CONTINUING EDUCATION

Promoting Childhood
Immunizations
Victoria Lynn Anderson, MSN

ABSTRACT
Immunization was perhaps the single most beneficial public health measure of the 20th century. Vaccine
manufacturers work in tandem with government, academic, and nongovernmental agencies to develop safe
and effective vaccines that decrease health costs and improve compliance. Despite overwhelming evidence of
vaccine safety, suspicion and misconception continues in small groups of hesitant or resistant parents, often
leading to outbreaks of vaccine-preventable infections. On the front lines of vaccination, nurse practitioners
can improve vaccination rates by developing a trusting relationship with parents and being armed with
information based on sound clinical evidence.

Keywords: adjuvants, adverse events, autism, compensation, FDA, IND, IOM, regulatory review, vaccine
Ó 2015 Elsevier, Inc. All rights reserved.

Victoria L. Anderson, MSN, CRNP, is a Family Nurse Practitioner at the Clinical Center, Department of Radiology and Center for
Interventional Oncology, National Institutes of Health in Bethesda, MD. She can be reached at niaidnp@gmail.com. This study was
supported by the Intramural Research Program of the National Institutes of Health, Clinical Center, Department of Radiology, National
Cancer Institute, Center for Interventional Oncology, and the Mark Hatfield Clinical Research Center. In compliance with national
ethical standards, the author reports no relationships with business or industry that would pose a conflict of interest.

INTRODUCTION number of children who reach their first birthday.1

I
mmunization is perhaps the single most impor-
tant public health measure of the 20th century.
Infectious diseases were once the leading cause of
death in the early 1900s, but, since the advent of
vaccines, they currently rank eighth.1 Vaccination is
also responsible for improving substantially the
At the turn of the 20th century, 100 of 1,000 babies
born in the United States died before their first
birthday, and today that rate has decreased dramatically
to 7 in 1,000 babies.2 Table 1 demonstrates that
introduction of vaccines has led to dramatic declines
vaccine-preventable diseases (VPDs).3

This CE learning activity is designed to augment the knowledge, skills, and attitudes of nurse practitioners and assist in their understanding of immunizations and their
impact on humans.
At the conclusion of this activity, the participant will be able to:
A. Describe the characteristics of a hesitant vs resistant parent
B. Address parental concerns by explaining major immunization concepts
C. Use current evidence to clarify the relationship between vaccines and autism
The author, reviewers, editors, and nurse planners all report no financial relationships that would pose a conflict of interest.
The author does not present any off-label or non-FDA-approved recommendations for treatment.

This activity has been awarded 1.0 contact hours for nurses and advanced practice nurses and 1.0 contact hours of pharmacology credit. The activity is valid for CE credit
until February 1, 2017.

Readers may receive the 1.0 CE credit free by reading the article and answering each question online at www.npjournal.org, or they may mail the test answers and
evaluation, along with a processing fee check for $10 made out to Elsevier, to PO Box 786, East Amherst, NY 14051. Required minimum passing score is 70%.

This educational activity is provided by Nurse Practitioner AlternativesÔ.

NPAÔ is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

Accreditation does not imply endorsement by the provider, Elsevier, or ANCC of recommendations or any commercial products displayed or discussed in conjunction with
the educational activity.

www.npjournal.org The Journal for Nurse Practitioners - JNP 1

Table 1. Rates of Vaccine Preventable Diseases and Table1. (continued)
Deathsa Hepatitis A
Diptheria Year Cases Reported Deaths
Year Cases Reported Deaths 1966 32859 N/A
1950 5796 410
2011 1139 N/A
2011 0 NA Hepatitis B b

Tetanus Year Cases Reported Deaths

Year Cases Reported Deaths 1966 1497 N/A
1950 486 336 2011 2495 N/A
2011 9 NA CDC¼ Center for Disease Control and Prevention
NA¼ Not available
Pertussis a
Table adapted from reference 3
b
A rapid rise in the number of cases was reported after 1966, following separation
Year Cases Reported Deaths
of Hepatitis B from all cases of Hepatitis and a peak of cases in 1986 of 26,107 is
1950 120,718 1,118 followed by a post vaccine fall in cases to 2,495 by 2011.

