Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 1 of 21 PageID 151

IN THE UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF TEXASFORT WORTH DIVISIONPUBLIC HEALTH AND MEDICALPROFESSIONALS FOR TRANSPARENCYandPATRICK AND STEPHANIE DE GARAY,

Civil Action No. 4:22-cv-915-P

Plaintiffs,
v.
U.S. FOOD AND DRUG
ADMINISTRATION,
Defendant.
ANSWER
Defendant Food and Drug Administration (“FDA” or “Defendant”), by andthrough undersigned counsel, hereby answers the Complaint (Doc. 1) filed by Public
Health and Medical Professionals for Transparency (“PHMPT”) and Patrick andStephanie de Garay (togetherthe “de Garays”), collectively “Plaintiffs.” All allegations
not specifically admitted, denied, or otherwise responded to below are hereby denied.
Moreover, to the extent that the Complaint refers to or quotes from external documents,
statutes, or other sources, Defendant may refer to such materials for their accurate andcomplete contents; however, Defendant’s references are not intended to be, and should
not be construed to be, an admission that the cited materials are: (a) correctly cited orquoted by Plaintiff; (b) relevant to this, or any other, action; or (c) admissible in this, orAnswer– Page 1

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 2 of 21 PageID 152

any other, action. Defendant responds to the Complaint as follows in the correspondingly
numbered paragraphs:
1.

Defendant denies the allegations in paragraph 1 except that Defendant

admits that FDA approved Moderna’s COVID-19 vaccine, marketed as Spikevax, for use
in individuals 18 years of age or older on January 31, 2022. This paragraph also contains
a citation to an FDA press release, to which no response is required. To the extent a
response is required, Defendant respectfully refers the Court to the press release for acomplete and accurate statement of its contents.
2.

Defendant denies the allegations in paragraph 2 except that Defendant

admits that FDA approved Pfizer-BioNTech’s COVID-19 vaccine, marketed as
Comirnaty, for use in individuals 12 to 15 years of age on July 8, 2022. This paragraphalso contains a citation to an FDA press release, to which no response is required. To theextent a response is required, Defendant respectfully refers the Court to the press release
for a complete and accurate statement of its contents.
3.

Paragraph 3 contains a quotation from an FDA press release, to which no

response is required. To the extent a response is required, Defendant respectfully refers
the Court to the press release for a complete and accurate statement of its contents.
4.

Paragraph 4 consists of a quotation from an FDA press release, to which no

response is required. To the extent a response is required, Defendant respectfully refers
the Court to the press release for a complete and accurate statement of its contents.

Answer– Page 2

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

5.

Page 3 of 21 PageID 153

Paragraph 5 consists of Plaintiffs’ allegations about the opinions of

unnamed individuals and organizations. Defendant lacks sufficient information to admit
or deny the allegations in this paragraph.
6.

Paragraph 6 consists of Plaintiffs’ characterization of PHMPT and its work.

Defendant lacks knowledge or information sufficient to form a belief about the truth or
falsity of the allegations in this paragraph.
7.

Defendant denies the allegations in paragraph 7 except that Defendant

admits that FDA is producing data and information related to the approval of Comirnaty
for individuals 16 years of age or older to PHMPT under the Freedom of Information Act(“FOIA”), in accordance with an order from this Court. This paragraph also contains
Plaintiffs’ characterization of PHMPT and its work, and Defendant lacks sufficientknowledge or information to form a belief about the truth or falsity of those allegations.
Additionally, this paragraph contains a link to an FDA webpage, to which no response isrequired. To the extent a response is required, Defendant respectfully refers the Court tothe cited webpage for a complete and accurate statement of its contents.
8.

Paragraph 8 contains Plaintiffs’ characterization of the purpose of

PHMPT’s FOIA request. Defendant lacks sufficient knowledge or information to form abelief about the truth or falsity of this allegation. Paragraph 8 also contains a quotationfrom a federal regulation, to which no response is required. To the extent a response isrequired, Defendant respectfully refers the Court to the cited regulation for a complete
and accurate statement of its contents.

Answer– Page 3

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

9.

