Threats and Challenges to Childhood Health I

Threats and Challenges to Childhood Health: Vaccines Daniel Salmon, PhD, MPH College of Medicine, University of Florida Institute for Vaccine Safety, Johns Hopkins Comparison of Maximum and Current Reported Morbidity, Vaccine-Preventable Diseases and Vaccine Adverse Events, United States Disease Smallpox Diphtheria Measles Mumps Pertussis Polio (paralytic) Rubella Cong. Rubella Synd. Tetanus H.Influenzae type b and Unknown ( < 5 yrs) Pre-vaccine Era* 48,164 175,885 503,282 152,209 147,271 16,316 47,745 823 1,314 20,000 2005 0 0 66 314 25,616 1 11 1 27 226 % change 100% 100% >99% >99% 83% >99% >99% >99% 98% 99% Total 1,064,854 26,262 -98% * Estimated because no national reporting existed in the prevaccine era Comparison of Maximum and Current Reported Morbidity, Vaccine-Preventable Diseases and Vaccine Adverse Events, United States Disease Smallpox Diphtheria Measles Mumps Pertussis Polio (paralytic) Rubella Cong. Rubella Synd. Tetanus H.Influenzae type b and Unknown ( < 5 yrs) Pre-vaccine Era* 48,164 175,885 503,282 152,209 147,271 16,316 47,745 823 1,314 20,000 2005 0 0 66 314 25,616 1 11 1 27 226 % change 100% 100% >99% >99% 83% >99% >99% >99% 98% 99% Total 1,064,854 26,262 -98% Vaccine Adverse Events 0 15,472 +++ * Estimated because no national reporting existed in the prevaccine era Evolution of Immunization Program and Prominence of Vaccine Safety 1 Prevaccine 2 Increasing Coverage 3 Loss of Confidence 4 Resumption of Confidence 5 Eradication Vaccinations Stopped Disease Incidence ? Feasible In era of BT Vaccine Coverage Adverse Events Eradication Outbreak Maturity Chen, CDC Undervaccinated Preschool Children • Black • Younger mothers who are not married and no college degree • Household income near poverty • Live in city Smith et al, Pediatrics, 2004. Unvaccinated Preschool Children Zero Dose Kids • • • • White Mother who is married and college degree Family annual income >$75,000 Parent expressed concern about vaccine safety Smith et al, Pediatrics, 2004. School Immunization Requirements 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 Easy Medium Hard Low (<0.5%) RI, OK, MO, HI, PA ND, CT, IL, NC, AL, NY, OH, KS, NJ, LA Medium (0.5% - 1.0%) AK, AZ, VT, CA, MD High (>1.0%) WA, ID, WI, MI, OR MA UT, SD, CO 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. Relative Risk of Measles and Pertussis in Exemptors from School Laws Measles Pertussis CO (1987-98)1 U.S. (1985-1992)2 22 35 5.9 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 Counties without outbreaks 4.7% 1.3% p = .001 Feikin et al, JAMA. 2000.. Mean State Percent and Inter-Quartile Ranges of Non-Medical Exemptions by Exemption Type, 1991-2004 Religious 4.0% Personal Belief/Philosophical 4.0% 3.0% Exemption Rate Exemption Rate 3.0% 2.0% 2.0% 1.0% 1.0% 0.0% 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 0.0% 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Omer et al., JAMA, 2006 Mean State Percent and Inter-Quartile Ranges of Non-Medical Exemptions by Exemption Ease, 1991-2004 Difficult 5.0% 4.0% Exemption Rate Medium 5.0% 5.0% 4.0% Exemption Rate Easy 4.0% 3.0% 2.0% 1.0% 0.0% 1990 1991 1992 1993 1994 1995 1996 19971998 1999 2000 2001 2002 20032004 Exemption Rate 3.0% 2.0% 1.0% 0.0% 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 20002001 2002 2003 2004 3.0% 2.0% 1.0% 0.0% 1990 1991 1992 19931994 1995 1996 1997 1998 1999 20002001 2002 2003 2004 Omer et al., JAMA, 2006 Associations between State Exemption Policies and Pertussis Incidence, 1986-2004 Unadjusted IRR (95% CI) Adjusted IRR (95% CI) Type of exemption Only Religious Exemption Personal Belief Exemption Reference 2.06 (1.77-2.40) Reference 1.48 (1.03-2.13) Exemption ease Difficult Medium Easy Reference 1.27 (1.06-1.51) 1.90 (1.60-2.28) Reference 1.35 (0.96-1.91) 1.53 (1.10-2.14) 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 • Survey 1,000 schools in 4 states (CO, MA, MO and WA) • School Implementation Procedures • School personnel KABs Salmon et al, Pediatrics, 2004 Association Between School Policies and Likelihood of Child Having an Exemption RESPONDENTS' REPORT OF SCHOOL POLICY School permits philosophical exemptions LESS LIKELY TO CLAIM EXCEMPTION NO EFFECT MORE LIKELY TO CLAIM EXCEMPTION 1.64 1.13 Instructions for completing immunization requirement mailed to parents pre-enrollment1 Increased administrative difficulty2 to claim an exemption If school permits philosophical exemptions, letter required from parent .50 .53 .68 .88 State Does Not Authorize Philosophical Exemptions (MA & MO) State Authorizes Philosophical Exemptions (CO & WA) .85 .78 .70 School has authority to deny exemption request 1.08 1.10 Exemption ever denied School has written policy to inform parents of the exemption option 1 – MO only for black bar - Question not asked in MA 2 – Administrative difficulty construct ranges from 0-4, based on (1) requirements for annual renewal; (2) letter from parent for religious exemption; (3) signature from religious leader, school or physician; and (4) informing parents requesting exemption of risks of not vaccinating .96 1.63 .84 .25 .5 1 2 4 Odds Ratio and 95% Confidence Interval Adjusted for type of school, whether respondent was trained as nurse and the state 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. WA State Counties’ School Entry Exemption Rates 2005-2006 San Juan 15.2% Whatcom 7.5% Skagit Island Clallam 6.1% 11.1% 7.7% Okanogan 8.2% Ferry 14.3% Pend Stevens Oreille 12% 12.2% Snohomish 6.3% Jefferson 19.4% Chelan 2.3% Kitsap 6.4% Douglas 1% King 5.1% Lincoln 7.1% Spokane 6.8% Grays Harbor 4.8% Mason 5.8% Thurston 7% Pierce 3.9% Kittitas 2.8% Grant 3.7% Adams 1.2% Whitman 3.1% Pacific 9.7% Lewis 3% Franklin Yakima 1.3% 1% Garfield Columbia 4% Wahkiakum 4.5% Cowlitz 2.6% Benton 3.2% Skamania 8.5% Walla Walla 2.7% Asotin 1.9% Clark 5.4% Klickitat 3.9% Statewide Total: 5.1% 4.0-4.9% >5.0% <2.0% 2.0-2.9% 3.0-3.9% WA State Dept. of Health – School Status Reports 2005-2006 Why Do Parents Claim Exemptions? • Survey of the parents of 800 Exemptions and 1600 Vaccinated children – 4 states (CO, MA, MO & WA) – Recruited from over 100 public and private elementary schools – Matched by state, school, & grade Salmon et al. Archives of Ped and Adolescent Med. 2005. Reasons Parents State for Not Vaccinating Reason for Not Vaccinating 1 1. Vaccine might cause harm 2. Vaccines might overload immune system 3. My child not at risk for the disease(s) 4. Disease(s) not dangerous Freq. 190 136 103 58 % 69 49 37 21 1 Not Mutually Exclusive Reasons Parents State for Not Vaccinating [CONTINUED] Reason for Not Vaccinating 1 Freq. % 5. Vaccine might not work 6. Ethical or moral issues 2 7. Contrary to religious beliefs 36 25 25 13 9 9 1 Not Mutually Exclusive 2 Includes use of aborted cell lines, fetal tissue and blood, animal testing, opposed to requirements, and restatement of above issues Parents Who Report a Moderate or Great Deal of Benefit When a Child Is Fully Vaccinated 100 75 % Non-Med Exempt % Vaccinated Percent 50 p<0.01 p<0.01 p=0.01 p=0.21 p=0.94 25 0 Child Community Vac Co.s Doctors Gov't Who Benefits when Child is Fully Vaccinated Parents Perceptions by Child's Vaccination Status 100 75 % Non-Med Exempt % Vaccinated Percent 50 25 0 p<0.01 p<0.01 p<0.01 p<0.01 p<0.01 p<0.01 Low Low Low Low Disease Disease Vaccine Vaccine Suscept Severity Efficacy Safety Low