Vaccine Safety and Vaccine Safety Communication

1. Vaccine Safety and Vaccine Safety Communication

Otherwise Known as
The Vaccine Wars

2. Objectives

List some of the events that led to the current
climate of vaccine safety concern
Describe factors that contribute to parental
concerns about vaccines
Develop talking points to address common
myths about vaccine safety
Develop answers to the question-What is
wrong with an alternative vaccine schedule?

3.

Vaccination is
the top Public
Health
achievement of
the 20th
Century
MMWR 1999; 48:241

4.

CDC, Epidemiology and Prevention of Vaccine-Preventable Diseases, 9th ed., 2006

5. Vaccine-Preventable Diseases: Baseline 20th Century & Current Morbidity

Vaccine-Preventable Diseases:
Baseline 20th Century & Current Morbidity
Disease
Smallpox
Diphtheria
Measles
Mumps
Pertussis
Polio (par.)
Rubella
CRS
Tetanus
Hib
Number of Cases
Baseline
2010*
48,164
0
175,885
0
503,282
57
152,209
2,528
147,271 21,291
16,316
0
47,745
6
823
0
1,314
8
20,000
16
*provisional
% Decrease
100.00
100.00
99.99
98.34
85.54
100.00
99.99
100.00
98.39
99.92
MMWR 1999;48:245, 2011;59:1700

6.

7. The Things You Hear…

Are vaccines safe?
Vaccines and autism
MMR
Thimerosal
Other vaccine ingredients
Vaccines in general
Too many vaccines overwhelm the immune
system
Diseases no longer exist—or aren’t that
dangerous
It is all a giant money-fueled conspiracy
Individual rights vs. public health needs

8. Parental Vaccine Safety Concerns

100
Percent
75
50
25
0
serious adverse
effects concerns
cause autism
Parental Belief
Freed et al, Pediatr 2010;125:654
refused
recommended
vaccine

9. Parents: Doubts About Vaccines

Gust et al Pediatr 2009;122:718

10. Why Parents Who Planned To Delay/Refuse Vaccine Changed Their Minds

Gust et al Pediatr 2009;122:718

11. How did we get here?

12. Real Vaccine Risks

1950-1980’s: Whole cell DTP vaccine
1976: Guillain-Barré from influenza vaccine
1980’s: OPV causing paralysis despite no
cases of polio
1990’s: intussusception from rotavirus
vaccine

13. How have we dealt with real vaccine risks?

14. Responses to real vaccination risks and problems

Elimination of killed measles vaccine
Transition from plasma derived Hep B
vaccine to recombinant Hep B vaccine
Transition from DTP to DTaP (Some
countries suspended pertussis immunization)
Transition from OPV to IPV
Withdrawal of first rotavirus vaccine

15.

16. Will H1N1 Influenza Vaccine Cause Guillain-Barre Syndrome?

17. H1N1 Influenza Vaccine Safety

Closely monitored by CDC and National Vaccine
Program Office
Multiple large population databases scoured for
adverse events related to H1N1 vaccine
Vaccine Safety Datalink
VA Health System and Dept. of Defense
PRISM Health Plan/Immunization Registry link
Indian Health Service
Emerging Infections Program
More than 10 million post-H1N1 vaccination lives
under observation

18.

19. 1998-99: The Vaccine Safety Concern 1-2 Punch

20. Wakefield History

Wakefield, A.J., et al. Lancet 351: 637-641, 1998

21. Thimerosal-the beginning

MMWR 1999; 48 (26):564-566

22. Wakefield …and the rest of the story

Findings never reproduced
Wakefield had serious financial conflicts
Co-authors withdraw from paper
Paper retracted from Lancet
Hearings held by British Health Authorities
Wakefield sanctioned and license revoked
The details of ”an elaborate fraud” published in the
British Medical Journal

23.

