Case 3:22-cv-00265 Document 50 Filed on 11/07/22 in TXSD Page 1 of 23

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF TEXAS
GALVESTON DIVISION

MICHAEL BAZZREA, et al.,

Plaintiffs,
v. Case No. 3:22-cv-265
LLOYD AUSTIN, III, et al.,
Defendants.

PLAINTIFFS’ MOTION FOR EVIDENTIARY HEARING AND

SUPPORTING MEMORANDUM OF LAW

Plaintiffs move this Honorable Court to convene an evidentiary hearing to

make findings regarding two outcome-determinative issues: (1) the provenance

and legal status of what Defendants have represented as “Comirnaty-labeled”

COVID-19 vaccines and which Defendants contend moots certain Plaintiff claims;

and (2) whether the Coast Guard has employed “digital tools,” including the

“Religious Accommodation Appeal Generator” (“RAAG”) and Denial Letter

Template Generator, see Ex. 1 (ECF 44-1), and a Denial Letter Template, see Ex. 2

(ECF 44-2), to categorically and automatically deny the Religious Accommodation

Requests (“RARs”) of Coast Guard members without any individualized

determinations or consideration of the merits of the request.

Since the issuance of the Department of Defense’s (“DoD”) COVID-19

vaccine mandate (“DoD Mandate”) through the present day, the DoD has

continuously and repeatedly mandated unlicensed Emergency Use Authorization

(“EUA”) vaccines. Official records of the Department of Defense (“DoD”), the

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Centers for Disease Control and Prevention (“CDC”), and the Food and Drug

Administration (“FDA”) confirm that over 49,000 of the 50,000 (or roughly 98%)

of the DoD’s inventory of FDA-licensed vaccines that they seek to mandate (and

the purportedly renders Plaintiffs’ claims moot) are in fact unlicensed and

misbranded EUA vaccines, most of which expired no later than November 1, 2022.

In a related proceeding in the Northern District of Florida, the DoD filed the

declaration of Air Force Colonel Tanya Rans, which includes a spreadsheet listing

all “BLA-Approved, Comirnaty-labeled” shots in the DoD inventory as of October

18, 2022. See Ex. 3, originally filed in Coker v. Austin, No. 3:21-cv-1211-AW-HTC

(N.D. Fla. Oct. 18, 2022), ECF 124-1, Rans Decl. & Ex. A. This official DoD record

and sworn testimony confirms Plaintiffs’ allegation that the DoD and Coast Guard

are mandating the unlicensed and untested “bivalent” vaccines that were granted

EUA on August 31, 2022, without any human testing whatsoever – see ECF 25, PL

Reply Br., at 9-10 – notwithstanding Defendants denials. See, e.g., ECF 47, DF Sur-

Reply Br., at 6-7 n.2 (dismissing Plaintiffs’ claims as speculation).

The Rans Declaration and spreadsheet includes unlicensed bivalent EUA

vaccines from lots GH9667, GH9702, and GJ6665 (collectively, the “G Lots”) that

are identified as “BLA-approved, Comirnaty-labeled” or “PFIZER GREY CAP

COMIRNATY” shots. See Ex. 3, Rans Decl., ¶ 4 & Ex. A. This is an admission that

each of the listed vials of bivalent vaccine is necessarily misbranded in violation of

numerous federal and state laws. It also demonstrates that Plaintiffs’ claims are

not moot because: (1) it represents yet another repetition of Defendants’ previous

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statutory violations; 1 and (2) that this violation is likely to be repeated by

Defendants against Plaintiffs because, even if they were to receive a primary series

of FDA-licensed vaccine, there is a reasonable expectation that they would be

required to take unlicensed EUA boosters as a condition for deployment or face

discharge for being non-deployable. See infra Section II.

The Rans Declaration and spreadsheet also includes “BLA-approved

Comirnaty-labeled” shots from Lots FW1330, FW1331, and FW1333 (collectively,

the “FW Lots”). 2 Each of these lots were manufactured at the Pharmacia & Upjohn

facility in Kalamazoo, Michigan (“Kalamazoo Facility”), which was not an FDA-

licensed manufacturing facility when these lots were manufactured, released into

interstate commerce, or received by the DoD and Coast Guard. Accordingly, none

of the shots from these lots is FDA-licensed and cannot be labeled as FDA-licensed

Comirnaty. See infra Section III.A. In addition, each of the shots from these lots

