DOE Et Al v. AUSTIN Et Al, Case Number 3 - 21-Cv-01211, 12 NOV 21, US District Court For The Northern District of Florida, Pages 12-15.cleaned

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Case 3:21-cv-01211-AW-HTC Document 47 Filed 11/12/21 Page 1 of 32
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IN THE UNITED STATES DISTRICT COURT FOR THE

NORTHERN DISTRICT OF FLORIDA
PENSACOLA DIVISION
JOHN DOE #1-#14 and JANE DOE

#1-#2,
Plaintiffs,
v. Case No. 3:21-cv-1211-AW-HTC
LLOYD AUSTIN, III, in his official
capacity as Secretary of Defense, et al.,
Defendants.
_______________________________/
ORDER DENYING PRELIMINARY INJUNCTION MOTIONS In
August, Secretary of Defense Lloyd Austin issued a mandate requiring all military
personnel to become vaccinated against COVID-19. Seven weeks later, sixteen
service members sued the Secretary and others, challenging the mandate. They
then filed two separate preliminary injunction motions, one raising statutory claims
and the other raising constitutional claims. ECF Nos. 3, 10. The government
defendants responded, the plaintiffs replied, and there was a telephonic hearing.
ECF Nos. 31, 33, 45. Having carefully considered all the arguments, I now deny
the motions.
It is worth saying at the outset what this case is not about. For one, it is not
about vaccine mandates generally. The plaintiffs argue that the military’s vaccine
https://dockets.justia.com/docket/florida/flndce/3:2021cv01211/409961
mandate should be viewed “as part of a larger effort by federal administrative
agencies and the Executive Branch to impose unconstitutional vaccination
mandates
1
for essentially all Americans,” ECF No. 11 at 8; see also ECF No. 10 at 2-3
(requesting “that this Court address the larger questions raised by federal vaccine
mandates”); ECF No. 3-2 at 23, but challenges to other mandates in other contexts
are not at issue here.1 This case addresses only the Secretary’s mandate, which
relates only to the affected servicemembers. Second, this case is not about the
wisdom of the Secretary’s decision—or whether the Secretary should mandate
vaccines. The plaintiffs argue that the mandate is imprudent and unwise—even
contrary to national security interests. Although those arguments relate to certain
legal points (like arbitrariness under the APA), the issues presented here are not that
broad. Courts don’t serve to review the wisdom of the other branches’ policy
decisions. See Tenn. Valley Auth. v. Hill, 437 U.S. 153, 194 (1978) (explaining that
a court’s “individual appraisal of the wisdom or unwisdom” of a policy “is to be put
aside” and that “[o]nce the meaning of an enactment is discerned and its
constitutionality determined, the judicial process comes to an end”).
The issue in this case is whether the mandate fails based on the specific APA
or constitutional claims these plaintiffs present. And the issue at this early stage of
1
For example, there is a recent OSHA requirement, see COVID-19
Vaccination and Testing, Emergency Temporary Standard, 86 Fed. Reg. 61,402
(Nov. 5, 2021) (to be codified at 29 C.F.R. pts. 1910, 1915, 1917, 1918, 1926, and
1928). That rule, which the Fifth Circuit stayed pending review, see BST Holdings,
LLC v. OSHA, No. 21-60845 (5th Cir. filed Nov. 6, 2021), is not at issue here.
2
the case is whether the plaintiffs have shown they are entitled to preliminary
injunctive relief.
I.
A preliminary injunction is no small thing. It is “an extraordinary and drastic
remedy” and should never be granted unless the party seeking it “clearly
establishe[s]” entitlement. Siegel v. LePore, 234 F.3d 1163, 1176 (11th Cir. 2000)
(quoting McDonald’s Corp. v. Robertson, 147 F.3d 1301, 1306 (11th Cir. 1998));
see also Texas v. Seatrain Int’l, S.A., 518 F.2d 175, 179 (5th Cir. 1975) (“[W]e must
remember that granting a preliminary injunction is the exception rather than the
rule.”). To secure an injunction, the plaintiffs must clearly establish four factors: (1)
that they have “a substantial likelihood of success on the merits”; (2) that they will
suffer irreparable injury without an injunction; (3) that they face a threatened injury
that “outweighs whatever damage the proposed injunction may cause” the
government; and (4) that “the injunction would not be adverse to the public
interest.” Siegel, 234 F.3d at 1176. They must clearly establish all four; a failure on
even one prong dooms their motion. ACLU of Fla., Inc. v. Miami-Dade Cty. Sch.
Bd., 557 F.3d 1177, 1198 (11th Cir. 2009).2
2
The plaintiffs also seek an administrative stay under the APA, 5 U.S.C. §
705. See ECF No. 3-2 at 40. A similar analysis applies for administrative stays and
preliminary injunctions. Nken v. Holder, 556 U.S. 418, 434 (2009).
3
II.
I will first consider plaintiffs’ APA claims against the FDA3and DOD. In
plaintiffs’ view, those entities acted unlawfully—the FDA by approving the
vaccines, and the DOD by mandating their use. Before turning to those claims,
though, it is helpful to cover some relevant background.
The parties do not agree on all the facts, but neither side requested an
evidentiary hearing. Regardless, many of the pertinent facts are essentially
undisputed.
Pfizer developed a COVID-19 vaccine, for which the FDA issued an
Emergency Use Authorization (“EUA”). This allowed Pfizer to distribute the
vaccine starting in December 2020. ECF No. 1-6 at 2-3. An EUA is not a full FDA
license. It instead represents the FDA’s conclusion that a product may be effective
against a disease in a public health emergency where there is no “adequate,

