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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,
Plaintiff,
-against -
FOOD AND DRUG ADMINISTRATION,
Defendant.
Civil Action No. ____________
COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
Plaintiff, as for its Complaint regarding a Freedom of Information Act request against the
above -captioned Defendant, alleges as follows:
INTRODUCTION
1. Until only a few weeks ago, all coronavirus vaccines available in the United States
were only authorized for emergency use by the U.S. Food and Drug Administration (the “ FDA”).1
2. On August 23, 2021, the FDA approved the Pfizer -BioNTech COVID- 19 Vaccine,
marketed as Comirnaty (the “ Pfizer Vaccine ”) for individuals 16 years of age and older.2
3. Although the FDA asserts that the Pfizer Vaccine “meets the high standards for
safety, effectiveness, and manufacturing quality the FDA requires of an approved product[,]”3
numerous public health officials, media outlets, journalists, scientists, politicians, public figures,
and others with large social or media platforms have publicly raised questions regarding the sufficiency of the data and information, the adequacy of the review, and the appropriateness of the
1 https://www.bmj.com/content/373/bmj.n1244 (last visited 9/5/2021).
2 https://www.fda.gov/news -events/press -announcements/fda -approves -first-covid- 19-vaccine (last visited 9/5/2021).
3Id. Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 1 of 20 PageID 1Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 1 of 20 PageID 1
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analyses relied upon by the FDA to license the Pfizer Vaccine.
4. PHMPT is an organization made up of public health professionals, medical
professionals, scientists, and journalists. PHMPT exists for the sole purpose o f disseminating to
the public the data and information in the biological product files for each of the COVID -19
vaccines.
5. In furtherance of its mission, and in an effort to ensure that the FDA acts in
furtherance of its commitment to transparency,4 PHMP T seeks to obtain the data and information
relied upon by the FDA to license the Pfizer Vaccine. The importance of releasing to the public
this information is also recognized under f ederal law which provides that: “A fter a license has been
issued, the fol lowing data and information in the biological product file are immediately available
for public disclosure unless extraordinary circumstances are shown : (1) All safety and
effectiveness data and information. (2) A protocol for a test or study . . .” 21 C.F.R. § 601.51(e) .
6. PHMPT therefore issue d a request to the FDA pursuant to the Freedom of
Information Act (5 U.S.C. § 552, as amended) (“ FOIA ”) for “[a]ll data and information for the
Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)5 with the exception of publicly available
reports on the Vaccine Adverse Events Reporting System .6” (the “FOIA Request ”).
7. The medical and scientific community and the publ ic have a substantial interest in
reviewing the data and information underlying the FDA’s approval of the Pfizer Vaccine.
4 https://www.fda.gov/about -fda/transparency (last visited 9/5/2021).
5 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (2) A protoc ol for a test or study . . . . (3) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information . . . . (4) A list of all active ingredients and any inactive ingredients
. . . . (5) An assay method o r other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particul ar
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
6 For the avoidance of doubt, the FOIA Request includes but is not limited to all of the data and information in the
biological product file, as defined in 21 C.F.R. § 601.51(a), for the Pfizer Vacc ine enumerated in 21 C.F.R. § 601.51(e)
with the exception of publicly available reports on the Vaccine Adverse Events Reporting System. Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 2 of 20 PageID 2Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 2 of 20 PageID 2
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Reviewing this information will settle the ongoing public debate regarding the adequacy of the
FDA’s review process. Releasing this data should also confirm the FDA’s conclusion that the
Pfizer Vaccine is safe and effective and , thus, increase confidence in the Pfizer Vaccine. The
public’s need for this information is urgent given the fact that COVID -19 vaccines are being
mandated to individuals across the country by federal, state, and local governments a s well as
private businesses.
8. In an effort to disseminate the requested information to the public as expeditiously
as possible, given the time sensitive nature of the issue, PHMPT requested expedited processing
of the FOIA Request pursuant to 5 U.S.C. § 552(a)(6)(E)(v)(II).
9. On September 9, 2021, the FDA denied PHMPT’s request for expedited processing
on the basis that PHMPT did “not demonstr ate[] a compelling need that involves an imminent
threat to the life or physical safety of an individual” or “that there exists an urgency to inform the public concerning actual or alleged Federal Government activity.” PHMPT brings this action to
challeng e the FDA’s determination and seeks an order compelling the FDA to produce responsive
records on an expedited basis.
PARTIES
10. Public Health and Medical Professionals for Transparency is a not -for-profit
organization with an office located at 1090 Texan Tra il, Suite 534, Fort Worth, Texas, 76051.
11. PHMPT’s members include:
a. Aaron Kheriaty, MD
Professor of Psychiatry, UCI School of Medicine
Director, Medical Ethics Program, UCI Health
b. Harvey Risch, MD, PhD
Professor of Epidemiology
Yale School of Public Health
c. Peter A. McCullough, MD, MPH, FACP, FACC,
FCCP, FAHA, FNKF, FNLA, FCRSA Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 3 of 20 PageID 3Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 3 of 20 PageID 3
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d. Carole H Browner, PhD, MPH
Distinguished Research Professor
UCLA David Geffen School of Medicine
e. Peter Doshi, PhD
Associate Professor, Pharmaceutical Health Services Research
University of Maryland School of Pharmacy
Baltimore, Maryland, U.S.A.
f. Linda Wastila, BSPharm, MSPH, PhD
Professor, Pharmaceutical Health Services Research
University of Maryland School of Pharmacy
g. Andrew Bostom, MD, MS
Associate Professor of Family Medicine (Research)
The Warren Alpert Medical School of Brown University
h. Erick H. Turner, MD
Associate Professor
Oregon Health & Science University
i. Aditi Bhargava, PhD
Professor Emerita
Department of ObGyn and Reproductive Sciences University of California
San Francisco
j. Joseph A. Ladapo, MD, PhD
Associate Professor of Medicine
Division of General Internal Medicine and Health Services Research
David Geffen School of Medicine at UCLA
k. Gabe Vorobiof, MD FACC FASE
Director, Adult Non -Invasive Cardiology Laboratories
UCLA Cardiovascular Center
Associate Clinical Professor of Medicine
David Geffen School of Medicine at UCLA
l. Donald W. Light, PhD
Professor of Comparative Health Policy and Psychiatry
Rowan University School of Osteopathic Medicine
Glassboro, New Jersey, U.S.A.
m. Allyson M Pollock, MBChB, FRCPH, FRCP (Ed) FRCGP
Clinical Professor of Public Health
Institute of Health and Society, Newcastle University
Newcastle upon Tyne, United Kingdom
n. Anthony J. Brookes, PhD
Professor of Genetics
University of Leicester
Leicester, United Kingdom
o. László G. Boros, MD
Scientific Advisor
SIDMAP, LLC and the Deutenomics Science Institute
p. Angela Spelsberg, MD, SM
Comprehensive Cancer Center Aachen Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 4 of 20 PageID 4Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 4 of 20 PageID 4
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Aachen, Germany
q. Christine Stabell Benn, MD, PhD, DMSc
Professor of Global Health
University of Southern Denmark
Copenhagen, Denmark
r. Peter Aaby, MSc, DMSc
Head of Bandim Health Project, Guinea -Bissau
University of Southern Denmark
Copenhagen, Denmark
s. Ulrich Keil, MD, PhD, FRCP (London)
Professor Emeritus
University of Muenster
Muenster, Germany
t. Barbara Mintzes, BA, MSc, PhD
Associate Professor, School of Pharmacy
The University of Sydney
Sydney, Australia
u. David Healy, MD FRCPsych
Professor of Psychiatry
McMaster University
Ontario, Canada
v. Tom Jefferson, MD MRCGP FFPHM
Senior Associate Tutor
University of Oxford
w. Byram W. Bridle, PhD
Associate Professor of Viral Immunology
Department of Pathobiology
University of Guelph, Ontario
x. Peter C. Gøtzsche, Professor, DrMedSci, MD, MSc
Director
Institute for Scientific Freedom
Copenhagen, Denmark
y. Janice E. Graham, PhD, FRSC, FCAHS
Division of Infectious Diseases
University research Professor
Dalhousie University
z. Justin Lee
Associate Editor
Arc Digital
aa. Serena Tinari
Co-President, Re- Check, Investigating and Mapping Health Affairs
bb. Catherine Riva
Co-President, Re- Check, Investigating and Mapping Health Affairs
cc. Dr. Ira Bernstein, MD
Dept. Family and Community Medicine
University of Toronto Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 5 of 20 PageID 5Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 5 of 20 PageID 5
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dd. Dr. Ondrej Halgas, PhD
Biomedical Researcher
University of Toronto
ee. Prof. David Me nkes
Associate Professor
University of Auckland
ff. Dr. Peter Abdelmalak
Adjunct Professor
McMaster University
12. The FDA is an agency within the Executive Branch of the United States
Government, organized within the Department of Health and Human Services. The FDA is an
agency within the meaning of 5 U.S.C. § 552(f).
JURISDICTION AND VENUE
13. This Court has jurisdiction over this action pursuant to 5 U.S.C. § 552(a)(4)(B) and
28 U.S.C. § 1331. Venue is proper within this District pursuant to 5 U.S.C. § 552(a)(4)(B) and 28
U.S.C. § 1391.
FACTS
A. FDA Approval of t he Pfizer Vaccine
14. On August 23, 2021, the FDA approved the Pfizer Vaccine for individuals 16 years
of age and older.7
15. There is an ongoing, public national debate regarding the adequacy of the data and
information, and analyses of same, relied upon by the FDA to license the Pfizer Vaccine.
16. On th e one hand, there are numerous public health officials, media outlets,
journalists, scientists, politicians, public figures, and others with large social or media platforms that have declared that the data and information underlying the licensure of the Pf izer Vaccine is
more than sufficient for licensure.
7 https://www.f da.gov/news -events/press -announcements/fda -approves -first-covid- 19-vaccine (last visited 9/5/2021). Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 6 of 20 PageID 6Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 6 of 20 PageID 6
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17. For example, in a press release issued on August 23, 2021, acting FDA
Commissioner Janet Woodcock stated that “the public can be very confident that [the Pfizer
Vaccine] meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
8
18. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research,
made similar remarks, stating that
[The FDA’s] scientific and medical experts cond ucted an incredibly
thorough and thoughtful evaluation of [the Pfizer Vaccine]. We
evaluated scientific data and information included in hundreds of
thousands of pages, conducted our own analyses of [the Pfizer
Vaccine’s] safety and effectiveness, and performed a detailed
assessment of the manufacturing processes, including inspections of
the manufacturing facilities[.]9
19. Peter Marks further stated that “although [the FDA] approved [the Pfizer Vaccine]
expeditiously, it was fully in keeping with [the FDA’s] existing high standards for vaccines in the
U.S.”10
20. President Biden also stated that the FDA’s approval meets the “gold standard.”11
21. Even prior to FDA approval of the Pfizer Vaccine, government officials, public
health authorities, and medical professionals repeatedly claimed that COVID -19 vaccines are “safe
and effective.”12
8 https://www.fda.gov/news -events/press -announcements/fda -approves -first-covid- 19-vaccine (last visited 9/8/2021).
9 Id.
10 Id.
11 https://www.cbsnews.com/news/biden -address -covid- 19-vaccine- pfizer -fda-approval- watch -live-stream -today -
2021 -08-23/ (last visited 9/8/2021) .
12 See, e.g. , https://www.cdc.gov/coronavirus/2019 -ncov/vaccines/safety/saf ety-of-vaccines.html#:~:text=COVID%
2D19%20vaccines%20are%20safe,vaccine%20as%20soon%20as%20possible. (last visited 9/8/2021). See also
https://www.hhs.gov/ (“COVID -19 vaccines are safe, effective, and free) (last visit ed 9/8/2021) ;
https://www.who.int/news -room/feature -stories/detail/vaccine -efficacy -effectiveness -and-protection (“COVID -19
vaccines have pro ven to be safe, effective and life -saving.”) (last visited 9/8/ 2021); https://www.
doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectivenes s (“COVID -19 vaccines are safe”)
(last visited 9/8/2021); https://www.wlns.com/news/gov -whitmer -and-dr-khaldun -respond -to-the-fda-approval- of-
pfizers -covid- 19-vaccine/ (quoting Governor Whitmer referring to the Pfizer Vaccine as a “safe, effective COVID -19 Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 7 of 20 PageID 7Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 7 of 20 PageID 7
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22. On the other hand, numerous public health officials, media outlets, journalists,
scientists, politicians, public figures, and others with large social or media platforms have publicly
raised questions regarding the sufficiency of the data and information, adequacy of the review, and
appropriateness of the analyses relied upon to license the Pfizer Vaccine, including a number of the scientists and journalists tha t are members of PHMPT.
23. For example, on June 1, 2021, a group of 27 clinicians and scientists, including
professors from Harvard Medical School and the UCLA School of Public Health, and members of PHMPT, filed a Citizen Petition
13 with the FDA, claiming that the available evidence for licensure
of the Pfizer Vaccine “is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.”
