Case 4:21-cv-01058-P Document 1 Filed 09/16/21

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UNITED STATES DISTRICT COURTNORTHERN DISTRICT OF TEXASPUBLIC HEALTH AND MEDICALPROFESSIONALS FOR TRANSPARENCY,-against-

Plaintiff,

Civil Action No. ____________

FOOD AND DRUG ADMINISTRATION,
Defendant.
COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF
Plaintiff, as for its Complaint regarding a Freedom of Information Act request against theabove-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 forsafety, 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 thesufficiency of the data and information, the adequacy of the review, and the appropriateness of thehttps://www.bmj.com/content/373/bmj.n1244 (last visited 9/5/2021).
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine (last visited 9/5/2021).
3
Id.
1
2

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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 of 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 infurtherance of its commitment to transparency, 4 PHMPT 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 federal law which provides that: “After 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 andeffectiveness data and information. (2) A protocol for a test or study . . .” 21 C.F.R. § 601.51(e).
6.

PHMPT therefore issued a request to the FDA pursuant to the Freedom ofInformation 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 public have a substantial interest inreviewing the data and information underlying the FDA’s approval of the Pfizer Vaccine.
https://www.fda.gov/about-fda/transparency (last visited 9/5/2021).
21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol 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 or 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 particular
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 Vaccine enumerated in 21 C.F.R. § 601.51(e)with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.
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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.

Thepublic’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 as well asprivate 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 processingof 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 demonstrate[] 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 thepublic concerning actual or alleged Federal Government activity.” PHMPT brings this action tochallenge 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 Trail, Suite 534, Fort Worth, Texas, 76051.
11.

PHMPT’s members include:
a.
b.
c.

Aaron Kheriaty, MD
Professor of Psychiatry, UCI School of Medicine
Director, Medical Ethics Program, UCI HealthHarvey Risch, MD, PhD
Professor of Epidemiology
Yale School of Public HealthPeter A. McCullough, MD, MPH, FACP, FACC,
FCCP, FAHA, FNKF, FNLA, FCRSAPage 3 of 4

Case 4:21-cv-01058-P Document 1 Filed 09/16/21

d.
e.

f.
g.
h.
i.

j.

k.

l.

m.

n.

o.
p.

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Carole H Browner, PhD, MPH
Distinguished Research Professor
UCLA David Geffen School of MedicinePeter Doshi, PhD
Associate Professor, Pharmaceutical Health Services Research
University of Maryland School of Pharmacy
Baltimore, Maryland, U.S.A.
Linda Wastila, BSPharm, MSPH, PhD
Professor, Pharmaceutical Health Services Research
University of Maryland School of Pharmacy
Andrew Bostom, MD, MS
Associate Professor of Family Medicine (Research)
The Warren Alpert Medical School of Brown University
Erick H. Turner, MD
Associate Professor
Oregon Health & Science University
Aditi Bhargava, PhD
Professor Emerita
Department of ObGyn and Reproductive Sciences University of California
San Francisco
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
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
Donald W. Light, PhD
Professor of Comparative Health Policy and Psychiatry
Rowan University School of Osteopathic Medicine
Glassboro, New Jersey, U.S.A.
Allyson M Pollock, MBChB, FRCPH, FRCP (Ed) FRCGPClinical Professor of Public HealthInstitute of Health and Society, Newcastle University
Newcastle upon Tyne, United Kingdom
Anthony J. Brookes, PhD
Professor of Genetics
University of Leicester
Leicester, United Kingdom
László G. Boros, MD
Scientific Advisor
SIDMAP, LLC and the Deutenomics Science InstituteAngela Spelsberg, MD, SM
Comprehensive Cancer Center Aachen
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Case 4:21-cv-01058-P Document 1 Filed 09/16/21

q.

r.

s.

t.

u.

v.
w.

x.

y.

z.
aa.
bb.
cc.

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Aachen, Germany
Christine Stabell Benn, MD, PhD, DMSc
Professor of Global Health
University of Southern Denmark
Copenhagen, Denmark
Peter Aaby, MSc, DMSc
Head of Bandim Health Project, Guinea-Bissau
University of Southern Denmark
Copenhagen, Denmark
Ulrich Keil, MD, PhD, FRCP (London)
Professor Emeritus
University of Muenster
Muenster, Germany
Barbara Mintzes, BA, MSc, PhD
Associate Professor, School of Pharmacy
The University of Sydney
Sydney, Australia
David Healy, MD FRCPsych
Professor of Psychiatry
McMaster University
Ontario, Canada
Tom Jefferson, MD MRCGP FFPHM
Senior Associate Tutor
University of Oxford
Byram W. Bridle, PhD
Associate Professor of Viral Immunology
Department of Pathobiology
University of Guelph, OntarioPeter C. Gøtzsche, Professor, DrMedSci, MD, MSc
Director
Institute for Scientific Freedom
Copenhagen, Denmark
Janice E. Graham, PhD, FRSC, FCAHS
Division of Infectious Diseases
University research Professor
Dalhousie University
Justin Lee
Associate Editor
Arc Digital
Serena Tinari
Co-President, Re-Check, Investigating and Mapping Health Affairs
Catherine Riva
Co-President, Re-Check, Investigating and Mapping Health Affairs
Dr. Ira Bernstein, MD
Dept. Family and Community Medicine
University of Toronto
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dd.
ee.
ff.

