COVID-19: HHS and DOD Transitioned Vaccine Responsibilities to HHS, but Need to Address Outstanding Issues
Fast Facts
Since May 2020, federal efforts to speed the development, manufacturing, and distribution of COVID-19 vaccines—previously known as Operation Warp Speed—have been led by the Departments of Health and Human Services and Defense. HHS took over sole responsibility for the work at the beginning of 2022.
It's unclear whether HHS is ready to fully assume all responsibilities, especially those formerly led by DOD. HHS has assessed its workforce capabilities, but it hasn't addressed the loss of DOD officials with specialized skills.
Our recommendations could help HHS better ensure that it can continue vaccine-related work without interruptions.
Highlights
What GAO Found
Starting in May 2020, federal efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines had been led by a partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DOD). Formerly known as Operation Warp Speed, the partnership was renamed the HHS-DOD COVID-19 Countermeasures Acceleration Group (CAG). According to HHS and DOD officials, the CAG dissolved and transitioned its responsibilities—including DOD-led vaccine activities—to HHS by December 31, 2021, as required by an April 2021 memorandum of understanding between the two departments.
Manufacturing of COVID-19 Vaccines
While HHS and DOD officials said they achieved transition milestones indicating that HHS is ready to assume responsibilities formerly led by DOD, it is unclear how HHS will address its workforce needs now that the CAG has dissolved. Specifically, GAO found that HHS has assessed its workforce capabilities, but lacks strategies for addressing these workforce needs. By formally providing its support until HHS develops and implements these strategies, DOD can help ensure that HHS can continue these responsibilities uninterrupted, including responsibilities for addressing ongoing vaccine needs for boosters or for any emerging COVID-19 variants. Moreover, HHS does not have a schedule that is consistent with best practices to help it manage remaining vaccine-related activities. Such a schedule could help HHS better plan actions and mitigate delays, and be a source for identifying lessons learned for any future pandemics.
The CAG developed a plan for conducting a joint, interagency lessons-learned review. This plan outlines an approach for collecting information—such as perspectives on challenges—from CAG staff, and for sharing the plan with HHS. However, the plan misses an opportunity to gather perspectives from key external stakeholders, including vaccine companies, critical to developing vaccines. Obtaining these perspectives could provide a more comprehensive understanding of areas where the CAG was successful and opportunities for improvement, which could help inform HHS's ongoing and future vaccine work.
Why GAO Did This Study
Vaccines have played a crucial role in battling the COVID-19 pandemic. The CAG worked with vaccine companies to develop COVID-19 vaccines, and made available a sufficient supply for all eligible people in the nation. An April 2021 memorandum of understanding between HHS and DOD called for the transfer of remaining CAG responsibilities to HHS and for identification of lessons learned.
The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines, among other things, the CAG's progress on (1) transitioning its responsibilities to HHS, and (2) developing a process for a joint interagency lessons learned review.
GAO reviewed CAG transition and contracting documents and interviewed or received written responses from CAG officials, federal agencies, and representatives from the six vaccine companies that worked with the CAG.
Recommendations
GAO is making five recommendations related to workforce needs, scheduling best practices for vaccine-related activities; and lessons learned from key stakeholders.
HHS did not concur with GAO's recommendation on workforce needs. GAO revised this recommendation based on updated information, but maintains that it continues to be valid, as discussed in the report.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Health and Human Services | The Secretary of Health and Human Services, in coordination with DOD, should develop and implement workforce strategies to address the workforce needs it identified as part of the CAG's transition to HHS. (Recommendation 1) |
The Department of Health and Human Services (HHS) did not concur with GAO's recommendation in 2022 but has since taken actions to address it. On January 1, 2022, the CAG transitioned to HHS and became the HHS Coordination Operations and Response Element (H-CORE). In January 2024, HHS provided documentation related to its workforce, including a decision memo from June 2023. The decision memo included workforce strategies in a three-tiered hiring process, to help H-CORE achieve workforce numbers determined in its fiscal year 2023 spending plan. In November 2024, HHS provided further documentation of the status of the H-CORE workforce strategies, including a progress update on the implementation of its hiring process. For example, in its first tier-converting temporary hires and detailees into permanent staff-HHS noted that all of the positions had been converted to permanent. HHS stated that it coordinated with DOD in the early stages of the transition from the CAG to the H-CORE. HHS further stated that once the initial process was developed, they did not need additional DOD support but maintained open communication channels with DOD to utilize when necessary. These actions fulfill the intent of the recommendation.
