COVID-19: Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation

What GAO Found

The federal government has taken several actions to increase the availability of COVID-19 vaccine doses and indicated it expects to have enough doses available for all adults in the United States by the end of May. As of April 1, 2021, the government had purchased 1.2 billion doses of one- and two-dose regimen vaccines. Also, vaccine companies reported making additional manufacturing sites operational, among other actions to expand capacity and mitigate challenges.

Federal officials said projecting future availability of vaccine doses can be difficult, in part because of uncertainty surrounding complex manufacturing processes. Given this uncertainty, coupled with the significant manufacturing and distribution increases needed to have enough vaccine doses available for all adults, managing public expectations is critical. GAO’s prior work has found that timely, clear, and consistent communication about vaccine availability is essential to ensure public confidence and trust, especially as initial vaccine implementation did not match expectations.

COVID-19 Vaccination Site

Stakeholders GAO interviewed identified challenges with initial COVID-19 vaccine implementation. For example, some stakeholders said states often did not have information critical to distribution at the local level, such as how many doses they would receive and when. The federal government has begun initiatives—outlined in a national response strategy—to improve implementation, such as creating new vaccination sites. In its March 2021 distribution strategy, CDC provided a high-level description of its activities and noted that more details would be included in future reports to Congress. To meet the expectations set by recent announcements, such as the planned expansion of vaccine eligibility to all adults and the introduction of tools to help individuals find vaccines, it will be imperative that the federal government effectively coordinate and communicate its plans, as GAO recommended in September 2020.

Why GAO Did This Study

Providing the public with safe and effective vaccines to prevent COVID-19 is crucial to mitigating the public health and economic impacts of the disease. The U.S. had almost 30 million reported cases and over 545,000 reported deaths as of March 27, 2021. The federal government took a critical step in December 2020 in authorizing the first two COVID-19 vaccines and beginning distribution of doses across the nation. The government had distributed about 180.6 million vaccine doses, and about 147.8 million doses had been administered, as of March 27, 2021, according to Centers for Disease Control and Prevention (CDC) data.

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 issues, actions the federal government has taken to increase the availability of COVID-19 vaccine doses, and challenges with initial vaccine implementation—that is, prioritizing, allocating, distributing, and administering vaccine doses—identified by stakeholders and steps the federal government has taken to improve vaccine implementation.

GAO reviewed documents from the Departments of Defense and Health and Human Services, transcripts of public briefings, data from CDC, and interviewed or received written responses from federal officials, vaccine company representatives, and select public health stakeholders. GAO incorporated technical comments from the Department of Defense, the Department of Health and Human Services, and the Federal Emergency Management Agency as appropriate.

For more information, contact Alyssa M. Hundrup at (202) 512-7114 or hundrupa@gao.gov.

