Topic Collection Cover Page

Medical Countermeasures Commercialization
Topic Collection
January 8, 2024

Medical Countermeasures 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

Each resource in this Topic Collection is placed into one or more of the following categories (click on the category name to be taken directly to that set of resources):

Centers for Medicare & Medicaid Services Guidance


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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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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Centers for Medicare & Medicaid Services. (2024). Commercial COVID-19 Oral Antivirals Memo.
This memo provides an update on the status of the transition of Paxlovid and Lagevrio to the commercial market, highlighting the overlap of USG-distributed and commercial products. Information on processing claims for these medications are provided as is a figure that depicts primary Medicare beneficiary coverage pathways for commercial anti-virals for COVID-19.
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General Information


U.S. Department of Health and Human Services. (2023). HHS and Pfizer Reach Agreement to Increase Patient Access to Paxlovid.
This press release explains how HHS and Pfizer reached an agreement that extends patient access to Paxlovid, maximizes taxpayer investment, and begins Paxlovid’s transition to the commercial market in November 2023.
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Operational Guidance


National Center for Immunization and Respiratory Diseases. (2021). Clinical Care Considerations for COVID-19 Vaccination. Centers for Disease Control and Prevention.
This page provides updates on Advisory Committee on Immunization Practices recommendations and clinical considerations for managing adverse events for the use of Pfizer-BioNTech, Moderna, and Janssen/Johnson & Johnson COVID-19 vaccines for the prevention of COVID-19 in the U.S..
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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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Public Health Emergency (PHE)/PREP Act


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. (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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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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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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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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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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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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Research


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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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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Kranzler, E., Luchman, J., Williams, C., et al. (2023). Recalled Exposure to COVID-19 Public Education Campaign Advertisements Predicts COVID-19 Vaccine Confidence. Journal of Health Communication. 28(3):144-155.
This study aimed to assess potential Campaign impact by examining the relationship between recalled Campaign exposure and COVID-19 vaccine confidence among American adults. During the study period (January 21–November 3, 2021), the Campaign additionally aimed to influence the “Movable Middle” segment of the population—vaccine-hesitant individuals who had not yet decided whether to get a COVID-19 vaccine. We additionally focused our reporting of results on those pertaining to the Movable Middle.
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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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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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To date, there have been no published evaluations of the impact of this campaign on COVID-19 vaccine uptake. This study is the first to assess the association between digital campaign media dose—an under-studied avenue for public education campaign dissemination—and an individual’s likelihood of receiving their first COVID-19 vaccination dose.
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Transition Guidance


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). COVID-19 Therapeutics Transition to Commercial Distribution: Frequently Asked Questions. U.S. Department of Health and Human Services.
This webpage provides answers to frequently asked questions about commercial distribution.
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Administration for Strategic Preparedness and Response. (2023). Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program. U.S. Department of Health and Human Services.
This guide is intended to provide direction as the U.S. Government (USG) prepares to wind down the current distribution of USG-procured COVID-19 therapeutics and transitions the COVID-19 Oral Antiviral (OAV) treatments (nirmatrelvir packaged with ritonavir [Paxlovid] and molnupiravir [Lagevrio]) to the commercial market. This guide aims to help jurisdictions and providers (1) plan for the transition away from USG ordering; (2) understand the impact of this transition on ordering mechanism; (3) understand how to manage inventory of USG distributed OAV products, including continued reporting requirements for remaining USG inventory; and (4) provide summary information about programs to provide access for uninsured and underinsured individuals once COVID-19 OAVs become commercially available. T
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Centers for Disease Control and Prevention. (2023). HHS Commercialization Transition Guidance. (Accessed 07/12/2023.)
This guidance from HHS provides direction to those participating in the COVID-19 Vaccination Program as the USG stops distributing COVID-19 vaccines through its current ordering system and the vaccines transition to traditional pathways for procurement, distribution and payment of COVID-19 vaccines. Additional guidance from CDC will become available in the days ahead. The document also includes information on exceptional orders after full-scale ordering closes, guidance on inventory and disposal management of vaccine and ancillary supplies, data reporting requirements, CDC programs for uninsured individuals, anticipated vaccine schedule for fall, and planning considerations.
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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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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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