Can troops be ordered to take the COVID vaccine? A guest post analyzes the law
Yet despite that apparently overarching concern, DoD has not required military personnel to take the COVID vaccine that the Commander-in-Chief is trying to get all Americans to receive.
Why? According to news reports, DoD is not ordering troops to protect themselves with the vaccine because of “federal law.” Consequently, about a third of the troops have declined the inoculation.
Actually, as a matter of constitutional law, even civilians can be obliged to take a vaccine (see e.g., here). Nevertheless, despite the absence of a constitutional bar, Congress has enacted federal statutes that do complicate things.
In our guest post today, Army Judge Advocate Major Whitney L. Wiles unpacks the legal architecture for us. In doing so, she discusses 10 U.S.C. § 1107a which apparently is the “federal law” DoD references. In situations involving vaccinations with only “emergency use” authorization, that statute requires “informed consent” – which military members can withhold.
But those requirements can be waived. The law does, however, oblige President Biden to first find that waiving the “informed consent” process (that currently permits military members to refuse the vaccine) is in the “interests of national security.” To date he has not made that determination
and – to my knowledge – Secretary Austin has not asked him to do so.
Addtionally, MAJ Wiles analyzes the military’s vaccination cases from the early 2000s where orders to take the anthrax inoculation were upheld. They are especially interesting because the 10 U.S.C. § 1107a waiver process was not employed.
Of course, MAJ Wiles, like everyone in government, asked me to remind readers that “the views presented in this article are those of the author and do not necessarily represent the views of the DoD or its Components.”
Here’s her analysis:
Mandatory Inoculation of the COVID Vaccine in the Armed Forces
by Major Whitney L. Wiles, USA, JAGC
I. Background and History of Vaccinations and Mandatory Inoculations
In December 2020 the Food and Drug Administration (FDA) provided emergency use authorization (EUA) for two COVID vaccines. Days after approval, the Department of Defense (DoD) began vaccinating employees, with informed consent, pursuant to the EUA.
Per military officials, it could be years before the FDA provides full approval of the drug. While the Pentagon has provided assurances that military personnel will not be required to take the vaccine until the FDA fully tests and accredits the drug, the President could order the mandated vaccination of troops while the drug remains in an EUA status.
This article explains the EUA process and outlines how a hypothetical mandatory COVID vaccination order would unfold if circumstances necessitate that course of action.
A. The FDA and EUAs
The development of necessary drugs in emergency situations is much different from the normal drug manufacturing process. As this universal, public-health crisis has evolved, the world has come together in an attempt to find a solution. In the United States, the federal government has invested in the private manufacturing efforts of pharmaceutical companies in an effort to speed up development and distribution of the vaccine—an effort that did result in the rapid development of the vaccine currently being administered under an EUA.
An EUA is a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies. . . .” EUAs permit the use of “unapproved” medicines to treat or prevent serious medical conditions during public health emergencies.
Before authorizing a drug for emergency use, the FDA must be satisfied that the drug’s benefits outweigh potential risks. The FDA’s “career scientists and physicians” evaluate all information provided from the drug manufacture; and, after screening participants for conflicts of interest, the FDA schedules meetings with scientific and public health experts throughout the country to analyze the drug.
Manufactures who receive an EUA must continue clinical trials throughout the process of requesting full FDA approval. After the EUA is granted, both the FDA and CDC conduct continuous safety monitoring.
The Food, Drug, and Cosmetic Act outlines these and other requirements for the authorization of emergency-use medical products. For emergency use of unapproved products, the Secretary of Health and Human Services (HHS) must establish conditions for approval that he or she “finds necessary or appropriate to protect the public health,” to include “appropriate conditions designed to ensure that individuals to whom the product is administered are 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 their benefits and risks.”
Stated another way, the Secretary HHS has the ability to require informed consent before administration of a drug under an EUA. Such is the case with the COVID vaccine: the Secretary HHS granted approval of the current COVID EUA upon the condition that the vaccine remain voluntary, and the DoD is abiding by this condition.
