13
 

Vaccination Mandates: The Public Health 

Imperative and Individual Rights 

KEVIN M. MALONE AND ALAN R. HINMAN 

In 1796, Edward Jenner demonstrated that inoculation with material from a 

cowpox (vaccinia) lesion would protect against subsequent exposure to smallpox. This began the vaccine era, although it was nearly 100 years until the next 

vaccine (against rabies) was introduced. In the twentieth century, many new 

vaccines were developed and used, with spectacular impact on the occurrence 

of disease. The Centers for Disease Control and Prevention (CDC) declared 

vaccinations to be one of the 10 great public health achievements of the twentieth century.1,2 

This chapter describes the impact of vaccines in dramatically reducing infectious diseases in the United States, the role of mandatory vaccination in achieving that impact, and the constitutional basis for these mandates. The chapter 

also briefly reviews the federal government’s role in immunization practices. 

BACKGROUND 

Concept for Community Disease Prevention 

Garrett Hardin’s classic essay The Tragedy of the Commons3 describes the challenges presented when societal interest conflicts with the individual’s interest. 

Hardin notes the incentives present when the cattle of a community are com262 
VACCINATION MANDATES 263 

mingled in a common pasture. At capacity, each owner still has an incentive to 

add additional cattle to the common because even though the yield from each 

animal decreases with the addition of more cattle, this decrease is offset for the 

individual owner by the additional animal. With this incentive, individual owners continue to add cattle to the commons to reap their individual benefit, leading 

to the inevitable failure of the common from overgrazing. The community interest in maximizing food production, therefore, can be achieved only by placing 

controls on the interests of the individual owners in favor of those of the 

community. 

Analogously, a community free of an infectious disease because of a high 

vaccination rate can be viewed as a common. As in Hardin’s common, the very 

existence of this common leads to tension between the best interests of the 

individual and those of the community. Increased immunization rates result in 

significantly decreased risk for disease. Although no remaining unimmunized 

individual can be said to be free of risk from the infectious disease, the herd 

effect generated from high immunization rates significantly reduces the risk for 

disease for those individuals. Additional benefit is conferred on the unimmunized person because avoidance of the vaccine avoids the risk for any adverse 

reactions associated with the vaccine. As disease rates drop, the risks associated 

with the vaccine come even more to the fore, providing further incentive to 

avoid immunization. Thus, when an individual in this common chooses to go 

unimmunized, it only minimally increases the risk of illness for that individual, 

while conferring on that person the benefit of avoiding the risk of vaccineinduced side effects. At the same time, however, this action weakens the herd 

effect protection for the entire community. As more and more individuals choose 

to do what is in their “best” individual interest, the common eventually fails as 

herd immunity disappears and disease outbreaks occur. To avoid this “tragedy 

of the commons,” legal requirements have been imposed by communities (in 

recent times, by states) to mandate particular vaccinations. 

Vaccine Safety and Effectiveness 

Vaccines are safe and effective. However, they are neither perfectly safe nor 

perfectly effective. Consequently, some persons who receive vaccines will be 

injured as a result, and some persons who receive vaccines will not be protected. 

Most adverse events associated with vaccines are minor and involve local soreness or redness at the injection site or perhaps fever for a day or so. Rarely, 

however, vaccine can cause more serious adverse events. Whether an adverse 

event that occurs after vaccination was caused by the vaccine or was merely 

temporally related and caused by some totally independent (and often unknown 

or unidentified) factor is often difficult to ascertain. This is particularly problematic during infancy, when a number of conditions may occur spontaneously. In 
264 CONTROL AND PREVENTION 

a given instance, determining whether vaccine was responsible may be impossible.4 Particularly when dealing with rare events, large-scale case–control studies or reviews of comprehensive records of large numbers of infants may be 

necessary to ascertain whether those who received a vaccine had a higher incidence of the event than those who did not. The CDC operates an extensive 

linked database involving several large health-maintenance organizations. This 

Vaccine Safety Datalink project includes more than 6 million persons (approximately 2% of the U.S. population) and has proved invaluable for attempting to 

determine causality.5 

Decisions about use of vaccines are based on the relative balance of risks and 

benefits. This balance may change over time. For example, recipients of oral 

polio vaccine (OPV) and their close contacts have a risk of developing paralysis 

associated with the vaccine of 1 in approximately every 2.4 million doses of 

vaccine distributed. This risk is small and was certainly outweighed by the much 

larger risk for paralysis from wild polioviruses at the time they were circulating 

in the United States. However, because wild polioviruses no longer circulate in 

the United States and the risk of importation of wild viruses has been greatly 

reduced by the global effort to eradicate polio, the balance has shifted. There 

has not been a case of paralysis in the United States from indigenously acquired 

wild poliovirus since 1979, and the entire Western Hemisphere has been free 

from wild poliovirus circulation since 1991.6 The Advisory Committee on Immunization Practices (ACIP), an advisory group to the CDC, recommended, in 

1997, that children should receive a sequential schedule with two doses of inactivated polio vaccine (IPV) (which carries no risk for paralysis but has slightly 

less effect in preventing community spread of wild poliovirus), followed by two 

doses of OPV. In 2000, the recommendation was made to switch to an all-IPV 

regimen.7 

An important characteristic of most vaccines is that they provide both individual and community protection. Most of the diseases against which we vaccinate are transmitted from person to person. When a sufficiently large proportion of individuals in a community is immunized, those persons serve as a 

protective barrier against the likelihood of transmission of the disease in the 

community, thus indirectly protecting those who are not immunized and those 

who received vaccine but are not protected (vaccine failures). One commentator 

has suggested that a social contract exists among parents to immunize their 

children not only to provide them individual protection, but also to contribute 

to the protection of other children who cannot be immunized or for whom the 

vaccine is not effective.8 The proportion of the population that has to be immune 

to provide this “herd immunity” varies according to the infectiousness of the 

agent. For poliomyelitis, that proportion is considered to be on the order of 

80%, whereas for measles it exceeds 90%. 

When a community has a high level of vaccination, an individual might decide 
VACCINATION MANDATES 265 

to not be vaccinated to avoid the small risk for adverse events while benefitting 

from the vaccination of others. Of course, if a sufficient number of individuals 

make this decision, the protection levels in the community decline, the herd 

immunity effect is lost, and the risk of transmission rises. 