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    GAO identified nine categories of contracting fraud schemes that occurred at the Department of Energy (DOE), including billing schemes, conflicts of interest, and payroll schemes. For example, a subcontractor employee at a site created fraudulent invoices for goods never received, resulting in a loss of over $6 million. In another scheme, a contractor engaged in years of widespread time card fraud, submitting inflated claims for compensation. The contractor agreed to pay $18.5 million to settle the case. DOE reported that it identified nearly $15 million in improper payments due to confirmed fraud in fiscal year 2019. However, due to the difficulty in detecting fraud, agencies—including DOE—incur financial losses related to fraud that are never identified or are settled without admission to fraud and are not counted as such. Fraud can also have nonfinancial impacts, such as fraudsters obtaining a competitive advantage and preventing legitimate businesses from obtaining contracts. DOE has taken some steps and is planning others to demonstrate a commitment to combat fraud and assess its contracting fraud risks, consistent with the leading practices in GAO's Fraud Risk Framework. However, GAO found that DOE has not assessed the full range of contracting fraud risks it faces. Specifically, GAO found DOE's methods for gathering information about its fraud risks captures selected fraud risks—rather than all fraud risks—facing DOE programs. As shown in the figure, DOE's risk profiles for fiscal years 2018 and 2019 did not capture four of nine fraud schemes that occurred at DOE. For example, one entity did not include any fraud risks in its risk profiles, yet GAO identified six types of fraud schemes that occurred at the entity's site. DOE plans to expand its risk assessment process, but officials expect the new process will continue to rely on a methodology that gathers information on selected fraud risks. The Fraud Risk Framework states that entities identify specific tools, methods, and sources for gathering information about fraud risks. Without expanding its methodology to capture, assess, and document all fraud risks facing its programs, DOE risks remaining vulnerable to these types of fraud. Fraud Risks Identified in Fiscal Years 2018 and 2019 Risk Profiles Compared with Types of Fraud Schemes That Have Occurred at DOE DOE is planning to develop an antifraud strategy in fiscal year 2022 and has taken some steps to evaluate and adapt to fraud risks, consistent with leading practices in GAO's Fraud Risk Framework. Part of DOE's effort to manage fraud risks includes adapting controls to address emerging fraud risks. Additionally, DOE is planning to expand its use of data analytics to detect contracting fraud, beginning in fiscal year 2022. DOE relies primarily on contractors to carry out its missions at its laboratories and other facilities, spending approximately 80 percent of its total obligations on contracts. GAO and DOE's Inspector General have reported on incidents of fraud by DOE contractors and identified multiple contracting fraud risks. GAO was asked to examine DOE's processes to manage contracting fraud risks. This report examines, for DOE, (1) types of contracting fraud schemes and their financial and nonfinancial impacts, (2) steps taken to commit to combating contracting fraud risks and the extent to which these risks have been assessed, and (3) steps taken to design and implement an antifraud strategy and to evaluate and adapt its approach. GAO reviewed relevant laws and guidance; reviewed agency media releases, Agency Financial Reports, and DOE Inspector General reports to Congress from 2013 through 2019; and reviewed documents and interviewed officials from 42 DOE field and site offices, contractors, and subcontractors, representing a range of sites and programs. GAO is making two recommendations, including for DOE to expand its fraud risk assessment methodology to ensure all fraud risks facing DOE programs are fully assessed and documented in accordance with leading practices. DOE concurred with GAO's recommendations. For more information, contact Rebecca Shea at (202) 512-6722 shear@gao.gov or Allison B. Bawden at (202) 512-3841, bawdena@gao.gov.
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  • Social Security Disability: Information on Wait Times, Bankruptcies, and Deaths among Applicants Who Appealed Benefit Denials
    In U.S GAO News
    GAO found that most applicants for disability benefits who appealed the Social Security Administration's (SSA) initial disability determination from fiscal years 2008 through 2019 waited more than 1 year for a final decision on their claim. Median wait times reached 839 days for claims filed in fiscal year 2015, following an increase of applications during the Great Recession. Wait times have decreased since then as SSA made substantial progress in reducing the wait for a hearing before an administrative law judge prior to the Coronavirus Disease 2019 (COVID-19) pandemic. Individuals who filed appeals of disability benefits decisions were older and had less education than the overall population of working-age adults. Among these disability applicants, wait times for a final decision did not significantly vary by age, sex, or education levels. GAO's analysis of available data from SSA and the Administrative Office of the U.S. Courts (AOUSC) found that from fiscal years 2014 through 2019, about 48,000 individuals filed for bankruptcy while awaiting a final decision on their disability appeals. This represents about 1.3 percent of the approximately 3.6 million disability applicants who filed appeals during those years. The applicants who filed for bankruptcy while awaiting a disability appeals decision were disproportionately female, older, and had more than a high school education as compared to the total population of disability applicants who filed appeals. Bankruptcies among individuals who were awaiting decisions about disability appeals