Non-Medical Vaccine Exemptions: Balancing Parental Rights and Public Health

U.S. Religious and Philosophical Vaccine Exemptions 

Philosophical and religious vaccine exemptions have been a hot topic lately with California's AB 2109 Bill which would require parents who wish to opt out of vaccination obtain an approved healthcare providers' signature that the parents have been advised of the risks of not vaccinating.  And Washington State's recent passing of the same type of bill has anti-vaxx groups in a collective apoplexy.  New Jersey is also discussing tightening their religious exemptions and a new bill S1759 has been submitted to the state Senate for a vote.  New Jersey has no philosophical exemption so its religious exemption has been easily used for parents to opt out of vaccines.

I like others have a problem with just religious exemptions for the reason that there are no recognised religious organisations that oppose vaccines and they also exclude secular beliefs.  In fact, there is no constitutional right or protection requiring religious exemptions to be provided.  There are no constitutional protections from compulsory vaccination for philosophical reasons either in spite of vapid assertions to the contrary.

An Equal Protection challenge to vaccination regulations was denied in Zucht v. King as the U.S. Supreme Court ruled that vaccination laws do not discriminate against schoolchildren to the exclusion of others similarly situated (i.e., children not enrolled in school). (221)  In the case of Adams v. Milwaukee, Justice Brandeis reaffirmed Jacobson's holding that states may delegate the power to order vaccinations to local municipalities, and that broad discretion must be granted in the application and enforcement of the resulting public health regulations. (222)  In Prince v. Massachusetts, the Supreme Court held that the First Amendment's Free Exercise Clause does not allow for the right to expose the community or one's children to harm from disease. (223)  An Arkansas court later affirmed that school vaccination requirements do not deprive individuals of liberty and property interests without due process of the law. (224) Moreover, even where a parent objects to compulsory vaccination, a child does not have an absolute right to enter school to receive an education. (225)  Clearly then, the rights of individuals to be free from unwanted government interference in the form of compulsory vaccinations have been severely limited by the courts where public health is at stake.

But what about the constitutionality of compulsory vaccinations where no exemptions at all are provided--i.e., neither for philosophical nor religious reasons?  Again, the judiciary has held that individual rights may be restricted in the name of the public welfare without violating the Constitution.

States that do offer religious exemptions place themselves in a more precarious position legally.

Some state courts have held that parents must be members of a "nationally recognized and established church or religious denomination" in order to claim an exemption, (229) but others have found that similar regulations violate the Equal Protection Clause of the Constitution by giving preference to certain religions over other. (230)  Moreover, some courts have gone as far as to say that providing any religious exemption violates the Equal Protection Clause because it "discriminate[s] against the great majority of children whose parents have no such religious convictions." (231)

As it stands now, 48 U.S. states allow religious exemptions and 20 allow philosophical exemptions.   Some retrospective analyses of Arkansas, which allowed philosophical vaccine exemptions beginning the 2003-2004 school year have revealed a startling trend which has been observed in other states as well.

Total exemptions numbered 529 in Year 1; 651 in Year 2; 764 in Year 3; and 1145 in Year 4. Between Years 1 and 2, the total number of exemptions granted rose by 23%. After philosophical exemptions were allowed in Year 3, total exemptions granted increased by 17% over the previous year, and by 50% more from Year 3 to 4 (Figure 1).

In Year 3, nonmedical exemptions (including religious and philosophical options) were 1.37-fold higher than nonmedical exemptions in Year 2 (139 versus 64) and 1.67-fold higher than nonmedical exemptions in Year 1 (110 versus 64), when religion was the only option for nonmedical exemptions. In Year 4, nonmedical exemptions (62) were 2.12-fold higher than in Year 2 and 2.58-fold higher than in Year 1. In Years 3 and 4, the majority of the nonmedical exemptions (58% [403 of 700] and 67% [721 of 1083], respectively) were based on philosophical rather than religious (297 and 362, respectively) reasons.

