Science & Tech Spotlight: Vaccine Safety

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.

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    Stakeholders GAO interviewed and studies GAO reviewed identified three factors that affect access to follow-up care for childhood cancer survivors—individuals of any age who were diagnosed with cancer from ages 0 through 19. These factors are care affordability, survivors' and health care providers' knowledge of appropriate care, and proximity to care. Childhood cancer survivors need access to follow-up care over time for serious health effects known as late effects—such as developmental problems, heart conditions, and subsequent cancers—which result from their original cancer and its treatment. Affordability: Survivors of childhood cancer may have difficulty paying for follow-up care, which can affect their access to this care. For example, one study found that survivors were significantly more likely to have difficulty paying medical bills and delay medical care due to affordability concerns when compared to individuals with no history of cancer. Knowledge: Survivors' access to appropriate follow-up care for late effects of childhood cancer can depend on both survivors' and providers' knowledge about such care, which can affect access in various ways, according to stakeholders GAO interviewed and studies GAO reviewed: Some survivors may have been treated for cancer at an early age and may have limited awareness of the need for follow- up care. Some primary or specialty care providers may not be knowledgeable about guidelines for appropriate follow-up care, which can affect whether a survivor receives recommended treatment. Follow-up care may include psychosocial care (e.g., counseling), and palliative care (e.g., pain management). Proximity: Survivors may have difficulty reaching appropriate care settings. Stakeholders GAO interviewed and studies GAO reviewed noted that childhood cancer survivors may have to travel long distances to receive follow-up care from multidisciplinary outpatient clinics—referred to as childhood cancer survivorship clinics. The lack of proximity may make it particularly difficult for survivors with limited financial resources to adhere to recommended follow-up care. The National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC)—agencies within the Department of Health and Human Services (HHS) that conduct activities specific to childhood cancer survivors, including research about access to care—have taken steps to implement three provisions in the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018 (Childhood Cancer STAR Act) relevant to access to care for survivors. For example, CDC has awarded a contract to develop software to improve the collection of information on individuals with childhood cancer, and NCI has funded three research projects focused on interventions aimed at addressing adverse outcomes among childhood cancer survivors. NCI has also funded research to study the health status and use of follow-up services of 2,000 young adult survivors. Stakeholders have raised questions about the ability of childhood cancer survivors to access needed follow-up care. According to the most recent data available, approximately 465,000 childhood cancer survivors—children, adolescents, and adults—were alive in the United States as of January 1, 2017. Although the 5-year survival rate for childhood cancer has increased from about 62 percent in the mid-1970s to about 86 percent in the mid-2010s, childhood cancer survivors may face late effects, which could require follow-up care across multiple stages of their lives. The conference report accompanying Public Law 115-245 included a provision for GAO to report on barriers to obtaining medical care for childhood cancer survivors, including psychosocial services and palliative care. This report identifies factors reported to affect access to follow-up care for this population. GAO spoke with officials from NCI and CDC and interviewed stakeholders such as providers who care for childhood cancer survivors, professional associations, and advocacy groups. Additionally, GAO reviewed peer-reviewed studies related to access to care for survivors, outcomes of treatment they may receive, and factors that may affect their access to follow-up care. To supplement this work, GAO reviewed the status of selected HHS activities to support access to care for childhood cancer survivors, including steps taken to implement selected provisions in the Childhood Cancer STAR Act. GAO provided a draft of this report to HHS for review and comment. HHS provided technical comments, which GAO incorporated as appropriate. For more information, contact Jessica Farb at (202) 512-7114 or FarbJ@gao.gov.
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  • Introductory Remarks of Deputy Attorney General at Announcement of Civil Antitrust Lawsuit Filed Against Google
    In Crime News
    This morning, the Department of Justice and eleven states filed an antitrust civil lawsuit against Google, for unlawfully maintaining a monopoly in general search services and search advertising in violation of section two of the Sherman Act.
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  • Department of Justice Announces Charges of North Korean and Malaysia Nationals for Bank Fraud, Money Laundering and North Korea Sanctions Violations
    In Crime News
    The Department of Justice announced a criminal complaint charging Ri Jong Chol, Ri Yu Gyong, North Korean nationals, and Gan Chee Lim, a Malaysia national. The three were charged with conspiracy to violate North Korean Sanctions Regulations and bank fraud, and conspiracy to launder funds. The defendants allegedly established and utilized front companies that transmitted U.S. dollar wires through the United States to purchase commodities on behalf of North Korean customers.
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  • Kansas Man Indicted with Hate Crime for Racially-Motivated Threat of a Minor and for Unlawfully Possessing a Firearm
    In Crime News
    The Justice Department announced that a federal grand jury in Kansas City, Kansas, returned an indictment charging Colton Donner, 25, with threatening an African-American male juvenile, because of the victim’s race and because the victim was living in a home in Paola, Kansas, in violation of Title 42, U.S. Code, Section 3631.
