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Standard childhood vaccines: Parental hesitancy or refusal

Authors
Julie A Boom, MD
C Mary Healy, MD
Section Editors
Morven S Edwards, MD
Jan E Drutz, MD
Deputy Editor
Mary M Torchia, MD
Disclosures
All topics are updated as new evidence becomes available and our peer review process is
complete.
Literature review current through: Mar 2014. | This topic last updated: feb 14, 2014.
INTRODUCTION This topic reviews the reasons why some parents refuse or are hesitant to
have their child(ren) immunized; the consequences of vaccine refusal; and an approach to the
management of parents who refuse vaccines for their children. Standard childhood immunizations
for children are discussed separately. (See "Standard immunizations for children and adolescents".)
BACKGROUND Immunization is one of the most effective preventative health measures and
has saved countless children from death or serious disability (figure 1). Despite this, immunization is
an emotional issue for many parents. As vaccine-preventable diseases become less common and
parents have little familiarity with the devastating effects of vaccine-preventable illnesses, the
benefits of immunization may seem less important than the potential adverse effects [1].
Mainstream media and Internet discussions on vaccines, fueled by celebrity opinion, often give
equal or greater weight to ill-informed opinion or anecdotal claims about the dangers of vaccines
compared with the rigorous scientific studies that prove vaccines are safe and effective [1-4]. The
mainstream media has a limited ability (or perhaps preference) to adequately communicate
scientific data on vaccines, and Internet sites are not subject to constraints regarding scientific
accuracy or fairness of their reporting. The resulting misinformation leads to unnecessary parental
concerns. Healthcare providers need to understand these concerns in order to effectively address
them and aid parents in choosing immunization for their children. (See 'Approach to
management' below.)
STATE LAWS REGARDING VACCINATION All 50 states in the United States require some
immunizations for school entry (typically for kindergarten, seventh grade, and college entry).
However, parents can elect to exempt their children from immunizations. There are three types of
exemption:
Medical exemptions are for children who have a valid medical contraindication to a vaccine
or vaccine component (eg, history of anaphylaxis to a previous dose of vaccine).
Religious exemptions are for individuals whose religious beliefs oppose immunizations.
Philosophical exemptions are for individuals with a personal, moral, or philosophical belief
against some or all immunizations.
All states allow medical exemptions; nearly all allow exemptions based upon religious beliefs, and
approximately 40 percent allow philosophical exemptions [5]. TheNational Conference of State
Legislatures provides a comprehensive list of state exemption statutes.
Observational studies suggest that the ease with which exemptions can be obtained impacts
exemption rates within communities [5-9]. States that allow philosophical and religious exemptions
have significantly higher vaccine exemption rates than those with religious exemptions only [10].
They also have higher rates of vaccine-preventable diseases [6,11,12]. The Pediatric Infectious
Diseases Society is opposed to legislation that permits philosophical exemption to mandatory
immunizations [13]. (See 'Consequences of vaccine refusal' below.)
EPIDEMIOLOGY
Prevalence The prevalence of vaccine refusal remains low. In a 1999 national survey,
immunizations were rated as extremely important by 87 percent of parents, and 84 percent said
they would not decline any immunizations [14]. In a 2009 national survey of parents or guardians of
children 6 years of age, 93.4 percent indicated that their youngest child had or would receive all
recommended vaccines, but only 80 percent reported believing that immunizations were very
important to childrens health [15].
Although the majority of parents agree to have their children immunized, vaccine refusal appears to
be increasing [5,9,14,16-19]. The proportion of children who are exempted from school
immunization requirements for nonmedical reasons is the primary measure of vaccine refusal in the
United States [5]. Between 1991 and 2004, the mean rate of nonmedical immunization exemptions
at kindergarten entry increased from 0.98 to 1.48 percent at the state level. Among states that
allowed exemptions forphilosophical/personal beliefs, the nonmedical exemption rate increased to
2.5 percent [6]. The rate of nonmedical exemptions at kindergarten entry varies geographically
(ranging from 1.1 to 24.2 percent by county in Washington state for 2010-2011; and from <0.1 to
6.5 percent for 2012-2013 nationally) [20,21]. In the 2003 and 2004 National Immunization Survey
(NIS), 6 percent of parents reported having refused at least one vaccine [16]. In another national
survey, 11.5 percent of parents reported having refused at least one vaccine in 2009 [18].
Many parents express concerns related to vaccines, even if they choose to vaccinate their children.
