Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges

What GAO Found

Operation Warp Speed (OWS)—a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD)—aimed to help accelerate the development of a COVID-19 vaccine. GAO found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. For example, OWS selected vaccine candidates that use different mechanisms to stimulate an immune response (i.e., platform technologies; see figure). Vaccine companies also took steps, such as starting large-scale manufacturing during clinical trials and combining clinical trial phases or running them concurrently. Clinical trials gather data on safety and efficacy, with more participants in each successive phase (e.g., phase 3 has more participants than phase 2).

Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021

As of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which—Moderna’s and Pfizer/BioNTech’s vaccines—have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued.

Technology readiness. GAO’s analysis of the OWS vaccine candidates’ technology readiness levels (TRL)—an indicator of technology maturity— showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials. However, as is done in a non-pandemic environment, all vaccine companies gathered initial safety and antibody response data with a small number of participants before proceeding into large-scale human studies (e.g., phase 3 clinical trials). The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events.

Manufacturing. As of January 2021, five of the six OWS vaccine companies had started commercial scale manufacturing. OWS officials reported that as of January 31, 2021, companies had released 63.7 million doses—about 32 percent of the 200 million doses that, according to OWS, companies with EUAs have been contracted to provide by March 31, 2021. Vaccine companies face a number of challenges in scaling up manufacturing to produce hundreds of millions of doses under OWS’s accelerated timelines. DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges, including:

  • Limited manufacturing capacity: A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks. Vaccine companies are working in partnership with OWS to expand production capacity. For example, one vaccine company told GAO that HHS’s Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the U.S. Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities.
  • Disruptions to manufacturing supply chains: Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic. For example, representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week. Vaccine companies and DOD and HHS officials told GAO they have undertaken several efforts to address possible manufacturing disruptions and mitigate supply chain challenges. These efforts include federal assistance to (1) expedite procurement and delivery of critical manufacturing equipment, (2) develop a list of critical supplies that are common across the six OWS vaccine candidates, and (3) expedite the delivery of necessary equipment and goods coming into the United States. Additionally, DOD and HHS officials said that as of December 2020 they had placed prioritized ratings on 18 supply contracts for vaccine companies under the Defense Production Act, which allows federal agencies with delegated authority to require contractors to prioritize those contracts for supplies needed for vaccine production.
  • Gaps in the available workforce: Hiring and training personnel with the specialized skills needed to run vaccine manufacturing processes can be challenging. OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel.

Why GAO Did This Study

As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic.

GAO was asked to review OWS vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges.

GAO administered a questionnaire based on HHS’s medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing.

For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or howardk@gao.gov or wrightc@gao.gov.