Medical exemptions constituted 21% of all exemptions in both Years 1 and 2. However, with the introduction of philosophical exemptions, the absolute number of medical exemptions dropped by more than half (from 139 in Year 2 to 64 in Year 3 and 62 in Year 4). Thus, medical exemptions accounted for only 8% of Year 3 and 5% of Year 4 exemptions.

Emphasis added.  This is a concerning statistic as it would appear "vaccine-friendly" physicians may have been issuing medical exemptions where they weren't medically-indicated.  This seems to be an unintended finding that should be addressed by public health officials in concert with state medical regulators.

A more recent study conducted by Safi et al. (2012) and includes additional years of data sets has confirmed the previous finding by Thompson et al. (2007).  However Safi et al. included some additional statistics which reveal a number of interesting findings:

Analysis of exemptions by vaccine type revealed that in the 2009 –2010 school year, 70.8% (1922) of exemptions were requested for all vaccines, 9.2% (249) were requested for two or more vaccines, and 20% (543) were requested for a single vaccine. A similar pattern also was seen for previous years. More than 92.8% of single-vaccine exemptions requested were for the measles, mumps, and rubella (MMR) vaccine and 4.6% were for both hepatitis B and varicella. Of 504 single MMR vaccine exemptions, 436 (86.5%) were requested for college students. MMR vaccine is the only required immunization for college enrollment in Arkansas.

The prevalence of children in home schools, not involved in any public school activities, who are undervaccinated is not known, nor of foreign children residing in Arkansas. Even though vaccine exemption–associated outbreaks have not yet been identified during this study period (2001–2010), the increasing trend of exemption in specific colleges in Arkansas raises particular concern because of previous links of infected (symptomatic or asymptomatic) exempted students with mumps and measles outbreaks. ^{[4], [9], [10], [11] and [12]}

Private schools are not included in the collection of these statistics and given the date of the incident, Safi et al. were unaware of this recent Arkansas boarding school measles outbreak. It has also become well-known that Waldorf Schools have become hotbeds for high vaccine exemptions and thus pertussis and measles outbreaks.  The MMR triple jab had the highest number of exemptions for school age and university students which appears to be a shameful repercussion of Wakefield et al.'s fraudulent and retracted Lancet paper even over a decade after the fact.

The recent moves by various states to tighten the ability to acquire non-medical vaccine exemptions are laudable but rather futile efforts that are easily overcome by determined anti-vaxx groups whether it be through convincing credulous politicians to ignore experts in Vermont, lobbying California to include naturopaths as an approved healthcare practitioner to provide vaccine exemption counselling for AB2109 (which is as good as a rubber stamp) and challenging states over the constitutionality of tightening existing religious exemptions such as New Jersey.  Parents who hold these beliefs will not be swayed by a brief meeting with a "healthcare practitioner" who will be undoubtedly shopped for in order to provide a signature needed to be on their way as quickly as possible.  These measures will not increase vaccination rates in any appreciable way.  Political-correctness and pseudo-scientific grandstanding have no business in public health policy, only solid scientific evidence does.

What can States do About Balancing Parental Rights with Public Health?

It's rather easy, in theory at least but would provide parents and public health with the fairest way to balance their respective interests bearing in mind that public health policies are measures to create benefit and protection for the majority of a population.

• Eliminate all religious exemptions and have just philosophical exemptions

States would eliminate, or more realistically reduce the number of legal challenges that can be made by simply providing philosophical exemptions.  There are secular reasons for seeking vaccine exemptions and no religious belief should be deemed superior to another in the matter of exemption from vaccines.

• Enact philosophical exemptions for particular vaccines and all vaccines

Track specific vaccine exemptions rather than make them "all or nothing".  States such as California and Colorado are already doing this (more or less).  This provides more accurate data regarding vaccine uptake and provides schools requisite information to manage outbreaks more fairly and effectively.  As it stands now, any student with a vaccine exemption is required to stay home from school in the event of an outbreak which can mean several weeks out during the school year.  This may be rightfully deserved according to some but ultimately, the children suffer for the parents' actions and tutors are provided by schools at taxpayer expense if a certain number of consecutive days are missed.

