School Immunization Requirements Daniel Salmon, PhD, MPH Associate Professor Johns Hopkins Bloomberg School of Public Health Compulsory Vaccination Laws in US • Massachusetts (1809) General Population Jacobson v. Massachusetts • Upheld rights of states to compel vaccination • Foundation for public health law • Focus on School Populations Zucht v. King (1922) Growth of State Laws requiring Vaccination • 20 States – 1963 • 29 State – 1970 Incidence of Measles according to evidence of Mandatory School Entry Requirements 1973 States With Laws Without Laws No. of States 35 16 1974 Cases 1 26.5 No. of States 40 Cases 1 33.1 53.9 11 55.4 1 = Cases per 100,000 <18 Years Adapted from Orenstein et al, JID; 1978. Incidence of Reported Measles in States Enforcing School Immunization Laws 1977 Cases 1 1978 (first 31 wks.) Cases 1 6 States that Strictly Enforce Laws 40.6 2.7 Remainder of Nation 90.3 35.2 1 = Reported Measles Cases per 100,000 < 18 years old Adapted from: Measles and school immunization Requirements – US, 1978, MMWR: 1978 School Immunization Laws • Prevent outbreaks • Provide safety net • Demonstrates public commitment to immunization • Assist introduction of new vaccines 80 70 60 50 40 30 20 10 0 Vaccine Coverage (%) Estimated Varicella Vaccination Coverage among Children 19-35 Months of Age by State US, National Immunization Survey, 2000 National Varicella Vaccine Coverage Level 67.8% 90 Idaho South Dakota Alaska Illinois Washington Iowa Utah Mississippi Montana Maine Wisconsin Vermont Wyoming Kansas Indiana North Dakota West Virginia Missouri Ohio Colorado Florida Nevada Minnesota Kentucky Nebraska Louisiana Arizona New Hampshire New Jersey New Mexico Delaware Michigan Tennessee- 1999 South Carolina New York Oklahoma- 1998 Texas Pennsylvania Georgia Alabama California Connecticut North Carolina Oregon Hawaii Virginia- 1999 Arkansas Massachusetts-… Rhode Island- 1999 Maryland- 1998 District of… State Indicates that a varicella childcare requirement was implemented prior to 2000. For these states, year of implementation is given. How School Immunization Requirements Work in US • All State Laws (not Federal) • Wide Variability in Implementation Antigens required Process for adding antigens or making changes Applicable Populations Who provides documentation Exemptions to School Immunization Laws TYPE OF EXEMPTION(S) ALLOWED Philosophic, Religious & Medical (20) Religious & Medical (29) Medical only (2) updated March 2005 www.vaccinesafety.edu State Implementation of Exemptions • Wide variability • Easy process = High rates Rota et al. AJPH, 2000 Easy Exemption Process Associated with High Rates Exemption Rate Administrative Difficulty Low (<0.5%) Medium (0.5% - 1.0%) High (>1.0%) Easy RI, OK, MO, HI, PA AK, AZ, VT, CA, MD WA, ID, WI, MI, OR Medium ND, CT, IL, NC, AL, NY, OH, KS, NJ, LA MA UT, SD, CO Hard WY, NH, MT, VA, IN, AR, MN, KY, GA, TN IA, DE, CS, ME, NM, TX, NV, FL, NE Rota et al AJPH, 2000. State Implementation of Exemptions • Wide variability • Easy process = High rates • Little contact between parents and health personnel • Majority of states (67%) never deny exemptions • States rely on schools to implement exemptions Rota et al. AJPH, 2000. Increased Risk of Disease for Exemptions • • • • • Measles Pertussis Haemophilus influenzae type b Varicella Pneumococcal Relative Risk of Measles and Pertussis in Exemptors from School Laws CO (1987-98)1 Measles Pertussis 22 5.9 U.S. (1985-1992)2 35 1= Feikin et al. JAMA. 2000. 