14
24. Separately, Professor Peter Doshi , a PHMPT member, has publicly questioned the
lack of transparency regarding the vaccine approval process ,15 which Peter Marks publicly
disputed.16 For example , Peter Doshi publicly claimed that the FDA’s EUA review of the Pfizer
Vaccine “seem[ed] wholly inadequate” becau se it “assigned only a single reviewer in each of two
key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do.”
17 In response, Peter Marks asserted that the reviewers Doshi referred to “are simply
the leads for each review discipline ” but failed to identify a single additional individual involved
vaccine”) (last visited 9/8/2021).
13 https://www.regulations.gov/document/FDA -2021 -P-0521 -0001 (last visited 9/8/2021).
14 See https://blogs.bmj.com/bm j/2021/06/08/why- we-petitioned -the-fda-to-refrain -from -fully -approving -any-covid-
19-vaccine- this-year/ (last visited 9/8/2021).
15 See https://blogs.bmj.com/bmj/2021/08/23/does -the-fda-think -these -data-justify -the-first-full-approval- of-a-covid -
19-vaccine/ (last visited 9/8/2021); https://blogs.bmj.com/bmj/2021/01/04/peter -doshi -pfizer -and-modernas -95-
effective -vaccines -we-need -more -details -and-the-raw-data/ (last visited 9/8/ 2021); https://blogs.bmj.com /bmj/2020/
11/26/peter -doshi- pfizer -and-modernas -95-effective -vaccines -lets-be-cautious -and-first-see-the-full-data/ (last
visited 9/8/2021).
16 https://www.statnews.com/2020/12/17/did -the-fda-understaff -its-review -of-the-pfizer -biontech -vaccine/ (last
visited 9/8/2021).
17 Id. Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 8 of 20 PageID 8Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 8 of 20 PageID 8
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in the review .18
25. Peter Doshi has also questioned the adequacy of the data on the basis that the Pfizer
Vaccine is only “13 months into the still ongoing, two year pivotal trial, with no reported data past
13 March 2020, unclear efficacy after six months due to unblinding, evidence of waning protection
irrespective of the Delta variant, and limited reporting of safety data.”19
26. Andrew Kheriaty, professor of psychiatry at UCI School of Medicine, Director of
the Medical Ethics Program at UCI Health,20 and also a member of PHMPT, has also questioned
the FDA’s approval process. For example, in an article published in the Wall Street Journal, Dr.
Kheriaty questio ned the need for student vaccination requirements based on, among other things,
a review21 by the FDA’s Vaccines and Related Biological Products Advisory Committee
(“VRBPAC ”) that indicates a risk of heart inflammation after vaccination.22
27. Government offi cials have raised similar concerns about the lack of transparency
in the review process, arguing that it is “essential” for the FDA to, among other things, “make the
data generated by clinical trials and supporting documents submitted to the FDA by developers
available to the public[.]”23 Despite all eyes on the COVID -19 vaccines and calls for transparency
regarding the FDA’s actions, the FDA did not convene its advisory group, VRBPAC, to have a
public meeting prior to licensure. Those interested were denied the opportunity to both hear
discussion about the data and to offer public comment about same.
18 Id.
19 https://blogs.bmj.com/bmj/2021/08/23/does -the-fda-think -these -data-justify -the-first-full-approval- of-a-covid- 19-
vacci ne/ (last visited 9/8/2021) .
20 https://www.aaronkheriaty.com/bio (last visited 9/8/2021).
21 https://www.fda.gov/media/150054/download (last visited 9/8/2021).
22 https://www.wsj.com/articles/university -vaccine- mandates -violate -medical -ethics -11623689220 (last visited
9/8/2021).
23https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20t o%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process_.pdf (last visited 9/8/ 2021). See also https://www.washingtontimes. com/
news/2021/aug/23/editorial -the-coincidental -timing -of-pfizers -vacci/ (last visited 9/8/2021). Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 9 of 20 PageID 9Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 9 of 20 PageID 9
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B. Vaccine Requirements
28. Over the objections of many, the Pfizer Vaccine is being mandated to individuals
across the country by the federal government,24 local governments,25 public and private
employers,26 universities, 27 schools,28 and various other institutions,29 and many more entities are
expected to follow suit.30
29. At the federal level, legislation was recently introduced that would require COVID-
24 See, e.g. , https://www.natlawrev iew.com/article/covid -19-vaccine- added -to-requirements -green -card-processing -
effective -oct-1 (last visited 9/8/ 2021); https://apnews.com/article/business -health -coronavirus -pandemic -
coronavirus -vaccine- 4cf7451267919302de4a7b591508e80c (last vi sited 9/8/2021); https://www.forbes.com/
sites/joewalsh/2021/08/09/us -military -will-require -covid- vaccinations -by-mid-september/?sh=78defacd6c9f (last
visited 9/8/2021); https://www.whitehouse.gov/briefing -room/statements -releases/2021/07/29/fact -sheet -president-
biden- to-announce -new-actions -to-get-more -americans -vaccinated -and-slow -the-spread -of-the-delta -variant/ (last
visited 9/8/2021).
25 See, e.g. , https://www.cnn.com/2021/08/12/us/san -francisco -vaccine- requirement/index.html (last visited
9/8/2021); https ://www1.nyc.gov/site/doh/covid/covid -19-vaccines -keytonyc.page (last visited 9/8/2021); https://
news.yahoo.com/orleans -now- requires -proof -vaccination -230433492.html (last visited 9/8/2021).
26 See, e.g. , https://www.cnbc.com/2021/08/06/united -airlines -vaccine -mandate -employees.html (last visited
9/8/2021); https://sanfrancisco.cb slocal.com/2021/08/02/covid -kaiser -permanente -makes -vaccination -mandatory -
for-all-employees/ (last visited 9/8/ 2021); https://abcnews.go.com/Health/wireStory/walmart -mandates -vaccines -
workers -headquarters -79177220 (last visited 9/8/2021); https://www.kpbs.org/news/2021/aug/17/encinitas -covid- 19-
vaccine -negative -test-employees/ (last visited 9/8/ 2021); https://www.cnbc.com/2021/08/09/covid- vaccine -
mandates -sweep -across -corporate -america- as-delta -surges.html (last visited 9/8/2021); https://www.reuters .com
/business/energy/chevron -begins -covid- 19-vaccination -mandates -wsj-2021- 08-23/ (last visited 9/8/ 2021); https://
thehill.com/policy/healthcare/569051 -pfizers -full-approval- triggers -new-vaccine- mandates (last visited 9/8/2021);
https://cvshealth.com/news -and-insights/statements/cvs -health -will-require -covid- 19-vaccinations -for-clinical -and-
corporate- employees (last visited 9/8/2021).
27 See https://universitybusiness.com/state -by-state-look-at-colleges -requiring -vaccines/ (last visited 9/8/ 2021). See
also, e.g. , https://www.nbcnews.com/health/health -news/colleges -universities -covid- vaccination -mandates -facing -
pushback- n1273916 (last visited 9/8/2021); https://www.colorado.edu/covid -19-updates/covid -19-vaccination (last
visited 9/8/2021); https://uhs.berkeley.edu/requirements/covid19 (last visited 9/8/2021); https://huhs. harvard
.edu/covid- 19-vaccine -requirement -faqs (last visited 9/8/2021); https://www2.gmu.edu/safe -return -campus
/vaccination -requirements (last visited 9/8/ 2021); https://www.pc.pitt.edu/news/vaccine -disclosure -requirements -
2021 -2022 -campus -housing (last visited 9/8/2021)
28 See, e.g. , https://www.npr .org/sections/back -to-school -live-updates/2021/08/20/1029837338/a -california -school-
district -mandates -vaccines -for-eligible -students (last visited 9/8/ 2021); https://patch.com/massachusetts /salem
/salem -school- committee -approves -vaccine- mandate- sports- band (last visited 9/8/2021); https://www.nbcnewyork
.com /news/coronavirus/nyc -will-require -vaccination -for-high- risk-school -sports/3232745/ (last visited 9/8/ 2021);
https://www.nj.com/hudson/2021/08/hoboken- believed -to-be-first-in-state-to-issue -mandate -for-students -12-and-up-
get-vaccine -or-face- weekly -testing.html (last visited 9/8/2021); https://www. mercury news .com /2021/08/19/la -
county -school -district -mandates -covid- vaccines -for-k12-kids-others -soon- may-follow/ (last visited 9/8/2021).
29 See, e.g. , https://www.reuters.com/world/us/new -york-city-mandates -covid- 19-vaccine- public -school- teachers -
staff-mayor -2021 -08-23/ (last visited 9/8/2021); https://www.cbsnews.com /news/california -covid- vaccine- teachers -
mandate/ (last visited 9/8/2021); https://www.nytimes.com/2021/08/18/us/washington -state-teacher -vaccine-
mandate.htm l (last visited 9/8/2021); https://www.governor.ny.gov/news/governor -cuomo -announces -covid -19-
vaccination -mandate -healthcare- workers (last visited 9/8/2021); https://www.cdph.ca.gov /Programs/CID/DCDCCase 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 10 of 20 PageID 10Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 10 of 20 PageID 10
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19 vaccines for air travel into or out of the United States31 and the Pentagon has mandated COVID -
19 vaccines for all military personnel.32 In addition, Present Biden recently announced vaccine
mandates for all employers with 100 or more emp loyees, all federal employees, and all employees
of federal contractors.33
30. At the state level, legislation has been introduced to require COVID -19 vaccines
for all post -secondary students,34 all state employees, 35 and even for all citizens of the state.36
31. As explained by Dr. Anthony Fauci, “a flood” of vaccine mandates will follow
FDA approval of a COVID- 19 vaccine37 and President Biden is actively encouraging “companies
in the private sector to step up the vaccine requirements[.]”38
/Pages/ COVID -19/FAQ -Health -Care -Worker- Vaccine- Requir ement.aspx (last visited 9/8/ 2021); https://www.
nytimes. com/2021/08/09/us/washington -state-workers -vaccine- mandate.html (last visited 9/8/ 2021); https://www.
denvergov.org/Government/COVID -19-Information/Public -Health -Orders -Response/News -Updates/2021/Mayor -
Hancock -Announces -COVID -19-Vaccine- Requirement -for-Employees (last visited 9/8/ 2021); See https://www.
bostonherald.com/2021/08/19/baker -issues -vaccine- mandate -for-42000- state-employees/ (last visited 9/8/2021).
30 See https:/ /www.mississippifreepress.org/15126/fda -fully -approves -pfizer -biontech -vaccine- mandates -to-follow/
(last visited 9/8/2021); https://www.huffpost.com/entry/vaccine -mandates -roll-out-fda-approval_n_6123 e028e 4b0
df3eacd5d657 (last visited 9/8/ 2021); https://www.theadvocate.com /baton_rouge/ news/coronavirus /article _9be6
d02c -0434- 11ec -b7b1- cb17d8495274 .html? utm_medium=social&utm_source =twitternoladotcom&utm_ campaign =
snd (last visited 9/8/ 2021). See also https://www.latimes.com/california/story/2021 -08-26/california -lawmakers -
grapple -with-statewide -covid -19-vaccine- mandate (last visited 9/8/2021).
31 https://www.congress.gov/bill/117th -congress/house -bill/4980?q=%7B%22search%22:%5b%224980%252 (last
visited 8/23/2021).
32 https://thehill.com/policy/defense/568996 -pentagon -to-mandate- covid -19-vaccine -for-military (last visited
8/23/2021).
33 https://www.whitehouse.gov/covidplan/ (last visited 9/13/2021). See also https://www.cnn.com/2021 /09/09/
politics/joe -biden -covid -speech/index.html (last visited 9/13/2021).
34 See New York bill S6495 available at https://www.nysenate.gov/legislation/bills/2021/S6495 (last visited
9/8/2021).
35 See, e.g. , https://www.nj.com/coronavirus/2021/08/murphy -orders -vaccination -requirement -for-all-nj-state-
workers -including -at-public -colleges.html (last visited 9/8/2021).
36 See New York bill A11179 available at https://www.nysenate.gov/legislation/bills/2019/A11179 . See generally
https://eastcountytoday.net/buffy -wicks -transportation -bill-could -become -california -vaccine- passport -bill/ (last
visited 9/8/2021).
37 https://www.usatoday.com/story/news/health/2021/08/06/anthony -fauci -covid- vaccine -mandates -fda-full-approv al
/5513121001/ (last visited 9/8/2021).