Impact of Vaccines 

The introduction and widespread use of vaccines have profoundly affected the 

occurrence of several infectious diseases. Smallpox was eradicated from the 

world—onset of the last naturally occurring case was in 1977—and vaccination 

against smallpox stopped. Poliomyelitis is on the verge of eradication (the last 

indigenous case in the United States associated with wild virus occurred in 1979, 

and only 20 to 30 countries were still reporting transmission as of mid-2001). 

Because approximately 11,000 infants are born every day in the United States, 

the need to ensure that children continue to be protected is ongoing. In addition, 

a continuing threat exists of importation of disease from other countries. In the 

United States, infants and young children are currently vaccinated against 11 

diseases: diphtheria, Haemophilus influenzae type b, hepatitis B, measles, 

mumps, pertussis, poliomyelitis, rubella, Streptococcus pneumoniae, tetanus, and 

varicella.9 In states with high risk for hepatitis A, children are also vaccinated 

against this disease. With the exception of tetanus, each of these diseases is 

spread from person to person by direct contact or by aerosol droplet transmission. Most of the diseases historically have had very high incidence in schoolaged children because of the high potential for transmission in the congregate 

setting. With more children in preschool programs, outbreaks have occurred at 

earlier ages. In contrast, hepatitis B has its highest incidence in young adulthood 

as a result of transmission through sexual contact or needle sharing. Tetanus is 

acquired by contamination of wounds and is not transmitted from person to 

person. Table 13–1 shows the representative annual morbidity (typically, average morbidity reported in the 3 years before introduction of the vaccine) in the 

twentieth century and the number of cases reported in 2000 for diseases against 

which children have been routinely vaccinated.10 Most diseases have declined 

by 99% or more (pneumococcal disease and varicella are not reportable conditions) and are at all-time lows. Vaccination coverage in 19–35-month-old children is at an all-time high (Table 13–2).11 

Modern Government Role in Immunization 

Vaccines are subject to licensure in the United States by the Food and Drug 

Administration (FDA) following studies that address safety and efficacy.12,13 

With declining vaccine production capacity in the United States, in 1986 Congress approved the National Childhood Vaccine Injury Act (NCVIA).14 This 

comprehensive law established the National Vaccine Program within the U.S. 
TABLE 13–1. Comparison of Twentieth Century Annual Morbidity* and Current 

Morbidity of Vaccine-Preventable Diseases of Children in the United States 

DISEASE 

TWENTIETH CENTURY 

ANNUAL MORBIDITY 2000† 

PERCENTAGE 

DECREASE 

Smallpox 48,164 0 100 

Diphtheria 175,885 4 99.99 

Measles 503,282 81 99.98 

Mumps 152,209 323 99.80 

Pertussis 147,271 6755 95.40 

Polio (paralytic) 16,316 0 100 

Rubella 47,745 152 99.70 

Congenital rubella syndrome 823 7 99.10 

Tetanus 1314 26 98.00 

Haemophilus influenzae type b 

and unknown ( 5 years) 

20,000 167 99.10 

*Typical average during the 3 years before vaccine licensure. 

†Provisional data. 

TABLE 13–2. Vaccination Coverage Levels Among Children 

Aged 19–35 Months in the United States, 2000 

VACCINE, DOSES COVERAGE (%) 

DTP, 3 94.1 

DTP, 4 81.7 

Polio, 3 89.5 

Hib, 3 93.4 

MMR, 1, 90.5 

Hepatitis B, 3 90.3 

Varicella 67.8 

Combined series 

4 DTP/3 polio/1 MMR 77.6 

4 DTP/3 polio/1 MMR/3 Hib 76.2 

4 DTP/3 polio/1 MMR/3 Hib/3 Hep B 72.8 

DTP, diphtheria and tetanus toxoids and pertussis vaccine; Hib, Haemophilus influenzae type b vaccine; MMR, measles-mumps-rubella vaccine; 

Hep B, hepatitis B vaccine. 

266 
VACCINATION MANDATES 267 

Department of Health and Human Services to coordinate and oversee all activities within the U.S. government related to vaccine research and development, 

vaccine-safety monitoring, and vaccination activities. In addition, the Act established the National Vaccine Injury Compensation Program (VICP) to compensate for injuries associated with routinely administered childhood vaccines (42 

U.S.C. §§ 300aa-10–300aa-23). At least some of the decline in the number of 

vaccine producers in the United States had been attributed to liability costs. The 

VICP effectively removes this as a significant consideration. 

Acknowledging that vaccines, as with any medication, are not without risk to 

the patient, that vaccines, unlike other medications, are a medical intervention 

generally given to healthy individuals, and that vaccination has benefits beyond 

the individual by significantly benefitting the public health through creation of 

herd immunity, the VICP was established to shift the monetary costs of vaccine 

injuries away from vaccine recipients and manufacturers. Using a vaccine injury 

table and a simplified administrative process through the U.S. Court of Federal 

Claims, this no-fault system is designed to fairly compensate children and their 

families (along with adult recipients of these vaccines) for the costs associated 

with the rare injuries related to vaccination. An excise tax on each dose of 

covered vaccine funds the compensation program. 

Individuals alleging vaccine injury must go through the VICP before filing 

any tort actions against the administering health-care provider or the vaccine 

manufacturer. If the judgment of the court is accepted, further actions against 

the provider and manufacturer are barred. Even if the judgment is declined, the 

NCVIA significantly narrows the scope of any tort action against the manufacturer. Since the inception of the VICP, few individuals have chosen to reject 

the judgment of the court and file suit against the provider or manufacturer. 

Thus, liability costs of the vaccine manufacturers have dropped dramatically 

since the establishment of the VICP. 

With the product liability incentive for vaccine improvement substantially 

reduced by the existence of the VICP, the role of the government in monitoring 

vaccine safety becomes more prominent. Beyond post-licensure surveillance requirements of the FDA, the NCVIA also established the Vaccine Adverse Event 

Reporting System (VAERS), which requires reporting of adverse events by vaccination providers (42 U.S.C. § 300aa-25). Providers must also record lot numbers of vaccines administered. Furthermore, various federal agencies, including 

the CDC’s National Immunization Program, have expanded vaccine-safety activities. In addition, with diminished liability costs, more pharmaceuticals have 

entered the vaccine production arena with the resultant competition leading to 

further vaccine improvements and development of new vaccines against other 

diseases. 