However, pursuant to 10 U.S.C. § 1107a, at the request of the Secretary of Defense, the Commander in Chief has the authority to waive the Secretary HHS’s voluntary condition and require service members to accept the unapproved, emergency-use vaccine. In such cases, the President must determine that complying with the informed consent requirement would not be “in the interest of national security.”
There has been no indication that Secretary of Defense Austin will request a presidential waiver of informed consent; and, prior to the inauguration, President Biden publicly stated he would not make vaccinations mandatory, but would do everything in his power to encourage people to do the “right thing.” But, what if circumstances change and conditions worsen?
The President has the authority to require the inoculation of service members with a drug authorized under an EUA. If a service member refuses to follow a commander’s order to accept the vaccine in this circumstance, commanders may issue clear, specific, and narrowly drawn orders for service members under their respective command to receive the vaccine.
Soldiers who willfully choose to disobey such orders risk punishment. Ensuing litigation would be somewhat analogous to cases involving mandatory anthrax vaccinations, which were argued in the early 2000s, discussed below. Spoiler alert: orders to receive the COVID vaccine would very likely be upheld as lawful.
B. Legal Precedence for Ordering Vaccinations
In 1970, the National Institutes of Health licensed the anthrax vaccine. In 1972, the authority to license drugs transferred to the FDA. In 1973, the FDA reviewed the safety and labeling of the anthrax vaccine—which did not include approval for the prevention of inhalation anthrax—and classified the drug as “safe and effective as labeled.”
In 1996, the anthrax vaccine’s manufacturer submitted an “investigational new drug” (IND) application to the FDA. This IND modified the labeling, administration method, and dosage of the already existing vaccine; specifically, it sought approval to use the drug for prevention of inhalation anthrax. The IND approval process is separate and distinct from the EUA process described above. The IND allowed studies to be performed in support of adding inhalation anthrax to the vaccine label.
In 1997, the Secretary of Defense wrote a letter to the FDA asserting that the DoD “had long maintained” that the license for the anthrax vaccine included licensing for inhalation anthrax. In response, the FDA replied that the DoD’s understanding that the drug could be used to prevent inhalation anthrax “was not inconsistent” with the drug’s existing license. 
The FDA’s response served as the basis by which the DoD began mandating inoculation of service members with the existing vaccine for the prevention of inhalation anthrax—despite the fact that the drug was never approved for such use.  In 1998, Congress passed 10 U.S.C. § 1107, which—much like the presidential waiver process in 10 U.S.C. § 1107a for EUAs described above—provided for the presidential waiver of informed consent for INDs or drugs unapproved for their labeled use.
However, the process for waiving informed consent, outlined in 10 U.S.C. § 1107 for INDs, was never followed for the anthrax vaccine. In 2000, the DoD stopped mandatorily vaccinating Soldiers given the anthrax vaccine manufacturer’s inability to pass FDA inspections.
Despite all of this, military appellate courts consistently upheld the lawfulness of orders to receive the anthrax vaccine when those orders were challenged.
C. Lawfulness of Vaccination Orders
Military orders are presumed to be lawful. The “essential attributes” of a lawful order include (1) issuance by a competent authority, (2) words that express a specific mandate, and (3) a nexus to military duty. When an order is “based upon a rule promulgated by an agency outside the normal purview of [the] Court,” the Court of Appeals for the Armed Forces (CAAF) has held that the agency’s administrative determinations should be treated with considerable deference.
In cases involving FDA determinations on the safety of vaccines, the CAAF has found that the degree of deference afforded to FDA determinations makes a military member’s burden to overcome the presumption of an order’s legality “particularly high.”
As previously mentioned, a presidential waiver was not secured prior to the enforced anthrax vaccinations in the late ’90s and early 2000s. Some service members who refused mandatory vaccination argued that the anthrax vaccination could not be lawfully mandated based on statutory, informed consent requirements.
Such was the case in Ponder v. Stone. In Ponder, the petitioner argued that in the absence of a presidential waiver of implied consent, he could not be lawfully ordered take the vaccine. He also argued that the mandatory use of the drug violated federal code prohibiting experimentation or biological testing on human subjects.