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    GAO's 19th annual assessment of the Department of Defense's (DOD) weapon programs comes at a time of significant internal changes to the department's acquisition process. Specifically, DOD began implementing its new acquisition framework intended to, among other things, deliver solutions to the end user in a timely manner. However, GAO found that many programs have planned acquisition approaches that, unless properly managed and overseen, could result in cost and schedule challenges similar to those GAO has reported on for nearly the past 2 decades. DOD's new acquisition framework allows program managers to use one or more of six acquisition pathways—including the major capability acquisition and middle-tier acquisition (MTA) pathways used by the programs GAO reviewed. Each pathway is governed by separate policies for milestones, cost and schedule goals, and reporting. Program managers can tailor, combine, and transition between pathways based on program goals and risks associated with the weapon system being acquired (see figure). Notional Use of Multiple Efforts and Multiple Pathways DOD's framework also introduces new considerations to program oversight. In particular, DOD has yet to develop an overarching data collection and reporting strategy for programs transitioning between acquisition pathways or conducting multiple efforts using the same pathway to deliver the intended capability. The lack of a strategy not only limits DOD's visibility into these programs but also hinders the quality of its congressional reporting and makes the full cost and schedule of the eventual weapon system more difficult to ascertain. DOD Plans to Invest Over $1.79 Trillion in Its Costliest Weapon Programs, but Not All Costs Are Reported DOD's reported costs primarily reflect major defense acquisition program (MDAP) investments (see table). However, DOD is increasingly using the MTA pathway to acquire weapon programs . The totals do not include all expected costs because, among other things, MTA estimates do not reflect any potential investments after the current MTA effort, and cost figures do not include programs that have yet to formally select a pathway or are classified or sensitive. Department of Defense Total Investments in Selected Weapon Programs GAO Reviewed (fiscal year 2021 dollars in billions)   Procurement reductions in DOD's costliest program—the F-35—drove an MDAP portfolio cost decrease since GAO's last annual report (see figure). Excluding this program, quantity changes and other factors such as schedule delays contributed to one-year portfolio cost growth. Sixteen MDAPs also showed schedule delays since GAO's 2020 report. Such delays are due, in part, to delivery or test delays and poor system performance. Major Defense Acquisition Program One-Year Cost Change Including and Excluding the F-35 Program (fiscal year 2021 dollars in billions) F-35 reported an overall procurement cost decrease of $23.9 billion in fiscal year 2020, primarily due to lower prime and subcontractor labor rates. As GAO found last year, DOD continues to expand its portfolio of the costliest MTA programs, expecting to spend $30.5 billion on current efforts. Due to inconsistent cost reporting by MTA programs, GAO could not assess cost trends across the MTA portfolio. However, GAO observed examples of cost changes on certain MTA programs compared with last year. Weapon Programs Do Not Consistently Plan to Attain Knowledge That Could Limit Cost Growth and Deliver Weapon Systems Faster Most MDAPs continue to forgo opportunities to improve cost and schedule outcomes by not adhering to leading practices for weapon system acquisitions. Some MTA programs also reported planning to acquire only limited product knowledge during program execution, leading to added risks to planned follow-on efforts. Further, while both MDAPs and MTA programs increasingly reported using modern software approaches and cybersecurity measures, they inconsistently implemented leading practices, such as frequently delivering software to users and conducting certain types of cybersecurity assessments during development. Why GAO Did This Study Title 10, section 2229b of the U.S. Code contains a provision for GAO to review DOD's weapon programs. This report assesses the following aspects of DOD's costliest weapon programs: their characteristics and performance, planned or actual implementation of knowledge-based acquisition practices, and implementation of selected software and cybersecurity practices. The report also assesses oversight implications of DOD's changes to its foundational acquisition guidance. GAO identified programs for review based on cost and acquisition status; reviewed relevant legislation, policy, guidance, and DOD reports; collected program office data; and interviewed DOD officials .
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  • Open Data: Agencies Need Guidance to Establish Comprehensive Data Inventories; Information on Their Progress is Limited
    In U.S GAO News
    The Open, Public, Electronic and Necessary Government Data Act of 2018 (OPEN Government Data Act) codifies and expands open data policy and generally requires agencies to publish information as open data by default, as well as develop and maintain comprehensive data inventories. The Office of Management and Budget (OMB) has not issued statutorily-required guidance for agencies to implement comprehensive data inventories, which could limit agencies' progress in implementing their requirements under the act. OMB also has not met requirements to publicly report on agencies' performance and compliance with the act. Access to this information could inform Congress and the public about agencies' open data progress and statutory compliance. Implementation Status of Selected OPEN Government Data Act Requirements   Assessment Federal data catalogue: By July 2019, the General Services Administration (GSA) must maintain a point of entry dedicated to sharing agency data assets with the public, known as the “Federal data catalogue”. The Office of Management and Budget (OMB) and GSA must ensure agencies can publish data assets or links on the website. ✓ Online repository: By July 2019, OMB, GSA, and the National Archives and Records Administration (NARA) must collaborate to develop and maintain an online repository of tools, best practices, and schema standards to facilitate the adoption of open data practices across the federal government. ✓ Implementation guidance: By July 2019, OMB must issue guidance for agencies to implement comprehensive inventories. ✖ Biennial report: By January 2020, and biennially thereafter, OMB must electronically publish a report on agency performance and compliance with this act. ✖ Legend: ✓Requirement fully met I ✖ Requirement not met Source: GAO analysis of Pub. L. No. 115-435, 132 Stat. 5529(Jan. 14, 2019), resources.data.gov, www.data.gov , and an interview with OMB staff. | GAO-21-29. GAO found that all 24 Chief Financial Officers (CFO) Act agencies display their data inventories on their websites, as well as on an online catalogue of federal data assets. Agencies took a variety of approaches to providing public access to individual data assets such as using Data.gov as the human-readable public interface, hosting searchable inventories on their own agency websites and providing lists of data or downloadable files on their websites. Information on the extent to which agencies regularly update their data inventories is limited. OMB and GSA do not have a policy to ensure the routine identification and correction of errors in electronically published information. The absence of such a policy limits publicly available information on agency progress. As of September 2020, seven of the 24 CFO Act agencies had also publicly released COVID-19 related datasets or linked to related information from their open data web pages as required by the Federal Data Strategy. These datasets provide data on a range of COVID-19 related topics including data on disease transmission and loans provided to businesses. Federal agencies create and collect large amounts of data in support of fulfilling their missions. Public access to open data—data that are free to use, modify, and share—holds great promise for promoting government transparency and engendering public trust. Access to open data is particularly important in the current pandemic environment as government agencies, scientists, and the public work to understand and respond to COVID-19 using data-focused approaches. The OPEN Government Data Act includes a provision for GAO to report on federal agencies' comprehensive data inventories. This report examines the extent to which 1) OMB, GSA, and NARA met their statutory requirements to facilitate the establishment of federal agencies' comprehensive data inventories; and 2) CFO Act agencies developed data inventories in accordance with OMB guidance. GAO reviewed agencies' websites and related documentation, and interviewed OMB staff and GSA and NARA officials. GAO is making two recommendations to OMB to issue required implementation guidance and report on agency performance. GAO also recommends that OMB and GSA establish policy to ensure the routine identification and correction of errors in agency data. GSA concurred with GAO's recommendation and OMB did not comment on the report. For more information, contact Michelle Sager at (202) 512-6806 or SagerM@gao.gov.
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    The United States Department of Justice announced today that it has obtained a Temporary Restraining Order in federal court to combat fraud related to the coronavirus (COVID-19) pandemic. The enforcement action, filed in Tampa, Florida, is part of the Justice Department’s ongoing efforts prioritizing the detection, investigation, and prosecution of illegal conduct related to the pandemic. The action was brought based on an investigation conducted by United States Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI), in coordination with the Vietnam Ministry of Public Security.
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    In Crime News
    On Jan. 5, 2021, President Donald J. Trump signed H.R. 8354, the Servicemembers and Veterans Initiative Act of 2020, a bill to permanently establish the Servicemembers and Veterans Initiative, or “SVI”, within the Civil Rights Division of the Department of Justice.
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