2011 15,216 0

Polio
Despite clear benefit, many parents choose not to
vaccinate their children, most often citing the fear of
Year Cases Reported Deaths
the unknown as their motive. In a time when the
1950 33,300 1,904
incidence of VPDs is very low to nonexistent, it is
2011 0 NA easy to see why parents would become distracted by
Measles stories of severe reactions to vaccination. Vaccination
Year Cases Reported Deaths scares propagated by the media and self-serving cli-
1950 319,124 468 nicians have led many parents to choose the risk of
2011 212 NA
infection over the risk of vaccination. This year, 592
cases of measles and 4 college campus mumps out-
Rubella
breaks have been reported across the nation, with
Year Cases Reported Deaths
the majority of these occurring in patients who were
1966 46,975 12
unvaccinated.4,5 Endemic in the US, pertussis cases
2011 4 NA still range from 20,000 to 40,000 cases yearly. However,
Mumps these numbers are dwarfed by the prevaccine rates
Year Cases Reported Deaths of 100,000 to 200,000 cases per year.6 Other than
1968 152,209 25 smallpox, vaccine-preventable diseases remain active
across the globe. When an outbreak of a VPD
2011 370 0
occurs it is frequently due to one unvaccinated
Varicella person. Exposure to infections is an inevitable
Year Cases Reported Deaths consequence of our global economy, thus stressing
1972 164,114 122 the importance of vaccinations domestically and
2011 12,041 NA worldwide.
Haemophilus Understanding the fear some parents have as they
Year Cases Reported Deaths
contemplate vaccinating their child and addressing
1991 2764 17
specific concerns for their child with scientific data is
a reasonable approach to improve immunization rates
2011 3184 NA
in this subgroup. This article aims to characterize the
continued vaccine-hesitant or -resistant parent and assess the