approved, and available alternative.” See generally 21 U.S.C. § 360bbb-3(a)-(c).
EUA drugs must include labeling and package inserts telling patients “of the option
to accept or refuse administration of the product.” Id. § 360bbb-3(e)(1)(A)(ii)(III).
3
The plaintiffs also include a claim against the Secretary of the Department
of Health and Human Services. ECF No. 3-2 at 14; see also ECF No. 1. But it is
unclear why HHS is an appropriate party. The FDA is part of HHS, but an order
against HHS is not necessary to effect the relief plaintiffs seek against the FDA.
4
On August 23, 2021—roughly eight months after the EUA first became
effective—the FDA approved a Biologics License Application (“BLA”) and issued
a full FDA license to produce and distribute the vaccine and label it with its
proprietary name, “Comirnaty.” ECF No. 1-4 at 2-3. The BLA approval requires
that Pfizer produce Comirnaty only at approved locations, subject to specific
manufacturing, packaging, and labeling requirements. Id. at 2
During the administrative process, several scientists filed a Citizens’ Petition
challenging the approval on various grounds. See generally ECF No. 1-12. But the
FDA denied that petition, explaining why the FDA felt evidence justified
approving the Comirnaty BLA. See generally ECF No. 1-13.
In addition, the FDA concluded Comirnaty’s BLA approval did not eliminate
the grounds for extending the vaccine’s EUA. ECF No. 1-6 at 3. The FDA
explained that the EUA allows some third doses and use in children under 16,
neither of which the BLA approval allows. Id. at 5-6. The FDA also concluded that
“there is not sufficient approved vaccine available for distribution to [the
approved] population in its entirety.” Id. at 6 n.9. Thus, Pfizer continues to produce
vials of vaccine that are labeled as an EUA drug with packaging material saying,
“This product has not been approved or licensed by the FDA . . . .” Id. at 12-13.
And there “remains . . . a significant amount of [Pfizer COVID-19 vaccine] that
was manufactured and labeled in accordance with [the EUA].” Id. at 12.
5
In the Summary Basis for Regulatory Action regarding Pfizer’s BLA
approval, the FDA explained that some vials of EUA-labeled vaccine are still
considered BLA-compliant—and are thus essentially Comirnaty—because they
have the BLA-approved chemical composition and were produced at a BLA
approved facility. See ECF No. 1-5 at 28. For those lots, the FDA maintains that the
EUA informed-consent provision, 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), is
inapplicable for the BLA-approved use: the two-dose regimen for those over 16.
ECF No. 31-13 ¶ 13. (A batch produced in a non-BLA-approved facility can exist
as an EUA drug but is not BLA-compliant and cannot be labeled Comirnaty. ECF
No. 1-5 at 28.) To keep it all straight, FDA requires Pfizer to identify which lots it
considers BLA compliant and list them on the Internet. ECF No. 1-5 at 28. 4
In short, what people think of as the Pfizer vaccine has two distinct FDA approval
statuses. It is licensed—that is, fully approved—for the two-dose application in
those 16 and older. But it is unlicensed and operating under an EUA— that is, an
emergency use authorization—for other applications, like for children under 16
and for certain third shots. Nonetheless, the FDA describes the two as the
4
See RE: Pfizer-BioNTech COVID-19 IMPORTANT PRODUCT
INFORMATION, Pfizer (Aug. 23, 2021), https://webfiles.pfizer.com/half-lot
number-letter-v3.
6
“same formulation” and “interchangeabl[e]” for medical purposes. See ECF No. 1-
6 at 3 n.8.5
On August 9, two weeks before the FDA approved Pfizer’s Comirnaty BLA,
the Secretary of Defense issued a memorandum announcing his intent to require
vaccination against COVID-19 either “immediately” upon FDA licensure or “no
5
The plaintiffs question whether the two products are, in fact, chemically
identical. See, e.g., ECF No. 45 at 16:17-19. Indeed, the Summary Basis for
Regulatory Action lists a redacted excipient for BLA-approved Comirnaty that
does not appear on the ingredient list in the EUA letter. Compare ECF No. 1-5 at 9
(listing 11 components, including .450 ml per vial of a redacted excipient), with
ECF No. 1- 6 at 7 (listing 10 components, all of which also appear on the Summary
Basis list). Excipients are “inactive” ingredients like “coatings, binders, and
capsules,” but they sometimes “may affect the safety and effectiveness of drug
products.” United States v. Generix Drug Corp., 460 U.S. 453, 454-55 (1983). In
Generix, the Supreme Court held that two products with the same active
ingredients were nonetheless not the same “drug” under the FDCA where the
district court had found that their different excipients created a reasonable
possibility that the unlicensed drug was “less safe and effective” than the licensed
one. Id. at 455-57. But the Court expressly declined to decide “whether two
demonstrably bioequivalent products, containing the same ingredients but different
excipients, might under some circumstances be the same ‘drug.’” Id. at 461.
Because an excipient is, by definition, an inactive ingredient— and because the
plaintiffs haven’t shown a “reasonable possibility” that excluding .450 ml of the
redacted excipient from a vial of the EUA vaccine makes it any “less safe and
effective” than Comirnaty, Generix, 460 U.S. at 455—I do not discount the FDA’s
conclusion that the two vaccines are medically interchangeable. See ECF No. 1-6
at 3 n.8; ECF No. 31-13 at ¶¶ 7-9. Of course, that does not mean the two vaccines
are legally indistinguishable—the FDA concedes they are not. See ECF No. 1-6 at
3 n.8. Still, EUA-labeled vials that Pfizer and the FDA “consider[] BLA
compliant,” ECF No. 1-5 at 28, presumably must include the redacted excipient to
meet Comirnaty’s licensing requirements. Cf. ECF No. 1-4 at 4 (“You must submit
information to your BLA for our review and written approval under 21 C.F.R.
601.12 for any changes in . . . the manufacturing [of Comirnaty].” (emphasis
added)).
7
later than mid-September, . . . whichever [came] first.” ECF No. 31-1 at 2. Then,
the day after Comirnaty’s approval, the Secretary of Defense issued another
memorandum that announced the DOD-wide vaccination mandate. ECF No. 31-2
at 2. The memorandum advised Pentagon leadership that “[m]andatory vaccination
. . . will only use COVID-19 vaccines that receive full licensure from the Food and
Drug Administration (FDA), in accordance with FDA-approved labeling and
guidance.” Id.
With that background in mind, I now turn to the plaintiffs’ specific statutory
claims.
A.
1. First, the plaintiffs contend the DOD mandate is invalid because it did not
go through notice-and-comment rulemaking. ECF No. 3-2 at 17. Long before the
DOD mandate issued, an existing regulation—Army Reg. 40-562—set out the
military’s vaccine policy. That regulation allows medical exemptions for, among
other things, a “medical contraindication relevant to a specific vaccine or other
medication.” Army Reg. 40-562 ¶ 2-6(a). As an example of what might justify a
medical exemption, it includes “[e]vidence of immunity based on serologic tests,
documented infection or similar circumstances,” id. ¶ 2-6(a)(1)(b), along with
many
8
other “exemption codes,” see Army Reg. 40-562 app’x C-1.6 The new mandate,
notwithstanding Army Reg. 40-562, includes no exception for natural immunity.
Indeed, the DOD has explicitly stated that even those who already recovered from
COVID-19 must be vaccinated.

