Talking to Concerned Parents
Melinda Wharton, M.D., M.P.H.
Centers for Disease Control
and PreventionPhoenix, Arizona
22 April 2009
Разделы презентаций
- Разное
- Английский язык
- Астрономия
- Алгебра
- Биология
- География
- Геометрия
- Детские презентации
- Информатика
- История
- Литература
- Математика
- Медицина
- Менеджмент
- Музыка
- МХК
- Немецкий язык
- ОБЖ
- Обществознание
- Окружающий мир
- Педагогика
- Русский язык
- Технология
- Физика
- Философия
- Химия
- Шаблоны, картинки для презентаций
- Экология
- Экономика
- Юриспруденция
What Immunization Providers Need to Know about Vaccine Safety and Talking to
Содержание
- 1. What Immunization Providers Need to Know about Vaccine Safety and Talking to
- 2. Overview of PresentationOverview of the U.S. vaccine
- 3. Vaccine Safety When the vaccine is under
- 4. What Do VAERS Reports Mean?VAERS has led
- 5. How Do We Decide What We
- 6. A Faster Approach to Vaccine Safety
- 7. Meningococcal Conjugate Vaccine and Guillain-Barré SyndromeVAERS: 24
- 8. Timing of Onset of GBS following Meningococcal Conjugate VaccineOnset intervals 2-33 daysMean 17.4 daysMedian 14.5 days
- 9. Update on Safety of Varicella Vaccine
- 10. Establishment of VZV Latency in Sensory-Nerve Ganglia Kimberlin D, Whitley R. N Engl J Med 2007;356:1338-1343
- 11. Herpes Zoster among Recipients of Varicella Vaccine
- 12. Слайд 12
- 13. Judicial Watch Investigates Side-Effects of HPV Vaccine
- 14. Adverse Events and HPV Vaccine: SummaryOver 21
- 15. Reports of Death Following HPV Vaccine20 U.S. death reports; unable to follow up 7
- 16. Syncope (Fainting) following HPV VaccineIncreased reporting of
- 17. General Recommendations on Immunization: Recommendations of the
- 18. Intussusception and RotaTeq®9.1 million doses distributed (March
- 19. Adverse Reactions Following MMRV and MMR+VFever is
- 20. Temporal Distribution of Seizures after MMRV VaccinationDays
- 21. Thimerosal and Autism: What Does the Science
- 22. Children Receiving Autism Services by Quarter, California, 2002-2007California Department of Developmental Services
- 23. Vaccines and Autism, StillMMR and autism (1998)Thimerosal
- 24. Vaccines and Autism: ContextHeuristics and biases Distrust
- 25. “Why doesn’t CDC study autism rates in
- 26. Number of Vaccines in the Routine Childhood
- 27. Recommended Schedule for Persons Aged 0-6 Years, U.S.