2 = Salmon et al, JAMA. 1999. School Exemption Rates in Counties With and Without Pertussis Outbreaks: Colorado Counties with outbreaks 4.7% Counties without outbreaks 1.3% p = .001 Feikin et al, JAMA. 2000. Nonmedical Exemptions for States With Religious Exemptions and With Personal Belief Exemptions -1991 - 2007 Personal Belief Exemptions Permitted Exemption Rate Only Religious Exemptions Permitted Omer et al., JAMA, 2006 Data Updated Nonmedical Exemptions by Ease of Exemption,1991 - 2007 Easy Exemption Policy Medium Exemption Policy Omer et al., JAMA, 2006 Data Updated Difficult Exemption Policy Mean (95% CI) Rates of Nonmedical Exemptions by Type & Ease of Exemption, 2006–2011 Omer et al., NEJM, 2012 Associations between State Exemption Policies and Pertussis Incidence, 19862004 Unadjusted IRR (95% CI) Adjusted IRR (95% CI) Only Religious Exemption Reference Reference Personal Belief Exemption 2.06 (1.77-2.40) 1.48 (1.03-2.13) Difficult Reference Reference Medium 1.27 (1.06-1.51) 1.35 (0.96-1.91) Easy 1.90 (1.60-2.28) 1.53 (1.10-2.14) Type of exemption Exemption ease Adjusting for allowing parental signature for school immunization forms, proportion inside urbanized area, income (11 categories), and education (7 categories) Omer et al, JAMA, 2006 Within State Variations in Implementing Exemptions • Wide variability in how schools interpret and enforce exemptions • Easier processes for granting exemptions associated with higher rates of exemptions • Schools often do not discuss risks and benefits with parents considering an exemption Salmon et al, Pediatrics, 2004 School Personnel KABs Associated with Children Having Exemption • • • • • • • Training of school personnel Perceived Susceptibility and Severity of Disease Perceived Safety and Efficacy of Vaccination Who Benefits from Vaccination (Individual and Community) Vaccine Misconceptions Children get more immunizations than are good for them Concerned immune system weakened by too many vaccines Confidence in local and state health departments Use of alternative medicine Salmon et al, AJPH, 2004. Relative Locations of Pertussis Space-time Clusters & Exemptions Spatial Clusters (Omer et al, AJE, 2008) Overlap of Exemptions Clusters with Pertussis Clusters Unadjusted OR 3.0 (2.5 – 3.6) Adjusted1 OR 3.4 (2.8 – 4.1) WA State Counties’ School Exemption Rates 1999 Whatcom San Juan Clallam Skagit Island Stevens Chelan Douglas King Grays Mason Harbor Pierce Lewis Cowlitz Kittitas Grant Skamania Klickitat 2.0-2.9% Lincoln Adams Franklin Yakima Clark <2.0% Ferry Snohomish Jefferson Pacific Okanogan Pend Oreille Benton 3.0-3.9% Source: WA State Department of Health Walla Walla 4.0-4.9% Spokane Whitman Garfield Asotin ≥5.0% WA State Counties’ School Exemption Rates 2004 Whatcom San Juan Clallam Skagit Island Chelan King Grays Harbor Mason Lewis Cowlitz Douglas Grant Skamania 2.0-2.9% Klickitat 3.0-3.9% Lincoln Adams Franklin Yakima Clark <2.0% Stevens Kittitas Pierce Pacific Ferry Okanogan Snohomish Jefferson Pend Oreille Walla Walla Benton 4.0-4.9% Source: WA State Department of Health Spokane Whitman Garfield Asotin ≥5.0% WA State Counties’ School Entry Exemption Rates, 2005-2006 San Juan 15.2% Island 11.1% Whatcom 7.5% Skagit 7.7% Clallam Snohomish 6.1% Chelan 6.3% Jefferson 2.3% Kitsap 19.4% King 6.4% 5.1% Grays Mason Kittitas Harbor 5.8% Pierce Thurston 2.8% 4.8% 3.9% 7% Pacific Lewis Yakima 9.7% 3% 1% Cowlitz Wahkiakum Skamania 2.6% 4.5% 8.5% Klickitat