A Case for Caution on the Vaccine Mandate

The United States Supreme Court will hear arguments in one of the most contentious cases of modern times on Friday, January 7, 2022: National Federation of Independent Business v. Department of Labor, which asks whether the plaintiffs are entitled to a stay of proceedings until the legality of a federal vaccination mandate can be authoritatively resolved on the merits.

Since early 2020, COVID-19 policymaking has been the focus of interest in the United States. Cases, hospitalizations, injuries, and fatalities have cycled many times in the last two years, with no obvious end in sight. By the end of 2020, a variety of vaccinations to prevent the illness would be available. The Pfizer and Moderna vaccines, for example, are based on a breakthrough mRNA technology. Both of these were approved by the Food and Drug Administration last summer, a step taken only when the FDA determines that vaccines (or other drugs or medical devices) "meet the FDA's rigorous scientific standards," a step taken only when the FDA determines that vaccines (or other drugs or medical devices) "meet the FDA's rigorous scientific standards." The FDA also changes its COVID booster shot guidelines on a regular basis. The FDA's effort has been supplemented by the Centers for Disease Control and Prevention (CDC), which as of December 29 has taken a categorical stance advising that everyone obtain their first or booster vaccination doses as soon as possible.

On November 5, the government proposed a new mandate under the Occupational Safety and Health Act that would require any company with more than one hundred employees to require all employees to be fully vaccinated against COVID-19 or, if not fully vaccinated (i.e., without the required booster shot), to present weekly evidence of a negative COVID test result, at which point they could work if suitably masked. The decree imposed a tangle of rules and prohibitions on businesses, making them responsible for a large portion of the program's administrative expenditures. Over the next six months, the government claims that this strategy would "save over 6,500 worker lives and avoid over 250,000 hospitalizations."

The asserted authority for the mandate comes from a provision in OSHA that allows for the issuance of an emergency temporary standard (ETS) if the secretary “determines (A) that employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and (B) that such emergency standard is necessary to protect employees from such danger.” In effect, the danger has to be real and the means must be appropriate to achieve that end. This mandate by the Occupational Health and Safety Administration was quickly subject to multiple challenges and, after much litigation, on December 17, a panel of the Sixth Circuit dissolved the stay of the mandate that had previously been put into place by the Fifth Circuit. On December 30, Solicitor General Elizabeth Prelogar presented her motion in opposition to a renewed stay.

The Legal Diagnosis

The question now is how the Supreme Court will rule on the stay request, which is of immense importance even if it is not a final judgment on the legality of the government’s action. The diversity of views expressed below gives evidence of the complexity of the legal issues.

The Fifth Circuit had first emphasized a number of classic administrative law issues. It emphasized first that any such unusual request had to meet a high standard of evidence, noting that "in its fifty-year existence, OSHA has only given ten ETSs." Only one of the six was successfully challenged in court." It went on to say that there were a number of flaws in the proposed mandate. It was a request for a "major" action, which should normally be addressed to Congress rather than the agency. The Fifth Circuit argued that this view is especially appropriate in this case since the risk faced and the solution addressed are not a suitable match. The mandate, it said, is over-inclusive because it includes many workplaces in which the mandate is not needed, and under-inclusive because there are many workplaces of fewer than a hundred workers where the likely risks are greater than those in workplaces covered by the order.

A three-judge panel in the Sixth Circuit reversed the decision when the case was moved there. Noting that these are not "normal times," it underlined that in cases like this, deferring to OSHA's competence in areas where it is expected to lead is the wisest course of action. It subsequently rejected the Fifth Circuit's reliance on the "rarely-used important questions" approach, concluding that, on subjects requiring knowledge, courts should defer to administrative agencies' competence on matters of this level of scientific complexity. When the plaintiffs’ move to have the entire case heard en banc was rejected, Chief Judge Jeffrey Sutton issued a lengthy dissent on December 15 which elaborated on many of the objections raised in the Fifth Circuit.

How Do We Achieve Immunity?

As should be obvious, the customary objections to the mandate have generally been based on administrative law, with problems such as whether an agency should make such a major decision without a command from Congress. Most reports of these administrative complications, however, leave out any analysis of the basic medical thesis that the government has taken for granted all along: that the vaccinations are safe and effective for their intended purpose.