Trust in HCP Low Trust in Govt Adjusted Odds Ratios of Child Having Non-Medical Exemption Associated with Parental Perceptions Perception Disease OR Susceptibility Severity Efficacy CI 2.8-6.0 1.5-3.2 1.3-3.0 4.1 2.2 2.0 Vaccine Trust Safety HC Providers 3.8 0.7 2.5-5.6 0.5-1.1 Government 1.9 1.3-2.8 Non-Medical Exemptions and Legal Issues • States are not required to offer nonmedical 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 • Three Prong Lemon Test – Legislature must have secular purpose – Primary effect must not advance nor inhibit religion – Must not result in excessive entanglement of government with religion Lemon v. Kurtzman, 403 U.S. 602 US District Court Ruling • Fails 2nd and 3rd Prong of Lemon Test, Clearly runs afoul of: – 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 McCarthy v. Boozman, 01-2266 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 Medical 2001-02 110 2002-03 2003-04 2004-2005 139 64 62 Religious Phil. Total 419 0 529 512 0 651 297 403 764 362 721 1145 Thompson et al, AJPM, 2007 GRAVETTE PEA RIDGE PEA RIDGE EUREKA SPRINGS Carroll BERRYVILLE OMAHA GREEN FOREST BRUNO-PY ATT BRUNO-PY ATT LEAD HILL BRUNO- Baxter MOUNTAIN HOME DECATUR BENTONVILLE ROGERS PYATT VIOLA SALEM MAMMOTH SPRING WILLIFORD RANDOLPH COUNTY MAYNARD Clay CORNING PIGGOTT Boone BERGMAN HARRISON FLIPPIN Randolph COTTER Benton GENTRY SILOAM SPRINGS SPRINGDALE HUNTSVILLE FARMINGTON FAYETTEVILLE PRAIRIE GROVE LINCOLN WEST FORK KINGSTON ALPENA Marion HARRISON YELLVILLESUMMIT VALLEY SPRINGS BRUNO-PY ATT Fulton IZARD NORFORK CALICO ROCK HIGHLAND BIGGERS-REYNO RECTOR Sharp EVENING SHADE WILLIFORD POCAHONTAS SLOAN-HENDRIX BLACK ROCK DELAPLAINE MARMADUKE GREENE COUNTY TECH PARAGOULD Izard LYNN RIVER VALLEY MOUNT PLEASANT CAVE CITY WALNUT RIDGE Greene BUFFALO ISLAND GOSNELL CENTRAL Madison GREENLAND ELKINS JASPER WESTERN GROVE BRUNO-PY ATT ST JOE . MARSHALL STONE COUNTY STONE COUNTY LESLIE WITTS SPRINGS RURAL SPECIAL SHIRLEY CLINTON MELBOURNE HOXIE Lawrence WALNUT RIDGE SWIFTON GREENE COUNTY TECH MOUNT JUDEA ST PAUL . Searcy Washington WINSLOW CEDARVILLE Newton DEER MOUNTAIN VIEW CUSHMAN Independence CORDCHARLOTTE SULPHUR ROCK WESTSIDE BROOKLAND CONSOLIDATED JONESBORO NETTLETON VALLEY VIEW BAY TRUMANN Craighead ARMOREL MANILA BLYTHEVILLE WEST FORK Stone ALREAD BATESVILLE RIVERSIDE Mississippi OSCEOLA SO. MISS. COUNTY MOUNTAINBURG OZARK Franklin OZARK Crawford ALMA OARK LAMAR DOVER HECTOR Cleburne WEST SIDE CONCORD SOUTHSIDE NEWARK MIDLAND JACKSON Poinsett WEINER HARRISBURG EAST POINSETT PLEASANT VIEW MULBERRY Johnson Van Buren SCOTLAND WONDERVIEW NEMO VISTA SOUTH SIDE GUY-PERKINS Jackson MARKEDREE NEWPORT CROSS COUNTY EARLE CLARKSVILLE VAN BUREN FORT SMITH LAVACA WESTSIDE ALTUS DENNING SCRANTON Pope RUSSELLVILLE QUITMAN BRADFORD HEBER WILBURN SPRINGS WHITE COUNTY CENTRAL PANGBURN BALD KNOB AUGUSTA EAST POINSETT TURRELL MARION COUNTY LINE CHARLESTON GREENWOOD HACKETT ROSE BUD PARIS MAGAZINE ATKINS POTTSVILLE DARDANELLE SO. CONWAY WESTERN YELL DANVILLE White SEARCY MCRAE Cross WYNNE MCCRORY PARKIN CRAWFORDSVILLE Conway GREENBRIER Sebastian BOONEVILLE HARTFORD MANSFIELD Faulkner CONWAY MAYFLOWER MT. VERNON/ ENOLA BEEBE Crittenden WEST MEMPHIS RIVERVIEW Woodruff COTTON PLANT VILONIA St. Francis FORREST CITY HUGHES Logan Yell OLA PLAINVIEWROVER PERRY-CASA EAST END PERRY-CASA Perry PERRYVILLE DES ARC CABOT PALESTINE/WHEATLEY WALDRON PULASKI COUNTY SPECIAL PARON JESSIEVILLE ODEN ODEN MOUNTAIN PINE Prairie BRINKLEY LEE COUNTY HAZEN DEVALLS BLUFF HAZEN FOURCHE VALLEY Pulaski N. LITTLE ROCK LITTLE ROCK BRY ANT Scott ACORN LONOKE Saline FOUNTAIN LAKE CLARENDON CLARENDON Lonoke CARLISLE ENGLAND HAZEN HUMPHREY Lee BARTONLEXA HELENA/ W.HELENA LAKE VIEW