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Vaccine Safety and Vaccine Safety Communication
Содержание
- 1. Vaccine Safety and Vaccine Safety Communication
- 2. ObjectivesList some of the events that led
- 3. Vaccination is the top Public Health achievement of the 20th CenturyMMWR 1999; 48:241
- 4. CDC, Epidemiology and Prevention of Vaccine-Preventable Diseases, 9th ed., 2006
- 5. Vaccine-Preventable Diseases: Baseline 20th Century & Current MorbidityMMWR 1999;48:245, 2011;59:1700*provisional
- 6. Слайд 6
- 7. The Things You Hear…Are vaccines safe?Vaccines and
- 8. Parental Vaccine Safety ConcernsFreed et al, Pediatr 2010;125:654
- 9. Parents: Doubts About VaccinesGust et al Pediatr 2009;122:718
- 10. Why Parents Who Planned To Delay/Refuse Vaccine Changed Their MindsGust et al Pediatr 2009;122:718
- 11. How did we get here?
- 12. Real Vaccine Risks1950-1980’s: Whole cell DTP vaccine1976:
- 13. How have we dealt with real vaccine risks?
- 14. Responses to real vaccination risks and problemsElimination
- 15. Слайд 15
- 16. Will H1N1 Influenza Vaccine Cause Guillain-Barre Syndrome?
- 17. H1N1 Influenza Vaccine SafetyClosely monitored by CDC
- 18. Слайд 18
- 19. 1998-99: The Vaccine Safety Concern 1-2 Punch
- 20. Wakefield, A.J., et al. Lancet 351: 637-641, 1998Wakefield History
- 21. Thimerosal-the beginningMMWR 1999; 48 (26):564-566
- 22. Wakefield …and the rest of the storyFindings
- 23. Слайд 23
- 24. Thimerosal historyMercury content of recommended vaccines reviewedRecommendation
- 25. Factors that have increased concernDistrustIndustryGovernmentDoctorsUncertaintyRapid increase in
- 26. Know Your Source
- 27. Слайд 27
- 28. What has been the effect?Falsehood flies, and
- 29. Lee et al NVIC 2010Permanent Medical Exemptions & Personal Beliefs Exemptions, Kindergarten Students, California
- 30. Слайд 30
- 31. Lee et al NVIC 2010Kindergarten PBEs by County2000
- 32. Слайд 32
- 33. San Diego Measles Outbreak 2008
- 34. Other Measles Outbreaks in the U.S.-2008131 cases
- 35. Слайд 35
- 36. …and in 2011Measles outbreak in Minnesota centered
- 37. Individual Risk of Exemption - PertussisAge Group
- 38. Refused pertussis vaccination22.8 times increased risk of pertussis
- 39. Refused varicella vaccination8.6 times increased risk of varicella
- 40. Other Vaccine Components and Autism It ain’t
- 41. How Can You Respond
- 42. How can you respond?Are vaccines safe?Do vaccines
- 43. Parental Immunization RefusalListen carefully to concernsencourage questionsDiscuss
- 44. Vaccine Safety Discussion StrategiesEmpathize: acknowledge that there
- 45. The Vaccine Safety Infrastructure
- 46. Vaccines are Safe Talking PointsHundreds of
- 47. Sample Sizes Needed During Clinical Trials to
- 48. Vaccine Adverse Events Reporting System (VAERS)National post-licensure
- 49. VAERSAdvantages covers US populationpermits monitoring for
- 50. Слайд 50
- 51. VAERSAdvantages covers US populationpermits monitoring for
- 52. VAERS HPV Data: Venous ThromboembolismTotal reports: 65;
- 53. Vaccine Safety Datalink (VSD)Collaboration between CDC and
- 54. Rapid Cycle Analysis, VSD
- 55. Examples of VSD studiesRisk of seizures following
- 56. Institute of Medicine Safety ReviewsMMR Vaccine and
- 57. Clinical Immunization Safety Assessment Network (CISA)6 centers
- 58. Talking Points on Vaccine Safety Issues
- 59. Know Your Source Talking PointsMajority of
- 60. Vaccine Safety InformationFreed et al Pediatr 2011;127:S107
- 61. Vaccines and Autism
- 62. What we know about vaccines and autismWakefield
- 63. Слайд 63
- 64. Слайд 64
- 65. Слайд 65
- 66. Thimerosal and Neuropsychological Function1047 children 7-10 years
- 67. 2008 California StudySchechter R, Arch Gen Psych 2008:65:19-24
- 68. What we know about autismHighly heritable (more
- 69. Aluminum ConcernsAluminum in vaccinesadjuvantmaximum amount 0.85 mg/doseAluminum
- 70. Aluminum Exposure: 1st 6 Months of LifeRobison et al NIC 2008
- 71. Do vaccines overwhelm the Immune System?Your immune
