Issue Briefs • Vaccination Requirements and Exemptions • Informed Consent in Vaccination • The Vaccine Industry - An Overview • The Rationing of Vaccines Against Pandemic Influenza Evaluating Risk, Benefits, and Safety in Vaccine Policy • Risk-Benefit Analyses and Vaccine Safety Monitoring • Risk Communication and Related Ethical Considerations Vaccines against Potential Agents of Bioterrorism • Bioterror Threats and Vaccines against Anthrax and Smallpox • Obstacles Facing Bioterror Vaccine Development Vaccines for Tropical Diseases and Global Research Priorities • Neglected Tropical Disease Vaccine Candidates and Financing • Vaccine Research Priorities and Obstacles to Access The Quest for an HIV Vaccine • Challenges in HIV Vaccine Development - An Overview • Logistical and Ethical Considerations of HIV Vaccine Clinical Trials • HIV Vaccine Clinical Trials: The Standard of Care Debate

Vaccination Requirements and Exemptions

Vaccination is one of a small group of medical interventions with direct and simultaneous benefits to individuals and communities. The more vaccinated individuals there are in a community, the greater the protection against disease. For this reason, vaccines have often been required or mandated. Today, the term “mandate” is imprecise when applied to immunization. The last time the U.S. required vaccination without exception—a true mandate—was during World War I.¹ Today, processes in place in the vast majority of states provide parents with significant latitude regarding whether to vaccinate their children.

In the U.S., all states require that children attending school either receive a series of immunizations (the specific requirements vary from state to state). Alternatively, parents in most states can seek exemptions from these requirements for either medical, religious, or philosophical reasons. Vaccination requirements for school and day care attendance are a key component of vaccine policy in the U.S. Public health officials see a number of advantages in this approach. Associating vaccines with school attendance, which is itself required by law, ensures that vaccines reach the greatest number of children. Children stand to benefit the most from vaccines, as they are often the most vulnerable to disease and the least likely to have been previously exposed to infection. While school-based vaccination requirements have doubtlessly contributed to the successes of the U.S. vaccination program, resistance to these policies is nothing new nor unique to the United State. The term “conscientious objector” originally referred to opponents of England’s coercive smallpox vaccine campaign in the late nineteenth century.²

The process of establishing a vaccine school-entry requirement

The Department of Health and Human Services’ National Vaccine Program, established in 1986, coordinates all federal vaccine research, safety monitoring, and immunization activities.³ The sequence of events that may lead to a state requirement begins with the vaccine must passing rigorous safety and efficacy standards in order to be licensed, a process coordinated through the FDA’s Center for Biologics Evaluation and Research (CBER). Newly licensed vaccines are evaluated by three expert committees who offer recommendations as to its use. These groups are the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention; the Committee of Infectious Diseases (COID) at the American Academy of Pediatrics; and the American Academy of Family Physicians (AAFP). A CDC recommendation generally also means that the vaccine will be covered by the Vaccine Injury Compensation Program, which addresses vaccine-associated adverse events, and the Vaccines for Children Act, a federal entitlement supporting vaccination of uninsured or underinsured children. Only after these federal actions do individual states consider whether to require the vaccine as a condition of school attendance, a step which either requires legislation or action from the Department of Health, depending on the state.⁴

State laws on exemptions

While all 50 U.S. states have school-entry requirements for vaccines, 48 allow exemptions for religious reasons (West Virginia and Mississippi are the only exceptions) and 20 allow for philosophical objections.⁵ All states also include exemptions for medical reasons, such as an allergy to a vaccine component. While private schools are not directly subject to these requirements, most choose to require a similar vaccination schedule as their state’s public schools. Only North Carolina requires vaccination of home-schooled children.

While parents face no legal penalty for refusing to vaccinate their children, they may be liable in civil court if their child infects another. The exemption process differs from state to state.