12.

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Dr. Ondrej Halgas, PhD
Biomedical Researcher
University of Toronto
Prof. David Menkes
Associate Professor
University of Auckland
Dr. Peter Abdelmalak
Adjunct Professor
McMaster University

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 anagency 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) and28 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 the Pfizer Vaccine
14.

On August 23, 2021, the FDA approved the Pfizer Vaccine for individuals 16 yearsof age and older. 7
15.

There is an ongoing, public national debate regarding the adequacy of the data andinformation, and analyses of same, relied upon by the FDA to license the Pfizer Vaccine.
16.

On the 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 Pfizer Vaccine ismore than sufficient for licensure.

7

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine (last visited 9/5/2021).

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17.

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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.” 818.

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
evaluated scientific data and information included in hundreds ofthousands 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[.] 919.

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 theU.S.” 1020.

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, publichealth authorities, and medical professionals repeatedly claimed that COVID-19 vaccines are “safeand effective.” 12https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine (last visited 9/8/2021).
Id.
10
Id.
11
https://www.cbsnews.com/news/biden-address-covid-19-vaccine-pfizer-fda-approval-watch-live-stream-today2021-08-23/ (last visited 9/8/2021).
12
See, e.g., https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-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 visited 9/8/2021);
https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection (“COVID-19
vaccines have proven to be safe, effective and life-saving.”) (last visited 9/8/2021); https://www.
doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectiveness (“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-ofpfizers-covid-19-vaccine/ (quoting Governor Whitmer referring to the Pfizer Vaccine as a “safe, effective COVID-19
8
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22.

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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, andappropriateness of the analyses relied upon to license the Pfizer Vaccine, including a number ofthe scientists and journalists that 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 licensureof 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 thelack 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” because 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/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid19-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-covid19-vaccine/ (last visited 9/8/2021); https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95effective-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/(lastvisited 9/8/2021).
16
https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/ (lastvisited 9/8/2021).
17
Id.

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Page 9 of 20 PageID 9in 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 questioned the need for student vaccination requirements based on, among other things,
a review 21 by the FDA’s Vaccines and Related Biological Products Advisory Committee(“VRBPAC”) that indicates a risk of heart inflammation after vaccination. 22
27.

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 thedata 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 apublic meeting prior to licensure. Those interested were denied the opportunity to both heardiscussion about the data and to offer public comment about same.
Id.
https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19vaccine/ (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).
23
https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%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).
18

19

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B.

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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-

See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processingeffective-oct-1 (last visited 9/8/2021); https://apnews.com/article/business-health-coronavirus-pandemiccoronavirus-vaccine-4cf7451267919302de4a7b591508e80c (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(lastvisited 9/8/2021); https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-presidentbiden-to-announce-new-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ (lastvisited 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.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatoryfor-all-employees/ (last visited 9/8/2021); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccinesworkers-headquarters-79177220 (last visited 9/8/2021); https://www.kpbs.org/news/2021/aug/17/encinitas-covid-19vaccine-negative-test-employees/ (last visited 9/8/2021); https://www.cnbc.com/2021/08/09/covid-vaccinemandates-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-andcorporate-employees (last visited 9/8/2021).
27
See https://universitybusiness.com/state-by-state-look-at-colleges-requiring-vaccines/ (last visited 9/8/2021). Seealso, e.g., https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccination-mandates-facingpushback-n1273916 (last visited 9/8/2021); https://www.colorado.edu/covid-19-updates/covid-19-vaccination (lastvisited 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-requirements2021-2022-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-schooldistrict-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-upget-vaccine-or-face-weekly-testing.html (last visited 9/8/2021); https://www.mercurynews.com/2021/08/19/lacounty-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-teachersstaff-mayor-2021-08-23/ (last visited 9/8/2021); https://www.cbsnews.com/news/california-covid-vaccine-teachersmandate/ (last visited 9/8/2021); https://www.nytimes.com/2021/08/18/us/washington-state-teacher-vaccinemandate.html (last visited 9/8/2021); https://www.governor.ny.gov/news/governor-cuomo-announces-covid-19vaccination-mandate-healthcare-workers (last visited 9/8/2021); https://www.cdph.ca.gov/Programs/CID/DCDC
24

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19 vaccines for air travel into or out of the United States 31 and the Pentagon has mandated COVID19 vaccines for all military personnel. 32 In addition, Present Biden recently announced vaccine
mandates for all employers with 100 or more employees, all federal employees, and all employeesof 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 vaccine 37 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-Requirement.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/MayorHancock-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_6123e028e4b0
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-lawmakersgrapple-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 (lastvisited 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-stateworkers-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/(lastvisited 9/8/2021).
37
https://www.usatoday.com/story/news/health/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-full-approval/5513121001/ (last visited 9/8/2021).
38
https://www.msn.com/en-us/news/us/biden-urges-private-companies-to-implement-covid-19-vaccine-requirements-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 toannounce vaccine mandates for their employees”) (last visited 8/23/2021); https://www.msn.com/en-us/news/us/now-

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32.