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  • The United States Welcomes Major Milestone in Afghanistan Peace Negotiations
    In Crime Control and Security News
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  • Financial Company Bankruptcies: Congress and Regulators Have Updated Resolution Planning Requirements
    In U.S GAO News
    Since 2015, Congress has not changed parts of the U.S. Bankruptcy Code (Code) related to financial companies or the Orderly Liquidation Authority (OLA). However, the Federal Deposit Insurance Corporation (FDIC) and the Board of Governors of the Federal Reserve System (Federal Reserve) have updated the resolution planning process to better match resolution planning requirements to the risks of companies. OLA is a regulatory alternative to bankruptcy for resolving failed, systemically important financial institutions, and resolution plans describe how a financial company may be resolved in an orderly manner if it fails. In November 2019, FDIC and the Federal Reserve finalized amendments to the Resolution Plans Required rule, establishing different filing cycles and content requirements for resolution plans based on the asset size and risk profile of companies. Regulators also finalized other rules related to OLA and resolution planning and proposed several additional rules. The 2007–2009 financial crisis and the failures of large, complex financial companies led some financial and legal experts to question the adequacy of the U.S. Bankruptcy Code for effectively reorganizing or liquidating these companies. These experts, government officials, and members of Congress responded by proposing changes to the Code and the supervisory process leading to a bankruptcy filing. The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) established OLA as a regulatory alternative to bankruptcy. Under OLA, the Secretary of the Treasury may appoint FDIC as a receiver to resolve systemically important financial institutions. In addition to OLA, the Dodd-Frank Act requires financial companies to file periodic resolution plans with the Financial Stability Oversight Council, Federal Reserve and FDIC describing how they could be resolved in an orderly manner in the event of material financial distress or failure. The Dodd-Frank Act also includes a provision for GAO to study, at specified intervals, the effectiveness of the Code in facilitating the orderly liquidation or reorganization of financial companies and ways to make the orderly liquidation process under the Code more effective. This report examines (1) proposed or enacted changes to the Code related to financial companies and OLA since 2015, and (2) regulatory actions related to resolution planning and OLA. GAO reviewed proposed legislation, regulations, prior GAO reports, and agency reports and presentations on financial company bankruptcies, OLA, and resolution planning. GAO also reviewed comment letters to the 2019 proposed Resolution Plans Required rulemaking. GAO interviewed officials from the Administrative Office of the United States Courts, FDIC, and the Federal Reserve. GAO also interviewed six industry stakeholders, including academics, a consumer group, industry associations, and former regulatory officials, about the 2019 Resolution Plans Required Rule. For more information, contact Michael Clements at (202) 512-8678 or ClementsM@gao.gov.
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  • Justice Department Files Complaint to Stop Distribution of Unapproved, Misbranded, and Adulterated “Poly-MVA” Products
    In Crime News
    The United States filed a civil complaint to stop a California company from distributing unapproved and misbranded drugs and adulterated animal drugs, the Department of Justice announced today.
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  • Federal Research: Agencies Need to Enhance Policies to Address Foreign Influence
    In U.S GAO News
    U.S. research may be subject to undue foreign influence in cases where a researcher has a foreign conflict of interest (COI). Federal grant-making agencies can address this threat by implementing COI policies and requiring the disclosure of information that may indicate potential conflicts. GAO reviewed five agencies—which together accounted for almost 90 percent of all federal research and development expenditures at universities in fiscal year 2018—and found that three have agency-wide COI policies, while two do not (see figure). The three agencies with existing policies focus on financial interests but do not specifically address or define non-financial interests, such as multiple professional appointments. In the absence of agency-wide COI policies and definitions on non-financial interests, researchers may not fully understand what they need to report on their grant proposals, leaving agencies with incomplete information to assess the risk of foreign influence. GAO found that, regardless of whether an agency has a conflict of interest policy, all five agencies require researchers to disclose information—such as foreign support for their research—as part of the grant proposal that could be used to determine if certain conflicts exist. Elements of Conflict of Interest (COI) Policies at Agencies with the Most Federal Research Expenditures at Universities Based on a review of university documents, GAO found that all 11 of the universities in its sample have publicly available financial and non-financial COI policies for federally funded research. These policies often align with the financial COI policies or requirements of the grant-making agencies. All five agencies have mechanisms to monitor and enforce their policies and disclosure requirements when there is an alleged failure to disclose required information. All agencies rely on universities to monitor financial COI, and most agencies collect non-financial information such as foreign collaborations, that can help determine if conflicts exist. Agencies have also taken actions in cases where they identified researchers who failed to disclose financial or non-financial information. However, three agencies lack written procedures for handling allegations of failure to disclose required information. Written procedures for addressing alleged failure to disclose required information help agencies manage these allegations and consistently apply enforcement actions. In interviews, stakeholders identified opportunities to improve responses to foreign threats to research, such as harmonizing grant application requirements. Agencies have begun to address such issues. The federal government reportedly expended about $42 billion on science and engineering research at universities in fiscal year 2018. Safeguarding the U.S. research enterprise from threats of foreign influence is of critical importance. Recent reports by GAO and others have noted challenges faced by the research community to combat undue foreign influence, while maintaining an open research environment that fosters collaboration, transparency, and the free exchange of ideas. GAO was asked to review federal agency and university COI policies and disclosure requirements. In this report, GAO examines (1) COI policies and disclosure requirements at selected agencies and universities that address potential foreign threats, (2) mechanisms to monitor and enforce policies and requirements, and (3) the views of selected stakeholders on how to better address foreign threats to federally funded research. GAO reviewed laws, regulations, federal guidance, and agency and university COI policies and requirements. GAO also interviewed agency officials, university officials, and researchers. GAO is making nine recommendations to six agencies, including that grant-making agencies address non-financial conflicts of interest in their COI policies and develop written procedures for addressing cases of failure to disclose required information. Five agencies agreed with GAO's recommendations. The National Science Foundation neither agreed nor disagreed with GAO's recommendation, but identified actions it plans to take in response. For more information, contact Candice N. Wright at (202) 512-6888 or wrightc@gao.gov.
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  • Man Pleads Guilty to Violating Endangered Species Act
    In Crime News
    A New York man pleaded guilty in U.S. District Court to selling a mounted leopard, which is an endangered species.
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