1The previous violations of the prohibition on mandating EUA products are set
forth in: (1) the September 13, 2021 Interchangeability Directive for Pfizer EUA
and licensed products, see ECF 1-7; (2) the May 3, 2021 Interchangeability
Directive for Moderna EUA and licensed products, see ECF 1-8; and (3)
Defendants’ previous offer of FW Lots of “Comirnaty-labeled” products that are
unlicensed EUA products. See generally ECF 25, PL Reply Br., at 7-10 & infra
Section IV.
2 The list also includes 60 doses from Lot 4302MF023 (which is Novavax, rather
than Pfizer, and subject to an EUA) and 11,298 “Comirnaty-labeled” doses from an
unidentified “(blank)” lot that “refers to sites that have not updated the logistics
system with the associated lot number.” Ex. 3, Rans Decl., Ex. A. The unidentified
doses should be presumed to be EUA bivalents lot because these lots were the most
recently manufactured (July 2022) and acquired (August or September 2022),
while the DoD has been in possession of the FW Lots for over four months starting
in June 2022.

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expired no later than October 31, 2022, and many expired well before that in

August or September 2022. See infra III.D. The unlicensed and/or expired FW and

G Lots account for over 49,000 of the just over 50,000 purportedly licensed

COVID-19 vaccines listed in the Rans Declaration.

The final section of this motion will address the Coast Guard’s “Digital

Tools” (i.e., the RAAG and Denial Letter Template) to categorically deny all RARs,

including those of Plaintiffs and Intervenor Plaintiffs. This can be easily

demonstrated by comparing the language in the Denial Template Generator with

the denial letters, as shown infra in Section V.

I. COMPOSITION, REGULATION AND LABELING OF BIOLOGICAL

PRODUCTS.

A. Biologics Are Unstable and Difficult to Ship and Store.

The federal Food, Drug, and Cosmetic Act (“FDCA”) proceeds from a

presumption of exclusion: a drug – or any “product” under the FDCA – is

presumptively NOT allowed to be distributed in commerce until the manufacturer

proves that the product can meet the statute’s extensive requirements. See 21 U.S.C.

§355(a) (“No person shall introduce or deliver for introduction into interstate

commerce any new drug, unless an approval of an application filed pursuant to

subsection (b) or (j) is effective with respect to such drug.”)(emphasis added). The

entire reason for a new drug application – and the burden on the applicant – is to

prove by “adequate and well-controlled studies,” see 21 C.F.R. §314.126, that the

drug is “safe” for mass distribution and “effective” for the purposes it claims. See

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21 U.S.C. §355(b)(1)(A)(i) (“…Such person shall submit…as part of the application

– full reports of investigations which have been made to show whether such drug

is safe for use and whether such drug is effective in use.”).

Biologics are regulated and held to analogous, but higher standards under

the Public Health Service Act (“PHSA”). 42 U.S.C. § 262. This is due in large part

to the chemical differences between drugs and biologics: drugs are, generally

speaking, stable chemical formulations, while biologics are not. Drugs are

produced in a form (pill, capsule, or liquid) with relatively long shelf-lives and

(typically) can be stored at room temperature or a normal household refrigerator.

By comparison, biologics are unstable formulations of viruses (or fragments) that

have been isolated and then attenuated in some fashion. They (typically) have very

limited shelf-lives; are frozen during shipment; and required to be stored in

commercial grade freezers, because they break down at normal room temperatures.

Notwithstanding that the current mRNA products at issue in this case contain no

Covid-19 virus at all, the shots have similar challenges to traditional vaccines with

regard to stability and storage. 3

Because of the chemical instability of biologics, the PHSA requires that a

biologics manufacturer demonstrate that the biologic: (1) is “safe, pure, and potent”

3See, e.g., Uddin MN, Roni MA. “Challenges of Storage and Stability of mRNA-
Based COVID-19 Vaccines.” Vaccines (Basel). 2021 Sep 17; 9(9):1033. PMCID:
PMC8473088. (“…instability and ultracold storage requirement of mRNA vaccines
remain major limitations. The stability of this emerging and fast-growing vaccine
platform is poorly understood, and it likely depends on multiple factors, such as
excipients, pH, and temperature.”).

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(the equivalent of a drug’s requirement to be “safe and effective”); and (2) that “the

facility in which the biological product is manufactured, processed, packed, or held

meets standards designed to assure that the biological product continues to be safe

pure and potent.” 42 U.S.C. §262(a)(2)(C)(emphasis added).

B. Biologics Have Stringent Labeling Requirements.

The PHSA includes detailed requirements regarding the labeling for biologics.

No person shall introduce or deliver for introduction into

commerce any biological product unless –
(A) a biologics license under this subsection or subsection (k) is
in effect for the biological product; and
(B) each package of the biological product is plainly marked
with –
(i) the proper name of the biological product contained
in the package;
(ii) the name, address, and applicable license number of
the manufacturer of the product; and
(iii) the expiration date of the biological product.

