This document summarizes information about immunization concerns and separating fact from fiction. It outlines reputable vaccine resources such as the CDC and Immunization Action Coalition websites. It addresses common vaccine concerns like safety, efficacy, and whether vaccines are necessary. It dispels myths such as those linking vaccines to autism. The document was written by Dr. Nancy Kelly from UT Southwestern Medical Center to provide evidence-based information on immunization topics.

1. Immunization Concerns:
Separating Fact from Fiction
Nancy R. Kelly MD, MPH
UT Southwestern Medical Center
Outline
Public health impact of vaccines
Vaccine schedules
School requirements
Vaccine refusal
f
General vaccine concerns
Common vaccine-specific concerns
vaccine-
Reputable and not-so-reputable resources
not-so-
Public Health Impact
Vaccines are one of the greatest success stories
in modern medicine.
1

2. Recommendations
Advisory Committee for
Immunization Practices (ACIP)
Recommendations
Advisory Committee for
Immunization Practices (ACIP)
2

3. Why Do Parents Refuse
Vaccines?
Misperceptions
– Child not susceptible to disease
– Disease not serious
– Vaccines don’t work
– Vaccines not safe
Parents don’t want to do anything that
might harm their child
When Parents Refuse Vaccines
Listen to their specific concerns
Address parental concerns
Provide information from reputable
sources
Know websites and resources parents are
using
Help parents feel their decision to
vaccinate is the right one
3

4. Problems with Vaccine
Refusal
Puts individual child at risk of disease
Puts community at risk of disease
outbreaks
– 95% vaccination rate needed for “herd
immunity”
– Some individuals can’t get vaccinated or don’t
respond to vaccine
General Vaccine Concerns
Concern
“I don’t think vaccines are safe.
How are they tested and
monitored?”
4

5. Vaccine Safety - Licensure
Vaccines must be FDA approved for use
in the US
– Process takes up to 10 years!
– Animal studies
– Human clinical trials
– Review by FDA (studies, vaccine plant
inspection)
– Licensure by FDA
– Monitoring of samples from each vaccine lot
Vaccine Safety - Monitoring
The Vaccine Adverse Event Reporting
System (VAERS)
– National program of CDC and the FDA
– Monitors safety of vaccines after licensure
– Anyone can report a problem after a vaccine
– Method of detecting possible adverse effects
– Doesn’t prove vaccine caused problem
Vaccine Safety - Monitoring
Vaccine Safety Datalink
– Created by CDC
– Partnerships with 8 large HMOs
– Patients’ medical records used to analyze
vaccine related information
– 5.5 million people in WA, OR, CA, CO, MN, MA
– Compare outcomes in vaccinated vs.
unvaccinated children
5

6. Concern
“Vaccines Don’t Work”
If vaccines works so well, then why do
vaccine-
vaccine-preventable diseases occur more
often in vaccinated people than
unvaccinated?
100 college students living in dorm
95 vaccinated 5 not vaccinated
MEASLES OUTBREAK
6/95 (6%) 4/5 (80%)
get measles get measles
Unvaccinated people were 35 x more likely to get
measles than vaccinated (JAMA, July 1999)
JAMA,
6

7. Concern
“ Vaccines aren’t Necessary”
Since almost everyone else is immunized,
and there is not much disease going
around,
around why does my child have to be
immunized?
Concern
“Vaccines aren’t Necessary”
Three good reasons:
– prevalent diseases (ex: pertussis) a child is at
pertussis)
high risk if not vaccinated
– less common diseases still present in
diseases,
environment (ex: measles) outbreaks occur
measles)
when immunization rates decrease.
– diseases eliminated from our country (polio),
(polio),
outbreaks still occur in other countries and
can cause disease in the US given increased
international travel.
Concern
“Babies are Too Young to Get
Vaccinated”
I would rather wait until my baby gets older
and stronger to give him his
immunizations.
immunizations
7