Page 4 of 21 PageID 154

Defendant denies the allegations in paragraph 9 except that Defendant

admits that Plaintiff PHMPT submitted a FOIA request to FDA for expedited processingof “[a]ll data and information for the Moderna Vaccine enumerated in 21 C.F.R.
§ 601.51(e), with the exception of publicly available reports on the Vaccine Adverse
Events Reporting System [‘VAERS’]” (citation omitted). Compl., Ex. 1. Defendant
admits that Plaintiff PHMPT also submitted a FOIA request for expedited processing of“[a]ll data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21
C.F.R. § 601.51(e), with the exception of publicly available reports on [VAERS]” andexcluding “any data and information responsive to and being produced in FOIA Control# 2021-5683 (previously made on behalf of PHMPT)” (citation omitted). Compl., Ex. 5.
This paragraph also cites a federal regulation, to which no response is required. To theextent a response is required, Defendant respectfully refers the Court to Plaintiff
PHMPT’s FOIA requests in Exhibits 1 and 5, and the cited regulation, for complete andaccurate statements of their contents.
10.

Defendant denies the allegations in paragraph 10 except that Defendant

admits that Plaintiffs de Garays submitted a FOIA request to FDA requesting “[a]ll dataand information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R.
§ 601.51(e) with the exception of publicly available reports on [VAERS]” (citation
omitted). Compl., Ex. 7. The remaining allegations concern Plaintiff de Garays’ minor
child. Defendant lacks sufficient knowledge or information to admit or deny these
allegations. This paragraph also cites a news article, to which no response is required.
To the extent a response is required, Defendant respectfully refers the Court to Plaintiff
Answer– Page 4

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 5 of 21 PageID 155

de Garays’ FOIA request in Exhibit 7 and the cited news article for complete andaccurate statements of their contents.
11.

Paragraph 11 consists of Plaintiffs’ allegations regarding interest from thegeneral public and the medical and scientific community in data and information related
to approval of the COVID-19 vaccines, to which no response is required. To the extent a
response is required, Defendant denies the allegations.
12.

Paragraph 12 consists of Plaintiffs’ allegations regarding the potential

effect of releasing Plaintiffs’ requested records, to which no response is required. To theextent a response is required, Defendant denies the allegations.
13.

Paragraph 13 contains Plaintiffs’ allegations regarding the need for

production of Plaintiffs’ requested records by unnamed segments of the public mandated
to receive the vaccine and unnamed public and private policy makers who continue tochange their vaccine policies, to which no response is required. To the extent a responseis required, Defendant lacks sufficient knowledge or information to admit or deny these
allegations.
14.

Paragraph 14 describes the interests of unnamed third-parties—including

legislators, policy makers, and parents—in the requested information and the potential
effects of delaying their release. Defendant lacks sufficient information to admit or denythese allegations.
15.

Defendant denies the allegations in paragraph 15 except that Defendant

admits that Plaintiffs have requested expedited processing of their FOIA requests
pursuant to 5 U.S.C. § 552(a)(6)(E)(v)(II). Defendant has insufficient information to
Answer– Page 5

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 6 of 21 PageID 156

admit or deny the remainder of Plaintiffs’ allegations regarding their reasons forrequesting expedited processing and intentions with respect to disseminating therequested materials.
16.

Defendant denies the allegations in paragraph 16 except that Defendant

admits that FDA denied Plaintiff PHMPT’s request for expedited processing of its FOIA
request related to Spikevax records on March 7, 2022, that Plaintiff PHMPT appealed thedenial on June 1, 2022, and that Defendant did not respond to the appeal prior to thecommencement of this action. To the extent Plaintiff alleges that the appeal remains
pending, that allegation is denied. Defendant avers that appeals for requests in litigation
are considered closed due to the change in jurisdiction from the agency to the federal
court.
17.

Admitted.

18.

Admitted.

19.

Paragraph 19 contains Plaintiffs’ characterization of their claims in thiscase, to which no response is required.
20.

Paragraph 20 consists of Plaintiffs’ description of PHMPT, to which no

response is required. To the extent a response is required, Defendant lacks sufficientknowledge or information to admit or deny these allegations.
21.