38 https://www.msn.com/en -us/news/us/biden -urges -private -companies -to-implement -covid- 19-vaccine -require
ments -following -pfizer -e2-80-99s-fda-approval/ar -AANEcYs?ocid=uxbndlbing (last visited 9/8/ 2021). See also
https://www.nytimes.com/2021/08/23/us/pfizer -vaccine -mandates.html (noting that FDA approval of the Pfizer
Vaccine “is opening the way for institutions like the military, corporate employers, hospitals and school districts to
announce vaccine mandates for their employees”) (last visited 8/23/2021); https://www.msn.com/en -us/news/us/now -Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 11 of 20 PageID 11Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 11 of 20 PageID 11
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32. More recently, it appears that mandates may now encompass additional booster
shots of the vaccine in order to retain a “fully vaccinated” status.39
C. The FOIA Request
33. In furtherance of PHMPT’s mission to disseminate information to the public , and
in an effort to ensure that the FDA acts consistent ly with its commitment to transparency ,40 on
August 27, 2021, PHMPT submitted the FOIA Request to the FDA. Pursuant to the FOIA Request,
PHMPT requested that the following documents be produced on an expedited basis:
All data and information for the Pfizer Vaccine enumerated in
21 C.F.R. § 601.51(e)41 with the exception of publicly available
reports on the Vaccine Adverse Events Reporting System.42
(Exhibit A.1.)43
34. Upon submitting the FOIA Request, PHMPT immediately received confirmation
that the FOIA Request was submitted successfully . (Exhibit A.2 .)
that-a-covid- 19-shot-is-fully -approved- employer -mandates -are-rolling -in-but-will-vaccination -rates -in-the-us-go-up
/ar-AANGDTy?ocid=uxbndlbing (last visited 8/23/2021); https://news.yahoo. com/surgeon -general -vivek -murthy -
says-205530053.html (quoting the Surgeon General referring to vaccine mandates as “reasonable”) (last visited
8/23/2021).
39 See https://www.nbcnews.com/health/health -news/u -s-announces -plan-offer- boosters -all-americans -starting -late-
n1277059 (quoting the U.S. Surgeon General stating “it is our clinical judgment that the time to lay out a plan for
Covid- 19 boosters is now”) (last visited 9/13/2021); https://www.youtube.com/watch?v=ciVGAPuruoQ at 17:21
(video of Rochelle P. Walensky, Director of the CDC, stating “we are planning for Americans to receive booster
shots ”) (last visited 9/13/2021).
40 https://www.fda.gov/news -events/press -announcements/fda -approves -first-covid- 19-vaccine (last visited
9/5/2021).
41 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (2) A protoc ol for a test or study . . . . (3) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information . . . . (4) A list of all active ingredients and any inactive ingredients
. . . . (5) An assay method o r other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particul ar
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA].”
42 For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biological
product file, as defined in 21 C.F.R. § 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the
exception of publicly available reports on the Vaccine Adverse Events Reporting System.
43 All “Exhibits” referenced herein are attached to this Complaint. Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 12 of 20 PageID 12Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 12 of 20 PageID 12
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35. On August 31, 2021, the FDA issued an acknowledgment and assigned case
number 2021- 5683 to the FOIA Request. ( Exhibit A.3 .)
D. Request for Expedited Processing
36. In the FOIA Request, PHMPT requested that the FDA process the FOIA Request
on an expedited basis pursuant to 5 U.S.C. § 552(a)(6)(E)(v)(II).
37. On September 9, 2021, the FDA denied PHMPT’s request for expedited processing
of the FOIA Request (the “ Denial Letter ”).44 In the Denial Letter, the FDA stated in relevant
part:
I have determined that your reques t for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated a
compelling need that involves an imminent threat to the life or physical safety of an individual. Neither have you demonstrated that there exists an urgency t o inform the public concerning actual or
alleged Federal Government activity. Therefore, I am denying your request for expedited processing.
(Exhibit A.4 .)
ARGUMENT
38. FOIA provides for “expedited processing of request for records” upon a showing
of “compelling need.” 5 U.S.C. § 552(a)(6)(E)(i)(II). When the person requesting information is
“primarily engaged in disseminating information urgency to inform the public concerning actual
or alleged Federal Government activity” constitutes a “compelling n eed” for expedited processing.
5 U.S.C. § 552(a)(6)(E)(v)(II).
39. PHMPT requested expedited processing of the FOIA Request on the basis that it is
“primarily engaged in disseminating information” and that there is an “urgency to inform the public concerning actual or alleged Federal Government activity.” In the Denial Letter, the FDA
44 The FOIA requires federal agencies to issue determinat ions on requests for expedited processing within ten days
from the date of the request. 5 U.S.C. § 552(a)(6)(E)(ii)(I). The FDA’s denial of PHMPT’s request for expedited
processing was issued 13 days after PHMPT issued the FOIA Request. Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 13 of 20 PageID 13Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 13 of 20 PageID 13
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challenged PHMPT’s request for expedited processing only on the basis that PHMPT allegedly
failed to “demonstrate[] a compelling need that involves an imminent threat to the lif e or physical
safety of an individual” or “that there exists an urgency to inform the public concerning actual or alleged Federal Government activity.” As explained below, the FDA is wrong as there is an urgent need for the medical and scientific community and the public to review the data and information underlying the FDA’s approval of the Pfizer Vaccine.
40. The FDA does not and cannot challenge that PHMPT is “primarily engaged in
disseminating information.” PHMPT is an organization made up of public hea lth professionals,
medical professionals, scientists, and journalists. PHMPT exists for the sole purpose of disseminating to the public the data and information in the biological product files for each of the COVID- 19 vaccines. PHMPT intends to make any records produced in response to the FOIA
request immediately available to the public through both its website and its individual members’ platforms. Many of PHMPT’s individual members, including all its members that are journalists,
are primarily engaged in disseminating information to the public and do so across various Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 14 of 20 PageID 14Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 14 of 20 PageID 14
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platforms, including through interviews,45 articles,46 blogs,47 essays,48 and podcasts.49 Therefore,
PHMPT and many of its members are “primarily engaged in disseminating information to the
general public,” and, as explained below, there is a clear “urgency to inform the public concerning actual or alleged Federal Government activity,” here, the data and information underlying the licensure by the FDA of the Pfizer Vaccine.
41. In determinin g whether there is “urgency to inform the public ,” courts consider:
“(1) whether the request concerns a matter of current exigency to the American public; (2) whether
the consequences of delaying a response would compromise a significant recognized interest; and
(3) whether the request concerns federal government activity.” Al-Fayed v. CIA, 254 F.3d 300, 310
(D.D.C. 2001) . All three factors are present here.
42. The FOIA Request concerns a matter of current exigency to the American public.
45 See, e.g. , https:// www.foxnews.com/transcript/ingraham -angle -on-mask -mandates -bidens -failure -in-his-role
(Harvey Risch) (last visited 8/26/2021)
46 See, e.g. , https://www.bmj.com/content/373/bmj.n1244 (Peter Doshi) (last visited 9/8/2021); https://www. bmj.com
/content/ 371/bmj.m4058 (Peter D oshi) (last visited 9/8/ 2021); https://www.bmj.com/content/371/bmj. m4037 (Peter
Doshi) (last visited 9/8/2021); https:// www.wsj.com/articles/are -covid- vaccines -riskier -than-advertised -11624 381749
(last visited 8/25/2021); https://www.wsj.com/articles/university -vaccine- mandates -violate -medical -ethics -
11623689220 (Aaron Kheriaty and Gerard V. Bradley) (last visited 9/8/2021);
https://thefederalist.com/2021/07/05/how -college -covid- vaccine- mandates -put-students -in-danger/ (Andrew Bostom,
Aaron Kheriaty, Peter A. McCullough, Harvey A. Rish, Michelle Cret ella, and Gerard V. Bradley) (last visited
9/8/2021); https://thefederalist.com/2021/08/18/why -forcing -unvaccinated -students -to-wear -cloth -masks -is-anti-
science/ (Andrew Bostom, Gerard Bradley, Aaron Kheriaty, and Harvey Risch) (last visited 9/8/2021);
https://www.bmj.com/content/bmj/374/bmj.n1737.full.pdf (Serena Tinari and Catherine Riva) (last visited 9/8/2021);
https://www.bmj.com/content/372/bmj.n627 (Serena Tinari) (last visited 9/8/ 2021);
https://ebm.bmj.com/content/early/2021/08/08/bmjebm -2021- 111735 (Sarah Tanveer, Anisa Rowhani -Farid,
Kyungwan Hong, Tom Jefferson, Peter Doshi) (last visited 9/8/ 2021); https://www.arcdigital.media/p/medical -
ethicist -sues-the-university (Justin Lee) (last visited 9/8/2021).
47 See, e.g. , https://blogs.bmj.com/bmj/2021/08/23/does -the-fda-think -these -data-justify -the-first-full-approval- of-a-
covid- 19-vaccine/ (Peter Doshi) (last visited 9/8/ 2021); https://blogs.bmj.com/bmj/2020/11/26/peter -doshi -pfizer -
and-modernas -95-effective -vaccines -lets-be-cautious -and-first-see-the-full-data/ (Peter Doshi) (last visited 9/8/ 2021).
See also https://www.re -check.ch/wordpress/en/covid- certificate/ (Cath erine Riva and Serena Tinari) (last visited
9/8/2021).
48 See https://www.andrewbostom.org/2021/06/why -collegiate -covid- 19-vaccine- mandates -are-lysenkoist -anti-
science/ (Andrew Bostom) (last visited 9/8/2021).
49 See, e.g. , https://www.andrewbostom.org/2021/05/dr -andrew -bostom -discusses -the-unfavorable -risk-benefit -ratio-
of-covid- 19-vaccination -of-very-low-covid -19-risk-12-to-17-year-olds-with-pfizers-emergency -use-authorization -
only- mrna -vaccine/ (Andrew Bostom) (last visited 9/8/2021). Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 15 of 20 PageID 15Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 15 of 20 PageID 15
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The FDA itself acknowledges this exigency in the Code of Federal Regulations, which expressly
provides that “[a]fter a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are
shown: (1) All safety and effectiveness data and information . . . .” 21 C.F.R. § 601.51(e) (emphasis
added). The FDA’s own regulations thus expressly recognize the importance of having the data and information relied upon to license a vaccine “immediately available for public disclosure.” Id. The FDA’s regulation not only supports the need for expedited treatment under FOIA but is also an independent legal basis that requires expedited treatment of th e FOIA Request.
43. This policy is not surprising given the FDA’s commitment to transparency and its
entire program to assure transparency, because a lack of transparency erodes the confidence t he
medical and scientific community and the public have in the conclusions reached by the FDA.
50
44. Beyond the FDA’s own regulations which admit the urgent need for transparency
and immediate disclosure in this situation, there are two additional reasons th at warrant expedited
treatment of this request.
45. First, as explained above, there is an ongoing, public national debate regarding the
adequacy of the data and information, and analyses of same, relied upon by the FDA to license the Pfizer Vaccine.
46. Although public health officials, media outlets, journalists, scientists, politicians,
public figures, and others with large social or media platforms that have declared that the data and
50 https://www.fda.gov/about -fda/transparency (last visited 9/8/ 2021). As required by Congress, the FDA may only
license vaccines that have been proven to be “safe and effective,” see, e.g. , 21 U.S.C. § 393, and the FDA makes this
determination based on, inter alia , clinical trial reports provided by the sponsor which must be sufficient to
demonstrate the product is both “safe” and “effective.” 21 C.F.R. 601.2(a). T he FDA explains in its guidance
materials that the clinical trials relied upon for approval are typically “1 to 4 years”
(https://www.fda.gov/patients/drug -development -process/step -3-clinical -research ) and the duration of clinical trials
should “reflect the product and target condition.” https://www.fda.gov/media/102332/download (last visited
9/8/2021). See also https://www.fda.gov/consumers/consumer -updates/it -really -fda-approved (last visited 9/8/2021);
https://www.fda.gov/about -fda/what -we-do (last visited 9/8/2021). Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 16 of 20 PageID 16Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 16 of 20 PageID 16
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information underlying the licensure of the Pfizer Vaccine is more than sufficient for licensure ,51
numerous public health officials, media outlets, journalists, scientists, politicians, public figures,
and others with large social or media platforms have publicly raised questions regarding the sufficiency of the data and inform ation, the adequacy of the review, and appropriateness of the
analyses relied upon to license the Pfizer Vaccine, including a number of the scientists and journalists that are members of PHMPT.
52
47. The public debate is unlikely to be settled without full d isclosure of the data and
information underlying the FDA’s conclusion that the Pfizer Vaccine is “safe and effective.”
48. Given the widespread and ongoing public debate, the medical and scientific
community and the public has an immediate need to review the data and information underlying the licensure of the Pfizer Vaccine. Public disclosure of this information will inform this ongoing
public debate.
