Rodden (Defendant) Response in Oppo Motion For Preliminary Injunction 23-Main

Case 3:21-cv-00317 Document 23 Filed on 11/22/21 in TXSD Page 1 of 51
IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF TEXAS
GALVESTON DIVISION
JAMES RODDEN, et al.,
Plaintiffs, Civil Action 3:21-cv-00317
v.
DR. ANTHONY FAUCI, in his official

capacity, et al.,
Defendants.
DEFENDANTS’ OPPOSITION TO MOTION FOR TEMPORARY

RESTRAINING ORDER AND PRELIMINARY INJUNCTION
TABLE OF CONTENTS
INTRODUCTION .............................................................................................................................1
BACKGROUND ................................................................................................................................4
I. The COVID-19 Pandemic.........................................................................................................4
II. Federal Regulation of and Guidance Concerning COVID-19 Vaccines ............................4
A. The Development and Authorization of COVID-19 Vaccines .................................. 4
B. Current Guidance on the Safety and Effectiveness of COVID-19 Vaccines for

Individuals Who Have Previously Been Infected With COVID-19 .......................... 6
III. Executive Order No. 14043 ......................................................................................................8
IV. This Lawsuit...............................................................................................................................10
LEGAL STANDARD ......................................................................................................................11
ARGUMENT .....................................................................................................................................11
I. Plaintiffs’ Claims Fail On Threshold Grounds. ....................................................................11
A. The Court Lacks Jurisdiction. ........................................................................................ 11
1. The Civil Service Reform Act Precludes Plaintiffs’ Claims. ................................ 11
2. Plaintiffs’ Claims Are Note Ripe. ............................................................................ 14
3. Plaintiffs’ Claims Against The Task Froce and The COVID-19 Response
Team Cannot Redress Their Injuries. ..................................................................... 16
B. Plaintiffs Fail To Identify A Cause Of Action............................................................. 18
1. Plaintiffs Do Not State Claims Under the APA. .................................................. 18
a) The Task Force and the White House COVID-19 Response Teams
Are Not Agencies. ............................................................................................ 18
b) Plaintiffs Do Not Challenge Final Agency Action. ..................................... 19
2. Plaintiffs Cannot Invoke Non-Statutory Review. ................................................. 20
i
II. Plaintiffs Fail to Establish Irreparable Injury. .......................................................................22
III. Plaintiffs Are Unlikely To Succeed On The Merits..............................................................25
A. Plaintiffs’ Substantive Due Process Claim is Unlikely to Succeed. ........................... 25
B. Plaintiffs’ FDCA Claim is Unlikely to Succeed. .......................................................... 29
C. Plaintiffs’ Arbitrary and Capricious Claim is Unlikely to Succeed. ........................... 33
IV. The Public Interest Weighs Heavily Against Injunctive Relief. ..........................................34
V. Any Relief Should Be Narrowly Tailored. .............................................................................37
CONCLUSION……………………………………………………………………...........38
ii
TABLES OF AUTHORITIES
Cases
Abbott Labs. v. Gardner,
387 U.S. 136 (1967) ................................................................................................................... 15
Alabama-Coushatta Tribe of Tex. v. United States,
757 F.3d 484 (5th Cir. 2014) .................................................................................................... 20
Am. Petroleum Inst. v. EPA,
683 F.3d 382 (D.C. Cir. 2012) ............................................................................................. 15, 6
Am.’s Frontline Drs. v. Wilcox,
No. EDCV 21-1243, 2021 WL 4546923 (C.D. Cal. July 30, 2021) .................................... 35
Anibowei v. Barr,
No. 3:16-cv-3495-D, 2019 WL 623090 (N.D. Tex. Feb. 14, 2019) .................................... 21
Armstrong v. Exec. Off. of the President,
90 F.3d 553 (D.C. Cir. 1996) .................................................................................................... 19
Bennett v. Spear,
520 U.S. 154 (1997) ................................................................................................................... 19
Bridges v. Hous. Methodist Hosp.,
---F. Supp. 3d---, 2021 WL 2399994 (S.D. Tex. June 12, 2021) .................................... passim
Broadway v. Block,
694 F.2d 979 (5th Cir. 1982) .................................................................................................... 12
BST Holdings, LLC v. OSHA,
--- F. 4th ---, 2021 WL 5279381 (5th Cir. Nov. 12, 2021) ......................................... 1, 29, 37
California v. Azar,
950 F.3d 1067 (9th Cir. 2020) .................................................................................................. 34
Cantu-Delgadillo v. Holder,
584 F.3d 682 (5th Cir. 2009) .................................................................................................... 26
Church v. Biden,
No. 21-cv-2815,2021 WL 5179215 (D.D.C. Nov. 8, 2021) ........................................... passim
City of Abilene v. EPA,
325 F.3d 657 (5th Cir. 2003) .................................................................................................... 33
City of Dallas v. Delta Air Lines, Inc.,
847 F.3d 279 (5th Cir. 2017) .................................................................................................... 22
iii
Clapper v. Amnesty Int’l, USA,

568 U.S. 398 (2013) ................................................................................................................... 15
Crane v. Napolitano,
No. 3:12-cv-03247-O, 2013 WL 8211660 (N.D. Tex. July 31, 2013) .......................... 12, 13
CREW v. Off. of Admin.,
566 F.3d 219 (D.C. Cir. 2009) .................................................................................................. 19
Cruzan ex rel. Cruzan v. Dir., Mo. Dep’t of Health,
497 U.S. 261 (1990) ................................................................................................................... 27
Danos v. Jones,
652 F.3d 577 (5th Cir. 2011) .................................................................................................... 21
Detroit Int’l Bridge Co. v. Canada,
189 F. Supp. 3d 85 (D.D.C. 2016) ........................................................................................... 20
Digital Generation, Inc. v. Boring,
869 F. Supp. 2d 761 (N.D. Tex. 2012) .................................................................................... 23
Doe v. Zucker,
520 F. Supp. 3d 217–53 (N.D.N.Y. 2021) ....................................................................... 26, 28
Dugan v. Rank,
372 U.S. 609 (1963) ................................................................................................................... 21
Elgin v. Dep’t of Treasury,
567 U.S. 1 (2012) ........................................................................................................................ 12
Engquist v. Or. Dep’t of Agric.,
553 U.S. 591 (2008) ..................................................................................................................... 1
EPIC v. Nat’l Sec. Comm’n on A.I.,
466 F. Supp. 3d 100 (D.D.C. 2020) ......................................................................................... 19
FCC v. Prometheus Radio Project,
141 S. Ct. 1150 (2021) ............................................................................................................... 33
Fleming v. Spencer,
718 F. App’x 185 (4th Cir. 2018) ............................................................................................. 14
Fornaro v. James,
416 F.3d 63 (D.C. Cir. 2005) .................................................................................................... 13
Franklin v. Massachusetts,
505 U.S. 788 (1992) .................................................................................................................... 18
Garcia v. United States,
iv
680 F.2d 29 (5th Cir. 1982) ......................................................................................... 16, 23, 36

Genesis Healthcare v. Symczyk,
569 U.S. 66 (2013) ..................................................................................................................... 38
Geyen v. Marsh,
775 F.2d 1303 (5th Cir. 1985) .................................................................................................. 20
Gill v. Whitford,
138 S. Ct. 1916 (2018) ............................................................................................................... 37
Griener v. United States,
900 F.3d 700 (5th Cir. 2018) .................................................................................................... 13
Griffith v. Fed. Labor Relations Auth.,
842 F.2d 487 (D.C. Cir. 1988) .................................................................................................. 21
Guilfoyle v. Beutner,
No. 2:21-cv-5009, 2021 WL 4594780 (C.D. Cal. Sept. 14, 2021) ....................................... 30
Harris v. Hahn,
827 F.3d 359 (5th Cir. 2016) .................................................................................................... 30
Harris v. Univ. of Mass., Lowell,
No. 21-11244, 2021 WL 3848012 (D. Mass. Aug. 27, 2021) ........................................ 28, 35
Hawkins v. Freeman,
195 F.3d 732 (4th Cir. 1999) .................................................................................................... 25
Heller v. Doe ex rel. Doe,
509 U.S. 312 (1993) ................................................................................................................... 29
Holland v. Nat’l Mining Ass’n,
309 F.3d 808 (D.C. Cir. 2002) .................................................................................................. 37
Humana, Inc. v. Jacobson,
804 F.2d 1390 (5th Cir. 1986) ........................................................................................... 22, 24
Inclusive Cmtys. Project, Inc. v. Dep’t of Treasury,
946 F.3d 649 (5th Cir. 2019) .................................................................................................... 17
Irizarry v. United States,
427 F.3d 76 (1st Cir. 2005) ....................................................................................................... 14
Jacobson v. Massachusetts,
197 U.S. 11 (1905) ..................................................................................................................... 26
Janvey v. Alguire,
647 F.3d 585 (5th Cir. 2011) .................................................................................................... 23
v
Johnson v. Brown,
---F. Supp. 3d---, 2021 WL 4846060 (D. Or. Oct. 18, 2021) .................................. 26, 30, 35
Jordan v. Fisher,
823 F.3d 805 (5th Cir. 2016) .................................................................................................... 11
Kerry v. Din,
576 U.S. 86 (2015) ..................................................................................................................... 28
Klaassen v. Trs. of Ind. Univ.,
No. 1:21-cv-238, --- F. Supp. 3d ---, 2021 WL 3073926 (N.D. Ind. July 18, 2021) .... passim
Larson v. Domestic & Foreign Commerce Corp.
337 U.S. 682 (1949) ............................................................................................................ 20, 21
Lewis v. Casey,
518 U.S. 343 (1996) ................................................................................................................... 24
Lloyd v. Sch. Bd. of Palm Beach Cnty.,
No. 9:21-cv-81715, 2021 WL 5353879 (S.D. Fla. Oct. 29, 2021) ....................................... 30
Lopez v. City of Houston,
617 F.3d 336 (5th Cir. 2010) ..................................................................................................... 14
Lujan v. Nat’l Wildlife Fed’n,
497 U.S. 871 (1990) ................................................................................................................... 20
Madsen v. Women’s Health Ctr., Inc.,
512 U.S. 753 (1994) ................................................................................................................... 37
Main St. Legal Servs., Inc. v. Nat’l Sec. Council,
811 F.3d 542 (2d Cir. 2016) ...................................................................................................... 19
Mass. Corr. Officers Union v. Baker,
No. 21-11599, 2021 WL 4822154 (D. Mass. Oct. 15, 2021) ............................................... 36
McCutcheon v. Enlivant ES, LLC,
No. 5:21-cv-00393, 2021 WL 5234787 (S.D.W. Va. Nov. 9, 2021) ..................................... 30
McDonald v. City of Chicago,
561 U.S. 742 (2010) ............................................................................................................ 25, 27
Meyer v. Bush,
981 F.2d 1288 (D.C. Cir. 1993) ................................................................................................ 19
Mississippi v. Johnson,
71 U.S. (4 Wall.) 475 (1866) ...................................................................................................... 17
NASA v. Nelson,
vi
562 U.S. 134 (2011) ................................................................................................................... 37

Navy Seal 1 v. Biden,),
No. 8:21-cv-02429-SDM-TGW, ECF No. 40 (M.D. Fla. Nov. 22, 2021 .................... 30, 38
Nat. Res. Def. Council, Inc. v. U.S. Dep’t of State,
658 F. Supp. 2d 105 (D.D.C. 2009) ......................................................................................... 20
Nken v. Holder,
556 U.S. 418 (2009) ................................................................................................................... 34
Norris v. Stanley,
--- F. Supp. 3d ---, 2021 WL 4738827 (W.D. Mich. Oct. 8, 2021) ................................ 30, 34
Norris v. Stanley,
No. 1:21-cv-756, 2021 WL 3891615 (W.D. Mich. Aug. 31, 2021) ................................ 28, 30
Norton v. S. Utah Wilderness All.,
542 U.S. 55 (2004) ..................................................................................................................... 20
Pelekai v. Hawaii,
No. 1:21-cv-343, 2021 WL 4944804 (D. Haw. Oct. 22, 2021) ............................................ 30
Pennhurst State Sch. & Hosp. v. Halderman,
465 U.S. 89 (1984) ..................................................................................................................... 21
Phillips v. City of N.Y.,
775 F.3d 538 (2d Cir. 2015) ...................................................................................................... 27
Planned Parenthood of Greater Tex. Surgical Health Servs. v. Abbott,
748 F.3d 583 (5th Cir. 2014) ............................................................................................. 28, 29
Prince v. Massachusetts,
321 U.S. 158–67 (1944) ............................................................................................................. 26
Raich v. Gonzales,
500 F.3d 850 (9th Cir. 2007) ............................................................................................. 25, 27
Rodriguez-Vélez v. Pierluisi-Urrutia,
No. 21-1366, 2021 WL 5072017 (D.P.R. Nov. 1, 2021) ...................................................... 26
Rollins v. Marsh,
937 F.2d 134 (5th Cir. 1991) .................................................................................................... 12
Roman Cath. Diocese of Brooklyn v. Cuomo,
141 S. Ct. 63 (2020) ............................................................................................................ 28, 35
Sackett v. EPA,
vii
566 U.S. 120 (2012) ................................................................................................................... 19

