WHETHER SECTION 564 AUTHORIZES EUA VACCINES
Below are relevant parts, in my opinion, to the argument in defense of not getting the COVID vaccine
“In this case, six current and former United States Coast Guard active-duty personnel challenged their separations from military service in the fall of 2022 for reportedly failing (or refusing) to receive Coronavirus Disease 2019 (COVID-19) vaccinations.
In support, plaintiffs raise a host of complex issues, namely:
whether the service-wide vaccine mandate violated the Emergency Use Product Act, 10 U.S.C. § 1107a, in ordering the Coast Guardsmen to receive an unlicensed, emergency use authorization (EUA) vaccine in the absence of a Presidential informed consent waiver;
whether the uniform denial of religious accommodation requests violated the Religious Freedom Restoration Act of 1993 (RFRA), 42 U.S.C. § 2000bb-1; the import and implementation of Congress’ recission of the vaccine mandate through the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 (FY 2023 NDAA), Pub. L. 117-263, 136 Stat. 2395, § 525 (2022);
the abrupt conversions of the Coast Guardsmen’s noticed disciplinary discharges for alleged violations of the Uniform Code of Military Justice (UCMJ) to administrative separations for the convenience of the government; and
whether the Coast Guardsmen were improperly denied certain procedural rights associated with their separations (e.g., administrative discharge boards, reenlistment boards, military counsel, separation pay, pre-separation medical treatment).
Citing their unlawful separations, plaintiffs sought retroactive reinstatement with constructive back pay and benefits consistent with the Military Pay Act, 37 U.S.C. § 204.
In the decision:
“In addition to religious accommodations, a number of service members across the military branches requested—and were granted in certain instances—medical and administrative exemptions and temporary waivers. See, e.g., Doster v. Kendall, 54 F.4th 398, 435 (6th Cir. 2022) (“[The Air Force] has granted well over 4,000 medical and administrative exemptions.”), pet’n for cert. granted, vacated and remanded as moot, __ U.S. __, 144 S. Ct. 481 (2023); Schelske v. Austin, 649 F. Supp. 3d 254, 28384 (N.D. Tex. 2022) (“The Army has granted thousands of exemptions on secular (i.e., medical or administrative) grounds . . . .”). The limited Coast Guard data in the record reveals that six of twelve permanent medical exemptions were granted, four were denied, and two remained pending as of January 2022. AR 133. No data was reported with respect to the Coast Guard’s assessment of temporary medical waivers or administrative exemptions. See id. It is estimated that some 8,400 service members were discharged or administratively separated from the Armed Forces as a whole due to their failure (or refusal) to be administered the COVID vaccine.”
and,
“On June 23, 2022, Mr. Gutierrez received a negative CG-3307 for not meeting the vaccination deadline. The CG-3307 noted that the Coast Guardsman’s actions violated Article 90 (Willfully Disobeying a Superior Commissioned Officer) and Article 92(2) (Failure to Obey other Lawful Order) of the UCMJ, subjecting him to administrative and punitive consequences to include prosecution and separation from military service. Four days later, Mr. Gutierrez’s command notified him of their intent to initiate involuntary discharge proceedings, recommending that the Coast Guardsman be separated for the convenience of the government due to his non-availability for worldwide assignment (i.e., immunization status). Mr. Gutierrez immediately executed an acknowledgement form stating: “I do not object to being discharged.” AR 669. Further acknowledging the possible implications of the as-yet determined character of his service, Mr. Gutierrez submitted a detailed letter in defense of an honorable discharge. He was honorably discharged effective July 29, 2022, with an E-3 reenlistment code. At the time of separation, Mr. Gutierrez had earned over sixteen years of creditable service…….
On September 6 and 15, 2022, respectively, Mr. [Christopher D.] Harkins received verbal and then written notice of a negative CG-3307 for not meeting the September 5, 2022 vaccination deadline. The CG-3307 noted that the Coast Guardsman’s actions violated Article 90 (Willfully Disobeying a Superior Commissioned Officer) and Article 92(2) (Failure to Obey other Lawful Order) of the UCMJ, subjecting him to administrative and punitive consequences to include prosecution and separation from military service. Mr. Harkins’ command then restricted his access to secure areas and files and initiated involuntary discharge proceedings, recommending that the Coast Guardsman be separated for the convenience of the government due to his non-availability for worldwide assignment (i.e., immunization status). Notwithstanding his continued objections—and an approved twenty-year retirement date of January 1, 2024—Mr. Harkins was discharged for the convenience of the government effective December 1, 2022. His character of service was honorable, with a reenlistment code of RE-3. At the time of separation, Mr. Harkins had earned exactly nineteen years of creditable service.”
