Introduction

The Centers for Disease Control and Prevention (CDC) estimate vaccines prevented 21 million hospitalizations and over 730,000 deaths among children between 1994 and 2013. Like many public health programs, immunization programs are invisible when they are working well. High vaccination coverage rates and low incidences of diseases indicate a successful immunization program. Measles outbreaks or emerging viruses like COVID-19, however, remind us of the important role immunizations play in the public health system.

School Requirements

From the time they are born, children receive numerous immunizations; there are 16 different recommended vaccines for children 0-18, some requiring multiple doses. The Advisory Committee on Immunization Practices (ACIP) recommends vaccine schedules for children, adolescents and adults based on scientific evidence and the benefits of preventing infectious diseases.

School and daycare immunization requirements serve as a "safety net" for children who do not receive their recommended immunizations as an infant or small child. All school requirement laws are state-based and usually reflect the recommendations of ACIP. It is important to note that some states give the state health officer or department of health the authority to change school requirements through administrative rule, one example is Wyoming. Others revise school requirements through a combination of rules and legislation or strictly by legislative action. Regardless of the process, the state legislature plays an important oversight role in these systems.

School requirements are not without controversy, however. Some parents and advocates contend that vaccine mandates infringe on a person's individual right to choose, especially if a parent is concerned that vaccines may harm children. Many states have exemption laws to accommodate those who may object to immunization mandates.

Exemptions

Although immunization requirements vary from state to state, all states allow exemptions for medical reasons, and almost all states (except California, Maine, Mississippi, New York and West Virginia) grant religious or philosophical exemptions for people who have sincerely held beliefs that prohibit immunizations. Currently, 45 states and DC have a religious exemption law and 15 states have a religious and philosophical exemption law. These laws allow parents to claim an exemption based on their personal, moral or other beliefs.

Financing Childhood Immunizations

According to the Association of State and Territorial Health Officials (ASTHO), every $1 spent on childhood immunizations saves $10.20 in avoided costs. Vaccines can still be a significant state investment; according to ASTHO, the price to fully vaccinate one child in the public sector increased from $282.19 in 2000 to $1,894.52 in 2014, the last year for which data is available. Factors pushing up costs include new vaccines and inflation.

Federal Programs

Federal funds pay for approximately 95 percent of all publicly funded vaccinations through the following two sources:

The Vaccines for Children Program provides free vaccines for children who are uninsured, Medicaid-eligible, underinsured (if receiving immunizations in a federally qualified health center or rural health clinic), Native American or Alaska Native. According to the U.S. Department of Health and Human Services (HHS), the Vaccines for Children program cost $4.7 billion in 2019.

Section 317 of the Public Health Services Act is a federal program administered by CDC and provides grants to states and territories, commonwealth trusts and several cities for vaccine purchase and programs such as outreach and disease surveillance. The Affordable Care Act (ACA) reauthorized the Section 317 grant program. Prior to enactment of the ACA, states could purchase only recommended childhood immunizations; however, the ACA authorizes states to purchase recommended vaccines for adults as well. The HHS secretary can negotiate and contract with vaccine manufacturers, allowing states to receive adult vaccines at a negotiated price and provide these vaccines to certain groups of adults, such as uninsured adults, in their immunization programs.

State Programs

The majority of states depend primarily on federal resources to purchase vaccines. However, federal programs do not cover all children, so many states supplement these funds.

Universal Purchase: As of 2018, 10 states (Alaska, Idaho, Maine, Massachusetts, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, and Washington) have universal purchase policies where the states or territories purchase all recommended vaccines for all children, including those who are fully insured. Four other states (Connecticut, Florida, South Dakota and Wyoming) have universal select programs that purchase all recommended vaccines for all children with the exception of one or more vaccines.

Insurance Requirements: The ACA requires new health plans and insurance policies to provide coverage without cost sharing, such as copayments or coinsurance, for certain preventive services. Preventive services in the law specifically include immunizations recommended by ACIP. Provisions allow for up to a one-year delay for coverage of a newly recommended ACIP vaccine.