The NCVIA also seeks to improve the knowledge level of parents through 
268 CONTROL AND PREVENTION 

its requirement that the CDC produce vaccine information materials for mandatory distribution by providers to patients or parents before administration of 

VICP-covered vaccines (42 U.S.C. § 300aa-26). Through these materials, called 

Vaccine Information Statements, parents are informed about the schedules for 

administration of the vaccines, are alerted to contraindications that dictate 

against administration to particular individuals, and are informed about potential 

adverse reactions to look for to encourage timely medical intervention, as 

needed. 

Most children in the United States receive their vaccinations in the private 

sector, from pediatricians or family physicians. A significant minority receive 

vaccinations in the public sector, typically from local health departments. There 

is considerable variation around the country.15 At current prices, the cost for 

vaccines alone (irrespective of physician fees) is approximately $600 in the 

private sector (CDC, unpublished data). Most employer-based insurance plans 

now cover childhood vaccinations. 

Since 1962, the federal government has supported childhood vaccination programs through a grant program administered by the CDC.16 These “317” grants, 

named for the authorizing statute, support purchase of vaccine for free administration at local health departments and support immunization delivery, surveillance, and communication and education. As of 2000, the CDC purchased 

over half the childhood vaccine administered in the United States through two 

federally overseen, state-administered programs. In addition to the 317 program, 

in 1994 the Vaccines for Children (VFC) 17 program began, under which all 

Medicaid-eligible children, all children who are uninsured, all American Indian 

and Alaska Native children, and insured children whose coverage does not include vaccinations (with limitations on the locations where this last group can 

receive VFC vaccine) qualify to receive routine childhood vaccines at no cost 

for the vaccine. The VFC program operates in both public health clinics and 

private provider offices. The 317 grant program provides additional vaccines to 

the states for administration to adults and to children who do not qualify for 

VFC vaccine. Additional federal assistance for vaccination is provided by the 

Children’s Health Insurance Program through expanded Medicaid eligibility for 

low-income children.18 Many states use state funds to purchase additional quantities of vaccine. 

The ACIP determines the vaccines to be administered in the VFC program 

and the schedules for their use. In addition, the ACIP issues recommendations 

for use of adult and pediatric vaccines in the United States and, generally in 

coordination with the American Academy of Pediatrics and the American Academy of Family Physicians, establishes a recommended schedule for administration of routine childhood vaccines. The ACIP recommendations are often considered by states as they determine which vaccinations to mandate for school 

attendance. 
VACCINATION MANDATES 269 

To assist parents in complying with the often complex vaccine schedules, 

many states and localities, with the assistance of the CDC and professional 

organizations, have established vaccination registries to send parents reminders 

when vaccines are due. In a mobile era when families move often and frequently 

change health-care providers, these registries also help avoid over-vaccination 

and ensure catch-up vaccination when needed.19 

School and Daycare Vaccination Laws 

School vaccination laws have played a key role in the control of vaccinepreventable diseases in the United States. The first school vaccination requirement was enacted in the 1850s in Massachusetts to prevent smallpox transmission in schools.20 By the beginning of the twentieth century, nearly half of the 

states had requirements for children to be vaccinated before they entered 

school. By 1963, 20 states, the District of Columbia, and Puerto Rico had such 

laws, with a variety of vaccines being mandated.21 However, enforcement was 

uneven. 

In the late 1960s, efforts were undertaken to eradicate measles from the 

United States. Transmission in schools was recognized as a significant problem.22 In the early 1970s, states that had school vaccination laws for measles 

vaccine had measles incidence rates 40% to 51% lower than states without such 

laws.23 In 1976 and 1977, measles outbreaks in Alaska and Los Angeles, respectively, led health officials to strictly enforce the existing requirements.24 

Advance notice was given that the laws were to be enforced, and major efforts 

were undertaken to ensure that vaccination could be easily obtained. In Alaska, 

on the announced day of enforcement, 7418 of 89,109 students (8.3%) failed to 

provide proof of vaccination and were excluded from school. One month later, 

fewer than 51 students were still excluded. No further cases of measles occurred.25 In Los Angeles, approximately 50,000 of 1,400,000 students ( 4%) 

were excluded; most were back in school within a few days, and the number of 

measles cases dropped precipitously. These experiences demonstrated that mandatory vaccination could be enforced and was effective. 

Because of declining vaccination levels in children, a nationwide Childhood 

Immunization Initiative was undertaken in 1977 to raise vaccination levels in 

children to 90% by 1979. An important component of this initiative was to 

support enactment and enforcement of school vaccination requirements. During 

a 2 year period, more than 28 million records were reviewed, and children in 

need were vaccinated.26 

An analysis of six states that strictly enforced comprehensive laws (affecting 

all grades) beginning with the 1977–1978 school year compared with the rest 

of the country showed that in the 1975–1976 school year, they had comparable 

incidence rates of measles. However, in the 1977–1978 school year, the six 
270 CONTROL AND PREVENTION 

states that strictly enforced the laws had incidence rates less than half those of 

the rest of the country; and in the 1978–1979 school year, the incidence rates 

were less than one tenth those of the rest of the country.27 An analysis of states 

with the highest and lowest incidences of measles in 1979–1980 found that states 

with the lowest incidence rates were significantly more likely to have laws covering the entire school population (rather than just first entrants) and more likely 

to be strictly enforcing the laws.28 

By the 1980–1981 school year, all 50 states had laws covering students 

first entering school. In most states, these laws affected children at all grade 

levels, as well as those involved in licensed preschool settings. Some of the 

laws specified the particular vaccines required (and the numbers of doses of 

each); others authorized the State Health Officer (or public health board) to 

designate which vaccines (and doses) were required, often after a public rulemaking process. 