In a 1999 national survey, 25 percent of parents expressed vaccine concerns [14]. In the 2003 and
2004 NIS, 9 percent of parents reported that they allowed their child to be immunized but were
doubtful it was the correct thing to do, and 13 percent reported having delayed a vaccine [16].
Approximately 90 percent of pediatric healthcare providers annually encounter at least one parent
who refuses some recommended vaccines, and 54 percent encounter a parent who refuses all
recommended vaccines [17,22].
Demographics There are important racial/ethnic and socioeconomic differences between
children who have received fewer than the recommended number of vaccines (undervaccinated
children) and children who have received no vaccines (unvaccinated children) [23-25]. In the 2001
NIS, undervaccinated children were more likely to be black, live in poverty in a central city, and
have an unmarried younger mother without a college education [23]. In
contrast, unvaccinated children were more likely to be white, have a married mother with a college
degree, and have an annual family income greater than $75,000. Additional studies confirm that
parents who refuse vaccines or seek philosophical exemptions are older (36 to 40 years) [26] and
have higher levels of education and household incomes [26-28]. Unvaccinated children also tend to
live in states that allow philosophical exemption, and cluster in certain counties [23,29].
Parents who seek vaccine exemptions may have a low level of trust in the government and
healthcare professionals and may use complementary or alternative medicine professionals whom
they consider to be reliable sources of vaccine information [26]. In a 2002 national survey, 12
percent of respondents who had at least one child <18 years of age living in the household were
opposed to compulsory vaccination [24]. Many of those opposed to compulsory vaccination
believed that vaccines were not necessary for protection against disease and did not plan to fully
immunize their youngest child.
Vaccine beliefs Scientific characterization of parents according to vaccine beliefs is difficult.
One study from the Centers for Disease Control and Prevention (CDC) has identified five types of
parents, according to clusters of attitudes and beliefs about vaccines [30]:
"Immunization advocates" (33 percent) strongly agree that vaccines are necessary, safe and
important
"Go along to get alongs" (26 percent) agree that vaccines are necessary and safe
"Health advocates" (25 percent) agree that vaccines are necessary but are less sure about
their safety
"Fence-sitters" (13 percent) slightly agree that vaccines are necessary and safe
"Worrieds" (3 percent) slightly disagree that vaccines are necessary and strongly disagree
that they are safe
Parental types also differ in their descriptions of their relationship with their provider, varying from
"good," for immunization advocates, to "neutral," for fence-sitters and worrieds [30]. Worrieds are
also skeptical that providers have their child's best interest at heart.
WHY PARENTS REFUSE VACCINES
General objections Parental concerns regarding vaccines can be classified into several major
categories that have remained relatively unchanged since the advent ofsmallpox vaccination in the
18th century: concerns about safety or side effects, religious objections (immunizations are a
violation of God's will), and philosophical objections (immunization is "not natural") [17,18,26,31-34].
Concerns about safety and side effects account for approximately 60 to 70 percent of vaccine
exemption requests [26,28,32]. Specific safety concerns include particular side effects (eg, Guillain-
Barr syndrome, intussusception) and concerns that vaccines overload the immune system,
possibly causing autism, autoimmune disease, or increased susceptibility to infection [14,26]. Some
safety concerns have a factual basis (eg, an early rotavirus vaccine [Rotashield] and
intussusception), whereas others are misconceptions (that multiple vaccines overwhelm the
immune system) [35]. Concerns about safety are intensified by negative word of mouth and media
messages [3,17].
Additional reasons for vaccine refusal include [15,17,18,26,32,35,36]:
Concern that vaccines don't work
Concerns about medical contraindications
Antigovernment sentiment
Belief that their child is not at risk
Belief that the disease is not dangerous
Belief that is it better to be naturally infected than vaccinated
Cost
Belief that the child is not at risk or that the disease is not dangerous is a consequence of the
success of childhood immunization programs (figure 1). As more diseases are successfully
prevented by immunization, the devastating sequelae of vaccine-preventable diseases are forgotten
[1]. Many parents are unaware of the risks to the individual and of the societal consequences of
refusing vaccines. (See 'Consequences of vaccine refusal' below.)
Specific objections Parents (and providers) may have a tendency to selectively protect against
diseases they believe are more severe (eg, Haemophilus influenzaetype b) and refuse vaccines
against diseases that they believe are not dangerous. As an example, varicella vaccine is one of
the more commonly refused vaccines [5,37,38].
Many studies demonstrate that underimmunized children have characteristics reflecting social
inequalities, rather than true philosophical objections to immunization. (See'Demographics' above.)
However, there is some evidence to suggest that parents whose children were underimmunized for
pertussis, hepatitis B, or measles had safety concerns (eg, autism, thimerosal) and wished to
selectively immunize their children [23,39].