49. There is also an urgent need for the public to have immediate access to the data and
information underlying the licensure of the Pfizer Vaccine because, over the objections of many,
this product is being mandated to individuals across the country by the federal government,
53 local
51 See, e.g. , supra ¶¶ 16-21.
52 See, e.g. , supra ¶¶ 22-27.
53 See, e.g. , https://www.natlawreview.com/article/covid -19-vaccine- added -to-requirements -green -card-processing -
effective -oct-1 (last visited 9/8/ 2021); https://apnews.com/article/business -health -coronavirus -pandemic -
coronavirus -vaccine- 4cf7451267919302de4a7b591508 e80c (last visited 9/8/ 2021); https://www.forbes.com/
sites/joewalsh/2021/08/09/us -military -will-require -covid- vaccinations -by-mid-september/?sh=78defacd6c9f (last
visited 9/8/2021); https://www.whitehouse.gov/briefing -room/statements -releases/2021/07/29/fact -sheet -president-
biden- to-announce -new-actions -to-get-more -americans -vaccinated -and-slow -the-spread -of-the-delta -variant/ (last
visited 9/8/2021). Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 17 of 20 PageID 17Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 17 of 20 PageID 17
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governments, 54 public and private employers,55 universities, 56 schools,57 and various other
institutions,58 and many are expected to follow suit.59
50. During a time when COVID- 19 vaccine mandates are being implemented60 over
54 See, e.g. , https://www.cnn.com/2021/08/12/us/san -francisco -vaccine- requirement/index.html (last visited
9/8/2021); https ://www1.nyc.gov/site/doh/covid/covid -19-vaccines -keytonyc.page (last visited 9/8/2021); https://
news.yahoo.com/orleans -now- requires -proof -vaccination -230433492.html (last visited 9/8/2021).
55 See, e.g. , https://www.cnbc.com/2021/08/06/united -airlines -vaccine -mandate -employees.html (last visited
9/8/2021); https://sa nfrancisco.cbslocal.com/2021/08/02/covid -kaiser -permanente -makes -vaccination -mandatory -
for-all-employees/ (last visited 9/8/ 2021); https://abcnews.go.com/Health/wireStory/walmart -mandates -vaccines -
workers -headquarters -79177220 (last visited 9/8/2021); https://www.kpbs.org/news/2021/aug/17/encinitas -covid- 19-
vaccine -negative -test-employees/ (last visited 9/8/ 2021); https://www.cnbc.com/2021/08/09/covid- vaccine -
mandates -sweep -across -corporate -america- as-delta -surges.html (last visited 9/8/2021); https://www.reuters .com
/business/energy/chevron -begins -covid- 19-vaccination -mandates -wsj-2021- 08-23/ (last visited 9/8/ 2021); https://
thehill.com/policy/healthcare/569051 -pfizers -full-approval- triggers -new-vaccine- mandates (last visited 9/8/2021);
https://cvshealth.com/news -and-insights/statements/cvs -health -will-require -covid- 19-vaccinations -for-clinical -and-
corporate- employees (last visited 9/8/2021).
56 See https://universitybusiness.com/state -by-state-look-at-colleges -requiring -vaccines/ (last visited 9/8/ 2021). See
also, e.g. , https://www.nbcnews.com/health/health -news/colleges -universities -covid- vaccination -mandates -facing -
pushback- n1273916 (last visited 9/8/2021); https://www.colorado.edu/covid -19-updates/covid -19-vaccination (last
visited 9/8/2021); https://uhs.berkeley.edu/requirements/covid19 (last visited 9/8/2021); https://huhs. harvard
.edu/covid- 19-vaccine -requirement -faqs (last visited 9/8/2021); https://www2.gmu.edu/safe -return -campus
/vaccination -requirements (last visited 9/8/ 2021); https://www.pc.pitt.edu/news/vaccine -disclosure -requirements -
2021 -2022 -campus -housing (last visited 9/8/2021)
57 See, e.g. , https://www.npr .org/sections/back -to-school -live-updates/2021/08/20/1029837338/a -california -school-
district -mandates -vaccines -for-eligible -students (last visited 9/8/ 2021); https://patch.com/massachusetts /salem
/salem -school- committee -approves -vaccine- mandate- sports- band (last visited 9/8/2021); https://www.nbcnewyork
.com /news/coronavirus/nyc -will-require -vaccination -for-high- risk-school -sports/3232745/ (last visited 9/8/ 2021);
https://www.nj.com/hudson/2021/08/hoboken- believed -to-be-first-in-state-to-issue -mandate -for-students -12-and-up-
get-vaccine -or-face- weekly -testing.html (last visited 9/8/2021); https://www. mercury news .com /2021/08/19/la -
county -school -district -mandates -covid- vaccines -for-k12-kids-others -soon- may-follow/ (last visited 9/8/2021).
58 See, e.g. , https://www.reuters.com/world/us/new -york-city-mandates -covid- 19-vaccine- public -school- teachers -
staff-mayor -2021 -08-23/ (last visited 9/8/2021); https://www.cbsnews.com /news/california -covid- vaccine- teachers -
mandate/ (last visited 9/8/2021); https://www.nytimes.com/2021/08/18/us/washington -state-teacher -vaccine-
mandate.htm l (last visited 9/8/2021); https://www.governor.ny.gov/news/governor -cuomo -announces -covid -19-
vaccination -mandate -healthcare- workers (last visited 9/8/2021); https://www.cdph.ca.gov /Programs/CID/DCDC
/Pages/ COVID -19/FAQ -Health -Care -Worker- Vaccine- Requir ement.aspx (last visited 9/8/ 2021); https://www.
nytimes. com/2021/08/09/us/washington -state-workers -vaccine- mandate.html (last visited 9/8/ 2021); https://www.
denvergov.org/Government/COVID -19-Information/Public -Health -Orders -Response/News -Updates/2021/Mayor -
Hancock -Announces -COVID -19-Vaccine- Requirement -for-Employees (last visited 9/8/ 2021); See https://www.
bostonherald.com/2021/08/19/baker -issues -vaccine- mandate -for-42000- state-employees/ (last visited 9/8/2021).
59 See https:/ /www.mississippifreepress.org/15126/fda -fully -approves -pfizer -biontech -vaccine- mandates -to-follow/
(last visited 9/8/2021); https://www.huffpost.com/entry/vaccine -mandates -roll-out-fda-approval_n_6123 e028e 4b0
df3eacd5d657 (last visited 9/8/ 2021); https://www.theadvocate.com /baton_rouge/ news/coronavirus /article _9be6
d02c -0434- 11ec -b7b1- cb17d8495274 .html? utm_medium=social&utm_source =twitternoladotcom&utm_ campaign =
snd (last visited 9/8/ 2021). See also https://www.latimes.com/california/story/2021 -08-26/california -lawmakers -
grapple -with-statewide -covid -19-vaccine- mandate (last visited 9/8/2021).
60 See, e.g. , supra ¶¶ 28-32. Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 18 of 20 PageID 18Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 18 of 20 PageID 18
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the objection of those that have questions about the data and information supporting the safety and
efficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from
employment, school, transportation, restaurants, entertainment facil ities, and the military, the
public has an urgent and immediate need to have access to this data. The urgent need for the public
to review this data is heightened by President Biden’s recent announcement of vaccine mandates for million s of Americans, including employers with 100 or more employees, federal employees,
and employees of federal contractors.
61
51. PHMPT wi ll forthwith disseminate any information it obtains in response to the
FOIA Request. PHMPT, as an entity primarily engaged in disseminating information, has a
recognized interest in timely contributing to the ongoing public debate regarding the adequacy of the data and information underlying the FDA’s approval of the Pfizer Vaccine.
52. Finally, t he information PHMPT seeks concerns actual or alleged federal
government activity – namely, whether the FDA properly approved the Pfizer Vaccine based on
adequate data and information. The FDA, which is committed to transparency, should immediately release the information PHMPT seeks in the FOIA Request.
53. Because the FDA denied PHMPT’s request for expedited processing, PHMPT is
entitled to immediately seek relief in this Court. 5 U.S.C. § 552(a)(6)(E)(iii).
Requested Relief
WHEREFORE , Plaintiff prays that this Court:
a. Provide for expeditious proceedings in this action;
b. Enter an Order directing the FDA to produce all documents responsive to the FOIA
Request on an expedited basis and in no event later than 10 days from the date of
61 https://www.whitehouse.gov/covidplan/ (last visited 9/13/2021). See also https://www.cnn.com/2021 /09/09/
politics/joe -biden -covid -speech/index.html (last visited 9/13/2021). Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 19 of 20 PageID 19Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 19 of 20 PageID 19
Page 20 of 20
any such order ;
c. Award Plaintiff its costs and reasonable attorneys’ fees incurred in this action as
provided by 5 U.S.C. § 552(a)(4)(E); and
d. Grant such other and further relief as the Court may deem just and proper.
Dated: September 1 6, 2021
SIRI & GLIMSTAD LLP
Aaron Siri (pro hac vice to be filed)
Elizabeth Brehm (pro hac vice to be filed)
Gabrielle Palmer (pro hac vice to be filed)
200 Park Avenue
17th Floor
New York, New York 10166 Tel: (212) 532 -1091
Fax: (646) 417- 5967
[email protected]
[email protected]
[email protected]
HOWIE LAW, PC
/s John Howie
John Howie
Texas Bar Number: 24027239 2608 Hibernia Street
Dallas, Texas 75204 Tel: (214) 622 -6340
[email protected]
Attorneys for Plaintiff
Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 20 of 20 PageID 20Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 20 of 20 PageID 20
Exhibit A.1 Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 1 of 9 PageID 21Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 1 of 9 PageID 21
FREEDOM OF INFORMATION ACT REQUEST
EXPEDITED PROCESSING REQUESTED
VIA ONLINE PORTAL August 27, 2021
Food and Drug Administration
Division of Freedom of Information
Office of the Secretariat, OC
5630 Fishers Lane, Room 1035 Rockville, MD 20857 Re: Pfizer -BioNTech COVID- 19 Vaccine Biological Product File (IR#0546)
Dear Sir or Madam :
This firm represents Public Health and Medical Professionals for Transparency
(“PHMPT ”).
On August 23, 2021, the Food and Drug Administration (“ FDA”) approved the Pfizer -
BioNTech COVID- 19 Vaccine, marketed as Comirnaty (the “ Pfizer Vaccine”) for individuals 16
years of age and older . On behalf of PHMPT and its individual members , please provide the
following records to [email protected] in electronic form:
All data and information for the Pfizer Vaccine enumerated in
21 C.F.R. § 601.51(e)1 with the exception of publicly available
reports on the Vaccine Adverse Events Reporting System .2
1 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and
information. (2) A protoc ol for a test or study . . . . (3) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information . . . . (4) A list of all active ingredients and any inactive ingredients
. . . . (5) An assay method o r other analytical method . . . . (6) All correspondence and written summaries of oral
discussions relating to the biological product file . . . . (7) All records showing the manufacturer’s testing of a particul ar
lot . . . . (8) All records showing the testing of and action on a particular lot by the [FDA]. ”
2 For the avoidance of doubt, this request includes but is not limited to all of the data and information in the biological
product file , as defined in 21 C.F.R. § 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the
exception of publicly available reports on the Vaccine Adverse Events Reporting System. Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 2 of 9 PageID 22Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 2 of 9 PageID 22
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Expedited Processing Requested
PHMPT request s expedited processing for this request. FOIA provides for “expedited
processing of requests for records” upon a showing of “compelling need.” 5 U.S.C.
§ 552(a)(6)(E)(i)(II). When the person requesting information is “primarily engaged in
disseminating information, urgency to inform the public concerning actual or alleged Federal Government activity” constitutes a “compelling need” for expedited processing. 5 U.S.C. § 552(a)(6) (E)(v)(II).
PHMPT is an organization made up of public health professionals, medical professionals,
scientists , and journalists . PHMPT exists for the sole purpose of disseminating to the public the
data and information in the biological product files f or each of the COVID -19 vaccines. PHMPT
intends to make any records produced in response to this FOIA r equest immediately available to
the public through both its website and its individual members’ platforms. Many of PHMPT’s
individual members , including all its members that are journalists, are primarily engaged in
disseminat ing information to the public and do so across various platforms, including through
interviews,
3 articles ,4 blog s,5 essays,6 and podcasts .7 Therefore, PHMPT and many of its
members are “primarily engaged in disseminating information to the general public ,” and, a s
explained below, there is a clear “urgency to inform the public concerning actual or alleged Federal
Government activity,” here, the data and information underlying the licensure of the Pfizer
Vaccine. Accordingly, expedited processing of this request is warranted.