The plaintiffs contend that because the mandate contradicts Army Reg. 40-
562, it essentially amends it. And, the plaintiffs argue, the Secretary cannot amend
Army Reg. 40-562 without notice-and-comment rulemaking. ECF No. 3-2 at
17-19; see also 5 U.S.C. § 553 (setting out notice-and-comment procedures for
rulemaking); Shalala v. Guernsey Mem’l Hosp., 514 U.S. 87, 100 (1995) (noting
that APA rulemaking is required when an agency “adopt[s] a new position
inconsistent with any of the Secretary’s existing regulations.”).
The problem for the plaintiffs is that the statute they rely on—5 U.S.C. §
553—is inapplicable “to the extent that there is involved . . . a military or foreign
affairs function of the United States.” Id. § 553(a)(1). The plaintiffs insist the
mandate is not really related to a “military function,” that the mandate is instead
“one piece in the larger federal administrative scheme to impose nearly universal
federal vaccine mandates (affecting 100 million Americans) as a condition of
6
The regulation also allows servicemembers to submit religious exemption
requests. See Army Reg. 40-562 ¶ 2-6(b)(3). The plaintiffs here do not present any
claims based on religion. See ECF No. 1 at 2 n.1.
9
employment.” ECF No. 33 at 16. But regardless of any broader federal
administrative scheme, the military’s decision to inoculate servicemembers plainly
involves a military function. The Ninth Circuit’s decision in Independent Guard

Association of Nevada, Local No. 1 v. O’Leary, on which plaintiffs rely, does not
suggest otherwise. ECF No. 33 at 15-16 (citing 57 F.3d 766 (9th Cir. 1995)). The
issue in that case was whether certain civilian contract guards were performing a
“military function.” O’Leary, 57 F.3d at 770. The military-function test is easily
satisfied here as to the plaintiffs, each of whom is an active-duty servicemember.
The plaintiffs have not shown a likelihood of success as to their notice-and
comment-rulemaking claim.7
2. The plaintiffs next argue that the mandate is arbitrary and capricious
because it lacks any legitimate basis. ECF No. 3-2 at 19-20. They point to the fact
that the mandate issued the day after the FDA’s Comirnaty approval, which they
say shows a lack of meaningful consideration of the mandate. They also contend
that DOD did not support its decision with substantial evidence, “as there is no
indication in the record that the DOD considered any evidence at all in deciding to
immediately impose the mandate for all service members on the day following
FDA approval,
7
In a footnote, the defendants argue a second statutory exception for
“matter[s] relating to agency management or personnel.” 5 U.S.C. § 553(a)(2)
(cited in ECF No. 31 at 23 n.9). Because the military-function exception applies, I
need not address this separate argument.
10
without exemption of service members whit natural immunity or pregnancy.” ECF

No. 3-2 at 20.
This argument is a difficult one because of the substantial deference afforded
to administrative decisions. See Dep’t of Com. v. New York, 139 S. Ct. 2551, 2569
(2019). There is substantial deference with most any agency decision, but this case
involves military affairs, where “the lack of competence on the part of the courts is
marked.” Rostker v. Goldberg, 453 U.S. 57, 65 (1981); accord id. at 66 (“The
operation of a healthy deference to legislative and executive judgments in the area
of military affairs is evident in several recent decisions of [the Supreme] Court.”).
Parties must show far more than that the agency made the wrong decision.
As noted at the outset, a federal court’s role is not to determine whether agencies
made the best or most prudent choice. The question is “whether the Secretary
examined the relevant data and articulated a satisfactory explanation for his
decision, including a rational connection between the facts found and the choice
made.” Dep’t of Com., 139 S. Ct. at 2569. At this stage, the plaintiffs have not
shown that they are likely to succeed on this point.
Next, to the extent plaintiffs rely on the administrative record to support their
claim (e.g., ECF No. 3-2 at 20 (“[T]here is no indication in the record . . . .”)), I
note that the administrative record is not before the court. Finally, the plaintiffs’
argument that the mandate is arbitrary and capricious because it “relied on facially
unlawful
11
FDA actions” (ECF No. 3-2 at 20) cannot succeed because plaintiffs have not
shown those actions were facially unlawful. See infra. This is not to say that the
plaintiffs’ challenge cannot ultimately succeed, but at this stage, they have not
shown enough.
3. The plaintiffs next argue that the mandate violates their statutory right to
refuse an EUA vaccine. ECF No. 3-2 at 20-21. Under the EUA statute, recipients
of EUA drugs must be “informed . . . of the option to accept or refuse
administration of the product.” 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III); see also 5
U.S.C. § 706(2)(C) (APA provision prohibiting agency action taken “in excess of
statutory jurisdiction, authority, or limitations, or short of statutory right”). And
under 10 U.S.C. § 1107a, “[i]n the case of the administration of [an EUA] product .
. . to members of the armed forces,” that statutory right to refuse “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). The DOD acknowledges that the President has not executed a wavier
under this section, ECF No. 45 at 52:8-9, so as things now stand, the DOD cannot
mandate vaccines that only have an EUA. 10 U.S.C. § 1107a(a)(1).
One problem with this argument is that the DOD’s guidance documents
explicitly say only FDA-licensed COVID-19 vaccines are mandated. See, e.g., ECF
No. 1-3 at 2 (DOD mandate memorandum) (“Mandatory vaccination against