Sampson v. Murray,
415 U.S. 61 (1974) ..................................................................................................................... 23
Scenic Am., Inc. v. U.S. Dep’t of Transp.,
836 F.3d 42 (D.C. Cir. 2016) .................................................................................................... 17
Sierra Club v. EPA,
939 F.3d 649 (5th Cir. 2019) .................................................................................................... 34
Sierra Club v. Peterson,
228 F.3d 559 (5th Cir. 2000) .................................................................................................... 19
Smith v. Biden,
No. 21-cv-19457, 2021 WL 5195688 (D.N.J. Nov. 8, 2021) ......................................... passim
Steadman v. Governor, U.S. Soldiers’ & Airmen’s Home,
918 F.2d 963 (D.C. Cir. 1990) .................................................................................................. 14
Stewart v. Potts,
996 F. Supp. 668 (S.D. Tex. 1998) .......................................................................................... 34
Talleywhacker, Inc. v. Cooper,
465 F. Supp. 3d 523 (E.D.N.C. 2020) ..................................................................................... 35
Taylor Energy Co. v. United States,
No. 20-cv-1720, 2021 WL 1876845 (E.D. La. May 10, 2021) ............................................. 21
Tellabs, Inc. v. Makor Issues & Rts., Ltd.,
551 U.S. 308 (2007) ..................................................................................................................... 4
Terveer v. Billington,
34 F. Supp. 3d 100 (D.D.C. 2014) ........................................................................................... 21
Texas v. EEOC
933 F.3d 433 (5th Cir. 2019) ..................................................................................................... 18
Texas v. United States,
523 U.S. 296 (1998) ................................................................................................................... 14
Texas v. United States,
524 F. Supp. 3d 598 (S.D. Tex. 2021) ..................................................................................... 34
Tigges v. Northam,
473 F. Supp. 3d 559 (E.D. Va. 2020) ...................................................................................... 35
TJM 64, Inc. v. Harris,
475 F. Supp. 3d 828 (W.D. Tenn. 2020) ................................................................................. 35
viii
Trump. v. Hawaii
138 S. Ct. 2392 (2018) ................................................................................................................ 37
Tubesing v. United States,
810 F.3d 330 (5th Cir. 2016) .................................................................................................... 13
United States v. Fausto,
484 U.S. 439 (1988) ................................................................................................................... 11
Valdez v. Grisham,
---F. Supp. 3d---, 2021 WL 4145746 (D.N.M. Sept. 13, 2021) ......................... 26, 28, 30, 35
Villareal v. Rocky Knoll Health Ctr.,
No. 21-cv-729, 2021 WL 5359018 (E.D. Wis. Nov. 17, 2021) ........................................... 30
Washington v. Glucksberg,
521 U.S. 702 (1997) ................................................................................................................... 26
Washington v. Harper,
494 U.S. 210 (1990) ................................................................................................................... 27
Williams v. Brown,
--- F. Supp. 3d ----, 2021 WL 4894264 (D. Or. Oct. 19, 2021) .............................. 28, 34, 35
Winter v. Nat. Res. Def. Council,
555 U.S. 7 (2008) ................................................................................................................. 11, 24
Wise v. Inslee,
No. 2:21-cv-2088, 2021 WL 4951571 (E.D. Wash. Oct. 25, 2021) .................................... 35
Workman v. Mingo Cnty. Bd. of Educ.,
419 F. App’x 348–56 (4th Cir. 2011) ...................................................................................... 28
Zucht v. King,
260 U.S. 174 (1922) ................................................................................................................... 26
United States Code

5 U.S.C. § 701(b)(1) ......................................................................................................................... 18
5 U.S.C. § 702 .................................................................................................................................. 18
5 U.S.C. § 704 .................................................................................................................................. 19
5 U.S.C. § 1212(a)(2) ....................................................................................................................... 13
5 U.S.C. § 1214(a)(1)(A) ................................................................................................................. 13
5 U.S.C. § 2301 ................................................................................................................................ 13
5 U.S.C. § 2302 ......................................................................................................................... 13, 14
ix
5 U.S.C. § 3301 ................................................................................................................... 22, 32, 37

5 U.S.C. § 3302 ......................................................................................................................... 32, 37
5 U.S.C. § 7301 ......................................................................................................................... 32, 37
5 U.S.C. § 7511 ................................................................................................................................ 14
5 U.S.C. § 7512 ......................................................................................................................... 12, 13
5 U.S.C. § 7513(d) .................................................................................................................... 12, 15
5 U.S.C. § 7702 ................................................................................................................................ 12
5 U.S.C. § 7703 ......................................................................................................................... 12, 15
10 U.S.C. § 1107a ............................................................................................................................ 32
21 U.S.C. § 360bbb-3 ................................................................................................................ passim
42 U.S.C. § 262 .................................................................................................................................. 4
Regulations
5 C.F.R. § 752.404 ........................................................................................................................... 15
Exec. Order No. 13991, Protecting the Federal Workforce and Requiring Mask-Wearing,
86 Fed. Reg. 7045 (Jan. 20, 2021) ............................................................................................ 18
Exec. Order No. 14043, Requiring Coronavirus Disease 2019 Vaccination for Federal
Employees,
86 Fed. Reg. 50,989 (Sept. 14, 2021) ............................................................................ 8, 29, 33
Other
CDC, COVID DATA Tracker – Cases, Deaths, and Testing (updated Nov. 21, 2021),
https://perma.cc/22V5-JMHA ................................................................................................. 4
CDC, COVID Data Tracker Weekly Review (updated Nov. 19, 2021),
https://perma.cc/2BX5-775Y ................................................................................................... 1
CDC, Delta Variant: What We Know About the Science (updated Aug. 26, 2021),
https://perma.cc/DZA6-F9LC ................................................................................................ 4
CDC, How COVID-19 Spreads (updated July 14, 2021),
https://perma.cc/SXB2-G9WA ............................................................................................... 4
CDC, Science Brief: SARS-CoV-2 Infection-induced and Vaccine-induced Immunity (updated Oct. 29,
2021),
https://perma.cc/CMT3-XU8X ............................................................................................... 7
CDC, Vaccines, Safety of COVID-19 Vaccines,
https://perma.cc/6TTN-T5U4 ................................................................................................. 6
x
FDA, Comirnaty Approved Prescribing Information (revised Aug. 20, 2021),