MMR vaccine Concern regarding the combination measles-mumps-rubella vaccine (MMR) can
be traced to a 1998 study in 12 children from the United Kingdom (UK) alleging that MMR damaged
the intestinal lining, allowing encephalopathic proteins to enter the bloodstream and brain, thereby
leading to the development of autism [40]. The paper was retracted from the public record in 2010,
and exposed as fraudulent in 2011 [41,42]. Despite overwhelming evidence disproving this theory, it
still is highlighted in media reports and on the Internet [2]. Large-scale population studies have
demonstrated that MMR and autism occur independently of each other and that gastrointestinal
disease and autism do not occur after MMR vaccine. This issue is discussed in detail separately.
(See "Autism and chronic disease: Little evidence for vaccines as a contributing factor", section on
'Enterocolitis and regression'.)
Despite the lack of an association between autism and MMR, MMR immunization rates in the UK
declined acutely (from 92 percent in 1995 to 79 percent in 2003) [43,44]. In June 2008, measles
was again endemic in the UK, 14 years after it had been eliminated [45,46].
HPV vaccine Human papillomavirus (HPV) vaccine is controversial for some patients and
providers. Attitudes of parents, partners, and clinicians influence completion of the vaccine series
[47]. Concerns regarding HPV vaccine are related to the belief that it may encourage sexual
activity, excessive influence by the pharmaceutical industry [48,49], and safety [36]. The 2009 death
of a British girl within hours of receiving HPV vaccine received widespread attention; autopsy
demonstrated that she died of an undiagnosed tumor and that her death was unrelated to HPV [50].
The media focus on the above concerns may have contributed to the number of adverse events
reported to the Vaccine Adverse Event Reporting System (VAERS) between June 2006 and
December 2008 (53.9 per 100,000 doses administered, 6.2 percent serious) [51]. However,
analysis of the VAERS reports shows that the adverse events were similar to those identified before
the vaccine was licensed. They were also similar to background rates of other vaccine-associated
adverse events, except for two categories: syncope and venous thromboembolism. The age group
for whom HPV vaccine is recommended (11 to 26 years) has an excess risk of immunization-
associated syncope [52]. Two subsequent studies, each including >600,000 doses of HPV, found
either no association with venous thromboembolism [53] or a nonsignificant association that
occurred exclusively among girls with other risk factors (eg, smoking, prolonged hospitalization)
[54]. (See "Recommendations for the use of human papillomavirus vaccines", section on 'Vaccine
safety'.)
Meningococcal conjugate vaccine The major concern regarding the quadrivalent
meningococcal conjugate vaccine is a possible association with Guillain-Barr syndrome (GBS)
[55]. GBS is an immune-mediated, rapidly evolving polyradiculoneuropathy with an estimated
incidence of 1 to 2 cases per 100,000 person-years. Although GBS has
been temporally associated with vaccination, a causal association has not been proven. The
possible association between quadrivalent meningococcal conjugate vaccine and GBS is discussed
separately. (See "Meningococcal vaccines", section on 'Possible association with Guillain-Barr
syndrome'.)
Influenza Parental concerns regarding influenza vaccines may include unknown side effects with
possible long-term problems, Guillain-Barr syndrome (GBS), thimerosal exposure, inadequate
testing to ensure safety in children, and the lack of need for protection against what may be
mistakenly thought of as a "mild type" of influenza [56].
Concerns about influenza-vaccine-associated GBS and other neurologic complications were
highlighted by the media during the 2009 H1N1 influenza pandemic. Cases of GBS occurred
following the administration of swine flu vaccine in the United States in 1976 and 1977, and some
commentators erroneously compared the rapid development of H1N1 vaccines to swine flu vaccine
development in 1976. However, monovalent H1N1 vaccine was developed using the same methods
that are used for seasonal influenza vaccine, and the increased risk of GBS following seasonal
influenza vaccine was found to be small or nonexistent [57-59]. (See "Seasonal influenza
vaccination in children", section on 'Adverse reactions' and "Seasonal influenza vaccination in
children", section on 'Adverse effects' and "Pathogenesis of Guillain-Barr syndrome in adults",
section on 'Influenza vaccination'.)
Thimerosal The use of thimerosal (ethylmercury) as a vaccine preservative has been
hypothesized to result in mercury-related neurologic effects, including the development of autism.
Numerous studies refute this hypothesis. Nonetheless, some parents remain unconvinced by the
scientific data. (See "Autism and chronic disease: Little evidence for thimerosal as a contributing
factor".)
