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Презентация на тему What Immunization Providers Need to Know about Vaccine Safety and Talking to

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

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What Immunization Providers Need to Know about Vaccine Safety  and Talking to Concerned Parents Melinda Wharton,
Текст слайда:

What Immunization Providers Need to Know about Vaccine Safety and Talking to Concerned Parents

Melinda Wharton, M.D., M.P.H.
Centers for Disease Control and Prevention

Phoenix, Arizona
22 April 2009


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Overview of PresentationOverview of the U.S. vaccine safety systemUpdates on a number of current vaccine safety issuesVaccines
Текст слайда:

Overview 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


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Vaccine Safety When the vaccine is under development, studies are done to find out if it is
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Vaccine 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 licensed
Other 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


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What Do VAERS Reports Mean?VAERS has led to early identification of serious adverse eventsNot every adverse event
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What 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 VAERS
Just 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


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How Do We Decide  What We Are Going to Worry About?Consistent pattern of clinical findingsBiologic plausibilityConsistency
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How Do We Decide What We Are Going to Worry About?

Consistent pattern of clinical findings
Biologic plausibility
Consistency of findings in other studies
Clustering 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


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A Faster Approach  to Vaccine Safety StudiesAlternative to traditional post-licensure vaccine safety study methods, which generally
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A 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.


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Meningococcal Conjugate Vaccine and Guillain-Barré SyndromeVAERS: 24 confirmed reports among vaccine recipients2 among persons 11-14 years of
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Meningococcal 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 age
Observed 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


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Timing of Onset of GBS following Meningococcal Conjugate VaccineOnset intervals 2-33 daysMean 17.4 daysMedian 14.5 days
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Timing of Onset of GBS following Meningococcal Conjugate Vaccine

Onset intervals 2-33 days
Mean 17.4 days
Median 14.5 days


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Update on Safety  of Varicella Vaccine Varicella vaccine strain can establish latency like wildtype varicella and
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Update 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


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Establishment of VZV Latency in Sensory-Nerve Ganglia Kimberlin D, Whitley R. N Engl J Med 2007;356:1338-1343
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Establishment of VZV Latency in Sensory-Nerve Ganglia

Kimberlin D, Whitley R. N Engl J Med 2007;356:1338-1343


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Herpes Zoster among Recipients of Varicella Vaccine VAERS: 981 reports of herpes zoster47 of 981 were hospitalized
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Herpes 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


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Judicial Watch Investigates Side-Effects of HPV Vaccine Wed, 05/14/2008 - 14:05 — gstasiewicz
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Judicial 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 Fitton


http://www.judicialwatch.org/story/2008/may/judicial-watch-investigates-side-effects-hpv-vaccine


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Adverse Events and HPV Vaccine: SummaryOver 21 million doses distributedAs of August 31, 2008, 10,326 VAERS reports
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Adverse Events and HPV Vaccine: Summary

Over 21 million doses distributed
As of August 31, 2008, 10,326 VAERS reports following Gardasil vaccination
6% serious events
27 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


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Reports of Death  Following HPV Vaccine20 U.S. death reports; unable to follow up 7
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Reports of Death Following HPV Vaccine

20 U.S. death reports; unable to follow up 7


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Syncope (Fainting) following HPV VaccineIncreased reporting of syncope among vaccineesAlthough usually not serious, syncope can result in
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Syncope (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 injuries
Syncope recognized to occur following vaccination, especially among adolescents and adults


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General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) “…, although syncopal episodes
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General 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)


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Intussusception and RotaTeq®9.1 million doses distributed (March 2006- August 31, 2007)*VAERS: 160 confirmed intussusception reports47 reports with
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Intussusception 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 vaccine
27 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


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Adverse Reactions Following MMRV and MMR+VFever is more common in the 5-12 days after vaccination following MMRV
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Adverse 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


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Temporal Distribution of Seizures after MMRV VaccinationDays Post-MMRV VaccineNumber of Seizures(2/06-9/07, after 47,137 vaccine visits)Klein, ACIP presentation,
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Temporal 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


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Thimerosal and Autism: What Does the Science Show?Ecologic studies: autism does not go down when thimerosal is
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Thimerosal 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 autism
Biochemical studies and animal models interesting but uninformative


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Children Receiving Autism Services  by Quarter, California, 2002-2007California Department of Developmental Services
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Children Receiving Autism Services by Quarter, California, 2002-2007

California Department of Developmental Services


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Vaccines and Autism, StillMMR and autism (1998)Thimerosal and autism (2001)Simultaneous administration of multiple vaccines and the “one
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Vaccines 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)


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Vaccines and Autism: ContextHeuristics and biases Distrust of governmentUnanswered questions about autism and real needs of familiesAdvocacyLitigationThe
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Vaccines and Autism: Context

Heuristics and biases
Distrust of government
Unanswered questions about autism and real needs of families
Advocacy
Litigation
The Internet


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“Why doesn’t CDC study autism rates in unvaccinated children?”Almost all children in the U.S. have received at
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“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 vaccines
Although 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


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Number of Vaccines in the Routine Childhood and Adolescent Immunization Schedule198519952006MeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioHib (infant) HepBVaricellaPneumococcal diseaseInfluenzaMeningococcal diseaseHepARotavirusHPVMeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioHib (infant) HepBVaricellaMeaslesRubellaMumpsDiphtheriaTetanusPertussisPolio71016
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Number 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


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Recommended Schedule for Persons Aged 0-6 Years, U.S.
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Recommended Schedule for Persons Aged 0-6 Years, U.S.


