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.
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.
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
|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)|
|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|
|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)|
|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)|
|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)|