8. Concern
“Babies are Too Young to Get
Vaccinated”
Infants are vaccinated to protect them
from disease when they are most
susceptible
tibl
– Pertussis – infects 8000/yr and kills 5-10 in
5-
the US, most under 1 year of age
– Children < 2 at greatest risk for Haemophilus
influenza B (Hib) infection
Concern
“Is it Better to be Naturally Infected
than Immunized?”
Wouldn’t it be better for my child just to get
natural disease rather than the vaccination
and then have better immunity against that
disease?
Concern
“Is it Better to be Naturally Infected
than Immunized?”
Natural infection causes better immunity than
vaccination (exceptions: Hib, pneumococcal and
tetanus)
Vaccines require several doses
Trade off for better immunity is risk of morbidity
from natural infection
– paralysis from polio
– mental retardation from Hib
– liver failure from hepatitis B
– deafness from mumps
– pneumonia from Varicella
8

9. Concern
Illness and Vaccination
My child has a cold and I don’t think she
should get her vaccinations today.
Concern
Illness and Vaccination
Mild illness NOT a contraindication to
getting vaccines
– Represents a missed vaccine opportunity
– No increased risk of adverse effects
– No evidence of decreased immune response
Moderate or severe illness, with or without
fever is reason to delay vaccines
– Evolving signs of illness may be confused
with an adverse reaction to vaccine
Concern
“Should I Use an ‘Alternate’ or
‘Selective’ Immunization Schedule?”
Alternate schedules - Delay vaccines
Selective schedules – Defer some vaccines
No evidence that vaccines given at age <2
years are harmful to recipient
Some of most serious childhood illnesses
attack children < 2 years
No evidence that giving multiple vaccines
at one time is harmful
9

10. Vaccine-
Vaccine-Specific Concerns
What vaccine should be given to this
newborn baby prior to discharge from the
hospital?
10

11. Concern
“If I don’t have Hepatitis B, why
should I immunize my baby at birth?
She will not be sexually active for
y
years.”
Hepatitis B
Hepatitis B
– Virus transmitted via blood or body fluids
– causes liver disease
Person-to-
Person-to-person spread can occur with
close non-sexual contact
non-
– Virus can survive in environment >1 week
– Transmission can occur by sharing
washcloths, razors, toothbrushes
– Some people with hepatitis B don’t have
symptoms but still can spread disease
A healthy 2 month old girl is seen at the local
health department for her vaccinations. She
received hepatitis B vaccine at birth.
What immunizations does she need today?
11

12. Concern
“I don’t want my baby to get
rotavirus vaccine. I heard it causes
bloody diarrhea”
Rotavirus
– Causes vomiting and diarrhea
– Risk of dehydration in young
Intussusception – a condition in which one
portion of the intestine telescopes into a nearby
portion causing intestinal obstruction
Concern
Rotavirus Vaccine & Intussusception
Rotashield® rotavirus vaccine tested in 10,054
children before licensed in 1998
Vaccine given to 1 million children (1998-1999)
(1998-
15 cases of intussusception in infants after
receipt of vaccine reported to VAERS
Vaccine attributable risk ~ 1/11,000
Rotashield® taken off the market in 1999
Example of how VAERS surveillance works
12

13. New Rotavirus Vaccine
RotaTeq®
– licensed in 2006
– Pre-licensure clinical trial >70,000 infants
Pre-
– Post-licensure studies - NO increased risk of
Post-
intussusception
– Decreased need for hospitalization or ED visit by
85%
Another New Rotavirus
Vaccine
Rotarix®
– licensed in 2008
– Requires only 2 doses
– Recent data from studies in Mexico suggest
slight increased risk of intussusception after 1st
dose (1/100,000)
– Risk of serious rotavirus disease > risk of
intussusception
– Vaccine label changed to reflect slight increased
risk
Concern
“I don’t want to get the flu shot
because it will make me sick.”
Can the flu shot cause the flu in otherwise
healthy individuals?
NO!
13

