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Immunizations Policy Issues Overview

Immunizations Policy Issues Overview

4/4/2011

School Requirements || Financing Childhood Immunizations || Vaccine Safety || Immunization Registries

Adult Immunizations || Archived Legislation || NCSL Resources || Other Resources

Immunizations are heralded as one of the 20th century's most cost-effective public health achievements.  Immunizations protect both individuals and the larger population, especially those people who have immune system disorders and cannot be vaccinated.  In their role as guardians of the public's health, states play a significant role in determining immunization policies.

As with other 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.  A measles outbreak or bioterrorism threats such as anthrax and smallpox, however, remind us of the important role immunizations play in the public health system. 

State legislators face decisions related to the increasingly complex vaccine schedules and recommendations.  They are asked to balance the need to protect the public's health against the difficulties presented by funding the recommended vaccines and addressing concerns of citizens who may object to mandatory immunization recommendations.  

2011 Recommended Childhood Immunization Schedule
Centers for Disease Control and Prevention

2010 National and State Vaccination Coverage Among Adolescents Aged 13 Through 17 years
Centers for Disease Control and Prevention

Childhood Immunizations
NCSL LegisBrief, November /December 2010

Meningitis Legislation and State Laws 

States with Religious and Philosophical Exemptions from School Immunization Requirements 

HPV Vaccine Legislation 

Immunization Snapshot Booklet
(2004 Publication)

School Requirements

Immunization Snapshot BookletFrom the time they are born, babies face numerous immunizations- up to 28 shots by age 2.  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 the ACIP.  It is important to note that some states give the state public health officer the authority to change school requirements through administrative rule.  Others revise school requirements through a combination of rules and legislation or strictly by legislative action.  Regardless, 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 rights to choose, especially if a parent is concerned that vaccines may harm children.  Therefore, many states have expanded their immunization exemption laws to accommodate those who may not believe in immunization mandates.

Immunization Action Coalition
State Mandates of Immunization and Vaccine Preventable Diseases

Exemptions

States have implemented a variety of immunization exemption laws and administrative rules.  Although exemption laws vary from state to state, all states allow exemptions for medical reasons, and almost all states (except Mississippi and West Virginia) grant religious exemptions for people who have sincere religious beliefs that prohibit immunizations.  Some states have passed laws allowing individuals to claim philosophic exemptions.  Currently, 20 states have some type of philosophical exemption law.  These laws allow parents to claim an exemption based on their personal, moral or other beliefs.

States with Religious and Philosophical Exemptions from School Immunization Requirements
National Conference of State Legislatures webpage. 

Financing Childhood Immunizations

According to the Association of State and Territorial Health Officials, every $1 spent on immunizations saves $16 in avoided costs, but vaccines are not cheap. The federal contract price for all vaccines recommended to age 18 increased from $45 in 1985 to $1,105 for males and $1,407 for females in 2008 for programs that receive immunization grants. Factors pushing up costs include new vaccines and inflation.

Federal Programs

Federal funds pay for approximately 95 percent of all publicly funded vaccinations.  The two sources of federal funds are:

Vaccines for Children Program (VFC): This 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.  In 2007, the National Immunization Program at the CDC awarded over $2.5 billion in VFC funds to state, local and territorial public health agencies for program operations and vaccine purchase.

Section 317 of the Public Health Services Act: is a federal program administered by the 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) reauthorizes the Section 317 grant program. Under section 317, 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 U.S. Department of Health and Human Services secretary can negotiate and contract with vaccine manufacturers, allowing states to receive adult vaccines at a negotiated price and provide these vaccines to 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 2010, 6 states (New Hampshire, New Mexico, Rhode Island, Vermont, Wisconsin, Wyoming), American Samoa, and the Northern Marianas Islands have universal purchase policies where the states or territory purchase all recommended vaccines for all children, including those who are fully insured.  Six other states (Alaska, Hawaii, Maine, Massachusetts, South Dakota, Washington) have universal select programs that purchase all recommended vaccines for all children with the exception of one or more vaccines.  Once purchased, these vaccines are distributed to all public and private providers, who may charge an administration fee.

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 the national Advisory Committee on Immunization Practices (ACIP)–15 health experts appointed by the U.S. Secretary of Health and Human Services, who recommend vaccine schedules for children, adolescents and adults. According to regulations from the secretary issued in July 2010, new insurance plans or policies as of September 23, 2010 are required to provide preventive services, including ACIP-recommended vaccines without imposing out of pocket costs on the policy holder. Provisions allow for up to a one year delay for coverage of a newly recommended ACIP vaccine.

According to the American Academy of Pediatrics, at least 29 states require insurance companies to cover childhood immunizations.  States vary on which immunizations are covered.  Some require those vaccines recommended by the American Academy of Pediatrics or the Advisory Committee on Immunization Practices (ACIP).  Some of these states choose to include an immunization mandate as part of their "well-child" coverage.  In this case, the requirement covers a wide variety of preventive services for children, which includes the recommended immunizations.

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 the vaccine manufacturers go to great lengths to make vaccines for both adults and children as safe as possible.  Unfortunately, vaccines are not 100 percent safe and can cause very rare side effects.  As immunizations become more effective, the diseases they prevent fade from memory, leaving only the rare side effects in the public's eye.  Parents may begin to think that the risk of having an adverse reaction is greater than the risk of contracting an infectious disease, such as measles.  Much of the movement to implement more flexible exemption laws stems from concerns about vaccine safety. 