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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, andin an effort to ensure that the FDA acts consistently 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 confirmationthat 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-murthysays-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-laten1277059 (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(lastvisited
9/5/2021).
41
21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol 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 or 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 particular
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 biologicalproduct 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.

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35.

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On August 31, 2021, the FDA issued an acknowledgment and assigned casenumber 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 processingof the FOIA Request (the “Denial Letter”). 44 In the Denial Letter, the FDA stated in relevantpart:
I have determined that your request for expedited processing does
not meet the criteria under the FOIA. You have not demonstrated acompelling 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 yourrequest for expedited processing.
(Exhibit A.4.)
ARGUMENT38.

FOIA provides for “expedited processing of request for records” upon a showingof “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 actualor alleged Federal Government activity” constitutes a “compelling need” 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 thepublic concerning actual or alleged Federal Government activity.” In the Denial Letter, the FDA
44
The FOIA requires federal agencies to issue determinations 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.

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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 life or physicalsafety 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 indisseminating information.” PHMPT is an organization made up of public health professionals,
medical professionals, scientists, and journalists.

PHMPT exists for the sole purpose ofdisseminating 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

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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 thegeneral 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 thelicensure by the FDA of the Pfizer Vaccine.
41.

In determining 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.

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 Doshi) (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-11624381749(lastvisited8/25/2021);
https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics11623689220(AaronKheriaty
andGerardV.
Bradley)(lastvisited
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 Cretella, and Gerard V. Bradley) (last visited
https://thefederalist.com/2021/08/18/why-forcing-unvaccinated-students-to-wear-cloth-masks-is-anti9/8/2021);
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)(lastvisited
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/medicalethicist-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-acovid-19-vaccine/ (Peter Doshi) (last visited 9/8/2021); https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizerand-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/ (Catherine 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-antiscience/ (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-ratioof-covid-19-vaccination-of-very-low-covid-19-risk-12-to-17-year-olds-with-pfizers-emergency-use-authorizationonly-mrna-vaccine/ (Andrew Bostom) (last visited 9/8/2021).
45

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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 biologicalproduct file are immediately available for public disclosure unless extraordinary circumstances areshown: (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 dataand 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 the 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 themedical 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 that warrant expedited
treatment of this request.
45.

First, as explained above, there is an ongoing, public national debate regarding theadequacy of the data and information, and analyses of same, relied upon by the FDA to license thePfizer 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 andhttps://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 thisdetermination based on, inter alia, clinical trial reports provided by the sponsor which must be sufficient todemonstrate the product is both “safe” and “effective.” 21 C.F.R. 601.2(a). The FDA explains in its guidancematerials 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).
50

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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 thesufficiency of the data and information, the adequacy of the review, and appropriateness of theanalyses relied upon to license the Pfizer Vaccine, including a number of the scientists andjournalists that are members of PHMPT. 52
47.

The public debate is unlikely to be settled without full disclosure of the data andinformation underlying the FDA’s conclusion that the Pfizer Vaccine is “safe and effective.”
48.

Given the widespread and ongoing public debate, the medical and scientificcommunity 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 andinformation 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

See, e.g., supra ¶¶ 16-21.
See, e.g., supra ¶¶ 22-27.
53See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processingeffective-oct-1 (last visited 9/8/2021); https://apnews.com/article/business-health-coronavirus-pandemiccoronavirus-vaccine-4cf7451267919302de4a7b591508e80c (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(lastvisited 9/8/2021); https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-presidentbiden-to-announce-new-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ (lastvisited 9/8/2021).
51
52

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governments, 54 public and private employers, 55 universities, 56 schools, 57 and various otherinstitutions, 58 and many are expected to follow suit. 59
50.