https://perma.cc/8D4K-KFKB ........................................................................................... 5, 6
FDA, Letter Approving Biologics License Application of BioNTech Mfg. (Aug. 23, 2021),
https://perma.cc/MTG9-E9EX ............................................................................................... 5
FDA, Letter of Authorization to Janssen Biotech, Inc., (Nov. 19, 2021),
https://perma.cc/Z68F-B3FK ................................................................................................. 5
FDA, Letter of Authorization to ModernaTX, Inc. (Nov. 19, 2021),
https://perma.cc/8XR6-27YW ................................................................................................. 5
FDA, Letter of Authorization to Pfizer Inc. (Nov. 19, 2021),
https://perma.cc/WE6M-DKG9 ......................................................................................... 5, 6
FDA, Moderna EUA COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (revised
Oct. 20, 2021),
https://perma.cc/JZ6Y-ZUJF ................................................................................................ 31
FDA, News Release – FDA Approves First COVID-19 Vaccine (Aug. 23, 2021),
https://perma.cc/BV3T-4GGP ................................................................................................ 5
Pandemic Response Accountability Committee, Top Challenges Facing Federal Agencies
(June 2020),
https://perma.cc/9D8L-J5MN ............................................................................................... 36
Task Force, COVID-19 Workplace Safety: Agency Model Safety Principles (updated Sept.13,
2021),
https://perma.cc/T9HR-NTZB ............................................................................................... 9
Task Force, FAQs, Vaccinations, Enforcement of Vaccination Requirement for Federal
Employees,
https://perma.cc/X78K-D9GD ........................................................................................ 9, 10
Task Force, FAQs, Vaccinations, Limited Exceptions to Vaccination Requirement,
https://perma.cc/X78K-D9GD ........................................................................................ 9, 10
Template: Request for a Medical Exception to the COVID-19 Vaccination Requirement,
https://perma.cc/F2VH-EYPP ................................................................................................ 9
Template: Request for a Religious Exception to the COVID-19 Vaccination Requirement,
https://perma.cc/69LP-T72Y ................................................................................................... 9
xi
INTRODUCTION
The United States is in the midst of the most serious public health crisis it has faced in
at least a century. To date, the virus that causes COVID-19 has infected more than 47 million
Americans, hospitalized more than 3 million, and killed over 760,000. See Centers for Disease
Control and Prevention (“CDC”), COVID Data Tracker Weekly Review (updated Nov. 19,
2021), https://perma.cc/2BX5-775Y. Nearly two years into the COVID-19 pandemic, over
80,000 cases are being reported in the United States every day, and case rates are once again
increasing throughout the nation. See id.
Across the country, there is a vigorous and ongoing debate about the proper response
to this pandemic, including the extent of the federal government’s authority to ensure that
private employers protect their employees from COVID-19. A panel of the Fifth Circuit
recently joined that debate, staying an Emergency Temporary Standard (“ETS”) issued by the
Occupational Safety and Health Administration (“OSHA”) that would require private sector
“employees of covered employers to undergo COVID-19 vaccination or take weekly COVID-
19 tests and wear a mask.” BST Holdings, LLC v. OSHA, --- F. 4th ---, 2021 WL 5279381, at
*1 (5th Cir. Nov. 12, 2021). The government strongly disagrees with that ruling and will
continue to defend the OSHA ETS. This case, however, is not about the federal government’s
authority, in its capacity as regulator, to require private employers to impose vaccine mandates.
To the contrary, the question presented is whether the federal government, in its capacity as
an employer, may require its own employees to be vaccinated against COVID-19 as a condition
of their employment. See Engquist v. Or. Dep’t of Agric., 553 U.S. 591, 598 (2008) (recognizing
that “the government as employer indeed has far broader powers than does the government
1
as sovereign”). This case is thus not governed by BST Holdings, and every court that has
considered a request to enjoin the Executive Order challenged here has denied it. See Rydie v.
Biden, No. 21-cv-2696, ECF No. 26 (D. Md. Nov. 19, 2021); Brnovich v. Biden, No. 2:21-cv-
01568-MTL, ECF No. 64 (D. Ariz. Nov. 10, 2021); Altschuld v. Raimondo, No. 21-cv-2779, ECF
No. 23 (D.D.C. Nov. 8, 2021); Church v. Biden, No. 21-cv-2815, 2021 WL 5179215 (D.D.C.
Nov. 8, 2021); Smith v. Biden, No. 21-cv-19457, 2021 WL 5195688 (D.N.J. Nov. 8, 2021), appeal
pending, No. 21-3091 (3d Cir.); Foley v. Biden, No. 4:21-cv-01098-O, ECF No. 18 (N.D. Tex.
Oct. 5, 2021). Indeed, binding precedent makes clear that Plaintiffs are not entitled to
emergency injunctive relief.
At the outset, this Court lacks jurisdiction over Plaintiffs’ claims. Congress has
specifically decided how federal employees may bring constitutional (and other) challenges to
the terms of their employment: through the express procedures of the Civil Service Reform
Act (“CSRA”), not immediate suits in federal district court. Even if that were not so, this case
is unripe because it is uncertain whether any Plaintiff will be suspended or terminated—indeed,
all but one of them have requested exceptions from the vaccination requirement, and they will
not be disciplined for lack of compliance while those requests remain pending.
Even if this Court had jurisdiction, Plaintiffs’ challenge would fail at the threshold.
They do not state claims under the Administrative Procedure Act (“APA”) because they have
not sued proper agency defendants, and vaguely defined “actions by the federal agencies and
agents of the federal government to enforce the Executive Order,” Compl. ¶ 3 n.4, ECF No.
1, are not the kind of discrete, final agency action that may be challenged under the APA. And
Plaintiffs cannot bypass the APA by invoking the narrow non-statutory review doctrine
2
because the vaccination requirement is clearly within the President’s authority to regulate the
federal workforce.
Nor do Plaintiffs face irreparable harm. Most federal employees can pursue
reinstatement with potential back pay pursuant to the CSRA and the Back Pay Act if they are
wrongfully terminated by the federal government. Binding precedent from the Supreme Court
and the Fifth Circuit confirms that termination in these circumstances (let alone potential
termination) is not irreparable harm, and BST Holdings—which concerns private companies
regulated by the government, not government employees—does not suggest otherwise.
Plaintiffs are also unlikely to succeed on the merits of their claims. There is no
fundamental right to avoid employment consequences based on a refusal to be vaccinated,
and for more than a century, courts have uniformly upheld vaccination requirements as
rationally related to the government’s legitimate interest in promoting health and safety.
Plaintiffs lack a private right of action to sue under the Federal Food, Drug, and Cosmetic Act
(“FDCA”), and they misinterpret its requirements in any event. Plaintiffs also cannot show
that the federal employee vaccination requirement is arbitrary and capricious under the APA
(even if it applied). Public health experts at CDC and the Food and Drug Administration
(“FDA”) have carefully examined the scientific evidence and have concluded that COVID-19
vaccines are warranted for people who have recovered from a prior infection, and it is
reasonable for the President to rely on these agencies’ scientific expertise.
Finally, the public interest is best served by allowing the federal government to decide
how best to protect the federal workforce from a deadly virus that has caused serious
disruption to its operations and by honoring Congress’s clear directive that federal
3
employment disputes should be addressed through the exclusive procedures of the CSRA.
The Court should deny Plaintiffs’ request for emergency injunctive relief.
BACKGROUND
I. The COVID-19 Pandemic
The virus SARS-CoV-2 causes a respiratory disease known as COVID-19. See CDC,
How COVID-19 Spreads (updated July 14, 2021), https://perma.cc/SXB2-G9WA. In July
2021, the United States began to experience “a rapid and alarming rise in . . . COVID-19 case
and hospitalization rates,” driven by an especially contagious strain of SARS-CoV-2 known as
the Delta variant. See CDC, Delta Variant: What We Know About the Science (updated Aug.
26, 2021), https://perma.cc/DZA6-F9LC. As of the filing of this brief, community
transmission rates remain high in the majority of U.S. states and territories.1 See CDC, COVID
DATA Tracker – Cases, Deaths, and Testing (updated Nov. 21, 2021),
https://perma.cc/22V5-JMHA. And daily case rates are once again increasing. Id.
II. Federal Regulation of and Guidance Concerning COVID-19 Vaccines
A. The Development and Authorization of COVID-19 Vaccines
FDA has authority to review and approve “biological products,” including vaccines, as
safe and effective for their intended uses. 42 U.S.C. § 262(a)(1), (i)(1). Under section 564 of
the FDCA, 21 U.S.C. § 360bbb-3, FDA may issue an “emergency use authorization” (“EUA”)
during a public health emergency, which authorizes the marketing of non-FDA-approved
vaccines (and other products) “intended for use” in responding to the emergency. In
1The Court may take judicial notice of these statistics and other factual information available
on government websites. Tellabs, Inc. v. Makor Issues & Rts., Ltd., 551 U.S. 308, 322-23 (2007).
4
December 2020, FDA issued EUAs for the Pfizer-BioNTech and Moderna COVID-19
vaccines, and in February 2021 it issued an EUA for the Janssen COVID-19 vaccine. See
FDA, Letter of Authorization to Pfizer Inc. (Nov. 19, 2021), https://perma.cc/WE6M-
DKG9 (“Pfizer EUA Letter”) (revising and reissuing December 2020 EUA); FDA, Letter of
Authorization to ModernaTX, Inc. (Nov. 19, 2021), https://perma.cc/8XR6-27YW
(“Moderna EUA Letter”) (same); FDA, Letter of Authorization to Janssen Biotech, Inc.,
(Nov. 19, 2021), https://perma.cc/Z68F-B3FK (“Janssen EUA Letter”) (revising and
reissuing February 2021 EUA). The EUAs are based on FDA’s review of extensive safety and
efficacy data, including from a Pfizer clinical trial with approximately 46,000 participants, a
Moderna clinical trial with approximately 30,000 participants, and a Janssen clinical trial with
approximately 43,000 participants. See Pfizer EUA Letter at 4; Moderna EUA Letter at 2;
Janssen EUA Letter at 2.
On August 23, 2021, the Pfizer-BioNTech COVID-19 vaccine obtained FDA
approval, under the name Comirnaty, for people aged 16 years and older. See FDA, Letter
Approving Biologics License Application of BioNTech Mfg. (Aug. 23, 2021),
https://perma.cc/MTG9-E9EX. This means that the vaccine has completed “the agency’s
standard process for reviewing the quality, safety and effectiveness of medical products.”
FDA, News Release – FDA Approves First COVID-19 Vaccine (Aug. 23, 2021),
https://perma.cc/BV3T-4GGP. In making the determination to approve Comirnaty, FDA
noted data demonstrating that the vaccine was 91.1% effective in preventing SARS-CoV-2
infection and between 95% and 100% effective in preventing severe COVID-19. FDA,
Comirnaty Approved Prescribing Information (revised Aug. 20, 2021) at 7, 15-18,
5
https://perma.cc/8D4K-KFKB. FDA concluded that the product is safe based on data from
approximately 12,000 vaccine recipients who were followed for safety outcomes for at least
six months after their second dose, as well as safety information from the millions of doses
administered under the EUA. Id. at 12.
Comirnaty is the same formulation as the Pfizer-BioNTech vaccine originally
authorized for emergency use, and the two vaccine products “can be used interchangeably
without presenting any safety or effectiveness concerns.” Ex. A (Decl. of Peter Marks, M.D.,
Ph.D) ¶ 10 (“Marks Decl.”); see id. ¶¶ 7–8. Whether or not it bears the “Comirnaty” label, this
formulation remains available for use as a two-dose primary vaccination series for individuals
12 years of age and older and for various other uses. See id. ¶ 8.
B. Current Guidance on the Safety and Effectiveness of COVID-19 Vaccines

