2014 UPDATES FROM THE CDC’S ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)
Decision-making by the Advisory Committee on Immunization .../media/Files/Activity Files... ·...
Transcript of Decision-making by the Advisory Committee on Immunization .../media/Files/Activity Files... ·...
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Decision-making by the
Advisory Committee on Immunization Practices
Melinda Wharton, MD, MPHDeputy Director, National Center for Immunization
& Respiratory Diseases
Institute of Medicine9 February 2012
National Center for Immunization & Respiratory Diseases
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Advisory Committee on Immunization Practices
q Establishes the standard of practice for immunization in the United States
q Evidence-based recommendations that consider:§ FDA Licensed indications and schedule
§ Disease burden overall and in high risk groups
§ Data on safety and efficacy in general and in specific groups§ Data on safety and efficacy in general and in specific groups
§ Feasibility in the context of existing recommendations
§ Equity in access to vaccine and good use of public funds (cost effectiveness)
§ Recommendations of other groups (i.e., AAP, AAFP, ACP, ACOG)
q Schedule represents a summation of individual vaccine recommendations, including recommendations for simultaneous administration
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Morbid Mortal Wkly Rep 1995;43:959-960
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How Much Risk is Too Much?Some Examples
q Smallpox vaccine§ Smallpox vaccine is associated with serious and sometimes fatal
adverse events
§ Smallpox vaccine recommended for laboratory workers who work with variola and related viruses
q Oral polio vaccine§ Vaccine-associated poliomyelitis: 1 in 750,000 first doses
q Rotavirus vaccines§ Intussusception following Rotashield: about 1 in 10,000 doses
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Rotavirus Test Results at NREVSS Laboratories, 2000-2010
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Tate J et al PIDJ in press
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Estimated reduction in US hospitalizations 2008: >40,000
Gastroenteritis and Rotavirus-coded Hospitalizations in 18 States,
children aged <5 yrs, 2000-2008
Vaccine recommended
Curns A et al JID 2010
5
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Number of Gastroenteritis and Rotavirus-confirmed Hospitalizations
NVSN 2006-2010
Payne D et al 20107
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RV1: Post-marketing IS studies
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RV5: Post-marketing IS studies
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Estimate of Benefits: InputsRotavirus Burden and Vaccination
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Updated inputs to model of Widdowson M, Meltzer M et al., Pediatrics 2007;119:684-97
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Estimate of Benefits: ResultsRotavirus Disease Prevented with Vaccination
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Estimate of Risk : Input IS risk in one vaccinated birth cohort
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Baseline Rate of Intussusception
000
5%
2%
<1%
18
68
0
0
7% Proportion of total rota1 doses given, by age group
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Age at Rotavirus Vaccine Dose 1
National Immunization Survey 2009
1%1%
6%
3%
1%
15
66
<1%
9% Percentage of total Rota1 doses given, by age group
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Estimate of Risk: Results Excess Intussusception Cases
1%1%4
4
Background: ~1,900 infants with IS annually
Number of cases caused by vaccine if RR = 4.6, by age group.TOTAL = 48
6%
3%
1%
15
66
<1%
9%
25
4
2
5
8
Percentage of total Rota1 doses given, by age group
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Estimate of Risk: Results Excess Intussusception
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Estimate of Risk: Results Attributable Intussusception Risk
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Estimated attributable risk following Rotashield: ~1 case per 10,000 infants , Peter G et al. Pediatrics 2002
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Benefits vs. Risks: Summary of Estimates One vaccinated birth cohort to age 5 years
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Insurance Coverage for Vaccines
q In general, health insurance covers ACIP-recommended vaccines that are administered by an in-network provider, although deductibles and co-pays may result in substantial out of pocket costs
q The Affordable Care Act requires that new health insurance plans must provide coverage for ACIP insurance plans must provide coverage for ACIP recommended vaccines without deductibles or co-pays, when delivered by an in-network provider
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Risks and Benefits
q ACIP’s decision-making process includes assessment of both risks and benefits of vaccination
q Vaccines – like any pharmaceutical product – do cause adverse events
q Vaccines are the most effective way to protect children from vaccine-preventable diseasesfrom vaccine-preventable diseases
q A decision to not vaccinate or to delay vaccination is not a risk-free decision
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www.cdc.gov/vaccines
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-mail: [email protected] Web: www.cdc.gov
National Center for Immunization & Respiratory Diseases
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
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Why Do We Give Vaccines at the Ages We Do?