CONSEQUENCES OF VACCINE REFUSAL Vaccine refusal increases the risk of vaccine-
preventable disease among unvaccinated individuals and the risk of vaccine-preventable disease
outbreaks in the general population.
For the individual Unvaccinated children have a higher risk of acquiring vaccine-preventable
illness than their vaccinated peers. In observational studies and mathematical modeling, the
magnitude of the increased risk is approximately ninefold for varicella and ranges from 22- to 35-
fold for measles and 6- to 28-fold for pertussis [60-64].
During January-August 2013, 159 measles cases occurred in residents of the United States
[65]; 82 percent occurred in individuals who were unvaccinated and 9 percent in individuals
with unknown vaccination status; among those who were unvaccinated, 79 percent had
philosophical or religious objections to vaccination.
Among Colorado children enrolled in a large health plan, 11 percent of pertussis cases were
attributed to vaccine refusal [61].
In a 2008 outbreak of invasive H. influenzae type b (Hib) disease in Minnesota, Hib
vaccination was deferred or refused by the guardians of three of the five cases; one of these
children died from Hib meningitis [66].
The risks of delaying immunization have not been well studied [5]. As a general rule, young children
are at greater risk for severe disease than older children who contract vaccine-preventable illnesses
(eg, pertussis, influenza). Delaying immunizations increases the duration of vulnerability for these
young children.
For the community The public health consequences of vaccine refusal are demonstrated by
multiple outbreaks of vaccine-preventable diseases in unvaccinated individuals, as illustrated
below:
Between 1985 and 1994, 13 disease outbreaks occurred in religious groups opposed to
immunization, resulting in 1200 cases and 9 deaths [67].
A measles outbreak at a college for Christian Scientist students resulted in 125 cases (attack
rate 15 percent) and three deaths (case fatality rate 2.2 percent) [68]. Another measles
outbreak at a camp attended by Christian Scientists had an attack rate of 25.2 percent [68].
Outbreaks of polio, rubella, measles, pertussis (345 cases, attack rate 20 percent), and H.
influenzae type b (Hib) have been reported in undervaccinated Amish communities [69-75].
Measles outbreaks occur on a regular basis in Europe and were reported across the United
States during 2008, mainly among children whose parents had refused immunization
[45,46,76-78]. (See 'MMR vaccine' above and 'For the individual' above.)
Suboptimal vaccination rates also result in disease outbreaks and deaths among vaccinated
individuals [62,79]. Vaccinated children may acquire infection through contact with vaccine
exemptors. Rates of disease among vaccinated individuals increase as vaccinated and
unvaccinated individuals mix in communities [62,63].
In a population-based study of children aged 3 to 18 years, the frequency of vaccine
exemptors directly correlated with the incidence of measles and pertussis in vaccinated
children [62]. Schools with pertussis outbreaks had more vaccine exemptors than schools
without outbreaks (4.3 versus 1.5 percent of students).
In observational studies in Michigan (1993-2004) and California (2010), census tracts with
clusters of nonmedical exemptions were two to three times more likely to overlap with census
tracts with clusters of pertussis than census tracts without clusters of medical exemptions
[11,80].
APPROACH TO MANAGEMENT
Overview of approach Parental vaccine refusal may evoke strong emotional responses in
medical providers, ranging from issues of trust in their relationships with patients to medicolegal
concerns [35]. It may be difficult to put aside these initial reactions, but establishing a
nonconfrontational dialogue from the first clinician-parent interaction is essential to ensuring a
successful result. The healthcare provider is one of the most important influences in decisions about
immunization, even among vaccine-hesitant parents [15,23,26,34,81,82].
When faced with vaccine-hesitant parents, the provider should be guided by the following
recommendations [83]:
Establish open, ongoing, nonconfrontational dialogue to identify concerns.
Target education to address specific parental concerns, using a variety of resources (table
1).
Maintain the provider-patient relationship.
Use vaccine schedules that deviate from the recommended schedule (eg, the schedule
recommended by Centers for Disease Control, American Academy of Pediatrics, and
American Academy of Family Physicians in the United States) (figure 2A-B) only when other
options, such as targeted education, have failed and the family would otherwise refuse
vaccination entirely.
Establish dialogue Dialogue should begin at the first provider-parent encounter and continue at
every subsequent interaction. The dialogue is more important than the outcome at any one visit
[84]. Providers must listen to their patients' parents to identify the forces that influence vaccine
concerns. Once the concerns are identified, the provider can establish a plan for targeted education
to address them. (See 'Why parents refuse vaccines' above.)