3 See, e.g. , https:// www.foxnews.com/transcript/ingraham -angle -on-mask -mandates -bidens -failure -in-his-role
(Harvey Risch) (last visited 8/26/2021)
4 See, e.g. , https://www.bmj.com/content/373/bmj.n1244 (Peter Doshi) (last visited 8/2 7/2021); https://www. bmj.com
/content/ 371/bmj.m4058 (Peter Doshi) (last visited 8/2 7/2021); https://www.bmj.com/content/371/bmj. m4037 (Peter
Doshi) (last visited 8/2 7/2021); https:// www.wsj.com/articles/are -covid- vaccines -riskier -than-advertised -11624
381749 (last visited 8/25/2021); https://www.w sj.com/articles/university -vaccine -mandates -violate -medical -ethics -
11623689220 (Aaron Kheriaty and Gerard V. Bradley ) (last visited 8/2 7/2021);
https://thefederalist.com/2021/07/05/how -college -covid- vaccine- mandates -put-students -in-danger/ (Andrew Bostom,
Aaron Kheriaty, Peter A. McCullough, Harvey A. Rish, Michelle Cretella, and Gerard V. Bradley ) (last visited
8/27/2021) ; https://thefederalist.com/2021/08/18/why -forcing -unvaccinated -students -to-wear -cloth -masks -is-anti-
science/ (Andrew Bostom, Gerard Bradley, Aaron Kheriaty, and Harvey Risch) (last visited 8/2 7/2021) ;
https://www.bmj.com/content/bmj/374/bmj.n1737.full.pdf (Seren a Tinari and Catherine Riva) (last visited
8/27/2021) ; https://www.bmj.com/content/372/bmj.n627 (Serena Tinari) (last visited 8/27/2021);
https://ebm.bmj.com/content/early/2021/08/08/bmjebm -2021- 111735 (Sarah Tanveer, Anisa Rowhani -Farid,
Kyungwan Hong, Tom Jefferson, Peter Doshi) (last visited 8/27/2021); https://www.arcdigital.media/p/medical -
ethicist -sues-the-university (Justin Lee) (last visited 8/27/2021).
5 See, e.g. , https://blogs.bmj.com/bmj/2021/08/2 3/does -the-fda-think -these -data-justify -the-first-full-approval- of-a-
covid- 19-vaccine/ (Peter Doshi) (last visited 8/2 7/2021); https://blogs.bm j.com/bmj/2020/11/26/peter -doshi -pfizer -
and-modernas -95-effective -vaccines -lets-be-cautio us-and-first-see-the-full-data/ (Peter Doshi) (last visited
8/27/2021). See also https://www.re -check.ch/wordpress/en/covid -certificate/ (Catherine Riva and Serena Tinari) (last
visite d 8/27/2021).
6 See https://www.andrewbostom.org/2021/06/why -collegiate -covid- 19-vaccine- mandates -are-lysenkoist -anti-
science/ (Andr ew Bostom) (last visited 8/2 7/2021).
7 See, e.g. , https://www.a ndrewbostom.org/2021/05/dr -andrew -bostom -discusses -the-unfavorable -risk-benefit -ratio-
of-covid- 19-vaccination -of-very-low-covid -19-risk-12-to-17-year-olds-with-pfizers -emergency -use-authorization -
only- mrna -vaccine/ (Andrew Bostom) (last visited 8/2 7/2021) . Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 3 of 9 PageID 23Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 3 of 9 PageID 23
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Recognizing the urgency to inform the public concerning the data and information
underlying a licensed vaccine , the Code of Federal Regulations expressly provides that “[a]fter a
license has been issued, the following data and information in the biological product file are
immediately available for public disclosure unless extraordinary circumstances are shown : (1) All
safety and effectiveness data and information…” 21 C.F.R. § 601.51(e) (emphasis added) . The
FDA’s own regulations thus expressly recognize the importance of having the data and information
relied upon to license a vaccine “immediately available for public disclosure.” Id. The FDA’s
regulation not only supports the need for expedited treatment under FOIA but is also an
independent legal basis that requires expedited treatment of this request.
This policy is not surprising given the FDA’s commitment to transparency and its entire
program to assure transparency , because a lack of transparency erodes the confidence the medical
and sci entific community and the public have in the conclusions reached by the FDA .8 There is
an urgent public need for such transparency with regard t o the Pfizer Vaccine. As required by
Congress, the FDA may only license vaccines that have been proven to be “safe and effective ,”
see, e.g., 21 U.S.C. § 393, and the FDA makes this determination based on, inter alia , clinical trial
reports provided by the sponsor which must be sufficient to demonstrate the product is both “safe”
and “effective.”9 21 C.F.R. 601.2(a). On August 23, 2021, the FDA granted approval to the Pfizer
Vaccine10 and, beyond the FDA’s own regulations which admit the urgen t need for transparency
and disclosure in this situation, there are two additional reasons that warrant expedited treatment
of this request.
First, there is a n ongoing, public national debate regarding the adequacy of the data and
information, and analyses of same, relied upon by the FDA to license the Pfizer Vaccine. On the
one hand, t here are numerous public health officials, media outlets, journalists, scientists,
politicians , public figures, and others with large social or media platforms that have declared that
the data and information underlying the licensure of the Pfizer Vaccine is more than sufficient for
licensure. For example, i n a press release issued on August 23, 2021, a cting FDA Commissioner
Janet Woodcock stated that “the p ublic can be very confident that [the Pfizer Vaccine] meets the
high standards for safety, effectiveness, and manufacturing quality the FDA requires of an
approved product.”11 Peter Marks, the director of FDA’s Center for Biologics Evaluation and
Research , made similar remarks, stating that
[The FDA’s] scientific and medical experts conducted an incredibly
thorough and thoughtful evaluation of [ the Pfizer Vaccine]. We
8 https://www.fda.gov/about -fda/transparency (last visited 8/27/2021).
9 The FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years”
(https://www.fda.gov/patients/drug -development -process/step -3-clinical -research ) and the duration of clinical trials
should “reflect the product and targe t condition.” https://www.fda.gov/media/102332/download (last visited
8/27/2021) . See also https://www.fda.gov/c onsumers/consumer -updates/it -really -fda-approved (last visited
8/27/2021) ; https://www.fda.gov/about -fda/what -we-do (last visited 8/2 7/2021).
10 See https://www.fda.gov/news -events/press -announcements/fda -approves -first-covid- 19-vaccine (last visited
8/27/2021). See also https://www.cnn.com/2021/08/23/health/fda -approval -pfizer -covid- vaccine/index.html (last
visited 8/2 7/2021). The Washington Post claims that approval of the Pfizer Vaccine was the “fastest in the agency’s
history.” https://www.washingtonpost.com/health/2021/08/23/pfizer -vaccine- full-approval/ (last visited 8/2 7/2021).
11 https://www.fda.gov/news -events/press -announcements/fda -approves -first-covid- 19-vaccine (last visited
8/27/2021). Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 4 of 9 PageID 24Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 4 of 9 PageID 24
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evaluated scientific data and information included in hundreds of
thousands of pages, conducted our own analyses of [the Pfizer
Vaccine’s] safety and effectiveness, and performed a detailed
assessment of the manufacturing processes, including inspections of
the manufacturing facilities[.]12
Peter Marks further stated that “although [the FDA] approved [the Pfizer Vaccine] expeditiously,
it was fully in keeping with [the FDA’s] existing high standards for vaccines in the U.S.”13
President Biden also stated that the FDA’s approval meets the “gold standard.”14 Even prior to
FDA approval of the Pfizer Vaccine, government officials, public health authorities, and medical
professionals repeatedly claimed that COVID -19 vaccines are “safe and effective.”15
On the other hand, numerous public health officials, media outlets, journalis ts, scientists,
politicians, public figures, and others with large social or media platforms have publicly raised
questions regarding the sufficiency of the data and information, the adequacy of the review, and
appropriateness of the analyses relied upon t o license the Pfizer Vaccine, including a number of
the scientists and journalists that are members of PHMPT . For example, on June 1, 2021, a group
of 27 clinicians, scientists, and patient advocates, including PHMPT members Peter Doshi, senior
editor for The BMJ and associate professor of pharmaceutical health services research at the
University of Maryland School of Pharmacy,16 and Peter A. McCullough, professor of medicine
at Texas A&M College of Medicine, filed a Citizen Petition17 with the FDA, claiming that the
available evidence for licensure of the Pfizer Vaccine “is simply not mature enough at this point
to adequately judge whether clinical benefits outweigh the risks in all populations.”18 Separately,
Peter Doshi has publicly questioned the lack of transparency regarding the vaccine approval
process19 which Peter Marks publicly disputed.20 Andrew Kheriaty, professor of psychiatry at UCI
12 Id.
13 Id.
14 https://www.cbsnews.com/news/biden -address -covid- 19-vaccine- pfizer -fda-approval- watch -live-stream -today -
2021 -08-23/ (last visited 8/27/2021) .
15 See, e.g. , https://www.cdc.gov/coronavirus/2019 -ncov/vaccines/safety/safety -of-vaccin es.html#:~:text=COVID%
2D19%20vaccines%20are%20safe,vaccine%20as%20soon%20as%20possible. (last visited 8/2 7/2021). See also
https://www.who.i nt/news -room/feature -stories/detail/vaccine -efficacy -effectiveness -and-protection (“COVID -19
vaccines have proven to be safe, effective and life- saving.”) (last visited 8/2 7/2021); https://www.
doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectiveness (“COVID -19 vaccines are safe”)
(last visited 8/2 7/2021); https://www.wlns.com/news/gov -whitmer -and-dr-khaldun -respond -to-the-fda-approval- of-
pfizers -covid- 19-vaccine/ (quoting Governor Whitmer referring to the Pfizer Vaccine as a “safe, effective COVID -19
vaccine”) (last v isited 8/2 7/2021).
16 https://www.bmj.com/about -bmj/editorial -staff/peter -doshi (last visited 8/2 7/2021).
17 https://www.regulations.gov/document/FDA -2021 -P-0521 -0001 (last visited 8/2 7/2021).
18 See https://blogs.bmj.com/bmj/2021/06/08/why -we-petitioned -the-fda-to-refrain -from -fully -approving -any-covid-
19-vaccine- this-year/ (last visited 8/2 7/2021).
19 See https://blogs.bmj.com/bmj/2021/08/23/does -the-fda-think -these -data-justify -the-first-full-approval- of-a-covid -
19-vaccine/ (last visited 8/2 7/2021); https://blogs.bmj.com/bmj/2021/01/04/peter -doshi- pfizer -and-modernas -95-
effective -vaccines -we-need -more -detail s-and-the-raw-data/ (last visited 8/2 7/2021); https://blogs.bmj.com /bmj/2020/
11/26/peter -doshi- pfizer-and-modernas -95-effective -vaccines -lets-be-cautious -and-first-see-the-full-data/ (last
visited 8/27/2021).
20 https://www.statnews.com/ 2020/12/17/did -the-fda-understaff -its-review -of-the-pfizer -biontech -vaccine/ (last
visited 8/2 7/2021). Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 5 of 9 PageID 25Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 5 of 9 PageID 25
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School of Medicine, Director of the Medical Ethics Program at UCI Health,21 and a member of
PHMPT, has also questioned the FDA’s approval process. For example, in an article published in
the Wall Street Journal, Dr. Kheriaty questioned the need for student vaccination requirements
based on, among other things, a review22 by the FDA’s Vaccines an d Related Biological Products
Advisory Committee that indicates a risk of heart inflammation after vaccination.23 Government
officials have raised similar concerns about the lack of transparency in the review process , arguing
that it is “essential” for the FDA to, among other things, “ make the data generated by clinical trials
and supporting documents submitted to the FDA by developers available to the public[.]”24
PHMPT incorporated by reference, as if cited and fully set forth herein, any and all articles, media,
and publications regarding or reflecting the public discussion, discourse and debate regarding the
Pfizer Vaccine, including all matters related to the licensure of this product.
Given this widespread and ongoing public debate, t he medical and scientific community
and the public has an immediate need to review the data and information underlying the licensure
of the Pfizer Vaccine . Public disclosure of this information will inform this ongoing public debate .
Releasing this data should also confirm the FDA’s conclusion and thus increase confidence in the
safety and efficacy of the Pfizer Vaccine. The FDA should produce the data and information
necessary t o address this widespread public debate by immediately producing the information
requested in this FOIA request.
There is also an urgent need for the public to have immediate access to the data and
information underlying the licensure of the Pfizer Vaccine because, over the objection s of many,
this product is being mandated to individuals across the country by the federal government,25 local
21 https://www.aaronkheriaty.com/bio (last visited 8/2 7/2021).
22 https://www.fda.gov/media/150054/download (last visited 8/2 7/2021).
23 https://www.wsj.com/ar ticles/university -vaccine- mandates -violate -medical -ethics -11623689220 (last visited
8/27/2021).
24https://w ww.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process_.pdf (last visited 8/2 7/2021). See also https://www.washingtontimes. com/
news/2021/aug/23/editorial -the-coincidental -timing -of-pfizers -vacci/ (last visited 8/2 7/2021).