COVID-19 will only use COVID-19 vaccines that receive full licensure from the
12
[FDA] in accordance with FDA-approved labeling and guidance.”); and ECF No.
1- 7 at 11 (Air Force guidance) (“Only an FDA-licensed vaccine may be mandated
. . . .”). The plaintiffs present a facial challenge, ECF No. 33 at 10 (“Plaintiffs’
claims are facial challenges to a generally applicable military regulation . . . .”),
and on its face, the mandate does not require anyone to take an EUA vaccine.
Notably, though, the plaintiffs have shown that the DOD is requiring
injections from vials not labeled “Comirnaty.” Indeed, defense counsel could not
even say whether vaccines labeled “Comirnaty” exist at all. ECF No. 45 at 48:5-7.
(Although the DOD’s response said it had an adequate Comirnaty supply, it later
clarified that it was mandating vaccines from EUA-labeled vials. See id. at 46:22-
47:3.) In the DOD’s view, this is fine because the contents of EUA-labeled vials are
chemically identical to the contents of vials labeled “Comirnaty” (if there are any
such vials). According to the DOD’s argument, this means servicemembers are not
required to accept “a product authorized for emergency use.” 10 U.S.C. §
1107a(a)(1). Rather, the DOD argues that once the FDA licensed Comirnaty, all
EUA-labeled vials essentially became Comirnaty, even if not so labeled. ECF No.
45 at 60:1-3. Thus, the DOD argues, the “product” injected is a chemical
formulation
13
that has received full FDA licensure—not merely an EUA—so § 1107a does not
apply. Id. at 65:1-6.8
The DOD’s interpretation of § 1107a is unconvincing. For starters, FDA
licensure does not retroactively apply to vials shipped before BLA approval. See 21
U.S.C. § 355(a) (“No person shall introduce . . . into interstate commerce any new
drug, unless an approval of an application [for FDA licensure] is effective with
respect to such drug.” (emphasis added)). Thus, as a legal matter, vaccines sent
before August 23—and vaccines produced after August 23 in unapproved
facilities—remain “product[s] authorized for emergency use under section 564 of
the Federal Food, Drug, and Cosmetic Act.” § 1107a(a)(1).9 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. And the distinction is more than mere labeling: to
be BLA compliant, the drug must be produced at approved facilities, see ECF No.
1-4 at 2; 21 C.F.R. §§ 600.11, 600.20-.21, and there is no indication that all
EUA-labeled
8
The plaintiffs also cite 10 U.S.C. § 1107, but the defendants correctly note
it does not apply. That statute covers “an investigational new drug or a drug
unapproved for its applied use,” and this vaccine (either under the EUA or the
BLA) is neither.
9
This distinction is the basis for the FDA’s comment that the BLA-compliant
vials and the EUA-compliant vials are “legally distinct,” even though their
chemical formulation is identical. See ECF No. 1-6 at 3 n.8. Thus, the DOD cannot
rely on the FDA to find that the two drugs are legally identical for § 1107a
purposes.
14
vials are from BLA-approved facilities.10 Moreover, the DOD concedes that some
of its current vials are not BLA-compliant, and that there is no policy to ensure that
servicemembers get only BLA-compliant vaccines. See ECF No. 45 at 61:10-12. It
is difficult to see how vials that the DOD admits are not BLA-compliant—and thus
could only be EUA products—could fall outside § 1107a’s prohibition on
mandatory administration.
Notwithstanding all of this, the plaintiffs have not shown a substantial
likelihood of success on this APA claim. The FDA’s Summary Basis for Regulatory
Action approving Comirnaty explains that certain lots of EUA-labeled vials are
nonetheless “BLA-compliant,” and that healthcare providers may disregard the
EUA-specific labeling when administering doses from those vials. ECF No. 1-5 at
28. The DOD claims it possesses “hundreds of thousands of BLA-compliant
vaccine doses that are EUA-labeled, and is using them.” ECF No. 30-14 ¶ 18. If
the DOD is, in fact, administering Comirnaty (albeit EUA-labeled Comirnaty), the
plaintiffs’ § 1107a issue disappears. Although there is apparently no DOD policy in
place to ensure that servicemembers receive BLA-compliant vaccines, see ECF
No. 45 at
10
The FDA’s Comirnaty approval letter redacts the approved manufacturing
locations, see ECF No. 1-4 at 2, and the EUA extension letter does not identify
which facilities were “identified and agreed upon” in Pfizer’s EUA application,
ECF No. 1- 6 at 8. The Summary Basis for Regulatory Action suggests that not all
Pfizer facilities are BLA compliant, because it contemplates that not all
EUA-labeled lots will contain BLA-compliant vials. See ECF No. 1-5 at 28.
15
61:10-12, no plaintiff claims he or she was specifically denied a BLA-compliant
dose or offered only a dose from a non-BLA-compliant vial. Because the plaintiffs
have not shown they are (or will be) required to receive an EUA-labeled, non-BLA
compliant vaccine, the plaintiffs have not shown a likelihood of
success.11 B.
The plaintiffs’ APA claims against the FDA do not fare better. These claims
break down into three categories. First, plaintiffs contend the FDA’s Comirnaty
approval is invalid because the FDA did not follow the Food, Drug & Cosmetic Act
(FDCA) and the Public Health Service Act (PHSA). Second, the plaintiffs argue
that the FDA wrongfully determined that EUA drugs and Comirnaty are
interchangeable.
11
The plaintiffs argue that the FDA cannot allow BLA-compliant vaccine
doses to bear an EUA label. ECF No. 33 at 24-25. But they cite no legal authority
for this proposition, and they do not dispute that the FDA’s Summary Basis for
Regulatory Action specifically included certain EUA-labeled lots under the BLA
approval. Regardless, the plaintiffs do not present this claim against the FDA.
Still, the statutes leave unclear what FDA labeling decisions are
discretionary. The FDA’s Comirnaty approval letter says that the labeling on
Comirnaty vials “must be identical” to what Pfizer submitted in its application,
ECF No. 1-4 at 4, but this label does not appear to be identical to an EUA label,
see ECF No. 1-5 at 28. And federal regulations require the FDA commissioner to
initiate license revocation proceedings if he determines that a licensed product is
“misbranded with respect to any [of its intended uses]” or “fails to conform to the
applicable standards established in the license . . . designed to ensure the continued
safety, purity, and potency” of the product. 21 C.F.R. § 601.5(b)(1)(iv), (vi). These
provisions could be read to prohibit distributing a fully licensed drug with an
EUA-specific label and package insert rather than those its BLA approval require.
16
Third, the plaintiffs argue that the FDA illegally extended the EUA for the vaccine
while simultaneously licensing the same product as Comirnaty.12 1. First, the
government’s papers argued with some force that plaintiffs lacked standing to
challenge the FDA’s approval. ECF No. 31 at 32-33. The plaintiffs would have
standing only if relief against the FDA would redress their injury, and the
government argued that any injury was “not caused by FDA’s actions, but by
DoD’s independent decision to require vaccination.” ECF No. 31 at 32-33. In fact,
the government argued, the DOD was going to impose a vaccine requirement with
or without Comirnaty’s full licensure. Id. at 33. But at the hearing, the
government’s counsel acknowledged that if the FDA’s licensure were set aside, that
would (at least for now) redress plaintiffs’ injuries because the DOD could not
mandate an unapproved drug absent a Presidential approval, see 10 U.S.C. §
1107a(a)(1), which has not happened. Thus, at this stage, the plaintiffs have shown
enough as to standing. But they still have not shown enough for preliminary
injunctive relief.
12
Although based on alleged FDCA and PHSA violations, the plaintiffs’
claims are APA claims. The plaintiffs have not identified a private cause of action
under the FDCA or PHSA. Cf. Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1284 n.10
(11th Cir. 2002). But the APA provides that a court may set aside agency action that
is “in excess of statutory jurisdiction, authority, or limitations, or short of statutory
right.” 5 U.S.C. § 706(2)(C); see also ECF No. 1 ¶¶ 126, 131. Here, the plaintiffs
have not shown a likelihood of success on their APA claim because they have not
shown a likelihood the FDA violated the FDCA or PHSA.
17
For one thing, there are procedural hurdles the plaintiffs have not overcome.
There is the “record rule,” which generally provides that courts reviewing agency
action should limit their review to “the administrative record already in existence,
not some new record made initially in the reviewing court.” Camp v. Pitts, 411 U.S.
138, 142 (1973); accord Pres. Endangered Areas of Cobb’s History, Inc. v. U.S.
Army Corps of Engineers, 87 F.3d 1242, 1246 (11th Cir. 1996) (“The role of the
court is not to conduct its own investigation and substitute its own judgment for the
administrative agency’s decision. Rather, the task of the reviewing court is to apply
the appropriate standard of review to the agency decision based on the record the
agency presents to the reviewing court.” (cleaned up)); see also Dep’t of Com. v.
New York, 139 S. Ct. 2551, 2573 (2019) (“In reviewing agency action, a court is
ordinarily limited to evaluating the agency’s contemporaneous explanation in light
of the existing administrative record. That principle reflects the recognition that
further judicial inquiry into executive motivation represents a substantial intrusion
into the workings of another branch of Government and should normally be
avoided.” (cleaned up)). Yet plaintiffs rely on extra-record evidence, including
expert affidavits.
The plaintiffs’ extra-record evidence does not appear to fall within the
narrow exceptions to the record rule. While the FDA’s decisions ordinarily may be
challenged “solely on the basis of the administrative record,” citizens who “wish[]
18
to rely on information or views not included in the administrative record” may
submit a citizen petition asking the FDA “Commissioner . . . to modify the action.”
21 C.F.R. § 10.45(f). In their filings, the plaintiffs introduce materials that the FDA
did not receive for consideration as part of the citizen petition challenging
Comirnaty’s licensure. See generally ECF No. 1-12 (citizen petition that does not
incorporate the rest of plaintiffs’ exhibits). Thus, the plaintiffs have not pursued an
available administrative route available to force the FDA to consider the materials
they submit here. As the defendants point out, ECF No. 31 at 36, “[u]nder ordinary
principles of administrative law, a reviewing court will not consider arguments that
a party failed to raise in a timely fashion before an administrative agency.” Mahon
v. USDA, 485 F.3d 1247, 1254-55 (11th Cir. 2007) (quoting Sims v. Apfel, 530 U.S.
103, 114 (2000) (Breyer, J., dissenting)). The plaintiffs respond by assuring the
court that their experts are well-qualified, see ECF No. 33 at 26-27, but they do not
explain how they can clear the procedural hurdles to challenge FDA action on the
basis of this expert testimony or their other exhibits.
On the merits, the plaintiffs haven’t made a substantial showing that the FDA
acted without a reasonable scientific basis. The FDA is entitled to substantial
deference because drug licensing decisions involve “scientific determination[s]”
within the FDA’s “area of special expertise.” Balt. Gas & Elec. Co. v. Nat. Res. Def.
Council, Inc., 462 U.S. 87, 103 (1983). Thus, even if the plaintiffs’ expert
19
declarations were properly before the court, they would need to overcome “an
extreme degree of deference” to the FDA. Nat’l Mining Ass’n v. Sec’y, U.S. Dep’t
of Lab., 812 F.3d 843, 866 (11th Cir. 2016) (quoting Kennecott Greens Creek
Mining Co. v. Mine Safety & Health Admin., 476 F.3d 946, 954 (D.C. Cir. 2007)).
The defendants have submitted their own expert declaration contesting many of the
plaintiffs’ scientific claims, ECF No. 31-13 ¶ 25, and the FDA also responded in
detail to the citizen petition challenging Comirnaty’s licensure, see ECF No. 1-13.
At most, the plaintiffs have shown that some experts disagree with the FDA’s
conclusions about Comirnaty’s safety and efficacy. But that does not create a
substantial likelihood of success on their APA claim. See Marsh v. Oregon Nat.
Res. Council, 490 US. 360, 378 (1989) (“When specialists express conflicting
views, an agency must have discretion to rely on the reasonable opinions of its
own qualified experts even if, as an original matter, a court might find contrary
views more persuasive.”).
The plaintiffs also argue that the FDA had improper motivations in
approving Comirnaty as quickly as it did. ECF No. 3-2 at 30-32. Normally, “a
court may not reject an agency’s stated reasons for acting simply because the
agency might also have had other unstated reasons,” including “political
considerations” or “an Administration’s priorities.” Dep’t of Com., 139 S. Ct. at
2573. To get around this principle, the plaintiffs must provide a “strong showing of
bad faith or improper
20
behavior,” id. (quoting Citizens to Pres. Overton Park v. Volpe, 401 U.S. 402, 420
(1971)). They rely on the FDA’s short timeframe, and they claim the license was a
pretext to allow for vaccine mandates. ECF No. 3-2 at 30-31. But the timeframe is
of course susceptible to other explanations, and it is not itself evidence of bad
faith— even if it shows that “political considerations” influenced the approval,
Dep’t of Com., 139 S. Ct. at 2573. And the claims of pretext are supported at this
stage only by conjecture.
2. The plaintiffs also argue that the FDA acted unlawfully when it issued
guidance saying Pfizer’s EUA vaccine may be used “interchangeably” with
Comirnaty “to provide the vaccination series without presenting any safety or
effectiveness concerns.” ECF No. 1-6 at 3 n.8; see also ECF No. 3-2 at 36. In the
plaintiffs’ view, the FDA determined that the two were “interchangeable” under 42
U.S.C. § 262(i)(3) without requiring Pfizer to go through the proper channels. ECF
No. 3-2 at 36. In their view, the EUA letter was an “attempt to retroactively license
the EUA vaccine, solely for the purpose of enabling the mandate.” Id. at 38.
The plaintiffs have serious standing issues challenging the interchangeability
determination. If the FDA’s goal were to “retroactively license” the EUA vaccine, it
had an odd way of doing so—in the same footnote describing the EUA vaccine and
Comirnaty as “interchangeabl[e],” the FDA clarifies that the two products are
“legally distinct.” ECF No. 1-6 at 3 n.8. More to the point, the FDA nowhere
claims
21
that EUA vaccine had been licensed as “interchangeable” with Comirnaty, the
process described in the statute the plaintiffs rely on. See 42 U.S.C. § 262(k)(4);
ECF No. 3-2 at 37. And because the DOD hasn’t mandated that the plaintiffs
receive anything other than “COVID-19 vaccines that receive full licensure from
the Food and Drug Administration,” ECF No. 1-3 at 2, the plaintiffs cannot show
that they are harmed by an interchangeability determination that does not purport
to grant formal licensure to the EUA vaccines.
Even if the plaintiffs could show injury from the FDA’s interchangeability
determination, they still have not shown a substantial likelihood that the FDA acted
unlawfully. The plaintiffs insist that the FDA “must be presumed” to have used the
word “interchangeably” in the sense that 41 U.S.C. § 262(i)(3) defines it. ECF No.
3- 2 at 37. But, the plaintiffs argue, the FDA may only make a statutory
interchangeability determination after a drug manufacturer submits an application
for licensure on the basis that its drug is “biosimilar” to an already-licensed drug.
See id. n. 14 (citing 41 U.S.C. § 262(k)(4)).
What the plaintiffs overlook is that the FDA used the word
“interchangeably” in a practical sense, not a legal one. The EUA letter explains
that the EUA drug and Comirnaty “can be used interchangeably . . . without
presenting any safety or effectiveness concerns,” but clarifies that they are “legally
distinct.” ECF No. 1-6 at 3 n.8. That is most plausibly interpreted as a factual,
medical claim rather than a
22
regulatory claim.13 The best evidence of this is that, as noted above, the FDA was
not considering whether to grant full approval to the EUA product on the basis that
it was “interchangeable” with Comirnaty in the statutory sense. Rather, the FDA
was extending an EUA authorization, a completely different regulatory
classification, that expressly requires Pfizer to indicate that EUA vaccines “ha[ve]
not been approved or licensed by the FDA.” ECF No. 1-6 at 13.
3. In addition, the plaintiffs contend it is unlawful for the FDA Secretary to
issue an EUA for a drug that is chemically identical to a drug with full FDA
approval (like Comirnaty), because the existence of an approved drug entails the
existence of an “available alternative” to the EUA drug. ECF No. 3-2 at 27. But the
plaintiffs have not shown at this stage that EUA decisions are even reviewable. Cf.
Ass’n of Am. Physicians & Surgeons v. USDA, 2020 WL 5745974, at *3 (6th Cir.
13
At any rate, the PHSA’s definition of “interchangeable” describes a drug
that can be substituted for a licensed “reference product without the intervention of
the healthcare provider who prescribed the reference product,” 42 U.S.C. §
262(i)(3), because it is “biosimilar” and “can be expected to produce the same
clinical result as the reference product,” 42 U.S.C. § 262(k)(4). For example, a
pharmacy might fill a doctor’s prescription for a name-brand drug with an
alternative the FDA has determined is “interchangeable,” even though the
pharmacy does not seek reapproval from the prescribing physician. Cf., e.g.,
Greentech, Inc. v. Immunex R.H. Corp., 964 F.3d 1109 (Fed Cir. 2020) (addressing
dispute between cancer treatment manufacturer and competitor who submitted a
biosimilar product for licensure under § 262). But because healthcare providers
administer COVID-19 vaccines directly, there is no scenario in which a patient
would receive an EUA vaccine as substitute to Comirnaty without his healthcare
provider’s intervention or approval.
23
Sept. 24, 2020) (“[E]mergency-use authorizations are exempt from review under
the APA.”); and compare 5 U.S.C. § 701(a)(2) (APA does not apply to agency
actions “committed to agency discretion by law”) with 21 U.S.C. § 360bbb-3(i)
(establishing EUA framework) (“Actions under the authority of this section . . . are
committed to agency discretion.”). The plaintiffs argue that 5 U.S.C. § 701(a)(2)
doesn’t apply because the FDCA provides “meaningful standards of review” for
EUA approvals. ECF No. 34 at 13 (citing Weyerhauser Co. v. U.S. Fish & Wildlife
Servs., 139 S. Ct. 361, 370 (2018)). But the statute at issue here—unlike the statute
in Weyerhauser— explicitly says that EUA decisions “are committed to agency
discretion.” 21 U.S.C. § 360bbb-3(i).
Regardless, even if the EUA decision were reviewable, the plaintiffs have
not shown a substantial likelihood of success on this claim. For one, they are not
required to take an EUA-only drug, so even without the EUA determination, the
Comirnaty decision would survive. Second, given the applicable deference and the
absence of the full administrative record here, they have not shown a likelihood of
success on the merits anyway. Finally, the plaintiffs have not shown that the FDCA
itself envisions “availability” as a binary category. In fact, patients receiving EUA
drugs must be informed “of alternatives to the product that are available.” 21
U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), suggesting that mere existence of some