As of the 1998–1999 school year, all states but four (Louisiana, Michigan, 

South Carolina, and West Virginia) had requirements covering all grades from 

kindergarten through 12th grade. In all states, the District of Columbia, and 

Puerto Rico, the requirements covered daycare centers; in 48 states (all but Iowa 

and West Virginia), the requirements covered Head Start programs. Thirty states, 

the District of Columbia, and Puerto Rico had some requirements for college 

entrance. The requirements covered diphtheria toxoid and polio, measles, and 

rubella vaccines in all 50 states; 49 states required tetanus toxoid, 46 required 

mumps vaccine, 44 required pertussis vaccine, and 28 required hepatitis B 

vaccine.29 

Since 1981, vaccination levels in school entrants have been 95% or higher 

for diphtheria and tetanus toxoids and pertussis vaccine (DTP), polio vaccine, 

and measles vaccine. All states require vaccination for children attending licensed daycare centers and as a result such children have vaccination levels 

90% or higher. Nonetheless, overall levels in preschool children have not been 

as high, as manifested by the resurgence of measles that occurred during 1989– 

1991, primarily affecting unvaccinated preschool-aged children.30 Levels in 

preschool-aged children have recently been raised to their currently high levels 

as a result of major efforts (and major infusions of resources) directed at this 

population.15 

The Task Force on Community Preventive Services is an independent 

body carrying out evidence-based reviews of the literature to assess the claims 

that preventive interventions directed to populations are effective. One of 

the 17 interventions reviewed for vaccine-preventable diseases was mandatory vaccination requirements. The Task Force found that sufficient evidence 

existed to demonstrate the effectiveness of these requirements in increasing 

vaccine coverage, thereby reducing disease incidence, and so recommended 

their use.31
VACCINATION MANDATES 271 

Historical Context 

Duffy’s description of smallpox vaccination in early American history highlights 

both the significant positive public health impact of vaccines and the ongoing 

challenges that this success presents20: 

Smallpox . . . was the great scourge of the American colonies until the introduction of 

inoculation or variolation, and the subsequent discovery of vaccination in 1796 relegated 

it to minor importance among the great epidemic diseases. As memories of the horrifying 

outbreaks of smallpox gradually faded, and a generation appeared which had had little 

contact with its victims, vaccination was neglected, and the incidence of smallpox began 

to rise. Beginning in the 1830s its attacks gradually intensified, and by the time of the 

Civil War the disorder was once again a serious problem. 

By chance, the rise of smallpox coincided with the enactment of compulsory school 

attendance laws and the subsequent rapid growth in the number of public schools. Since 

the bringing together of large numbers of children clearly facilitated the spread of smallpox, and since vaccination provided a relatively safe preventive, it was natural that compulsory school attendance laws should lead to a movement for compulsory 

vaccination. . . .” 

Many other childhood diseases for which vaccines were developed also frequently occurred in school-based outbreaks; consequently, when polio and measles vaccines were introduced in 1955 and 1963, respectively, adding them to 

the list of requirements for school entry was a logical consideration. The 1963 

survey of state laws found that, of 20 states with requirements, 18 included 

smallpox, 11 included diphtheria, 10 included polio, 7 included tetanus, and 5 

included pertussis. Measles requirements were soon added. By 1970, 20 states 

required measles vaccination, and by 1983 all 50 states did.32 

LEGAL AUTHORITIES—CONSTITUTIONAL BASIS OF 

MANDATORY VACCINATION 

Police Power 

The first state law mandating vaccination was enacted in Massachusetts in 1809; 

in 1855, Massachusetts became the first state to enact a school vaccination requirement. The constitutional basis of vaccination requirements rests in the police power of the state. Nearly 100 years ago, the U.S. Supreme Court issued 

its landmark ruling in Jacobson v. Massachusetts,33 upholding the right of states 

to compel vaccination. The Court held that a health regulation requiring smallpox vaccination was a reasonable exercise of the state’s police power that did 

not violate the liberty rights of individuals under the Fourteenth Amendment to 

the U.S. Constitution. The police power is the authority reserved to the states 

by the Constitution and embraces “such reasonable regulations established directly by legislative enactment as will protect the public health and the public 

safety”a (197 U.S. at 25, 25 S.Ct. at 361). 
272 CONTROL AND PREVENTION 

In Jacobson, the Commonwealth of Massachusetts had enacted a statute that 

authorized local boards of health to require vaccination. Jacobson challenged 

his conviction for refusal to be vaccinated against smallpox as required by regulations of the Cambridge Board of Health. While acknowledging the potential 

for vaccines to cause adverse events and the inability to determine with absolute 

certainty whether a particular person can be safely vaccinated, the Court specifically rejected the idea of an exemption based on personal choice.b To do 

otherwise “would practically strip the legislative department of its function to 

[in its considered judgment] care for the public health and the public safety 

when endangered by epidemics of disease” (197 U.S. at 37, 25 S.Ct. at 366). 

The Court elaborated on the tension between personal freedom and public health 

inherent in liberty: “The liberty secured by the Constitution of the United States 

to every person within its jurisdiction does not import an absolute right in each 

person to be, at all times and in all circumstances, wholly freed from restraint. 

There are manifold restraints to which every person is necessarily subject for 

the common good. On any other basis organized society could not exist with 

safety to its members” (197 U.S. at 26, 25 S.Ct. at 361). 

School Vaccination Laws 

The Supreme Court in 1922 addressed the constitutionality of childhood vaccination requirements in Zucht v. King.34 The Court denied a due process Fourteenth Amendment challenge to the constitutionality of city ordinances that excluded children from school attendance for failure to present a certificate of 

vaccination holding that “these ordinances confer not arbitrary power, but only 

that broad discretion required for the protection of the public health”c (260 U.S. 

at 177, 43 S.Ct. at 25). 

More recently, in the face of a measles epidemic in Maricopa County, Arizona, the Arizona Court of Appeals rejected the argument that an individual’s 

right to education would trump the state’s need to protect against the spread of 

infectious diseases short of confirmed cases of measles in the particular school. 