25 See, e.g ., https://www.natlawreview.com/article/covid -19-vaccine- added -to-requirements -green -card-processing -
effective -oct-1 (last vis ited 8/27/2021); https://apnews.com/article/business -health -coronavirus -pandemic -
coronavirus -vaccine- 4cf7451267919302de4a7b591508e80c (last visited 8/27/2021); https://www.forbes.com/
sites/joewalsh/2021/08/09/us -military -will-require -covid- vaccinations -by-mid-september/?sh=78defacd6c9f (last
visited 8/27/2021) ; https://www.whitehouse.gov/briefing -room/sta tements -releases/2021/07/29/fact -sheet -president -
biden- to-announce -new-actions -to-get-more -americans -vaccinated -and-slow -the-spread -of-the-delta -variant/ (last
visited 8/27/2021) . Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 6 of 9 PageID 26Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 6 of 9 PageID 26
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governments , 26 public and private employers ,27 universities , 28 schools ,29 and various other
institutions ,30 and many are expected to follow suit .31 At the federal level, legislation was recently
introduced that would require COVID -19 vaccines for air travel in to or out of the United States32
and the Pentagon has mandated the COVID- 19 vaccines for all military personnel.33 At the state
26 See, e.g. , https://www.cnn.com/2021/08/12/us/san -francisco -vaccine- requirement/index.html (last visited
8/27/2021); https ://www1.nyc.gov/site/doh/covid/covid -19-vaccines -keytonyc.page (last visited 8/2 7/2021); https://
news.ya hoo.com/orleans -now- requires -proof -vaccination -230433492.html (last visited 8/2 7/2021).
27 See, e.g. , https://www.cnbc.com/2021/08/06/united -airlines -vaccine- mand ate-employees.html (last visited
8/27/2021); https://sanfrancisco.cbslocal.com/2021/08/02/covid -kaiser -permanente -makes -vaccination -mandatory -
for-all-employees/ (last visited 8/2 7/2021); https://abcnews.go.com/Health/wireStory/walmart -mandates -vaccines -
workers -headquarters -79177220 (last visited 8/2 7/2021); https://www.kpbs.org/news/2021/aug/17/encinitas -covid-
19-vaccine- negative -test-employees/ (last visited 8/2 7/2021); https://www.cnbc.com/2021/08/09/covid- vaccine -
mandates -sweep -across -corporate -america- as-delta -surges.html (last visited 8/2 7/2021); https://www.reuters .com
/business/energy/chevron -begins -covid- 19-vaccination -mandates -wsj-2021- 08-23/ (last visited 8/2 7/2021); https://
thehill.com/policy/healthcare/569051 -pfizers -full-approval- triggers -new-vaccine- mandates (last visited 8/2 7/2021);
https://cvshealth.com/news -and-insights/statements/cvs -health -will-require -covid- 19-vaccinations -for-clinical -and-
corporate- employees (last visited 8/2 7/2021).
28 See https://universitybusiness.com/state -by-state-look-at-colleges -requiring -vaccines/ (last visited 8/2 7/2021). See
also, e.g. , https://www.nbcnews.com/health/health -news/colleges -universities -covid- vaccination -mandates -facing -
pushback- n1273916 (last visited 8/2 7/2021); https://www.colorado.edu/covid -19-updates/covid -19-vaccination (last
visited 8/2 7/2021); https://uhs.berkeley.edu/req uirements/covid19 (last visited 8/2 7/2021); https://huhs. harvard
.edu/covid- 19-vaccine -requirement -faqs (last visited 8/2 7/2021); https://www2.gmu.edu/safe -return -campus
/vaccination -requirements (last visited 8/2 7/2021); https://www.pc.pitt.edu/news /vaccine- disclosure -requirements -
2021 -2022 -campus -housing (last visited 8/2 7/2021)
29 See, e.g. , https://www.npr.org/sections/back -to-school -live-updates/2021/08/20/1029837338/a -california -school-
district -mandates -vaccines -for-eligible -students (last visited 8/2 7/2021); https://patch.com/massachusetts /salem
/salem -school- committee -approves -vaccine- mandate- sports- band (last visited 8/2 7/2021); https://www.nbcnewyork
.com /news/coronavirus/nyc -will-require -vaccination -for-high- risk-school -sports/3232745/ (last visited 8/2 7/2021);
https://www.nj.com/hudson/2021/08/hoboken- believed -to-be-first-in-state-to-issue -mandate -for-students -12-and-up-
get-vaccine -or-face- weekly -testing.html (last visited 8/27/2021); https://www. mercury news .com /2021/08/19/la -
county -school -district -mandates -covid- vaccines -for-k12-kids-others -soon- may-follow/ (last visited 8/27/2021) .
30 See, e.g. , https://www.reuters.com/world/us/new -york-city-mandates -covid- 19-vaccine- public -school- teachers -
staff-mayor -2021 -08-23/ (last visit ed 8/2 7/2021); https://www.cbsnews.com/news/california -covid- vaccine- teachers -
mandate/ (last visited 8/2 7/2021); https://www.nytimes.com/2021/08/18/us/washington -state-teacher -vaccine-
mandate.html (last visited 8/2 7/2021); https://www.governor.ny.gov/news/governor -cuomo -announces -covid- 19-
vaccination -mandate -healthcare- workers (last visited 8/2 7/2021); https://www.cdph.ca.gov /Programs/CID/DCDC
/Pages/ COVID -19/FAQ -Health -Care -Worker- Vaccine- Requirement.aspx (last visited 8/2 7/2021); https://www.
nytimes. com/2021/08/09/us/washington -state-workers -vaccine- mandate.html (last visited 8/2 7/2021); https://www.
denvergov.org/Government/COVID -19-Information/Public -Health -Orders -Response/News -Updates/2021/Mayor -
Hancock -Announces -COVID -19-Vaccine- Requirement -for-Employees (last visited 8/2 7/2021); See https:// www.
bostonherald.com/ 2021/08/19/baker -issues -vaccine- mandate -for-42000- state-employees/ (last visited 8/2 7/2021).
31 See https://www.mississippifreepress.o rg/15126/fda -fully -approves -pfizer -biontech -vaccine- mandates -to-follow/
(last visited 8/2 7/2021) ; https://www.huffpost.com/entry/vaccine -mandates -roll-out-fda-approval_n_6123 e028e 4b0
df3eacd5d657 (last visited 8/2 7/2021) ; https://www.theadvocate.com /baton_rouge/ news/coronavirus /article _9be6
d02c -0434- 11ec -b7b1- cb17d8495274 .html? utm_medium=social&utm_source =twitternoladotcom&utm_ campaign =
snd (last visited 8/2 7/2021). See also https://www.latimes.com/california/story/2021 -08-26/california -lawmakers -
grapple -with-statewide -covid -19-vaccine- mandate (last visited 8/27/2021).
32 https://www.congress.gov/bill/117th -congress/house -bill/4980?q=%7B%22search%22:%5b%224980%252 (last
visited 8/23/2021).
33 https://thehill.com/policy/defense/568996 -pentagon -to-mandate- covid -19-vaccine -for-military (last visited
8/23/2021). Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 7 of 9 PageID 27Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 7 of 9 PageID 27
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level, legislation has been introduced to require COVID- 19 vaccines for all post -secondary
students ,34 all state employees, 35 and even for all citizens of the state.36 As explained by Dr.
Anthony Fauci , “a flood” of vaccine mandates will follow FDA approval of a COVID -19 vaccine37
and President Biden is actively encouraging “companies in the private sector to step up the vaccine
requirements[.]”38 During a time when COVID- 19 vaccine mandates are being implemented over
the objection of those that have questions about the data and information supporting the safety and
efficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from
employment , school, transportation, and the military, the public has an urgent and immediate need
to have access to this data. PHMPT incorporate s by reference, as if cited and fully set forth herein,
any and all articles, media, and publications regarding or reflec ting the public discussion, discourse
and debate regarding mandated or potential mandates of the Pfizer Vaccine.
PHMPT certif ies that the information in this request is true and correct to the best of its
knowledge and belief.
PHMPT is a nonprofit and asks that you waive any and all fees or charges pursuant to 5
U.S.C. § 552(a)(4)(A)(iii) on the basis that “disclosure of the [requested] information is in the
public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government[.]” Specifically, disclosure of the requested information
will immediately address the ongoing public debate about the safety and efficacy of the Pfizer
Vaccine and the clinical trials underlying the FDA’s approval of same. The information PHMPT
request s will not contribute to any commercial activities.
Note that if only portions of a requested file are exempted from release, the remainder must
still be released . We therefore request that we be provided with all non- exempt portions which are
reasonably segregable or can be deidentified . We further request that you describe any redacted,
deleted , or withheld material in detail and specify the statutory basis for the denial as well as your
reasons for believing that the alleged statutory justification applies. Please also separately state
your reasons for not invoking your discretionary powers to release the requested documents in the
34 See New York bill S6495 available at https://www.nysenate.gov/legislation/bills/ 2021/S6495 (last visited
8/27/2021).
35 See, e.g. , https://www.nj.com/coronavirus/2021/08/murphy- orders -vaccination -requirement -for-all-nj-state-
workers -including- at-public -colleges.html (last visited 8/2 7/2021).
36 See New York bill A11179 available at https://www.nysenate.gov/legislation/bills/2019/A11179 . See generally
https://eastcountytoday.net/buffy -wicks -transportation -bill-could -become -california -vaccine- passport -bill/ (last
visited 8/27/2021).
37 https://www.usatoday.com/story/news/health/2021/08/06/anthony- fauci -covid- vaccine -mandates -fda-full-approv
al/5513121001/ (last visited 8/2 7/2021).
38 https:// www.msn.com/en -us/news/us/biden -urges -private -companies -to-implement -covid- 19-vaccine- require
ments -following -pfizer -e2-80-99s-fda-approval/ar -AANEcYs?ocid=uxbndlbing (last visited 8/2 7/2021). See also
https://www.nytimes.com/2021/08/23/us/pfizer -vaccine -mandates.html (noting that FDA approval of the Pfizer
Vaccine “is opening the way for institutions like the military, corporate employers, hospitals and school districts to
announce vaccine mandates for their employees”) (last visited 8/23/2021); https://www.msn.com/en -us/news/us/now -
that-a-covid- 19-shot-is-fully -approved- empl oyer-mandates -are-rolling -in-but-will-vaccination -rates -in-the-us-go-up
/ar-AANGDTy?ocid=uxbndlbing (last visited 8/23/2021); https://news.yahoo.com/surgeon -general -vivek-murthy -
says-205530053.html (quoting the Surgeon General referring to vaccine mandates as “reasonable”) (last visited
8/23/2021). Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 8 of 9 PageID 28Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 8 of 9 PageID 28
Page 8 of 8
public interest. Such statements may help to avoid unnecessary appeal and litigation. PHMPT
reserves all rights to appeal the withholding or deletion of any information.
A determination regarding expedite d processing should be made within ten (10) days.
Access to the requested records should be granted within twenty (20) business days from the date
of your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial of this r equest and PHMPT may immediately file an administrative appeal or an action .
If you would like to discuss our requests or any issues raised in this letter, please feel free
to contact Aaron Siri at (212) 532- 1091 or [email protected]
during normal business hours. Thank
you for your time and a ttention to this matter.
Very truly yours,
/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth Brehm, Esq.