2 The Journal for Nurse Practitioners - JNP Volume 11, Issue 1, January 2015
current research about the relevant perspectives and
practices. Potential answers are presented for
common questions or concerns parents have about
vaccination. The nurse practitioner (NP) can support
long-term efforts to monitor vaccine safety by
reporting (AEs) promptly to the Vaccine Adverse
Event Reporting System (VAERS) of the Center for
Disease Control and Prevention (CDC). The data are
evaluated with an aim to enhance overall post-
marketing surveillance and improve vaccine safety.
WHO IS THE VACCINE-HESITANT/RESISTANT
PARENT?
The sequelae of VPDs, like iron lungs, braces, pa-
ralysis, blindness, deafness, infertility, and death, are a
distant memory for most parents and grandparents in
the US. Many parents are terrorized by fears fueled
by notable celebrities and unscrupulous medical re-
searchers who indict vaccines as the cause of autism,
diabetes, arthritis, and a variety of autoimmune dis-
eases. These loving, but misinformed parents, eager
to protect their children, become hesitant to vacci-
nate and some are even resistant. This behavior has
led to intermittent and serious outbreaks of VPDs
across the country.
About 1% to 2% of parents nationwide absolutely
refuse vaccinations for their children and an addi-
tional 11% to 19% are hesitant or elect to delay
vaccines.7 A number of factors influence these
the decision to vaccinate including: information/
knowledge about the vaccine; past personal or close
family and friend experiences with vaccinations;
perception of vaccine importance; perception
of vaccine risk, including trust in vaccines,
research and development, and regulation; social
pressure/responsibility; and religious and moral
convictions.7,8
Parental acceptance of vaccination ranges from
vaccine-acceptor to vaccine-hesitant to vaccine-
rejector.6 Accepting parents have a high trust in
health-care providers, have their children fully
immunized, and do not offer many concerns about
vaccination.7 Hesitant parents may choose alternate
vaccination schedules or refuse specific vaccines.
These parents tend to cite concerns that their child’s
immune system will become overwhelmed with too
many vaccines or that the side effects, such as pain or
www.npjournal.org
fever, are too great of a risk. They may worry about
severe, very uncommon side effects, such as Guillain-
Barré syndrome, encephalitis, or unsubstantiated
adverse effects, such as autism or autoimmune
diseases like type 1 diabetes. These parents often
predict that their child will recover easily from a
vaccine-preventable disease, even if exposed,
which they feel is unlikely because the rate of
VPDs remains low in the US. Some parents actu-
ally consider it beneficial for their child to contract
a VPD, so they will develop a “safer” natural
immunity.7,8
Parents who chose not to vaccinate (refusal) at
all are hesitant parents on the extreme end of the
spectrum. These parents’ refusal may be entirely
based on religious reasoning as currently seen among
the Amish in the US. Resistant parents may severely
distrust the federal government, specifically regula-
tory agencies or the health-care structure.7 They
fear vaccines because they distrust pharmaceutical
companies.7 They trust homeopathic or naturopathic
practitioners more than classically trained physicians
and nurses.9 They may have misinformation about
adverse reactions to a vaccine, such as death or
seizure. They may even have had personal experience
with a vaccine side effect that was unacceptable or
extreme.7-9 Often these parents’ convictions to not
vaccinate are insurmountable.
Research supports the concept that primary-care
providers can promote acceptance of vaccination in
most hesitant parents. A commonly cited interven-
tion is to build a trustworthy relationship and to be
as transparent as possible with information.7-9 A
trustworthy relationship is built with supportive
open communication that allows hesitant parents an
opportunity to verbalize their specific concerns in a
nonjudgmental environment.
Some health-care providers are also vaccine-
hesitant or -resistant. Like parents, they perceive a
greater risk of vaccines over benefits. Many believe
that vaccinating children denies that child free choice,
whereas others feel that vaccination unnaturally cre-
ates antibody formation, affecting normal self versus
non-self recognition of the immune system; most all
agree that the risks of natural infection are minimal
due to advances in medicine and today’s US health-
care system.
The Journal for Nurse Practitioners - JNP 3
ANSWERING THE DIFFICULT QUESTIONS
Because they are the face on the vaccination
campaign on a daily basis, NPs need to be able to
discuss VPDs; current vaccines available; vaccine
scheduling, including spacing strategies; and any
known common and adverse side effects. In what
follows are common questions or concerns and an-
swers that can be tailored to meet the needs of par-
ents. Links to education tools and further reading are
also provided.
QUESTION: ARE VACCINES TESTED AND MONITORED
FOR SAFETY?