42 U.S.C. §262(a)(1). A regulated product – biologic or drug – must be

meticulously correct in its labeling in order to track potentially adulterated

or dangerous products, any adverse reactions to them, to aid in product

identification (and if necessary, recall efforts), and ultimately ensure the

health and safety of individuals being injected with these substances. The

FDA has even gone so far as to issue guidance to industry on naming

conventions for biologics after the passage of the 2009 Biologic Price

Competition and Innovation Act (“BPCI”).

Among other things, the proper name of a biological product

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helps health care providers identify the product’s drug substance

and distinguish biological products from one another…

To help ensure patient safety and allow the Agency and the
manufacturer to swiftly identify and address a problem, FDA
aims to track adverse events to a specific manufacturer (and as
appropriate, to a lot or manufacturing site for a particular
biological product) and allow surveillance systems to detect
safety signals throughout the life cycle of a product. Identifying
a biological product’s manufacturer can help target remedial
action (including recall) to avoid implicating a broader set of
products for which no such problem exists. 4

Mislabeling is a crime under both the FDCA and the PHSA. “A drug or device

shall be deemed to be misbranded… [i]f its labeling is false or misleading in any

particular.” 21 U.S.C. §352(a)(1)(emphasis added); see also 21 U.S.C. §333(a)

(describing penalties for misbranding with intent to defraud or mislead). The

PHSA states that “No person shall falsely label or mark any package or container

of any biological product or alter any label or mark on the package or container of

the biological product so as to falsify the label or mark.” 42 U.S.C. §262(b)

(penalties for violations are listed under subsection (f), including a fine not

exceeding $500 or imprisonment not to exceed one year, or both). It is a violation

to misbrand a product, or to introduce or receive a misbranded product. 21 U.S.C.

§331(a)-(c). District courts are specifically given the authority to enjoin violations

of misbranding or adulteration of products. See 21 USC § 332(a).

4 See U.S. DHHS, FDA, CDER, CBER, “Nonproprietary Naming of Biologic

Products” at 4 (Jan. 2017), available at: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/nonproprietary-naming-
biological-products-guidance-industry (last visited Nov. 4, 2022).

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The code of federal regulations supplements the statutes with the FDA’s

extensive requirements on mislabeling and misbranding. See, e.g., 21 C.F.R.

§ 201.1 - 201.328 (for drugs), and 21 C.F.R. §610.60 - 610.68 (for biologics).

Package labeling requirements are not optional, nor are they discretionary. “The

following items shall appear on the label affixed to each container…” 21 C.F.R.

§610.60(a)(emphasis added). In the event that a product’s container does not have

sufficient space to include all of the required label items, then the biologic

container must be in a package that includes all of the required labeling

information. Id.

The FDA – as the agency charged with overseeing these requirements – has a

number of mechanisms in place to help ensure that both the biologics themselves

and the facilities where they are “manufactured, processed, packed, or held” can

account for a biologic’s care and handling from its initial manufacture, packing,

shipping, storage, delivery, holding, and ultimately injection into its intended human

recipients. Defendant FDA’s need (and statutory duty) to track biologics relies upon

a number of different mechanisms, particularly in an age of digital submissions,

alongside the demands of tracking massive numbers of doses of a vaccine.

II. DEFENDANTS ARE MANDATING MISBRANDED, UNLICENSED

BIVALENT EUA VACCINES.

The Rans Declaration provides a list of “BLA-approved, Comirnaty-labeled”

vaccines, Ex. 3, Rans Decl., ¶ 4, that are identified as “PFIZER GREY CAP

COMIRNATY.” Id., Ex. A. This list includes the FW Lots, as well as vaccines from

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Lot Numbers GH9667, GH9702, and GH6665.

On October 20, 2022, Air Force Master Sergeant Nickolas Kupper accessed

the Centers for Disease Control and Prevention’s (“CDC”) vaccine lot number

database to identify the National Drug Code (“NDC”) for the G Lots. The NDC for

each of the three G Lots is 59267-0304. See Ex. 4, Kupper Decl., ¶ 4 & Kupper Ex.

A (query results from CDC database). According to the CDC NDC website, NDC

59627-0304 is the NDC assigned to the EUA Pfizer bivalent COVID-19 vaccine, 5

rather than 0069-2025, which is the NDC for Pfizer Grey Cap Comirnaty. See infra

Section III.A.