Paragraph 21 consists of Plaintiffs’ characterization of PHMPT’smembership. Defendant has insufficient information to admit or deny the allegations inthis paragraph.

Answer– Page 6

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

22.

Page 7 of 21 PageID 157

Paragraph 22 consists of a statement by Plaintiffs about the de Garays’

residency and adverse events suffered by their fourteen-year-old child following
vaccination in Pfizer’s clinical trial for 12- to 15-year-olds. Defendant lacks sufficientknowledge or information to admit or deny these allegations.
23.

Defendant denies the allegations in paragraph 23 except that Defendant

admits the allegations in the first sentence. The second sentence consists of Plaintiff’s
legal conclusion, to which no response is required.
24.

Paragraph 24 consists of Plaintiffs’ legal conclusions regarding jurisdiction

and venue, to which no response is required.
25.

Paragraph 25 contains legal conclusions regarding FDA’s licensure of

vaccines, to which no response is required. To the extent a response is required,
Defendant respectfully refers the Court to the cited statute and regulation for complete
and accurate statements of their contents. This paragraph also contains citations tovarious webpages on FDA’s website, to which no response is required. To the extent a
response is required, Defendant respectfully refers the Court to the cited webpages forcomplete and accurate statements of their contents.
26.

Paragraph 26 contains allegations regarding Pfizer and Moderna’s motives

and work on COVID-19 vaccines, to which no response is required. To the extent thisparagraph alleges that Pfizer and Moderna submitted information about clinical trials fortheir COVID-19 vaccines to FDA in their Biologic License Applications (“BLAs”),
Defendant admits that allegation.
27.
Answer– Page 7

Admitted.

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 8 of 21 PageID 158

28.

Admitted.

29.

Paragraph 29 contains a characterization of the public’s interest in the

documents produced in Plaintiff PHMPT’s separate FOIA case and the number ofdownloads of those documents from Plaintiff PHMPT’s website. The Defendant lacks
sufficient knowledge or information to admit or deny these allegations.
30.

Paragraph 30 contains an allegation regarding what independent experts

and researchers intend to do or will do with the produced materials. Defendant lacks
sufficient knowledge or information to admit or deny the allegation.
31.

Paragraph 31 contains allegations regarding Pfizer’s work on clinical trials

for its COVID-19 vaccine, to which no response is required.
32.

Defendant denies the second sentence of this paragraph. Defendant aversthat 1,119 adolescents 12 through 15 years of age received the study drug and wereanalyzed for efficacy in Pfizer’s pivotal study of the vaccine in this age group, and thatmany more adolescents received the vaccine both before and after licensure. See
Comirnaty Prescribing Information, § 14.2, available athttps://www.fda.gov/media/151707/download. The remainder of paragraph 32 contains
allegations regarding the personal experiences of the de Garays and their minor childduring and after Pfizer’s clinical trials, as described in an online video, to which no
response is required. To the extent a response is required, Defendant lacks knowledge orinformation sufficient to form a belief about the truth or falsity of the allegations in thisparagraph. Defendant respectfully refers the Court to the cited video link and affidavit

Answer– Page 8

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 9 of 21 PageID 159(attached as Exhibit 7 to the Complaint) for complete and accurate statements of theircontents.
33.

Defendant denies the allegations in paragraph 33 except that Defendant

admits that FDA granted emergency use authorization and subsequently licensed the useof the 12-15-Year-Old Pfizer Vaccine on July 8, 2022. Defendant respectfully refers the
Court to the cited FDA press release for a complete and accurate statement of its
contents. All other allegations in Paragraph 33 are denied.
34.

Admitted. Defendant respectfully refers the Court to the cited FDA press

release for a complete and accurate statement of its contents.
35.

Paragraph 35 cites selected portions of a federal regulation, to which no

response is required. To the extent a response is required, Defendant respectfully refers
the Court to the cited regulation for a complete and accurate statement of its contents.
36.

Paragraph 36 consists of Plaintiffs’ unspecified allegations regarding an“ongoing, national public debate” about the adequacy of information relied upon forlicensure of the COVID-19 vaccine, to which no response is required.
37.