alternative does not mandate immediate withdrawal of EUA determinations.
24
***
The plaintiffs have not shown a likelihood of success on any of their
statutory claims.
III.
Beyond their statutory arguments, the plaintiffs present three constitutional
claims: Substantive Due Process, the unconstitutional conditions doctrine, and
Equal Protection. ECF No. 11 at 21, 26, 27 . (The constitutional claims are against
the military defendants only, not the FDA.) But they have not shown a substantial
likelihood of success on any of them.
A.
The parties contest the applicable standard of review. The plaintiffs want
strict scrutiny, ECF No. 11 at 24-25, while the DOD urges rational-basis review,
ECF No. 31 at 48. To justify strict scrutiny, the plaintiffs must show that the case
involves a suspect class or some fundamental right. Panama City Med. Diagnostic,
Ltd. v. Williams, 13 F.3d 1541, 1545 (11th Cir. 1994) (considering equal protection
claim); see also Doe v. Moore, 410 F.3d 1337, 1343 (11th Cir. 2005) (explaining
that substantive due process challenges merit strict scrutiny only if the plaintiff
identifies
25
a fundamental right). There is no suspect class here,14 so the question is whether
there is a fundamental right at stake.
To allege a successful substantive due process claim, a plaintiff must give a
“careful description of the fundamental interest at issue” and show that the interest
is “deeply rooted in this Nation’s history and tradition, and implicit in the concept
of ordered liberty, such that neither liberty nor justice would exist if [it] were
sacrificed.” Doe v. Moore, 410 F.3d 1337, 1344 (11th Cir. 2005) (quoting Williams
v. King, 543 U.S. 1152, 1239 (2005)). Because substantive due process involves
unenumerated rights, courts must be “reluctant to expand the concept.” Washington
v. Glucksberg, 521 U.S. 702, 720 (1997) (quoting Collins v. City of Harker Heights,
503 U.S. 115, 125 (1992)).
14
The plaintiffs claim that mandating vaccines for servicemembers but not
for illegal immigrants constitutes alienage-based discrimination, ECF No. 11 at 28,
but they do not get far with this argument. Equal Protection “keeps governmental
decisionmakers from treating differently persons who are in all relevant respects
alike.” Nordlinger v. Hahn, 505 U.S. 1, 10 (1992). (The Fourteenth Amendment’s
Equal Protection Clause refers only to the States, but it “has been ‘reverse
incorporated’ into the Fifth Amendment’s Due Process Clause” to apply against the
federal government too. Nat’l Parks Conservation Ass’n v. Norton, 324 F.3d 1229,
1241 n.4 (11th Cir. 2003) (citing Bolling v. Sharpe, 347 U.S. 497, 499-500
(1954)).) It is true that alienage can trigger strict scrutiny in an Equal Protection
analysis. See Graham v. Richardson, 403 U.S. 365, 376 (1971). But the DOD
mandate—the only policy at issue in this case—doesn’t differentiate based on
alienage. It applies to all servicemembers, regardless of alienage.
26
Here, the plaintiffs struggle to identify the specific fundamental interest at
issue. They explicitly disclaim any general constitutional right to refuse
vaccinations or other medications.15 ECF No. 11 at 23. And although they point to
end-of-life and assisted-suicide cases, id. at 21-22 (citing Cruzan v. Dir., Mo. Dep’t
of Health, 197 U.S. 261, 278 (1990), and Glucksberg, 521 U.S. at 722 n.17), they
have not asserted the specific rights identified in those inapposite decisions. The
plaintiffs’ best effort at specificity is their argument that the Constitution protects
military personnel from being forced to accept “an unwanted, unnecessary, and
unproven experimental vaccine.” ECF No. 45 at 69:17-18. But they have not
pointed to any legal authority showing that such a right is “deeply rooted in this
Nation’s history and tradition.” Glucksberg, 521 U.S. at 721 (quoting Moore v City
of E. Cleveland, 431 U.S. 494, 503 (1977) (plurality op.)). Even if they had, now
that Comirnaty is FDA-approved, it is not “experimental” in any legally relevant
sense. And—Comirnaty’s approval aside—if Pfizer’s vaccines existed only under