Gabrielle G. Palmer, Esq. Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 9 of 9 PageID 29Case 4:21-cv-01058-P Document 1-1 Filed 09/16/21 Page 9 of 9 PageID 29
Exhibit A.2 Case 4:21-cv-01058-P Document 1-2 Filed 09/16/21 Page 1 of 2 PageID 30Case 4:21-cv-01058-P Document 1-2 Filed 09/16/21 Page 1 of 2 PageID 30
/0 /1 /2 /3 /1 /2 /4 /2 /5/6 /7 /8 /i255 /6 /10/11 /8 /i255 /12 /13 /14 /15 /13 /16 /17 /i255 /18 /19 /20 /21 /22 /23 /24/25 /17 /22 /19 /20
/26 /17 /17 /27 /16 /28 /1 /1 /29 /29 /29 /30 /25 /31 /31 /13 /16 /16 /32 /25 /17 /25 /30 /21 /32 /25 /30 /33 /19 /34 /1 /16 /31 /23 /22 /27 /17 /16 /1 /21 /19 /22 /1 /6 /10/11 /12 /13 /14 /15 /13 /16 /17 /1 /27 /23 /19 /31 /13 /16 /16 /35 /23 /13 /14 /15 /13 /16 /17 /30 /31 /21 /24 /5 /1 /5
/36 /37/38 /39 /i255 /41 /42 /43 /44 /42 /45 /46 /i255 /47 /48 /49 /50 /51 /52 /53/54 /46 /51 /48 /49
/41 /42 /43 /44 /42 /45 /46 /42 /52 /55
/56/42 /49 /42 /52 /54 /57
/7 /13 /16 /31 /23 /22 /27 /17 /22 /19 /20 /i255 /19 /21
/12 /13 /14 /15 /13 /16 /17 /13 /23 /28/i255 /59/60 /61 /62 /63 /64/65 /66
/67/25 /68 /i255 /8 /24 /19 /15 /20 /17 /i255 /69/22 /70 /70 /22 /20 /33 /i255 /17 /19
/71 /25 /72 /28/i255 /73 /74 /75 /76 /77 /77
/37/52 /78 /54 /49 /51 /79 /54 /46 /51 /48 /49
/10/23 /33 /25 /20 /22 /80 /25 /17 /22 /19 /20
/81 /25 /24/13 /28/i255 /82 /63 /83 /84 /85 /86 /i255 /88/65 /89 /84 /90 /91 /i255 /89 /61 /92 /i255 /93/65 /92 /85 /86 /89 /84 /i255 /82 /66 /60 /94 /65 /62 /62 /85 /60 /61 /89 /84 /62 /i255 /94 /60 /66 /i255 /95 /66 /89 /61 /62 /96 /89 /66 /65 /61 /86 /97
/71 /23 /22 /24/25 /23 /72 /i255 /71 /26 /19 /20 /13 /28 /i255 /74 /98 /74 /99 /75 /100 /74 /99 /98 /77 /101 /98 /10/17 /26 /13 /23 /i255 /71 /26 /19 /20 /13 /28 /i255 /102 /24/25 /22 /70 /28 /i255 /94 /60 /85 /89 /103 /62 /85 /66 /85 /84 /84 /96 /76 /86 /60 /64
/104/54 /51 /57 /51 /49 /78 /i255 /39 /105 /105 /52 /42 /45 /45
/8 /32 /32 /23 /13 /16 /16 /i255 /5 /28 /i255 /74 /77 /77 /i255 /82 /89 /66 /106 /i255 /107/108 /65 /61 /63 /65
/8 /32 /32 /23 /13 /16 /16 /i255 /2 /28 /i255 /98 /109 /90 /91 /i255 /110 /84 /60 /60 /66
/18 /22 /17 /72 /28 /i255 /111/65 /112/i255 /113 /60 /66 /106
/114 /17 /25 /17 /13 /28 /i255 /111/113
/115 /22 /27 /i255 /18 /19 /32 /13 /28 /i255 /98 /77 /98 /116 /116/117 /51 /57 /57 /51 /49 /78 /i255 /39 /105 /105 /52 /42 /45 /45
/8 /32 /32 /23 /13 /16 /16 /i255 /5 /28 /i255 /74 /77 /77 /i255 /82 /89 /66 /106 /i255 /107/108 /65 /61 /63 /65
/8 /32 /32 /23 /13 /16 /16 /i255 /2 /28 /i255 /98 /109 /90 /91 /i255 /110 /84 /60 /60 /66
/18 /22 /17 /72 /28 /i255 /111/65 /112/i255 /113 /60 /66 /106
/114 /17 /25 /17 /13 /28 /i255 /111/113
/115 /22 /27 /i255 /18 /19 /32 /13 /28 /i255 /98 /77 /98 /116 /116
/118 /42 /46 /54 /51 /57 /45
/12 /13 /14 /15 /13 /16 /17 /13 /23 /i255 /81 /25 /24/13 /28 /i255 /107/89 /66 /60 /61 /i255 /119 /85 /66 /85
/12 /13 /14 /15 /13 /16 /17 /13 /23 /i255 /6 /22 /70 /13 /i255 /120 /28 /i255 /121 /122/123 /77 /75 /124 /116 /12 /13 /14 /15 /13 /16 /17 /i255 /125 /13 /17 /17 /13 /23 /28/i255 /121 /122/123 /77 /75 /124 /116 /i255 /99 /i255 /110 /126 /107/i255 /99 /i255 /82 /94 /85 /127 /65 /66
/107/96 /96 /66 /60 /108 /89 /84 /i255 /110 /121 /111/107 /128 /76 /96 /92 /94
/12 /13 /14 /15 /13 /16 /17 /13 /32 /i255 /7 /25 /17 /13 /i255 /6 /23 /19 /24/28 /i255 /12 /13 /14 /15 /13 /16 /17 /13 /32 /i255 /7 /25 /17 /13 /i255 /129 /19 /28 /i255
/114 /15 /130 /131 /13 /31 /17 /i255 /19 /21 /i255 /12 /13 /14 /15 /13 /16 /17 /28
/132/54 /51 /133 /42 /52 /i255 /48 /50 /i255 /36 /42 /42 /45
/134 /15 /16 /17 /22 /21 /22 /31 /25 /17 /22 /19 /20 /28/i255 /82 /88/93 /82 /95 /i255 /85 /62 /i255 /89 /i255 /61 /60 /61 /96 /66 /60 /94 /85 /90 /76 /i255 /95/91 /65 /i255 /85 /61 /94 /60 /66 /64/89 /90 /85 /60 /61 /i255 /85 /90 /i255 /62 /65 /65 /106 /62 /i255 /112/85 /84 /84 /i255 /86 /60 /61 /90 /66 /85 /83 /63 /90 /65 /i255 /90 /60 /i255 /90 /91 /65 /i255 /96 /63 /83 /84 /85 /86 /i255 /92 /65 /83 /89 /90 /65
/89 /83 /60 /63 /90 /i255 /90 /91 /65 /i255 /62 /89 /94 /65 /90 /97 /i255 /89 /61 /92 /i255 /65 /94 /94 /85 /86 /89 /86 /97 /i255 /60 /94 /i255 /90 /91 /65 /i255 /82 /94 /85 /127 /65 /66 /i255 /108 /89 /86 /86 /85 /61 /65 /76 /i255 /119 /65 /65 /i255 /84 /65 /90 /90 /65 /66 /i255 /94 /60 /66 /i255 /94 /63 /66 /90 /91 /65 /66 /i255 /92 /65 /90 /89 /85 /84 /62 /76
/135 /136 /137 /42 /105 /51 /46 /42 /105 /i255 /138 /52 /48 /139 /42 /45 /45 /51 /49 /78
/12 /13 /25 /16 /19 /20 /28 /i255 /126/65 /64/60 /61 /62 /90 /66 /89 /90 /65 /92 /i255 /140/66 /141 /65 /61 /86 /97 /i255 /90 /60 /i255 /121 /61 /94 /60 /66 /64/i255 /90 /91 /65 /i255 /82 /63 /83 /84 /85 /86
/134 /15 /16 /17 /22 /21 /22 /31 /25 /17 /22 /19 /20 /28/i255 /82 /88/93 /82 /95 /i255 /92 /85 /62 /62 /65 /64/85 /61 /89 /90 /65 /62 /i255 /85 /61 /94 /60 /66 /64/89 /90 /85 /60 /61 /i255 /90 /60 /i255 /90 /91 /65 /i255 /96 /63 /83 /84 /85 /86 /76 /i255 /95/91 /65 /66 /65 /i255 /85 /62 /i255 /89 /61 /i255 /85 /64/64/65 /92 /85 /89 /90 /65 /i255 /61 /65 /65 /92 /i255 /90 /60 /i255 /85 /61 /94 /60 /66 /64
/90 /91 /65 /i255 /96 /63 /83 /84 /85 /86 /i255 /60 /94 /i255 /90 /91 /65 /i255 /92 /89 /90 /89 /i255 /89 /61 /92 /i255 /85 /61 /94 /60 /66 /64/89 /90 /85 /60 /61 /i255 /63 /61 /92 /65 /66 /84 /97 /85 /61 /141 /i255 /84 /85 /86 /65 /61 /62 /63 /66 /65 /i255 /60 /94 /i255 /90 /91 /65 /i255 /82 /94 /85 /127 /65 /66 /i255 /142 /89 /86 /86 /85 /61 /65 /76 /i255 /119 /65 /65
/84 /65 /90 /90 /65 /66 /i255 /94 /60 /66 /i255 /94 /63 /66 /90 /91 /65 /66 /i255 /92 /65 /90 /89 /85 /84 /62 /76
/138 /52 /51 /49 /46 /i255 /i255 /i255 /47 /52 /42 /54 /46 /42 /i255 /39 /49 /48 /46 /143 /42 /52 /i255 /41 /42 /43 /44 /42 /45 /46 /i255 /i255 /i255 /47 /57 /48 /45 /42
/69/22 /17 /26 /22 /20 /i255 /5 /4 /i255 /130 /15 /16 /22 /20 /13 /16 /16 /i255 /32 /25 /72 /16 /i255 /19 /21 /i255 /17 /26 /13 /i255 /16 /15 /130 /24/22 /16 /16 /22 /19 /20 /i255 /19 /21 /i255 /72 /19 /15 /23 /i255 /19 /20 /70 /22 /20 /13 /i255 /23 /13 /14 /15 /13 /16 /17 /144 /i255 /72 /19 /15 /i255 /29 /22 /70 /70 /i255 /23 /13 /31 /13 /22 /34 /13 /i255 /130 /72 /i255 /13 /70 /13 /31 /17 /23 /19 /20 /22 /31 /i255 /24/25 /22 /70 /i255 /25 /20 /i255 /6 /10/11 /8 /i255 /18 /19 /20 /17 /23 /19 /70
/81 /15 /24/130 /13 /23 /30 /i255 /11 /21 /i255 /72 /19 /15 /i255 /20 /13 /13 /32 /i255 /17 /19 /i255 /31 /19 /24/24/15 /20 /22 /31 /25 /17 /13 /i255 /29 /22 /17 /26 /i255 /6 /7 /8 /i255 /23 /13 /33 /25 /23 /32 /22 /20 /33 /i255 /72 /19 /15 /23 /i255 /23 /13 /14 /15 /13 /16 /17 /144 /i255 /27 /70 /13 /25 /16 /13 /i255 /23 /13 /21 /13 /23 /i255 /17 /19 /i255 /17 /26 /22 /16 /i255 /18 /19 /20 /17 /23 /19 /70 /i255 /81 /15 /24/130 /13 /23 /30 /i255 /12 /13 /14 /15 /13 /16 /17 /16
/23 /13 /31 /13 /22 /34 /13 /32 /i255 /25 /21 /17 /13 /23 /i255 /145 /28 /4 /4 /i255 /71 /30 /67/30 /i255 /102 /30 /114 /30 /129 /30 /i255 /29 /22 /70 /70 /i255 /130 /13 /i255 /31 /19 /20 /16 /22 /32 /13 /23 /13 /32 /i255 /17 /19 /i255 /26 /25 /34 /13 /i255 /130 /13 /13 /20 /i255 /23 /13 /31 /13 /22 /34 /13 /32 /i255 /19 /20 /i255 /17 /26 /13 /i255 /21 /19 /70 /70 /19 /29 /22 /20 /33 /i255 /130 /15 /16 /22 /20 /13 /16 /16 /i255 /32 /25 /72 /30
/11 /21 /i255 /72 /19 /15 /23 /i255 /22 /20 /21 /19 /23 /24 /25 /17 /22 /19 /20 /25 /70 /i255 /20 /13 /13 /32 /16 /i255 /31 /26 /25 /20 /33 /13 /144 /i255 /25 /20 /32 /i255 /72 /19 /15 /i255 /20 /13 /13 /32 /i255 /17 /19 /i255 /31 /25 /20 /31 /13 /70 /i255 /72 /19 /15 /23 /i255 /23 /13 /14 /15 /13 /16 /17 /144 /i255 /27 /70 /13 /25 /16 /13 /i255 /31 /19 /20 /17 /25 /31 /17 /i255 /17 /26 /13 /i255 /7 /22 /34 /22 /16 /22 /19 /20 /i255 /19 /21 /i255 /6 /23 /13 /13 /32 /19 /24/i255 /19 /21
/11 /20 /21 /19 /23 /24/25 /17 /22 /19 /20 /i255 /130 /72 /i255 /17 /13 /70 /13 /27 /26 /19 /20 /13 /144 /i255 /24/25 /22 /70 /144 /i255 /19 /23 /i255 /21 /25 /68 /30 /i255 /71 /70 /13 /25 /16 /13 /i255 /22 /20 /31 /70 /15 /32 /13 /i255 /72 /19 /15 /23 /i255 /31 /19 /20 /17 /23 /19 /70 /i255 /20 /15 /24/130 /13 /23 /i255 /22 /20 /i255 /17 /26 /13 /i255 /31 /19 /23 /23 /13 /16 /27 /19 /20 /32 /13 /20 /31 /13 /30 /i255 /6 /19 /23 /i255 /31 /19 /20 /17 /25 /31 /17
/22 /20 /21 /19 /23 /24/25 /17 /22 /19 /20 /144 /i255 /27 /70 /13 /25 /16 /13 /i255 /16 /13 /13 /i255 /6 /7 /8 /146 /16 /i255 /6 /10/11 /8 /i255 /27 /25 /33 /13 /30/i255 /107/84 /84 /i255 /92 /89 /90 /89 /i255 /89 /61 /92 /i255 /85 /61 /94 /60 /66 /64/89 /90 /85 /60 /61 /i255 /94 /60 /66 /i255 /90 /91 /65 /i255 /82 /94 /85 /127 /65 /66 /i255 /142 /89 /86 /86 /85 /61 /65 /i255 /65 /61 /63 /64/65 /66 /89 /90 /65 /92 /i255 /85 /61 /i255 /74 /98 /i255 /59/76 /110 /76 /122/76 /i255 /147
/116 /77 /98 /76 /75 /98 /148 /65 /149 /i255 /112/85 /90 /91 /i255 /90 /91 /65 /i255 /65 /150 /86 /65 /96 /90 /85 /60 /61 /i255 /60 /94 /i255 /96 /63 /83 /84 /85 /86 /84 /97 /i255 /89 /108 /89 /85 /84 /89 /83 /84 /65 /i255 /66 /65 /96 /60 /66 /90 /62 /i255 /60 /61 /i255 /90 /91 /65 /i255 /142 /89 /86 /86 /85 /61 /65/47 /48 /49 /50 /51 /52 /53/54 /46 /51 /48 /49 /i255 /151 /44 /53/152 /42 /52 /55 /i255 /36 /118 /39 /153 /154 /155 /156 /156 /157 /158Case 4:21-cv-01058-P Document 1-2 Filed 09/16/21 Page 2 of 2 PageID 31Case 4:21-cv-01058-P Document 1-2 Filed 09/16/21 Page 2 of 2 PageID 31
Exhibit A.3 Case 4:21-cv-01058-P Document 1-3 Filed 09/16/21 Page 1 of 2 PageID 32Case 4:21-cv-01058-P Document 1-3 Filed 09/16/21 Page 1 of 2 PageID 32
200 Park Avenue
17th Floor
New York NY 10166 USAPUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR
TRANSPARENCY
AARON SIRI Requester reference:August 31, 2021
FOIA Control #:
2021-5683In Reply refer to
Dear Requester:
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records
regarding:
All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly
available reports on the Vaccine Adverse Events Reporting System.