Religious and philosophical exemptions

The distinction between a philosophical and religious exemption is vague and difficult to establish legally. For religious exemptions, courts look for an objection based on tenets of a specific religion, although “a sincere and meaningful belief... held with the strength of traditional religious convictions” has as also been accepted.⁶ Parents who refuse vaccination on philosophical grounds often cite their right to determine the medical care of their children without the state’s interference. The Supreme Court has ruled on several occasions that required vaccination by the state is permissible, and that “the very concept of ordered liberty precludes allowing every person to make his own standards on matters of conduct in which the society as a whole has important interests.”⁷

Exemptions and herd immunity

The decision to refuse immunization has a societal consequence. In a community in which most people are vaccinated, the likelihood of members being exposed to the corresponding infection is quite low. As a result, it may be in an individual’s best interest not to get vaccinated, as they already benefit from the high vaccination rate reducing the likelihood of infection without exposing themselves to any vaccine-associated risks, however small. An individual refusing vaccination by this logic could be termed a “free rider.” However, if too many individuals take this approach, the community’s immunity will not be sufficient to prevent outbreaks of disease, and, since no vaccine is 100% effective, even those vaccinated will be at increased risk.⁸

The impact of exemptions

In 2003, about 38,000 children received exemptions from state vaccination requirements.⁹ A study published in the Journal of the American Medical Association found that children exempted from immunization were 35 times more likely to contract measles and 5.9 times more likely to get pertussis.¹⁰ A similar study in found that the risk of measles was 35 times greater in unvaccinated than vaccinated children.¹¹ Both studies showed that a community with lower rates of immunization had higher rates of infection among vaccinated children than those with higher community-wide vaccination rades.. A similar correlation between exemption rates and incidence of vaccine-preventable disease has been found in both the United Kingdom and Japan.¹²

-- By Ben Kleifgen, Temple University School of Medicine (bkleifgen@temple.edu)

For more information

• National Network for Immunization Information: http://www.immunizationinfo.org/
• Immunization Action Coalition: http://www.immunize.org

¹ Omer, SB et al. 2006. Nonmedical exemptions to school immunization requirements: secular trends and association of state policies with pertussis incidence. JAMA 296, 1757-1763.
² Durbach, N.. 2002. Class, Gender, and the Conscientious Objector to Vaccination, 1898-1907. The Journal of British Studies, Vol. 41, No. 1. pp. 58-83.
³ Malone KM, Hinman AR. 2003. Vaccination Mandates: The Public Health Imperative and Individual Rights. In: Goodman RA, Rothstein MA, Hoffman RE, et al., eds. Law in Public Health Practice. New York: Oxford University Press, 2003: 262-84
⁴ National Network for Immunization Information
⁵The 20 states that allow exemptions for philosophical reasons are Arizona, Arkansas, Idaho, Louisiana, Maine, Michigan, Minnesota, Missouri, Nebraska, New Mexico, North Dakota, California, Colorado, Ohio, Oklahoma, Texas, Utah, Vermont, Washington, and Wisconsin (Kasbak 2004).
⁶ Malone KM, Hinman AR. 2003. Vaccination Mandates: The Public Health Imperative and Individual Rights. In: Goodman RA, Rothstein MA, Hoffman RE, et al., eds. Law in Public Health Practice. New York: Oxford University Press, 2003: 262-84
⁷ Ibid.
⁸ Plotkin, SA., and Orenstein, WA. 2004. Vaccines, 4^th ed. Elsevier Inc., Philadelphia, PA.
⁹ Kasprak J (2004). Exemptions from Childhood Immunization Requirements. OLR Research Report.
¹⁰ Feikin DR, Lezotte DC, Hamman RF, Salmon DA, Chen RT, and Hoffman RE. 2000. Individual and Community Risks of Measles and Pertussis Associated With Personal Exemptions to Immunization. JAMA 284:3145-3150.
¹¹ Salmon DA, Haber M, Gangarosa EJ, Phillips L, Smith NJ, and Chen RT (1999). Health Consequences of Religious and Philosophical Exemptions from Immunization Laws: Individual and Societal Risk of Measles. JAMA 282:47.
¹² Plotkin, SA., and Orenstein, WA. 2004. Vaccines, 4^th ed. Elsevier Inc., Philadelphia, PA.