The Vaccine Mandate: A Case for Caution

 

New York, NY – October 25, 2021: Municipal workers of the city march across Brooklyn bridge and rally at City Hall Park against vaccination mandate.

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

COVID-19 policymaking has been at the center of attention in the United States since early 2020. Over the past two years, the cases, hospitalizations, injuries, and deaths have had multiple cycles with no clear end in sight. By the end of 2020, a number of different vaccines had become available to prevent the disease. Two of these, the Pfizer and Moderna vaccines, rely on a new mRNA technology. With great expectations, 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.” The FDA also continuously updates its recommendations for approved booster shots for COVID. The work of the FDA has been complemented by that of the Centers for Disease Control and Prevention (CDC), which as of December 29 had adopted a categorical position of recommending that all individuals get their initial or booster shots of the vaccines as soon as possible.

On November 5, the government went beyond vaccination recommendations and proposed the new mandate under the Occupational Safety and Health Act, compelling any firm employing more than one hundred workers to require all employees either to be 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 order introduced a maze of requirements and prohibitions that burden employers with many of the administrative costs of the program. The government claimed this protocol would “save over 6,500 worker lives and prevent over 250,000 hospitalizations over the course of the next six months.”

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.

Initially, the Fifth Circuit had stressed a number of traditional administrative law points. It noted first that any such extraordinary request had to meet a heavy burden of proof, so much so that “in its fifty-year history, OSHA has issued just ten ETSs. Six were challenged in court; only one survived.” It then further noted that this proposed mandate suffered from a number of defects. It was a request for a “major” action that ordinarily should be directed to Congress, not the agency. In this instance that position is especially appropriate, the Fifth Circuit argued, because there is no good fit between the peril faced and the remedy addressed. 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.

After the case was transferred to the Sixth Circuit, a three-judge panel took the opposite position. Noting that these are not “normal times,” it insisted that on matters like this, it is best to defer to the expertise of OSHA in areas where it is expected to lead. It then rejected the Fifth Circuit’s reliance on the “seldom-used major questions” doctrine, and concluded that on matters that require expertise, the general rule is that courts ought to defer to the expertise of administrative agencies on matters of this degree 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 evident, the usual arguments raised against the mandate have proceeded largely on administrative law grounds, dealing with questions such as whether an agency should decide a question of this magnitude without a directive from Congress. But what is missing from most accounts of these administrative complexities is any careful examination of the key medical proposition that the government has taken as a given all along: namely, that the vaccines are safe and effective for their intended purpose.

The purpose of these dual standards is well accepted under standard FDA law—a product that is not safe should not be used. But an authoritative definition of safety has long proved elusive. No product is absolutely safe. In practice, determinations of safety are judgment calls, where it is first commonly asked how large the risks are relative to the benefits and whether some kind of warning can be issued to ease the dangers of a misapplication of some drug or vaccine. Effectiveness is also a central question—even if a drug or vaccine poses only minor risks, it should not be taken if it has only modest abilities to treat the condition in question.

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 might be more credible if they addressed these claims with some thoroughness, but they have consistently declined to respond to them.

The omission is glaring—so long as it is possible to identify who has natural immunity, the mandate is necessarily overbroad. Simply, its estimate of benefits, already questionable on other grounds, is necessarily inflated as well, which allows the Supreme Court to avoid entering into the medical thicket to resolve these issues. It can simply postpone the mandate until the government repairs, at the very least, this gaping hole in its 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.

In the end, the government case grows truly feeble when it fails to take into account recent developments involving the omicron variant, which is swiftly becoming the dominant strain. The government’s earlier estimates of benefits are too high, and its estimates of costs are too low. This is not the record to support an unprecedented government mandate covering some eighty million people. The administrative law points are elegant, but in modern times it is well also to recall the ancient Hippocratic Oath: first, do no harm.

© 2022 by the Board of Trustees of Leland Stanford Junior University.

Published in Healthcare, Law
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  1. Bryan G. Stephens Thatcher
    Bryan G. Stephens
    @BryanGStephens

    It has nothing to do with health, and everything to do with compliance. 

    • #1
  2. Nanocelt TheContrarian Member
    Nanocelt TheContrarian
    @NanoceltTheContrarian

    Richard is just too reasonably polite. If historic safety standards for vaccines were applied, the vaccines would be off the market by now. In lieu of that, as it will not happen, we should demand black box warnings:  1). Warning! This vaccine may increase your risk of death.  2). Warning! This vaccine may increase your risk of acquiring COVID. Then the mandates—all of the mandates, by government agencies or executives or by private companies or organizations, should be withdrawn. Sadly, the Supreme Court may UPHOLD all the mandates. That even one court in the land, or even one judge, would act to allow any of the mandates, is a proof that our entire judicial system is devoid of any awareness of reality.

    We are way beyond corrupt and wholesale violations of the Nuremberg Codes.  And the Helsinki Declaration.

    • #2
  3. JacobHyatt Coolidge
    JacobHyatt
    @JacobHyatt

    Great post thanks for writing it 

    • #3
  4. Nanocelt TheContrarian Member
    Nanocelt TheContrarian
    @NanoceltTheContrarian

    Great post! Thanks.

    • #4
  5. Full Size Tabby Member
    Full Size Tabby
    @FullSizeTabby

    I have assumed the 100 employee threshold was intended to pre-empt a challenge to OSHA jurisdiction based on whether the business was engaged in “interstate commerce.” I know the definition of “interstate commerce” that the federal government is permitted to regulate has been expanded to include almost any activity, including noncommercial activity. But many have wanted to challenge that expansion, and I’ve suspected OSHA didn’t want this regulation to become a vehicle for that challenge. 

    • #5
  6. Full Size Tabby Member
    Full Size Tabby
    @FullSizeTabby

    I think a major ground for caution in authorizing a mandate is that no one can tell us with certainty what any of the vaccines do or do not do. When first rolled out, vaccine proponents told us getting “fully vaccinated” was a one time two shot event, would prevent the vaccinated from getting the disease, and would prevent the vaccinated person from spreading the disease.

    But just a few months later the vaccine proponents were telling the public that none of what they had said earlier was true. “Fully vaccinated” might require a third shot. Already, there are advocates that a fourth shot will be required. How can a government justify a mandate when there is no consistency to what the mandate is?

    After many people who perceive themselves at low risk due to the Covid disease nonetheless got shots for the specific purpose of not spreading the disease to others around them, the vaccine advocates changed the information to tell people that the shots do no such thing. How can a government justify a mandate of something that isn’t protecting others? 

    After many people received Covid vaccines based on advocates’ claims that the people would not get the disease, the vaccine advocates changed the information to say that the vaccinated could still get the disease, but with less severe effects. So, the benefit of the Covid vaccine seems to be limited to reducing, for most people, the severity of the disease when a vaccinated person comes into contact with the virus. That is an almost entirely personal benefit. The “public health” benefit to support a government (or employer) mandate are almost nonexistent. 

    Finally, as to the “grave threat” to worker health used to justify OSHA involvement, ever since just a few months into 2020 it has been clear that people of general working age are at quite low risk due to Covid-19. The vast majority of the risk is to people aged well beyond most working people. 

    • #6
  7. The Reticulator Member
    The Reticulator
    @TheReticulator

    Full Size Tabby (View Comment):
    the vaccine advocates changed the information to say that

    “The vaccine advocates” is a pretty broad category.  Perhaps you meant “some vaccine advocates?”

    • #7