for Individuals Who Have Previously Been Infected with COVID-19
CDC advises that COVID-19 vaccines are safe and effective, and it recommends that
all eligible individuals receive a vaccine “as soon as possible.” CDC, Vaccines, Safety of
COVID-19 Vaccines, https://perma.cc/6TTN-T5U4. As recently reiterated by CDC’s Chief
Medical Officer for COVID-19 Emergency Response, the “best way to stop COVID-19,
including the emergence of variants, is with widespread COVID-19 vaccination,” in addition
to other preventive measures, such as mask wearing and physical distancing. Ex. B (Decl. of
Dr. John T. Brooks) ¶ 12 (“Brooks Decl.”). This is true regardless of whether an individual
has experienced a prior infection, as detailed below.
With respect to safety, expert regulators at FDA and CDC have not identified a pattern
of adverse events associated with receiving a COVID-19 vaccine after prior SARS-CoV-2
infection, and FDA has considered and rejected suggestions that people with prior infections
6
are at “heightened risk for adverse effects” from the vaccine. See Marks Decl. ¶ 25. With
respect to effectiveness in the previously infected population, CDC experts have extensively
researched the issue. After reviewing over 90 peer-reviewed and pre-print publications, as well
as certain unpublished data, CDC issued a Science Brief in which it “continued to recommend
COVID-19 vaccination for all eligible persons, including those who have been previously
infected with SARS-CoV-2.” CDC, Science Brief: SARS-CoV-2 Infection-induced and Vaccine-
induced Immunity (updated Oct. 29, 2021), https://perma.cc/CMT3-XU8X. CDC’s bottom-
line finding is that “[s]ubstantial immunologic evidence and a growing body of epidemiologic
evidence indicate that vaccination after infection significantly enhances protection and further
reduces risk of reinfection.” Id. at 1.
CDC’s conclusion is well supported. First, while a SARS-CoV-2 infection and a
COVID-19 vaccination both may stimulate an immune response, the immune response for
the previously infected “is more variable than the immune response to vaccination.” Brook
Decl. ¶ 7. Vaccines “produce a more consistent and on average a stronger and more
predictable level of antibodies than infection with SARS-CoV-2,” and “a more predictable
immune response.” Id. ¶¶ 6-7. This is in part because more severe cases of COVID-19 will
generally produce higher levels of antibodies than mild or asymptomatic ones. Id. ¶ 6. And
because people with more severe cases are more likely to be included in studies, the available
data regarding the degree of immunity that infection confers (particularly for milder cases) is
less reliable than the data that exists for vaccine immunity. Id. ¶ 8. In addition to providing
more consistent immune responses, vaccinations also have a demonstrated track record of
providing “strong protection against COVID-19 illness, including against severe disease,
7
hospitalization and death.” Id. ¶ 9.
Even putting aside whether COVID-19 vaccinations are more or less effective than
natural infections at producing an immune response in particular individuals, the data show
that the vaccine provides benefits to individuals who have already been infected, both at the
individual and public health level. In particular, studies have shown that “vaccination after
infection safely strengthens the immune response by significantly increasing antibody levels,”
“protects better against reinfection than infection without subsequent vaccination,” and
“significantly reduces the likelihood that a previously-infected person will become infected
again, which thereby protects them against another potentially serious illness and also
decreases the number of persons at risk for reinfection who could pose a threat of transmitting
infection to others.” Id. ¶¶ 10-11.
III. Executive Order No. 14043
On September 9, 2021, President Biden issued Executive Order No. 14043. See
Requiring Coronavirus Disease 2019 Vaccination for Federal Employees, Exec. Order No.
14043, 86 Fed. Reg. 50,989 (Sept. 14, 2021) (the “Executive Order”). The Executive Order
reflects the President’s determination that the ongoing COVID-19 emergency threatens “[t]he
health and safety of the Federal workforce, and the health and safety of members of the public
with whom they interact, [which] are foundational to the efficiency of the civil service.” Id. at
50,989. “[I]n light of public health guidance”—particularly CDC’s determination “that the
best way to slow the spread of COVID-19 and to prevent infection by the Delta variant or
other variants is to be vaccinated”—the Executive Order instructs each federal agency to
“implement, to the extent consistent with applicable law, a program to require COVID-19
8
vaccination for all of its federal employees, with exceptions only as required by law.” Id. at
50,989–50,990. It also directs the Safer Federal Workforce Task Force (“Task Force”) to
“issue guidance . . . on agency implementation of this requirement.” Id.
The Task Force guidance, like the Executive Order, recognizes that federal employees
may be eligible for exceptions to the vaccination requirement based on a medical condition or
religious objection, see Task Force, Frequently Asked Questions (“FAQs”), Vaccinations,
Limited Exceptions to Vaccination Requirement, https://perma.cc/X78K-D9GD
(“Exception FAQs”), and instructs each agency to “follow its ordinary process to review and
consider what, if any, accommodation it must offer” under applicable federal law, see Task
Force, FAQs, Vaccinations, Enforcement of Vaccination Requirement for Federal
Employees, https://perma.cc/X78K-D9GD (“Enforcement FAQs”); see also Template:
Request for a Medical Exception to the COVID-19 Vaccination Requirement,
https://perma.cc/F2VH-EYPP; Template: Request for a Religious Exception to the COVID-
19 Vaccination Requirement, https://perma.cc/69LP-T72Y.
Per Task Force guidance, federal employees who have not requested or received an
exception should be fully vaccinated “no later than November 22, 2021.” Task Force,
COVID-19 Workplace Safety: Agency Model Safety Principles at 1 (updated Sept.13, 2021),
https://perma.cc/T9HR-NTZB. That guidance further provides that an employee who
requests an exception should not be subject to discipline while the request is under
consideration, and that if any such exception request is denied, the employee should be given
two weeks from the denial to receive the first (or only) dose of a COVID-19 vaccine before
being subject to discipline. See Enforcement FAQs; Exception FAQs. Each agency or agency
9
component that employs a named Plaintiff intends to follow this guidance. In other words,
no named Plaintiff with a pending exception request will be subject to discipline while his or
her request is pending, and if any Plaintiff’s request is denied, he or she will be provided a
period of at least two weeks following the denial in which initiate the vaccination process
before being subject to any discipline. See Ex. C (Decl. of Susan A. Yarwood, U.S. Secret
Service) (“Secret Serv. Decl.”); Ex. D (Decl. of John D. Cunningham, Immigration & Customs
Enforcement (“ICE”)) (“ICE Decl.”); Ex, E (Decl. of Joseph Salvator, Transp. Sec. Admin.
(“TSA”)) (“TSA Decl.”); Ex. F (Decl. of Garry R. Newton, U.S. Dep’t of the Navy) (“Navy
Decl.”); Ex. G (Decl. of Laura Glading, Federal Aviation Admin. (“FAA”) (“FAA Decl.”); Ex.
H. (Decl. of Joseph Abbott, U.S. Dep’t of Agriculture (“USDA”) (“USDA Decl.”).
As these agencies confirm, an employee who does not comply with the vaccination
requirement (and does not have a pending exception request) may be subject to a phased
enforcement process intended to “help employees understand and accept the benefit of
becoming fully vaccinated.” E.g., Secret Serv. Decl. ¶ 3. That process begins with a period of
education and counseling about the benefits of vaccination. See Secret Serv. Decl.; ICE Decl.;
TSA Decl.; Navy Decl.; FAA Decl.; USDA Decl. At the conclusion of this period, employees
who remain unvaccinated may be subject to progressive discipline, which may include a
proposed suspension followed by, where appropriate, proposed removal from employment.
Id.
IV. This Lawsuit
Plaintiffs are eleven federal employees who purport to represent a class of all “federal
employees outside the uniformed services who have naturally acquired immunity to COVID-
10
19 and who do not wish to take the vaccine.” Compl. at 8. On November 5, 2021, Plaintiffs
filed both the complaint and a motion for emergency relief. ECF No. 3 (“Mot.”). Plaintiffs’
motion pertains to only three of the five counts alleged in the Complaint: Count One, which
alleges a violation of the Ninth and Fourteenth Amendments; Count Four, which alleges a
violation of the FDCA; and Count Five, which alleges that the Executive Order is “arbitrary
and capricious within the meaning of the [APA],” Compl. ¶ 235; see Mot. at 2.
LEGAL STANDARD
“A preliminary injunction is an extraordinary remedy never awarded as of right.” Winter
v. Nat. Res. Def. Council, 555 U.S. 7, 24 (2008) (citation omitted). The party seeking such relief
bears the burden to show: (1) “a substantial threat of irreparable injury,” (2) “a substantial
likelihood of success on the merits,” (3) “that the threatened injury if the injunction is denied
outweighs any harm that will result if the injunction is granted,” and (4) “that the grant of an
injunction will not disserve the public interest.” Jordan v. Fisher, 823 F.3d 805, 809 (5th Cir.
2016) (citation omitted). A preliminary injunction should not be “granted unless the party
seeking it has clearly carried the burden of persuasion on all four requirements.” Id.
ARGUMENT
I. Plaintiffs’ Claims Fail On Threshold Grounds.
A. The Court Lacks Jurisdiction.
1. The Civil Service Reform Act Precludes Plaintiffs’ Claims.
The CSRA constitutes “an integrated scheme of administrative and judicial review,
designed to balance the legitimate interests of the various categories of federal employees with
the needs of sound and efficient administration.” United States v. Fausto, 484 U.S. 439, 445
(1988). It “prescribes in great detail the protections and remedies applicable to such action,
11
including the availability of administrative and judicial review.” Id. at 443. As the Fifth Circuit
has explained, the CSRA’s remedies are “the comprehensive and exclusive procedures for settling
work-related controversies between federal civil-service employees and the federal
government.” Rollins v. Marsh, 937 F.2d 134, 139 (5th Cir. 1991) (emphasis added).2 “Thus,
when a particular employee’s class or asserted claim has been excluded from the CSRA’s
framework for administrative and judicial review of adverse personnel actions, that excluded
employee cannot seek redress in a federal district court.” Crane v. Napolitano, No. 3:12-cv-
03247-O, 2013 WL 8211660, at *2 (N.D. Tex. July 31, 2013). Particularly relevant here, “the
CSRA precludes district-court adjudication of a covered employee’s challenge to a covered
adverse employment action, even when the employee raises constitutional challenges to federal statutes and
seeks equitable relief.” Id. (citing Elgin v. Dep’t of Treasury, 567 U.S. 1 (2012) (emphasis added));
see also, e.g., Broadway v. Block, 694 F.2d 979, 986 (5th Cir. 1982) (the same as to APA). Where
CSRA preclusion applies, a court lacks jurisdiction. See, e.g., Elgin, 567 U.S. at 8.
Under the CSRA, different administrative and judicial review procedures apply
depending on the nature of the challenged employment action and the types of claims asserted.
More serious “adverse actions”—suspension for more than 14 days, reduction in grade,
reduction in pay, removal, or furlough of 30 days or less, 5 U.S.C. § 7512— may generally be
appealed directly to the Merit Systems Protection Board (“MSPB”), with judicial review in the
Federal Circuit. Id. §§ 7513(d), 7703(b)(1). Corrective action for a less severe “personnel
action” may generally be sought from any agency administrative or negotiated grievance rights,
2Only claims of discrimination, which Plaintiffs do not assert here, may be brought in district
court as specifically provided for by the CSRA, 5 U.S.C. §§ 2302(d), 7702, 7703(b)(2).
12
through Equal Employment Opportunity Commission (“EEOC”) complaints if an EEO
protected basis is alleged, or from the Office of Special Counsel (“OSC”) if the applicant or
employee alleges a prohibited reason for the action. Id. § 1214(a)(3); id. § 2302.3 No relief is
available outside of those channels because “so far as review of determinations under the
CSRA is concerned, what you get under the CSRA is what you get.” Fornaro v. James, 416 F.3d
63, 67 (D.C. Cir. 2005) (Roberts, J.).
Here, Plaintiffs’ complaint could be characterized as a challenge to a current
“significant change in duties, responsibilities, or working conditions,” 5 U.S.C.
§ 2302(a)(2)(A)(xii), or as a challenge to a hypothetical future removal or suspension, see id.
§ 7512. Regardless of the nature of the challenge or whether the CSRA might provide a
remedy, the statute precludes Plaintiffs from pursuing their claims in this Court. See e.g., Griener
v. United States, 900 F.3d 700, 703 (5th Cir. 2018) (CSRA shows “Congress’s intent to entirely
foreclose judicial review to employees to whom the CSRA denies statutory review”); Crane,
2013 WL 8211660, at *3 n.2 (“If the CSRA provides a remedy for Plaintiffs’ challenged
disciplinary action, then the CSRA’s remedy is Plaintiffs’ exclusive avenue for redressing their
claims. . . . If the CSRA does not provide a remedy for Plaintiffs’ challenged disciplinary action
3 “Personnel actions” are defined comprehensively to include, inter alia, a disciplinary or

corrective action, detail, transfer, reassignment, performance evaluation, pay or benefits
decision, or any other “significant change in duties, responsibilities, or working conditions.”
See 5 U.S.C. § 2302(a)(2). Congress authorized OSC to investigate whether a challenged
“personnel action” constitutes one or more of thirteen specified “prohibited personnel
practices,” including failure to provide “[a]ll employees . . . fair and equitable treatment . . .
with proper regard for their . . . constitutional rights.” 5 U.S.C. §§ 1212(a)(2), 1214(a)(1)(A),
2302(b)(1)–(13); id. § 2301(b)(2). OSC thus has jurisdiction to investigate an employee’s claim
that a personnel action violated the Constitution. See Tubesing v. United States, 810 F.3d 330,
333 (5th Cir. 2016).
13
. . . , then a federal district court cannot provide relief because it would be affording a greater
remedy than that provided by the CSRA.”); see also Rydie, ECF No. 26, at 6 (concluding that
challenge to Executive Order 14043 was likely precluded by the CSRA).4
2. Plaintiffs’ Claims Are Not Ripe.
Even if this action were not precluded by the CSRA, the Court would still lack
jurisdiction because Plaintiffs’ claims are speculative and unripe. See Lopez v. City of Houston,
617 F.3d 336, 341 (5th Cir. 2010) (noting that “[r]ipeness is a component of subject matter
jurisdiction”). As Plaintiffs confirm in their supplemental filing, see ECF No. 16 (“Suppl. Br.”)
at 2, ten of the eleven Plaintiffs have submitted requests for exceptions to the vaccination
requirement. These requests remain pending, id.; see also Secret Serv. Decl. ¶ 6; ICE Decl. ¶ 10;
TSA Decl. ¶ 6; Navy Decl. ¶ 6; FAA Decl. ¶ 6; USDA Decl. ¶ 6, and as discussed above, each
Plaintiff’s employing agency must consider each request on an individualized basis and grant
any exception required by law. Because Plaintiffs’ exception requests are still pending and
could be granted, their potential injuries depend “upon ‘contingent future events that may not
occur as anticipated, or indeed may not occur at all.’” Texas v. United States, 523 U.S. 296, 300
4 On available information, Plaintiff Rodden appears to be a probationary employee, which

means that he lacks appeal rights to the MSPB right now. See 5 U.S.C. § 7511(a)(1)(A)(i). Yet
Plaintiff Rodden could at least bring his constitutional claim to OSC, id. § 2302(a)(2)(B)
(definition of “covered position” for purposes of OSC complaints), and the “CSRA plainly
precludes extrastatutory judicial review of constitutional claims that are asserted before an
employee has exhausted his remedies available under the statute.” Fleming v. Spencer, 718 F.
App’x 185, 188 n.2 (4th Cir. 2018); see also, e.g., Irizarry v. United States, 427 F.3d 76, 79 (1st Cir.
2005); Steadman v. Governor, U.S. Soldiers’ & Airmen’s Home, 918 F.2d 963, 967 (D.C. Cir. 1990).
The same principle would hold if any Plaintiff had “brought his constitutional claim to the
OSC and been denied an opportunity to pursue that claim in the Federal Circuit.” Fleming,
718 F. App’x at 188; after exhausting, such a plaintiff might be able to assert constitutional
claims in district court. Yet no Plaintiff here alleges that he has exhausted claims before OSC.
14
(1998) (citation omitted). This dispute is thus constitutionally unripe. See Clapper v. Amnesty
Int’l, USA, 568 U.S. 398, 416 (2013) (fears of “hypothetical future harm” are not “certainly
impending” as required under Article III). As another court recently concluded in rejecting a
similar challenge to the Executive Order, potential injuries based on “hypothetical predictions
of the outcomes of . . . exemption requests” are “insufficient to ‘render an issue ripe for
review.’” Church, 2021 WL 5179215, at *9 (quotation omitted).
Plaintiffs’ claims are also prudentially unripe in light of the administrative mechanisms
for resolving Plaintiffs’ exception requests and determining whether and what discipline could
be imposed if any Plaintiffs do not receive an exception. See Am. Petroleum Inst. v. EPA, 683
F.3d 382, 386 (D.C. Cir. 2012) (“In the context of agency decisionmaking, letting the
administrative process run its course before binding parties to a judicial decision prevents
courts from ‘entangling themselves in abstract disagreements over administrative policies, and
. . . protect[s] the agencies from judicial interference’ in an ongoing decision-making process.’”
(quoting Abbott Labs. v. Gardner, 387 U.S. 136, 148 (1967)). Even if Plaintiffs’ requests are
denied by their employers, it is impossible to know with certainty what discipline the agencies
would impose, and termination from employment is not a foregone conclusion. This is
evidenced by the attached agency declarations, which describe the extensive procedures that
are available to each named Plaintiff. See Secret Serv. Decl.; ICE Decl.; TSA Decl.; Navy Decl.;
FAA Decl.; USDA Decl.. If removal is ultimately pursued, federal employees generally have
additional procedural protections under federal law, up to and including review by the MSPB
and Federal Circuit. See 5 C.F.R. § 752.404; 5 U.S.C. §§ 7513(d), 7703(b)(1); see also ICE Decl.
¶ 8. At a minimum, allowing these procedures to play out would solidify any dispute between
15
Plaintiffs and their employing agencies and create a concrete record that could guide the Court
in its ultimate resolution of the issues.
For the same reason, the claims of Plaintiff Mezzacapo, the only Plaintiff who has not
submitted an exemption request, also are unripe. First, she may yet request an exception,
which would forestall discipline and, if granted, would moot her claim. See ICE Decl. ¶ 11.
And second, it is uncertain whether, when, and to what extent she will face workplace
discipline. See id. ¶¶ 14–16. She has not yet been counseled or disciplined for being
unvaccinated and, if the disciplinary process is initiated, she will have ample opportunities to
contest any proposed suspension or removal from employment through a multi-step
administrative process. See id. If, at the conclusion of this process, she ultimately were
removed, “she would have various options for challenging her removal, including her statutory
rights of appeal before the MSPB, or to initiate an EEO complaint with ICE, or to file a
grievance (which would begin at the arbitration step, as per the CBA).” Id. ¶ 17. As with the
other Plaintiffs, prudential ripeness principles counsel in favor of “letting the administrative
process run its course” with respect to Ms. Mezzacapo “before binding parties to a judicial
decision” regarding the terms of her employment. Am. Petroleum Inst., 683 F.3d at 386; see also
Garcia v. United States, 680 F.2d 29, 31 (5th Cir. 1982) (a court has “no right to speculate that
the administrative bodies will make erroneous decisions which must be reversed by a court
decision”).
3. Plaintiffs’ Claims Against the Task Force and the COVID-19