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| Department of Defense | The Secretary of Defense, in coordination with HHS, should establish a mechanism—such as through an interagency agreement—to provide support to HHS until it develops and implements workforce strategies to address the workforce needs it identified as part of the CAG's transition to HHS. (Recommendation 2 |
The Department of Defense (DOD) did not concur with GAO's recommendation in 2022 but has since taken action to address it. In 2022, DOD emphasized HHS's lead role in addressing workforce needs, once the CAG had completed the transition of its responsibilities to HHS at the end of 2021. However, DOD also clarified that it was open to providing assistance to HHS, at HHS's request. HHS has since finalized its workforce strategies for the CAG-which became the HHS Coordination Operations and Response Element (H-CORE) in 2022. In November 2024, HHS stated that it coordinated with DOD in the early stages of the transition from the CAG to the H-CORE. Once the initial process was developed, HHS officials stated they did not need additional DOD support for their workforce strategies. This action fulfills the intent of the recommendation.
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| Department of Health and Human Services | The Secretary of Health and Human Services should develop a schedule that is consistent with the best practices established in the GAO Schedule Assessment Guide to manage remaining vaccine-related responsibilities. (Recommendation 3) |
In July 2022, HHS stated that the department developed a schedule and used operational planning guidance, including GAO's Schedule Assessment Guide, when developing plans for how to implement vaccine campaigns. HHS subsequently provided relevant supporting documentation, including an example of a planning guide for specific vaccine efforts, examples of milestone charts, and examples of critical activities. However, this documentation did not include sufficient detail to show that HHS had developed a schedule consistent with the best practices established in GAO's Schedule Assessment Guide. For example, it did not contain specificity to allow us to identify the sequencing of activities, confirm that the critical path is valid, or ensure reasonable total float, as described in the GAO Schedule Assessment guide. In November 2024, HHS stated that the vaccine planning efforts were complete, and in January 2025 we requested the completed schedule file. As of March 2025, we have not yet received HHS's response.
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| Department of Health and Human Services | The Secretary of Health and Human Services, in coordination with DOD, should expand the CAG's lessons-learned review to also obtain and incorporate input from key external stakeholders, such as vaccine companies and other federal agencies that coordinated with the CAG on its vaccine-related responsibilities. (Recommendation 4) |
The Department of Health and Human Services (HHS) agreed with GAO's recommendation and has taken action to address it. Specifically, in March 2022, HHS finalized a draft of an after-action review for its response to COVID-19 vaccine development and administration. The after-action report did not clearly specify the extent to which input was incorporated from key external stakeholders, but HHS later provided additional information. Specifically, in November 2024 HHS provided documentation describing how it obtained and incorporated feedback from key stakeholders, including vaccine companies, the Department of Defense, and other HHS entities such as the Centers for Disease Control and Prevention and the National Institutes of Health in its after-action review. These actions fulfill the intent of the recommendation.
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| Department of Defense | The Secretary of Defense, in coordination with HHS, should expand the CAG's lessons-learned review to obtain and incorporate input from key external stakeholders, such as vaccine companies and other federal agencies that coordinated with the CAG on its vaccine-related responsibilities. (Recommendation 5) |
The Department of Defense (DOD) did not concur with GAO's recommendation in 2022 but has since taken action to address it. In May 2022, DOD stated that it was supportive of gathering and documenting lessons learned. It further stated that HHS, as the agency responsible for continuing the CAG's work, would assume responsibility to obtain and incorporate additional inputs from key external stakeholders. HHS finalized a draft of an after-action review for its response to COVID-19 vaccine development and administration in March 2022. Further, in November 2024, HHS provided documentation describing how it obtained and incorporated feedback from key stakeholders, including DOD, as well as vaccine companies, and other HHS entities such as the Centers for Disease Control and Prevention and the National Institutes of Health. These actions demonstrate HHS and DOD coordination to obtain and incorporate input from key external stakeholders on lessons learned and therefore fulfill the intent of the recommendation.
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