14. Influenza Vaccine
Influenza
– Contagious seasonal viral respiratory infection
Two Immunization Methods
– Injection
Inactivated trivalent influenza vaccine (TIV)
contains only non-infectious virus
non-
– Nasal Spray
Live attenuated influenza vaccine (LAIV)
weakened virus can’t replicate in the lungs
Influenza Vaccine
Is it possible to get the flu if you
received an influenza vaccine?
YES !
Vaccine strains may not match circulating
viral strains
Individuals may not mount adequate
immune response
Takes ~ 2 weeks to mount a response
A healthy 11 year old girl comes to the health
department for her vaccines. She has had
all the recommended vaccines through age
4 years.
What vaccines does she need today?
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15. Concern
“I heard the Meningococcal Vaccine
Causes Guillain-Barre”
Guillain-
Meningococcemia
– Bacteria causes blood infection or meningitis
– A risk
At i k
– Children with immune-deficiencies
– Healthy children < 1 yr and adolescents 15-18 yrs
– Freshman living in college dorms
– Recommendations
– MCV4 vaccine for healthy 11-12 year olds
– Booster dose at 16 yrs
What is Guillain-Barre?
Guillain-
Guillain-Barré
Guillain-Barré Syndrome (GBS) - disorder
involving inflammatory de-myelination
de-
of peripheral nerves, characterized by the
progressive, symmetrical weakness
15

16. Concern
Meningococcemia Vaccine and
Guillan-
Guillan-Barre
February 2008, > 15 million doses MCV4
distributed.
p
VAERS reports - 26 cases of GBS within 6 wks of
vaccination
Initial data - possible small increased risk of GBS
Warning added to vaccine information statement
Further research - 1.4 million patients studied and
NO cases of GBS within 6 wks of vaccination
warning about GBS removed
Concern
“I don’t want my child to get the
MMR vaccine because I heard it
causes autism”
MMR Vaccine
Measles
– Contagious respiratory infection
– 1/20 may develop pneumonia
– 1/1000 may die
Mumps
– Respiratory virus causing fever and swollen salivary
glands
– Can cause orchitis in older males, encephalitis
Rubella
– Usually mild illness (fever and rash) in children
– Can cause birth defects if pregnant woman infected
16

17. Concern
“Does MMR Cause Autism?”
“Wakefield Study”
– Andrew Wakefield, British gastroenterologist
– Published in Lancet, 1998
– suggested a connection between MMR
vaccine, gastrointestinal symptoms, and autism
– Study of 12 children with developmental delay
(8 with autism)
Wakefield Study Flaws
Very small sample size
No control group
– Should study prevalence of autism in
vaccinated vs. unvaccinated children
Possible bias in data collection
– Endoscopic and neuropsychological
assessments not blinded
– Data not collected systematically or
completely
Wakefield Study
In 2004, 10 of the 13 authors retracted the
study’s interpretation
In February 2010, Lancet retracted the
manuscript
In January 2011, British Medical Journal
claimed study was fraudulent
17

18. The Lancet Retraction
Study Found to be Fraudulent
The Damage…
Vaccination rates dropped
80% in UK in 2003-2004 (95% needed for
2003-
herd immunity)
Measles epidemic in England and Wales
in 2008
Parental mistrust in vaccines
Resources spent on this rather than
finding true cause of autism
Mistrust in medical community
18

19. Why Did Parents Believe
This?
Study in literature must be true
Signs of autism appear around the same
time children receive the MMR vaccine -
misinterpreted as causal relationship
i i t t d l l ti hi
The cause of autism is unknown
MMR was something to blame
Media coverage /TV shows/celebrity
testimonials
Re: Airing of television show “Eli Stone” in early 2008
No Evidence that
MMR Causes Autism
Numerous larger studies (> 23) found NO
association between MMR vaccine and
autism
1 year birthday video study - signs of
autism present prior to MMR
In 2004, Institute of Medicine (IOM)
concluded no association between MMR
vaccine and autism
19

20. Reputable and
Not-so-
Not-so-Reputable
Immunization Resources
I i ti R
20

21. Reputable Vaccine Resources
www.cdc.gov Centers for Disease Control
www.immunize.org Immunization Action Coalition
1-800-CDC-INFO
800-CDC- Telephone advice re: vaccines
nipinfo@cdc.gov Email for vaccine questions
www.cispimmunize.org Childhood Immunization
Support Program
www.hhs.gov/nvpo
www hhs gov/nvpo National Vaccine Program
Office
www.immunizationinfo.org National Network for
Immunization Information
(NNii)
www.michigan.gov/mdch MI school shot requirements
www.dshs.state.tx.us TX school shot requirements
Myers MG, Pineda D. “Do Vaccines Cause That? A Guide for
“Do
Evaluating Vaccine Safety Concerns” 2008
Concerns”
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