Answer: Yes, every vaccine undergoes stringent re-
view before licensing. The total process from vaccine
concept to licensing can take up to 10 years and,
during this time, the Food and Drug Administration
(FDA) monitors its development every step of the
way. Even after licensing, vaccine safety continues
to be monitored with periodic safety reports and
inspections of vaccine manufacturing sites.
BACKGROUND ABOUT VACCINE DEVELOPMENT, THE
US REGULATORY PROCESS, VACCINE ADVERSE-EVENT
REPORTING, AND DATA ANALYSIS
Food and Drug Administration Regulatory Process
In 1902, Congress passed the Biologics Control Act,
or Virus-Toxin Law, that directed the FDA to
regulate biologics, which was followed in part from
the tragic death of 13 children who inadvertently
received diphtheria antitoxin contaminated with
tetanus spores.9 Under the guidelines of this Act, the
FDA has authority to inspect manufacturing facilities
and batch certification guidelines.9
The US Public Service Act of 1944 mandated that
the federal government issue licenses for biologic
products, including vaccines.10 The pathway to
vaccine licensure is spelled out in the federal code as
the Investigation New Drug (IND) process. In brief,
a prospective clinical study to evaluate a new drug or
biologic is submitted to the FDA.11 The IND process
begins with a sponsor’s intention to investigate a
substance for the prevention or treatment of human
disease. An IND submission package must include
information on all investigators, background on the
drug or biologic, preclinical data (must have evaluable
data of this substance in appropriate preclinical
4 The Journal for Nurse Practitioners - JNP
[animal/primate] model), the clinical study design,
proposed data collection and analysis, chemical and
manufacturing information for the substance, known
safety data in humans, the clinical protocol, and
informed consent/assent. The clinical protocol
should be performed under the review and approval
of an internal or external review board as well as
a data safety and monitoring board.12 The IND
“package” is submitted to the appropriate FDA area
for review, which, in the case of vaccines, is the
Center for Biologics Evaluation and Research
(CBER) and the Division of Vaccine Research
and Review (DVRR).12 The IND review team is
assembled based on the content and complexity of
the proposed clinical trial and vaccine.12,13 Once the
IND is received, the team has 30 days to make its
comments and to meet with the sponsor.13 The IND
team either allows the study to continue, or places
it on “hold,” with stipulations. “Hold” issues are
generally related primarily to concerns for
patient safety.12
INDs usually start with a Phase I clinical study
design, primarily to address safety and tolerability of
a vaccine. The IND can be amended to include Phase
II studies evaluating the immunogenicity of the vac-
cine and giving an estimate of rates of adverse effects.
A Phase III study, critical to licensure, generally enrolls
large numbers of subjects to evaluate risks/benefits of
the proposed vaccine.12 In Phase III, manufacturing
reproducibility is evaluated by checking multiple lots
of vaccine for consistent levels of antigen. 12
Beyond licensure, manufacturers are required to
provide ongoing reports of safety for licensed vac-
cines. These reports may influence current labeling
and use. Another post-licensure safety measure is
manufacturer facility inspection and lot testing.
Except for influenza vaccine, with manufacturing
facilities that are inspected yearly, all other vaccine
manufacturing sites are inspected every 2 years.
Vaccine lot testing is ongoing and includes evaluating
the sterility, purity, and potency of the vaccine.12
POSTMARKETING VACCINE SAFETY TOOLS
After licensure, the FDA can request postmarketing
studies (Phase IV) to evaluate the vaccine further.12
To help capture postmarketing data in general, the
CDC and FDA established the VAERS in 1990.14
Volume 11, Issue 1, January 2015
Unlike directed postmarketing studies, VAERS is a
voluntary system and reporting is open to anyone
(patient, parent-guardian, or clinician) who suspects
that they or someone else has had a vaccine-
related AE.
Any post-vaccination medical concern that the
patient, or his or her family, may have is considered
an AE and is reportable to VAERS.14 Under the
National Childhood Vaccine Injury Act, health-care
workers are mandated by law to report serious AEs
(death, hospitalization, prolonged hospitalization,
disability, or birth defect), as listed in the VAERS’s
“Table of Reportable Events” on the CDC website
(http://vaers.hhs.gov/resources/VAERS_Table_of_
Reportable_Events_Following_Vaccination.pdf).
Another CDC-sponsored safety surveillance tool
was also launched in 1990, the Vaccine Safety
Datalink (VSD).15 The VSD collects data from nine
different sites across the US on vaccination, and other
relevant clinical information to observe the safety
of vaccines. Data from the VSD are correlated with
preeproduct-release safety data and ongoing VAERS
reporting, and can be rapidly dispersed to the public.15
