October 1, 2022

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COVID-19: HHS and DOD Transitioned Vaccine Responsibilities to HHS, but Need to Address Outstanding Issues

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<div>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.</div>

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.

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