This demonstrates that Defendants seek to mandate EUA products that are

both unlicensed and misbranded as “Comirnaty-labeled.” Ex. 3, Rans Decl., ¶ 4.

The PHSA prohibits unlicensed products from being labeled using the proprietary

name for an FDA-licensed product. See 42 U.S.C. § 262(a)(1)(B)(i). Misbranding

an unlicensed product as a licensed product violates not only the PHSA and FDA

regulations, see supra Section I.B, but also numerous federal and state laws

regarding consumer protection, unfair or deceptive trade practices, and product

liability. The Rans Declaration and Exhibit A thereto constitute a binding

5 See CDC, COVID-19 Vaccine Related Codes, available at:

https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html
(“CDC NDC Website”) (last visited Oct. 25, 2022); see also Ex. 5, Pfizer-BioNTech
COVID-19 Vaccine, Bivalent, Package Insert, at 29 (identifying “Multiple Dose
Vials” of Pfizer bivalent vaccines as having NDC “59267-0304-2” for a carton of 10
multiple dose vials and NDC “59267-0304-1” for a multiple dose vial); id. at 35-38
(FDA-approved product labels for Pfizer bivalent vaccines stating “For use under
Emergency Use Authorization.”).

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admission of knowing illegal conduct by all Defendants that also implicates the

manufacturers.

III. NONE OF THE FW LOTS ARE FDA-LICENSED.

A. Each of the FW Lots Was Manufactured at the Kalamazoo

Facility, Which Was Not an FDA-Approved Facility.

Each of the FW Lots was manufactured at the Kalamazoo Facility in January

2022 (FW1330 and FW1331 expiring September 30, 2022) or February 2022

(FW1333 expiring October 31, 2022). See Ex. 5, FW1330 Lot Release Letter, at 1;

Ex. 6, FW1331 Lot Release Letter, at 1 (same as ECF 37-1, Burk Decl., Ex. 1); Ex. 7,

FW 1333 Lot Release Letter, at 1. As explained below, official FDA and CDC records

confirm that the Kalamazoo Facility was not an FDA-approved on any of the

relevant dates (i.e., manufacturing, lot release, or shipment date). 6

1. The FDA-Approved Product Labeling in Effect on All

Relevant Dates Did Not List the Kalamazoo Facility as
an FDA-Approved Facility.

The first Biologics License Application (“BLA”) for a COVID-19 vaccine

approved was granted to the German company BioNTech Manufacturing, GmbH,

6 Moreover, each of these lot release letters includes the Submission Tracking
Number (“STN”) 125742/36 associated with the December 16, 2021 Supplemental
Approval (“December 16 Letter”), see Ex. 8, December 16 Letter, at 1, of the Puurs,
Belgium facility as the sole manufacturer of the at that time new Tris/Sucrose
formulation, rather than the STN 12574/44 associated with the non-public
January 14, 2022 letter (“January 14 Letter”) submitted by Defendants. See ECF
37-2, Burk Decl., Ex. 1. The January 14 Letter purported to approve the Kalamazoo
Facility, and thus any lots manufactured there would have been associated with the
January 14 Letter STN (12574/44), rather than the December 16 Letter, which was
assigned STN (12574/36). See Ex. 8, December 16 Letter, at 1. The December 16
Letter could not have authorized manufacture at the Kalamazoo Facility.

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on August 23, 2021, license No. 2229, with the licensed, proprietary name

“Comirnaty.” See ECF 1-15, August 23, 2021 Comirnaty Purple Cap Approval Letter,

at 1. The BLA Approval Letter authorized the final formulated product to be

“manufactured, filled, labeled and packaged” at the Pfizer facility in Puurs,

Belgium and at the Kalamazoo Facility, id., as set forth in the Pfizer Comirnaty

Purple Cap package insert (Ex. 9), a screenshot of which is reproduced below. 7

On December 16, 2021, the FDA granted approval for a BLA Supplement for

a new 30 microgram dose of a Tris/Sucrose formulation in a “Grey Cap” (non-

dilute) to be manufactured at only one facility: Belgium, NV in Puurs, Belgium. See

Ex. 8, December 16 Letter, at 1. The December 24, 2021 package insert for the

Comirnaty Tris/Sucrose “Grey Cap” vial reflects only one facility approved to

conduct all four functions, analysis, manufacture, pack, and label: Pfizer

7The NDC label identifier for the original Purple Cap COMIRNATY is 0069-1000.
See Ex. 10, August 23, 2021 Comirnaty Purple Cap Package Insert at 14-15. Purple
Cap Comirnaty was never produced or marketed in the United States because the
marketing start and end date were both August 23, 2021. See id. at 20.