Key points in establishing the dialogue include [84]:
Acknowledging a shared goal (what is best for the child)
Acknowledging the large volume of complex, conflicting information about vaccine benefits
and safety
Offering to help them to gather the best information to make an informed decision (table 1)
Identify concerns Respectful listening is critical in identifying the source of parental concerns.
Parents receive vaccine information from media reports that grab audience attention, present
information that is easy to understand, and highlight pro- and antivaccine viewpoints in a limited
time frame. A few sensational, anecdotal reports alleging harm may receive equal or greater
attention than large-scale population studies that prove vaccine safety [1]. Erroneous impressions
regarding vaccine safety may be supplemented by stories parents have heard from family or friends
or have read on the Internet. Visual imagery of children allegedly hurt by vaccines is more
compelling than faceless statistics about diseases parents have never seen or experienced.
Some parental concerns may not be immediately obvious. Parents may be concerned that their
infant will suffer during vaccine administration. They may fear committingharm (giving an unsafe
vaccine) more than allowing harm (taking a chance that their child will develop a disease).
Providers must listen carefully and respectfully to understand these concerns, even if it is time
consuming.
One author provides a practical approach to categorizing vaccine-hesitant parents according to the
source and conviction of their concerns [85]:
The "uninformed but educable" have received an antivaccine message from families or
friends but seek information to counter this.
The "misinformed but correctable" have been influenced by antivaccine messages from the
media or the Internet but are relatively unaware of medically accurate provaccination
arguments.
The "well-read and open-minded" have explored the pro- and antivaccination messages but
want their provider's input in interpreting the information.
The "convinced and contented" are strongly antivaccination but want to demonstrate their
willingness to listen to the other side of the argument (often to satisfy a family member).
The "committed and missionary" are strongly antivaccine and want to convince the provider
to agree with their arguments.
The first three groups tend to respond positively to information and dialogue, whereas the latter two
are unlikely ever to change their position, although the "convinced and contented" may moderate
their beliefs over time [85].
Target education Most parental vaccine concerns are amenable to dialogue and discussion.
Providers should target education to specific parental concerns and/orbeliefs, realizing that some
parents may need information from a variety of resources (table 1). Visual imagery and anecdotes
from parents who are vaccine advocates may be used to support the educational message
(eg, Families Fighting Flu, Meningitis Angels, National Meningitis Association, Vaccine-preventable
disease: The forgotten story).
Focused education that directly addresses the source of vaccine concerns may have an important
impact [17,86]. However, data on the overall success rates of education are limited. The
HealthStyles survey indicates that approximately one-third of parents want more information about
immunizations and that the healthcare provider is one of the most influential factors in decisions
about immunization, even among vaccine-hesitant parents [23,26,81,87].
Targeted immunization materials that provide unbiased, accurate statistical information, avoid scare
tactics, and are not judgmental may be helpful in improving immunization acceptance in certain
groups of vaccine-hesitant parents [39,88]. Parents are skeptical of aggressive pro-and antivaccine
messages [17]. Emphasizing mandatory school entry requirements in an effort to influence parents
is not helpful [89].
The provider must address relevant concerns while fully explaining vaccine benefits and risks.
Potential areas for targeted education include:
Vaccine limitations
Adverse events
Misconceptions
Pain
Vaccine limitations It is important to acknowledge that although vaccines are very safe, they
are not completely risk free or 100 percent effective. Providing this information is important in
establishing credibility, but the information must be placed in a proper context for parents who may
overestimate the risks of vaccines and underestimate the risks from vaccine-preventable diseases
[1]. It may be helpful to reframe the discussion by defining the options in terms of benefits with risks,
rather than emphasizing the risks [35].
Adverse events Adverse events related to vaccines must be put into context. Most vaccine-
associated adverse events are minor and self-limited (eg, local skin reactions, transient low-grade
fever). Serious adverse events from an individual vaccine occur rarely, but these should be weighed
against the risks associated with the natural infection. As examples:
The risk of acquiring measles during an outbreak may be 35 times higher in an unvaccinated
than in a vaccinated person [63].
The risk of measles-associated encephalopathy or subacute sclerosing panencephalitis
following natural measles is 1000 times higher than the risk of encephalopathy from measles
vaccine (1 in 1 million) [90].
Misconceptions It is important to dispel myths, correct misinformation, and direct parents to
scientifically sound information (table 1) [35]. Providers should avoid using ambiguous language or
complicated scientific terms when communicating the science supporting vaccine safety and
effectiveness.