More information about this complicated process,
as just simplified, can be accessed at the FDA website
(http://www.fda.gov), the VSD page (http://www.
cdc.gov/vaccinesafety/activities/vsd.html), or the
VAERS webpage (http://vaers.hhs.gov/resources/
VAERS_Brochure.pdf).
QUESTIONS
1. What are adjuvants and why are they needed in
vaccines?
2. Why does my child’s vaccine contain formal-
dehyde or mercury?
Answers to 1 and 2: Vaccines produce an immune
response to induce immunity to the intended virus or
bacteria. Inactivated vaccines often require a sub-
stance to help bolster the immune response, called
an adjuvant.16 Aluminum in many chemical forms,
when combined with the attenuated virus, produces
a better immune response than the vaccine does
alone.16,17 Aluminum is used, in some form, in
vaccines against human papilloma virus influenza,
hepatitis A, hepatitis B, diphtheria-tetanus-pertussis
(DTaP or Tdap), Hemophilus influenzae type B, and
www.npjournal.org
pneumococcal infection.16,17 There are 60 years of
experience with aluminum as an adjuvant and, to date,
there is no evidence to support a safety concern with
its use.16,17
Attenuating or weakening a virus or bacterial
toxin involves products like formalin or formalde-
hyde. Formaldehyde is a naturally occurring sub-
stance in our body and in our environment.18 The
amount of formaldehyde that can be left in a vaccine
after the many dilutions is still infinitesimal.
It is estimated that a newborn has 50 to 70 times
more formaldehyde naturally in their bodies than is
contained in a single dose of vaccine.18
Thimerasol is a mercury-based preservative used
to prevent contamination of vaccines.19 Based on
concerns that this preservative may contribute to
neurologic disorders such as autism, since 2001 it has
been removed entirely or is found in minute amounts
in multiple-dose influenza vaccines.19
Are There Ingredients in Vaccines I Should Worry
About?
Answer: Many ingredients are involved in the end
product of a vaccine, although, per dose, the volumes
are exceedingly small. If a child has had a severe, life-
threatening allergic response to a type of food, such
as eggs, gelatin, or yeast, or an antibiotic, such as
neomycin, or latex, the child may not be eligible for
some vaccines.
BACKGROUND
Preservative
Thimerasol is an organomercurial and has been used
as a preservative in vaccines since the 1930s.19 It came
under scrutiny in 2001 in an article suggesting that
mercury-poisoned individuals exhibited the same
symptoms as autistic children.20 The Institute of
Medicine (IOM) first studied ethyl mercury in 2001
but could neither accept nor reject a causal relationship
between thimerasol and pervasive developmental
disorders.19 The committee recommended thimerasol
be removed from all childhood vaccines, although
further studies did not support a causal relationship
between thimerasol and autism.19 There is no
evidence that thimerasol leads to pervasive
developmental delay or autism.
The Journal for Nurse Practitioners - JNP 5
Adjuvants
Adjuvants historically have been used to increase
the immunogenicity of a vaccine. Aluminum in salt
form (aluminum hydroxide, aluminum phosphate,
alum [potassium aluminum sulfate], or mixed
aluminum salts) is the only FDA adjuvant in licensed
vaccines.21
Antibiotics
An antibiotic is added to a vaccine to prevent bac-
terial contamination.18 The worry is that adding
antibiotics to a vaccine may increase the risk of an
allergic reaction or anaphylaxis. Antibiotics associated
with severe allergic reactions include sulfonamides,
penicillins, and cephalosporins, and for that reason
the most common antibiotics used in vaccines
are polymyxin B, neomycin, streptomycin, and
gentamycin.18
Vaccine schedule questions:
1. Why are vaccines combined?
2. Will combined vaccines cancel each other out?
3. Will they overwhelm my baby’s immune
system?
4. Can they be given individually or spaced apart
somehow?
Answers to 1-4: Vaccines are combined to ensure
that the child is protected as quickly as possible from
vaccine-related infections. Combination vaccines
have been available since the 1940s and are devel-
oped to limit the number of needle injections a baby
will be given, to ensure protection as soon as possible,
and to overall reduce the cost and inconvenience of
vaccines. Combination vaccines are safe. All combi-
nation vaccines undergo clinical testing for efficacy
and safety before licensing by the FDA. Furthermore,
the FDA often mandates that vaccines be monitored
for safety after licensing and that there is also a
VAERS to help monitor safety.
Babies are exposed to immunologic challenges
immediately at birth. As babies pass through the birth
canal and breathe, they are immediately colonized
with trillions of bacteria, and thus they carry the
bacteria in their bodies but are not infected by them.
A healthy baby’s immune cells are busy making an-
tibodies and will not tire or get overworked by
vaccines. Despite their size, they have very robust
6 The Journal for Nurse Practitioners - JNP
immune systems that can handle and process many
vaccines. In fact, exposure to vaccines produces less of