Response Team Cannot Redress Their Injuries.
This Court also lacks jurisdiction because an order against the Defendants sued here
would not redress Plaintiffs’ asserted injuries. Plaintiffs acknowledge that they are not seeking
16
relief against President Biden, see Compl. ¶ 35 n.7, nor can they do so, see, e.g., Mississippi v.
Johnson, 71 U.S. (4 Wall.) 475, 501 (1866). For those reasons, Plaintiffs cannot obtain an
injunction against the Executive Order itself. See also, e.g., Foley, ECF No. 18, at 3 (dismissing
direct challenge to the Executive Order because the “judicial branch lacks the jurisdiction to
enjoin the President of the United States”); Rydie, ECF No. 26, at 7 (similar).
Plaintiffs are correct that they could theoretically challenge the Executive Order by
seeking relief against a specific agency’s implementation of it, but that is not what they have
done. Instead, Plaintiffs have brought claims against the Task Force, the White House
COVID-19 Response Team, and their members. But Plaintiffs lack standing to sue those
entities because an order running against them would provide Plaintiffs no relief. See, e.g.,
Inclusive Cmtys. Project, Inc. v. Dep’t of Treasury, 946 F.3d 649, 655 (5th Cir. 2019) (discussing
Article III redressability requirement). The Task Force and the COVID-19 Response Team
merely issue nonbinding guidance: the requirement that agencies implement a vaccination
mandate flows from the Executive Order itself. Even if the Court were to vacate that
guidance, agencies would still be obligated, under the Executive Order, to require COVID-19
vaccination of their employees. Relief against the Defendants named here therefore cannot
redress Plaintiffs’ asserted injuries. Cf., e.g., Scenic Am., Inc. v. U.S. Dep’t of Transp., 836 F.3d 42,
53 (D.C. Cir. 2016) (vacatur of guidance insufficient to redress injury).5
5 Although certain of the Plaintiffs’ employers are members of the Task Force, and they are
named as Defendants in that capacity, Plaintiffs do not identify any specific action that they
have taken in their capacity as employers. Plaintiffs have also named the United States as a
Defendant. A Plaintiff bringing APA claims may name the United States provided that “any
mandatory or injunctive decree shall specify the Federal officer or officers (by name or by
title), and their successors in office, personally responsible for compliance.” 5 U.S.C. § 702.
17
B. Plaintiffs Fail To Identify A Cause Of Action.
Even if the Court had jurisdiction, Plaintiffs’ claims would fail because they do not
identify a cause of action through which they can assert their substantive theories.
1. Plaintiffs Do Not State Claims Under the APA.
Simply put, Plaintiffs may not invoke the APA because they do not challenge final
agency action, or indeed agency action at all.6
a) The Task Force and the White House COVID-19