24. Thimerosal history

Mercury content of recommended vaccines
reviewed
Recommendation to reduce mercury
exposure
Delay in Hepatitis B vaccination of newborns
to minimize mercury exposure
Once MMR couldn’t be targeted as a cause
of autism, thimerosal became an attractive
target

25. Factors that have increased concern

Distrust
Industry
Government
Doctors
Uncertainty
Rapid increase in the number of vaccines
Rapid increase in the number of autism cases
Internet/Media/Celebrities

26. Know Your Source

27.

28. What has been the effect?

Falsehood flies, and the truth comes
limping after; so that when men
come to be undeceived, it is too
late: the jest is over and the tale has
had its effect
Jonathan Swift, The Examiner Nov. 9, 1710

29.

Permanent Medical Exemptions & Personal Beliefs
Exemptions, Kindergarten Students, California
Lee et al NVIC 2010

30.

30

31.

Kindergarten PBEs by County
2000
2008
Lee et al NVIC 2010

32.

33. San Diego Measles Outbreak 2008

Physician Office
Charter School
<12 months old
2º Transmission

34. Other Measles Outbreaks in the U.S.-2008

131 cases from Jan-June 2008 (Average cases
=63 annually 2000-2007)
Washington outbreak (n=19) included 16 schoolaged children-all unimmunized
Illinois outbreak (n=30) included 25 school-aged
children-all unimmunized
Altogether 91% of cases were unimmunized
89% related to imported cases
MMWR 2008; 57:893

35.

36. …and in 2011

Measles outbreak in Minnesota centered in
Somali population
Measles in Utah
Measles in Arizona
Large mumps outbreak in New Jersey 2010
California pertussis outbreak-10 deaths
MMWR, 2011; 60(20):666-668
MMWR 2010;59:125-129

37. Individual Risk of Exemption - Pertussis

Individual Risk of Exemption Pertussis
Age Group
Rate per
100,000
exemptors
Rate per
100,000
vaccinated
Relative Risk
(95% CI)
3- 5
191
11
17 (9 - 31)
6-10
142
9.4
15 (9 - 25)
11-14
35
19
1.9 (0.8 - 5)
15 -18
0
13
0 (0 - 2)
3 -18
80
13
5.9 (4 - 8)
Feikin, JAMA, 2001;284:3145

38.

Refused pertussis vaccination
• 22.8 times increased risk of pertussis

39.

Refused varicella vaccination
– 8.6 times increased risk of varicella

40. Other Vaccine Components and Autism It ain’t over ‘til the fat lady sings…

Aluminum
Bovine serum albumen
Adjuvants
Yeast proteins
Human cell line derivatives
…………………..

41. How Can You Respond

42. How can you respond?

Are vaccines safe?
Do vaccines cause autism?
Aren’t we overwhelming the immune
system?
Isn’t natural immunity better?
Diseases no longer exist—or aren’t that
dangerous
It is all a giant money-fueled conspiracy
It’s my right to decide what’s best for my
child

43. Parental Immunization Refusal

Listen carefully to concerns
– encourage questions
Discuss known risks and benefits
– risks to unimmunized child
Concerns about specific vaccines
– discuss
– administer other vaccines
Multiple injection concerns
– modify schedule
Revisit discussion in future visits
Document

44. Vaccine Safety Discussion Strategies

Empathize: acknowledge that there are
many conflicting messages in the media
Assess level of scientific evidence
desired
Maximize benefits to their child
– not a public health discussion
– vaccines provide protection
– risk of disease for omitted vaccines
Use personal stories
Provide appropriate resources
– e.g., CDC, AAP, NNII, CHOP

45. The Vaccine Safety Infrastructure

46. Vaccines are Safe Talking Points

Hundreds of millions of vaccines are given every
year in U.S. with no problem
Billions of vaccines are given in the world every
year with no problem
Vaccine safety infrastructure is large
VAERS
VSD
CISA
FDA
CDC