During a time when COVID-19 vaccine mandates are being implemented 60 overSee, 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://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatoryfor-all-employees/ (last visited 9/8/2021); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccinesworkers-headquarters-79177220 (last visited 9/8/2021); https://www.kpbs.org/news/2021/aug/17/encinitas-covid-19vaccine-negative-test-employees/ (last visited 9/8/2021); https://www.cnbc.com/2021/08/09/covid-vaccinemandates-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-andcorporate-employees (last visited 9/8/2021).
56
See https://universitybusiness.com/state-by-state-look-at-colleges-requiring-vaccines/ (last visited 9/8/2021). Seealso, e.g., https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccination-mandates-facingpushback-n1273916 (last visited 9/8/2021); https://www.colorado.edu/covid-19-updates/covid-19-vaccination (lastvisited 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-requirements2021-2022-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-schooldistrict-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-upget-vaccine-or-face-weekly-testing.html (last visited 9/8/2021); https://www.mercurynews.com/2021/08/19/lacounty-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-teachersstaff-mayor-2021-08-23/ (last visited 9/8/2021); https://www.cbsnews.com/news/california-covid-vaccine-teachersmandate/ (last visited 9/8/2021); https://www.nytimes.com/2021/08/18/us/washington-state-teacher-vaccinemandate.html (last visited 9/8/2021); https://www.governor.ny.gov/news/governor-cuomo-announces-covid-19vaccination-mandate-healthcare-workers (last visited 9/8/2021); https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.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/MayorHancock-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_6123e028e4b0
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-lawmakersgrapple-with-statewide-covid-19-vaccine-mandate (last visited 9/8/2021).
60
See, e.g., supra ¶¶ 28-32.
54

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the objection of those that have questions about the data and information supporting the safety andefficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from
employment, school, transportation, restaurants, entertainment facilities, and the military, thepublic 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 millions of Americans, including employers with 100 or more employees, federal employees,
and employees of federal contractors. 61
51.

PHMPT will forthwith disseminate any information it obtains in response to the

FOIA Request. PHMPT, as an entity primarily engaged in disseminating information, has arecognized interest in timely contributing to the ongoing public debate regarding the adequacy ofthe data and information underlying the FDA’s approval of the Pfizer Vaccine.
52.

Finally, the information PHMPT seeks concerns actual or alleged federal

government activity – namely, whether the FDA properly approved the Pfizer Vaccine based onadequate 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 isentitled 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 ofhttps://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).
61

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any such order;c.

Award Plaintiff its costs and reasonable attorneys’ fees incurred in this action asprovided by 5 U.S.C. § 552(a)(4)(E); andd.

Grant such other and further relief as the Court may deem just and proper.

Dated: September 16, 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
aaron@sirillp.com
ebrehm@sirillp.com
gpalmer@sirillp.com
HOWIE LAW, PC/s John Howie
John Howie
Texas Bar Number: 24027239
2608 Hibernia Street
Dallas, Texas 75204
Tel: (214) 622-6340
jhowie@howielaw.net
Attorneys for Plaintiff

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Exhibit A.1

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FREEDOM OF INFORMATION ACT REQUESTEXPEDITED PROCESSING REQUESTEDVIA 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 PfizerBioNTech 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 thefollowing records to foia@sirillp.com 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

21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be madeavailable for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data andinformation. (2) A protocol 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 or 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 particular
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 biologicalproduct 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.
1

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Expedited Processing Requested
PHMPT requests 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 indisseminating 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 thedata and information in the biological product files for each of the COVID-19 vaccines. PHMPT
intends to make any records produced in response to this FOIA request immediately available tothe 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 indisseminating information to the public and do so across various platforms, including throughinterviews, 3 articles, 4 blogs, 5 essays, 6 and podcasts. 7 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 of the Pfizer
Vaccine. Accordingly, expedited processing of this request is warranted.

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 8/27/2021); https://www.bmj.com/content/371/bmj.m4058 (Peter Doshi) (last visited 8/27/2021); https://www.bmj.com/content/371/bmj.m4037 (Peter
Doshi) (last visited 8/27/2021); 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-ethics11623689220(AaronKheriaty
andGerardV.
Bradley)(lastvisited8/27/2021);
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-antiscience/ (Andrew Bostom, Gerard Bradley, Aaron Kheriaty, and Harvey Risch) (last visited 8/27/2021);
https://www.bmj.com/content/bmj/374/bmj.n1737.full.pdf (Serena Tinari and Catherine Riva) (last visited
8/27/2021);
https://www.bmj.com/content/372/bmj.n627(Serena
Tinari)(lastvisited8/27/2021);
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/medicalethicist-sues-the-university (Justin Lee) (last visited 8/27/2021).
5
See, e.g., https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-acovid-19-vaccine/ (Peter Doshi) (last visited 8/27/2021); https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizerand-modernas-95-effective-vaccines-lets-be-cautious-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) (lastvisited 8/27/2021).
6
See
https://www.andrewbostom.org/2021/06/why-collegiate-covid-19-vaccine-mandates-are-lysenkoist-antiscience/ (Andrew Bostom) (last visited 8/27/2021).
7
See, e.g., https://www.andrewbostom.org/2021/05/dr-andrew-bostom-discusses-the-unfavorable-risk-benefit-ratioof-covid-19-vaccination-of-very-low-covid-19-risk-12-to-17-year-olds-with-pfizers-emergency-use-authorizationonly-mrna-vaccine/ (Andrew Bostom) (last visited 8/27/2021).
3