Clark 3.9% 5.4% <2.0% 2.0-2.9% WA State Dept. of Health Okanogan 8.2% Douglas 1% 3.0-3.9% Grant 3.7% Benton 3.2% Ferry 14.3% Lincoln 7.1% Adams 1.2% Pend Stevens Oreille 12.2% 12% Spokane 6.8% Whitman 3.1% Garfield Franklin Columbia Walla 1.3% Asotin 4% Walla 1.9% 2.7% Statewide Total: 5.1% 4.0-4.9% >5.0% WA State Counties’ School Entry Exemption Rates 2006-2007 Whatcom 8.1% San Juan 13.5% Clallam 7.9% Jefferson 14.9% Island 9.0% Kitsap 9.5% Grays Mason Harbor 7.4% 4.1% Thurston 8.0% Pacific 3.6% Wahkiakum (no report) Clark 6.1% <2.0% Snohomish 7.5% Chelan 3.1% King 5.5% Kittitas Pierce 5.1% 6.3% Lewis 3.7% Cowlitz 3.8% Okanogan 10.6% Skagit 6.7% Skamania 9.5% 2.0-2.9% Yakima 1.2% Klickitat 7.8% 3.0-3.9% WA State Dept. of Health Douglas 2.1% Grant 5.1% Benton 4.1% Ferry 30.5% Lincoln 9.1% Adams 1.4% Pend Stevens Oreille 16.5% 17.8% Spokane 9.2% Whitman 5.7% Garfield 3.7% Columbia Asotin Walla Walla 7.5% 3.5% 3.8% Franklin 1.5% Statewide Total: 6.0% 4.0-4.9% >5.0% WA State Counties’ School Entry Exemption Rates 2007-2008 Whatcom San Juan 9.9% 9.9% Okanogan Skagit Island 7.8% Jefferson 13.7% Wahkiakum (No Report) 4.2% 3.7% 4.5% 5.1% Cowlitz 3.6% 1.8% 5.8% WA State Dept. of Health – School Status Reports 2007-2008 6.5% Columbia Walla Walla 4.9% (no report) 0.0% Asotin 4.8% Klickitat 5.5% 7.2% 2.0-2.9% Benton 3.7% Skamania Whitman Garfield Franklin Yakima 1.7% Adams 3.5% Lewis 4.0% 9.2% 10.2% Grant Kittitas Pierce Clark <2.0% 19.3% Spokane Lincoln 5.5% Mason Thurston Douglas 3.4% King 10.6% 6.3% Chelan 3.1% Kitsap 8.0% Pacific 13.5% Snohomish 7.9% 4.9% 25.8% 13.8% Clallam Grays Harbor Ferry 13.6% 11.7% Pend Stevens Oreille 3.0-3.9% Statewide Total: 6.3% 4.0-4.9% >5.0% >10.0% WA State Counties’ School Entry Exemption Rates 2012-2013 Whatcom San Juan 7.5% 11.6% Okanogan Skagit 5.7% Island 5.3% Jefferson 12.4% Wahkiakum 10.3% 4.4% Cowlitz 4.7% 1.9% No Data WA State Dept. of Health – School Status Reports 2007-2008 4.9% Columbia Walla Walla 3.0% 0.0% 0.0% Asotin 4.3% Klickitat 7.2% 6.4% 2.0-2.9% Benton 3.0% Skamania Whitman Garfield Franklin Yakima 0.8% Adams 2.5% Lewis 3.3% 6.1% 10.6% 1.8% 4.7% 3.4% Spokane Grant Kittitas Pierce Clark <2.0% 14.2% Lincoln 4.7% Mason Thurston Douglas 0.6% King 5.4% 3.1% Chelan 2.9% Kitsap 4.9% Pacific 8.7% Snohomish 4.1% 2.0% 8.2% Pend Stevens Oreille 5.1% Clallam Grays Harbor Ferry 4.9% 3.0-3.9% Statewide Total: 4.5% 4.0-4.9% >5.0% >10.0% Why Do Parents Claim Exemptions? Comparison of Maximum and Current Reported Morbidity, Selected Vaccine-Preventable Diseases, United States, 2011 Disease Smallpox Diphtheria Measles Mumps Pertussis Polio (paralytic) Rubella Cong. Rubella Synd. Tetanus H.Influenzae type b and unknown ( < 5 yrs) Total Pre-vaccine Era* 2011 % change 29,005 21,053 530,217 162,344 200,752 16,316 47,745 152 580 20,000 0 0 212 370 15,216 0 4 0 9 8 100% 100% >99% >99% 92% 100% >99% 100% 98% >99% 1,064,854 15,607 99% * Estimated because no national reporting existed in the prevaccine era Comparison of Maximum and Current Reported Morbidity, Selected Vaccine-Preventable Diseases & Vaccine Adverse Events, United States, 2011 Disease Smallpox Diphtheria Measles Mumps Pertussis Polio (paralytic) Rubella Cong. Rubella Synd. Tetanus H.Influenzae type b and unknown ( < 5 yrs) Total Reported Vaccine Adverse Events** Pre-vaccine Era* 2011 % change 29,005 21,053 530,217 162,344 200,752 16,316 47,745 152 580 20,000 0 0 212 370 15,216 0 4 0 9 8 100% 100% >99% >99% 92% 100% >99% 100% 98% >99% 