Administration

GAO-21-342SP, Science & Tech Spotlight: Vaccine Safety, February 24, 2021

GAO - OIG -

Why this Matters Safe vaccines are critical to fighting diseases, from polio to COVID-19. Research shows that the protection provided by U.S. licensed vaccines outweighs their potential risks. However, misinformation and unjustified safety concerns can cause people to delay or refuse vaccination, which may increase preventable deaths and prolong negative social and economic impacts. The Science What is it? A vaccine is generally considered safe when the benefits of protecting an individual from disease outweigh the risks from potential side effects (fig. 1). The most common side effects stem from the body's immune reaction and include swelling at the injection site, fever, and aches. Figure 1. Symptoms of polio and side effects of the polio vaccine. A vaccine is generally considered safe if its benefits (preventing disease) outweigh its risks (side effects). In rare cases, some vaccines may cause more severe side effects. For example, the vaccine for rotavirus—a childhood illness that can cause severe diarrhea, dehydration, and even death—can cause intestinal blockage in one in 100,000 recipients. However, the vaccine is still administered because this very rare side effect is outweighed by the vaccine's benefits: it saves lives and prevents an estimated 40,000 to 50,000 childhood hospitalizations in the U.S. each year. The two messenger RNA (mRNA) vaccines authorized for COVID-19—a disease that contributed to more than 415,000 American deaths between January 2020 and January 2021—can cause severe allergic reactions. However, early safety reporting found that these reactions have been extremely rare, with only about five cases per 1 million recipients, according to data from January 2021 reports by the Centers for Disease Control and Prevention. In general, side effects from vaccines are less acceptable to the public than side effects from treatments given to people who already have a disease. What is known? Vaccine developers assess safety from early research, through laboratory and animal testing, and even after the vaccine is in use (fig. 2). Researchers may rely on previous studies to inform future vaccine trials. For example, safety information from preclinical trials of mRNA flu vaccine candidates in 2017 allowed for the acceleration of mRNA COVID-19 vaccine development. Vaccine candidates shown to be safe in these preclinical trials can proceed to clinical trials in humans. In the U.S., clinical trials generally proceed through three phases of testing involving increasing numbers of volunteers: dozens in phase 1 to thousands in phase 3. Although data may be collected over years, most common side effects are identified in the first 2 months after vaccination in clinical trials. After reviewing safety and other data from vaccine studies, the Food and Drug Administration (FDA) may license a vaccine to be marketed in the U.S. There are also programs to expedite—but not bypass—development and review processes, such as a priority review designation, which shortens FDA’s goal review time from 10 to 6 months. Safety monitoring continues after licensing. For example, health officials are required to report certain adverse events—such as heart problems—following vaccination, in order to help identify potential long-term or rare side effects that were not seen in clinical trials and may or may not be associated with the vaccine. Figure 2. Vaccine safety is assessed at every stage: development through post-licensure. Following a declared emergency, FDA can also issue emergency use authorizations (EUA) to allow temporary use of unlicensed vaccines if there is evidence that known and potential benefits of the vaccine outweigh known and potential risks, among other criteria. As of January 2021, two COVID-19 vaccines had received EUAs, after their efficacy and short-term safety were assessed through large clinical trials. However, developers must continue safety monitoring and meet other requirements if they intend to apply for FDA licensure to continue distribution of these vaccines after the emergency period has ended. What are the knowledge gaps? One knowledge gap that can remain after clinical trials is whether side effects or other adverse events may occur in certain groups. For example, because clinical trials usually exclude certain populations, such as people who are pregnant or have existing medical conditions, data on potential adverse events related to specific populations may not be understood until vaccines are widely administered. In addition, it can be difficult to determine the safety of new vaccines if outbreaks end suddenly. For example, vaccine safety studies were hindered during the 2014-2015 Ebola epidemic when a large increase in the number of cases was followed by a sharp decrease. This disrupted the clinical trials of Ebola vaccine candidates, because the trials require many infected and non-infected people. Furthermore, a lack of understanding and/or misinformation about the steps taken to ensure the safety of vaccines hinders accurate public knowledge about safety concerns, which may cause people to delay or refuse vaccination. This resulting hesitancy may, in turn, increase deaths, social harm, and economic damage. Opportunities Continuing and, where necessary, improving existing vaccine safety practices offers the following opportunities to society: Herd immunity. Widespread immunity in a population, acquired in large part through safe and effective vaccines, can slow the spread of infection and protect those most vulnerable. Health care improvements. Vaccinations can reduce the burden on the health care system by reducing severe symptoms that require individuals to seek treatment. Eradication. Safe vaccination programs, such as those combatting smallpox, may eliminate diseases to the point where transmission no longer occurs. Challenges There are a number of challenges to ensuring safe vaccines: Public confidence. Vaccine hesitancy, in part due to misinformation or historic unethical human experimentation, decreases participation in clinical trials, impeding identification of side effects across individuals with different racial, ethnic, and socioeconomic backgrounds. Mutating viruses. Some viruses, such as those that cause the flu or COVID-19, may mutate rapidly and thus may require new or updated vaccines, for which ongoing safety monitoring is important. Long-term and rare effects. Exceedingly rare or long-term effects may not be identified until after vaccines have been widely administered. Further study is needed to detect any such effects and confirm they are truly associated with the vaccine. Policy Context & Questions What steps can policymakers take to improve public trust and understanding of the process of assessing vaccine safety? How can policymakers convey the social importance of vaccines to protect the general public and those who are most vulnerable? How can policymakers leverage available resources to support ongoing vaccine development and post-licensure safety monitoring? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.