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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 alicense 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 scientific community and the public have in the conclusions reached by the FDA. 8 There isan urgent public need for such transparency with regard to 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
Vaccine 10 and, beyond the FDA’s own regulations which admit the urgent need for transparency
and disclosure in this situation, there are two additional reasons that warrant expedited treatmentof this request.
First, there is an ongoing, public national debate regarding the adequacy of the data andinformation, and analyses of same, relied upon by the FDA to license the Pfizer Vaccine. On the
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 thatthe data and information underlying the licensure of the Pfizer Vaccine is more than sufficient forlicensure. 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 thehigh 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 andResearch, made similar remarks, stating that
[The FDA’s] scientific and medical experts conducted an incredibly
thorough and thoughtful evaluation of [the Pfizer Vaccine]. We
https://www.fda.gov/about-fda/transparency (last visited 8/27/2021).
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 target condition.” https://www.fda.gov/media/102332/download (last visited
8/27/2021). See also https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (last visited
8/27/2021); https://www.fda.gov/about-fda/what-we-do (last visited 8/27/2021).
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 (lastvisited 8/27/2021). 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 8/27/2021).
11
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine(lastvisited8/27/2021).
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evaluated scientific data and information included in hundreds ofthousands 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, journalists, scientists,
politicians, public figures, and others with large social or media platforms have publicly raisedquestions regarding the sufficiency of the data and information, the adequacy of the review, andappropriateness of the analyses relied upon to license the Pfizer Vaccine, including a number ofthe scientists and journalists that are members of PHMPT. For example, on June 1, 2021, a groupof 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 Petition 17 with the FDA, claiming that theavailable 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
process 19 which Peter Marks publicly disputed. 20 Andrew Kheriaty, professor of psychiatry at UCI
12
13

Id.
Id.

https://www.cbsnews.com/news/biden-address-covid-19-vaccine-pfizer-fda-approval-watch-live-stream-today2021-08-23/ (last visited 8/27/2021).
15
See, e.g., https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html#:~:text=COVID%
2D19%20vaccines%20are%20safe,vaccine%20as%20soon%20as%20possible. (last visited 8/27/2021). See also
https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection (“COVID-19
vaccines have proven to be safe, effective and life-saving.”) (last visited 8/27/2021); https://www.
doh.wa.gov/Emergencies/COVID19/VaccineInformation/SafetyandEffectiveness (“COVID-19 vaccines are safe”)(last visited 8/27/2021); https://www.wlns.com/news/gov-whitmer-and-dr-khaldun-respond-to-the-fda-approval-ofpfizers-covid-19-vaccine/ (quoting Governor Whitmer referring to the Pfizer Vaccine as a “safe, effective COVID-19
vaccine”) (last visited 8/27/2021).
16
https://www.bmj.com/about-bmj/editorial-staff/peter-doshi (last visited 8/27/2021).
17
https://www.regulations.gov/document/FDA-2021-P-0521-0001 (last visited 8/27/2021).
18
See https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid19-vaccine-this-year/ (last visited 8/27/2021).
19
See https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid19-vaccine/ (last visited 8/27/2021); https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95effective-vaccines-we-need-more-details-and-the-raw-data/ (last visited 8/27/2021); 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/(lastvisited 8/27/2021).
20
https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/ (lastvisited 8/27/2021).
14

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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 review 22 by the FDA’s Vaccines and 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, arguingthat 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 thePfizer Vaccine, including all matters related to the licensure of this product.
Given this 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 licensureof 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 thesafety and efficacy of the Pfizer Vaccine. The FDA should produce the data and informationnecessary to 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 andinformation 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, 25 local