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Current Parent ConcernsFocus groups with first time mothers in 3 cities: Chicago, Portland, and RichmondMost participants had
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Current Parent Concerns

Focus groups with first time mothers in 3 cities: Chicago, Portland, and Richmond
Most participants had high levels of knowledge and of concern
Many 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


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What Parents  Are Concerned About (2008)It is painful for children to get so many shots during
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What 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


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Why Do We Give Vaccines at the Ages We Do?To provide protection from vaccine preventable diseases at
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Why 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 risk
Given 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



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Advisory Committee on Immunization PracticesEvidence-based recommendations based on:Licensed indications and scheduleBurden of disease to be preventedEfficacy and
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Advisory Committee on Immunization Practices

Evidence-based recommendations based on:
Licensed indications and schedule
Burden of disease to be prevented
Efficacy and effectiveness of the vaccine
Safety 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


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Missed OpportunitiesDefinition: Healthcare encounter in which a child is eligible to receive a vaccination but is not
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Missed 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


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Safety and Efficacy Issues Potentially Associated with the ScheduleData generally available on concurrent administration at licensureInterference between
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Safety 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 observed
Need 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


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Outpatient Visits for Fever by Day after Vaccine at Northern California Kaiser Permanente: 1995-2008Vaccine Safety Datalink; Immunization
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Outpatient Visits for Fever by Day after Vaccine at Northern California Kaiser Permanente: 1995-2008

Vaccine Safety Datalink; Immunization Safety Office, CDC


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Data on Simultaneous Administration for a Licensed Vaccine: ROTARIX484 healthy infants randomized into two groups All received
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Data 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 months
Co-administration: n=249
Separate administration: n=235
Prespecified criteria for noninferiority of antibody response met for all antigens

Abu-Elyazeed et al, ICAAC 2007


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The Science of Studying More than One Thing at a TimeRapid advances in multiple fields of biology
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The 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 level
These new “systems biology” approaches are beginning to be applied to questions about vaccines


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Other IssuesRecommendations and requirements – should everything that is recommended be required?Public health vs. individual decisionsDifferent perceptions
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Other 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 diseases
The expectation of “personalized medicine”
Are some children uniquely susceptible to adverse events?


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Is Our Immunization Schedule “One Size Fits All”?Contraindications and precautions do provide guidance for decision-makingFlexibility in timing
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Is Our Immunization Schedule “One Size Fits All”?

Contraindications and precautions do provide guidance for decision-making
Flexibility in timing within the recommended schedule
Some children are vulnerable, and screening usually not possible
Vulnerable children can be protected -- with safer vaccines for everyone


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SMEI and “Vaccine Encephalopathy”Epileptic encephalopathies, without other specific cause identified, with first seizure onset within 72 hours
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SMEI 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 2002-2003
Diagnoses:
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


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What Determines Credibility?  Low Concern SettingsAll other factors15-20%Competence/Expertise80-85%Randall Hyer, NIC, 2005
Текст слайда:

What Determines Credibility? Low Concern Settings

All other factors
15-20%

Competence/
Expertise
80-85%

Randall Hyer, NIC, 2005


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What Determines Credibility?  High Concern SettingsAll other factors15-20%Competence/Expertise15-20%Honesty/openness15-20%Listening/caring/Empathy50%Randall Hyer, NIC, 2005
Текст слайда:

What 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


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Measles Cases Reported to CDC/NCIRD  January 1 to July 11, 2008 (N= 132)San Diego, CAOutbreak N=12(CA
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Measles 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


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Invasive H. influenzae type B disease -- Minnesota, 20085 cases of invasive Hib disease in children
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Invasive H. influenzae type B disease -- Minnesota, 2008

5 cases of invasive Hib disease in children <5 years of age; 1 death
Geographically dispersed and not epidemiologically linked
3 children had received no vaccinations because of parental refusal; 2 were partially vaccinated
Ongoing Hib vaccine shortage


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Where That Leaves UsWhen we do more than one thing at a time, it’s complicated - and
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Where That Leaves Us

When we do more than one thing at a time, it’s complicated - and we should acknowledge that
We 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


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www.cdc.gov/vaccinesafety
Текст слайда:

www.cdc.gov/vaccinesafety


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