GAO-21-123, Bureau of Prisons: Opportunities Exist to Better Analyze Staffing Data and Improve Employee Wellness Programs, February 24, 2021

GAO - OIG -

The Bureau of Prisons (BOP) has multiple methods for assessing its staffing levels to determine shortfalls, but each contains inconsistencies in either terminology or methodology and we found reliability concerns with each. For two methods, BOP was unable to provide supporting documentation, and for the third, a BOP official stated that the method did not account for different institutions' characteristics. By developing a reliable method for calculating staffing levels at BOP institutions, or amending existing methods, BOP would have a more accurate picture of the extent of any shortfalls and could take corrective action to address identified workforce gaps. BOP has practices for addressing staffing challenges, such as using overtime, but has not assessed associated risks to staff and inmate safety, such as officer fatigue and decreased observation skills. Overtime expenditures, without adjusting for inflation, have increased 102 percent from 2015 through 2019. Conducting a risk assessment of its overtime use would better position BOP to identify the potential risks of overtime and respond, as appropriate. Overtime Expenditures at Bureau of Prisons (BOP) Institutions from Fiscal Years 2015 through 2019 Note: Data are expenditures in nominal dollars, and have not been adjusted for inflation. For more details, see figure 4 in GAO-21-123 BOP could improve data collection efforts to enhance its employee wellness programs. For example, BOP operates an Employee Assistance Program, which provides counseling and referral services to employees, and BOP is working to improve the program. However, BOP has not collected program feedback from employees in a systematic way. By developing a method to routinely collect and evaluate feedback, BOP would be better positioned to help ensure employee satisfaction and to identify ways to continually enhance the program. As of November 2020, BOP employed more than 37,000 individuals responsible for the care and custody of more than 125,000 federal inmates in BOP institutions. Questions have been raised about BOP's ability to fully staff its institutions, the effects of staffing shortfalls, and the mental health of corrections staff. GAO was asked to examine BOP staffing levels and other related challenges. This report examines, among other objectives: (1) the methods BOP uses to assess staffing levels; (2) the practices BOP uses to address any staffing challenges, and the extent to which it assesses their effectiveness; and (3) what, if anything, BOP could do to improve staff mental health and related services. Among other methods, GAO examined program and staffing documentation and data, and interviewed BOP officials knowledgeable about budget and personnel practices. GAO is making 7 recommendations, including that BOP develop and implement a reliable method for calculating staffing levels, or amend existing methods; conduct a risk assessment of its overtime use; and develop and implement a method to routinely collect and evaluate employee feedback on its Employee Assistance Program. The Department of Justice concurred with our recommendations. For more information, contact Gretta L. Goodwin at (202) 512-8777 or GoodwinG@gao.gov.

GAO-21-147, Pregnant Women in DOJ Custody: U.S. Marshals Service and Bureau of Prisons Should Better Align Policies with National Guidelines, January 25, 2021