Monroe HOLLY GROVE MARVELL STUTTGART MOUNT IDA MENA HATFIELD Montgomery CADDO HILLS Garland LAKE HAMILTON BENTON CUTTER-MORNING STAR HARMONY HOT GROVE SPRINGS MAGNET COVE GLEN ROSE POYEN BAUXITE VAN COVE Polk UMPIRE KIRBY LAKESIDE BISMARCK WHITE HALL SHERIDAN DOLLARWAY Jefferson Hot Spring ALTHEIMER UNIFIED Arkansas DEWITT Phillips ELAINE WICKES DIERKS DEQUEEN Pike CENTERPOINT OUACHITA MALVERN DOLLARWAY Clark CARTHAGE ARKADELPHIA DELIGHT Grant PINE BLUFF WATSON CHAPEL GRADY GOULD GILLETT Howard MURFREESBORO Sevier LOCKESBURG HORATIO MINERAL SPRINGS NASHVILLE Cleveland CARTHAGE SPARKMAN GURDON Dallas FORDYCE RISON WOODLAWN KINGSLAND STAR CITY DUMAS DELTA SPECIAL BLEVINS PRESCOTT Lincoln Desha MCGEHEE EMMET ASHDOWN FOREMAN SARATOGA HOPE BEARDEN CAMDEN FAIRVIEW NEVADA HARMONY GROVE WARREN MONTICELLO ARKANSAS CITY Little River Hempstead SPRING HILL TEXARKANA Nevada MCNEIL Ouachita STEPHENS SMACKOVER MOUNT HOLLY Calhoun DREW CENTRAL HAMPTON DERMOTT Bradley NORPHLET HERMITAGE Drew LAKESIDE FOUNTAIN HILL Exemptions per 1000 0 >0 to to <=5 <=10 GENOA CENTRAL LAFAYETTE COUNTY WALDO Miller FOUKE TAYLOR BRADLEY BRIGHT STAR MAGNOLIA WALKER WALKER EMERSON Chicot MOUNT HOLLY UNION EL DORADO STRONG HUTTIG CROSSETT HAMBURG PARKERS CHAPEL EUDORA Lafayette Columbia JUNCTION CITY Union Ashley >5 >10 to <=15 Source: Arkansas Center for Health Improvement, the Department of Education, Arkansas Department of Health and the Census 2002 TIGER Lines Files. >15 0 5 10 20 30 Miles Thompson et al, AJPM, 2007 Impact of Philosophical Exemption in Arkansas Exemptions Total % Increase from Previous Year Absolute Increase from Previous Year 2001-02 529 2002-03 2003-04 2004-2005 651 23% 122 764 17% 113 1145 50% 381 Absolute or % Increase? Thompson et al, AJPM, 2007 Association of Immunization Managers (AIM) Position • Must be used sparingly, approached cautiously, and considered only after an appropriate vaccine implementation period – – – – – Funding for vaccine Physician/provider and public support Stable and adequate vaccine supply Adequate data to assure vaccine safety Significant uptake in the recommended population to reduce the compliance burden on the school/child care system Association of Immunization Managers (AIM) Position – cont. • Inappropriate application of mandates risks loss of support for immunization programs • Must be pursued through existing state processes. Legislators, advocates, consumer groups, manufacturers, and others interested in pursuing school and child care immunization requirements should first contact the state health agency immunization program. Association of Immunization Managers (AIM) Position – cont. • Measures to add or alter exemptions to laws must be carefully coordinated with state immunization policy and goals. Opening existing laws for this purpose risks having an effective mandate weakened, altered in an undesirable way, or even revoked entirely. Human Papillomavirus (HPV) • • • • Most common STI 100+ genotypes Often asymptomatic and transient Can lead to cervical, vaginal, vulvar, anal and penile cancer and genital warts • Vaccine highly efficacious against 4 strains causing 70% of cervical cancer and 90% of warts Compulsory HPV Vaccine • Texas – All 6th grade girls in 2008 – Passed by Governor Order • No public comment – Overturned by legislature Compulsory HPV Vaccine in Other States • 24 States and DC have laws pending • Virginia passed HPV vaccine mandated – Exemption for HPV vaccine expanded – Exemption not changed for other vaccines – May cause slippery slope Threats and Challenges to Childhood Health: Vaccines Daniel Salmon, PhD, MPH College of Medicine, University of Florida Institute for Vaccine Safety, Johns Hopkins