Response Teams Are Not Agencies.
A plaintiff invoking the APA must challenge action taken by an “agency.” See 5 U.S.C.
§§ 701(b)(1), 702, 704. “[T]he President is not an agency,” and so his actions, including
executive orders, are not directly subject to APA review. See Franklin, 505 U.S. at 796.
The Task Force and the COVID-19 Response Team are also not agencies. The Task
Force is a creation of executive order; its function is to “provide ongoing guidance to heads
of agencies on the operation of the Federal Government, the safety of its employees, and the
continuity of Government functions during the COVID-19 pandemic.” Exec. Order No.
13991, Protecting the Federal Workforce and Requiring Mask-Wearing, 86 Fed. Reg. 7045,
Sec. 4(e) (Jan. 20, 2021). Its guidance is not on its own binding on the public, nor even on any
federal agency. The COVID-19 Response Team is a collection of policy advisers from across
the Executive Branch with no existence apart from its individual members. And no matter
how influential their guidance might be, it is the responsibility of federal agency employers to
Here, however, Plaintiffs have failed to state APA claims, see infra Part I.B.1, and make no
other allegations suggesting redressable wrongdoing on the part of the United States itself.
6 An APA claim that fails to challenge final agency action is properly dismissed for lack of
jurisdiction. See, e.g., Texas v. EEOC, 933 F.3d 433, 440-41 (5th Cir. 2019).
18
take direct action to implement the Executive Order. “[U]ltimate authority to set objectives,
determine policy, and establish programs rests elsewhere . . . .” Armstrong v. Exec. Off. of the
President, 90 F.3d 553, 564 (D.C. Cir. 1996) (National Security Council not an agency). Thus,
neither the Task Force nor the COVID-19 Response Team is an agency. See, e.g., Meyer v. Bush,
981 F.2d 1288, 1297 (D.C. Cir. 1993) (Task Force on Regulatory Relief was not an agency: it
lacked “substantial independent authority” and President did not create an agency anytime he
convened “a group of cabinet officers and perhaps White House staff in some sort of
committee”);7 see also, e.g., Main St. Legal Servs., Inc. v. Nat’l Sec. Council, 811 F.3d 542 (2d Cir.
2016); CREW v. Off. of Admin., 566 F.3d 219 (D.C. Cir. 2009). Such entities lack “statutory
grants of authority” and thus their authority does not “flow from a source independent from the
President.” Main St. Legal Servs., 811 F.3d at 558 (emphasis added).
b) Plaintiffs Do Not Challenge Final Agency Action.
Review under the APA is limited to “‘final agency action for which there is no other
adequate remedy in a court.’” Sackett v. EPA, 566 U.S. 120, 125 (2012) (quoting 5 U.S.C.
§ 704). “Final agency actions are actions which (1) ‘mark the consummation of the agency’s
decisionmaking process,’ and (2) ‘by which rights or obligations have been determined, or
from which legal consequences will flow.’” Sierra Club v. Peterson, 228 F.3d 559, 565 (5th Cir.
2000) (quoting Bennett v. Spear, 520 U.S. 154, 178 (1997)). The Complaint seeks relief against
what it calls the “Federal Employee Vaccine Mandate,” which it defines to be Executive Order
7 Meyer considered the definition of “agency” under the Freedom of Information Act
(“FOIA”). But its analysis remains instructive here, as “all APA agencies are FOIA agencies,
but not vice-versa.” EPIC v. Nat’l Sec. Comm’n on A.I., 466 F. Supp. 3d 100, 107 (D.D.C. 2020).
19
14043, along with unspecified “actions by the federal agencies and agents of the federal
government to enforce the Executive Order.” Compl. ¶ 3 n.4. That does not suffice.
As described above, the Executive Order cannot be final agency action because the
President is not an agency. And because any guidance issued by the Task Force or the
COVID-19 Response Team was issued to assist the President in the exercise of his own
powers, such actions are likewise not subject to review under the APA. See, e.g., Nat. Res. Def.
Council, Inc. v. U.S. Dep’t of State, 658 F. Supp. 2d 105, 111 (D.D.C. 2009) (no APA review
possible when “the State Department stands in the President’s shoes by exercising the
President’s inherent discretionary power under the Constitution”); Detroit Int’l Bridge Co. v.
Canada, 189 F. Supp. 3d 85, 100 (D.D.C. 2016) (similar).
In any case, Plaintiffs fail to carry their burden of identifying a “circumscribed, discrete
agency action[]” challengeable under the APA. Norton v. S. Utah Wilderness All., 542 U.S. 55,
62-63 (2004); see also, e.g., Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 891 (1990); Alabama-
Coushatta Tribe of Tex. v. United States, 757 F.3d 484, 491 (5th Cir. 2014). The Court should
dismiss Plaintiffs’ “impermissible programmatic challenge.” Lujan, 497 U.S. at 490.
2. Plaintiffs Cannot Invoke Non-Statutory Review.
With the APA unavailable, Plaintiffs reach for “so-called ‘non-statutory’ equitable
jurisdiction.” Compl. ¶ 46. But their reliance on Larson v. Domestic & Foreign Commerce Corp.,
337 U.S. 682 (1949), see Compl. ¶ 48, is misplaced. For starters, Larson was a case about
sovereign immunity, decided before the APA was amended to “waive[] sovereign immunity
for suits seeking nonmonetary relief” against federal agency action. Geyen v. Marsh, 775 F.2d
1303, 1307 (5th Cir. 1985). “Most challenges to federal agency action are now brought via the
20
APA,” Anibowei v. Barr, No. 3:16-cv-3495-D, 2019 WL 623090, at *4 (N.D. Tex. Feb. 14, 2019),
and Plaintiffs cannot evade the APA’s limitations on judicial review by attempting to invoke
ultra vires or non-statutory review. See also Danos v. Jones, 652 F.3d 577, 582 (5th Cir. 2011)
(“assum[ing] for the sake of analysis that the Larson exception to sovereign immunity may still
apply in certain cases after the 1976 amendments to the [APA]”).
To the extent Larson has any current application, it is in “suits for specific relief against”
individual officers. Id. (quoting Larson, 337 U.S. at 689). As discussed above, Plaintiffs’ claims
are against the United States, the Task Force, and the White House COVID-19 Response
Team, and only against individual officers to the extent they are members of such entities.
Larson does not apply in instances, such as this one, where “the effect of the judgment would
be to restrain the Government from acting.” Dugan v. Rank, 372 U.S. 609, 620 (1963) (citation
omitted); see also Taylor Energy Co. v. United States, No. 20-cv-1720, 2021 WL 1876845, at *3
(E.D. La. May 10, 2021) (finding Larson inapplicable to the extent that “the named Defendants
are the United States and its agencies”).
In any event, Larson is a doctrine “of last resort intended to be of extremely limited
scope.” Terveer v. Billington, 34 F. Supp. 3d 100, 123 (D.D.C. 2014) (quoting Griffith v. Fed. Labor
Relations Auth., 842 F.2d 487, 493 (D.C. Cir. 1988)). The “modern cases make clear” that an
officer may be said to act ultra vires “only when he acts ‘without any authority whatever.’”
Pennhurst State Sch. & Hosp. v. Halderman, 465 U.S. 89, 101-02 n.11 (1984) (citation omitted); see
also Larson, 337 U.S. at 689 (suit must allege that official is “not doing the business which the
sovereign has empowered him to do,” not just that the official acted illegally). Here, Plaintiffs
are challenging an executive order setting the terms and conditions of federal employment.
21
Whatever the ultimate legality of that order under the dubious claims that Plaintiffs pursue,
the “business” of the “sovereign” certainly encompasses issuing that kind of directive. See,
e.g., 5 U.S.C. § 3301 (authorizing the President to “prescribe such regulations for the admission
of individuals into the civil service in the executive branch as will best promote the efficiency
of that service). Accordingly, Larson does not apply.
II. Plaintiffs Fail To Establish Irreparable Injury.
To satisfy their burden of proving irreparable harm, Plaintiffs must demonstrate “a
significant threat of injury from the impending action, that the injury is imminent, and that
money damages would not fully repair the harm.” Humana, Inc. v. Jacobson, 804 F.2d 1390, 1394
(5th Cir. 1986). Yet as every federal court to consider the question has held, a federal
employee’s choice between complying with a COVID-19 vaccination mandate and suffering
job-related consequences is not irreparable harm. See Rydie, ECF No. 26, at 12-13; Altschuld,
ECF No. 23, at 8; Church, 2021 WL 5179215, at *13–15; Smith, 2021 WL 5195688, at *8–9.
There is no reason for this Court to depart from that unbroken line of authority. Therefore,
the Court should deny Plaintiffs’ motion. See City of Dallas v. Delta Air Lines, Inc., 847 F.3d 279,
285 (5th Cir. 2017) (“Failure to sufficiently establish any one of the four factors requires this
Court to deny the movant’s request for a preliminary injunction.” (citation omitted)).
Plaintiffs claim to face three forms of irreparable harm: “unrecoverable financial
damages,” Mot. at 28, “the harm coerced vaccin[ation] will cause some (statistically speaking),”
id., and “the violation of constitutional limitations,” id. at 29. None of these alleged harms
support Plaintiffs’ claim for extraordinary relief. First, Plaintiffs’ claims of financial harm,
which stem from the routine “financial pressure or other concerns that accompany loss of a
22
job,” id. at 28, are insufficient under well-established precedent. The Supreme Court has long
held that, “absent a genuinely extraordinary situation,” the loss of employment is not an
irreparable harm. Sampson v. Murray, 415 U.S. 61, 92 n.68 (1974). That is because “irreparable”
harm requires that there be “no adequate remedy at law, such as monetary damages.” Janvey
v. Alguire, 647 F.3d 585, 600 (5th Cir. 2011). And as the Fifth Circuit has recognized, “[i]t is
practically universal jurisprudence in labor relations in this country that there is an adequate
remedy for individual wrongful discharge after the fact of discharge,” i.e., “reinstatement and
back pay.” Garcia, 680 F.2d at 31–32. So even if Plaintiffs were certain to be terminated for
their refusal to be vaccinated—and they are not8—any financial consequences of termination
would not be irreparable because Plaintiffs could seek back pay and reinstatement pursuant to
the CSRA and the Back Pay Act. See Sampson, 415 U.S. at 92 n.68 (“We have held that an
insufficiency of savings or difficulties in immediately obtaining other employment—external
factors common to most discharged employees and not attributable to any unusual actions
relating to the discharge itself—will not support a finding of irreparable injury, however
severely they may affect a particular individual.”); Digital Generation, Inc. v. Boring, 869 F. Supp.
2d 761, 781 (N.D. Tex. 2012) (similar).
Plaintiffs’ second asserted harm—the side effects that “some” individuals may
experience from vaccination—also fails. Most importantly, no one is being forcibly
vaccinated: if Plaintiffs are right on the merits, they can decline vaccination and seek
8 See supra Part I.A.2. As the court in Church v. Biden observed when confronted with similar
facts, the fact that Plaintiffs may still be granted an exemption and avail themselves of
additional processes introduces “points of temporal ambiguity [that] call into question the
‘imminence’ of the harm” they allegedly face. 2021 WL 5179215, at *14.
23
recompense for any adverse employment consequences at the conclusion of litigation. See,
e.g., Smith, 2021 WL 5195688, at *8 (“Plaintiffs are undeniably being presented with a difficult
choice—comply with the vaccine mandate or risk losing their employment. They are,
however, presented with a choice”); Klaassen v. Trs. of Ind. Univ., --- F. Supp. 3d ---, 2021 WL
3073926, at *25 (N.D. Ind. July 18, 2021) (similar), denying mot. for inj. pending appeal, 7 F.4th 592
(7th Cir. 2021) (Easterbrook, J.), emergency application for relief denied, No. 21A15 (Barrett, J., in
chambers) (Aug. 12, 2021); Bridges v. Hous. Methodist Hosp., ---F. Supp. 3d---, 2021 WL 2399994,
at *2 (S.D. Tex. June 12, 2021) (similar), appeal filed, No. 21-20311 (5th Cir. June 14, 2021).
And even if Plaintiffs did not have this option, it is their burden to demonstrate that irreparable
harm is “imminent,” Humana Inc., 804 F.2d at 1394, and not merely possible, but “likely,”
Winter, 555 U.S. at 21–22. Plaintiffs’ vague allegations do not satisfy these standards.9
Finally, Plaintiffs cannot rely on alleged constitutional violations to establish irreparable
harm for many of the same reasons discussed above. The worst harm that Plaintiffs face is
not the loss of a constitutional right but the possibility of workplace discipline if they decide
not to comply with a condition of employment. Thus, Plaintiffs may simply decline
vaccination—i.e., exercise the supposed constitutional rights that they invoke—and seek
appropriate relief (up to and including back pay and reinstatement) for any alleged unlawful
workplace discipline that follows. Especially given that their constitutional claims are not likely
9 Nor can Plaintiffs rely on the harms they speculate, without citation, will allegedly befall
“unnamed class members.” Suppl. Br. at 3-4. “[N]amed plaintiffs who represent a class must
allege and show that they personally have been injured, not that injury has been suffered by
other, unidentified members of the class to which they belong and . . . purport to represent.”
Lewis v. Casey, 518 U.S. 343, 357 (1996) (citation omitted). Here, Plaintiffs have not even
moved for, much less obtained, class certification.
24
to succeed, see infra Part. III.A, Plaintiffs cannot meet their burden to show irreparable harm.
See Chaplaincy of Full Gospel Churches v. England, 454 F.3d 290, 301 (D.C. Cir. 2006) (mere
allegations of constitutional harm do not establish irreparable harm).
For all these reasons, the question of irreparable harm is not controlled by BST Holdings.
That case involved vaccination policies for private-sector employees who, if terminated for their
failure to receive a vaccine, would not necessarily have a post-termination remedy against
either their private employer or the government agency that imposed the vaccination
requirement. By contrast here, as explained above, Plaintiffs may seek back pay and
reinstatement under the laws governing federal employment.
III. Plaintiffs Are Unlikely To Succeed On The Merits.
A. Plaintiffs’ Substantive Due Process Claim is Unlikely to Succeed.
Count One alleges a substantive due process violation. See Compl. ¶¶ 149–77.
Plaintiffs argue that conditioning federal employment on vaccination implicates fundamental
rights and that the Executive Order is therefore subject to strict judicial scrutiny. See id.
¶¶ 151–58; see also Mot. at 24–25. This argument fails. As numerous courts have held,
vaccination requirements (and, a fortiori, vaccination conditions on employment) are subject to
rational basis review, under which the Executive Order easily passes muster.
The Court’s substantive due process analysis must begin with “a careful, specific
description of the right at issue.” McDonald v. City of Chicago, 561 U.S. 742, 797 (2010) (Scalia,
J., concurring); see also, e.g., Raich v. Gonzales, 500 F.3d 850, 863 (9th Cir. 2007) (court must
“adopt a narrow definition of the interest at stake”); Hawkins v. Freeman, 195 F.3d 732, 739
(4th Cir. 1999) (cautioning against “analyzing the claimed right at too general a level”). The
25
Court must then determine whether the asserted right—“thus narrowly defined,” McDonald, 561
U.S. at 797—is “deeply rooted in this Nation’s history and tradition” and “implicit in the
concept of ordered liberty,” i.e., “fundamental,” Washington v. Glucksberg, 521 U.S. 702, 721
(1997) (internal quotations omitted). If the challenged government action infringes upon a
fundamental right, it receives heightened judicial scrutiny; if not, it receives rational basis
review. See, e.g., Cantu-Delgadillo v. Holder, 584 F.3d 682, 687 (5th Cir. 2009).
This case involves a purported right to hold federal employment while refusing to be
vaccinated against a highly contagious virus. Federal courts have repeatedly and uniformly
held that the American legal tradition does not recognize a fundamental right to refuse
vaccination. See, e.g., Rodriguez-Vélez v. Pierluisi-Urrutia, No. 21-1366, 2021 WL 5072017, at *15
(D.P.R. Nov. 1, 2021); Valdez v. Grisham, No. 21-cv-783, ---F. Supp. 3d---, 2021 WL 4145746,
at *5 (D. New Mex. Sept. 13, 2021); Johnson v. Brown, ---F. Spp. 3d---, 2021 WL 4846060, at
*13 (D. Or. Oct. 18, 2021); Dixon v. De Blasio, No. 21-cv-5090, ---F. Supp. 3d---, 2021 WL
4750187, at *8 (E.D.N.Y. Oct. 12, 2021). Indeed, “vaccination requirements, like other public-
health measures, have been common in this nation.” Klaassen, 7 F.4th at 593; see also Doe v.
Zucker, 520 F. Supp. 3d 217, 249–53 (N.D.N.Y. 2021). What is more, over a century ago, the
Supreme Court held “that a state may require all members of the public to be vaccinated
against smallpox,” under penalty of criminal sanctions. Klaassen, 7 F.4th at 593 (citing Jacobson
v. Massachusetts, 197 U.S. 11 (1905)); see also Prince v. Massachusetts, 321 U.S. 158, 166–67 (1944)
(the Constitution does not provide “freedom from compulsory vaccination”); Zucht v. King,
260 U.S. 174, 177 (1922) (similar).
Plaintiffs’ attempts to frame the asserted right in broad terms such as “privacy” or
26
“bodily integrity,” Compl. ¶ 156, are unavailing. See, e.g., McDonald, 561 U.S. at 797 (collecting
Supreme Court cases requiring a narrow definition of the asserted right); Raich v. Gonzales, 500
F.3d at 864 (criminal ban on marijuana use does not implicate the right to “preserve bodily
integrity” but rather a purported “right to use marijuana to preserve bodily integrity”). And
there is no merit to Plaintiffs’ assertion that the Executive Order implicates the “right to refuse
unwanted medical care,” Mot. at 24 (cleaned up). The Supreme Court has recognized this
right only in the context of “forced administration of life-sustaining medical treatment,”
Cruzan ex rel. Cruzan v. Dir., Mo. Dep’t of Health, 497 U.S. 261, 279 (1990), and “forced
administration of antipsychotic drugs,” Washington v. Harper, 494 U.S. 210, 236 (1990). Such
interventions are far more intrusive than vaccinations, which are a common feature of modern
life. Moreover, the policies at issue here do not force anyone to receive medical care; federal
employees may seek an exception based on a medical condition or religious objection, or (if
ultimately terminated after having the benefit of the ample procedures afforded federal
employees) they may choose to pursue other employment. See, e.g., Klaassen, 2021 WL
3073926, at *25 (public university’s COVID-19 vaccination requirement was “a far cry” from
forcible provision of medical care); Bridges, 2021 WL 2399994, at *2 (similar).
Plaintiffs’ criticism of Jacobson misses the mark. See Mot. at 25–26. Jacobson has not
been abrogated; as the Seventh Circuit recently observed, it is binding precedent
demonstrating that “there can’t be a constitutional problem with [requiring] vaccination
against SARS-Cov-2.” Klaassen, 7 F.4th at 593; see also Phillips v. City of N.Y., 775 F.3d 538, 542
(2d Cir. 2015). In any event, the relevant question here is not whether Jacobson is
distinguishable, as Plaintiffs contend, but “whether the asserted interest” (in refusing
27
vaccination) “is supported by ‘this Nation’s history and practice,’” Kerry v. Din, 576 U.S. 86, 95
(2015). Cases such as Jacobson, Zucht, and Prince make clear that it is not, and Plaintiffs fail to
reference any history or tradition that might suggest otherwise. See Klaassen, 2021 WL 3073926
at *23–24 (rejecting substantive due process claim because of dearth of “historic rules, laws,
or traditions” suggesting the existence of a right to be free from vaccination requirements).
Accordingly, Courts have “consistent[ly] use[d] . . . rational basis review to assess
mandatory vaccination measures.” Klaassen, 2021 WL 3073926, at *24; accord, e.g., Workman v.
Mingo Cnty. Bd. of Educ., 419 F. App’x 348, 355–56 (4th Cir. 2011); Williams v. Brown, --- F.
Supp. 3d ----, 2021 WL 4894264, at *8 (D. Or. Oct. 19, 2021); Valdez, 2021 WL 4145746, at
*5; Norris v. Stanley, 2021 WL 3891615, at *1–*2; Harris v. Univ. of Mass., Lowell, No. 21-11244,
2021 WL 3848012, at *6 (D. Mass. Aug. 27, 2021); Zucker, 520 F. Supp. 3d at 249–53; see also
Roman Cath. Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 70 (2020) (Gorsuch, J., concurring)
(describing Jacobson as having correctly “applied rational basis review” to a state-imposed
vaccination requirement). Rational basis review applies here.
“Under rational basis review, courts must presume that the [measure] in question is
valid and sustain it so long as [it] is rationally related to a legitimate state interest.” Planned
Parenthood of Greater Tex. Surgical Health Servs. v. Abbott, 748 F.3d 583, 594 (5th Cir. 2014). The
challenged measure “is presumed constitutional,” and “[t]he burden is on the one attacking
the [measure] to negative every conceivable basis which might support it.” Heller v. Doe ex rel.
Doe, 509 U.S. 312, 320 (1993) (quotation omitted). Here, there should be no serious dispute
that the Executive Order is rationally related to the government’s strong interest in promoting
“the health and safety of the Federal workforce, and the health and safety of members of the
28
public with whom they interact” during the COVID-19 pandemic. 86 Fed. Reg. at 50,989; see,
e.g., Klaassen, 2021 WL 3073926, at *26 (public university’s COVID-19 vaccination requirement
furthered its “legitimate interest in promoting the health of its campus communities”).
Plaintiffs argue that the Executive Order is “not narrowly tailored to its stated
purpose.” Suppl. Br. at 8–9; see Compl. ¶¶ 158–75. But these arguments are simply irrelevant
because “there is no least restrictive means component to rational basis review.” Planned
Parenthood, 748 F.3d at 594. The Executive Order is rationally related to legitimate government
interests, so it must be upheld even if “there is an imperfect fit between means and ends.” Id.
(quoting Heller, 509 U.S. at 321); see also, e.g., Harris v. Hahn, 827 F.3d 359, 365, 369 (5th Cir.
2016) (upholding state law that was “both underinclusive and overinclusive” under rational
basis review). Plaintiffs cite no case holding that a vaccination requirement lacked a rational
basis, and Defendants are aware of none.10 Accordingly, the Executive Order plainly
comports with substantive due process.
B. Plaintiffs’ FDCA Claim is Unlikely to Succeed.
Next, Plaintiffs assert that the Executive Order violates “their statutory rights to decline
a product authorized for Emergency Use only,” which purportedly exist under section 564 of
the FDCA. See Compl. ¶¶ 207–214; Mot. at 20–23. This claim fails at the threshold. As
10Plaintiffs assert, without citation, that Count One “is substantively identical to a claim raised
in BST Holdings.” Suppl. Br. at 8. In fact, the Fifth Circuit’s opinion in BST Holdings does not
address substantive due process at all and thus provides no support for Count One. Instead,
BST Holdings concluded that the Plaintiffs were likely to succeed on their claim that the OSHA
ETS “exceeds OSHA’s statutory authority.” 2021 WL 5279381, at *3; see id. at *3–*7. The
Court also noted, but did not decide, potential constitutional issues “under the Commerce
Clause and the nondelegation doctrine.” Id. at *3; see id. at *7–*8. This case does not involve
any of these constitutional issues, nor any of the statutory issues discussed in BST Holdings.
29
several courts—including one in this District—have held, “Section 564 does not include a
private right of action.” Doe v. Franklin Square Union Free Sch. Dist., --- F. Supp. 3d ----, 2021
WL 4957893, at *20 (E.D.N.Y. Oct. 26, 2021); accord Bridges, 2021 WL 2399994, at *2 (section
564 “does not confer a private opportunity to sue the government”); Navy Seal 1 v. Biden, No.
8:21-cv-02429-SDM-TGW, ECF No. 40 (M.D. Fla. Nov. 22, 2021); Lloyd v. Sch. Bd. of Palm
Beach Cnty., No. 9:21-cv-81715, 2021 WL 5353879, at *4–*5 (S.D. Fla. Oct. 29, 2021); Guilfoyle
v. Beutner, No. 2:21-cv-5009, 2021 WL 4594780, at *27 (C.D. Cal. Sept. 14, 2021).11
In any event, Plaintiffs’ interpretation of section 564 is incorrect. Every court to
consider the issue has concluded that section 564 does not prevent employers from imposing
workplace discipline, up to and including termination, on employees who choose not to
receive an EUA vaccine. See Bridges, 2021 WL 2399994, at *2; Villareal v. Rocky Knoll Health
Ctr., No. 21-cv-729, 2021 WL 5359018, at *3 (E.D. Wis. Nov. 17, 2021); McCutcheon v. Enlivant
ES, LLC, No. 5:21-CV-00393, 2021 WL 5234787, at *3 (S.D.W. Va. Nov. 9, 2021; Valdez,
2021 WL 4145746, at *4; Norris v. Stanley, --- F. Supp. 3d ---, 2021 WL 4738827, at *3 (W.D.
11 Moreover, the Executive Order does not require Plaintiffs to use a product that is only
available under an EUA. Contra Compl. ¶ 230 (asserting that Plaintiffs will “effectively be
forced to take an EUA approved vaccine”). Millions of vaccine doses have now been
manufactured in compliance with the Biologics License Application for Comirnaty, which
FDA approved on August 23, 2021, “and they are not subject to the EUA requirements when
used for the approved indication,” i.e., administered to adults for the prevention of COVID-
19. Marks Decl. ¶ 13. Accordingly, this case does not present the question whether section
564 forbids the government (or any other employer) from requiring employees to be
vaccinated with a product that is only available under an EUA. See Valdez, 2021 WL 4145746,
at *4 (rejecting claim that state vaccine mandate violated the EUA statute because “FDA has
now given its full approval – not just emergency use authorization – to the Pfizer vaccine”);
Norris v. Stanley, No. 1:21-cv-756, 2021 WL 3891615, at *2 (W.D. Mich. Aug. 31, 2021)
(similar); Robert v. Austin, No. 1:21-cv-02228, Order at 6, ECF No. 12, (D. Colo. Sept. 1, 2021)
(similar).
30
Mich. Oct. 8, 2021); Johnson v. Brown, 2021 WL 4846060, at *18 (D. Or. Oct. 18, 2021); Pelekai
v. Hawaii, No. 1:21-cv-343, 2021 WL 4944804, at *6 n.9 (D. Haw. Oct. 22, 2021); see also U.S.
Dep’t of Justice, Office of Legal Counsel, Whether Section 564 of the Food, Drug, and
Cosmetic Act Prohibits Entities from Requiring the Use of a Vaccine Subject to an Emergency
Use Authorization, 45 Op. O.L.C. __, 2021 WL 3418599 (July 6, 2021).
The relevant portion of section 564 provides:
With respect to the emergency use of an unapproved product, the Secretary [of
Health and Human Services], to the extent practicable given the applicable
circumstances [justifying the authorization of products for emergency use],
shall, for a person who carries out any activity for which the authorization is
issued, establish such conditions on an authorization under this section as the
Secretary finds necessary or appropriate to protect the public health, including
the following:
(ii) Appropriate conditions designed to ensure that individuals to whom the