Paragraph 37 contains allegations regarding declarations from unnamed

individuals that the information underlying licensure of Spikevax is “more thansufficient.” Defendant lacks sufficient knowledge or information to admit or deny these
allegations.
38.

Paragraph 38 consists of quotations from two FDA press releases regarding

the approval of the Moderna COVID-19 vaccine, to which no response is required. To

Answer– Page 9

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 10 of 21 PageID 160

the extent a response is required, Defendant respectfully refers the Court to the citedpress releases for complete and accurate statements of their contents.
39.

Paragraph 39 provides citations to several government websites, to which

no response is required. To the extent a response is required, Defendant respectfullyrefers the Court to the cited websites for complete and accurate statements of theircontents.
40.

Paragraph 40 provides citations to an FDA press release and to a Center for

Disease Control’s (“CDC”) website link, to which no response is required. To the extent
a response is required, Defendant respectfully refers the Court to the cited press release
and website for complete and accurate statements of their contents.
41.

Paragraph 41 consists of Plaintiffs’ allegations about the opinions of

unnamed individuals and organizations. Defendant lacks sufficient knowledge orinformation to admit or deny the allegations in this paragraph.
42.

Paragraph 42 contains quotations from and citations to several website links

from third parties and a link to a Citizen Petition filed by individual members of Plaintiff
PHMPT, to which no response is required. To the extent a response is required,
Defendant respectfully refers the Court to the cited websites for complete and accurate
statements of their contents. To the extent that Plaintiffs allege that a group of 27
individuals filed a Citizen Petition on June 1, 2021 related to COVID-19 vaccines,
Defendant admits the allegation and avers that petitioners withdrew their petition on July23, 2021. See Withdrawal Letter from Linda Wastila, July 23, 2021, docket no. FDA-

Answer– Page 10

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 11 of 21 PageID 161

2021-P-0521-1560, available at https://www.regulations.gov/document/FDA-2021-P0521-1560.
43.

Paragraph 43 contains Plaintiffs’ quotation from and citation to a statement

posted on a self-publication website, to which no response is required. To the extent a
response is required, Defendant respectfully refers the Court to the cited webpage for acomplete and accurate statement of its contents. Defendant denies that the referenced
paper has been published.
44.

Paragraph 44, and its subparagraphs a-e, consists of Plaintiffs’

characterization of five papers, to which no response is required. To the extent a
response is required, Defendant respectfully refers the Court to the cited papers forcomplete and accurate statements of their contents.
45.

Paragraph 45, and its subparagraphs a-e, consists of Plaintiffs’

characterization of five papers, to which no response is required. To the extent a
response is required, Defendant respectfully refers the Court to the cited papers forcomplete and accurate statements of their contents.
46.

Paragraph 46 contains Plaintiffs’ characterizations of the exigency

regarding COVID-19 vaccines and invasiveness of policy decisions, to which no
response is required. This paragraph also contains several citations to website links,
largely from 2021, regarding vaccine mandates enacted by institutions other than
Defendant, to which no response is required. To the extent a response is required,
Defendant respectfully refers the Court to the cited websites for complete and accurate
statements of their contents.
Answer– Page 11

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

47.

Page 12 of 21 PageID 162

Defendant has insufficient information to admit or deny what vaccine

policies might be adopted by educational institutions prospectively. This allegation also
contains citations to various webpages, to which no response is required. To the extent a
response is required, Defendant respectfully refers the Court to the cited webpages.
Paragraph 47 also contains allegations about a vaccine mandate announced in
Washington D.C., to which no response is required. To the extent a response is required,
Defendant respectfully refers the Court to the cited news article for a complete andaccurate statement of its contents.
48.

Defendant has insufficient information to admit or deny the first sentenceof Paragraph 48. Defendant admits that PHMPT submitted a FOIA request on February
23, 2022, and that the request sought expedited handling. The remainder of theparagraph sets forth a selected portion of the FOIA request, to which no response isrequired. To the extent a response is required, Defendant respectfully refers the Court to
Exhibit 1 of the Complaint for a complete and accurate statement of the contents of the
FOIA request.
49.