Allowing selective exemptions would prevent unnecessary exclusions from school.  For example, a student with an exemption for hepatitis b would be allowed to remain in school in the event of a measles outbreak.  Parents who have an "all vaccines" exemption on file for their children would of course be required to stay home in the event of an outbreak of any VPD.  Outbreak control measures may include requiring students stay out of school for an outbreak of a VPD anywhere in the school district rather than just at the school of enrolment given disease transmission dynamics and incubation periods.

• Standardise criteria for state vaccine mandates

Rigorous criteria for determining which vaccine antigens should be mandated by a state is currently being used in the State of Washington as reported by Lantos et al. (2010):

Washington became one of the first states to develop explicit criteria when its Board of Health convened an Immunization Advisory Committee in 2005 to provide recommendations for how to determine whether a new antigen should be part of the State's required immunizations for entry into school or child care.⁵¹ The Washington State Board of Health realized, in part, that rigorous criteria were needed as it became clear that several vaccines in development were likely to be recommended for children and adolescents and proponents were likely to propose mandates. Indeed, in 2005, the quadrivalent conjugate meningococcal vaccine was licensed, followed by the first human papillomavirus (HPV) vaccine and the first rotavirus vaccine in 2006.

Washington State's 9 criteria are grouped into 3 categories: vaccine effectiveness, public health disease burden, and implementation.⁵² These criteria are meant to sufficiently address the different layers involved in public policy decisions. There are 4 criteria of vaccine-effectiveness; (1) the vaccine containing the antigen has been recommended by Advisory Committee on Immunization Practices; (2) its effectiveness has been established by immunogenicity; (3) it is cost-effective from a society perspective; and (4) it is safe with an acceptable level of adverse effects. The 2 public health burden criteria are (1) that the vaccine containing the antigen prevents a disease that has significant morbidity and/or mortality; and (2) that vaccinating children and adolescents reduces transmission of the disease. The last 3 criteria reflect implementation of the vaccination program: the vaccine must be acceptable to the medical community and the public, the administrative burdens of delivering the vaccine must be acceptable, and the burden of compliance for vaccination is considered reasonable for the parent.

The process for evaluating an antigen for inclusion in school mandates in Washington State involves 3 steps. The Board of Health first does a preliminary review of the antigen of interest to determine whether there is enough information about the antigen for the 9 criteria to be used. Second, a group of representatives from public health, primary care, epidemiology, ethics, and others (such as parents and school administrators) is appointed by the Board. Finally, these appointees review the antigen in question using the 9 criteria and provide a recommendation to the Board. Although these criteria and the process in which an antigen is evaluated against them require some clarifications, they offer a deliberate and informed approach to determining which vaccines should, and should not, be required for school entry.⁵¹ Washington State's Board of Health used these criteria to include the meningococcal vaccine as part of the require immunizations for school entry in 2005. Washington State does not include the HPV or rotavirus vaccines in its school immunization laws.

Other states have come to different decisions. As of June 2009, school mandates exist in 18 states for the meningococcal vaccine,⁵³ and in 2 states (District of Columbia and Virginia) for the HPV vaccine.⁵⁴ No state has a school mandate for the rotavirus vaccines.

Such a process will ensure that an evidence-based approach will be implemented to decide which vaccines should be part of school vaccine mandates.  Such an evidence-based and transparent method may also serve to address some parental fears about vaccinating by addressing individual state's VPD epidemiology.

• Require private and parochial schools to adopt and record the same mandatory vaccines and/or exemptions as public schools

The State of West Virginia (which only has a medical vaccine exemption) requires this already.  Many or most U.S. private and parochial schools do not require vaccines for school entry and/or attract anti-vaxx parents with easy opt outs for vaccines.  Some of these schools have exemption rates of over 80%, particularly Waldorf Schools.  Since schools are the primary sources of disease transmission, there is simply no justification for allowing private and/or parochial schools different standards for vaccine requirements.