q To provide protection from vaccine preventable diseases at the earliest age possible, or before periods of increased risk
q Given concurrently with other vaccines to coincide with established schedule of well-child visits
q Reflect ages at which vaccines are tested in clinical q Reflect ages at which vaccines are tested in clinical trials, and generally consistent with labeling
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THE CHILDHOOD IMMUNIZATION SCHEDULE
Advisory Committee on Immunization Practices
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Comparing Vaccinated, Unvaccinated, and Undervaccinated Children and their Households
q Undervaccinated compared with fully vaccinated:§ More likely to be Black than Hispanic or non-Hispanic white; young
mother; less likely to be married; more likely to have ≤12 years education; more likely to be poor; ≥4 children compared with only child
q Unvaccinated compared with undervaccinated:q Unvaccinated compared with undervaccinated:§ More likely to be non-Hispanic white; mother more likely to have
college degree and be ≥30 years old; household income >$75K; ≥4 children compared with only child
q Unvaccinated compared with fully vaccinated:§ More likely to be non-Hispanic white than Hispanic; more likely to
have ≥4 children compared with only child
§ A larger proportion of the unvaccinated were boys (57.3%)
Smith PJ et al. Pediatrics 2004;114:187-195
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50
60
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Per
cen
t Vac
cin
ated
(95
% C
I)
Cumulative percent of children born in 2007 vaccinated with 1 dose of MMR vaccine, by month of age, United States
Source: 2008-2010 National Immunization Survey
0
10
20
30
40
12 13 14 15 16 17 18 ≥19
Per
cen
t Vac
cin
ated
(95
% C
I)
Age (months)
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National Immunization Survey, 2010
Vaccine %
MMR (≥1 dose) 91.5%
DTaP (≥3 doses) 95.0%
Varicella (≥1 dose) 90.4%
Hib (≥3 doses) 91.8%
PCV4 (4 doses) 83.3%
Morbid Mortal Wkly Rep 2011;60 (34):1157-1163
PCV4 (4 doses) 83.3%
Hep B (≥3 doses) 91.8%
Rotavirus (2 or 3 doses) 59.2%
Poliovirus 93.3%
4:3:1:3:3:1:4 70.2%
No vaccines 0.7%
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50
60
70
80
90
100
Per
cen
t va
ccin
ated
(95
% C
I)Cumulative percent of children born in 2007 vaccinated with 1st
dose of DTaP vaccine, by month of age, United States
0
10
20
30
40
50
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 ≥19
Per
cen
t va
ccin
ated
(95
% C
I)
Age (months)
Source: 2008-2010 National Immunization Survey
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National Immunization Survey (NIS)
q Primary coverage assessment tool for children 19-35 months and adolescents 13-17 years of age
q Random digit dialing survey
q Very large number of households contacted; for childhood survey§ ~1,000,000 households per year identified§ ~1,000,000 households per year identified
§ ~34,000 households per year complete interview
§ ~22,000 households per year used in analysis
q Provider-verified immunization histories are collected§ Survey instruments are mailed to providers who mail or fax back
responses
§ Only provider-verified vaccinations are used for estimation of vaccine coverage
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The Science of Studying More than One Thing at a Time
q Rapid advances in multiple fields of biology have made it possible to study complex biological reactions at the cellular level
q These new “systems biology” approaches are beginning to be applied to questions about vaccines
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Outpatient Visits for Fever by Day after Vaccine at Northern California Kaiser Permanente:
1995-2008Age 12-23 months
6241 total fever visits after 302,670 MMR+V, 147,762 MMR, 46,390 MMRV, 38,251 VZV
200
250
300
350
Even
ts /
100,
000
Dos
es
MMRMMR+VMMRVV
0
50
100
150
200
0 5 10 15 20 25 30 35 40Days after Immunization
Even
ts /
100,
000
Dos
es
Vaccine Safety Datalink; Immunization Safety Office, CDC
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Data on Simultaneous Administration for a Licensed Vaccine: ROTARIX
q 484 healthy infants randomized into two groups
q 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
q Prespecified criteria for noninferiority of antibody response met for all antigens
Abu-Elyazeed et al, ICAAC 2007
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Safety and Efficacy Issues Potentially Associated with the Childhood Vaccination Schedule
q Data generally available on concurrent administration at licensure
q Interference between concurrently administered vaccines theoretically possible but generally not observed§ Need for spacing of live virus vaccines
q Safety or efficacy issues associated with concurrent or antecedent exposure to vaccine components (e.g., diphtheria toxoid-containing vaccines)
q Cumulative exposure to vaccine components
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Missed Opportunities
q Definition: Healthcare encounter in which a child is eligible to receive a vaccination but is not vaccinated
q What causes missed opportunities?§ Referrals from immunization provider
§ Deferrals of vaccination• Provider unaware that vaccines are due• Provider unaware that vaccines are due
• Failure to provide simultaneous vaccinations
• Inappropriate contraindications
• Office policies/administrative barriers
§ Non-vaccinating health care providers