Vaccine Law

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Vaccine Law PolicyRoss D. Silverman, JD,
MPHSIU School of Medicinersilverman_at_siumed.eduN
ovember 4, 2006
John McPherson
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Outline

• Background
• Exemptions based on religious or moral grounds
• Recent developments
• Are we near the tipping point?
• Policy Options
• Vaccine Shortages, Bioterrorism Avian Flu

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Brief HistoryU.S. Policy

• Top Public Health Achievement of 20th Century
• Mandatory for entrance into public schools,
  licensed day care and pre-schools (Head Start)
• Variations from state to state

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Source MMWR 45(RR-12)1-35, 09/06/1996
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Herd Immunity
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Legal Authority to Require VaxDue Process
Equal Protection

• Jacobson v. Massachusetts (1904)Liberty does
  not import an absolute right in each person to
  be, at all times and in all circumstances, wholly
  freed from restraint. There are manifold
  restraints to which every person is necessarily
  subject for the common good.197 U.S. 11, 14
• Zucht v. King (1922) - vaccination of children

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Religion Vaccination - Judicial

• Prince v. Massachusetts (1944)Parents may be
  free to become martyrs themselves. But it does
  not follow that they are free to make martyrs
  of their children. 321 U.S. 158, 170.

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Immunization Law. Different.

• Public health is different
• Organized to provide an aggregate benefit to the
  health of all the people in a community.
  (Gostin)
• Public health law is different
• Police Powers Courts loathe to review
  Slow/subtle
• Immunization of children is different
• Medical tx, preventive tx, patient parental
  rights, privacy, state interests, informed
  consent
• Immunization law is different
• legislatures pass laws, health departments
  boards determine mandates exemption process,
  schools enforce

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? law focus on individual rights
? side effect concerns
expanded exemptions
? in exemption use/ ? enforcement
Unprotected Pool
Population Protections from Vaccine-preventable
Infectious Disease
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Exemption Laws 2004
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Three States Recently In The News

• New York where does religion end and philosophy
  begin?
• Wyoming no investigation into beliefs
• Arkansas no religious exemption at all gtgt new
  vaccination law

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Religion Administrative Issues
Seeger Krishna
"Established" only
Not Considered
Strict Review
Submit form
How can religious beliefs be assessed?
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Whats the difference between a personal belief
and a religion?(Whatever the judge says it is.)

• Turner v. Liverpool Central School District
  (S.D.N.Y., March 2001)
• Congregation of Universal Wisdom
• Two-pronged analysis for religious exemption - Is
  the belief religious? Genuinely and sincerely
  held?
• judge cant assess credibility
• any arguably religious belief must be considered
  religious
• belief does not have to fall in line with any
  particular dogma, only genuinely and sincerely
  held.

• Although
• No regular meetings
• Low parent knowledge of religion
• Parent history of inconsistent action regarding
  her beliefs
• Parent testimony re vax inconsistent and ever
  changing
• Beliefs closely tied to chiropractic ethic
• Court ruled in favor of the parent and determined
  belief was religious

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Conclusions re Religion

• Low threshold for exemption
• Magic words
• No discernable difference between religion
  moral exemption

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LePage v. Wyoming Jones v. Wyoming St. Dept.
of Health(March 2001)

• Wyoming statute Waivers shall be authorized by
  the state or county health officer upon
  submission of written evidence of religious
  objection or medical contraindication to the
  administration of any vaccine.
• Court all the applicant must do is submit the
  form and the state must approve. State may not
  ask for reasons or investigate.

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McCarthy v. Boozman Boone v. Boozman(Arkansas
2002)

• The provisions of this section shall not apply if
  the parents or legal guardian of that child
  object thereto on the grounds that immunization
  conflicts with the religious tenets and practices
  of a recognized church or religious denomination
  of which the parent or guardian is an adherent or
  member.
• Courts Unconstitutional. No religious exemption
  permitted for anyone.

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The Tipping PointOne Media Event Away?