may have been unrelated to the applicant's claimed disability. GAO's analysis of SSA disability administrative data and death data found that of the approximately 9 million disability applicants who filed an appeal from fiscal year 2008 through 2019, 109,725 died prior to receiving a final decision on their appeal. This represents about 1.2 percent of the total number of disability applicants who filed an appeal during those years. The annual death rate of applicants awaiting a final disability decision has increased in recent years. From fiscal years 2011 through 2018, the annual death rate for applicants pursuing appeals increased from 0.52 percent to 0.72 percent. Applicants who filed their initial disability claim during years of peak wait times and appealed their initial decision died at a higher rate while awaiting a final decision than applicants who filed their initial claim in years with shorter wait times. Disability applicants awaiting a final decision about their appeal who were male died at higher rates than applicants who were female and those who were older died at higher rates than those who were younger. Death rates were largely similar across reported education levels. Deaths among individuals who were awaiting decisions about disability appeals may have been unrelated to the applicant's claimed disability. The Social Security Administration (SSA) manages two large disability benefit programs–Disability Insurance (DI) and Supplemental Security Income (SSI). As of December 2019, these programs provided benefits to approximately 12.3 million adults living with disabilities and their eligible dependents. A disability applicant who is dissatisfied with SSA's initial disability determination can appeal the decision to multiple escalating levels of review. From fiscal years 2008 through 2019, SSA received approximately 9 million appeals of initial DI or SSI decisions. GAO has previously reported that applicants who appeal a benefits denial can potentially wait years to receive a final decision, during which time an applicant's health or financial situation could deteriorate. Given the heightened risk of worsening medical and financial conditions for disability applicants, GAO was asked to examine the incidence of such events while applicants await a final decision on their disability claim. This report examines the status of disability applicants while they awaited a final benefits decision including 1) their total wait times across all levels of disability appeals within SSA, 2) their incidence of bankruptcy, and 3) their incidence of death. For wait times, bankruptcies, and deaths, GAO also examined variations across certain demographic characteristics of applicants. GAO obtained administrative data from SSA for all adult disability applicants from fiscal years 2008 through 2019 who filed an appeal to their initial disability determination. GAO used these data to calculate wait times across appeals levels, rates of approvals and denials, and appeals caseloads, and examined changes in these three areas over time. To describe the incidence of bankruptcy among individuals awaiting a disability appeals decision, GAO matched SSA disability data to AOUSC bankruptcy data for fiscal years 2014 through 2019. To describe the incidence of death among individuals awaiting a disability appeals decision, GAO matched the disability data to SSA's Death Master File. For all of these analyses, GAO also examined variations across demographic characteristics of applicants, including age, sex, and reported education level. GAO also reviewed relevant policies, federal laws and regulations, and agency publications, and interviewed agency officials. For more information, contact Elizabeth Curda at (202) 512-7215 or CurdaE@gao.gov.
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  • Acting Assistant Attorney General Brian C. Rabbitt Delivers Remarks Announcing Goldman Sachs/1mdb Enforcement Actions
    In Crime News
    Good Afternoon. I am Brian Rabbitt, Acting Assistant Attorney General for the Department of Justice’s Criminal Division. I am joined today by Acting U.S. Attorney Seth DuCharme of the Eastern District of New York, Assistant Director in Charge Bill Sweeney of the FBI, Stephanie Avakian, Director of the Enforcement Division at the Securities and Exchange Commission, and Assistant General Counsel for Enforcement Jason Gonzalez of the Federal Reserve Board. We are here today to announce enforcement actions of historic significance.
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  • Owner of Oil Chem Inc. Pleads Guilty to Violating the Clean Water Act
    In Crime News
    The president and owner of Oil Chem Inc. pleaded guilty in federal court in Flint, Michigan, to a criminal charge of violating the Clean Water Act stemming from illegal discharges of landfill leachate — totaling more than 47 million gallons — into the city of Flint sanitary sewer system over an eight and a half year period.
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  • Seven Charged in Connection with a $2.1 Million Money Laundering Scheme that Involved Money from the Paycheck Protection Program
    In Crime News
    Seven individuals were charged in an indictment in the District of South Carolina with laundering over $750,000 of fraudulently obtained funds, including over $390,000 obtained from a fraudulent Paycheck Protection Program (PPP) loan. The seven individuals used a variety of methods to launder the money, including laundering the money through a casino. The indictment also identifies over $2.1 million in funds from twelve different bank accounts allegedly associated with the fraud scheme as subject to forfeiture which agents seized.
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  • Physical Infrastructure: Preliminary Observations on Options for Improving Climate Resilience of Transportation Infrastructure
    In U.S GAO News