• Limit the number of philosophical vaccine exemptions

Given the alarming numbers of philosophical and religious exemptions that some state school districts and counties are issuing, it has become necessary to cap the number of non-medical exemptions for any given school.  These exemptions are based upon pseudo-scientific information that is easily available to credulous parents concerned with vaccine adverse effects; there is no reason to continue to entertain these fallacious beliefs and extraordinary senses of entitlement in the form of high numbers of vaccine exemptions that erode herd immunity.

Herd immunity assumes the equal distribution of susceptible people; this very crucial aspect of herd immunity is compromised by high numbers of non-vaccinated geographically-clustered, particularly at a school level.  In order to achieve herd immunity threshold, the minimum percentage of people vaccinated for a disease is based upon vaccine effectiveness, disease transmissibility or infectiousness (for example measles is far more transmissible than hepatitis b so a higher percentage of people need to be vaccinated for the former than the latter), population mixing and vaccine failure.  For example, measles vaccination uptake to achieve herd immunity threshold is estimated to be 90-93% due to the extremely high infectiousness of measles and an estimated 5% primary vaccine failure rate.  And again, that is also assuming an equal distribution of susceptible people in a large population.

There are several school districts and/or counties throughout the U.S. that do not reach this threshold, California being a glaring example.  Using measles again as an example of how to cap philosophical exemptions and hypothetical school A with a student population of 1000 students, the upper limit for the number of unvaccinated children must be lower than 7% to account for clustering of susceptible children, let's arbitrarily say 4% which would be 40 students.  Medical exemptions would be provided first, next allow selective vaccinators in order of one and two vaccines refused and if the 4% exemption for measles vaccination hasn't been met then full vaccine exemptions can be provided for the remainder.  A higher number of exemptions could be allowed for say, hepatitis a and b but a lower number for pertussis.  Such a system would "reward" those who have their children vaccinated the most according to state mandates and encourage at least some vaccination.

Implementation of philosophical exemptions could be done by lottery and monitoring of medical exemptions which would have the potential for abuse should be considered.

• Requirement of an informed consent statement for philosophical exemptions

This is in line with what Washington State has already enacted and what California may be next in doing.  With all due respect to these state's public health officials, higher standards of informed consent with greater efficiency need to be implemented.  Instead of requiring a signature from a "healthcare provider" which can mean naturopaths who are notoriously anti-vaccine or one of Dr. Bob Sears "vaccine-friendly" doctors, hold public seminars for potential philosophical exemption-seekers with qualified professional scientists and/or physicians.  Said professional scientists and/or physicians would be very familiar with anti-vaccine arguments, websites and purveyors of vaccine misinformation in order to more adequately address parental concerns and objections to vaccines.  A single speaker could reach hundreds of parents at a time taking the burden off of individual providers, disseminate much more relevant information, while dismantling anti-vaccine myths and provide statements of informed consent at the end of the seminar.

Some may ask why even bother to have philosophical exemptions but I feel as though our society can withstand a certain amount of individual freedoms without infringing on the safety of others.  However, there are some areas of the U.S. that appear to have a disproportionate number of parents who feel as though their own entitlements supersede those of the community to the point that once-eliminated or lowly endemic vaccine-preventable diseases are creating outbreaks with their direct actions.

Although philosophical and religious vaccine exemptions are a politically-charged issue, medical science must be the basis for public health decisions and not emotive, politically-motivated ones.  Contrary to popular belief, we do not have a constitutional right to philosophical nor religious vaccine exemptions; the courts have been clear on that.  Such exemptions are a privilege and unfortunately, a privilege which is being abused to the point of endangering society and must be adapted to protect the larger society while maintaining some ability for individual freedoms.