https://www.aaronkheriaty.com/bio (last visited 8/27/2021).
https://www.fda.gov/media/150054/download (last visited 8/27/2021).
23
https://www.wsj.com/articles/university-vaccine-mandates-violate-medical-ethics-11623689220 (last visited
8/27/2021).
24
https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%20transparency%20i
n%20vaccine%20review%20process_.pdf (last visited 8/27/2021). See also https://www.washingtontimes.com/
news/2021/aug/23/editorial-the-coincidental-timing-of-pfizers-vacci/ (last visited 8/27/2021).
25
See, e.g., https://www.natlawreview.com/article/covid-19-vaccine-added-to-requirements-green-card-processingeffective-oct-1 (last visited 8/27/2021); https://apnews.com/article/business-health-coronavirus-pandemiccoronavirus-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(lastvisited 8/27/2021); https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-presidentbiden-to-announce-new-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ (lastvisited 8/27/2021).
21
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governments, 26 public and private employers, 27 universities, 28 schools, 29 and various otherinstitutions, 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 into or out of the United States 32
and the Pentagon has mandated the COVID-19 vaccines for all military personnel. 33 At the stateSee, 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 8/27/2021); https://
news.yahoo.com/orleans-now-requires-proof-vaccination-230433492.html (last visited 8/27/2021).
27
See, e.g., https://www.cnbc.com/2021/08/06/united-airlines-vaccine-mandate-employees.html (last visited
8/27/2021); https://sanfrancisco.cbslocal.com/2021/08/02/covid-kaiser-permanente-makes-vaccination-mandatoryfor-all-employees/ (last visited 8/27/2021); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccinesworkers-headquarters-79177220 (last visited 8/27/2021); https://www.kpbs.org/news/2021/aug/17/encinitas-covid19-vaccine-negative-test-employees/ (last visited 8/27/2021); https://www.cnbc.com/2021/08/09/covid-vaccinemandates-sweep-across-corporate-america-as-delta-surges.html (last visited 8/27/2021); https://www.reuters.com/business/energy/chevron-begins-covid-19-vaccination-mandates-wsj-2021-08-23/ (last visited 8/27/2021); https://thehill.com/policy/healthcare/569051-pfizers-full-approval-triggers-new-vaccine-mandates (last visited 8/27/2021);
https://cvshealth.com/news-and-insights/statements/cvs-health-will-require-covid-19-vaccinations-for-clinical-andcorporate-employees (last visited 8/27/2021).
28
See https://universitybusiness.com/state-by-state-look-at-colleges-requiring-vaccines/ (last visited 8/27/2021). Seealso, e.g., https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccination-mandates-facingpushback-n1273916 (last visited 8/27/2021); https://www.colorado.edu/covid-19-updates/covid-19-vaccination (lastvisited 8/27/2021); https://uhs.berkeley.edu/requirements/covid19 (last visited 8/27/2021); https://huhs.harvard.edu/covid-19-vaccine-requirement-faqs (last visited 8/27/2021); https://www2.gmu.edu/safe-return-campus/vaccination-requirements (last visited 8/27/2021); https://www.pc.pitt.edu/news/vaccine-disclosure-requirements2021-2022-campus-housing (last visited 8/27/2021)
29
See, e.g., https://www.npr.org/sections/back-to-school-live-updates/2021/08/20/1029837338/a-california-schooldistrict-mandates-vaccines-for-eligible-students (last visited 8/27/2021); https://patch.com/massachusetts/salem/salem-school-committee-approves-vaccine-mandate-sports-band (last visited 8/27/2021); https://www.nbcnewyork.com/news/coronavirus/nyc-will-require-vaccination-for-high-risk-school-sports/3232745/ (last visited 8/27/2021);
https://www.nj.com/hudson/2021/08/hoboken-believed-to-be-first-in-state-to-issue-mandate-for-students-12-and-upget-vaccine-or-face-weekly-testing.html (last visited 8/27/2021); https://www.mercurynews.com/2021/08/19/lacounty-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-teachersstaff-mayor-2021-08-23/ (last visited 8/27/2021); https://www.cbsnews.com/news/california-covid-vaccine-teachersmandate/ (last visited 8/27/2021); https://www.nytimes.com/2021/08/18/us/washington-state-teacher-vaccinemandate.html (last visited 8/27/2021); https://www.governor.ny.gov/news/governor-cuomo-announces-covid-19vaccination-mandate-healthcare-workers (last visited 8/27/2021); https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/FAQ-Health-Care-Worker-Vaccine-Requirement.aspx (last visited 8/27/2021); https://www.
nytimes.com/2021/08/09/us/washington-state-workers-vaccine-mandate.html (last visited 8/27/2021); https://www.
denvergov.org/Government/COVID-19-Information/Public-Health-Orders-Response/News-Updates/2021/MayorHancock-Announces-COVID-19-Vaccine-Requirement-for-Employees (last visited 8/27/2021); See https://www.
bostonherald.com/2021/08/19/baker-issues-vaccine-mandate-for-42000-state-employees/ (last visited 8/27/2021).
31
See https://www.mississippifreepress.org/15126/fda-fully-approves-pfizer-biontech-vaccine-mandates-to-follow/(last visited 8/27/2021); https://www.huffpost.com/entry/vaccine-mandates-roll-out-fda-approval_n_6123e028e4b0
df3eacd5d657 (last visited 8/27/2021); 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 8/27/2021). See also https://www.latimes.com/california/story/2021-08-26/california-lawmakersgrapple-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 (lastvisited 8/23/2021).
33
https://thehill.com/policy/defense/568996-pentagon-to-mandate-covid-19-vaccine-for-military (last visited
8/23/2021).
26

