Vaccine Safety and Vaccine Safety Communication Otherwise Known as The Vaccine Wars
Jan 13, 2016
Vaccine Safety and Vaccine Safety Communication
Otherwise Known as The Vaccine Wars
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?
Vaccination is the top Public
Health achievement of
the 20th Century
MMWR 1999; 48:241
CDC, Epidemiology and Prevention of Vaccine-Preventable Diseases, 9th ed., 2006
Vaccine-Preventable Diseases:Baseline 20th Century & Current Morbidity
Number of Cases Disease Baseline 2010* % Decrease Smallpox 48,164 0 100.00 Diphtheria 175,885 0 100.00 Measles 503,282 57 99.99 Mumps 152,209 2,528 98.34 Pertussis 147,271 21,291 85.54 Polio (par.) 16,316 0 100.00 Rubella 47,745 6 99.99 CRS 823 0 100.00 Tetanus 1,314 8 98.39 Hib 20,000 16 99.92
MMWR 1999;48:245, 2011;59:1700*provisional
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
Parental Vaccine Safety Concerns
Freed et al, Pediatr 2010;125:654
Parents: Doubts About Vaccines
Gust et al Pediatr 2009;122:718
Why Parents Who Planned To Delay/Refuse Vaccine Changed Their Minds
Gust et al Pediatr 2009;122:718
How did we get here?
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
How have we dealt with real vaccine risks?
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
Will H1N1 Influenza Vaccine Cause Guillain-Barre
Syndrome?
H1N1 Influenza Vaccine Safety
Closely monitored by CDC and National Vaccine Program Office
Multiple large population databases scoured for adverse events related to H1N1 vaccineVaccine Safety DatalinkVA Health System and Dept. of DefensePRISM Health Plan/Immunization Registry link Indian Health ServiceEmerging Infections Program
More than 10 million post-H1N1 vaccination lives under observation
1998-99: The Vaccine Safety Concern 1-2 Punch
Wakefield, A.J., et al. Lancet 351: 637-641, 1998
Wakefield History
Thimerosal-the beginning
MMWR 1999; 48 (26):564-566
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
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
Factors that have increased concern
DistrustIndustryGovernmentDoctors
Uncertainty Rapid increase in the number of vaccines Rapid increase in the number of autism
cases Internet/Media/Celebrities
Know Your Source
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
Lee et al NVIC 2010
Permanent Medical Exemptions & Personal Beliefs Exemptions, Kindergarten Students, California
30
2008
Lee et al NVIC 2010
Kindergarten PBEs by County2000
<1
2 m
on
ths
old
San Diego Measles Outbreak 2008
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 school-aged 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
…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):666-668MMWR 2010;59:125-129
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
Refused pertussis vaccination• 22.8 times increased risk of pertussis
Refused varicella vaccination– 8.6 times increased risk of varicella
Other Vaccine Components and AutismIt ain’t over ‘til the fat lady sings…
AluminumBovine serum albumenAdjuvantsYeast proteinsHuman cell line derivatives…………………..
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
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
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
The Vaccine Safety Infrastructure
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 largeVAERSVSDCISAFDACDC
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
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
VAERS Advantages
covers US populationpermits monitoring for known adverse
eventsdetects signals for previously
unrecognized/rare adverse eventsgenerates hypothesis
Limitationsrisk of underreporting or over reportingincomplete 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
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
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
No. CA Kaiser Permanente
So. CA Kaiser Permanente
Kaiser Permanente Colorado
HealthPartners
Marshfield ClinicHarvard Pilgrim
CDC
OutcomeExposure
window (days) Medical Setting 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
Rapid Cycle Analysis, VSD
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
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
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
Talking Points on Vaccine Safety Issues
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 siteScientific studies cited and are currentLack of financial conflict of interest (selling a
book)Experience in fieldLack of anecdotes
Vaccine Safety Information
Freed et al Pediatr 2011;127:S107
Vaccines and Autism
What we know about vaccines and autism
Wakefield retraction Danish study California study Recent studies Causes of autism
HeritabilityEarly recognitionChanges that had to occur in utero
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
2008 California Study
Schechter R, Arch Gen Psych 2008:65:19-24
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;68:459-465J Peds 2011, April 19 epub
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
Aluminum Exposure: 1st 6 Months of Life
Robison et al NIC 2008
Do vaccines overwhelmthe 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
1900 1960 1980 2011
Vaccine Antigens Vaccine Antigens Vaccine Antigens Vaccine Antigens
Smallpox ~200 Smallpox ~200 Diphtheria 1 Diphtheria 1
Diphtheria 1 Tetanus 1 Tetanus 1
Tetanus 1 Pert-WC ~3000 Pert-AC 2-5
Pert-WC ~3000 Polio 15 Polio 15
Polio 15 Measles 10 Measles 10
Mumps 9 Mumps 9
Rubella 5 Rubella 5
Hib 2
Varicella 69
PCV 14
Hepatitis B
Hepatitis A
MCV
RV
HPV
Influenza*
1
1
4
2-7
4
6-114
Total ~200 Total ~3217 Total ~3041 Total 142-258
Offit et al, Pediatrics 2002;109:124 *Influenza yearly, new strains every year
Is natural immunity Is natural immunity better?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 pricedeafness, brain damage, hospitalization, pneumonia,
paralysis, permanent scars
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….
Parents’ ChoiceParents’ Choicevs. the “Greater Good”vs. the “Greater Good”
Not vaccinating puts your child at Not vaccinating puts your child at riskrisk
Not vaccinating your child also puts Not vaccinating your child also puts others at riskothers at risk
3 innocent bystanders infected 3 innocent bystanders infected during San Diego measles outbreakduring San Diego measles outbreak
Personal beliefs about immunization are
affecting people who do not share those
beliefs
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
http://www.immunizeca.org
California Immunization Coalition materials
What about alternative vaccine schedules?
What about the Sears schedule?
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
What’s Wrong with Alternative Vaccine Schedules?
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
Being Unimmunized Leaves You at Risk
Talking Points The unimmunized are at increased risk to
develop disease and expose othersAll of the measles cases in San Diego in
2008 were unimmunized3 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
The Details of What’s Wrong With Alternative Vaccine Schedules
Sears Message #1Doctors 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
Sears Message #2You Can’t Trust CDC, AAP, your
doctorPossible 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
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…..”
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
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
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 riskPertussis 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
California Immunization Coalition materials
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)