47. Sample Sizes Needed During Clinical Trials to Detect Increases in Rates of Rare Vaccine Adverse Events

Rates of Event (%)
Sample Size*
No. Potentially Affected
Annually1
0.1 vs. 0.2
50,000
4,000
0.1 vs. 0.3
17,500
8,000
0.05 vs. 0.1
100,000
2,000
0.01 vs. 0.02
500,000
400
0.01 vs. 0.03
175,000
800
* Two-arm, power=80%, alpha (2 sided)=5%
1 If the entire birth cohort (approx. 4 million children) received the vaccine each year
Adapted from Ellenberg SS: Safety considerations for new vaccine development. Pharmacoepidemiol Drug
Safety 10(5):411-5, 2001

48. Vaccine Adverse Events Reporting System (VAERS)

National post-licensure safety
surveillance system jointly operated
by CDC and FDA
Spontaneous reporting system in
existence since 1990
– reports submitted by clinicians,
manufacturers, patients/parents and
others
Subject to well-described limitations
of passive surveillance

49. VAERS

Advantages
covers US population
permits monitoring for known adverse
events
detects signals for previously
unrecognized/rare adverse events
generates hypothesis
Limitations
risk of underreporting or over reporting
incomplete data
lack of availability of denominator data

50.

51. VAERS

Advantages
– covers US population
– permits monitoring for known adverse
events
– detects signals for previously unrecognized
/rare adverse events
– generates hypothesis
Limitations
– risk of underreporting or overreporting
– incomplete data
– lack of availability of denominator data

52. VAERS HPV Data: Venous Thromboembolism

Total reports: 65; US reports: 41
– Pending evaluation: 6; Unable to follow-up or “no case”:
17
– Confirmed cases: 18
» Hormonal contraception current use (n=14)
• 12 cases – Oral Contraceptive Pills
• 2 cases on Nuvaring (increase risk of clots)
• Some have additional risk factors
» No hormonal contraception use (n=4)
• 1 case of pregnancy
• 1 case obesity, smoking, truck driver
• 1 case long bus ride preceded to the VTE onset
• 1 case had no reported risk factors

53. Vaccine Safety Datalink (VSD)

Collaboration between CDC and 8 managed care organizations
Data from 8.8 million members captured annually (3% of US population)
Group Health
Cooperative
Northwest Kaiser
Permanente
HealthPartners
Marshfield Clinic
No. CA Kaiser
Permanente
So. CA Kaiser
Permanente
Kaiser Permanente
Colorado
CDC
Harvard
Pilgrim

54.

Rapid Cycle Analysis, VSD
Exposure
window (days) Medical Setting
Outcome
Signal?
Guillain Barré Syndrome
(GBS)
1 to 42
All
NO
Seizures
0 to 42
Inpatient, ED
NO
Syncope
0
All
NO
Appendicitis
0 to 42
Inpatient, ED
NO
Stroke
0 to 42
Inpatient, ED
NO
Venous
Thromboembolism (VTE)
1 to 42
All
NO
Anaphylaxis
0 to 2
All
NO
Other Allergic rxns
0 to 2*
All
NO

55. Examples of VSD studies

Risk of seizures following pertussis
and MMR vaccines
Risk of inflammatory bowel disease
after measles-containing vaccines
Febrile seizures after MMRV and
influenza vaccines
Guillain-Barre syndrome after H1N1
influenza vaccine

56. Institute of Medicine Safety Reviews

MMR Vaccine and Autism
Multiple Immunizations and Immune
Dysfunction
Vaccines and SIDS
Thimerosal and Neurodevelopmental
Disorders
HBV Vaccine and Demyelination
Vaccines and autism
Influenza vaccine and neurological
complications

57. Clinical Immunization Safety Assessment Network (CISA)

6 centers established to review
vaccine safety
– Northern CA Kaiser, Columbia, Johns
Hopkins, Vanderbilt, Stanford, Boston
University
Investigate immunologic, pathologic
and genetic mechanisms of possible
vaccine related adverse events
Provide consultation to providers
regarding vaccine adverse events