The goal of these two requirements is generally understood under FDA law: a product that is unsafe should not be utilized. However, an official definition of safety has eluded us for a long time. There is no such thing as a completely safe product. In practice, safety decisions are made on a case-by-case basis, with the first question being how high the risks are in relation to the benefits, and whether a warning may be provided to mitigate the hazards of a medicine or vaccine misapplication. Effectiveness is also a key consideration—even if a treatment or vaccination carries only low risks, it should not be used if it can only treat the ailment in issue to a limited extent.

These two concerns are pervasive. Here, the most obvious question is whether the CDC’s conclusion withstands scrutiny. Clearly, if the vaccines were undeniably as safe and effective as the government claims, there would be no need for any mandate at all. A few unvaccinated stragglers might be left behind, but the high level of vaccination compliance would necessarily call into question the government’s claim that the mandate is required to avoid 6,500 deaths and 250,000 hospitalizations (setting aside the question of whether the vaccines could even deliver those results). By the end of 2021, US vaccination rates revealed that about 244 million people, or 74 percent of the population, had already taken at least one shot, and that about 204 million people, or 62 percent of the population, had taken a full course of treatment. Some 61 million people, or about 20 percent of the population, had received a booster. But at no point does OSHA’s analysis use this voluntary rate of vaccine uptake as the proper baseline against which to measure its claims of further improvement. Instead, it treats the baseline as though it were zero.

These numbers do show a relatively low rate for boosters, which brings up the question of why this is so. Nothing whatsoever in the November 5 mandate addresses this issue. Indeed, it suffers from two major defects. First, the report does not consider all the relevant variables well known at the time that could influence the desirability of an additional shot. Specifically, the report fails to address whether persons who have already been exposed to the virus have immunities that are safer and more effective than those which can be obtained from the mRNA vaccine. Instead, it concludes that there should be no statutory exemption for persons with natural immunities, even in the face of evidence available before November 5 challenging assumptions about the relationship between a country’s vaccination rate and the growth in new cases of COVID-19. A new study conducted in Houston hospitals bolsters the value of natural immunity, concluding that in contrast with data involving the earlier alpha and delta variants of the virus, there is now “direct evidence” that the omicron variant “infects unvaccinated and vaccinated people similarly.”

That evidence cuts against the claim that the federal vaccine mandate will work well, and should force the OSHA and the CDC to confront the possibility that its mandate may be far less effective than allowing natural immunities to take their course. The CDC minimizes the possibility that natural immunity may outperform vaccine-conferred immunity by saying that it “may offer some protection” of indefinite duration. Given these uncertainties, it is highly risky to launch a major government program at vast administrative expense against a moving target.

The CDC position has been attacked multiple times, including in written testimony by Drs. Jayanta Bhattacharya and Martin Kulldoff, who, after reviewing the literature, conclude:

“[R]ecovered COVID patients have strong, long-lasting protection against severe disease if reinfected, and evidence about protective immunity after natural infection is stronger than the evidence from the vaccines. Hence, it makes no sense to require vaccines for recovered COVID patients. For them, it simply adds a risk, however small.”

That position is also advanced in a letter from the law firm of Siri Glimstad, coupled with a general statement insisting that the CDC “fails to rebut the clear, consistent, and irrefutable science demonstrating the superiority of natural immunity compared with vaccine immunity.” Additional work has long established that it is highly unlikely that any person who has had a COVID-19 infection will be reinfected.

Looking Out for Potential Harm

The CDC and OSHA would be more believable if they responded to these allegations more thoroughly, but they have continuously refused to do so.

The oversight is glaring: as long as it is feasible to determine who possesses natural immunity, the mandate must be overbroad. Simply put, its benefit estimate, which is already problematic on other grounds, is inevitably exaggerated, allowing the Supreme Court to avoid wading into the medical quagmire to settle these difficulties. It can simply postpone the requirement until the administration, at the very least, corrects this glaring flaw in its track record.

But the case against the mandate goes deeper, touching on major concerns about the mRNA vaccines on grounds of both safety and effectiveness. One key component of the safety-effectiveness analysis is to identify a medical treatment’s unwelcome side effects.  The speed at which these vaccines received FDA approval and recent news that Pfizer may have understated adverse effects in its vaccine clinical trials should give pause to all. It is unacceptable for the government to seek a mandate without thoroughly sifting the evidence of potential harm.

Finally, the government's case becomes seriously weakened when it ignores recent findings regarding the omicron form, which is rapidly becoming the dominant strain. The government's previous benefits forecasts were too high, while its cost predictions were too low. This is not the track record to back an extraordinary government mandate affecting over 80 million people. The administrative law principles are beautiful, but it's also worth remembering the old Hippocratic Oath in current times: first, do no harm.

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