Vaccine Law &
Policy
Ross D. Silverman, JD, MPH
SIU School of Medicine
rsilverman@siumed.edu
November 4, 2006
John McPherson
(c) 2006 RD Silverman
Outline
• Background
• Exemptions based on religious or moral
grounds
– Recent developments
– Are we near the tipping point?
• Policy Options
• Vaccine Shortages, Bioterrorism & Avian
Flu
(c) 2006 RD Silverman
Brief History
U.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
(c) 2006 RD Silverman
TABLE 1. The maximum number of cases of specified vaccine-preventable diseases
ever reported for a calendar year compared with the number of cases of disease and
vaccine adverse events reported for 1995 -- United States
===================================================================================================
Maximum
no. reported
Year(s)
Reported
Percentage
cases during
maximum no.
no. cases
change in
Category
prevaccine era
cases reported
during 1995 *
morbidity
------------------------------------------------------------------------------------------------Disease
Congenital rubella syndrome
20,000 +
1964-65
7
(-99.96)
Diphtheria
206,939
1921
0
(-99.99)
Invasive Haemophilus
influenzae
20,000 +
1984
1,164
(-94.18)
Measles
894,134
1941
309
(-99.97)
Mumps
152,209
1968
840
(-99.45)
Pertussis
265,269
1934
4,315
(-98.37)
Poliomyelitis (wild)
21,269
1952
0
(-99.99)
Rubella
57,686
1969
146
(-99.75)
Tetanus
601
1948
34
(-97.82)
Vaccine adverse events &
0
10,594
------------------------------------------------------------------------------------------------* Provisional totals.
+ Estimated because national reporting did not exist in the prevaccine era.
& Total number reported to the Vaccine Adverse Events Reporting System (VAERS).
===================================================================================================
Source: MMWR 45(RR-12);1-35, 09/06/1996
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Herd Immunity
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Legal Authority to Require Vax
Due 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.
(c) 2006 RD Silverman
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
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Infectious Disease
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 >>
new vaccination law
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Religion: Administrative Issues
What is “religion”?
How can religious beliefs
be assessed?
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What’s 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 can’t 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.
(c) 2006 RD Silverman
The Tipping Point:
One 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 optouts when available
• Smallpox side effects
discussion
(c) 2006 RD Silverman
Health professionals
with limited working
knowledge of many
vaccine-preventable
infectious diseases
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John McPherson
State Enforcement of Laws
Rota 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
(c) 2006 RD Silverman
August 2, 2003
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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“If you build it…
they will come.”
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Give individual freedom with one
hand, take away public health
protection with other (Colorado)
•
14000
12000
•
10000
•
8000
6000
4000
2000
•
0
1987 1990
Religious
1994 1998
Moral
•
% 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 284:3145-3150 (2000)
(c) 2006 RD Silverman
Arkansas Students Requesting
Exemptions from School Immunization
Exemption
Medical
2001-2
110
20%
Religious
419
79.2%
Philosophic 0
2002-3 2003-4
2004-5
139
21.4%
512
78.6%
0
101
8.6%
366
33.4%
728
66.5%
64
8.4%
297
38.9%
403
52.7%
Rick D. Hogan, 2005
(c) 2006 RD Silverman
Michigan - Hard Policy Choices
90
3.00
80
2.50
70
60
2.00
50
1.50
40
30
$ (millions)
Vax Rates %
% Exemptions
1.00
20
0.50
10
0
0.00
1994
1995
1996
1997
1998
1999
2000
MI Dept. of Community Health
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John McPherson
(c) 2006 RD Silverman
Additional vaccine issues:
• Distrust of the vaccine system generally
• Vaccine supply & liability
• Bioterrorism
– Anthrax
– Smallpox
– BioShield
• Avian Influenza &
Pandemic preparedness
(c) 2006 RD Silverman
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
(c) 2006 RD Silverman
Sources
•
•
•
•
•
•
Silverman RD. No more kidding around: restructuring non-medical
childhood immunization exemptions to ensure public health protection.
Ann Health Law. 2003 Summer;12(2):277-94.
Feikin DR et. al. Individual and community risks of measles and
pertussis associated with personal exemptions to immunization. JAMA.
2000 Dec 27;284(24):3145-50.
Rota JS et al. Processes for obtaining nonmedical exemptions to state
immunization laws. Am J Public Health. 2001 Apr;91(4):645-8.
Salmon DA et al. Knowledge, Attitudes, and Beliefs of School Nurses
and Personnel and Associations With Nonmedical Immunization
Exemptions. Pediatrics. 2004 Jun;113(6):e552-9.
Fredrickson DD et al. Childhood Immunization Refusal: Provider and
Parent Perceptions. Fam Med. 2004 Jun;36(6):431-9.
Arkansas Statutes, § 6-18-702. Immunization. 2004.
(c) 2006 RD Silverman