- 28. Current Parent ConcernsFocus groups with first time
- 29. What Parents Are Concerned About (2008)It
- 30. Слайд 30
- 31. Why Do We Give Vaccines at the
- 32. Advisory Committee on Immunization PracticesEvidence-based recommendations based
- 33. Missed OpportunitiesDefinition: Healthcare encounter in which a
- 34. Safety and Efficacy Issues Potentially Associated with
- 35. Outpatient Visits for Fever by Day after
- 36. Data on Simultaneous Administration for a Licensed
- 37. The Science of Studying More than One
- 38. Other IssuesRecommendations and requirements – should everything
- 39. Is Our Immunization Schedule “One Size Fits
- 40. SMEI and “Vaccine Encephalopathy”Epileptic encephalopathies, without other
- 41. What Determines Credibility? Low Concern SettingsAll other factors15-20%Competence/Expertise80-85%Randall Hyer, NIC, 2005
- 42. What Determines Credibility? High Concern SettingsAll other factors15-20%Competence/Expertise15-20%Honesty/openness15-20%Listening/caring/Empathy50%Randall Hyer, NIC, 2005
- 43. Measles Cases Reported to CDC/NCIRD January
- 44. Invasive H. influenzae type B disease --
- 45. Where That Leaves UsWhen we do more
- 46. www.cdc.gov/vaccinesafety
- 47. Скачать презентанцию
Overview of PresentationOverview of the U.S. vaccine safety systemUpdates on a number of current vaccine safety issuesVaccines and autism (April 2009 edition)What are parents concerned about, and how to better address
Слайды и текст этой презентации
Слайд 1What Immunization Providers Need to Know about Vaccine Safety and
Talking to Concerned Parents
and PreventionPhoenix, Arizona
22 April 2009
Слайд 2Overview of Presentation
Overview of the U.S. vaccine safety system
Updates on
a number of current vaccine safety issues
Vaccines and autism (April
2009 edition)What are parents concerned about, and how to better address those concerns
Слайд 3Vaccine Safety
When the vaccine is under development, studies are
done to find out if it is safe and effective
FDA
review: if safe and effective, vaccine can be licensedOther issues (manufacturing etc.) also considered by FDA
Ongoing monitoring by both CDC and FDA and by the manufacturer after licensure
Post-licensure studies by the manufacturer
Vaccine Adverse Event Reporting System (VAERS)
Special studies
If vaccine safety issues are identified, actions are taken
Слайд 4What Do VAERS Reports Mean?
VAERS has led to early identification
of serious adverse events
Not every adverse event caused by the
vaccine is reported to VAERSJust because something is reported to VAERS, it doesn’t mean it’s caused by the vaccine
Publicly accessible database: http://vaers.hhs.gov/info.htm
Слайд 5How Do We Decide What We Are Going to Worry
About?
Consistent pattern of clinical findings
Biologic plausibility
Consistency of findings in other
studiesClustering of cases in time after vaccination, especially in a “biologically plausible” interval
Observed cases > expected cases
Calculations require knowing what the incidence of the condition is, and how many doses of vaccine have been given
Слайд 6A Faster Approach
to Vaccine Safety Studies
Alternative to traditional post-licensure
vaccine safety study methods, which generally take years to complete
The
Rapid Cycle Analysis approach in the Vaccine Safety Datalink:Tests specific hypotheses with well-defined outcomes
Each week, evaluate the number of events in vaccinated persons
Compare it to the expected number of events based on a comparison group
Weekly analyses with statistical adjustment for multiple looks
Lieu TA, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care. 2007 Oct;45:S89-95.
Слайд 7Meningococcal Conjugate Vaccine and Guillain-Barré Syndrome
VAERS: 24 confirmed reports among
vaccine recipients
2 among persons 11-14 years of age
20 among persons
15-19 years of ageObserved cases > expected cases for 15-19 year olds
Calculation assumes complete reporting and administration of all doses of vaccine distributed
Benefits of vaccination still outweigh risks, even if magnitude of risk is greater than that observed to date
ACIP, October 2007
Слайд 8Timing of Onset of GBS following Meningococcal Conjugate Vaccine
Onset intervals
2-33 days
Mean 17.4 days
Median 14.5 days
Слайд 9Update on Safety
of Varicella Vaccine
Varicella vaccine strain can
establish latency like wildtype varicella and later reactivate as zoster
Available
data suggest that risk of reactivation less than for wildtype virus
Слайд 10Establishment of VZV Latency in Sensory-Nerve Ganglia
Kimberlin D, Whitley R.
N Engl J Med 2007;356:1338-1343
Слайд 11Herpes Zoster among Recipients of Varicella Vaccine
VAERS: 981 reports
of herpes zoster
47 of 981 were hospitalized
Median age: 2.5
years (range 12 mo-12 yr)Median interval from vaccination to zoster: 7.3 months (range 3 days-4.3 years)
21 of 43 were on the face
Of 17 with viruses typed, 10 vaccine type
Of 12 episodes associated with meningitis, 4 vaccine type
Слайд 13Judicial Watch Investigates Side-Effects of HPV Vaccine
Wed, 05/14/2008 - 14:05
— gstasiewicz
"The FDA adverse event reports on the HPV
vaccine read like a catalog of horrors. Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports."