In response to these arguments, the court highlighted the Executive Order underpinning the presidential waiver statute, which read that the requirements of presidential waiver were for “internal management” only and conferred “no right or benefit, substantive or procedural” on any person or party.
The court also relied on language in Secretary of the Navy Instruction 6230.4, implementing the DoD’s anthrax vaccination program, for the proposition that the anthrax vaccine was a “FDA-licensed product and not an IND requiring informed consent for its administration.” Ultimately, the court found the DoD was not using the petitioner as a human subject of an experiment, which would have required his informed consent under federal law.
Similar arguments emerged in United States v. Schwartz, where the appellant contended his order to receive the anthrax vaccine was unlawful because (1) he had a statutory right under 10 U.S.C. § 1107 (the IND informed consent waiver statute) not be vaccinated with an investigational new drug without his consent, and (2) the order to receive the vaccine violated his constitutional right to refused “unwanted medical treatment.” 
The United States Navy-Marine Corps Court of Criminal Appeals dismissed the first argument, finding the anthrax vaccine was an FDA-licensed product and not an IND, which would require informed consent. The court also found the order did not violate the appellant’s constitutional right to refuse unwanted medical treatment. Even if the appellant had a limited right to refuse medical treatment, that right would not overcome an otherwise lawful order.
The military has a “compelling interest” in ensuring the health of the force, and frequently curtails the personal liberty and physical privacy, of service members with the goal of ensuring good order and discipline. Even orders to take vaccines with severe, documented side effects have been found to be lawful; and, mandated inoculation of such vaccines has been upheld by the Supreme Court.
In United States v. Kisala, the CAAF also addressed this issue. On appeal, Specialist Kisala argued his order to take the anthrax vaccine was unlawful because the drug was investigational, was not approved for prevention of inhalation anthrax, and a presidential waiver of informed consent was never secured. The CAAF acknowledged the controversy regarding whether the anthrax vaccine’s 1970 licensure took it “outside the definition of a ‘drug approved for its applied use’ within the meaning of 10 USC § 1107(g)(2).’”
Nonetheless, the court found appellant failed to establish that the vaccine was investigational, new, or unapproved for his applied use, based on (1) the high degree of deference afforded to the FDA’s statement that prevention of inhalation anthrax was “not inconsistent” with the drug’s label, and (2) the “particularly high burden” on appellant to overcome the presumption of the order’s lawfulness when that order is derived from a rule promulgated by an outside agency.
Other service members attempted to defend against court-martial allegations by invoking the defenses of duress and necessity. In United States v. Washington, Airman Basic Christopher Washington refused his sixth and final round of the anthrax vaccine after reading news articles, and listening to congressional hearings, regarding concerns about the vaccine’s safety and effectiveness.
Prior to trial, defense asserted it would not contest the lawfulness of the inoculation order. After this concession, the military judge ruled the order lawful. The prosecution then moved to exclude defense evidence challenging the safety and effectiveness of the vaccination program. Defense objected and asserted this evidence was central to the defenses of duress and necessity.
The military judge granted the government motion to exclude the evidence, reasoning that any perceived threat to Washington’s health came from the implementation of a lawful policy decision—not an unlawful threat or natural physical force.
Duress is a valid defense where the defendant is compelled or coerced to commit a crime “by some human agency, under threat of serious imminent harm” to the defendant or others. For the defense to apply, the crime committed must be “of a lesser magnitude than the harm threatened,” and must have consisted of conduct that produced in the defendant a “reasonable fear” of immediate death or serious bodily harm.
Somewhat related, the defense of necessity is traditionally a “choice of evils defense,” where the defendant must have a reasonable belief that his actions were necessary. The pressure of the circumstance must not be brought about by “human agency, but by the situation itself.”
Washington argued that the plain reading of Rule for Court-Martial 916 permitted him to defend against a charge of disobeying a lawful order with the defense of duress, given his reasonable belief that acceptance of the vaccine would cause him death or serious bodily injury.