• Parents with little exposure to illnesses
• Media interest
• Internet - health care info
• Distrust of government

• Globalism
• Cost of containment
• Increased use of opt-outs when available
• Smallpox side effects discussion

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Health professionals with limited
working knowledge of many vaccine-preventable infe
ctious diseases
John McPherson
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State Enforcement of LawsRota et al, 2001, Hogan
2005

• Process to get exemption in many states easier
  than getting vaccinated
• More complicated exemption process leads to lower
  exemption rates
• 28 states no authority to deny exemption
  request only 16 states reported ever denying
• 34 states did not require renewal of exemption
• Only 9 states reported giving parents info about
  dangers of not vaccinating

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August 2, 2003
People
weekly
The tipping point?
VACCINES HURT OUR BABY Katherine Zeta-Jones and
Michael Douglas speak for the first time about
their struggles following the mysterious, tragic
illness of their daughter Carys, and why parents
should think twice before saying yes to the
next shot.
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(No Transcript)
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If you build itthey will come.
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Give individual freedom with one hand, take away
public health protection with other (Colorado)

• of Religious exemptions dip slightly from
  1987-1998 however, philosophical exemptions
  increase by 83
• Philosophical exemptions rise from 74 to 87 of
  total exemptions
• Relative Risk for Measles 22x greater for child
  exemptors 5.9 x for pertussis (however, 62x
  greater and 16x greater, respectively, for
  children of day care and primary school age)
• Annual incidence rates significantly associated
  with frequency of exemptors
• 11 of vaccinated children known to have
  contracted measles from exemptor (67 unknown
  exposure source)

Feikin, et. al., JAMA 2843145-3150 (2000)
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Arkansas Students Requesting Exemptions from
School Immunization
Exemption 2001-2 2002-3 2003-4 2004-5
Medical 110 20 139 21.4 64 8.4 101 8.6
Religious 419 79.2 512 78.6 297 38.9 366 33.4
Philosophic 0 0 403 52.7 728 66.5
Rick D. Hogan, 2005 Rick D. Hogan, 2005 Rick D. Hogan, 2005 Rick D. Hogan, 2005 Rick D. Hogan, 2005 Rick D. Hogan, 2005
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Michigan - Hard Policy Choices
MI Dept. of Community Health
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The future of infectious disease control?
John McPherson
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Additional vaccine issues

• Distrust of the vaccine system generally
• Vaccine supply liability
• Bioterrorism
• Anthrax
• Smallpox
• BioShield
• Avian Influenza Pandemic preparedness

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Conclusions

• Exemptions in general, esp. moral, more
  frequently obtained
• Blurring of line between religious and
  philosophical, coupled with little scrutiny of
  declarations, make exemptions easier to get even
  in states w/o moral grounds
• Political legal environment, while sympathetic
  to public health concerns, still underfunds
  public health and prioritizes individual
  interests over community health
• Most protective political solution unlikely
  absent epidemic therefore should fight for as
  robust an exemption process as possible
• New untested vaccines for use in emergency
  circumstances will place significant additional
  pressures on public health education efforts and
  risk goodwill
• Distrust in vaccines undermines all types of
  public health emergency planning

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Sources

• Silverman RD. No more kidding around
  restructuring non-medical childhood immunization
  exemptions to ensure public health protection.
  Ann Health Law. 2003 Summer12(2)277-94.
• Feikin DR et. al. Individual and community risks
  of measles and pertussis associated with personal
  exemptions to immunization. JAMA. 2000 Dec
  27284(24)3145-50.
• Rota JS et al. Processes for obtaining nonmedical
  exemptions to state immunization laws. Am J
  Public Health. 2001 Apr91(4)645-8.
• Salmon DA et al. Knowledge, Attitudes, and
  Beliefs of School Nurses and Personnel and
  Associations With Nonmedical Immunization
  Exemptions. Pediatrics. 2004 Jun113(6)e552-9.
• Fredrickson DD et al. Childhood Immunization
  Refusal Provider and Parent Perceptions. Fam
  Med. 2004 Jun36(6)431-9.
• Arkansas Statutes, 6-18-702. Immunization.
  2004.