For many service members adversely affected by the military’s 2021 COVID-19 shot mandate, September 14 is recognized as “Terry Adirim Day.”
Five years ago, Dr. Terry Adirim, who previously served as the Acting Principal Deputy Assistant Secretary of Defense for Health Affairs, signed the so-called vaccine interchangeability memorandum. The memo indicated that the Pfizer-BioNTech Emergency Use Authorization (EUA) COVID-19 shot and the FDA-approved Comirnaty shot could be used interchangeably, directing military health care providers to administer available EUA doses to carry out the Defense Department’s shot mandate “as if the doses were the licensed vaccine.”
Legal Controversies Surrounding the Mandate
Davis Younts contends, “That sentence is the legal error.” The retired Air Force Lieutenant Colonel and military defense attorney told The Gateway Pundit, “FDA’s ‘interchangeable’ language was a clinical statement about completing a two-dose series with the same formulation.”
“It was not a finding that an EUA vial had become a licensed product, and it was not a waiver of informed consent,” he added. “An EUA answers whether a provider may use a product; it does not answer whether a commander may order a service member to take it.”
Former Defense Secretary Lloyd Austin’s August 24, 2021, mandate said mandatory vaccination would “only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” The Adirim memo then directed clinics to use unlicensed EUA doses “as if” they were licensed. “As if” is not a source of legal authority, Younts noted.
A year later, in August 2022, a group of military whistleblowers submitted a 41-page memorandum to members of Congress, claiming that the Pentagon had “unlawfully administered” EUA shots instead of those that had been fully approved by the Food and Drug Administration.
Members of the military have the Constitutional right to refuse experimental products or those that have not received FDA approval, but this was ignored by the Biden administration. “The cleanest legal hook is statutory, not a free-floating constitutional claim,” Younts asserted. Under 21 U.S.C. § 360bbb-3, a person offered an EUA product must be informed of the option to accept or refuse. For members of the armed forces, 10 U.S.C. § 1107a(a)(1) says that refusal option may be waived only by the President, in writing, and only if the President determines that complying with the consent requirement is “not in the interests of national security.”
President Biden never issued that written waiver, Younts pointed out. “Without it, an order to take an EUA product was not a lawful order, [emphasizing] informed consent is not negated by calling two products interchangeable.”
Legal Distinctions Cannot be Ignored
The plaintiffs contended that EUA vaccines were not subject to the Pentagon’s shot mandate, as the mandate specified it applied only to “COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.”
“That reading matches the face of the Austin memorandum,” Younts noted. “The Adirim memo tried to close the gap by treating medical similarity as legal identity.”
In January 2025, the U.S. Court of Federal Claims rejected that move in Harkins v. United States, 174 Fed. Cl. 592. Judge Armando Bonilla wrote that the government’s argument “fails to appreciate … the critical distinction between medical and legal interchangeability.”
The court held that “the FDA identifies the formally approved and EUA vaccines as ‘legally distinct,’” that “FDA licensure does not retroactively apply to vials shipped before [Biologics License Application (BLA)] approval,” and that “Section 1107a’s explicit cross-reference to the EUA provisions suggests a concern that drugs mandated for military personnel be actually BLA-approved, not merely chemically similar to a BLA-approved drug.”
The holding in one sentence: “the Coast Guard had no authority to mandate them by fiat or by default.” The same court later restated the point: conflating EUA shots with FDA-approved shots “in seeking to sidestep the informed consent requirement” was “legally improper.”
In November 2021, Coker v. Austin challenged the Pentagon’s shot mandate in federal court, arguing that the shots available to service members were falsely branded as FDA-approved and licensed products, even though they were actually EUA products. Coker v. Austin, No. 3:21-cv-1211 (N.D. Fla.), was dismissed as moot on August 25, 2023, after Congress directed rescission of the mandate in the FY 2023 NDAA and Secretary Austin revoked the order on January 10, 2023 (See 688 F. Supp. 3d 1116).