Given the nature of the spread of measles and the lag time in getting laboratory 

confirmation of cases, the court in Maricopa County Health Department v. Harmon35 was satisfied that it is prudent to take action to combat disease by excluding unvaccinated children from school when there is a reasonably perceived, 

but unconfirmed, risk for the spread of measles (156 Ariz. at 166, 750 P.2d at 

1369). Although the court considered the right to education under Arizona’s 

constitution, the decision is instructive in showing the reach of the police power 

to ensure the public health. The court in Maricopa specifically noted that Jacobson did not require that epidemic conditions exist to compel vaccination (156 

Ariz. at 166, 750 P.2d at 1369). 
VACCINATION MANDATES 273 

Parens Patriae 

Further authority to compel vaccination of children comes under the doctrine 

of parens patriae in which the state asserts authority over child welfare. In the 

1944 case of Prince v. Massachusetts,36 which involved child labor under an 

asserted right of religious freedom, the U.S. Supreme Court summarized the 

doctrine, noting that 

Neither rights of religion nor rights of parenthood are beyond limitation. Acting to guard 

the general interest in youth’s well being, the state as parens patriae may restrict the 

parent’s control by requiring school attendance, regulating or prohibiting the child’s 

labor, and in many other ways. Its authority is not nullified merely because the parent 

grounds his claim to control the child’s course of conduct on religion or conscience. 

Thus, he cannot claim freedom from compulsory vaccination for the child more than for 

himself on religious grounds. The right to practice religion freely does not include liberty 

to expose the community or the child to communicable disease or the latter to ill health 

or death.d (321 U.S. at 166–7, 64 S.Ct. at 442) 

LEGAL ISSUES AND CONTROVERSIES—EXEMPTIONS TO 

MANDATORY VACCINATION 

Although vaccines are safe and effective, they are neither perfectly safe nor 

perfectly effective. Some persons who receive vaccines will have an adverse 

reaction, and some will not be protected. In developing vaccines, the challenge 

is to minimize the likelihood of adverse effect while maximizing effectiveness. 

Some people have medical conditions that increase the risk for adverse effect, 

and therefore they should not receive vaccines. Recognizing this fact, all state 

vaccination laws provide for exemptions for persons with contraindicating 

conditions. 

The religious beliefs of some people are in opposition to vaccination, and 

other people oppose vaccination on other grounds, including philosophic. In 

addition, some persons are not opposed to all vaccines but oppose the concept 

of mandatory vaccination or mandates for specific vaccines. In the latter case, 

they may believe they (or their children) are not at risk for a particular disease 

or that, if contracted, the disease is not severe. If the disease in question is 

uncommon (as is the case in the United States today for most vaccinepreventable diseases), they might not be willing to undertake any level of risk 

of adverse effect. 

Forty-eight states allow religious exemptions (all but Mississippi and West 

Virginia), and 15 (California, Colorado, Idaho, Louisiana, Maine, Michigan, 

Minnesota, New Mexico, North Dakota, Ohio, Oklahoma, Utah, Vermont, 

Washington, and Wisconsin) permit philosophic exemptions29 (RH Snyder, National Immunization Program [NIP], CDC, personal communication). The criteria for allowing these exemptions vary greatly. Some states require member­
274 CONTROL AND PREVENTION 

ship in a recognized religion,e whereas others merely require an affirmation of 

religious (or philosophic) opposition. Nationwide, fewer than 1% of school entrants have medical, religious, or philosophic exemptions to mandatory vaccination. Seven states had more than 1% with exemptions in the 1997–1998 school 

year (Colorado, Michigan, Oregon, South Dakota, Utah, Washington, and West 

Virginia [those with philosophic exemptions are italicized]). Michigan had the 

highest level of exemption at 2.3% (RH Snyder, NIP, CDC, personal communication.). However, in some communities, the levels of exemptors may be as 

high as 5%. In 1995, 84% of California schools had fewer than 1% of students 

with exemptions, but 4% of schools had 5% or more with exemptions (NA 

Smith, Immunization Program, California Department of Public Health, personal 

communication). 

Thirteen outbreaks of measles were identified during 1985–1994 in religious 

groups opposing vaccination. These outbreaks resulted in more than 1200 cases 

and 9 deaths. Outbreaks of polio (in the 1970s), pertussis, and rubella have been 

documented among Amish groups.37 Salmon et al.38 found that persons with 

religious or philosophic exemptions were 35 times more likely to contract measles than were vaccinated persons during 1985–1992. They also found that persons living in communities with high concentrations of exemptors were themselves at increased risk for measles because of increased risk for exposure. 

Rota et al.39 studied the processes required to obtain religious and philosophic 

exemptions to school vaccination laws and found an inverse correlation between 

the complexity of the exemption process and the proportion of exemptions filed. 

None of 19 states with the highest level of complexity in gaining exemptions 

had more than 1% of students exempted compared with 5 of 15 states with the 

simplest procedure. In these latter states, less effort was required to claim a 

nonmedical exemption than to fulfill the vaccination requirement. 

Is There a Constitutional Right to a Religious Exemption 

from Mandatory Vaccination? 

Challenges to mandatory vaccination laws based on religion or philosophic belief have led various courts to hold that no constitutional right exists to either 

religious or philosophic exemptions. 

First Amendmentf free exercise clause 

Freedom to believe in a religion is absolute under the First Amendment. However, freedom to act in accordance with one’s religious beliefs “remains subject 

to regulation for the protection of society.”40 The U.S. Supreme Court in the 

1963 case of Sherbert v. Verner41 established a balancing test for determining 

whether a regulation violated a person’s First Amendment right to free exercise 

of religion. The test, which prevailed until 1990, required the government to 

justify any substantial burden on religiously motivated conduct by a compelling 
VACCINATION MANDATES 275 

government interest and by means narrowly tailored to achieve that interest (374 

U.S. at 406–8, 83 S.Ct. at 1795–6). 

Notwithstanding the state’s power as parens patriae, instances occur in which 

a parent’s claim of religious freedom under the Free Exercise Clause will prevail, 

as in Wisconsin v. Yoder.42 Yoder involved a challenge by Amish parents of a 

Wisconsin law that required formal education of children to age 16 years. The 

parents asserted that formal schooling beyond the eighth grade would gravely 

endanger the free exercise of their religion because of their belief that the values 

taught in higher education, including the exposure to worldly influences, are in 

marked variance with Amish values and the Amish way of life. While acknowledging the state’s interest in universal education, the U.S. Supreme Court, in 

applying the Sherbert compelling interest test, rejected Wisconsin’s argument 

of a compelling state interest in requiring formal education of the Amish beyond 

eighth grade given the strong religious interference of such a requirement and 

the fact that the Amish provided adequate alternative informal vocational education. The Court in Yoder articulated its application of the compelling interest 

test as follows. “[W]here fundamental claims of religious freedom are at stake,” 

the Court will not accept a state’s “sweeping claim” that its interest in compulsory education is compelling; “despite its admitted validity in the generality of 

cases, we must searchingly examine the interests that the State seeks to promote 

. . . and the impediment to those objectives that would flow from recognizing 

the claimed Amish exemption” (406 U.S. at 221, 92 S.Ct. at 1536). 