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Manufacturing Belgium NV (i.e., Puurs, Belgium). See Ex. 10, Dec. 22, 2021

Comirnaty Tris/Sucrose Package Insert, at 18. The package insert has a marketing

start date of December 22, 2021, with NDC label identifier of 0069-2025 (Grey Cap,

Comirnaty-labeled, do not dilute). The package insert has no current marketing

end date. Accordingly, the Kalamazoo Facility was not an FDA-licensed

manufacturing location when the FW Lots were manfuactured.

For reasons that are not entirely clear, Pfizer/BioNTech submitted an

updated package insert that the FDA approved on May 19, 2022 (the day before it

became orderable by the DoD), and with a May 18, 2022 marketing start date and

no marketing end date. See Ex. 11, May 19, 2022 Comirnaty Tris/Sucrose Package

Insert, at 32. Once again, only the Pfizer site in Puurs, Belgium is listed as the only

location where analysis, manufacture, pack and labeling may be performed. See id.

at 32-33. Neither the Kalamazoo Facility, nor any other U.S. location is listed in

the package insert. Accordingly, the Kalamazoo Facility was not an FDA-approved

manufacturing location when it was released into interstate commerce by the Lot

Release Letter or when it became orderable by DoD.

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Even assuming arguendo that the manufacturing site information was not

required, the previous, archived package inserts submitted by Plaintiffs listed the

approved manufacturers, a list that did not include the Kalamazoo Facility. See Ex.

10, Dec. 22, 2021 Comirnaty Tris/Sucrose Package Insert at 19; Ex. 11, May 19,

2022 Comirnaty Tris/Sucrose Package Insert, at 33-34. The currently effective

version of the package insert for the bivalent lots also lists the approved

manufacturers, a list that now includes the Kalamazoo Facility and the Hospira

facility in McPherson, Kansas. See Ex. 12, Pfizer Bivalent COVID-19 Vaccine

Package Insert, at 39-40.

2. The Supplemental Approval Letters and Product

Labeling Confirm that the Kalamazoo Facility was
Not an FDA-Approved Facility.
First, all of the Supplemental Approvals expressly approve the manufacture

of “COMIRNATY” at specific manufacturing locations. See Ex. 9, December 16

Letter, at 1; Ex. 13, July 8, 2022 2021 Supplemental Approval Letter (“July 8

Letter”), at 1; Ex. 14, August 25, 2022 Supplemental Approval Letter (“August 25

Letter”), at 1. For the January 14 Letter, by contrast, the word “COMIRNATY” is

not used and thus does not approve the manufacture of COMIRNATY at the

Kalamazoo Facility. The letter uses only the generic name “Covid-19 vaccine

(mRNA).” ECF 37-2, Burk Decl., Ex. 1., January 14 Letter, at 1.

Second, each of the other approval letters specifically require or approve

draft labels and package inserts that reflect the new approved locations,

formulation and/or indications. See Ex. 8, December 16 Letter, at 1-2; Ex. 13, July

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8 Letter, at 1-2; Ex. 14, August 25 Letter, at 1-2. This is because a manufacturer

must file a supplemental BLA, and receive prior FDA approval, before the

manufacturer can use a new manufacturing location (or formulation or

indication). See 21 C.F.R. § 601.12(b)(1) (“a supplement shall be submitted for any

change in the product, production process, … facilities …”). Further, the

manufacturer must submit proposed changes to the label and package insert to

reflect the changes for which approval is sought in the supplemental BLA. See 21

C.F.R. § 601.12(f). The January 14 Letter, by contrast, makes no reference to any

labeling changes to add the Kalamazoo Facility as an approved manufacturing

location on the label and package insert, as required by FDA regulations. This

should render the January 14 Letter invalid on its face, as there is no indication

that the FDA did (or legally could) waive the mandatory labeling requirements in

its regulations and governing statute.

Third, the vials themselves do not list Pharmacia & Upjohn or the Kalamazoo

Facility as the manufacturer. Instead, the vials list “BioNTech Manufacturing

GmbH & Pfizer Inc.” See ECF 25-2, Aug. 18, 2022 Letter from Sen. Ron Johnson

to CDC, DoD and FDA, at 1 (vial from Lot FW1331 with “9/2022” expiration date).

Fourth, the STN for the three FW Lot Release Letters, see Exs. 5-7, matches

that for the December 16 Letter (STN BL 125742/36), see Ex. 8, rather than for the

January 14 Letter (STN BL 125742/44). See ECF 37-2, Burk Decl., Ex. 1.

Defendants have not even attempted to explain this discrepancy.