Autism The most common vaccine myth, that vaccines cause autism, has suggested a
number of hypotheses to substantiate the link (eg, that MMR or thimerosal [ethylmercury]
cause autism). The myths related to autism and MMR and thimerosal are discussed
separately (see "Autism and chronic disease: Little evidence for vaccines as a contributing
factor" and "Autism and chronic disease: Little evidence for thimerosal as a contributing
factor").
Overwhelming the immune system Parents may worry that multiple vaccines overwhelm
the immune system, possibly causing autism, autoimmune disease, or susceptibility to
infections. The following observations provide evidence against this claim [91-93]:
With manufacturing advances and discontinuation of smallpox immunization, children
are exposed to fewer antigens today than they were in 1980 [35]. The currently
recommended immunizations for children younger than two years in the United States
(figure 2A-B) contain approximately 300 bacterial and viral protein or polysaccharide
antigens, compared with >3000 such antigens in the seven vaccines administered in
1980 [94-96].
Evidence of adverse effects related to exposure to multiple antigens is lacking. In a
cohort of 1047 children who were exposed to an average of >10,000 antigens by age 24
months (predominantly through whole cell pertussis vaccine), there was no association
between increasing antigen exposure and adverse neuropsychologic outcomes (eg,
general intellectual function, speech and language, verbal memory, attention and
executive function, tics, achievement, visual spatial ability, and behavior regulation) [96].
The infant immune system can respond to multiple antigens (conservative estimates
suggest thousands) simultaneously [35,94,97]. This is illustrated by the observations that
mild or moderate illness does not interfere with an infant's ability to generate protective
immune responses to vaccines and that combinations of vaccines induce immune
responses comparable to those given individually [97].
Vaccinated and unvaccinated children do not differ in their susceptibility to infectious
diseases for which there are no vaccines (eg, enterovirus, candida) [98-100]. On the
other hand, infection with vaccine-preventable disease can predispose to severe
invasive infections with other pathogens (eg, methicillin-resistant Staphylococcus
aureus) [101,102].
Vaccines are not necessary As vaccine-preventable diseases become less common and
parents have little familiarity with the devastating effects of vaccine-preventable illnesses,
some parents may believe that vaccines are no longer necessary [1]. These parents must be
educated regarding the persistence of vaccine-preventable diseases and the potential for a
rapid increase in vaccine-preventable disease incidence when immunization rates decline
[35]. (See 'Consequences of vaccine refusal' above.)
Pain Providers can educate parents on available methods to reduce pain when multiple vaccine
injections are required at a single visit. These may include nonpharmacologic options, such as oral
sucrose for infants; stroking, rocking, or "blowing the pain away for older children"; or
pharmacologic management if indicated (eg, topical anesthetics placed 30 to 60 minutes prior to
injection) [103-105].
Maintain relationship When educational efforts fail to persuade parents to immunize their
children, providers may be faced with a dilemma about whether or not to refer the family to another
provider [106,107]. Factors influencing this decision include lack of shared goals, absence of trust in
the clinician-family relationship, and fear of litigation if the child subsequently contracts a vaccine-
preventable disease or transmits a vaccine-preventable disease to an individual with vaccine
contraindications or who was too young to be immunized [107]. Although we recognize that a
provider may choose to dismiss a family form his or her practice when poor communication and
distrust have become insurmountable [108], we encourage providers to maintain relationships with
families who refuse immunization.
The American Academy of Pediatrics (AAP) Committee on Bioethics suggests that pediatricians
should endeavor not to discontinue care for patients solely because their parents refuse or delay
vaccines [83,109]. The decision to immunize belongs, ultimately, to the parents. The benefits of
immunization must be weighed against those of the provider maintaining a positive relationship with
the family. Maintenance of the relationship permits time for ongoing dialogue and targeted
education and ensures that the child has a medical home.
Although the AAP Committee on Bioethics acknowledges that the welfare of the child is paramount,
it advises providers to tolerate parental decisions "not likely to be harmful to the child" [83]. Using
this paradigm, immunization of an individual child is favored when community immunization rates
are low and disease prevalence is high, or if the child has a medical predisposition to a disease.
The risk to the community attributable to unimmunized children infecting children who are unable to
be immunized and the community cost of caring for children with vaccine-preventable diseases
should also be considered [110,111]. Rarely, providers may be obliged to involve state agencies to
provide immunization against parental wishes (eg, when a child is placed at risk during an
epidemic) [83]. (See 'Consequences of vaccine refusal' above.)
