In the years before COVID-19 dramatically altered our political landscape, the smattering of parents throughout the country who questioned the necessity of routine childhood immunizations caught the attention of news media. Derided for touting scientifically unsubstantiated theories, such as linking vaccines to autism, these Americans were assigned the pejorative “anti-vaxxers” and hardly ever taken seriously, except as a perceived threat.

Now with COVID vaccines accessible to the general public, a cold war has broken out between those who believe almost everyone should have to get them, and those who consider vaccination to be a personal medical procedure that warrants more individualized risk assessment.

Advocates of blanket COVID vaccine mandates have tried to conflate those insisting on individual risk assessment with the ideological anti-vaxxers. While there is some overlap between the two, many people who never thought twice about immunizing their children against measles, mumps, and rubella have balked at the thought of injecting their children with an experimental medical solution to a virus that poses a negligible threat to them. Indeed, the CDC’s best estimate of the infection fatality rate for individuals ages 0-19 is 0.00002, meaning the survivability rate for that age group is 99.998%.

Never in American history have schoolchildren been required to receive vaccines that had not already undergone years—usually at least a decade—of safety trials. Nor have we required children to receive vaccines for diseases that primarily pose a risk to adults or the elderly. To date, there are no studies being conducted on the effects of COVID vaccines on the approximately 38% of children who have naturally acquired immunity.

Yet as soon as the Pfizer BioNTech vaccine received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for the 5-11 age range at the end of October, a number of U.S. cities and educational institutions imposed mandates for this group of kids, or declared such requirements imminent.

Officials from San Francisco announced that in early 2022 the city intends to require young children to show proof of vaccination in order to enter places of public accommodation. Former New York City Mayor Bill de Blasio imposed the same requirements for children ages 5-11. Krieger Schechter, a private school in Maryland, and Berkeley-Carroll in Brooklyn, New York, now require students starting at age 5 to receive a COVID vaccine. The School of American Ballet at Lincoln Center has likewise imposed a mandate that includes students as young as 6. In one of the more bizarre efforts at mass vaccination, New York City has been offering to pay children $100 to get the vaccine. (They “may use a parent’s email address to redeem their Visa gift card.”) Given that obesity and diabetes are two of the most significant risk factors for COVID pediatric hospitalizations, it is profoundly ironic that de Blasio has encouraged kids to imagine how much candy $100 can buy.

Mandate proponents typically point to the list of immunization requirements for schoolchildren, along with a 1905 Supreme Court case, Jacobson v. Massachusetts, to support their belief that COVID vaccine mandates are legal. But there are crucial differences between longstanding school immunization requirements and novel COVID vaccine mandates, ranging from the nature of the disease in question, to the length of time the vaccines have been tested, to the vaccines’ legal status.

The EUA status of the Pfizer BioNTech vaccine for 5-to-11-year-olds is one potential battleground for litigation. In 2004, under Section 564 of the Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3, Congress permitted the FDA to grant EUAs so that any American in a personal emergency can choose whether or not to explore potentially lifesaving treatments that have not gone through the full testing regime. In other words, the legal basis for EUAs is a matter of the individual right to access experimental treatments, not of government right to compel such treatments. EUA products, by definition, have not yet been proven safe and effective according to FDA standards.

Indeed, Congress has recognized that Americans should not be forced to take medical products that have not been deemed safe and effective by the federal agency charged with the power to to decide. The same federal statute that authorizes EUA products also requires, among other things, that potential recipients of such medications be informed “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” According to a plain reading, individuals have a statutory right to “refuse administration” of a vaccine approved only for emergency use. The language leaves no doubt that Congress intended for any decision to take such products to be made free of coercion, pressure, or duress. A city or school system that withholds children’s access to education, extracurricular, and recreational activities—all crucial to their cognitive and emotional development—violates both the letter and the spirit of the statute.

Some advocates of vaccine mandates point to a July 2021 opinion written by the Office of Legal Counsel (OLC), a unit of the Department of Justice that advises the president and all other executive branch agencies. According to the OLC opinion, recipients of EUA vaccines need only be told that they have the right to refuse or accept administration of a product. However, the OLC claims, the statute does not preclude making public or private employment contingent upon receipt of an EUA product. In other words, the entity that administers the vaccine must inform you that you have the right to refuse it, but if you do, your employer can terminate you, your school district can transfer or suspend your children, and your mayor can shut you out of public life. Such a reading makes a mockery of the notion of informed consent, and cannot possibly be what Congress meant.

The OLC implicitly recognized the illogic of its interpretation when it acknowledged that its “reading … does not fully explain why Congress created a scheme in which potential users of the product would be informed that they have ‘the option to accept or refuse’” it. Nor did it fully explain why the statute explicitly permits the president to only waive informed consent for individuals in the military. If the statute meant to allow the overriding of informed consent for everyone outside the military too, it would have said so.

The most obvious explanation for the OLC’s strained interpretation of the EUA statute is a need to support the political conviction that vaccine mandates are the only way out of the pandemic, regardless of their legality or effectiveness. Some courts, including a federal District Court in Indiana and another in Texas, have accepted some version of the OLC’s interpretation of the statute, and likely for similar reasons (although they are not bound by OLC opinions). Yet there remains no legal precedent for mandating EUA vaccines for anyone outside of the military. There is certainly no history of doing so for children.

The reason no adult plaintiff had an opportunity to challenge mandates on this basis is that the Pfizer Comirnaty vaccine had received full FDA approval by the time any employer mandate cases made it to court. (There remains a viable EUA argument based on the Comirnaty vaccine’s unavailability. Nevertheless, confusion as to whether Comirnaty is identical to the readily available but merely EUA approved Pfizer BioNtech has allowed courts, for the most part squeamish about being first to strike down employer mandates, to dodge the issue).