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs
change, and you no longer need the requested records, please contact us to cancel your request, as charges may be
incurred once processing of your request has begun. For more information on processing fees, please see
http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm.
Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-day time
limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the
complexity of your request and whether sensitive records, voluminous records, extensive search, and/or consultation
with other HHS components or other executive branch agencies are involved. Please note that requests for medical
device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process.
If you have any questions about your request, please call Claire B. Stansbury, Information Technician, at (301) 796-
8979 or write to us at:
Food and Drug Administration
Division of Freedom of Information
5630 Fishers Lane, Room 1035
Rockville, MD 20857
If you call or write, use the FOIA control number provided above which will help us to answer your questions more
quickly.
You also have the right to seek dispute resolution services from:
Office of Government Information Services and/or FDA FOIA Public Liaison
National Archives and Administration Office of the Executive Secretariat
8601 Adelphi Road – OGIS US Food Administration
College Park, MD 20740-6001 5630 Fishers Lane, Room 1050
Telephone:202-741-5770 Email: [email protected]
Toll-Free: 1-877-684-6448
Email:[email protected]
Fax: 202-741-5769
DirectorSARAH KOTLERSincerely,Case 4:21-cv-01058-P Document 1-3 Filed 09/16/21 Page 2 of 2 PageID 33Case 4:21-cv-01058-P Document 1-3 Filed 09/16/21 Page 2 of 2 PageID 33
Exhibit A.4 Case 4:21-cv-01058-P Document 1-4 Filed 09/16/21 Page 1 of 2 PageID 34Case 4:21-cv-01058-P Document 1-4 Filed 09/16/21 Page 1 of 2 PageID 34
200 Park Avenue
17th Floor
New York NY 10166 USAPUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR
TRANSPARENCY
AARON SIRI Requester reference:September 09, 2021
IR#0546FOIA Control #:
2021-5683In Reply refer to
Dear Requester:
This is in reference to your request(s) for record(s) from the Food and Drug Administration (FDA) pursuant to the
Freedom of Information Act (FOIA).
All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly
available reports on the Vaccine Adverse Events Reporting System.
The Electronic Freedom of Information Act (EFOIA) Amendments of 1996 amended the FOIA by adding section
(a)(6)(E), 5 U.S.C. 552(a)(6)(E), to require agencies to consider requests for expedited processing and grant them
whenever a "compelling need" is shown and in other cases as determined by the agency. The term "compelling need" is
defined as (1) involving "an imminent threat to the life or physical safety of an individual," or (2) in the case of a request
made by "a person primarily engaged in disseminating information, urgency to inform the public concerning actual or
alleged Federal Government activity."
I have determined that your request for expedited processing does not meet the criteria under the FOIA. You have not
demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither
have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal
Government activity. Therefore, I am denying your request for expedited processing. The responding agency office will
process your request in the order in which it was received.
You have the right to appeal this determination. By filing an appeal, you preserve your rights under FOIA and give the
agency a chance to review and reconsider your request and the agency's decision. Your appeal must be mailed within 90
days from the date of this response, to: Director, Office of the Executive Secretariat, US Food & Drug Administration,
5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: [email protected]. Please clearly mark both the
envelope and your letter "FDA Freedom of Information Act Appeal."
You may also contact the FDA FOIA Public Liaison, Office of the Executive Secretariat, 5630 Fishers Lane, Room
1050, Rockville, MD 20857; email: [email protected].
If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information
Services (OGIS), the Federal FOIA Ombudsman’s office, offers mediation services to help resolve disputes between
FOIA requesters and Federal agencies. The contact information for OGIS is: Office of Government Information
Services, National Archives and Records Administration, 8601 Adelphi Road–OGIS, College Park, MD 20740-6001,
Telephone: 202-741-5770, Toll-Free: 1-877-684-6448, E-mail: [email protected], Fax: 202-741-5769.
DirectorSARAH KOTLERSincerely,Case 4:21-cv-01058-P Document 1-4 Filed 09/16/21 Page 2 of 2 PageID 35Case 4:21-cv-01058-P Document 1-4 Filed 09/16/21 Page 2 of 2 PageID 35
JS 44 (Rev. 10/20) - TXND (10/20) CIVIL COVER SHEET
The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
I.(a) PLAINTIFFS DEFENDANTS
(b)County of Residence of First Listed Plaintiff County of Residence of First Listed Defendant
(EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY)
NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.
(c)Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known)
II. BASIS OF JURISDICTION (Place an “X” in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff
and One Box for Defendant) (For Diversity Cases Only)
1 U.S. Government 3 Federal Question PTF DEF PTF DEF
Plaintiff (U.S. Government Not a Party) Citizen of This State 1 1 Incorporated orPrincipal Place 4 4
of Business In This State
2 U.S. Government 4 Diversity Citizen of Another State 2 2 Incorporated andPrincipal Place 5 5
Defendant (Indicate Citizenship of Parties in Item III) of Business In Another State
Citizen or Subject of a 3 3 Foreign Nation 6 6
Foreign Country
IV. NATURE OF SUIT (Place an “X” in One Box Only) Click here for: Nature of Suit Code Descriptions .
CONTRACT TORTS FORFEITURE/PENALTY BANKRUPTCY OTHER STATUTES
110 Insurance PERSONAL INJURY PERSONAL INJURY 625 Drug Related Seizure 422 Appeal 28 USC 158 375 False Claims Act
120 Marine 310 Airplane 365 Personal Injury - of Property 21 USC 881 423 Withdrawal 376 Qui Tam (31 USC
130 Miller Act 315 Airplane Product Product Liability 690 Other 28 USC 157 3729(a))
140 Negotiable Instrument Liability 367 Health Care/ 400 State Reapportionment
150 Recovery of Overpayment 320 Assault, Libel & Pharmaceutical PROPERTY RIGHTS 410 Antitrust
& Enforcement of Judgment Slander Personal Injury 820 Copyrights 430 Banks and Banking
151 Medicare Act 330 Federal Employers’ Product Liability 830 Patent 450 Commerce
152 Recovery of Defaulted Liability 368 Asbestos Personal 835 Patent - Abbreviated 460 Deportation
Student Loans 340 Marine Injury Product New Drug Application 470 Racketeer Influenced and
(Excludes Veterans) 345 Marine Product Liability 840 Trademark Corrupt Organizations
153 Recovery of Overpayment Liability PERSONAL PROPERTY LABOR 880 Defend Trade Secrets 480 Consumer Credit
of Veteran’s Benefits 350 Motor Vehicle 370 Other Fraud 710 Fair Labor Standards Act of 2016 (15 USC 1681 or 1692)
160 Stockholders’ Suits 355 Motor Vehicle 371 Truth in Lending Act 485 Telephone Consumer
190 Other Contract Product Liability 380 Other Personal 720 Labor/Management SOCIAL SECURITY Protection Act
195 Contract Product Liability 360 Other Personal Property Damage Relations 861 HIA (1395ff) 490 Cable/Sat TV
196 Franchise Injury 385 Property Damage 740 Railway Labor Act 862 Black Lung (923) 850 Securities/Commodities/
362 Personal Injury - Product Liability 751 Family and Medical 863 DIWC/DIWW (405(g)) Exchange
Medical Malpractice Leave Act 864 SSID Title XVI 890 Other Statutory Actions
REAL PROPERTY CIVIL RIGHTS PRISONER PETITIONS 790 Other Labor Litigation 865 RSI (405(g)) 891 Agricultural Acts
210 Land Condemnation 440 Other Civil Rights Habeas Corpus: 791 Employee Retirement 893 Environmental Matters
220 Foreclosure 441 Voting 463 Alien Detainee Income Security Act FEDERAL TAX SUITS 895 Freedom of Information
230 Rent Lease & Ejectment 442 Employment 510 Motions to Vacate 870 Taxes (U.S. Plaintiff Act
240 Torts to Land 443 Housing/ Sentence or Defendant) 896 Arbitration
245 Tort Product Liability Accommodations 530 General 871 IRS—Third Party 899 Administrative Procedure
290 All Other Real Property 445 Amer. w/Disabilities - 535Death Penalty IMMIGRATION Act/Review or Appeal of
Employment Other: 462 Naturalization Application Agency Decision
446 Amer. w/Disabilities - 540 Mandamus & Other 465 Other Immigration 950 Constitutionality of
Other 550 Civil Rights Actions State Statutes
448 Education 555 Prison Condition
560 Civil Detainee -
Conditions of
Confinement
V. ORIGIN (Place an “X” in One Box Only)
1 Original
Proceeding 2 Removed from
State Court3 Remanded from
Appellate Court 4 Reinstated or
Reopened5 Transferred from
Another District
(specify)6 Multidistrict
Litigation -
Transfer8 Multidistrict
Litigation -
Direct File
VI. CAUSE OF ACTIONCite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity ):
Brief description of cause:
VII. REQUESTED IN
COMPLAINT:CHECK IF THIS IS A CLASS ACTION
UNDER RULE 23, F.R.Cv.P. DEMAND $ CHECK YES only if demanded in complaint:
JURY DEMAND: Yes No
VIII. RELATED CASE(S)
IF ANY(See instructions):
JUDGE DOCKET NUMBER
DATE SIGNATURE OF ATTORNEY OF RECORD
FOR OFFICE USE ONLY
RECEIPT # AMOUNT APPLYING IFP JUDGE MAG. JUDGE26 USC 7609PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR
TRANSPARENCY
Tarrant
Howie Law PC / 2608 Hibernia Street, Dallas Texas 75204
(212) 622-6340 FOOD AND DRUG ADMINISTRATION
5 U.S.C. § 552(a)(4)(B) and 28 U.S.C. § 1331
Freedom of Information Act, 5 U.S.C. § 552
Sep 16, 2021 /s John Howie
JS 44 Reverse (Rev. 10/20) - TXND (10/20)
INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
Authority For Civil Cover Sheet
The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as
required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is
required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of
Court for each civil complaint filed. The attorney filing a case should complete the form as follows:
I.(a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use
only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and then
the official, giving both name and title.
(b)County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the
time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land
condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.)
(c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting
in this section "(see attachment)".
II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X"
in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below.
United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here.
United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box.
Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment
to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes
precedence, and box 1 or 2 should be marked.
Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the
citizenship of the different parties must be checked . (See Section III below ; NOTE: federal question actions take precedence over diversity
cases.)
III. Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this
section for each principal party.
IV. Nature of Suit. Place an "X" in the appropriate box. If there are multiple nature of suit codes associated with the case, pick the nature of suit code
that is most applicable. Click here for: Nature of Suit Code Descriptions .
V. Origin. Place an "X" in one of the seven boxes.
Original Proceedings. (1) Cases which originate in the United States district courts.
Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section 1441.
Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filing
date.
Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date.
Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers or
multidistrict litigation transfers.
Multidistrict Litigation – Transfer. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C.
Section 1407.
Multidistrict Litigation – Direct File. (8) Check this box when a multidistrict case is filed in the same district as the Master MDL docket.
PLEASE NOTE THAT THERE IS NOT AN ORIGIN CODE 7. Origin Code 7 was used for historical records and is no longer relevant due to
changes in statue.
VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional
statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service.
VII. Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P.
Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction.
Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded.
VIII. Related Cases. This section of the JS 44 is used to reference related cases, if any. If a related case exists, whether pending or closed, insert the
docket numbers and the corresponding judge names for such cases. A case is related to this filing if the case: 1) involves some or all of the same
parties and is based on the same or similar claim; 2) involves the same property, transaction, or event; 3) involves substantially similar issues of
law and fact; and/or 4) involves the same estate in a bankruptcy appeal.
Date and Attorney Signature. Date and sign the civil cover sheet.