Defendant denies the allegations in paragraph 49 except that Defendant

admits that FDA denied Plaintiff PHMPT’s request for expedited processing on March 7,2022. The remainder of Paragraph 49 sets forth a selected portion of FDA’s
correspondence regarding the FOIA request, to which no response is required. To theextent a response is required, Defendant respectfully refers the Court to Exhibit 2 of theComplaint for a complete and accurate statement of the contents of the correspondence.
50.

Admitted.

Answer– Page 12

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 13 of 21 PageID 163

51.

Admitted.

52.

Paragraph 52 contains a legal conclusion, to which no response is required.

Defendant admits that it did not respond to PHMPT’s FOIA appeal prior to thecommencement of this action. To the extent Plaintiffs allege that FDA’s determination of
PHMPT’s FOIA appeal remains pending, that allegation is denied.
53.

To the extent Plaintiffs characterize PHMPT’s mission and efforts in thismatter, Defendant has insufficient information to admit or deny the allegations.
Defendant admits that PHMPT submitted the FOIA request quoted in Paragraph 53 on
August 8, 2022, and that the request sought expedited processing. This paragraph also
cites to FDA’s website, to which no response is required. To the extent a response isrequired, Defendant respectfully refers the Court to the cited website for a complete andaccurate statement of its contents. The remainder of the paragraph sets forth a selected
portion of the FOIA request, to which no response is required. To the extent a responseis required, Defendant respectfully refers the Court to Exhibit 5 of the Complaint for acomplete and accurate statement of the contents of the FOIA request.
54.

Defendant denies the allegations in paragraph 54 except that Defendant

admits that FDA denied Plaintiff PHMPT’s request for expedited processing on August
15, 2022. The remainder of Paragraph 54 sets forth a selected portion of FDA’s
correspondence regarding the FOIA request, to which no response is required. To theextent a response is required, Defendant respectfully refers the Court to Exhibit 6 of theComplaint for a complete and accurate statement of the contents of the correspondence.

Answer– Page 13

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

55.

Page 14 of 21 PageID 164

Defendant denies the allegations in paragraph 55 except that Defendant

admits that Plaintiff de Garays submitted the quoted FOIA request to FDA on August 22,
2022, which sought expedited processing. Defendant has insufficient information toadmit or deny the assertion in paragraph 55 regarding Plaintiffs’ reasons for submitting a
FOIA request. This paragraph also cites FDA’s website, to which no response isrequired. To the extent a response is required, Defendant respectfully refers the Court tothe cited website for a complete and accurate statement of its contents. The remainder ofthe paragraph sets forth a selected portion of the FOIA request, to which no response isrequired. To the extent a response is required, Defendant respectfully refers the Court to
Exhibit 7 of the Complaint for a complete and accurate statement of the contents of the
FOIA request.
56.

Defendant denies the allegations in paragraph 56 except that Defendant

admits that FDA denied Plaintiff de Garays’ request for expedited processing on August29, 2022. The remainder of Paragraph 56 sets forth a selected portion of FDA’s
correspondence regarding the FOIA request, to which no response is required. To theextent a response is required, Defendant respectfully refers the Court to Exhibit 8 of theComplaint for a complete and accurate statement of the contents of the correspondence.
57.

Paragraph 57 consists of legal conclusions and quotations from the FOIA,

to which no response is required. The allegations in this paragraph also purport tocharacterize a statute, which speaks for itself. To the extent a response is required,
Defendant respectfully refers the Court to the FOIA, 5 U.S.C. § 552, for a complete andaccurate statement of its contents.
Answer– Page 14

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

58.

Page 15 of 21 PageID 165

Paragraph 58 consists of legal conclusions, quotations from the FOIA, anda case citation, to which no response is required. To the extent a response is required,
Defendant respectfully refers the Court to the FOIA, 5 U.S.C. § 552, and to the casecitation for a complete and accurate statement of their contents.
59.

Paragraph 59 consists of legal conclusions, to which no response isrequired.
60.

