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) |
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, which granted approval for workforce numbers for H-CORE that were determined from a fiscal year 2023 spending plan. However, these documents did not sufficiently provide specificity on HHS' strategies to address its identified workforce needs, as we recommended. We requested additional information from HHS in February 2024. As of April 2024, we have not yet received HHS's response.
|
| 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 |
In May 2022, DOD emphasized HHS's lead role in addressing workforce needs, once the CAG completed the transition of its responsibilities to HHS at the end of 2021. In April 2024, DOD reiterated HHS's lead role and stated that it did not plan to take further action. We agree with and recognize the importance of HHS developing and implementing workforce strategies to address its workforce needs. We also recognize the unique workforce capabilities that DOD demonstrated as part of the CAG, as described in our report. Given DOD's unique capabilities, we maintain the importance of HHS having access to DOD's support, to the extent necessary, until HHS develops and implements its workforce strategies. Therefore, we will continue to monitor this recommendation until HHS develops and implements its workforce strategies. As of April 2024, we have not yet received HHS's clarifying information on its workforce needs.
|
| 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 told us that the development of plans for the implementation of vaccine campaigns is guided by a schedule and operational planning guidance. They indicated that GAO's Schedule Assessment Guide is considered and informs vaccine planning, and they provided an example of a planning guide for the under 5/6 years of age vaccine planning efforts that they noted outlines the schedule and demonstrates how these best practices were incorporated. Upon our review of the supporting documentation, we do not see sufficient evidence that HHS has developed a schedule consistent with the best practices established in GAO's Schedule Assessment Guide for the remaining vaccine-related responsibilities. Specifically, the documentation provided does not include a schedule file (for example, a Microsoft Project file) that shows activity durations and their logical predecessors and successors. In August 2022, GAO asked for additional documentation to support that HHS has developed a schedule that adheres to at least the best practices for 1) sequencing all activities, 2) confirming the critical path is valid, and 3) ensuring reasonable total float, as described in the GAO Schedule Assessment Guide. In January 2024, HHS provided an update on the status, providing examples of milestone charts and critical activities. We reviewed the documentation and determined that 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, and requested additional information in February 2024. As of April 2024, we have not yet received HHS's response.
|
| 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) |
In July 2022, HHS stated that as it conducts after-action reviews and gathers lessons learned, it aims to include key stakeholders including, but not limited to federal partners, manufacturers, and others as appropriate. In January 2024, HHS provided an update on its lessons learned activities, noting that it had completed its efforts to obtain and incorporate input from these stakeholders. We reviewed the documentation and in February 2024, requested additional specificity on how HHS conducted the lessons learned effort and with which agencies they coordinated. As of April 2024, we have not yet received HHS's response.
|
| 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) |
In May 2022, DOD stated that it is supportive of gathering and documenting lessons learned. It further stated that HHS, as the sole successor organization to the CAG, should assume responsibility to obtain and incorporate additional inputs from key external stakeholders. In April 2024, DOD stated that it does not plan to take action in response to the recommendation. We recognize HHS's role, and agree that it should take lead responsibility for obtaining and incorporating input from external stakeholders. We further recognize the critical role that DOD played as part of the CAG and the important functions that several of its component agencies provided, such as acquisition support. As such, we continue to believe that DOD's coordination on obtaining and incorporating lessons learned will be an integral aspect of HHS's efforts. We will continue to monitor this recommendation until HHS conducts any further lessons learned outreach to external stakeholders, including the extent to which it coordinates with DOD in doing so. As of April 2024, we have not yet received HHS's clarifying information on its efforts to conduct lessons learned.
|