Little recent case law directly addresses the existence of a First Amendment 

free exercise right to a religious exemption from mandatory vaccination because 

48 states have provided by statute for religious exemptions to school vaccination 

laws.29 However, dicta in both Sherbert43 and Yoder44 referring to the Jacobson 

and Prince decisions clearly indicate that on both parens patriae and police 

power grounds the U.S. Supreme Court sees a compelling state interest in mandating vaccination of children because of the health threat to the community 

and to the children themselves. With little practical alternative to vaccination to 

avoid or be a disease risk (e.g., inability to avoid contact with other persons, 

except for those totally isolated from society), mandatory vaccination of all 

school children should also meet the “narrowly tailored” criterion of Sherbert. 

In addition, in a case that predates the Yoder decision and enactment of a 

statutory religious exemption by Arkansas, the Arkansas Supreme Court in 

Wright v. DeWitt School District45 held that no First Amendment right existed 

to a religious exemption given the state’s compelling interest in mandating vaccination under its police power to protect the public health.g (238 Ark. at 913, 

385 S.W.2d at 648). Significantly, the U.S. Supreme Court in Yoder referenced 

the Wright decision in dicta regarding cases in which the health of the child or 

public health are at issue, with the implication that a vaccination mandate providing no religious exemption would meet the compelling state interest test (406 

U.S. at 230, 92 S.Ct. at 1540–1). 
276 CONTROL AND PREVENTION 

Whether a vaccination law that does not provide for religious exemptions 

would meet the compelling state interest test is essentially moot now because 

of a U.S. Supreme Court ruling that significantly lowers the bar for states to 

prevail. In its 1990 decision in Employment Div., Dept. of Human Resources of 

Oregon v. Smith,46 the Supreme Court rejected the compelling interest test and 

established a new standard that holds that “the right of free exercise does not 

relieve an individual of the obligation to comply with a ‘valid and neutral law 

of general applicability on the ground that the law proscribes (or prescribes) 

conduct that his religion prescribes (or proscribes)’ ” (494 U.S. at 879, 110 S.Ct. 

at 1600 [quoting United States v. Lee, 455 U.S. 252, 263, n. 3, 102 S.Ct. 1051, 

1058, n. 3 (1982)]). 

Congress attempted to legislatively override the ruling in Smith by enacting 

the Religious Freedom Restoration Act of 1993 (RFRA), which reestablished 

the compelling interest test as the standard for considering the constitutionality 

of free exercise claims.47 However, the U.S. Supreme Court in City of Boerne 

v. Flores48 struck down RFRA, holding that Congress had exceeded its constitutional authority in implementing the statute (521 U.S. at 510–37, 117 S.Ct. at 

2160–72). Thus, the Smith standard is the current law. Whether judged under 

the neutral law of general applicability test of Smith or the compelling interest 

test of Sherbert, it is reasonable to conclude that there is no First Amendment 

free exercise right to an exemption from mandatory vaccination requirements. 

Is a Statutory Religious Exemption Constitutional? 

With no First Amendment free exercise right to a religious exemption, the next 

question is whether the states have the discretion to allow such exemptions by 

statute. The court decisions are mixed. The Establishment Clauseh of the First 

Amendment establishes the constitutional limits within which a state may accommodate a religious exemption to a law of general application, including 

whether such an exemption is allowed and how inclusively the exemption must 

be defined. As noted above, 48 states have provided by statute for religious 

exemptions to school vaccination laws.29 

In Brown v. Stone,49 the Mississippi Supreme Court struck down the religious 

exemption that appeared in the Mississippi school vaccination statute, holding that 

the statutory religious exemption violated the Equal Protection Clause of the Fourteenth Amendment because it would “require the great body of school children 

to be vaccinated and at the same time expose them to the hazard of associating 

in school with children exempted under the religious exemption who had not been 

immunized” (378 So.2d at 223). Thus, the Jacobson argument comes full circle. 

The fact that no vaccine confers immunity on all vaccinees illustrates the point 

that even persons who comply with vaccination statutes can be placed at increased 

risk by exposure to individuals never vaccinated because of exemptions. 
VACCINATION MANDATES 277 

First amendment—establishment clause 

Most challenges to religious-based vaccination exemptions have been decided 

by the courts on establishment grounds and concern the inclusiveness of such 

exemptions rather than their existence. The U.S. Supreme Court in Lemon v. 

Kurtzman,50 a case involving state supplementation of parochial school salaries, 

defined a three-pronged test for determining whether a state religious accommodation complies with the Establishment Clause: “First, the statute must have 

a secular legislative purpose; second, its principal or primary effect must be one 

that neither advances nor inhibits religion; finally, the statute must not foster 

‘an excessive government entanglement with religion’ ” (403 U.S. at 612–3, 91 

S.Ct. at 2111 [citation omitted] [quoting Walz v. Tax Commission, 397 U.S. 664, 

674, 90 S.Ct. 1409, 1414 (1970)]). 

Scope of statutory exemptions—sincerely held religious belief 

In Sherr v. Northport-East Northport Union Free School District,51 the plaintiffs 

had been denied an exemption under the state’s religious exemption statute by 

the school district because, although they claimed religious opposition to vaccination, they were not “bona fide members of a recognized religious organization” whose teachings oppose vaccination, as required by New York law (672 

F.Supp. at 84 [quoting subsection 9 of N.Y. Pub. Health L. § 2164]). The U.S. 