However, CAAF found this interpretation to be wholly inconsistent with military values—specifically, “the willingness of the individual to sacrifice his or her life or well-being for the sake of the nation.” If we permit the lawfulness of military orders to be challenged based on a defendant’s fear of bodily injury, how could the military enforce battlefield orders, which reasonably expose service members to the dangers of war? The rule itself must be read “in conjunction with the guidance on disobedience of lawful orders and the essential purposes of military law.” Similar considerations apply when analyzing the defense of necessity.
II. Application and Conclusion
It remains unlikely that service members will be required to take COVID vaccines prior to full FDA approval of the drug. However, if the Secretary of Defense requests a presidential waiver, and service members are ordered to take the vaccine while the drug remains in an EUA status, those orders—which will be presumed lawful—would very likely to be enforced as such by military judges and upheld as lawful on appeal.
The hypothetical order to receive a mandatory COVID vaccination would be an issue of first impression; and, it would be distinguishable from the anthrax vaccination order in several ways. Anthrax vaccinations were ordered under the same authority with which commanders order the flu shot.
Despite the fact that an IND was pending, the vaccination itself had been around for thirty years and was determined to be neither new nor investigatory. Although it was argued that a waiver should have been requested and executed, the DoD—after communicating with the FDA—determined that the process outlined in 10 U.S.C. §1107—the presidential waiver process for INDs—need not be followed.
In contrast, the DoD has subscribed to the Secretary HHS’s condition of voluntariness outlined in COVID vaccine’s EUA approval. The statutorily mandated procedures of 10 U.S.C. §1107a will be followed if the COVID vaccination is to become mandatory.
This will make challenging a COVID vaccination order’s lawfulness more difficult. Arguments levied in Ponder, Schwartz, and Kisala—regarding the lawfulness of an inoculation order in the absence of a presidential waiver of informed consent—would not be available to those challenging mandatory COVID vaccination.
Ultimately, it seems telling that orders to accept the anthrax vaccine were repeatedly found to be lawful, even where: (1) a presidential waiver was not secured for mandatory inoculation of a vaccine that was not even labeled for the condition it was meant to prevent (inhalation anthrax), (2) an “Investigation New Drug” application was pending, and (3) the drug never received FDA approval for prevention of inhalation anthrax.
Questions regarding the lawfulness of mandatory COVID inoculation—under the statutory procedures specifically permitting inoculation of troops with an EUA drug—would be simpler than the questions posed in anthrax cases.
Much like in the anthrax cases, the defenses of duress and necessity would likely fail in litigation challenging mandatory COVID vaccination. The Washington case makes this abundantly clear. Accused service members would likely be precluded from even arguing these defenses unless they also contest the lawfulness of the order generally.
The inherent dangers associated with military service, prevent an application of these defenses that would undercuts the core military values—specifically, “the willingness of the individual to sacrifice his or her life or well-being for the sale of the nation.”
Perhaps an accused could argue that, unlike the anthrax vaccine—which had been around for thirty years prior to the DoD mandatory vaccination program—the COVID vaccine truly is “new” and “experimental.” An accused could argue that this rapid and exceptional development of the COVID vaccine triggers application of federal code restricting testing of chemical or biological agents on human subjects, absent informed consent.
However, this argument would be difficult to make in the face of a statutory process specifically legislated to permit the mandatory inoculation of an EUA drug when in the interest of national security. Additionally, the counter argument to the incredibly fast timeline for the development of the COVID vaccine is that advancements in technology and science are what permitted its speedy, but safe, development.
The FDA has assured that the speed at which the COVID vaccine was developed did not sacrifice the scientific standards, integrity of the review process, or the safety of the currently authorized drugs. The FDA considered “tens of thousands of study participants,” during a three-phase testing process, in determining that the COVID-19 vaccine may be safely administered.
Hopefully—given the large number of service members who are voluntarily accepting vaccination, coupled with ongoing efforts to combat the pandemic—the Secretary of Defense will never feel compelled to request a presidential waiver of the COVID vaccine EUA’s required conditions. If, however, we do come to that unfortunate occurrence, the arguments discussed in this article should be informative in navigating the way forward.