The supremacy clause of the United States Constitution dictates that federal laws prevail over conflicting state and local laws and regulations. Thus, any COVID vaccine mandate imposed by state or local governments, including public schools or universities, cannot withstand EUA challenges. While the supremacy clause argument is not applicable when challenging mandates imposed by private institutions (because they are not bound by the Bill of Rights in the same way that the government is), such entities should face tort lawsuits if they premise access to education and other goods and services upon taking an EUA vaccine and anyone suffers injury from a vaccine.

Parents can also pursue constitutional claims on behalf of their children if public schools impose COVID vaccine requirements, or if cities require proof of vaccination to access places of public accommodation. The Ninth and 14th Amendments to the United States Constitution protect the right of individuals—both children and adults—to bodily integrity and to decline unnecessary medical treatment.

Jacobson is frequently cited to support the proposition that a court should assess vaccine mandates using what is known as rational basis review, which applies when due process is observed and fundamental rights are not at stake. This essentially means that the government need only demonstrate that it has a legitimate interest, and that there is a reasonable link between that interest and the law enacted to effectuate it. So far, courts have found that as long as the government can point to a CDC webpage that claims, for example, the inferiority of natural immunity to that induced through vaccination (regardless of sourcing or accuracy), rational basis review is satisfied. In practice, most laws and regulations withstand rational basis review.

This contrasts with strict scrutiny, which comes into play when the government infringes on a fundamental right. In such cases, it must show that it has a compelling interest and that the law is narrowly tailored to meet that interest.

But reliance on Jacobson is misplaced. The plaintiff in that case was a Swedish American minister who defied a Cambridge city Board of Health regulation requiring inhabitants to receive a smallpox vaccination or face a $5 fine, the equivalent of about $150 today. (That Jacobson could pay a one-time fine—rather than lose his job or be shut out of society—also contrasts heavily with current COVID vaccine mandates.) Rejecting Jacobson’s contention that the city’s regulation violated his 14th Amendment rights, the court held that it was an appropriate exercise of the state’s police power in light of the danger posed to the community by a smallpox outbreak, which “threaten[ed] the safety of all.” Indeed, smallpox killed approximately 30% of those it infected, and disfigured a substantial number of survivors. The deadliness of the disease to all age groups factored into the degree of scrutiny that the court utilized in evaluating the constitutionality of the regulation.

Putting aside that Jacobson actually preceded the development of rational basis review, which the court officially formulated in the 1930s, the regulation in question invoked state police power from the legislature. The court stated that it declined to “defy the will of its constituted authorities, acting in good faith for all, under the legislative sanction of the state.” So far, most vaccine mandates in the United States have been handed down by federal executive decree or been formulated by employers, unchecked by state legislative process, concomitant accountability, and due process. The legislature’s involvement typically necessitates input from a variety of voices with disparate knowledge and experiences.

But perhaps most crucially, when Jacobson was decided, interracial marriage was still illegal in many states, and women did not have the right to vote at the federal level. Jacobson was notoriously cited to justify the infamous 1927 Buck v. Bell decision, in which the Supreme Court upheld a state law permitting the sterilization of mentally ill women. After both Jacobson and Buck, the court decided a number of cases recognizing the importance of bodily autonomy and integrity, including Cruzan v. Missouri Department of Health in 1990 (“[t]he principle that a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment may be inferred from our prior decisions”) and Washington v. Glucksberg in 1997 (“the right to refuse unwanted medical treatment [is] so rooted in our history, tradition, and practice as to require special protection under the Fourteenth Amendment”).

True, no case explicitly holds that strict scrutiny ought to apply to some or all vaccine mandates. But no precedent prevents courts from holding that, in light of contemporary understandings of personal autonomy and bodily integrity, COVID vaccine mandates must be reviewed through the lens of strict scrutiny.

In current circumstances, governments probably won’t be able to demonstrate that existing mandates are narrowly tailored to effectuate a compelling interest. For starters, the government has no compelling interest in forcibly vaccinating those with naturally acquired immunity (due to recovery from a COVID infection), because doing so does not make them less of a threat to others than they already are. Nor is the science settled on whether the vaccines we have now reduce or prevent transmission. From a social science and public health perspective, mandates appear counterproductive, as they tend to make people more skeptical rather than less, a principle that public health advocates used to understand.

When it comes to children, particularly those with naturally acquired immunity, the government simply cannot demonstrate a compelling interest in effectively forcing them to receive a COVID vaccine. The point can and should be made that in the United States we have never inoculated children to protect adults, a proposition that is ethically as well as legally dubious.

For children from religious families, the First Amendment provides another legal avenue through which to challenge mandates. Religious exemptions are being granted from COVID vaccine mandates with relative frequency. An avalanche of religious exemption requests may prompt those adjudicating them to grant fewer, but courts have made clear that such denials will be assessed pursuant to the strict scrutiny standard, putting those with a potential qualifying religious exemption at an advantage.

I am hopeful that legal challenges to these vaccine mandates—particularly any directed at children—will succeed. At the same time, the fact that this battle is being fought in courtrooms is disheartening. In a democracy, the question of whether parents should be put under coercive pressure to give their young children a medical treatment that hasn’t been tested over the long term is one that shouldn’t be settled by lawyers and judges. But that is the upshot of politicizing medicine and science, a process that began almost as soon as the pandemic did.

 


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