District Court for the Eastern District of New York found that New York’s 

limitation of the religious exemption violated both the Establishment and Free 

Exercise clauses of the First Amendment.i 

The court found that this limitation violated the Establishment Clause by 

running afoul of at least the last two prongs of the Lemon testj

: (1) by inhibiting 

the religious practices of individuals who oppose vaccination of their children 

on religious grounds but are not members of a religious organization recognized 

by the state and (2) by restricting the exemption to “recognized religious organizations” requires that the government involve itself in religious matters to 

an inordinate degree through such government approval (672 F.Supp. at 89–90). 

In addition, the court held that the limiting language violated the Free Exercise 

Clause because no compelling societal interest existed to justify the burden 

placed on the free religious exercise of “certain individuals while other persons 

remain free to avoid subjecting their children to a religiously objectionable medical technique because they may belong to a particular religious organization to 

which the state has given a stamp of approval” (672 F.Supp. at 90–1). There 

“surely exist less restrictive alternative means of achieving the state’s aims than 

the blatantly discriminatory restriction . . . the state has devised” (672 F.Supp. 

at 91). Striking down New York’s limitation, the court found that “sincerely 

held religious beliefs” in opposition to vaccination, whether or not as part of a 

recognized religion, should suffice (672 F.Supp. at 98). 
278 CONTROL AND PREVENTION 

Do Statutory Religious Exemptions Encompass Philosophic Opposition? 

Strength of convictions aside, defining “religious” belief can be difficult, and understanding its implications for philosophic exemptions that a state may or may 

not wish to voluntarily confer is a challenge. As the Supreme Court noted in 

Yoder: “to have the protection of the Religion Clauses, the claims must be rooted 

in religious belief” (406 U.S. at 215, 92 S.Ct. at 1533). Decisions by the U.S. 

Supreme Court in two conscientious objector cases indicate that a bright line 

may not always exist between the religious and the philosophic and that at least 

some amount of philosophic opposition to vaccination may rise to the level of 

being religious and therefore incorporated into a voluntarily conferred religious 

exemption, regardless of whether the state explicitly provides for a philosophic 

exemption.k In United States v. Seeger52 and Welsh v. United States,53 the Court 

interpreted “religious,” as it appeared in a federal statutory religious-based conscientious objector exemption from military conscription, very expansively to 

extend beyond traditional religious beliefs. Seeger defined the test as “[a] sincere 

and meaningful belief which occupies in the life of its possessor a place parallel 

to that filled by the God of those admittedly qualifying for the exemption” (380 

U.S. at 176, 85 S.Ct. at 859). The Court elaborated in Welsh: “to be ‘religious’ 

. . . this opposition... [must] stem from... moral, ethical, or religious beliefs 

about what is right and wrong and that these beliefs be held with the strength of 

traditional religious convictions” (398 U.S. at 340, 90 S.Ct. at 1796). 

However, the Welsh Court clarified that “moral, ethical, or religious principles” do not incorporate “considerations of policy, pragmatism, or expediency” 

(398 U.S. at 342–3, 90 S.Ct. at 1798). Yoder provides further illumination: “A 

way of life, however virtuous and admirable, may not be interposed as a barrier 

to reasonable state regulation of education if it is based on purely secular considerations.... [T]he 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. Thus, if the Amish asserted their claims 

because of their subjective evaluation and rejection of the contemporary secular 

values accepted by the majority, much as Thoreau rejected the social values of 

his time and isolated himself at Walden Pond, their claims would not rest on a 

religious basis. Thoreau’s choice was philosophical and personal rather than 

religious, and such belief does not rise to the demands of the Religion Clauses” 

(406 U.S. at 215–6, 92 S.Ct. at 1533). Thus, the court in Mason v. General 

Brown Central School District54 rejected fear of the possible side effects from 

vaccination, although based on strong convictions, as rising to the level of religious beliefs because of evidence that the plaintiff’s beliefs were “simply an 

embodiment of secular chiropractic ethics” (851 F.2d at 51–2). Mason, and 

similar decisions, indicate that the expansive religious interpretation of Seeger 

and Welsh should not be read too broadly. 
VACCINATION MANDATES 279 

Impact of Evolving Privacy Rights 

Finally, the general concept of a liberty interest in bodily integrity was first 

articulated by then-Judge, later Justice, Cardozo in Schloendorff v. Society of 

New York Hospital: “Every human being of adult years and sound mind has a 

right to determine what shall be done with his own body” regarding medical 

needs.55 Recognition by the courts in recent years of a liberty right, or right to 

privacy, in medical decision making emanating from the due process clause of 

the Fourteenth Amendment and noted most prominently by the U.S. Supreme 

Court in its 1973 decision Roe v. Wade56 might be used as the basis of a claimed 

privacy right by a college student subject to mandatory vaccination. However, 

the Court in Roe, referencing Jacobson, noted that the medical privacy right is 

not unlimited and must be balanced against important state interests in regulation 

(410 U.S. at 154, 193 S.Ct. at 727). More recently, in dicta in the 1990 “right 

to die” case of Cruzan v. Director, Missouri Dept. of Health,57 the U.S. Supreme 

Court again acknowledged the viability of the Jacobson holding, leading to the 

conclusion that, as long as the public health need for widespread vaccination 

exists, the courts will not recognize a privacy right to refuse state-mandated 

vaccination and will uphold the police power of states to mandate vaccination. 

PRACTICE CONSIDERATIONS AND EMERGING ISSUES 

As new vaccines have been introduced and recommended for universal use in 

infants and children, states have responded by expanding the scope of their 

vaccination laws. Vaccination laws were first enacted to control epidemic diseases. Now they are also used to increase coverage with vaccines that are 

deemed important to protect the public’s health even in the absence of epidemics. This practice is increasingly becoming subject to challenge, particularly with 

vaccines such as the varicella vaccine. Varicella is typically a mild disease in 

children, although nationwide it accounts for more than 50 deaths each year. 

Some parents have argued that no compelling state interest exists in preventing 

this disease. With hepatitis B vaccine, the argument has been that most hepatitis 

B occurs in adults whose sexual or drug-using behavior puts them at risk and 

that school children should not be forced to be vaccinated against a disease that 

often results from voluntary behavior of adults. 