The dismissal did not uphold the interchangeability theory. “It ended the injunction fight because the policy had been withdrawn,” Younts explained. “The earlier related Florida decision, Doe #1 v. Austin, 572 F. Supp. 3d 1224 (N.D. Fla. 2021), is the better cite for the legal distinction: DOD acknowledged the President had not executed a § 1107a waiver, ‘so as things now stand, the DOD cannot mandate vaccines that only have an EUA.’” Harkins later applied that same distinction to real service members who were offered only the unlicensed product.
What’s more, service members revealed that the vials labeled Comirnaty, which were claimed to have full FDA approval, contained lot numbers linked to EUA vaccines. This alarming discovery prompted further inquiry.
On August 18, 2022, Sen. Ron Johnson (R-WI) sent a letter to former Secretary of Defense Lloyd Austin and others seeking clarification on several matters associated with the shot. The senator raised concerns about why certain lot numbers labeled as Comirnaty matched those of EUA vaccine lots. His office received no response. Johnson’s letter to Secretary Austin, FDA Commissioner Robert Califf, and CDC Director Rochelle Walensky specifically asked why lot numbers appearing on vials labeled Comirnaty, including lot FW1331, also appeared on CDC lists of EUA lots. No adequate public response followed.
Adirim’s Memo: An Utter Farce
For countless service members, this absence of response was sufficient evidence to prove that a fully FDA-approved COVID-19 shot was never made available to them. The shots that were provided were EUA products, rendering their administration unlawful and turning Adirim’s letter into a complete sham. “Harkins turned that clinic-level fact into a legal finding,” Younts shared. “Where a service member was ordered to receive a ‘fully FDA-approved’ shot but was offered only an EUA vial, and no presidential waiver existed, the service’s later findings that the member violated Articles 90 and 92 of the UCMJ were in error. The member retained the statutory option to refuse the product that was actually on the table.”
The ramifications of Adirim’s memo extended far beyond individual service members; they raised critical questions about the integrity of military health protocols and the adherence to legal standards regarding medical treatments. “The memo’s damage was not only medical; it taught commanders that a health-affairs memorandum could do what Congress reserved to the President,” Younts argued. That is why the word “interchangeable” still matters. Similarity of formulation cannot repeal a consent statute, he added.
On May 7, 2025, War Secretary Pete Hegseth took the right step by declaring the mandate was, indeed, “unlawful as implemented.” Nonetheless, the fight for transparency and justice continues. “Hegseth had already described the implementation as unlawful in April 2025; the May 7, 2025, document is supplemental guidance to the military records boards on how to review claims of service members harmed by the mandate,” Younts explained. “The administrative correction matters. It still does not replace the statutory point: no presidential § 1107a waiver was ever issued.”
Adirim’s previous actions, now synonymous with this ongoing struggle, serve as a reminder of the need for accountability within military health practices and the protection of service members’ rights.
“Medical interchangeability is not legal identity. The Adirim memo treated them as the same thing. The statute does not,” said Younts. “An EUA authorizes a provider to use a product. It does not authorize a commander to compel it. Only a written presidential finding under 10 U.S.C. § 1107a can remove a service member’s option to refuse, and that finding was never issued.”
“Calling an EUA vial interchangeable with Comirnaty did not turn the vial into Comirnaty,” he continued. “The Court of Federal Claims said the products remained ‘legally distinct,’ and that the services had ‘no authority to mandate them by fiat or by default.’”
For Younts, “Informed consent is not a courtesy the Department of Defense can write out of existence with a health-affairs memorandum.” Rather, “It is a condition Congress attached to emergency-use products, and Congress named the only official who can waive it: the President.”
The National Academy of Public Administration (NAPA) in Washington, D.C., is conducting an independent after-action review of the military’s 2021 COVID-19 shot mandate. The Pentagon did not respond to requests for comment by press time.
