Decision-making by the Advisory Committee on Immunization Practices Melinda Wharton, MD, MPH Deputy Director, National Center for Immunization & Respiratory Diseases Institute of Medicine 9 February 2012 National Center for Immunization & Respiratory Diseases
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 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
Morbid Mortal WklyRep 1995;43:959-960
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
Rotavirus Test Results at NREVSS Laboratories, 2000-2010 Tate J et al PIDJ in press 3
Gastroenteritis and Rotavirus-coded Hospitalizations in 18 States, children aged <5 yrs, 2000-2008 Estimated reduction in US hospitalizations 2008: >40,000 Vaccine recommended Curns A et al JID 2010 5
Number of Gastroenteritis and Rotavirus-confirmed Hospitalizations NVSN 2006-2010 Payne D et al 2010 7
RV1: Post-marketing IS studies 8
RV5: Post-marketing IS studies 9
Estimate of Benefits: Inputs Rotavirus Burden and Vaccination Updated inputs to model of Widdowson M, Meltzer M et al., Pediatrics 2007;119:684-97 11
Estimate of Benefits: Results Rotavirus Disease Prevented with Vaccination 12
Estimate of Risk : Input IS risk in one vaccinated birth cohort 13
Baseline Rate of Intussusception <1% 0 0 0 0 2% 5% 18 68 7% Proportion of total rota1 doses given, by age group 14
Age at Rotavirus Vaccine Dose 1 National Immunization Survey 2009 1% 1% 1% <1% 3% 6% 15 66 9% Percentage of total Rota1 doses given, by age group 15
Estimate of Risk: Results Excess Intussusception Cases Background: ~1,900 infants with IS annually Number of cases caused by vaccine if RR = 4.6, by age group. TOTAL = 48 4 4 1% 1% 1% <1% 8 5 3% 2 9% 2 5 66 15 6% Percentage of total Rota1 doses given, by age group 16
Estimate of Risk: Results Excess Intussusception 17
Estimate of Risk: Results Attributable Intussusception Risk Estimated attributable risk following Rotashield: ~1 case per 10,000 infants, Peter G et al. Pediatrics 2002 18
Benefits vs. Risks: Summary of Estimates One vaccinated birth cohort to age 5 years 19
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 recommended vaccines without deductibles or co-pays, when delivered by an in-network provider
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 diseases q A decision to not vaccinate or to delay vaccination is not a risk-free decision
www.cdc.gov/vaccines For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findingsand 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. National Center for Immunization & Respiratory Diseases
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
Advisory Committee on Immunization Practices THE CHILDHOOD IMMUNIZATION SCHEDULE
Comparing Vaccinated, Unvaccinated, and UndervaccinatedChildren 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: 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
Percent Vacc cinated (95% CI) 100 90 80 70 60 50 40 30 20 10 0 Cumulative percent of children born in 2007 vaccinated with 1 dose of MMR vaccine, by month of age, United States 12 13 14 15 16 17 18 19 Age (months) Source: 2008-2010 National Immunization Survey
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% HepB ( 3 doses) 91.8% Rotavirus (2 or 3 doses) 59.2% Poliovirus 93.3% 4:3:1:3:3:1:4 70.2% Novaccines 0.7% Morbid Mortal WklyRep 2011;60 (34):1157-1163
Cumulative percent of children born in 2007 vaccinated with 1st dose of DTaP vaccine, by month of age, United States Percent vaccin nated (95% CI) 100 90 80 70 60 50 40 30 20 10 0 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Age (months) Source: 2008-2010 National Immunization Survey
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 ~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
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
Events / 100,00 00 Doses 350 300 250 200 150 100 50 Outpatient Visits for Fever by Day after Vaccine at Northern California Kaiser Permanente: 1995-2008 Age 12-23 months 6241 total fever visits after 302,670 MMR+V, 147,762 MMR, 46,390 MMRV, 38,251 VZV MMR MMR+V MMRV V 0 0 5 10 15 20 25 30 35 40 Days after Immunization Vaccine Safety Datalink; Immunization Safety Office, CDC
Data on Simultaneous Administration for a Licensed Vaccine: ROTARIX q 484 healthy infants randomized into two groups q All received Pediarix, PCV7, and ActHibat 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-Elyazeedet al, ICAAC 2007
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
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 Failure to provide simultaneous vaccinations Inappropriate contraindications Office policies/administrative barriers Non-vaccinating health care providers