Vaccine Safety

State and federal policymakers, government agencies, vaccine manufacturers, the medical community and parents all agree on one thing- they want to keep children safe and healthy. The federal government and vaccine manufacturers go to great lengths to make vaccines for both adults and children as safe as possible. Vaccines can still cause very rare side effects. Much of the movement to implement more flexible exemption laws stems from concerns about vaccine safety.

Federal Programs

Once the medical community begins to use a vaccine, suspected adverse reactions can be reported to the Vaccine Adverse Event Reporting System (VAERS). This system, coordinated by CDC and FDA, serves as an early warning system to detect problems that may be related to vaccines. VAERS receives approximately 30,000 reports annually. In addition, CDC works with eight large managed care organizations to run the Vaccine Safety Datalink Project. This system contains the medical and immunization histories of more than 7.5 million people and helps CDC assess whether an adverse reaction is purely coincidental or is directly linked to an immunization.

When an adverse event occurs and permanent side effects result, individuals can file a claim with the federal National Vaccine Injury Compensation Program (VICP). The program provides financial assistance and is designed as a "no fault" system for adverse effects on the Vaccine Injury Table (VIT). Families are granted the presumption that the vaccine caused a child's injury or death, if no other medical cause can be found for a specific list of known vaccine-associated side effects. If an adverse event is not on the VIT, families must prove causality. Funding for the VICP comes from the Vaccine Injury Compensation Trust Fund, funded from an excise tax of $0.75 on every dose of covered vaccine that is purchased.

Thimerosal and Mercury

Thimerosal, a preservative that contains a form of mercury, was used in very small amounts for over 50 years as a preservative in some vaccines and to protect vaccines from bacterial contamination. Some parents, researchers and others have voiced concerns about a potential link between health problems, particularly autism, and vaccines containing thimerosal. According to CDC, there is no convincing evidence of harm caused by the small amounts of thimerosal in vaccines, except for minor effects like swelling and redness at the infection site due to sensitivity to thimerosal.

Immunization Information Systems

Immunization information systems (IIS) are confidential, electronic systems that contain vaccination histories within a geographic area. Data from IIS can help lawmakers and state health officials identify and address areas with lower immunization rates. While states track immunizations across the lifespan, IIS can help ensure that children who are too young to fall under school vaccine requirements receive the recommended vaccinations at the recommended ages. Electronic registries can help doctors check a child's immunization history through a centralized database, without depending on the parents for a paper record.

All 50 states, the District of Columbia and all U.S. territories have at least one regional or local IIS. In 2018, according to CDC, 95% of children under age six participated in a state or local IIS. The rate for 2016 was 94%.

General Population Immunization

While policymakers often prioritize the immunization of children, there are vaccines and vaccine policies that promote general health and safe vaccination rates across age groups. Unlike vaccination efforts for children, fewer requirements exist for adult immunizations. Instead, states and federal health agencies often employ messaging campaigns and the expansion of vaccine administration authority to health providers to maintain safe vaccination rates for the influenza virus and other preventable illnesses.

The Adult Immunization Schedule recommended by ACIP is not as extensive as its counterpart for children and adolescents. Although it includes vaccines such as Hepatitis B, tetanus and varicella, these apply only to certain at-risk populations and adults in certain occupations. Most adult immunization policies focus on influenza (flu) and pneumococcal (pneumonia) vaccinations.

The ACA increased insurance coverage for adults with private and public health insurance. HHS also supports adult immunizations through the National Adult Immunization Plan. The plan lists four goals (infrastructure, access, demand and innovate) and suggests actions and priorities for federal, state and local partners to consider for implementation of vaccine policies and protocols.

Influenza Immunizations

CDC recommends the influenza vaccine for everyone age six months and over. CDC estimates that between 12,000 and 56,000 people die each year from influenza or its complications. Of these deaths, an estimated 90 percent involve people age 65 or older.

Scope of Practice

Another way to increase adult immunization rates is to broaden the pool of individuals who can administer vaccines. Physicians and nurses typically give vaccines to adults and children. Over the years, many states have expanded certain health care providers' roles to increase the pool of health care professionals who can give shots in hopes of increasing immunization rates. Although physician assistants and nurse practitioners fall within this category, pharmacists are the newest group to expand their scope of practice to include vaccine administration.

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