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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 vaccine 37
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 andefficacy 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 needto have access to this data. PHMPT incorporates by reference, as if cited and fully set forth herein,
any and all articles, media, and publications regarding or reflecting the public discussion, discourseand debate regarding mandated or potential mandates of the Pfizer Vaccine.
PHMPT certifies 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 theoperations 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
requests will not contribute to any commercial activities.
Note that if only portions of a requested file are exempted from release, the remainder muststill be released. We therefore request that we be provided with all non-exempt portions which arereasonably 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 yourreasons 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
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-stateworkers-including-at-public-colleges.html (last visited 8/27/2021).
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/(lastvisited 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 8/27/2021).
38
https://www.msn.com/en-us/news/us/biden-urges-private-companies-to-implement-covid-19-vaccine-requirements-following-pfizer-e2-80-99s-fda-approval/ar-AANEcYs?ocid=uxbndlbing (last visited 8/27/2021). 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 toannounce vaccine mandates for their employees”) (last visited 8/23/2021); https://www.msn.com/en-us/news/us/nowthat-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-murthysays-205530053.html (quoting the Surgeon General referring to vaccine mandates as “reasonable”) (last visited
8/23/2021).
34

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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 expedited processing should be made within ten (10) days.
Access to the requested records should be granted within twenty (20) business days from the dateof your receipt of this letter. Failure to respond in a timely manner shall be viewed as a denial ofthis request 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 foia@sirillp.com during normal business hours. Thankyou for your time and attention to this matter.
Very truly yours,/s/ Aaron Siri
Aaron Siri, Esq.
Elizabeth Brehm, Esq.
Gabrielle G. Palmer, Esq.

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Exhibit A.2

012312425

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Case 4:21-cv-01058-P Document 1-2 Filed 09/16/21

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515

Case 4:21-cv-01058-P Document 1-3 Filed 09/16/21

Page 1 of 2 PageID 32

Exhibit A.3

Case 4:21-cv-01058-P Document 1-3 Filed 09/16/21

Page 2 of 2 PageID 33

August 31, 2021

In Reply refer to
FOIA Control #:2021-5683

PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR
TRANSPARENCY
AARON SIRI
200 Park Avenue
17th Floor
New York NY 10166 USA

Requester reference:

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 needschange, 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 thecomplexity 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) 7968979 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
National Archives and Administration
8601 Adelphi Road – OGIS
College Park, MD 20740-6001
Telephone:202-741-5770
Toll-Free: 1-877-684-6448
Email:ogis@nara.gov
Fax: 202-741-5769

and/orFDA FOIA Public Liaison
Office of the Executive Secretariat
US Food Administration
5630 Fishers Lane, Room 1050
Email: FDAFOIA@fda.hhs.gov

Sincerely,

SARAH KOTLER
Director

Case 4:21-cv-01058-P Document 1-4 Filed 09/16/21

Page 1 of 2 PageID 34

Exhibit A.4

Case 4:21-cv-01058-P Document 1-4 Filed 09/16/21

Page 2 of 2 PageID 35

September 09, 2021

In Reply refer to
FOIA Control #:2021-5683

PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR
TRANSPARENCY
AARON SIRI
200 Park Avenue
17th Floor
New York NY 10166 USA

Requester reference:IR#0546

Dear Requester:This is in reference to your request(s) for record(s) from the Food and Drug Administration (FDA) pursuant to theFreedom 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 themwhenever a "compelling need" is shown and in other cases as determined by the agency. The term "compelling need" isdefined 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 notdemonstrated 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 willprocess 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 theagency 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: FDAFOIA@fda.hhs.gov. Please clearly mark both theenvelope 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: FDAFOIA@fda.hhs.gov.
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: ogis@nara.gov, Fax: 202-741-5769.
Sincerely,

SARAH KOTLER
Director

CIVIL COVER SHEETJS 44 (Rev. 10/20) - TXND (10/20)

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 asprovided 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
PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR
TRANSPARENCY(b) County of Residence of First Listed Plaintiff Tarrant

DEFENDANTS
FOOD AND DRUG ADMINISTRATIONCounty of Residence of First Listed Defendant(EXCEPT IN U.S. PLAINTIFF CASES)NOTE:(c) Attorneys (Firm Name, Address, and Telephone Number)(IN U.S. PLAINTIFF CASES ONLY)IN LAND CONDEMNATION CASES, USE THE LOCATION OF
THE TRACT OF LAND INVOLVED.

Attorneys (If Known)

Howie Law PC / 2608 Hibernia Street, Dallas Texas 75204(212) 622-6340
II. BASIS OF JURISDICTION (Place an “X” in One Box Only)
1

U.S. Government
Plaintiff

3

Federal Question(U.S. Government Not a Party)

2

U.S. Government
Defendant

4

Diversity(Indicate Citizenship of Parties in Item III)

III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff(For Diversity Cases Only)
PTF
Citizen of This State
1
2

2

Incorporated and Principal Placeof Business In Another State

5

5

Citizen or Subject of a
Foreign Country33Foreign Nation

6

6

Click here for: Nature of Suit Code Descriptions.