The AAP advises that dismissing vaccine-refusing families should be an option of last resort but
recognizes that distrust and poor communication may, rarely, make termination of the clinician-
patient relationship advisable [83]. In this unusual situation, the provider should offer sufficient
information to assist families to find another provider and allow adequate time for the transition to
occur, thus avoiding potentially harmful lapses in medical care [106].
Alternative schedules Deviations from the recommended childhood immunization schedule
should be used only when all other options have failed. Alternative schedules should not be used as
a substitute for establishing parental dialogue or targeted education [1,83].
Alternative schedules are not founded in science and entail multiple visits to the provider's office. A
committee convened by the Institute of Medicine to study the health outcomes related to the
recommended childhood immunization schedule in the United States found no conclusive evidence
of adverse events related to multiple immunizations or other aspects of the immunization schedule,
suggesting that the current recommended schedule is safe [112]. Alternative schedules increase
the risk of noncompliance and the duration of vulnerability to vaccine-preventable diseases and
may increase the risk of adverse effects [113]. However, the use of an alternative schedule may
allay the fears of some parents enough that they permit their child to be immunized.
The most popular of the alternative immunization schedules are the "selective vaccine schedule"
and "alternative vaccine schedule" published by Dr. Robert Sears [114]. Dr. Sears's book casts
doubt on clinicians' understanding of vaccine research and the motives of the pharmaceutical
industry and suggests that the immunization schedule recommended by the Centers for Disease
Control and Prevention, American Academy of Pediatrics, and American Academy of Family
Physicians is in the public's, but not necessarily the individual's, best interest. His alternative
schedules prioritize immunizations that he considers more important on the basis of his experience
as a pediatrician in private practice, while delaying or skipping others. Only two vaccines are
administered at a time, and only one aluminum-containing vaccine is given at any one visit.
Although Dr. Sears's approach may seem to be a reasonable compromise between hesitant
parents and their providers, there are multiple inherent problems. Critics of Dr. Sears's book explain
in detail how it fails to distinguish good from bad science when discussing vaccine research,
misinterprets vaccine safety data, underestimates the risks to children of vaccine-preventable
diseases by considering only his limited personal experience, is ambiguous regarding the disproven
associations of MMR and thimerosal with autism, and does not fully grasp the scientific method
[115].
Timely receipt of vaccines during the first year of life has no adverse effect on neuropsychologic
outcomes. Review of data from the Vaccine Safety Datalink study, which included 1047 children,
indicate that the 47 percent of children who received their vaccines on time (2 hepatitis B, three
diphtheria-tetanus-pertussis, three H. influenzaetype b, and two polio vaccines within 30 days of the
recommended age) performed as well or better at age 7 to 10 years on every measure of
neuropsychologic outcome than the 23 percent of children who received all of the recommended
vaccines, but not on time; and the 20 percent of children who did not receive all of the
recommended vaccines [116].
The schedules proposed in Dr. Sears's book are potentially harmful, extending the duration of
vulnerability for vaccine-preventable diseases that continue to cause outbreaks. For example, under
the "alternative" schedule, it is recommended that MMR be separated into three components:
mumps is given at 12 months, rubella at two years, and measles at three years. Single-antigen
measles vaccine is no longer available in the United States [117]. Under the "selective" schedule,
titers for measles, mumps, and rubella are checked at age 10 years, and vaccination considered if
not immune. Delayed administration of polio, varicella, hepatitis A, and hepatitis B vaccines is also
suggested for reasons that are not founded in science.
Special precautions Children who have not been immunized are at risk to develop or transmit
vaccine-preventable disease. Parents of children who refuse immunizations must take special
precautions with respect to these risks. When their child is ill, they must inform the healthcare
providers that the child has not been vaccinated so that the providers can consider vaccine-
preventable illnesses in their differential diagnosis and take the necessary steps to prevent infection
of other patients. The Centers for Disease Control and Prevention, American Academy of
Pediatrics, and American Academy of Family Physicians has developed a handout for parents to
remind them of these risks and responsibilities [118].
Documentation Providers should document each discussion with parents about the risks of not
immunizing [83]. The American Academy of Pediatrics (AAP) has developed guidelines for
providers faced with this situation and provides sample waiver documentation to cover this
eventuality (available through the American Academy of Pediatrics ). Another sample waiver is
available through the Immunization Action Coalition.
PREVENTION Specific strategies to prevent parental vaccine refusal have not been studied.
However, given that primary care providers are one of the most influential factors in decisions about
immunization [23,26,81], it is reasonable for providers to establish open, honest, nonconfrontational
dialogue about the importance of childhood vaccinations beginning with the first provider-parent
interaction. Providers also should share their own or their practice's philosophy regarding delaying
or refusing vaccination to avoid the potential for future disagreements.