product is administered are informed--
(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.
21 U.S.C. § 360bbb-3(e)(1)(A).
This provision “confers certain powers and responsibilities to the Secretary of [HHS]
in an emergency.” Bridges, 2021 WL 2399994, at *2. For each COVID-19 vaccine made
available under an EUA, HHS properly implemented the provision by requiring that potential
vaccine recipients receive a Fact Sheet informing them, for example, that they have a “choice
to receive or not receive” the vaccine. See, e.g., FDA, Moderna EUA COVID-19 Vaccine Fact
Sheet for Recipients and Caregivers at 4 (revised Oct. 20, 2021), https://perma.cc/JZ6Y-
ZUJF. Plaintiffs do not allege otherwise; in fact, neither the Secretary nor any agency of HHS
has been named as a defendant in this case. Section 564(e)(1)(A) is directed solely at the
31
Secretary, whom it grants broad discretion to establish conditions on the authorization of a
medical product for emergency use. See 21 U.S.C. § 360bbb-3(e)(1)(A) (advising the Secretary
to implement the provisions “to the extent practicable” and “as the Secretary finds necessary
or appropriate to protect the public health”); id. § 360bbb-3(i) (“Actions under the authority
of this section by the Secretary . . . are committed to agency discretion.”). The provision says
nothing about whether any employer—public or private—may require its employees to
become vaccinated using an EUA product. See, e.g., Bridges, 2021 WL 2399994, at *2.
As Plaintiffs observe, see Mot. at 21, a separate statute allows the President to waive the
condition described in section 564(e)(1)(A)(ii)(III) for members of the armed forces “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). According to Plaintiffs, Congress’s enactment of
this statute suggests that Congress did not “intend[] the President . . . to be able to waive
[section 564(e)(1)(A)(ii)(III)] for civilians.” Mot. at 21. But the President has not attempted to
waive section 564(e)(1)(A)(ii)(III) for civilians. To the extent any Plaintiffs are prospective
recipients of an EUA vaccine, they are to be informed “of the option to accept or refuse
administration of the product,” and “of the consequences, if any, of refusing administration
of the product.” 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III). Plaintiffs apparently do not like their
options, but they are receiving all the information contemplated by the FDCA, which cannot
plausibly be read to cabin the President’s broad authority to prescribe conditions of federal
civil service employment, see, e.g., 5 U.S.C. §§ 3301, 3302, 7301.
In short, nothing in the FDCA prevents any employer—public or private—from
making workplace discipline a consequence of refusing to become vaccinated. Accordingly,
32
Plaintiffs’ FDCA claim cannot succeed.
C. Plaintiffs’ Arbitrary and Capricious Claim is Unlikely to Succeed.
Plaintiffs’ final claim is that the “Vaccine Mandate” is arbitrary and capricious and
“cannot survive APA review” because it applies to individuals who have previously had
COVID-19. Mot. at 26. This claim fails for the simple reason that, as discussed above, the
Executive Order—which directs agencies to require vaccination of all employees, with only
such exceptions as are required by law—is not subject to judicial review under the APA. See
supra Part I.B.1. But even assuming the federal employee vaccination requirement were subject
to arbitrary-and-capricious review, Plaintiffs would have no claim. Pursuant to the APA’s
“deferential” standard, a court “may not substitute its own policy judgment for that of the
agency” and instead “simply ensures that the agency has acted within a zone of
reasonableness.” FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021); see also City of
Abilene v. EPA, 325 F.3d 657, 664 (5th Cir. 2003) (agency need only satisfy “minimal standards
of rationality”). The vaccination requirement easily meets this standard.
Plaintiffs contend that the Executive Order and the Task Force guidance do not
“offer[] any explanation as to why naturally acquired immunity is not a permissible ground for
federal employees to forego taking a COVID-19 vaccine.” Mot. at 26. But the Executive
Order explicitly relies on the CDC’s determination that vaccination is the best way to slow the
spread of COVID-19. 86 Fed. Reg. at 50,989. And as discussed above, the public health
experts at CDC—after conducting an extensive review of relevant studies and data and issuing
a comprehensive brief on the issue—unequivocally recommend vaccination for individuals
who have recovered from a prior SARS-CoV-2 infection. It is reasonable for the President to
33
rely on this expert evaluation of relevant scientific and medical data in setting public health
protocols for the federal workforce. See, e.g., Sierra Club v. EPA, 939 F.3d 649, 680 (5th Cir.
2019) (“A reviewing court must be most deferential to the agency where, as here, its decision
is based upon its evaluation of complex scientific data within its technical expertise.” (citation
omitted)); Stewart v. Potts, 996 F. Supp. 668, 678 n.8 (S.D. Tex. 1998) (APA does not permit a
court to “evaluate [agency’s] scientific methods”).
Plaintiffs and their declarants may disagree with this assessment, but that is no basis
for invalidating agency action under the APA. See, e.g., Huawei Tech. USA, Inc. v. FCC, 2 F.4th
421, 451 (5th Cir. 2021) (an agency may “weigh[] the evidence differently than [a commenter]
and reach[] contrary but reasonable policy conclusions”); California v. Azar, 950 F.3d 1067,
1096 (9th Cir. 2020) (a court is “prohibited from ‘second-guessing the [agency’s] weighing of
risks and benefits and penalizing [it] for departing from the . . . inferences and assumptions’
of others” (citation omitted) (alteration in original)). Moreover, numerous courts have
considered and rejected “natural immunity” arguments similar to the ones Plaintiffs advance
here. E.g., Norris v. Stanley, 2021 WL 4738827, at *4; Bauer v. Summey, No. 2:21-cv-2952, --- F.
Supp. 3d ----, 2021 WL 4900922, at *11 (D.S.C. Oct. 21, 2021); Williams, 2021 WL 4894264,
at *3.
IV. The Public Interest Weighs Heavily Against Injunctive Relief.
Where a plaintiff challenges a government policy, the third and fourth elements of the
test for preliminary relief “merge” into a single consideration. Texas v. United States, 524 F.
Supp. 3d 598, 663 (S.D. Tex. 2021) (citing Nken v. Holder, 556 U.S. 418, 435 (2009)). This factor
tilts decisively in the government’s favor.
34
First, enjoining the Executive Order would harm the public interest in slowing the
spread of COVID-19 among millions of federal employees and the members of the public
with whom they interact. As the Supreme Court has recognized, “[s]temming the spread of
COVID-19 is unquestionably a compelling interest.” Cuomo, 141 S. Ct. at 67. Accordingly,
numerous courts reviewing “executive action designed to slow the spread of COVID-19” have
concluded that “[t]he public interest in protecting human life—particularly in the face of a
global and unpredictable pandemic—would not be served by” an injunction. Tigges v. Northam,
473 F. Supp. 3d 559, 573–74 (E.D. Va. 2020); see also, e.g., Rydie, ECF No. 26, at 14; Altschuld,
ECF No. 23, at 11; Church, 2021 WL 5179215, at *18–19; Smith, 2021 WL 5195688, at *9; Am.’s
Frontline Drs. v. Wilcox, No. EDCV 21-1243, 2021 WL 4546923, at *8 (C.D. Cal. July 30, 2021);
Valdez, 2021 WL 4145746, at *13, Harris, 2021 WL 3848012, at *8; Williams, 2021 WL 4894264,
at *10–11; Wise v. Inslee, No. 2:21-cv-2088, 2021 WL 4951571, at *6 (E.D. Wash. Oct. 25, 2021),
Mass. Corr. Officers, 2021 WL 4822154, at *7–8; Johnson, 2021 WL 4846060, at *26–27; TJM 64,
Inc. v. Harris, 475 F. Supp. 3d 828, 840–41 (W.D. Tenn. 2020); Talleywhacker, Inc. v. Cooper, 465 F.
Supp. 3d 523, 543 (E.D.N.C. 2020).12
12 Plaintiffs minimize the government’s interest in slowing the spread of the virus by asserting
that “those with natural immunity [do not] spread Covid-19.” Mot. at 30. But “there is no
FDA-authorized or approved antibody test that can determine if an individual person is
protected against SARS-CoV2- infection,” including for the previously infected. Brooks Decl.
¶ 7. Moreover, it is “impossible to accurately test and verify whether any single person has
infection-induced immunity” against SARS-CoV-2 “comparable to the immunity provided by
current vaccination.” Id. And as noted above, the “data on infection-induced immunity are
less robust than the data on vaccine-induced immunity and thus more limited in their
generalizability.” Id. ¶ 8. So, if employers cannot know whether an employee is immune, there
is no way to know whether an employee will spread the virus in the workplace. Plaintiffs’
allegation that those who claim to have “natural immunity” will not “spread Covid-19” in the
workplace therefore strains credulity. See Mot. at 30. In any event, as discussed above,
35
Second, “[t]he effective administration of the federal government, in which Defendants
and the public have a deep and abiding interest, would likely be hampered by an injunction.”
Rydie, ECF No. 26, at 14. The COVID-19 pandemic has interfered with numerous aspects of
the government’s work by, e.g., forcing office closures; hampering employees’ access to paper-
based records; limiting official travel; and causing staffing shortages. See generally Pandemic
Response Accountability Committee, Top Challenges Facing Federal Agencies (June 2020),
https://perma.cc/9D8L-J5MN. Thus, enjoining the Executive Order would likely interfere
with the government’s ability to resume normal, pre-pandemic operations.
Third, a preliminary injunction would harm the government’s interest in handling
employment disputes through the administrative procedures established by Congress. As
discussed more fully above, the CSRA creates comprehensive procedures for work-related
controversies involving most federal civil servants. See supra Part I.A.1. In Garcia, for example,
a federal employee “discharged for violation of work rules” sought to preliminarily enjoin his
discharge without first exhausting his administrative remedies. 680 F.2d at 30–31. The Fifth
Circuit found it “quite clear” that granting the requested injunction “would have a far more
disruptive effect on the administrative processes established by the government to handle
cases such as these than would, on balance, be the burden on the employee resulting from a
refusal to grant the injunction.” Id. at 32. So too here.
The foregoing public interest heavily outweighs any harm Plaintiffs might experience.
requiring vaccines for those who have already had COVID-19 will help stop the spread of the
virus. See also Brooks Decl. ¶ 12.
36
Plaintiffs do not face an imminent prospect of removal, and they may avoid discipline by
receiving a COVID-19 vaccination prior to or during any disciplinary proceeding. Nearly all
of them have requested exceptions to the vaccination requirement, which might be granted;
and they will not face discipline as long as their requests are under consideration. Accordingly,
granting the pending motion would harm the public interest far more than denying the motion
would harm Plaintiffs.13
V. Any Relief Should Be Narrowly Tailored.
If the Court were to disagree with Defendants’ arguments, any relief should be no
broader than necessary and only extend to Plaintiffs with standing. “A plaintiff’s remedy must
be tailored to redress the plaintiff’s particular injury,” Gill v. Whitford, 138 S. Ct. 1916, 1934
(2018), and “injunctive relief should be no more burdensome to the defendant than necessary
to provide complete relief to the plaintiffs,” Madsen v. Women’s Health Ctr., Inc., 512 U.S. 753,
765 (1994). Nationwide injunctions, in contrast, “take a toll on the federal court system—
preventing legal questions from percolating through the federal courts, encouraging forum
shopping, and making every case a national emergency for the courts and for the Executive
13 BST Holdings does not resolve the public-interest factor in Plaintiffs’ favor. In that case, the
Fifth Circuit found that a stay was in the public interest because OSHA likely overstepped its
statutory and constitutional authority in issuing a vaccination requirement for private-sector
employees. 2021 WL 5279381, at *8. No such concern exists here. Federal law explicitly
grants the President the authority to regulate the terms and conditions of federal employment.
See 5 U.S.C. §§ 3301, 3302, 7301; see also, e.g. NASA v. Nelson, 562 U.S. 134, 148 (2011) (“Time
and again [the Supreme Court has] recognized that the Government has a much freer hand in
dealing with citizen employees than it does when it brings its sovereign power to bear on
citizens at large.”); Rydie, ECF No. 26, at 7-8 (noting that the “executive branch has wide
authority to establish and enforce requirements of employment within the federal
government”).
37
Branch.” Trump. v. Hawaii, 138 S. Ct. 2392, 2425 (2018) (Thomas, J., concurring); see also, e.g.,
Holland v. Nat’l Mining Ass’n, 309 F.3d 808, 815 (D.C. Cir. 2002) (“Allowing one circuit’s
statutory interpretation to foreclose . . . review of the question in another circuit would squelch
the circuit disagreements that can lead to Supreme Court review.”).
Plaintiffs propose to represent a class, but they have not moved for class certification
and no class has been certified. Cf., e.g., Genesis Healthcare v. Symczyk, 569 U.S. 66, 67 (2013)
(noting that “a putative class acquires an independent legal status once it is certified under
Rule 23”). And the Executive Order at issue here has been challenged in numerous other
cases, underscoring why this Court should not attempt to decide its legality for all parties and
for all time. See Foley, No. 21-1098 (N.D. Tex.); Church, No. 21-2815 (D.D.C.); Jensen v. Biden,
No. 21-5119 (W.D. Wash.); Rydie, No. 21-2696 (D. Md.); Altschuld, No. 21-2779 (D.D.C.);
Costin v. Biden, No. 21-2484 (D.D.C.); Brnovich, No. 21-1568 (D. Ariz.); Navy Seal I, No. 21-
2429 (M.D. Fla.); Smith, No. 21-19457 (D.N.J.), No. 21-3091 (3d Cir.); Brass v. Biden, No. 21-
2778 (D. Colo.); Donovan v. Vance, No. 21-5148 (W.D. Wash.); Bjerken v. Federal Agency Heads,
No. 21-142 (D. Mont.).
CONCLUSION
For the foregoing reasons, the Court should deny Plaintiffs’ motion.
Dated: November 22, 2021 Respectfully submitted,
JENNIFER B. LOWERY
Acting United States Attorney
Southern District of Texas
s/Jimmy A. Rodriguez
Jimmy A. Rodriguez
38
Assistant United States Attorney