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B. The FW Lots Expired No Later Than October 31, 2022.

The product labels and the Lot Release Letters both state that the expiration

date for Lots FW1330 and FW1331 is September 30, 2022, see Ex. 5-6, and the

expiration date for Lot FW 1333 is October 31, 2022. See Ex. 7. Further, the

currently effective and all previous, archived versions of the Pfizer Comirnaty Grey

Cap package insert state that: “Regardless of storage condition, the

vaccine should not be used after the expiration date printed on the vial

and cartons.” 8

In the Coker v. Austin proceeding, Defendants also submit an April 14, 2022

FDA letter that purports to “extend[] the expiration period … from 9 months to 12

months.” See Ex. 15, Coker v. Austin, No. 3:21-cv-1211-AW-HTC (N.D. Fla. Oct. 18,

2022), ECF 124-2, Burk Decl., Ex. 1. Defendants do not, however, cite any authority

that would permit the FDA to waive or override a labeling requirement mandated

by statute and FDA regulations, or the actual expiration date stated in the product

labeling. See 42 U.S.C. 42 U.S.C. § 262(a)(1)(B)(iii); 21 C.F.R. §610.60(a)(4).

At most, the April 14 Letter would have permitted Pfizer to modify the

expiration date printed on the product labeling, which was not done. 9 Pfizer could

8Aug. 22, 2022 Comirnaty Tris/Sucrose Package Insert at 15 (Current, effective

Aug. 22, 2022)(emphasis added), available at:
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=48c86164-
de07-4041-b9dc-f2b5744714e5&type=display (last visited Oct. 25, 2022); Ex. 10,
Dec. 22, 2021 Comirnaty Tris/Sucrose Package Insert, at 13; Ex. 11, May 19, 2022
Comirnaty Tris/Sucrose Package Insert, at 27.
9 This would have been trivially easy to do because, as of April 14, 2022, all of these
lots were in Pfizer’s possession and were not even orderable by the DoD until May
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have revised the package insert to state that the expiration should be extended in

accordance with the April 14 Letter, but it did not do so, and all versions of the

FDA-approved package inserts (whether before or after April 14, 2022) contain the

same directive not to use the product after the expiration date stated on the label.

Moreover, the PHSA and FDA labeling regulations all refer to the requirements

that must be stated on the “product,” 42 U.S.C. §262(a)(1), 21 C.F.R. §610.60(a),

and do not refer to the FDA’s approval letter. These package inserts, approved by

the FDA after the issuance of the April 14 Letter, must trump the previous April 14

Letter, both as a matter of law and the practical reality that patients, doctors and

pharmacists must rely on what is actually stated on the packaging. Accordingly, all

doses from Lot FW1330 and FW1331 expired as of September 30, 2022, and all

doses from Lot FW1333 will expire at the latest on October 31, 2022 (i.e., six days

from the date of this filing). 10

C. Many FW Lots and Nearly All FW1333 Lots Expired Prior to

Expiration Date Printed on Label.

The FDA-approved labeling provides that, regardless of the expiration date

stated on the label, once the vials are taken out of deep freeze they may be

18, 2022. The FDA’s FW1333 Lot Release Letter, issued several days later on April
19, 2022, states that the expiration date is “October 31, 2022.” Ex. 7, FW 1333 Lot
Release Letter, at 1.
10Even assuming arguendo that the April 14 Letter could override FDA regulations
and the FDA-approved labeling, Defendants have provided no evidence
whatsoever that any of the doses in the FW Lots met the requirement for expiration
date extension, namely, that these vials were continuously stored “between -90 ⁰C
and -60 ⁰C.” ECF 124-1, April 14 Letter, at 1.

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refrigerated at “2 ⁰C to 8 ⁰C” at which point they have a “10-week refrigerated

expiry date.” Ex. 11, May 19, 2022 Comirnaty Tris/Sucrose Package Insert, at 25-

26 (“16 How Supplied/Storage and Handling”). Any vials shipped or received at 2

⁰C to 8 ⁰C must “be stored at 2 ⁰C to 8 ⁰C” and “they should not be refrozen.” Id.

These FDA requirements are reflected in DoD and Armed Services transportation

and storage procedures, which stipulate that Pfizer Gray Cap Comirnaty must be

“ship[ped] refrigerated” at “2C to 8C with a 10 week shelf life.” Ex. 4, Kupper Decl.,

¶ 8 & Ex. C, Slide 18.

Defendants’ filings indicate that they received the FW Lots in early June

2022. These lots were then redistributed from Ft. Detrick to military facilities at

refrigerated temperatures rather than deep freeze, which triggered the 10-week

expiration period that ended in August 2022. See Ex. 4, Kupper Decl., ¶ 10.