Publicity about adverse events alleged to be caused by vaccine fuels controversy about the wisdom or necessity of requiring vaccination, particularly in the 

absence of visible threat from disease. In the 1970s, concern about the possibility 

of pertussis vaccine causing sudden infant death syndrome or infantile spasms 

led to debate about pertussis vaccination requirements, even though studies 

showed that the vaccine caused neither event.58 More recently, concern about 

the possibility that measles-mumps-rubella vaccine (MMR) might cause autism 
280 CONTROL AND PREVENTION 

has led to congressional hearings and challenges to requirements for this vaccine.59 Persons opposed to vaccination have extensively used the Internet to 

communicate their beliefs. 

Of course, the appearance of new adverse events caused by vaccines further 

feeds the controversy. The occurrence of intestinal intussusception after administration of the recently licensed rotavirus vaccine led to withdrawal of the vaccine and lent some support to the arguments of those opposed to vaccination.60 

CONCLUSION 

School vaccination requirements have been a key factor in the prevention and 

control of vaccine-preventable diseases in the United States. Their constitutional 

basis rests in the police power of the state as well as in the parens patriae 

doctrine. No constitutional right exists to either a religious or philosophic exemption to these requirements, although most states allow religious exemptions 

and several allow philosophic exemptions. The courts have generally upheld 

these exemptions. Most litigation regarding exemptions has focused on the scope 

of the exemption, with courts holding that religious exemptions may not be 

limited to members of organized religions but rather must allow all who have 

sincerely held religious beliefs in opposition to vaccination to qualify. “Religious” may be defined broadly enough to incorporate some amount of philosophic opposition but should not be interpreted to bring purely secular-based 

“philosophic” opposition to vaccination within the meaning of religion. 

With the increasing numbers of vaccines being introduced and the generally 

low level of visible threat from disease, continued challenges to school vaccination requirements are expected. School vaccination laws continue to play a 

central role in avoiding “the tragedy of the commons” by preventing disease 

through high vaccination coverage. These laws can be expected to be upheld by 

the courts as long as the balance of protecting the public health is achieved by 

mandating such requirements. 

Notes 

a Compulsory vaccination is not beyond the police power without arbitrariness or extreme injustice under particular facts. (See note b regarding medical-based exemption). 

In Jacobson, the Court—in addition to holding that providing for compulsory vaccination is within the police power of a state—also held that such authority may be 

delegated to a local body (197 U.S. at 25, 25 S.Ct. at 361). 

b	 In dicta, the Court in Jacobson indicated, however, that there would be a liberty right 

to an exemption based on known medical contraindication “to protect the health and 

life of the individual concerned” (197 U.S. at 39, 25 S.Ct. at 366). (Dicta is discussion 

in a court decision that addresses an issue outside the direct facts presented by the 

case and therefore outside the court’s holding and thus is of no precedential value in 

directing future court decisions.) 
VACCINATION MANDATES 281 

c See also Brown v. Stone (378 So. 2d 218, 222–3) (Miss. 1979), cert. denied 449 

U.S. 887 (1980) for discussion regarding the logical nexus between mandatory vaccination and school attendance: “overriding and compelling public interest... [in] exclusion of a child until such immunization has been effected, not only as a protection 

of that child but as a protection of the large number of other children comprising the 

school community and with whom he will be daily in close contact in the school 

room.” 

d	 See also In re: Christine M., 157 Misc.2d 4, 595 N.Y.S.2d 606 (N.Y. Fam. Ct. 1992) 

in which the court, citing Prince, held that a father’s knowing failure to have his child 

vaccinated against measles in the midst of a measles outbreak, and not qualifying for 

a statutory religious exemption, caused the child to be a “neglected child” under state 

law. However, the court declined to order vaccination because the measles outbreak 

had ended by then and the child was not yet old enough to be subject to the school 

attendance law. 

e But see discussion regarding holding in Sherr striking down state religious exemption 

requirement that an individual be a “bona fide member of a recognized religious 

organization.” 

f	 The First Amendment to the U.S. Constitution states in pertinent part, “Congress shall 

make no law respecting an establishment of religion, or prohibiting the free exercise 

thereof. . . .” The Free Exercise and Establishment Clauses have been held applicable 

to the States through the Due Process Clause of the Fourteenth Amendment.40 

g	 See also Cude v. State, 237 Ark. 927, 377 S.W.2d 816 (Ark. 1964) (upholding ruling 

of neglect and appointment of temporary guardian to consent to vaccination of children 

despite parents’ good faith religious beliefs in opposition). 

h See note f, above. 

i See also Davis v. State, 294 Md. 379, 451 A.2d 107 (Md. 1982), which held that 

limiting religious exemption to children whose parents were “members” (as statute 

provided) or “adherents” (as health department regulation further attempted to narrow 

the qualification) of a “recognized church or religious denomination” opposing vaccination violated the Establishment Clause. On the basis of rules of statutory construction in Maryland, the court severed the offending religious exemption from the statute 

and upheld the conviction of Davis under the remaining statute that compelled vaccination (294 Md. at 382–5, 451 A.2d at 114–5). Rules of statutory construction vary 

so that in the Sherr case the court struck down the limiting “bona fide members of a 

recognized religious organization” language but otherwise upheld the religious exemption. In addition, the court enjoined enforcement of the “bona fide” language as 

to one of the two sets of plaintiffs, who otherwise qualified, and further enjoined the 

state from enforcing the offending language in the future (672 F.Supp. at 97–9). 

j The court in Sherr, having noted the constitutional infirmity of the “bona fide” limitation under the other two prongs of Lemon, did not resolve whether the “bona fide” 

portion of the religious exemption possessed a secular purpose as required under the 

first prong. However, in dicta, the court noted that the legislature may have had a 

number of secular purposes for adopting such language, including “as a guard against 

claims of exemption on the basis of personal moral scruples or unsupported fear of 

vaccinations, as a means of allowing certain exemptions without risking lessened effectiveness of the state’s inoculation program due to the granting of a large number 

of exemptions, or perhaps because of the difficulties inherent in devising a legally 

workable definition of religion” (672 F.Supp. at 89). 

k Fifteen states provide a separate philosophic exemption to school attendance vacci­
282 CONTROL AND PREVENTION 

nation laws, in addition to religious exemptions29 (RH Snyder, NIP, CDC, personal 

communication). 

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284 CONTROL AND PREVENTION 

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