an immune response the older we get, meaning that
sometimes older people need “stronger” vaccines
than the young.
If one delays or chooses to limit vaccinations for
their child, that child’s risk for acquiring an infec-
tion is increased. The spacing of vaccines has to do
with how the immune system works. Some vaccines
require boosters for full protection. These vaccines
are primarily the ones given very early in life, but
also include the vaccine for measles mumps and
rubella. Once the full series is completed, the child
will be protected for life. The one vaccine that
requires updates throughout life is tetanus and
influenza.
BACKGROUND
Overview of Vaccines
Vaccines are biologics that mimic the infection they
are aimed to prevent and therefore have both ex-
pected and unintended side effects. Today there are
vaccines available to treat 25 viral and bacterial
infections.21,22 These vaccines range from single-
antigen to combination-antigen products. There
are two types of vaccines: live attenuated and
inactivated.22
The majority of live attenuated vaccines are for
viruses. These vaccines are manufactured by modi-
fying a disease-producing organism to produce anti-
gen to stimulate the formation of antibody, without
causing the disease.22 Generally, these vaccines create
a vigorous immune response and are dosed once.
They include measles, mumps, rubella (MMR),
vaccinia (smallpox/monkeypox), varicella zoster,
yellow fever, bacillus Calmette-Guerin (BCG), oral
polio, cholera, rotavirus, typhoid, and intranasal
influenza (BCG, cholera, and oral polio are not
available in the US).22
Inactivated vaccines use a part of an organism for
the immune system to recognize.22 These vaccines
can be whole cell or fractional. They require multiple
vaccinations to achieve adequate immunity. Whole
cell vaccines, such as inactivated polio, hepatitis A,
rabies, and influenza, are inactivated (unable to
replicate) by treatment with heat or formalin.21,22
Volume 11, Issue 1, January 2015
Fractional vaccines are inactivated and then purified
further to contain only the elements desired. These
vaccines are subdivided into subunit, toxoid, and
polysaccharide vaccines.21,22 Subunit vaccines
(hepatitis B, influenza, acellular pertussis, human
papillomavirus, and anthrax) use a part of the viral
protein, and there is no chance for a natural reversion
to disease.21,22 Toxoid vaccines (diphtheria and
tetanus) use the toxins produced by the putative
bacteria after treatment with formalin and are then
adsorbed onto an adjuvant such as alum.28 Conjugating
a bacterial protein with a complex sugar (polysaccharide)
has produced improved vaccines for Hemophilus,
pneumococcus, and meningococcus.21,22
Autism Questions
1. Could my child develop autism from a vaccine?
2. I remember a scientific study about autism and
vaccines, was it true?
3. Did the courts pay a family whose child had
autism from a vaccine?
Answer to question 1: No. There is no study sup-
porting the idea that autism is associated with vacci-
nation. The IOM has reviewed extensively all
published reports about autism and has concluded
that there is no convincing evidence to support that
any vaccine causes autism.
Answer to question 2: A study published in The
Lancet reported a link between the MMR vaccine
and development of an irritable bowel disease and
autism (see next section). Unfortunately, it was later
found that the lead author fabricated information
about his study patients and did so to gain financially.
The author’s motives and unethical behavior came to
light several years after the report was published and
he lost his medical license.
Answer to question 3: Yes, in one case, a family was
compensated when their daughter, who had an un-
derlying genetic disease, received a vaccine and
developed a form of autism. After multiple vaccina-
tions she developed high fevers and brain injury.
Because no one could be certain that she developed
autism due to her genetic disease and not vaccines;
the court decided that vaccination could have
aggravated her genetic disease and that her family
should receive compensation.
www.npjournal.org
BACKGROUND
In February 1998, The Lancet published an article
written by Andrew Wakefield and colleagues that
was the result of a now disputed critical examination
of 12 pediatric/adolescent subjects who were re-
ported to have developed enterocolitis and regressive
autism after MMR vaccination.23 The fallout of this
article and Wakefield’s press conferences thereafter,
was catastrophic. Vaccination rates plummeted and
cases of autism associated with the MMR were
increasingly brought before federal and state agencies.
Calls for Wakefield to replicate his study in larger
numbers were unanswered.24,25 Investigations into
the findings noted discrepancies from onset of
symptoms and receipt of the MMR and claims that
these children had colitis, when in fact they did not.
Moreover, evidence showed he had an unethical
relationship with a lawyer planning to sue the
pharmaceutical companies while he was studying
these children and had created plans to develop
