1. School Immunization Requirements and the Role of Non-Medical Exemptions Daniel Salmon, PhD, MPH Institute for Vaccine Safety Johns Hopkins School of Public Health

2. Comparison of 20 th Century Annual Morbidity and Current Morbidity, Vaccine Preventable Diseases 20th Century Annual Morbidity † 2004* Percent Decrease Smallpox Diphtheria Measles Mumps Pertussis Polio (paralytic) Rubella Congenital Rubella Syndrome Tetanus H. influenzae, type b and unknown (<5 yrs) 48,164 175,885 503,282 152,209 147,271 16,316 47,745 823 1,314 20,000 ‡ 0 37 236 18,957 0 12 0 27 172 100% 99.99% 99.84% 87.13% 100% 99.97% 100% 97.95% 99.14% Disease † CDC. MMWR April 2, 1999. 48: 242-264 *Provisional 2004 Data ‡ Data are estimated

3. Compulsory Laws 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)

4. Growth of State Laws requiring Vaccination 20 States – 1963 29 State – 1970

5. Incidence of Measles according to evidence of Mandatory School Entry Requirements States No. of StatesCases 1 No. of StatesCases 1 With Laws 3526.5 40 33.1 Without Laws 1653.91155.4 19731974 Adapted from Orenstein, Halsey, Hayden et al, JID; 1978. 1 = Cases per 100,000 <18 Years

6. 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 40.62.7 Remainder of Nation90.335.2 Adapted from: Measles and school immunization Requirements – US, 1978, MMWR: 1978 1 = Reported Measles Cases per 100,000 < 18 years old

7. Measles Outbreak in Fairbanks, Alaska, 1976-1977 Recognized during outbreak that school law not being enforced Notified parents that school would exclude unvaccinated children Vaccination Clinics made available Excluded 7,418 children (8.3%) Within 60 days, only 51 children not met requirement By 1980, all 50 states had school immunization requirements Middaugh et al. JAMA. May 1978: 239(20): 2128-2130

8. School Immunization Laws Prevent outbreaks Provide safety net Demonstrates public commitment to immunization Assist introduction of new vaccines

9. 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% Vaccine Coverage (%) State Indicates that a varicella childcare requirement was implemented prior to 2000. For these states, year of implementation is given. J Seward 2001 Presentation to ACIP

10. updated March 2005 www.vaccinesafety.edu TYPE OF EXEMPTION(S) ALLOWED Exemptions to School Immunization Laws Religious & Medical (29) Medical only (2) Philosophic, Religious & Medical (19)

11. State Implementation of Exemptions Wide variability Easy process = High rates Rota JS. AJPH. April 2000: 91: 645-8.

12. Easy Exemption Process Associated with High Rates 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 MAUT, SD, CO Hard WY, NH, MT, VA, IN, AR, MN, KY, GA, TN IA, DE, CS, ME, NM, TX, NV, FL, NE Exemption Rate Rota JS. AJPH. April 2000: 91: 645-8.

13. State Implementation of Exemptions Wide variability Easy process = High rates Easier to claim exemption than fulfill requirement Little contact between parents and health personnel Majority of states (67%) never deny exemptions States rely on schools to implement exemptions Rota JS. AJPH. April 2000: 91: 645-8.

14. Relative Risk of Measles and Pertussis in Exemptors from School Laws CO (1987-98) 1 225.9 U.S. (1985-1992) 2 35 1= Feikin et al. JAMA. 2000 Dec 27: 284(24): 3145-50. 2=Salmon et al, JAMA. 1999 July 7; 282(1): 47-53. MeaslesPertussis

15. School Exemption Rates in Counties With and Without Pertussis Outbreaks: Colorado Counties with outbreaks4.7% Counties without outbreaks1.3% p =.001 Feikin et al. JAMA. 2000 Dec 27: 284(24): 3145-50.

16. Mean State Exemption Rates, by Exemption Type, 1991-2003

17. Association between State Immunization Policies and Pertussis Unadjusted IRR (95%CI) Adjusted IRR 1 (95%CI) Exemptions Ease Model Philosophical Exemptions Model Exemptions Ease1.43 (1.10-1.85)1.34 (1.03-1.73) Philosophical Exemptions1.99 (1.26-3.14)1.98 (1.26-3.12) Parental Signature1.26 (0.62-2.57)1.01 (0.53-1.95)0.71 (0.37-1.38) 1 = Adjusting for proportion Black and Hispanic and Inside Urban Area Omer et al. Unpublished

18. Association between State Policies and Pertussis, by Age Groups Omer et al. Unpublished

19. Association between State Policies and Pertussis, by Year Year Omer et al. Unpublished

21. Within State Variations in Implementing Exemptions Survey 1,000 schools in 4 states (MA, MO, CO and WA) School Implementation Procedures School personnel KABs Salmon et al. Pediatrics. 2004 June 6; 113(6): 552-559.

22. Association Between School Policies and Likelihood of Child Having an Exemption Instruction for Completing Immunization Requirement Mailed to Parent Pre- Enrollment (MO, CO, WA) School Permits Philosophical Exemption (MA & MO) Ease of Obtaining Exemption (MA & MO) 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 Salmon et al. AJPH, March 2005

23. School Personnel KABs Associated with Children Having Exemption 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. Pediatrics, June 2004.

24. 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. In press.

25. Differences between Parents of Exempt and Vaccinated Children? Who Benefits from Vaccination Susceptibility and Severity of Disease Safety and Efficacy of Vaccination Vaccine Misconceptions Trust in Government Type of Primary Health Care Provider Salmon et al. Archives of Ped and Adolescent Med. In press.

26. Non-Medical Exemptions and Legal Issues States are not required to offer non- medical exemptions If states do offer non-medical exemptions –Can create administrative requirements –May not be able to focus on nature of religion

27. 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

28. US District Court Ruling 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

29. Arkansas Reaction Momentum gaining for broadly written PE Letter to Fay Boozman AR Medical Society requests our assistance

30. 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 In Press

31. 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 et al. AJPH In Press

32. Arkansas Non-Medical Exemption DOH rejects authority to deny exemption request Includes assessment of impact of change in law

33. Non-Medical Exemption Schemes With State Examples +- + QUADRANT 1 Examination of an applicant’s strength/sincerity of beliefs QUADRANT 2 Minimal or no administrative discretion regarding exemption request California, Colorado Washington, Texas (2003) - QUADRANT 3 Exemptions limited by offering only to groups with certain characteristics Arkansas (pre-2003), New York (pre-1987) Texas (pre-2003) QUADRANT 4 Exemptions offered with no discernible or consistent standards Degree of public health protection based on administrative procedures that may limit the number and clustering of exemptions. Degree of legal security based on potential for constitutional invalidity. Arkansas (post 2003) New York (post 1987) LEGAL SECURITY PUBLIC HEALTH PROTECTION

34. School Immunization Requirements and the Role of Non-Medical Exemptions Daniel Salmon, PhD, MPH Institute for Vaccine Safety Johns Hopkins School of Public Health