TORTS

110 Insurance
120 Marine
130 Miller Act
140 Negotiable Instrument
150 Recovery of Overpayment& Enforcement of Judgment
151 Medicare Act
152 Recovery of Defaulted
Student Loans(Excludes Veterans)
153 Recovery of Overpayment
of Veteran’s Benefits
160 Stockholders’ Suits
190 Other Contract
195 Contract Product Liability
196 Franchise

REAL PROPERTY
210 Land Condemnation
220 Foreclosure
230 Rent Lease & Ejectment
240 Torts to Land
245 Tort Product Liability
290 All Other Real Property

PERSONAL INJURY
310 Airplane
315 Airplane Product
Liability
320 Assault, Libel &Slander
330 Federal Employers’
Liability
340 Marine
345 Marine Product
Liability
350 Motor Vehicle
355 Motor Vehicle
Product Liability
360 Other Personal
Injury362 Personal Injury Medical Malpractice
CIVIL RIGHTS
440 Other Civil Rights
441 Voting
442 Employment
443 Housing/Accommodations
445 Amer. w/Disabilities Employment
446 Amer. w/Disabilities Other
448 Education

and One Box for Defendant)
PTF
DEF
Incorporated or Principal Place
4
4of Business In This State

Citizen of Another State

IV. NATURE OF SUIT (Place an “X” in One Box Only)
CONTRACTDEF
1

PERSONAL INJURY
365 Personal Injury Product Liability
367 Health Care/
Pharmaceutical
Personal Injury
Product Liability
368 Asbestos Personal
Injury Product
Liability
PERSONAL PROPERTY
370 Other Fraud
371 Truth in Lending
380 Other Personal
Property Damage
385 Property Damage
Product Liability
PRISONER PETITIONS
Habeas Corpus:
463 Alien Detainee
510 Motions to Vacate
Sentence
530 General
535 Death Penalty
Other:
540 Mandamus & Other
550 Civil Rights
555 Prison Condition
560 Civil Detainee Conditions ofConfinement

FORFEITURE/PENALTYBANKRUPTCYOTHER STATUTES

625 Drug Related Seizureof Property 21 USC 881
690 Other

422 Appeal 28 USC 158
423 Withdrawal
28 USC 157

375 False Claims Act
376 Qui Tam (31 USC
3729(a))400 State Reapportionment
410 Antitrust
430 Banks and Banking
450 Commerce
460 Deportation
470 Racketeer Influenced andCorrupt Organizations
480 Consumer Credit(15 USC 1681 or 1692)
485 Telephone Consumer
Protection Act
490 Cable/Sat TV
850 Securities/Commodities/
Exchange
890 Other Statutory Actions
891 Agricultural Acts
893 Environmental Matters
895 Freedom of Information
Act
896 Arbitration
899 Administrative Procedure
Act/Review or Appeal of
Agency Decision
950 Constitutionality ofState Statutes

LABOR
710 Fair Labor Standards
Act
720 Labor/Management
Relations
740 Railway Labor Act
751 Family and Medical
Leave Act
790 Other Labor Litigation
791 Employee Retirement
Income Security Act

IMMIGRATION
462 Naturalization Application
465 Other Immigration
Actions

PROPERTY RIGHTS
820 Copyrights
830 Patent
835 Patent - Abbreviated
New Drug Application
840 Trademark
880 Defend Trade Secrets
Act of 2016
SOCIAL SECURITY
861 HIA (1395ff)
862 Black Lung (923)863 DIWC/DIWW (405(g))
864 SSID Title XVI
865 RSI (405(g))
FEDERAL TAX SUITS
870 Taxes (U.S. Plaintiff
or Defendant)
871 IRS—Third Party
26 USC 7609

V. ORIGIN (Place an “X” in One Box Only)
1 Original
Proceeding

2 Removed fromState Court

3

Remanded from
Appellate Court

4 Reinstated or
Reopened

5 Transferred from
Another District(specify)

6 Multidistrict
Litigation Transfer
Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity):

5 U.S.C. § 552(a)(4)(B) and 28 U.S.C. § 1331
VI. CAUSE OF ACTION Brief description of cause:
Freedom of Information Act, 5 U.S.C. § 552
DEMAND $VII. REQUESTED INCHECK IF THIS IS A CLASS ACTION
UNDER RULE 23, F.R.Cv.P.
COMPLAINT:VIII. RELATED CASE(S)(See instructions):
IF ANYJUDGEDATESIGNATURE OF ATTORNEY OF RECORD

Sep 16, 2021

/s John HowieCHECK YES only if demanded in complaint:Yes
No
JURY DEMAND:

DOCKET NUMBERFOR OFFICE USE ONLYRECEIPT #AMOUNTAPPLYING IFP

8 Multidistrict
Litigation Direct File

JUDGEMAG. JUDGEJS 44 Reverse (Rev. 10/20) - TXND (10/20)

INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
Authority For Civil Cover SheetThe 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, isrequired 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)
(b)

(c)

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 thenthe official, giving both name and title.
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 thetime 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.)
Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, notingin 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, thecitizenship 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 thissection 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 codethat 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 tochanges 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 thedocket 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 oflaw and fact; and/or 4) involves the same estate in a bankruptcy appeal.
Date and Attorney Signature. Date and sign the civil cover sheet.