alternative vaccines and genetic tests before his results
were published. In 2004, 10 of his coauthors
retracted the conclusions of his study and, after 12
years of mounting evidence of criminal and ethical
fraud, The Lancet retracted the article entirely.24
The damage was done. Wakefield, whose singular
motive was to make money by cooperating in law-
suits against vaccine makers and by being an entre-
preneur in genetic studies laboratories, had stoked the
anti-vaccination pyre, which drove vaccination rates
down and measles outbreaks up.
VACCINES RISK AND REVIEW OF THE 2011 IOM
REPORT
Research, development, and manufacture of vac-
cines do not net major profits for the pharmaceutical
industry. Thus, the federal government and
academia work closely with the pharmaceutical in-
dustry to promote early-phase development of vac-
cines. Vaccine development was threatened in the
1970s and early 1980s by an overwhelming number
of lawsuits especially related to the DTaP, which
forced many vaccine manufacturers out of the vac-
cine business.26
The US Government, in response, created a
compensatory court, the National Vaccine Injury
The Journal for Nurse Practitioners - JNP 7
Compensation Program, to mediate claims of harm.26 In 2009, in response to the anti-vaccination
The program is funded by a small tax on vaccines. environment, the Health and Resources Services
Diagnosis of autism often occurs around age 2 Administration (HRSA) contracted with the IOM
years and, coincidentally, the MMR vaccine is given to rigorously review AEs commonly cited for 8 of
at around 12 to 18 months. In the absence of a cause the 12 covered vaccines in VAERS (MMR, DTaP,
of autism, the search for the origins of sometimes hepatitis B, meningococcal conjugate virus, varicella,
severely disabling neurodevelopmental disorder led human papillomavirus, and influenza).27
scientists and lay people alike to consider vaccines. In The IOM reviewed 158 AEs reported to be
2002, a special Omnibus Autism Proceeding (OAP), associated with vaccines.27 The IOM reviewers
housed within the US Court of Federal Claims Office mined published studies of the vaccine, assessing
of Special Masters, was created due to of the thousands them for scientific rigor and methodology.27 They
of claims of autism in relation to the MMR.27 The also reviewed case studies, animal and in vitro studies,
OAP consolidated all the cases into theory test cases to as well as the natural history of the diseases.
test: (1) autism’s relation to the MMR with vaccines The IOM reviewers were unable to attribute
containing the preservative thimerasol (an ethyl causality to a large number of AEs associated with the
mercury); or (2) vaccines with thimerasol.27 vaccines they evaluated. The AEs found to have a
The OAP concluded that autism was not associated convincing relationship or a favorable acceptance for
with thimerasol-containing vaccines or the MMR; relationships are listed in Table 2.
however, vaccine manufacturers have since voluntarily Most importantly, the IOM provided clear evi-
removed thimerasol from their products.27 dence that: (1) autism was not associated with the
MMR; (2) type 1 diabetes was not associated with
the MMR or the DTaP; and (3) inactivated influenza
Table 2. IOM conclusions of AE’s and Vaccine Causalitya vaccine was not related to Bell’s palsy or exacerbation
of asthma or reactive airway disease in adults or
Data Favor
children.28
Data Convincingly Acceptance of
Support a Causal a Causal A subsequent review 67 journal articles published
Relationship of Relationship of after the IOM review included vaccines not reviewed
Adverse Event Adverse Event to by the IOM: conjugated pneumococcal vaccine 13;
Vaccine to Vaccine Vaccine rotavirus vaccines; hepatitis A; Hemophilus influenzae
MMR Inclusion-body Transient B; and the inactivated polio vaccine. The review
encephalitis, arthralgia in
anaphylaxis, women and
supported the IOM’s findings of no causal relation-
febrile seizure children ship between the MMR and autism, or type 1 diabetes
and DTaP; however, they did favor a relationship
Hepatitis B Anaphylaxis
between disseminating varicella disease in immuno-
Influenza Anaphylaxis
compromised children.29 With regard to the vaccines
DT-, TT-, and Anaphylaxis not evaluated in the IOM 2011 report, the review
aP-containing (TT only)
vaccines
identified a moderate potential relationship between
the MMR, DTaP, varicella, and hepatitis A and the
Meningococcus Anaphylaxis
development of thrombocytopenic purpura and
Any injected Deltoid bursitis, moderate risk of intussusception in all the rotavirus
vaccine syncope
vaccines.29
Human Anaphylaxis
papillomavirus
THE AUTISM CASE WITH FINANCIAL COMPENSATION
Influenza Oculorespiratory In 2008, the federal government awarded the parents
syndrome
of Hannah Poling $20 million over her lifetime
aP ¼ acellular pertussis; DT ¼ diphtheria toxin; MMR ¼ measles, mumps, rubella;
TT ¼ tetanus toxin.
as compensation due to vaccine-related injuries.30
a
Table adapted IOM report of Adverse Events of Vaccines: Evidence and Causality.28 Hannah was described as a normal interactive,