Vaccine Safety Information from the CDC

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 the 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, the CDC works with eight large managed care organizations to run the Vaccine Safety Datalink (VSD) Project.  This system contains the medical and immunization histories of more than 7.5 million people and helps the CDC assess whether an adverse reaction is purely coincidental or is directly linked to an immunization. 

When an unfortunate event occurs and permanent side effects result, individuals can file a claim with the federal National Vaccine Injury Compensation Program (VICP).  VICP assists families that have suffered from vaccine side effects and helps stabilize the vaccine supply by decreasing the number of lawsuits against manufacturers.  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.  However, 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 $.75 on every dose of covered vaccine that is purchased.

Thimerosal and Mercury

Thimerosal is a preservative that contains a form of mercury. Thimerosal 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 the Centers for Disease Control and Prevention (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.

In July 1999, the Federal government asked vaccine manufacturers to work towards eliminating or reducing the use of thimerosal, a preservative which contains small amounts of mercury, in any products currently available on the market.  Since 2001, with the exception of some influenza vaccines, thimerosal is not used as a preservative in routinely recommended childhood vaccines.  As of 2008, seven states—California, Delaware, Illinois, Iowa, Missouri, New York and Washington—have laws banning or limiting the used of mercury in childhood immunizations. 

Vaccine Safety and Autism
State Legislatures magazine, October/ November 2010
Mercury and Vaccines Information from the CDC

Immunization Registries

Immunization registries are confidential, computerized systems that contain children's vaccination histories within a geographic area.  They help ensure that children who are too young to fall under school vaccine requirements receive the recommended vaccinations at the recommended ages.  Children often will move from doctor to doctor during their early years, and the paper trail may become disjointed and incomplete. 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 immunization registry. In 2009, according to the CDC, 77 percent of children under age 6 participated in a state or local registry. Legislation established statewide registries in 29 states, and administrative rules established them in two. Of these 31 states, only 14 require reporting by providers.

Click here for a 2009 Child Participation Map providing the percentage of children participating in an immunization information system (IIS) in the United States from the Centers for Disease Control and Prevention.

Adult Immunization

Adult immunization policy differs greatly from the efforts for children.  Unlike those for children, few requirements exist for adult immunizations and very little public health infrastructure supports mass vaccination of adults.  While Medicare covers influenza and pneumococcal vaccines for adults age 65 or older, no federal programs comparable to the children's VFC Program exist to help adults who may not have access to good medical care or cannot afford recommended vaccines.

The Adult Immunization Schedule recommended by the Advisory Committee on Immunization Practices (ACIP) is much simpler than its counterpart for children and adolescents.  Although it includes vaccine such as Hepatitis B, tetanus and varicella, these apply only to certain at-risk populations and adults in certain occupations.  Most adult immunization policy focuses on influenza (flu) and pneumococcal (pneumonia) immunizations for older adults.

Influenza Immunizations

CDC estimates that 25,000 people die each year from influenza or its complications.  Of these deaths, an estimated 90 percent involve people age 65 or older.  The CDC recommends the influenza vaccine for everyone age six months and over.

Stateline: A Shot in the Arm
State Legislatures magazine, October/ November 2010
H1N1 State and Federal Resources
2009 State Pandemic and H1N1 (Swine) Flu Legislation

Scope of Practice

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

Archived Immunization Legislation

The following links lead to charts showing legislative activity on a variety of topics involved in immunization policy from 2002-2005.

2005 Legislation  | 2004 Legislation  | 2003 Legislation  |  2002 Legislation

NCSL Resources

Childhood Immunizations
NCSL LegisBrief, November /December 2010

Vaccine Safety and Autism
State Legislatures magazine, October/ November 2010

Childhood Immunizations
NCSL postcard including information on school requirements, immunization funding, and immunization registries, May 2008.

States with Religious and Philosophical Exemptions from School Immunization Requirements
NCSL webpage.

Exemptions for Childhood Immunizations
NCSL LegisBrief explains different exemptions for school requirements and possible implications June/July, 2006.

Other Resources

All Kids Count
All Kids Count is a national resource for immunization registries.

American Academy of Pediatrics
The American Academy of Pediatrics' comprehensive Web site has vaccine information, videos, fact sheets and brochures

CDC's Vaccines and Immunizations Website 
The CDC's Vaccines and Immunizations Website is a comprehensive source for immunization information. The site includes frequently asked questions, vaccine recommendations, funding information, fact sheets, and information on vaccine safety.

Child Trends DataBank
The Child Trends DataBank Web site summarizes trends in childhood immunization and provides links to other sources.

Every Child by Two
Every Child by Two is a resource for parents to understand the critical need for timely infant immunizations.

Immunization Action Coalition
The Immunization Action Coalition provides links to all State immunization program websites.

The Immunization Gateway: Your Vaccine Fact-Finder
Online immunization fact finder links to many of the latest vaccine resources.

Institute for Vaccine Safety
The Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health provides independent assessment of the safety of vaccines. 

Keep Kids Healthy
Keepkidshealthy.com offers a guide to vaccinations.

MEDLINEplus Health Information
The MEDLINEplus Web site on immunizations and vaccinations includes information for adults, women and seniors. This site also links to many other immunization resources on the Web.

National Foundation for Infectious Diseases
The National Coalition for Adult Immunization Web site provides fact sheets, immunization schedules, and other resources that pertain particularly to adults.

The National Network for Immunization Information
The National Network for Immunization Information's Web site contains state-by-state information, news briefs, how to evaluate internet information and resource kits for state legislators.

The National Vaccine Program Office
The National Vaccine Program Office contains information on immunization laws in the U.S. and abroad.

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