    What GAO Found GAO's Disaster Resilience Framework serves as a guide for analysis of federal actions to facilitate and promote resilience to natural disasters and changes in the climate across many policy areas, including transportation. The framework is organized around three guiding principles—information, integration, and incentives—and a series of questions that can help identify opportunities to enhance federal efforts to promote disaster resilience. Specifically, the integration principle states that integrated analysis and planning can help decision makers take coherent and coordinated actions to promote resilience. For example, in October 2019, GAO reported that no federal agency, interagency collaborative effort, or other organizational arrangement has been established to implement a strategic approach to climate resilience investment that includes periodically identifying and prioritizing projects. Such an approach could supplement individual agency climate resilience efforts and help target federal resources toward high-priority projects. GAO recommended that Congress consider establishing a federal organizational arrangement to periodically identify and prioritize climate resilience projects for federal investment. The Federal Highway Administration (FHWA) has taken steps to encourage states to enhance the climate resilience of federally funded roads by developing agency policy, providing technical assistance to states, and supporting climate resilience research funding, among other actions. In addition, as part of ongoing work on FHWA's federal-aid highway program, GAO identified options that could further enhance the climate resilience of federally funded roads, based on a literature review and interviews with knowledgeable stakeholders (see table). Some of these options are similar to recommendations made previously by GAO. Further, according to FHWA officials, some of these options would likely require additional congressional direction or authority to implement. Options to further enhance resilience of federally funded roads, as suggested by relevant literature and knowledgeable stakeholders Option Integrate climate resilience into Federal Highway Administration policy and guidance. Update design standards to account for climate change and resilience best practices. Provide authoritative, actionable, forward-looking climate information. Add climate resilience funding eligibility requirements, conditions, or criteria to formula grant programs. Expand the availability of discretionary funding for climate resilience improvements. Alter the Emergency Relief (ER) program by providing incentives for, or conditioning funding on, pre-disaster resilience actions. Expand the availability of ER funding for post-disaster climate resilience improvements. Establish additional climate resilience planning or project requirements. Link climate resilience actions or requirements to incentives or penalties. Condition eligibility, funding, or project approval on compliance with climate resilience policy and guidance. Source: GAO analysis of literature and interviews with knowledgeable stakeholders. | GAO-21-561T Why GAO Did This Study Since 2013, GAO has included Limiting the Federal Government's Fiscal Exposure by Better Managing Climate Change Risks in its High Risk List. In addition, according to the U.S. Global Change Research Program, a changing climate threatens the performance of the U.S. transportation system across all modes, including roads. Congress authorized approximately $43 billion of fiscal year 2021 formula funding for the U.S. Department of Transportation's FHWA's federal-aid highway program, which primarily funds highway planning and construction. This testimony discusses (1) GAO's framework for identifying opportunities to enhance the climate resilience of transportation infrastructure; and (2) preliminary observations on actions taken and options to further enhance the climate resilience of federally funded roads. This work is based on GAO reports issued from 2014 through 2019, a review of literature, and interviews conducted with FHWA officials and knowledgeable stakeholders conducted as part of on-going work. GAO expects to issue a report on the results of its ongoing work in summer 2021.
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  • United States Unseals Superseding Indictment Charging Nationwide Money Laundering Network
    In Crime News
    The Justice Department today announced the unsealing of a superseding indictment charging six individuals with participating in a conspiracy to launder millions of dollars of drug proceeds on behalf of foreign cartels.  This superseding indictment is the result of a nearly four-year investigation into the relationship between foreign drug trafficking organizations and Asian money laundering networks in the United States, China, and elsewhere.
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  • 15 Named In $26 Million International Trade Fraud Scheme
    In Crime News
    A federal grand jury in Houston, Texas, has returned a criminal indictment against eight individuals, while a related civil complaint has charged 14 individuals and one company relating to international trade fraud violations stemming from a decade-long scheme involving tires from China.  
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  • International Criminal Investigative Training Assistance Program (ICITAP) Director Greg Ducot Delivers Remarks at the Virtual Fourth International Forensic Science Symposium
    In Crime News
    Good morning, honorable and distinguished guests of this fourth International Symposium of Forensic Sciences convened virtually from the capital of the United Mexican States.
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  • Six Charged in Connection with a $3 Million Paycheck Protection Program Fraud Scheme
    In Crime News
    Six individuals were charged in an indictment with fraudulently obtaining approximately $1.5 million in Paycheck Protection Program (PPP) loans on behalf of five businesses based in Georgia and South Carolina.
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