8 The Journal for Nurse Practitioners - JNP Volume 11, Issue 1, January 2015
communicative child, who was vaccinated with
nine vaccines and soon developed rashes, high
fevers, and swiftly regressed developmentally.30 She
was diagnosed with a mitochondrial disorder.30
Her parents would later bring their daughter’s case
to the Vaccine Injury Compensation Program for
compensation. The court ruled that vaccines
“aggravated” Hannah’s undiagnosed mitochondrial
disorder and may have led to the development of
her symptoms.30 At no point did they indicate that
vaccines were the direct cause of her autism. Studies
of children with autism spectrum disorders have
concluded that some may have mitochondrial
disorders, and that the regressive developmental
deterioration seen in children with autism is identical
to that in patients with mitochondrial diseases.29
Question Natural and Herd Immunity
1. Isn’t it better for my child to get the disease?
2. Could I just rely on herd immunity to protect
my child?
Answer to question 1: Although it is true that
recovering from a vaccine-preventable disease will
provide lifelong immunity, the child could suffer and
may develop serious complications, such as brain
damage, infections, sterility, or paralysis.
Answer to question 2: Herd immunity only works
when everyone gets immunized. Outbreaks of in-
fections occur because of introduction of an infection
to an unvaccinated person, who then spreads it to
other unvaccinated people. Recent significant out-
breaks of measles in 15 states have been attributed to
unvaccinated persons.4
BACKGROUND
Disease Versus Vaccination
Although the debate may continue about what
adverse effect is truly attributable to a vaccine, the
evidence is very clear when it comes to the sequelae
of natural infection. Before the conjugate pneu-
mococcal vaccine became a part of the schedule in
2000, over 17,000 cases of invasive pneumococcal
infections occurred each year in children under
age 5.31 Meningitis occurred in 700 patients, and
at least 200 would die from complications.30
Chickenpox, often treated as an innocuous disease
www.npjournal.org
by anti-vaccination proponents who encourage
chickenpox parties, resulted in 100 deaths per year
before vaccination. Polio resulted in flaccid paralysis
in 1% of its victims and 5% to 10% of these pa-
tients died.31
The eradication of smallpox was due to herd
immunity. A herd requires a substantial number of
immune persons, in this case via vaccination, to
reduce the likelihood that an infected person would
come in contact with a susceptible (nonimmune/
unvaccinated) person(s). The smallpox vaccination
campaign by the World Health Organization began
in 1967.32 The campaign began in endemic countries
in Africa, South America, and Asia, aided by US
funding, a freeze-dried vaccine, and a new bifurcated
needle system. Strategies to vaccinate masses changed
to vaccinating all contacts of an index case. Impeded
by local wars, civil unrest, refugees, and other polit-
ical and social blocks, the campaign ended 10 years
later in Somalia as the last case was seen.32,33
Smallpox was officially declared eradicated at the
33rd conference of the World Health Organization
in 1980.34
CONCLUSIONS
Vaccination accounts for healthier, longer, lives for
all, but especially among infants and children. We as
a society have enjoyed what generations before us
could not—the comfort that we will not be afflicted
by the same childhood diseases that they feared.
There are no substantial data suggesting the AEs
that rarely occur with vaccination outweigh the
remarkable benefits of vaccines. Federal and
nonfederal agencies support vaccination and make
every effort to ensure a safe and efficacious vaccine
supply. Clinicians should continue to make every
effort to ensure proper immunization for their pa-
tients at every visit, and to report known or sus-
pected AEs to the CDC.
AUTHOR’S NOTE
I have a 16-year-old son with autism. His diagnosis
came late at age 12, well after he had completed all
necessary vaccinations. In researching this study, I
gave myself comfort validating what I believed all
along—that vaccinations did not cause my son harm.
The Journal for Nurse Practitioners - JNP 9
LINKS FOR RESOURCES
Common ingredients in US vaccines:
 http://www.fda.gov/BiologicsBloodVaccines/
SafetyAvailability/VaccineSafety/ucm187810
.htm/.
Thimerasol questions and answers:
 http://www.fda.gov/BiologicsBloodVaccines/
Vaccines/QuestionsaboutVaccines/ucm070430.
htm/.
Disease questions and answers from the Immu-
nization Action Coalition:
 http://www.immunize.org/handouts/vaccine
-questions.asp/.
 http://www.historyofvaccines.org/.
Link to government, nongovernment, and con-
sumer sites about vaccines:
 http://www.vaccines.gov/more_info/guide/
index.html/.
Links to educational resources:
 http://www.cdc.gov/vaccines/vac-gen/
default.htm/.
 http://www.cdc.gov/vaccines/vac-gen/safety/
default.htm/.
 http://www.cdc.gov/vaccines/parents/info
graphics/journey-of-child-vaccine.html/.
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1555-4155/14/$ see front matter
© 2015 Elsevier, Inc. All rights reserved.
http://dx.doi.org/10.1016/j.nurpra.2014.10.016
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