GAO - OIG -

GAO analyses of available data show that from calendar year 2017 through 2019, there were at least 1,220 pregnant women in U.S. Marshals Service (USMS) custody and 524 pregnant women in Bureau of Prisons (BOP) custody. Pregnant Women in USMS and BOP Custody: Number, Age, Race, and Length of Time in Custody from 2017 through 2019 aUSMS does not track pregnancy outcomes, so length of time in custody may include time when the women were not pregnant. For BOP, the length of time represents only the period of pregnancy. GAO analyses also show that pregnant women were held at a variety of facility types from 2017 through 2019. For example, pregnant women spent 68 percent of their time in USMS custody in non-federal facilities where USMS has an intergovernmental agreement. BOP data show that pregnant women spent 21 percent of their time in BOP custody while pregnant at Carswell—BOP's only female Federal Medical Center. While USMS and BOP both have policies that address the treatment and care of pregnant women, not all policies fully align with national guidance recommendations on 16 pregnancy-related care topics. For example, national guidance recommends specialized nutrition and when needed, mental health care. USMS policies fully align on three of 16 care topics and BOP policies fully align on eight of 16. By taking steps to more closely align agency standards and policies with national guidance as feasible, USMS and BOP would be better positioned to help ensure the health of pregnant women in their custody. USMS and BOP data show that the agencies provide a variety of medical care and special accommodations to pregnant women, and both agencies track the use of restraints. For example, USMS data show that women receive prenatal care and BOP data show that women receive prenatal vitamins and lower bunk assignments, among other things. However, USMS could do more to collect data on pregnant and postpartum women in their custody who are placed in restrictive housing. While USMS requests that facilities that hold USMS prisoners submit data on a regular basis indicating which prisoners were placed in restrictive housing, facilities are not required to indicate if any of these prisoners are pregnant or postpartum. In addition, USMS does not have a requirement for facilities to immediately notify USMS when such women are placed in restrictive housing. By requiring these notifications and data collection, USMS would be better positioned to ensure that facilities are complying with its USMS Detention Standards and Department of Justice (DOJ) guidance that state pregnant and postpartum women should not be placed in restrictive housing except in rare situations. Policymakers and advocacy groups have raised questions about the treatment of incarcerated pregnant women, including the use of restrictive housing—removal from the general prisoner population with the inability to leave the cell for the majority of the day—and restraints. Within DOJ, USMS is responsible for prisoners awaiting trial or sentencing. BOP is responsible for sentenced prisoners. GAO was asked to review issues related to pregnant women in USMS and BOP custody. This report examines (1) what DOJ data indicate about pregnant women in USMS and BOP custody; (2) the extent to which USMS and BOP policies align with national guidance on pregnancy-related care; and (3) what is known about the care provided and the extent to which USMS and BOP track when pregnant women are placed in restrictive housing or restraints. GAO analyzed available agency data from calendar years 2017 through 2019, which were the most recent data available; compared agency policies to relevant national guidance; and interviewed officials and a non-generalizable sample of prisoners who had been pregnant in USMS or BOP custody. GAO is making six recommendations, including that USMS and BOP take steps to more closely align their policies with national guidance on pregnancy-related care as feasible, and that USMS require facilities to collect data on and notify USMS when pregnant or postpartum women are placed in restrictive housing. DOJ concurred with our recommendations. For more information, contact Gretta L. Goodwin at (202) 512-8777 or goodwing@gao.gov.

GAO-21-415T, Defense Budget: Opportunities Exist to Improve DOD's Management of Defense Spending, February 24, 2021

GAO - OIG -

GAO's previous work has shown that a number of opportunities exist for the Department of Defense (DOD) to strengthen management of defense spending, which would help the department address the challenges it faces, especially in a constrained budget environment. These opportunities include: Improving budgeting execution of funds. DOD does not fully obligate the funds appropriated to it and can improve both its budgeting for and its use of the resources that are provided to it. For example, GAO found that DOD has left billions of dollars in appropriated amounts unspent over the past 10 fiscal years. Better estimating annual budget requirements and obligating appropriations provided by Congress within the period of availability established by Congress would help DOD minimize these cases of under-execution. More clearly determining future resource requirements related to overseas contingency operations. DOD and Congress need a clearer determination of DOD's future resource requirements, in particular how and whether to incorporate enduring Overseas Contingency Operations (OCO) costs—costs that will endure beyond ongoing contingency operations—into DOD's base budget. These costs could total tens of billions of dollars a year. However, few details exist as to what makes up these enduring costs or how they were derived, raising questions about how much should be included as future requirements. Reducing improper payments. Addressing improper payments—payments that should not have been made or were made in an incorrect amount—is an area where better financial management could save DOD billions of dollars. In its fiscal year 2020 agency financial report, DOD estimated that it paid about $11.4 billion in improper payments, or about 1.7 percent of all payments it made that year. DOD has taken steps to reduce improper payments in some areas, but DOD's estimates of its improper payments in other areas indicate more remains to be done. Sustaining and refining department-wide business reform efforts. DOD must transform its overall business operations so that it can more efficiently and effectively use its resources. In recent years, DOD reported notable achievements from its most recent department-wide business reform efforts, including $37 billion in savings from fiscal years 2017 to 2021 as a result of these efforts. However, GAO previously found that while DOD's reported savings were largely reflected in its budget materials, the analyses underlying these estimates were not always well documented and the savings were not always the result of business reform. Moreover, uncertainty about the leadership structure at DOD for overseeing and reforming business operations, including the recent elimination of the Chief Management Officer position, calls into question whether efforts to fundamentally transform how the department does business can be realized and sustained. GAO has previously highlighted the importance of DOD providing clear department-wide guidance on roles, responsibilities, authorities, and resources for business reform efforts will be necessary for DOD to make progress in these efforts. Decisions by DOD and Congress regarding long-term defense needs will have a meaningful impact on the nation's fiscal future. As the single largest category of discretionary spending, defense spending is likely to play a large role in any discussion of future federal spending. GAO and others have found that DOD faces challenges that are likely to put pressure on its budget moving forward. DOD is the only major federal agency that has been unable to receive a clean audit opinion on its financial statements. This testimony provides information on how DOD can better manage defense spending, specifically related to its ability to (1) accurately estimate its budgetary requirements and execute its appropriated funds, (2) determine resource requirements related to overseas contingency operations, (3) reduce improper payments, and (4) sustain and refine department-wide reform efforts. For this testimony, GAO reviewed and summarized its recent work on DOD budget and financial management issues and departmental reform efforts. In prior work on which this testimony is based, GAO made recommendations that DOD take steps to better estimate its annual budget requirements and future fiscal needs for OCO, reduce improper payments, and refine and formalize its departmental reform efforts. DOD generally concurred with these recommendations and is working toward implementing them. For more information, contact Elizabeth A. Field at (202) 512-2775 or fielde1@gao.gov.