This is confirmed by the testimony submitted by U.S. Marine Corps Captain

Joshua Hoppe. CAPT Hoppe is stationed in Yuma, Arizona, which according to the

Rans Declaration had doses of Pfizer Grey Cap Comirnaty from Lot FW1333 as of

October 18, 2022. See Ex. 3, Rans Decl., Ex. A. On October 19 and 21, 2022, the

Yuma Clinic informed CAPT Hoppe that the Yuma Clinic no longer had any

Comirnaty-labeled vaccines because all of the doses they had expired August 26,

2022 (i.e., due to the 10-week refrigeration expiration period). See Ex. 16, Hoppe

Decl., ¶¶ 4-5.

D. Unrebutted Evidence that CDC Lists the FW Lots as EUA.

The CDC maintains a listing of “all lots for COVID-19 vaccines made

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available under Emergency Use Authorization (EUA) for distribution in the United

States.” See CDC’s EUA Lot Release Database, available at:

https://vaccinecodeset.cdc.gov/LotNumber. The CDC listed all of the FW Lots as

EUA products until as recently as October 18, 2022. This is confirmed by the

August 4, 2022 Declaration of Army Lieutenant Mark Bashaw, which was included

in the declaration of Coast Guard Lieutenant Chad Coppin referenced in Plaintiffs’

September 6, 2022 Reply Brief. See ECF 27-1, Coppin Decl., at 26 (Bashaw Decl.,

¶¶ 10-11). In the attached declaration LT Bashaw reaffirms his August 4, 2022

testimony. See Ex. 17, Bashaw Decl., ¶ 8.

IV. PLAINTIFFS’ STATUTORY CLAIMS ARE NOT MOOT.

Plaintiffs’ statutory claims are not moot because Defendants’ violations are

“capable of repetition, yet evading review” and “there [is] a reasonable expectation

that [Plaintiffs will] be subjected to the same action again.” Fla. Bd. of Bus. Regul.

v. N.L.R.B., 605 F.2d 916, 920 (5th Cir. 1979) (citation and quotation marks

omitted). Defendants have consistently mandated unlicensed EUA shots from at

least September 14, 2021, see ECF 1-7, Pfizer Interchangeability Directive, through

the present, as confirmed by the fact that they are mandating unlicensed,

misbranded bivalent EUA shots.

In fact, Defendants have been requiring EUA boosters as a condition for

deployment for several months. Plaintiffs provide the sworn declaration U.S.

Marine Corps Senior Chief Petty Officer (“SCPO”) Dixon Brown, who serves as a

Senior Enlisted Medical Advisor responsible for EUA and informed consent

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compliance matters at Camp Pendleton, California. SCPO Brown’s declaration

confirms that the U.S. Marine Corps requires EUA boosters for new accessions and

for deployments. 11

Accordingly, there is a reasonable expectation that Plaintiffs will be subject

to this same statutory violation again because, even if each Plaintiff were to become

fully vaccinated with an FDA-licensed vaccine, they would be required to take an

unlicensed EUA vaccine to be deployable. Refusal to take the unlicensed vaccine

could thus still result in discharge or other adverse consequences.

V. THE COAST GUARD HAS USED DIGITAL TOOLS TO

CATEGORICALLY DENY COAST GUARD MEMBERS’ RELIGIOUS
LIBERTIES.

The Coast Guard has employed “Digital Tools,” including the RAAG and

Denial Letter Template, to categorically deny all Coast Guard members’ RARs,

including those of several Plaintiffs and Intervenor Plaintiffs. This can be easily

demonstrated by comparing the language in the Denial Template Generator with

the denial letters of Plaintiffs. Plaintiffs provide the sworn declaration and

supporting documents of Coast Guard LT Chad Coppin, an Intervenor Plaintiff,

showing how the Denial Letter Template was (incorrectly) used for his denial

letter. See Ex. 20, Coppin, Decl.

The Congressional Letter and whistleblower documents demonstrate the

11See Ex. 18, SCPO Brown Decl., ¶¶ 14-15 & SCPO Brown Ex. 4. Due to the credible
threat of retaliation, Plaintiffs intend to submit, under seal, additional declarations
and testimony from other fully vaccinated service members throughout the Armed
Services who have been required to take EUA boosters.