-Tom Fittonhttp://www.judicialwatch.org/story/2008/may/judicial-watch-investigates-side-effects-hpv-vaccine
Слайд 14Adverse Events and HPV Vaccine: Summary
Over 21 million doses distributed
As
of August 31, 2008, 10,326 VAERS reports following Gardasil vaccination
6%
serious events27 deaths in the U.S. reported to VAERS, without a common pattern that would suggest they were caused by the vaccine
Cases of Guillain-Barre syndrome reported; to date, no evidence that Gardasil has increased the rate of GBS above that expected
Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.
http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm
Слайд 16Syncope (Fainting) following HPV Vaccine
Increased reporting of syncope among vaccinees
Although
usually not serious, syncope can result in falls, which sometimes
cause serious injuries, especially head injuriesSyncope recognized to occur following vaccination, especially among adolescents and adults
Слайд 17General Recommendations on Immunization: Recommendations of the Advisory Committee on
Immunization Practices (ACIP)
“…, although syncopal episodes are uncommon …
vaccine providers should strongly consider observing patients for 15 minutes after they are vaccinated. If syncope develops, patients should be observed until symptoms resolve.” MMWR 2006; 55 (No. RR-15)
Слайд 18Intussusception and RotaTeq®
9.1 million doses distributed (March 2006- August 31,
2007)*
VAERS: 160 confirmed intussusception reports
47 reports with onset 1-21 days
after vaccine27 of 47 were within 1-7 days
Observed cases < expected cases, assuming 75% of intussusception cases reported to VAERS and 75% of distributed vaccine administered
Haber, Pediatrics, 2008
Слайд 19Adverse Reactions Following MMRV and MMR+V
Fever is more common in
the 5-12 days after vaccination following MMRV (22%) than following
MMR+V (15%)Data from CDC Vaccine Safety Datalink sites indicate the rate of febrile seizures following MMRV (9 per 10,000 vaccinated ) was approximately 2 times higher than among those receiving MMR+V at the same visit (4 per 10,000 vaccinated)
Merck postlicensure surveillance has identified a similar trend
Слайд 20Temporal Distribution of Seizures
after MMRV Vaccination
Days Post-MMRV Vaccine
Number of Seizures
(2/06-9/07,
after 47,137 vaccine visits)
Klein, ACIP presentation, February 2008
Слайд 21Thimerosal and Autism:
What Does the Science Show?
Ecologic studies: autism does
not go down when thimerosal is removed from childhood vaccines
Epidemiologic
studies: well-designed studies demonstrate no association between thimerosal exposure from vaccines and autismBiochemical studies and animal models interesting but uninformative
Слайд 22Children Receiving Autism Services
by Quarter, California, 2002-2007
California Department of
Developmental Services
Слайд 23Vaccines and Autism, Still
MMR and autism (1998)
Thimerosal and autism (2001)
Simultaneous
administration of multiple vaccines and the “one size fits all”
immunization schedule (2007)Mitochondrial disorders (2008)
Слайд 24Vaccines and Autism:
Context
Heuristics and biases
Distrust of government
Unanswered questions about
autism and real needs of families
Advocacy
Litigation
The Internet
Слайд 25“Why doesn’t CDC study autism rates in unvaccinated children?”