an EUA, there would only be a procedural barrier preventing the mandate. See 10
U.S.C. § 1107a(a)(1).16 (The plaintiffs have not asserted that § 1107a(a)(1) is
unconstitutional.)
15
That framing distinguishes the legal issues here from Jacobson v.
Massachusetts, 197 U.S. 11, 28 (1905) (holding that state smallpox vaccine
mandate did not violate constitutional liberty interests).
16
Once a drug receives an EUA, it is no longer considered under “clinical
investigation” under the PHSA or the FDCA. 21 U.S.C. § 360bbb-3(k). The
27
As to whether Comirnaty is “unnecessary,” ECF No. 45 at 69:18, that is a
policy question left for the military to decide as a personnel matter, not for a court
to declare as a matter of fundamental right. Cf Gilligan v. Morgan, 413 U.S. 1, 10
(1973) (“It would be difficult to think of a clearer example [than military affairs] of
the type of governmental action that was intended by the Constitution to be left to
the political branches . . . [or one] in which the courts have less competence.”).
Because the plaintiffs have identified no clearly defined fundamental right “deeply
rooted in this Nation’s history and tradition,” they have not triggered heightened
scrutiny. Moore, 410 F.3d at 1134. Nor have they cited a single case applying strict
scrutiny to a vaccine mandate. See contra Klassen v. Tr. of Ind. Univ., 7 F.4th 592,
593 (7th Cir. 2021), emergency application for relief denied, No. 21A15 (Barrett,
J., in chambers) (Aug. 12, 2021) (applying rational-basis review to university