1,064,854 15,607 99% 9,318 100% 0 * Estimated because no national reporting existed in the prevaccine era ** Reported to VAERS – may or may not be due to vaccination Chen Why Do Parents Claim Exemptions? • Perceived Susceptibility and Severity of Disease • Perceived Safety and Effectiveness of Vaccination • Trust in Health Care Providers and the Gov’t Salmon et al. Archives of Ped and Adolescent Med. 2005. Non-Medical Exemptions and Legal Issues • States are not required to offer non-medical exemptions • If states offer non-medical exemptions Can create administrative requirements May not be able to focus on nature of religion Arkansas • State Permits Religious Exemption (7/02) "immunization conflicts with the religious tenets and practices of a recognized church or religious denomination of which the parent . . . is an adherent or member." Must provide copy of religious doctrine and details of religious organization • Parent requests exemption for Hepatitis B • State rejects exemption request • Parent files lawsuit – goes to US District Court US District Court • Arkansas religious exemption violates Establishment and Free Exercise Clauses of the 1st Amendment Equal Protection Clause of the 14th Amendment • Eliminated Religious Exemption • Severed from School Requirement and Medical Exemption • Judge suggests legislative relief Lemon v. Kurtzman, 403 U.S. 602 Arkansas Reaction • Momentum gaining for broadly written PE • Johns Hopkins Letter to Fay Boozman • AR Medical Society requests our assistance Model Legislation for Non-Medical Exemption • Parent Furnish signed, personal statement explaining reasons for exemption request Documentation from licensed physician or DOH that parent has received individual educational counseling • State weighs strength of parent conviction with risks of granting exemption: Vaccination Rates Community vulnerability to disease outbreaks Prevalence of VPDs Salmon et al, AJPH 2005 Model Legislation for Non-Medical Exemption (cont) • State may reject exemption request based on this balance • Appeals process for exemptions that have been declined • If exemption granted, must be annually renewed Salmon, Sapsin, Teret, Halsey Arkansas Non-Medical Exemption • DOH rejects authority to deny exemption request • Includes assessment of impact of change in law Impact of Philosophical Exemption in Arkansas Exemption Type 2001-02 2002-03 2003-04 2004-2005 Medical 110 139 64 62 Religious 419 512 297 362 Phil. 0 0 403 721 Total 529 651 764 1145 Thompson et al, AJPM, 2007 Impact of Philosophical Exemption in Arkansas Exemptions 2001-02 529 2002-03 2003-04 2004-2005 651 764 1145 % Increase from Previous Year 23% 17% 50% Absolute Increase from Previous Year 122 113 381 Total Absolute or % Increase? Thompson et al, AJPM, 2007 Texas Requires HPV Vaccine • All 6th grade girls in 2008 • Passed by Governor Order No public comment Texas Requires HPV Vaccine • All 6th grade girls in 2008 • Passed by Governor Order No public comment • State legislature repealed School law issues moving forward • How to balance parental autonomy with public health goal of preventing disease? • Can states with high exemption rates and easy exemptions lower rates through administrative requirements? • What to do with new vaccines as they become available? School Immunization Requirements Daniel Salmon, PhD, MPH Associate Professor Johns Hopkins Bloomberg School of Public Health
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