58. Talking Points on Vaccine Safety Issues

59. Know Your Source Talking Points

Majority of sites found on an Internet search of
“Vaccines” are anti-vaccine sites
NNII site provides tips on how to evaluate the
credibility of Web sites
http://www.immunizationinfo.org
How to identify a credible web site
Scientific studies cited and are current
Lack of financial conflict of interest (selling a book)
Experience in field
Lack of anecdotes

60. Vaccine Safety Information

Parents Level of Trust: Websites
100
%
75
A lot
Not at all
Some
Do not use
50
25
0
Freed et al Pediatr 2011;127:S107
Source

61. Vaccines and Autism

62. What we know about vaccines and autism

Wakefield retraction
Danish study
California study
Recent studies
Causes of autism
Heritability
Early recognition
Changes that had to occur in utero

63.

64.

65.

66. Thimerosal and Neuropsychological Function

1047 children 7-10 years of age
Formal neuropsychological testing
Correlated outcome with thimerosal exposure
No evidence for a link between thimerosal exposure
and neuropsychological functioning
Thompson WW, NEJM 2007;357:1281

67. 2008 California Study

Schechter R, Arch Gen Psych 2008:65:19-24

68. What we know about autism

Highly heritable (more than breast cancer)
Behavioral changes of autism often present
before 1 year of age
Autism associated with an increase in the
number of neurons (i.e. insult occurs in utero)
Ongoing studies specifically looking at risk of
vaccines: none identified
Autism hasn’t gone away despite thimerosal
being taken out of vaccines
Rates of autism may not be any different now
than they were 40 years ago
Arch Gen Psychiatry 2011;68:459-465
J Peds 2011, April 19 epub

69. Aluminum Concerns

Aluminum in vaccines
– adjuvant
– maximum amount 0.85 mg/dose
Aluminum exposure
– deodorant
– food
» adults average 7-9 mg/day
200 mg in antacids
– breast milk
» 0.04 mg/L
– formula
» 0.225 mg/L

70. Aluminum Exposure: 1st 6 Months of Life

120
Milligrams
100
80
60
40
20
0
Breast Milk
Formula
Soy Formula
Vaccines
Source
Robison et al NIC 2008

71. Do vaccines overwhelm the Immune System?

Your immune system responds to
hundreds of things every day
There is no evidence that children
get more infections right after they
are immunized
Clinical trials test multiple vaccines
Increased vaccine purity

72.

1900
Vaccine
Smallpox
1960
Antigens Vaccine
~200 Smallpox
1980
Antigens Vaccine
~200 Diphtheria
2011
Antigens Vaccine
1 Diphtheria
1
Diphtheria
1 Tetanus
1 Tetanus
1
Tetanus
1 Pert-WC
~3000 Pert-AC
2-5
15 Polio
15
10 Measles
10
Mumps
9 Mumps
9
Rubella
5 Rubella
5
Hib
2
Pert-WC
Polio
~3000 Polio
15 Measles
Varicella
69
PCV
14
Hepatitis B
Hepatitis A
MCV
RV
HPV
Influenza*
Total
Antigens
~200 Total
Offit et al, Pediatrics 2002;109:124
~3217 Total
~3041 Total
1
1
4
2-7
4
6-114
142-258
*Influenza yearly, new strains every year

73. Is natural immunity better?

For some infections natural immunity is “better” because it
lasts longer
Natural immunity is not complete
• whooping cough, rotavirus
• Multiple types of some disease agents
(Pneumococcus, influenza)
Natural immunity is only better if you survive the illness
without serious consequences
Natural immunity comes at a price
deafness, brain damage, hospitalization, pneumonia,
paralysis, permanent scars

74. Diseases Are Not That Bad

Prior to the availability of pneumococcal vaccine
there were 200 deaths/year from this disease
Out of the 5 cases of Hib reported last year in
Minnesota, one died
San Diego measles outbreak-out of 12 cases,
one hospitalized
Quote your own experience….