vaccine mandate)).17
B.
Because strict scrutiny doesn’t apply, we are left with rational-basis review.
This is a “highly deferential” review, under which plaintiffs have the burden of
plaintiffs have offered no other judicially manageable way to determine whether a

drug is “experimental” under their asserted substantive due process right.
17
The plaintiffs cite Roman Catholic Diocese of Brooklyn v. Cuomo, 141 S.
Ct. 63, 67 (2020), which they contend shows strict scrutiny applies. That case did
apply strict scrutiny to a COVID-19 restriction, but it did so in the context of a Free
Exercise claim. Id. There is no such claim here.
28
“negat[ing] every conceivable basis that might support [the DOD mandate], even if
that basis has no foundation in the record.” Leib v. Hillsborough Cnty. Pub. Transp.
Comm’n, 558 F.3d 1301, 1306 (11th Cir. 2009). In other words, there must be no
“reasonably conceivable state of facts that could provide a rational basis for the”
mandate. Williams v. Pryor, 240 F.3d 944, 948 (11th Cir. 2001) (quoting FCC v.
Beach Commc’ns, Inc., 508 U.S. 307, 314 (1993)) (cleaned up). And “[a] statute
survives rational basis review even if it seems unwise or if the rationale for it seems
tenuous.” Locke v. Shore, 634 F.3d 1185, 1196 (11th Cir. 2011) (quoting Romer v.
Evans, 517 U.S. 620, 632 (1996)) (cleaned up).
The plaintiffs have not met their extraordinary burden of showing the
mandate lacks any rationality. They note the absence of certain vaccine
justifications in the record, but the defendants have no evidentiary burden in this
regard; they can base their mandate “on rational speculation unsupported by
evidence or empirical data.” Beach Commc’ns, 508 U.S. at 315. And it matters not
that the defendant’s decision may be the wrong one, so long as there is at least
some arguable basis for it.
The plaintiffs also argue that “[t]he DOD mandate also violates equal
protection insofar as it singles out, and discriminates against, Plaintiffs based on
their medical history, disabilities and/or medical conditions.” ECF No. 11 at 22.
They do not fully develop this argument, but it apparently relates to their
complaint that military personnel previously infected with COVID-19 will not
receive exemptions
29
from the vaccine mandate. See ECF No. 11 at 18, ECF No. 3-2 at 10-11. To the
extent they argue that the mandate is irrational because it treats servicemembers
with natural immunity the same as those without—it requires vaccination even for
those who have recovered from a COVID-19 infection—plaintiffs could not
succeed because this is a facial challenge. They have to show more than an
unconstitutional application as to some; they “must demonstrate that no possible
application” of the mandate is constitutional. Doe v. Sullivan, 938 F.2d 1370, 1383
(D.C. Cir. 1991). So although the plaintiffs point to the medical consensus that
natural immunity provides greater protection than vaccination alone, that is
insufficient to sustain their facial challenge. Relatedly, policies survive this
standard even when they are “significantly over-inclusive or under-inclusive,” so
long as they bear some rational connection to the policy’s goal. Williams, 240 F.3d
at 948.
At bottom, the plaintiffs have not met the heavy burden of showing facial
irrationality.
C.
Finally, the plaintiffs have not shown any likelihood of success on their
unconstitutional conditions claim. It is true that “the government may not deny a
benefit to a person because he exercises a constitutional right.” Koontz v. St. Johns
Water Mgmt. Dist., 570 U.S. 595, 604 (2013) (quoting Regan v. Tax’n With
Representation of Wash., 461 U.S. 540, 545 (1983)). But there is no conditioned
30
benefit in this case; the whole basis of the plaintiffs’ lawsuit is that the DOD
requires them to be vaccinated, not that the DOD is “coercing [the plaintiffs] into
giving [] up” a constitutional right in exchange for extra benefits. Id. Even if
continued employment in the military were a conditional benefit for the purposes
of the doctrine, the plaintiffs would still fail because a “condition cannot be
unconstitutional if it could be constitutionally imposed directly,” Rumsfeld v. F. for
Acad. & Inst. Rts., Inc., 547 U.S. 47, 59-60 (2006). As discussed above, plaintiffs
have not shown a likelihood of success on their claim that the DOD mandate cannot
constitutionally be imposed directly.
IV.
In conclusion, the plaintiffs have not shown they are entitled to the
preliminary injunctive relief they seek.18 Because they have not shown a likelihood
18
The defendants have raised certain alternative arguments that need not be
addressed. Their ripeness argument is jurisdictional, but in denying preliminary
injunctive relief, I have not determined that the court does have jurisdiction. It is
plaintiffs’ burden to show the court has jurisdiction, and the nature of their burden
depends on the stage of the proceedings. Lujan v. Defs. of Wildlife, 504 U.S. 555,
561 (1992). Because we are still at the pleading stage, and because the complaint
itself does not show any lack of ripeness, I have proceeded to consider the motion.
Cf. id. Of course, if the plaintiffs could not establish a likelihood that their claims
are ripe, they could not show a likelihood of success on the merits. Cf. Food &
Water Watch, Inc. v. Vilsack, 808 F.3d 905, 913 (D.C. Cir. 2015) (“[A] party who
seeks a preliminary injunction must show a substantial likelihood of standing.”).
But if they did not, that would only be a basis for denying preliminary injunctive
relief—not dismissing the case at this stage. And because I am denying
preliminary injunctive relief on other grounds, I have not further addressed
ripeness.
31
of success on the merits, I need not evaluate the other preliminary injunction
factors. The motions (ECF Nos. 3, 10) are DENIED.
An initial scheduling order and an order addressing the plaintiffs request to