Paragraph 60 consists of a legal conclusion, to which no response isrequired.
61.

Paragraph 61 consists of a legal argument, to which no response is required.

To the extent a response is required, Defendant respectfully refers the Court to Exhibits 4,6, and 8 of the Complaint for complete and accurate statements of the contents of FDA’s
correspondence denying expedited processing.
62.

Paragraph 62 consists of Plaintiffs’ characterization of PHMPT and its

work. Defendant lacks knowledge or information sufficient to form a belief about thetruth or falsity of the allegations. This paragraph also cites to various webpages, to which
no response is required. To the extent a response is required, Defendant respectfullyrefers the Court to the cited webpages for full and accurate statements of their contents.
63.

Paragraph 63 consists of Plaintiffs’ characterization of the de Garays as

public advocates, and various appearances they have made in that capacity, to which no
response is required. This paragraph also contains several website links to media
appearances made by the de Garays, to which no response is required. To the extent a
response is required, Defendant respectfully refers the Court to the cited website links for
Answer– Page 15

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 16 of 21 PageID 166

a complete and accurate statement of their contents. Defendant lacks knowledge orinformation sufficient to form a belief about the truth or falsity of the remaining
allegations in this paragraph regarding the de Garays’ minor child.
64.

Paragraph 64 consists of a legal conclusion, to which no response isrequired.
65.

Paragraph 65 quotes selected portions of federal regulations and sets forth alegal conclusion, to which no response is required. To the extent a response is required,
Defendant respectfully refers the Court to the cited regulations for complete and accurate
statements of their contents.
66.

Paragraph 66 cites selected portions of a federal statute, regulations, and

FDA webpages, and sets forth legal conclusions, to which no responses are required. To
the extent a response is required, Defendant respectfully refers the Court to the citedstatute, regulations, and webpages for complete and accurate statements of their contents.
67.

Paragraph 67 consists of a legal conclusion, to which no response isrequired.
68.

Paragraph 68 characterizes Plaintiffs’ previous allegations and citedmaterials in Paragraphs 36-45, to which no response is required. To the extent a responseis required, Defendant respectfully refers the Court to Defendant’s responses to
Paragraphs 36-45, and to the cited materials for complete and accurate statements of theircontents.
69.

Paragraph 69 restates Plaintiffs’ previous allegations about a public debate

regarding the COVID-19 vaccines among unnamed individuals, to which no response is
Answer– Page 16

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 17 of 21 PageID 167

required. To the extent a response is required, Defendant lacks sufficient knowledge orinformation to admit or deny these allegations.
70.

Paragraph 70 contains Plaintiffs’ speculations about what information will

settle public discourse about the safety and efficacy of COVID-19 vaccines, to which no
response is required
71.

Paragraph 71 consists of a legal conclusion, to which no response isrequired. To the extent that Plaintiffs allege that the COVID-19 vaccines referenced in
the FOIA requests that are the subject of this action continue to be mandated by entities
other than Defendant, Defendant lacks knowledge or information sufficient to form abelief about the truth or falsity of the allegation.
72.

Paragraph 72 contains an allegation regarding the Pentagon’s continued

mandate of COVID-19 vaccines based on news articles, to which no response is required.
To the extent a response is required, Defendant respectfully refers the Court to the citednews articles for complete and accurate statements of their contents, and additionally
avers that on December 23, 2022, the President signed into law the National Defense
Authorization Act for Fiscal Year 2023 (NDAA), which directs the Secretary of Defense
to rescind the military’s COVID-19 vaccination requirement within 30 days ofenactment. See James M. Inhofe National Defense Authorization Act for Fiscal Year2023, 117th Cong. § 525 (2022).
73.

Paragraph 73 contains Plaintiffs’ allegations regarding the relevancy of therequested records for the United States Military and the refusal of service members toreceive the COVID-19 vaccines. Defendant lacks sufficient knowledge or information to
Answer– Page 17

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 18 of 21 PageID 168

admit or deny these allegations. This paragraph also cites to a news article, to which no
response is required. To the extent a response is required, Defendant respectfully refers
the Court to the cited news article for a complete and accurate statement of its contents.
74.