Southern District of Texas
Attorney in Charge
Texas Bar No. 24037378
Federal ID No. 572175
1000 Louisiana, Suite 2300
Houston, Texas 77002
Tel: (713) 567-9532
Fax: (713) 718-3303
[email protected]
Attorneys for Defendant
CERTIFICATE OF SERVICE
I hereby certify that foregoing document was served on all counsel of record via the
Court’s ECF system on November 22, 2021.
s/Jimmy A. Rodriguez
Jimmy A. Rodriguez
39

Rodden (Defendant) Response in Oppo Motion For Preliminary Injunction 23-Main

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Case 3:21-cv-00317 Document 23 Filed on 11/22/21 in TXSD Page 1 of 51

IN THE UNITED STATES DISTRICT COURT

JAMES RODDEN, et al.,

Plaintiffs, Civil Action 3:21-cv-00317

DR. ANTHONY FAUCI, in his official

DEFENDANTS’ OPPOSITION TO MOTION FOR TEMPORARY

I. The COVID-19 Pandemic.........................................................................................................4

II. Federal Regulation of and Guidance Concerning COVID-19 Vaccines ............................4

A. The Development and Authorization of COVID-19 Vaccines .................................. 4

B. Current Guidance on the Safety and Effectiveness of COVID-19 Vaccines for

III. Executive Order No. 14043 ......................................................................................................8

IV. This Lawsuit...............................................................................................................................10

LEGAL STANDARD ......................................................................................................................11

I. Plaintiffs’ Claims Fail On Threshold Grounds. ....................................................................11

A. The Court Lacks Jurisdiction. ........................................................................................ 11

1. The Civil Service Reform Act Precludes Plaintiffs’ Claims. ................................ 11

2. Plaintiffs’ Claims Are Note Ripe. ............................................................................ 14

B. Plaintiffs Fail To Identify A Cause Of Action............................................................. 18

1. Plaintiffs Do Not State Claims Under the APA. .................................................. 18

b) Plaintiffs Do Not Challenge Final Agency Action. ..................................... 19

2. Plaintiffs Cannot Invoke Non-Statutory Review. ................................................. 20

II. Plaintiffs Fail to Establish Irreparable Injury. .......................................................................22

III. Plaintiffs Are Unlikely To Succeed On The Merits..............................................................25

A. Plaintiffs’ Substantive Due Process Claim is Unlikely to Succeed. ........................... 25

B. Plaintiffs’ FDCA Claim is Unlikely to Succeed. .......................................................... 29

C. Plaintiffs’ Arbitrary and Capricious Claim is Unlikely to Succeed. ........................... 33

V. Any Relief Should Be Narrowly Tailored. .............................................................................37

Clapper v. Amnesty Int’l, USA,

680 F.2d 29 (5th Cir. 1982) ......................................................................................... 16, 23, 36

562 U.S. 134 (2011) ................................................................................................................... 37

566 U.S. 120 (2012) ................................................................................................................... 19

United States Code

5 U.S.C. § 3301 ................................................................................................................... 22, 32, 37

FDA, Comirnaty Approved Prescribing Information (revised Aug. 20, 2021),

increasing throughout the nation. See id.

“employees of covered employers to undergo COVID-19 vaccination or take weekly COVID-

emergency injunctive relief.

is unripe because it is uncertain whether any Plaintiff will be suspended or terminated—indeed,

regulated by the government, not government employees—does not suggest otherwise.

fundamental right to avoid employment consequences based on a refusal to be vaccinated,

reasonable for the President to rely on these agencies’ scientific expertise.

I. The COVID-19 Pandemic

How COVID-19 Spreads (updated July 14, 2021), https://perma.cc/SXB2-G9WA. In July

and hospitalization rates,” driven by an especially contagious strain of SARS-CoV-2 known as

26, 2021), https://perma.cc/DZA6-F9LC. As of the filing of this brief, community

II. Federal Regulation of and Guidance Concerning COVID-19 Vaccines

A. The Development and Authorization of COVID-19 Vaccines

during a public health emergency, which authorizes the marketing of non-FDA-approved

FDA, Letter of Authorization to Pfizer Inc. (Nov. 19, 2021), https://perma.cc/WE6M-

Authorization to ModernaTX, Inc. (Nov. 19, 2021), https://perma.cc/8XR6-27YW

(Nov. 19, 2021), https://perma.cc/Z68F-B3FK (“Janssen EUA Letter”) (revising and

Janssen EUA Letter at 2.

On August 23, 2021, the Pfizer-BioNTech COVID-19 vaccine obtained FDA

Approving Biologics License Application of BioNTech Mfg. (Aug. 23, 2021),

https://perma.cc/BV3T-4GGP. In making the determination to approve Comirnaty, FDA

Comirnaty Approved Prescribing Information (revised Aug. 20, 2021) at 7, 15-18,

administered under the EUA. Id. at 12.

Comirnaty is the same formulation as the Pfizer-BioNTech vaccine originally