Almost all
children in the U.S. have received at least some vaccines;
only 3 per 1000 children have received no vaccinesAlthough recognized autism spectrum disorders more common than previously reported (up to 6 per 1000), disease is infrequent enough that a large population needed to identify sufficient cases for a study
Unvaccinated children probably very different from other children in terms of:
Health care utilization
Other exposures
Слайд 26Number of Vaccines in the Routine Childhood and Adolescent Immunization
Schedule
1985
1995
2006
Measles
Rubella
Mumps
Diphtheria
Tetanus
Pertussis
Polio
Hib (infant)
HepB
Varicella
Pneumococcal disease
Influenza
Meningococcal disease
HepA
Rotavirus
HPV
Measles
Rubella
Mumps
Diphtheria
Tetanus
Pertussis
Polio
Hib (infant)
HepB
Varicella
Measles
Rubella
Mumps
Diphtheria
Tetanus
Pertussis
Polio
7
10
16
Слайд 28Current Parent Concerns
Focus groups with first time mothers in 3
cities: Chicago, Portland, and Richmond
Most participants had high levels of
knowledge and of concernMany participants know someone who is not fully vaccinating their child
All vaccines are not seen by many parents as equally important to protect children
Unclear what impact these concerns have had on immunization coverage
Preliminary report, NCIRD Office of Communication Science
Слайд 29What Parents
Are Concerned About (2008)
It is painful for children
to get so many shots during one doctors visit (43%)
My
child getting too many vaccines in one doctor’s visit (40%)Vaccines causing fevers in my child (36%)
The ingredients in vaccines are unsafe (34%)
Children get too many vaccines in the first two years of life (33%)
Vaccines may cause learning disabilities (such as autism) (33%)
Vaccines are not tested enough for safety (32%)
HealthStyles, 2008
Слайд 31Why Do We Give Vaccines at the Ages We Do?
To
provide protection from vaccine preventable diseases at the earliest age
possible, or before periods of increased riskGiven concurrently with other vaccines to coincide with established schedule of well-child visits
Reflect ages at which vaccines are tested in clinical trials, and generally consistent with labeling
Слайд 32Advisory Committee on Immunization Practices
Evidence-based recommendations based on:
Licensed indications and
schedule
Burden of disease to be prevented
Efficacy and effectiveness of the
vaccineSafety of the vaccine
Feasibility of programmatic implementation
Equity in access to vaccine and good use of public funds
Recommendations of other groups
Schedule represents a summation of individual vaccine recommendations, including recommendations for simultaneous administration
Слайд 33Missed Opportunities
Definition: Healthcare encounter in which a child is eligible
to receive a vaccination but is not vaccinated
What causes
missed opportunities?Referrals from immunization provider
Deferrals of vaccination
Provider unaware that vaccines are due
Failure to provide simultaneous vaccinations
Inappropriate contraindications
Office policies/administrative barriers
Non-vaccinating health care providers
Слайд 34Safety and Efficacy Issues Potentially Associated with the Schedule
Data generally
available on concurrent administration at licensure
Interference between concurrently administered vaccines
theoretically possible but generally not observedNeed for spacing of live virus vaccines
Safety or efficacy issues associated with concurrent or antecedent exposure to vaccine components (e.g., diphtheria toxoid-containing vaccines)
Cumulative exposure to vaccine components
Слайд 35Outpatient Visits for Fever by Day after Vaccine at Northern
California Kaiser Permanente: 1995-2008
Vaccine Safety Datalink; Immunization Safety Office, CDC
Слайд 36Data on Simultaneous Administration for a Licensed Vaccine: ROTARIX
484 healthy
infants randomized into two groups
All received Pediarix, PCV7, and
ActHib at 2, 4, and 6 months and either ROTARIX concurrently at 2 and 4 months or separately at 3 and 5 monthsCo-administration: n=249
Separate administration: n=235
Prespecified criteria for noninferiority of antibody response met for all antigens
Abu-Elyazeed et al, ICAAC 2007
Слайд 37The Science of Studying More than One Thing at a
Time
Rapid advances in multiple fields of biology have made it
possible to study complex biological reactions at the cellular levelThese new “systems biology” approaches are beginning to be applied to questions about vaccines
Слайд 38Other Issues
Recommendations and requirements – should everything that is recommended
be required?