Education should start at the prenatal visit and continue at all subsequent well-child visits. At each
encounter, providers should listen to parental concerns to identify sources of misinformation or
other factors that may lead to vaccine hesitancy. Providers can then provide individualized
education to address specific concerns or misconceptions.
Education should be multifaceted, with providers answering questions unambiguously, avoiding
complicated statistics, and providing information that is easily understood and "personal." Providers
should make full use of the online resources outlined in the table (table 1). Some parents may find
the information on the Vaccine Information Statements adequate to address their needs, but others
may require more detailed scientific information or may find simple question-and-answer pamphlets
or personal testimonials from vaccine advocates more helpful [1,119].
In a randomized trial, vaccine-hesitant parents (defined by a score of 25 on the Parent Attitudes
about Childhood Vaccines [PACV] survey) who received educational information (a video, written
information, and written instructions for finding accurate information on the Internet) at the two-week
health supervision visit had decreased PACV scores at the two-month visit compared with those
who received usual care [120].
How the provider initiates the conversation about vaccines may play a role in vaccine acceptance.
In an observational study in which 93 discussions about vaccines at health supervision visits were
initiated by the provider, 74 percent of providers used a presumptive approach (eg, Hes due for
three shots today) and 26 percent used a participatory approach (eg, What would you like to do
about shots?) [121]. The presumptive approach was associated with decreased parental
resistance to immunizations (26 versus 83 percent).
RESOURCES Most parents trust advice from their child's healthcare provider [23,26,81].
However, it is useful for both parents and providers to access reputable sources where accurate
and easy-to-understand vaccine information is available.
Focus groups suggest that most parents trust information from the Centers for Disease Control and
Prevention (CDC) or American Academy of Pediatrics (AAP) [88]. A list of additional reputable
vaccine Web sites is provided in the table (table 1). Parents who need more information than the
clinician can provide during an office visit can be directed to these resources.
Many of the organizations in the list provide publications or question-and-answer tear sheets that
can be purchased or downloaded for use in office waiting rooms or for parents to take away and
read. Posters and publications describing the consequences of vaccine-preventable diseases are
also available for download or purchase from some of the sources in the table, which include public
health agencies, organizations specializing in vaccine education, and parent-advocacy groups. The
latter may be particularly useful for vaccine-hesitant parents because they highlight identifiable,
serious, and sometimes fatal consequences of refusing immunization, using anecdotes and visual
imagery to counter those used with such great effect by antivaccine activists [122].
For providers, the CDC, in partnership with the AAP and the American Academy of Family
Physicians (AAFP), has developed Provider Resources for Vaccine Conversations with Parents.
They provide communication tips for providers, current vaccine safety information, answers to
common questions, and disease-specific fact sheets that can be downloaded as a handout for
parents to supplement Vaccine Information Statements and guide parent risk-benefit discussions
[1].
SUMMARY AND RECOMMENDATIONS
Immunizations are one of the safest and most cost-effective preventative health measures
(figure 1). However, misinformation may lead parents to hesitate or refuse to immunize their
child(ren). (See 'Background' above.)
Concern about vaccine safety is the most common reason for vaccine refusal. (See 'General
objections' above.)
Vaccine refusal may result in vaccine-preventable disease in the individual and/or outbreaks
of vaccine-preventable disease in unvaccinated and vaccinated individuals.
(See 'Consequences of vaccine refusal' above.)
The healthcare provider is one of the most influential factors in the decision whether or not to
immunize a child. When faced with vaccine-hesitant parents, the provider should be guided by
the following recommendations (see 'Overview of approach' above):
Establish open, ongoing, nonconfrontational dialogue to identify concerns
Target education to specific concerns, using a variety of resources (table 1)
Maintain the provider-patient relationship
Use vaccine schedules that deviate from the recommended schedule only when other
options have failed and the family would otherwise refuse vaccination entirely
Targeted education may include acknowledgment of vaccine limitations, provision of
accurate estimates of the risks of adverse events and vaccine-preventable disease, correction
of misconceptions, and discussion of techniques to alleviate immunization-related pain.
(See 'Target education' above.)
While we recognize that a provider may choose to dismiss a family from his or her practice
when poor communication and distrust have become insurmountable, we encourage providers
to maintain relationships with families who refuse immunization. (See 'Maintain
relationship' above.)
We do not suggest deviation from the recommended immunization schedule (Grade 2C).
(See 'Alternative schedules' above.)
Use of UpToDate is subject to the Subscription and License Agreement.
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