associated physician visit or other outpatient visit (such as hospital observation, E-visit, or emergency department services). A testing-related service is a medical visit furnished during the PHE that results in ordering or administering a COVID-19 lab test. The law also eliminated cost sharing for Medicare Advantage enrollees for both the COVID-19 lab test and testing-related services and prohibited the use of prior authorization or other utilization management requirements for these services during the PHE.
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Office of the Federal Register, National Archives and Records Administration. (2023). Eleventh Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. U.S. Government Publishing Office.
This amendment (effective as of May 11, 2023) is an update to the determination of a public health emergency and: clarifies the disease threat, adds two new limitations on distribution, extends the time period of coverage for certain Covered Countermeasures and Covered Persons, clarifies the time period of coverage for Covered Persons authorized under the Declaration, and extends the duration of the Declaration to December 31, 2024.
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The White House. (2023). FACT SHEET: Actions Taken by the Biden-Harris Administration to Ensure Continued COVID-19 Protections and Surge Preparedness After Public Health Emergency Transition.
This fact sheet details the significant steps the administration has taken to ensure all individuals have continued access to lifesaving protections such as vaccines, treatments and tests, and that the nation is well prepared to manage the risks of COVID-19 after the end of the public health emergency.
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U.S. Department of Health and Human Services. (2023). COVID-19 Public Health Emergency (PHE).
This fact sheet provides links to resources that can help health care stakeholders better understand the COVID-19 public health emergency.
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U.S. Department of Health and Human Services. (2023). Fact Sheet: End of the COVID-19 Public Health Emergency.
This fact sheet explains current flexibilities enabled by the COVID-19 emergency declaration and how they will be impacted by the end of the COVID-19 public health emergency on May 11, 2023.
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U.S. Department of Health and Human Services. (2023). Fact Sheet: HHS Announces ‘HHS Bridge Access Program For COVID-19 Vaccines and Treatments’ to Maintain Access to COVID-19 Care for the Uninsured.
This fact sheet describes the "Bridge Access Program For COVID-19 Vaccines and Treatments Program," designed to maintain broad access to COVID-19 vaccines for millions of uninsured Americans. The program will create a unique $1.1 billion public-private partnership to help maintain uninsured individuals’ access to COVID-19 care at their local pharmacies, through existing public health infrastructure, and at their local health centers.
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U.S. Department of Health and Human Services. (2023). Fact Sheet: HHS Announces Intent to Amend the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19.
The U.S. Department of Health and Human Services announced amendments to the Public Readiness and Emergency Preparedness Act declaration, aiming to strengthen the nation's defense against COVID-19 through medical countermeasures. These amendments expand the range of qualified persons authorized to prescribe, dispense, and administer COVID-19 vaccines and treatments, including licensed pharmacists, pharmacy interns, and qualified pharmacy technicians. The changes also provide liability protection for covered countermeasures, such as vaccines, therapeutics, and diagnostics. The amendments seek to increase vaccine accessibility, accelerate the vaccination process, and ensure adequate healthcare workforce availability during the ongoing public health emergency.
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U.S. Department of Health and Human Services. (2023). Letter to U.S. Governors from HHS Secretary Xavier Becerra On planning for the COVID-19 PHE.
This press release highlights information and resources for U.S. governors to help manage the transition away from the COVID-19 public health emergency.
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U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (2022). Reductions in Deaths and Hospitalizations Associated with COVID-19 Vaccinations Among Medicare Beneficiaries: Full Year 2021 Estimates.
This report provides analysis on the association between COVID-19 hospitalizations and deaths among Medicare beneficiaries and COVID-19 vaccination rates. The report underscores the importance of maintaining vaccines access throughout the COVID-19 vaccine commercialization process to continue to prevent hospitalization and death, especially in vulnerable populations.
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U.S. Food and Drug Administration. (2023). Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines.
This press release provides information regarding the amendment to the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals.
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