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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 small­
pox. 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 twen­
tieth century.1,2
This chapter describes the impact of vaccines in dramatically reducing infec­
tious diseases in the United States, the role of mandatory vaccination in achiev­
ing 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 chal­
lenges presented when societal interest conflicts with the individual’s interest.
Hardin notes the incentives present when the cattle of a community are com­

262
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 own­
ers continue to add cattle to the commons to reap their individual benefit, leading
to the inevitable failure of the common from overgrazing. The community in­
terest 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 unimmuni­
zed 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 vaccine-
induced 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 sore­
ness 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 problem­
atic 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 impos­


sible.4 Particularly when dealing with rare events, large-scale case–control stud­
ies or reviews of comprehensive records of large numbers of infants may be
necessary to ascertain whether those who received a vaccine had a higher in­
cidence 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 (approx­
imately 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 Im­
munization Practices (ACIP), an advisory group to the CDC, recommended, in
1997, that children should receive a sequential schedule with two doses of in­
activated 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 indi­
vidual and community protection. Most of the diseases against which we vac­
cinate are transmitted from person to person. When a sufficiently large propor­
tion 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 transmis­
sion. Most of the diseases historically have had very high incidence in school-
aged 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, aver­
age 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 con­
ditions) and are at all-time lows. Vaccination coverage in 19–35-month-old chil­
dren 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 Con­
gress 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

TWENTIETH CENTURY PERCENTAGE


DISEASE ANNUAL MORBIDITY 2000† 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 20,000 167 99.10
and unknown ( 5 years)

*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, Haemo­
philus 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 activ­
ities within the U.S. government related to vaccine research and development,
vaccine-safety monitoring, and vaccination activities. In addition, the Act estab­
lished the National Vaccine Injury Compensation Program (VICP) to compen­
sate 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 manufac­
turer. 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 re­
quirements of the FDA, the NCVIA also established the Vaccine Adverse Event
Reporting System (VAERS), which requires reporting of adverse events by vac­
cination providers (42 U.S.C. § 300aa-25). Providers must also record lot num­
bers of vaccines administered. Furthermore, various federal agencies, including
the CDC’s National Immunization Program, have expanded vaccine-safety ac­
tivities. 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 man­
datory 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 pro­
grams through a grant program administered by the CDC.16 These “317” grants,
named for the authorizing statute, support purchase of vaccine for free admin­
istration at local health departments and support immunization delivery, sur­
veillance, 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 in­
clude 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 quan­
tities 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 Acad­
emy of Family Physicians, establishes a recommended schedule for administra­
tion of routine childhood vaccines. The ACIP recommendations are often con­
sidered 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 vaccine-
preventable diseases in the United States. The first school vaccination require­
ment was enacted in the 1850s in Massachusetts to prevent smallpox transmis­
sion 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 prob­
lem.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, re­
spectively, 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 oc­
curred.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 man­
datory 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 cov­
ering 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 rule-
making 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 li­
censed 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 manda­
tory 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 small­
pox, and since vaccination provided a relatively safe preventive, it was natural that com­
pulsory school attendance laws should lead to a movement for compulsory
vaccination. . . .”

Many other childhood diseases for which vaccines were developed also fre­
quently occurred in school-based outbreaks; consequently, when polio and mea­
sles 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 re­
quirement. The constitutional basis of vaccination requirements rests in the po­
lice 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 small­
pox 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 di­
rectly 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 reg­
ulations 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 spe­
cifically 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 vac­
cination requirements in Zucht v. King.34 The Court denied a due process Four­
teenth Amendment challenge to the constitutionality of city ordinances that ex­
cluded 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, Ari­
zona, 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. Har­
mon35 was satisfied that it is prudent to take action to combat disease by ex­
cluding 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 Ja­
cobson 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 vaccine-
preventable 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, Na­
tional Immunization Program [NIP], CDC, personal communication). The cri­
teria for allowing these exemptions vary greatly. Some states require member­
274 CONTROL AND PREVENTION
e
ship in a recognized religion, whereas others merely require an affirmation of
religious (or philosophic) opposition. Nationwide, fewer than 1% of school en­
trants have medical, religious, or philosophic exemptions to mandatory vacci­
nation. 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 commu­
nication.). 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 mea­
sles than were vaccinated persons during 1985–1992. They also found that per­
sons living in communities with high concentrations of exemptors were them­
selves 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 be­
lief 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. How­
ever, 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 acknowl­
edging 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 edu­
cation. 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 compul­
sory 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 man­
dating 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 vac­
cination 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 pro­
viding 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 consti­
tutional 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 ac­
commodate 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 Four­
teenth 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 accom­
modation 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 vac­
cination, they were not “bona fide members of a recognized religious organi­
zation” 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 or­
ganizations” 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 med­
ical 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 un­
derstanding 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 con­
scientious 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 princi­
ples” 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 con­
siderations. . . . [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 re­
ligious 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 dis­
eases. 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 epidem­
ics. 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 contro­
versy 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 vac­
cine.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 admin­
istration of the recently licensed rotavirus vaccine led to withdrawal of the vac­
cine 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 ex­
emption 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. “Reli­
gious” may be defined broadly enough to incorporate some amount of philo­
sophic 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 vacci­
nation 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 ex­
treme injustice under particular facts. (See note b regarding medical-based exemption).
In Jacobson, the Court—in addition to holding that providing for compulsory vacci­
nation 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 vac­
cination and school attendance: “overriding and compelling public interest . . . [in] ex­
clusion 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 vac­
cination violated the Establishment Clause. On the basis of rules of statutory construc­
tion in Maryland, the court severed the offending religious exemption from the statute
and upheld the conviction of Davis under the remaining statute that compelled vac­
cination (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 ex­
emption. 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” limi­
tation 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 ef­
fectiveness 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
29
nation laws, in addition to religious exemptions (RH Snyder, NIP, CDC, personal
communication).

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