Paragraph 74 contains Plaintiffs’ allegations about recent U.S. Armypolicies regarding unvaccinated service members. Defendant lacks sufficient knowledge
or information to admit or deny this allegation. This paragraph also cites to a news
article, to which no response is required. To the extent a response is required, Defendantrespectfully refers the Court to the cited news article for a complete and accurate
statement of its contents and also avers that the NDAA requires the military’s COVID-19
vaccination requirement to be rescinded within 30 days of NDAA’s enactment. See
supra ¶ 72.
75.

Paragraph 75 contains Plaintiffs’ allegations regarding military recruitment.

Defendant lacks sufficient knowledge or information to admit or deny these allegations.
This paragraph also cites to several news articles, to which no response is required. To
the extent a response is required, Defendant respectfully refers the Court to the citednews articles for complete and accurate statements of their contents.
76.

Paragraph 76 contains Plaintiffs’ allegation regarding unnamed policy

makers’ review of COVID-19 vaccine requirements for students in the 2022-2023 school
year. Defendant lacks sufficient knowledge or information to admit or deny thisallegation.
77.

Paragraph 77 consists of Plaintiffs’ opinion regarding the usefulness of its

FOIA requests for the public, to which no response is required.
Answer– Page 18

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

78.

Page 19 of 21 PageID 169

Paragraph 78 consists of allegations regarding unspecified objections to the

COVID-19 vaccines and unnamed individuals expelled from various institutions.
Defendant lacks sufficient knowledge or information to admit or deny these allegations.
This paragraph also consists of a legal conclusion about the urgency of Plaintiffs’ request,
to which no response is required.
79.

Paragraph 79 contains legal conclusions and citations to federal regulations,to which no response is required. To the extent a response is required, Defendantrespectfully refers the Court to the cited regulations and exhibits for complete andaccurate statements of their contents.
80.

Paragraph 80 consists of Plaintiffs’ description and characterization of the

public interest in the requested materials based on activity on PHMPT’s website.
Defendant lacks knowledge or information sufficient to form a belief about the truth or
falsity of these allegations.
81.

Paragraph 81 consists of a legal conclusion, to which no response isrequired.
The remaining paragraph of the Complaint contains Plaintiffs’ requested relief, towhich no response is required. To the extent a response is required, Defendant denies
that Plaintiffs are entitled to any relief.

AFFIRMATIVE DEFENSES
1. Some or all of the requested documents and information are exempt fromdisclosure. 5 U.S.C. § 552(b).
Answer– Page 19

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 20 of 21 PageID 170

2. Plaintiff’s FOIA request is improper and unduly burdensome to the extent it
does not reasonably describe the records sought as required by 5 U.S.C.
§ 552(a)(3)(A).
3. Defendant is entitled to invoke all exemptions under the FOIA and any otherapplicable laws.
4. To the extent Plaintiff’s complaint seeks documents or information that were
not asserted in their original FOIA request, such matters are barred as
unexhausted.
5. Plaintiffs are not entitled to attorneys’ fees or costs.
Dated: January 6, 2023.

Respectfully submitted,
LEIGHA SIMONTON
United States Attorney/s/ Clay Mahaffey
Clay R. Mahaffey
Wyoming Bar No. 6-3355
Assistant United States Attorney
809 Cherry Street
Suite 1700
Fort Worth, Texas 76102
Telephone: (817) 872-9127
Email: clay.mahaffey@usdoj.gov
ATTORNEYS FOR DEFENDANT

Answer– Page 20

Case 4:22-cv-00915-P Document 17 Filed 01/06/23

Page 21 of 21 PageID 171

CERTIFICATE OF SERVICE
I hereby certify that on January 6, 2023, I electronically filed the foregoing
document with the Clerk of the Court for the U.S. District Court, Northern District ofTexas, using the Electronic Case Filing System of the Court. I hereby certify that I have
served all counsel and parties of record electronically or by another manner authorized byFederal Rule of Procedure 5(b)(2).
/s/ Clay R. Mahaffey
Clay R. Mahaffey
Assistant United States Attorney

Answer– Page 21