Public health vs. individual decisions
Different perceptions of benefits associated
with prevention of some vaccine-preventable diseasesThe expectation of “personalized medicine”
Are some children uniquely susceptible to adverse events?
Слайд 39Is Our Immunization Schedule “One Size Fits All”?
Contraindications and precautions
do provide guidance for decision-making
Flexibility in timing within the recommended
scheduleSome children are vulnerable, and screening usually not possible
Vulnerable children can be protected -- with safer vaccines for everyone
Слайд 40SMEI and “Vaccine Encephalopathy”
Epileptic encephalopathies, without other specific cause identified,
with first seizure onset within 72 hours of vaccination
Cases ascertained
by child neurologists in Australia and New Zealand 2002-2003Diagnoses:
SMEI – 8 patients
SMEB – 4 patients
Lennox-Gastaut syndrome – 2 patients
Molecular analysis:
Heterozygous mutations of SCN1A in 11 of 14 cases
Berkovic et al, Lancet Neurology 2006
Слайд 41What Determines Credibility?
Low Concern Settings
All other factors
15-20%
Competence/
Expertise
80-85%
Randall Hyer, NIC,
2005
Слайд 42What Determines Credibility?
High Concern Settings
All other factors
15-20%
Competence/
Expertise
15-20%
Honesty/openness
15-20%
Listening/caring/
Empathy
50%
Randall Hyer, NIC,
2005
Слайд 43Measles Cases Reported to CDC/NCIRD January 1 to July 11,
2008 (N= 132)
San Diego, CA
Outbreak N=12
(CA =11, HI =1) Source=Switzerland,
D5 Jan 25-Feb 16
Missaukee County, MI Outbreak, N=4 Source=Unknown, D5 Feb 29-Apr 8
Pima County, AZ Outbreak N=18 Source=Switzerland, D5
Feb 13-May 2
Los Angeles, CA N=2 Source=Unknown Mar 23-Apr 16
Fairfax, VA N=1 Source=India Feb 25
Milwaukee County, WI Outbreak, N=6 Source=China-H1
Mar 19-Apr 25
Nassau County, NY N=1, Source=Israel Apr 4
New York City, NY
N=27 Sources:
Israel (1)
Belgium (2) D4
Italy (1)
Other Import-
associated (10)
Source Unknown (13)
Jan 18-Jun 10
Honolulu, HI
N=4 Sources:
Italy (2)
China (1)
Philippines (1)
Feb 5-May 22
Pittsburgh, PA N=1 Source=Unknown Apr 12
Chicago, IL
N=1 Source=Switzerland Apr 17
Grant County, WA
Outbreak N=19
Source= Japan
Apr 12 - May 30
Vernon County, WI
N=1
Source=Germany
Apr 25
Scott County, AR
N=2
Source= Unknown
Feb 12-Feb 22
San Francisco, CA N=2, Sources:
India (1), Italy (1) Apr 18, Jun 22
D.C. N=1
Source Unknown Apr 20
Chaves Co, NM N=1, Unknown Mar 17
Baton Rouge , LA N=1, Russia May 14
Du Page Co, I L Outbreak N=27
Source=Italy, D4
May 15-Jun 25
Fulton Co, GA N=1 Pakistan May 14
Cass Co, MO N=1
Source Unknown Apr 7
Слайд 44Invasive H. influenzae type B disease -- Minnesota, 2008
5 cases
of invasive Hib disease in children
1 deathGeographically dispersed and not epidemiologically linked
3 children had received no vaccinations because of parental refusal; 2 were partially vaccinated
Ongoing Hib vaccine shortage
Слайд 45Where That Leaves Us
When we do more than one thing
at a time, it’s complicated - and we should acknowledge
thatWe need to help immunization providers help parents deal with a very complex set of decisions
Vaccination is the best way to protect children from 16 vaccine-preventable diseases