GAO-21-396T, Covid-19: Key Insights from GAO's Oversight of the Federal Public Health Response, February 24, 2021

GAO - OIG -

More than a year after the U.S. declared COVID-19 a public health emergency, the pandemic continues to result in catastrophic loss of life and substantial damage to the economy. It also continues to lay bare the fragmented nature of our public health sector, the fragility of the nation's medical supply chain, and longstanding disparities in health care access, treatment, and outcomes. GAO has made 44 recommendations to federal agencies. Of these recommendations, 16 relate to the following public health topics: COVID-19 Testing. GAO has made two recommendations to date to improve the federal government's efforts in diagnostic testing for COVID-19, critical to controlling the spread of the virus. In January 2021, GAO recommended that the Department of Health and Human Services (HHS) develop and make publicly available a comprehensive national COVID-19 testing strategy. Vaccines and Therapeutics. GAO has made two recommendations to improve transparency, communication, and coordination around the government's efforts to develop, manufacture, and distribute vaccines and therapeutics to prevent and treat COVID-19. For example, in September 2020, GAO recommended that HHS establish a time frame for a national vaccine distribution and administration plan that follows best practices, with federal and nonfederal coordination. Medical Supply Chain. GAO has made seven recommendations for the federal government to respond to vulnerabilities highlighted by the pandemic in the nation's medical supply chain, including limitations in personal protective equipment and other supplies necessary to treat individuals with COVID-19. In January 2021, GAO recommended that HHS establish a process for regularly engaging with Congress and nonfederal stakeholders as the agency refines and implements its supply chain strategy for pandemic preparedness, to include the role of the Strategic National Stockpile. COVID-19 Health Disparities. GAO has made three recommendations to improve COVID-19 data by race and ethnicity, as available data show communities of color bear a disproportionate burden of COVID-19 positive tests, cases, hospitalizations, and deaths. In September 2020, GAO recommended that the Centers for Disease Control and Prevention involve key stakeholders to help ensure the complete and consistent collection of demographic data. COVID-19 Data. GAO has made two recommendations to improve the collection of data needed to respond to COVID-19 and prepare for future pandemics. GAO recommended in January 2021 that HHS establish an expert committee to help systematically define and ensure the collection of standardized data across the relevant federal agencies and related stakeholders; the absence of such data hinders the ability of the government to respond to COVID-19, communicate the status of the pandemic with citizens, or prepare for future pandemics.  Although the responsible agencies generally agreed with the majority of the 16 recommendations, only one has been fully implemented. GAO maintains that implementing these recommendations will improve the federal government's public health response and ability to recover as a nation. As of February 17, 2021, the U.S. had about 27 million cumulative reported cases of COVID-19 and more than 486,000 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions. Five relief laws, including the CARES Act, have appropriated $3.1 trillion to address the public health and economic threats posed by COVID-19. The CARES Act also includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to COVID-19. This testimony summarizes GAO's insights from its oversight of the federal government's pandemic response in a series of comprehensive reports issued from June 2020 through January 2021. In particular, the statement focuses on the public health response, including testing, vaccines and therapeutics, medical supply chain, health disparities, and health data. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials and stakeholders for the series of reports on which this testimony is based. See https://www.gao.gov/coronavirus/. GAO has made 44 recommendations for agencies and four matters for congressional consideration in its comprehensive series of bimonthly reports on the federal response to COVID-19 over the last year. GAO will issue its next report in this series in March 2021. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov.

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