- 72. Offit et al, Pediatrics 2002;109:124*Influenza yearly, new strains every year
- 73. Is natural immunity better?For some infections natural
- 74. Diseases Are Not That Bad
- 75. Parents’ Choice vs. the “Greater Good”Not vaccinating
- 76. Personal beliefs about immunization are affecting people who do not share those beliefs
- 77. You can’t hide in the herdHerd immunity
- 78. http://www.immunizeca.orgCalifornia Immunization Coalition materials
- 79. What about alternative vaccine schedules?
- 80. What about the Sears schedule?
- 81. The Sears ScheduleBased on the premise that
- 82. What’s Wrong with Alternative Vaccine Schedules?
- 83. What’s Wrong With Alternative Immunization Schedules?There is
- 84. Being Unimmunized Leaves You at Risk Talking
- 85. The Details of What’s Wrong With Alternative Vaccine Schedules
- 86. Sears Message #1 Doctors don’t understand vaccines
- 87. Sears Message #2 You Can’t Trust CDC,
- 88. Sears Message #3 Diseases Are Not
- 89. Sears Message #4 Hide in the
- 90. Sears Message #5 Natural Infection is
- 91. Why Should I Put My Child At
- 92. http://immunizeca.orgCalifornia Immunization Coalition materials
- 93. Information for Health-Care Professionals NNII (www.immunizationinfo.org) VEC (www.vaccine.chop.edu) IAC
- 94. Скачать презентанцию
ObjectivesList some of the events that led to the current climate of vaccine safety concernDescribe factors that contribute to parental concerns about vaccinesDevelop talking points to address common myths about vaccine
Слайды и текст этой презентации
Слайд 2Objectives
List some of the events that led to the current
climate of vaccine safety concern
Describe factors that contribute to parental
concerns about vaccinesDevelop talking points to address common myths about vaccine safety
Develop answers to the question-What is wrong with an alternative vaccine schedule?
Слайд 5Vaccine-Preventable Diseases:
Baseline 20th Century & Current Morbidity
MMWR 1999;48:245, 2011;59:1700
*provisional
Слайд 7The 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 dangerousIt is all a giant money-fueled conspiracy
Individual rights vs. public health needs
Слайд 10Why Parents Who Planned To Delay/Refuse Vaccine Changed Their Minds
Gust
et al Pediatr 2009;122:718
Слайд 12Real 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
Слайд 14Responses to real vaccination risks and problems
Elimination of killed measles
vaccine
Transition from plasma derived Hep B vaccine to recombinant Hep
B vaccineTransition from DTP to DTaP (Some countries suspended pertussis immunization)
Transition from OPV to IPV
Withdrawal of first rotavirus vaccine
Слайд 17H1N1 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 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
Слайд 22Wakefield
…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 AuthoritiesWakefield sanctioned and license revoked
The details of ”an elaborate fraud” published in the British Medical Journal
Слайд 24Thimerosal history
Mercury content of recommended vaccines reviewed
Recommendation to reduce mercury
exposure
Delay in Hepatitis B vaccination of newborns to minimize mercury
exposureOnce MMR couldn’t be targeted as a cause of autism, thimerosal became an attractive target
Слайд 25Factors 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
Слайд 28What 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 effectJonathan Swift, The Examiner Nov. 9, 1710
Слайд 29Lee et al NVIC 2010
Permanent Medical Exemptions & Personal Beliefs
Exemptions, Kindergarten Students, California
Слайд 34Other 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 unimmunizedIllinois 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
Слайд 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 deathsMMWR, 2011; 60(20):666-668
MMWR 2010;59:125-129
Слайд 37Individual 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
Слайд 40Other Vaccine Components and Autism It ain’t over ‘til the fat
lady sings…
Aluminum
Bovine serum albumen
Adjuvants
Yeast proteins
Human cell line derivatives
…………………..