proceed anonymously (ECF No. 4) will issue separately.
SO ORDERED on November 12, 2021.
s/ Allen Winsor
United States District Judge
32

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https://dockets.justia.

IN THE UNITED STATES DISTRICT COURT FOR THE

JOHN DOE #1-#14 and JANE DOE

personnel to become vaccinated against COVID-19. Seven weeks later, sixteen

agencies and the Executive Branch to impose unconstitutional vaccination

wisdom of the Secretary’s decision—or whether the Secretary should mandate

contrary to national security interests. Although those arguments relate to certain

a court’s “individual appraisal of the wisdom or unwisdom” of a policy “is to be put

constitutionality determined, the judicial process comes to an end”).

A preliminary injunction is no small thing. It is “an extraordinary and drastic

Bd., 557 F.3d 1177, 1198 (11th Cir. 2009).2

plaintiffs’ view, those entities acted unlawfully—the FDA by approving the

though, it is helpful to cover some relevant background.

evidentiary hearing. Regardless, many of the pertinent facts are essentially

Pfizer developed a COVID-19 vaccine, for which the FDA issued an

Emergency Use Authorization (“EUA”). This allowed Pfizer to distribute the

against a disease in a public health emergency where there is no “adequate,

to accept or refuse administration of the product.” Id. § 360bbb-3(e)(1)(A)(ii)(III).

effective—the FDA approved a Biologics License Application (“BLA”) and issued

that Pfizer produce Comirnaty only at approved locations, subject to specific

manufacturing, packaging, and labeling requirements. Id. at 2

During the administrative process, several scientists filed a Citizens’ Petition

approving the Comirnaty BLA. See generally ECF No. 1-13.

“there is not sufficient approved vaccine available for distribution to [the

And there “remains . . . a significant amount of [Pfizer COVID-19 vaccine] that

In the Summary Basis for Regulatory Action regarding Pfizer’s BLA

considered BLA-compliant—and are thus essentially Comirnaty—because they

have the BLA-approved chemical composition and were produced at a BLA

EUA informed-consent provision, 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), is

statuses. It is licensed—that is, fully approved—for the two-dose application in

emergency use authorization—for other applications, like for children under 16

the Secretary of Defense issued a memorandum announcing his intent to require

vaccination against COVID-19 either “immediately” upon FDA licensure or “no

at 2. The memorandum advised Pentagon leadership that “[m]andatory vaccination

Drug Administration (FDA), in accordance with FDA-approved labeling and

DOD mandate issued, an existing regulation—Army Reg. 40-562—set out the

other things, a “medical contraindication relevant to a specific vaccine or other

medication.” Army Reg. 40-562 ¶ 2-6(a). As an example of what might justify a

medical exemption, it includes “[e]vidence of immunity based on serologic tests,

documented infection or similar circumstances,” id. ¶ 2-6(a)(1)(b), along with

notwithstanding Army Reg. 40-562, includes no exception for natural immunity.

COVID-19 must be vaccinated.

Army Reg. 40-562 without notice-and-comment rulemaking. ECF No. 3-2 at

that APA rulemaking is required when an agency “adopt[s] a new position

inconsistent with any of the Secretary’s existing regulations.”).

federal vaccine mandates (affecting 100 million Americans) as a condition of

employment.” ECF No. 33 at 16. But regardless of any broader federal

administrative scheme, the military’s decision to inoculate servicemembers plainly

involves a military function. The Ninth Circuit’s decision in Independent Guard

“military function.” O’Leary, 57 F.3d at 770. The military-function test is easily

satisfied here as to the plaintiffs, each of whom is an active-duty servicemember.

The plaintiffs have not shown a likelihood of success as to their notice-and

without exemption of service members whit natural immunity or pregnancy.” ECF

This argument is a difficult one because of the substantial deference afforded

operation of a healthy deference to legislative and executive judgments in the area

of military affairs is evident in several recent decisions of [the Supreme] Court.”).

shown that they are likely to succeed on this point.