75. Parents’ Choice vs. the “Greater Good”

Not vaccinating puts your child at
risk
Not vaccinating your child also
puts others at risk
3 innocent bystanders infected
during San Diego measles
outbreak

76. Personal beliefs about immunization are affecting people who do not share those beliefs

77. You can’t hide in the herd

Herd immunity is very
important
Elimination of H. flu disease
Decrease in influenza and
pneumococcal disease in
elderly because of pediatric
immunization
Drop in Hepatitis A disease in
California
But, you can’t hide in the herd,
especially if your herd thinks like
you do

78.

California
Immunization
Coalition materials
http://www.immunizeca.org

79. What about alternative vaccine schedules?

80. What about the Sears schedule?

81. The Sears Schedule

Based on the premise that it is better to
spread out vaccines
Based on Dr. Sears’ opinion about what
diseases are dangerous and what diseases a
child is likely to encounter
Based on the assumption that aluminum in
vaccines causes a problem
Based on the premise that as long as enough
people don’t follow the schedule, herd
immunity will be maintained

82. What’s Wrong with Alternative Vaccine Schedules?

83. What’s Wrong With Alternative Immunization Schedules?

There is no scientific basis for them
They leave children at risk for disease
They leave our community at risk for
outbreaks, including among those who are
immunized
They increase healthcare costs

84. Being Unimmunized Leaves You at Risk Talking Points

The unimmunized are at increased risk to
develop disease and expose others
All of the measles cases in San Diego in
2008 were unimmunized
3 of them were too young to be immunized
and were exposed in a doctor’s office
Unimmunized children are at increased risk
for pertussis, mumps, chickenpox in schools

85. The Details of What’s Wrong With Alternative Vaccine Schedules

86. Sears Message #1 Doctors don’t understand vaccines

Possible Responses
Find a doctor you trust
Doctor’s do not blindly follow anyone’s
recommendations
CDC, ACIP, and the AAP Committee on
Infectious Disease have experts in public health,
infectious disease, and pediatrics whose job it is
to gather and interpret ALL of the data

87. Sears Message #2 You Can’t Trust CDC, AAP, your doctor

Possible Responses
What motive does your individual physician
have to recommend vaccines if they don’t
believe in them?
Why do you trust your doctor when they
recommend drugs or surgery?
Show me a report that people at CDC make
money from pharmaceutical companies

88. Sears Message #3 Diseases Are Not That Bad

Possible Responses
Over 400 children died in the U.S. from H1N1
influenza
At least 10% of people with meningococcal
disease die
San Diego measles outbreak-out of 12 cases,
one hospitalized
“I just took care of a patient with…..”

89. Sears Message #4 Hide in the Herd

Possible Responses
Everyone else is NOT immunized
It depends on what herd you are in- a partially
immunized herd is a dangerous herd
5 cases of Hib reported this week in Minnesota
suggesting that herd immunity is waning
You will be thrown out of the herd (quarantined)
if an outbreak occurs

90. Sears Message #5 Natural Infection is Better

Possible Responses
Natural immunity comes at a cost-death,
deafness, mental retardation, paralysis, chronic
hepatitis
Natural immunity doesn’t work for many
diseases because there are so many types
You are taking a chance with letting your child
develop natural immunity

91. Why Should I Put My Child At Risk For The Greater Good? Talking Points

Because you are actually putting your child at
risk by not having them immunized.
Measles exemptors: 35x increased risk
Pertussis exemptors: 5.9x increased risk
When you or your child are not immunized,
you put others at risk: measles in San Diego
None of us want to see a resurgence of the
diseases we have largely eliminated

92.

California
Immunization
Coalition materials
http://immunizeca.org

93. Information for Health-Care Professionals

NNII (www.immunizationinfo.org)
VEC (www.vaccine.chop.edu)
IAC (www.immunize.org)
CDC/NIP (www.cdc.gov/nip)
AAP (www.aap.org)
AAFP (www.aafp.org/)
IVS (www.vaccinesafety.edu)
Vaccine Page (www.vaccines.org)
Every Child by Two (www.ecbt.org)