Слайд 42How 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 dangerousIt is all a giant money-fueled conspiracy
It’s my right to decide what’s best for my child
Слайд 43Parental 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
concernsmodify schedule
Revisit discussion in future visits
Document
Слайд 44Vaccine Safety Discussion Strategies
Empathize: acknowledge that there are many conflicting
messages in the media
Assess level of scientific evidence desired
Maximize benefits
to their childnot 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
Слайд 46Vaccines 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 problemVaccine safety infrastructure is large
VAERS
VSD
CISA
FDA
CDC
Слайд 47Sample Sizes Needed During Clinical Trials to Detect Increases in
Rates of
Rare Vaccine Adverse Events
* 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
Слайд 48Vaccine Adverse Events Reporting System (VAERS)
National post-licensure safety surveillance system
jointly operated by CDC and FDA
Spontaneous reporting system in existence
since 1990reports submitted by clinicians, manufacturers, patients/parents and others
Subject to well-described limitations of passive surveillance
Слайд 49VAERS
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 reportingincomplete data
lack of availability of denominator data
Слайд 51VAERS
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 overreportingincomplete data
lack of availability of denominator data
Слайд 52VAERS HPV Data:
Venous Thromboembolism
Total reports: 65; US reports: 41
Pending evaluation:
6; Unable to follow-up or “no case”: 17
Confirmed cases:
18Hormonal 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
Слайд 53Vaccine 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 Clinic
Harvard Pilgrim
CDC
Слайд 55Examples 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 vaccinesGuillain-Barre syndrome after H1N1 influenza vaccine
Слайд 56Institute 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 autismInfluenza vaccine and neurological complications
Слайд 57Clinical Immunization Safety Assessment Network (CISA)
6 centers established to review
vaccine safety
Northern CA Kaiser, Columbia, Johns Hopkins, Vanderbilt, Stanford, Boston
UniversityInvestigate immunologic, pathologic and genetic mechanisms of possible vaccine related adverse events
Provide consultation to providers regarding vaccine adverse events
Слайд 59Know 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
Слайд 62What 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
Слайд 66Thimerosal 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 functioningThompson WW, NEJM 2007;357:1281
Слайд 68What 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
Слайд 69Aluminum 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
Слайд 71Do 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 immunizedClinical trials test multiple vaccines
Increased vaccine purity
Слайд 73Is 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
Слайд 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 diedSan Diego measles outbreak-out of 12 cases, one hospitalized
Quote your own experience….
Слайд 75Parents’ 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
Слайд 77You 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 immunizationDrop in Hepatitis A disease in California
But, you can’t hide in the herd, especially if your herd thinks like you do
Слайд 81The 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 encounterBased 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
Слайд 83What’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 immunizedThey increase healthcare costs
Слайд 84Being 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 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
Слайд 86Sears 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
Слайд 87Sears 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
Слайд 88Sears 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 dieSan Diego measles outbreak-out of 12 cases, one hospitalized
“I just took care of a patient with…..”
Слайд 89Sears 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 herd5 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
Слайд 90Sears 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 typesYou are taking a chance with letting your child develop natural immunity
Слайд 91Why 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
Слайд 93Information 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)
