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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?
% 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
Are vaccines safe? Vaccines and autism MMR Thimerosal Other vaccine ingredients Vaccines in general Too many vaccines overwhelm the immune system Diseases no longer existor arent that dangerous It is all a giant money-fueled conspiracy Individual rights vs. public health needs
75
Percent
50
25
Parental Belief
Freed et al, Pediatr 2010;125:654
Wakefield History
Thimerosal-the beginning
Mercury content of recommended vaccines reviewed Recommendation to reduce mercury exposure Delay in Hepatitis B vaccination of newborns to minimize mercury exposure Once MMR couldnt be targeted as a cause of autism, thimerosal became an attractive target
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
Permanent Medical Exemptions & Personal Beliefs Exemptions, Kindergarten Students, California
30
Charter School
2 Transmission
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
3- 5
6-10
11-14
15 -18
3 -18
0
80
13
13
0 (0 - 2)
5.9 (4 - 8)
Are vaccines safe? Do vaccines cause autism? Arent we overwhelming the immune system? Isnt natural immunity better? Diseases no longer existor arent that dangerous It is all a giant money-fueled conspiracy Its my right to decide whats best for my child
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
Sample Sizes Needed During Clinical Trials to Detect Increases in Rates of Rare Vaccine Adverse Events
Rates of Event (%)
0.1 vs. 0.2
Sample Size*
50,000
17,500
100,000 500,000 175,000
8,000
2,000 400 800
* 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
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
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
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
Marshfield Clinic
Harvard Pilgrim
CDC
Outcome
Guillain Barr Syndrome (GBS)
Signal?
NO
Seizures
Syncope Appendicitis
0 to 42
0 0 to 42
Inpatient, ED
All Inpatient, ED
NO
NO NO
Stroke
Venous Thromboembolism (VTE) Anaphylaxis Other Allergic rxns
0 to 42
Inpatient, ED
NO
1 to 42 0 to 2 0 to 2*
NO NO NO
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
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
Investigate immunologic, pathologic and genetic mechanisms of possible vaccine related adverse events Provide consultation to providers regarding vaccine adverse events
75
50
25
Source
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
Milligrams
80
60
40 20 0 Breast Milk Formula Soy Formula Vaccines
Source
Robison et al NIC 2008
1900
1960
1980
2011
Vaccine
Smallpox
Antigens Vaccine
~200 Smallpox Diphtheria Tetanus Pert-WC Polio
Antigens Vaccine
~200 Diphtheria 1 Tetanus 1 Pert-WC ~3000 Polio 15 Measles Mumps Rubella
Antigens Vaccine
1 Diphtheria 1 Tetanus ~3000 Pert-AC 15 Polio 10 Measles 9 Mumps 5 Rubella Hib Varicella PCV Hepatitis B Hepatitis A MCV RV HPV Influenza*
Antigens
1 1 2-5 15 10 9 5 2 69 14 1 1 4 2-7 4 6-114 142-258
Total
~200 Total
~3217 Total
~3041 Total
Personal beliefs about immunization are affecting people who do not share those beliefs
http://www.immunizeca.org
Sears Message #3
Sears Message #4
Sears Message #5
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
http://immunizeca.org