In the Discussion:
“I. EMERGENCY USE PRODUCTS ACT
Federal law generally prohibits the introduction into interstate commerce any new drug or biologic without formal FDA approval that the product is safe and effective for the intended use. See Vanda Pharms., Inc. v. United States, __ Fed. Cl. __, No. 23-629, 2025 WL 260709, at *2–3 (Jan. 22, 2025) (discussing FDA drug approval process). In the wake of the September 11 attacks and the anonymous anthrax-laden mailings in the weeks that followed, the nation grew increasingly anxious about potential chemical, biological, radiological, and nuclear threats. In response, the President proposed Project BioShield during his 2003 State of the Union Address. “Among the principal components of the proposed Project BioShield legislation were provisions to enable [the] FDA to authorize medical products for use during emergencies even before they are proven to be safe and effective under ordinary FDA review.”23 As part of the FY 2004 NDAA, Congress enacted two complementary pieces of legislation critical to evaluating this case: Authorization for Medical Products for Use in Emergencies, Pub. L. No. 108–136, § 1603(a), 117 Stat. 1392, 1684 (2003) (codified at 21 U.S.C. § 360bbb-3); and Emergency Use Products, Pub. L. No. 108–136, § 1603(b)(1), 117 Stat. 1392, 1684 (2003) (codified at 10 U.S.C. § 1107a).
In amending § 564 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 360bbb et seq., Congress authorized the FDA to short-circuit the federal agency’s standard health and safety review and approval processes for medical countermeasures, including vaccines, during duly designated emergency situations. The temporary bypass of formal regulatory review allows the FDA to quickly authorize unapproved medical products or unapproved uses of approved medical products to diagnose, treat, and prevent serious or life-threatening diseases. Among the public safeguards imposed by Congress is the requirement, to the extent practical, of informed consent. Specifically, § 564(e) specifies the information individuals being administered EUA products should receive, including: (I) that the Secretary [of Health and Human Services (HHS)] has authorized the emergency use of the product; (II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and (III) 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.
……..Congress enacted the Emergency Use Products Act, 10 U.S.C. § 1107a, to address the administration of EUA vaccines to military personnel, and the requirement of informed consent:
In the case of the administration of a product authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act to members of the armed forces, the condition described in section 564(e)(1)(A)(ii)(III) of such Act and required under paragraph (1)(A) or (2)(A) of such section 564(e), designed to ensure that individuals are informed of an option to accept or refuse administration of a product, may be waived only by the President only if the President determines, in writing, that complying with such requirement is not in the interests of national security.
10 U.S.C. § 1107a(a)(1). In the aftermath of the litigation linked to the Anthrax Vaccine Immunization Program, DOD formally adopted the following interpretation of § 1107a:
In the event that an EUA granted by the Commissioner of Food and Drugs includes a condition that potential recipients are provided an option to refuse administration of the product, the President may, pursuant to section 1107a of Reference (e), waive the option to refuse for administration of the medical product to members of the armed forces. Such a waiver is allowed if the President determines, in writing, that providing to members of the armed forces an option to refuse is not in the interests of national security. Only the Secretary of Defense may ask the President to grant a waiver of an option to refuse…….
Following the persuasive teachings of Collins, the Court finds that the Coast Guard abdicated its duty with respect to the group of involuntarily separated plaintiffs to either award separation pay and require a commitment of continued service in the Ready Reserves or make (and document) the affirmative decision “that the conditions under which the member is discharged do not warrant payment of such pay” as required under 10 U.S.C. § 1174(b)(1). As with the other collateral benefits discussed herein, the award of separation pay to plaintiffs Byrd, Harkins, Nolan, and Powers must await the results of the reassessments of their religious accommodation requests to conclusively determine whether they were properly involuntarily discharged. In contrast, Messrs. Gutierrez’s and Musgrave’s voluntary separations render them ineligible to receive separation pay by operation of § 1174(e)(2)(A).
CONCLUSION
For the foregoing reasons, the named plaintiffs’ motion for judgment on the administrative record (ECF 26) is GRANTED-IN-PART and DENIED-IN-PART and, conversely, defendant’s cross-motion to dismiss and for judgment on the administrative record (ECF 27) is DENIED-IN-PART and GRANTED-IN-PART. The parties shall FILE a joint status report on or before February 13, 2025, proposing a schedule of continued proceedings in this case, including addressing the issue of class certification and any proposed remand proceedings. It is so ORDERED.”
___________________ Judge Armando O. Bonilla