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USCG denied all, or nearly all, RARs and dismissed appeals “en masse with the

help of computer-assisted technology, indicating that no case-by-case

determinations were taking place.” ECF 43-1, at 2. The use of these tools to

implement the Categorical RAR Ban is fully consistent with the sworn testimony

presented by Plaintiffs, including that of Navy Chaplain Lieutenant Justin Brown,

who is assigned to the Coast Guard, describing the directives from Coast Guard

leadership that RARs would not be granted and that, even if an RAR was granted,

the member would still be separated. 12

It is also consistent with the findings of the DoD’s Office of the Inspector

General’s (“IG”) June 2, 2022 Report to Secretary Austin (“DoD IG Report”). See

Ex. 19. There, the DoD IG made DoD-wide preliminary findings that the RAR

processes implemented by the various Armed Services applied “generalized

assessments rather than the individualized assessments required by Federal law

and the DoD and Military Services policies,” Ex. 19, DoD IG Report at 1, i.e., RFRA,

DoDI 1300.17 and COMDTINST 1000.15.

This is also consistent with the findings of several courts that Secretary

Austin and the DoD have implemented a DoD-wide Categorical RAR Ban. The

Department of the Navy, of which the Coast Guard is a part, also employed similar

12See, e.g., ECF 25-9, Brown Supp. Decl., ¶ 7 (September 20, 2021 email informed
service members that “even if a religious accommodation or medical exemption
were approved the member was likely to still be administratively separated.”); ECF
1-2, Wilder Decl., ¶ 7 (commander informed Plaintiff Wilder that members would
not “be allowed to continue to serve if exempted. …. either way if they don’t get the
vaccine, [you] will be discharged.”).

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“digital tools” to implement the Navy’s Categorical RAR Ban and to automatically

generate denial letters. See ECF 60-9, Navy Whistleblower Testimony; Navy

SEALs 1-26 v. Austin, 2022 WL 34443, at *6 (N.D. Tex. Jan. 3, 2022) (granting PI

based on Navy process).

VI. THE COURT MUST CONVENE AN EVIDENTIARY HEARING AND

PERMIT PLAINTIFFS TO DEPOSE DEFENDANTS’ OFFICIALS.

Plaintiffs have provided official records and sworn testimony from

Defendants demonstrating that: (1) Defendants have once again attempted to

mandate unlicensed, misbranded, and expired EUA vaccines and misrepresented

those products as FDA-licensed “Comirnaty-labeled” vaccines; and (2) that the

Coast Guard has unlawfully used “Digital Tools” to categorically deny Coast Guard

members’ RARs and therefore their religious liberties, including those of Plaintiffs

and Intervenor Plaintiffs. This Court should permit Plaintiffs to seek discovery of

relevant documents that would bear these issues and to depose Defendants’

officials who have generated these records or who can testify on behalf of the

agency pursuant to Rule 30(b)(6) of the Federal Rules of Civil Procedure.

VII. CONCLUSION

The Court should grant Plaintiffs’ motion to convene an evidentiary hearing,

or find based on the record before it that Plaintiffs’ statutory claims are not moot;

that the G Lots are misbranded, unlicensed EUA lots; that all FW Lots expire no

later than November 1, 2022; and that the Coast Guard’s “Digital Tool” and RAAG

have been used to categorically deny Coast Guard members RARs, without any

individualized determination, in violation of Plaintiffs’ and putative Class

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Members’ rights under RFRA, the First Amendment Free Exercise Clause, and the

Fifth Amendment’s Procedural Due Process Clause.

Dated: November 7, 2022 Respectfully Submitted,

/s/ Dale Saran

Dale Saran, Esq.
MA Bar #654781
19744 W 116th Terrace
Olathe, KS 66061
Telephone: 480-466-0369
Email: [email protected]

/s/ Brandon Johnson

Brandon Johnson
DC Bar No. 491370
/s/ Travis Miller
Travis Miller
Texas Bar #24072952
Defending the Republic
2911 Turtle Creek Blvd., Suite 300
Tel. (214) 707-1775
Email: [email protected]
Email: [email protected]

/s/ Simon Peter Serrano

S. Peter Serrano, Esq.
WA Bar #54769
5238 Outlet Dr.
Pasco, WA 99301
Telephone: 530-906-9666
Email: [email protected]

Attorneys for Plaintiffs

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CERTIFICATE OF SERVICE

This is to certify that on this 7th day of November, 2022, the foregoing

Plaintiffs’ Reply Brief was e-filed using the CM/ECF system.

Respectfully Submitted,

/s/ Travis Miller

Travis Miller

CERTIFICATE OF CONFERENCE

I hereby certify that I conferred with counsel for Defendants by email on

November 4, 2022, and that Defendants oppose this motion.

/s/ Travis Miller

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