FOIA request (Exhibit A to complaint) — PHMPT v. FDA

Record facts

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 1-1 · 2021-09-16 · Docket on CourtListener

Full text

Exhibit A.1 
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FREEDOM OF INFORMATION ACT REQUEST 
EXPEDITED PROCESSING REQUESTED 
 
VIA ONLINE PORTAL 
  
 
August 27, 2021 
 
Food and Drug Administration 
Division of Freedom of Information 
Office of the Secretariat, OC 
5630 Fishers Lane, Room 1035 
Rockville, MD 20857 
 
 
Re: Pfizer-BioNTech COVID-19 Vaccine Biological Product File (IR#0546) 
 
 
 
Dear Sir or Madam:  
 
This firm represents Public Health and Medical Professionals for Transparency 
(“PHMPT”).   
 
On August 23, 2021, the Food and Drug Administration (“FDA”) approved the Pfizer-
BioNTech COVID-19 Vaccine, marketed as Comirnaty (the “Pfizer Vaccine”) for individuals 16 
years of age and older.  On behalf of  PHMPT and its individual members, please provide the 
following records to 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 
 
 
1 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following information shall be made 
available for immediate disclosure absent extraordinary circumstances: “(1) All safety and effectiveness data and 
information. (2) A 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 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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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 in 
disseminating information, urgency to inform the public concerning actual or alleged Federal 
Government activity” constitutes a “compelling need” for expedited processing. 5 U.S.C. 
§ 552(a)(6)(E)(v)(II).   
 
PHMPT is an organization made up of public health professionals, medical professionals, 
scientists, and journalists.  PHMPT exists for the sole purpose of disseminating to the public the 
data and information in the biological product files for each of the COVID-19 vaccines.  PHMPT 
intends to make any records produced in response to this 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 platforms, including through 
interviews, 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. 
 
 
3
 See, 
e.g., 
https://www.foxnews.com/transcript/ingraham-angle-on-mask-mandates-bidens-failure-in-his-role 
(Harvey Risch) (last visited 8/26/2021) 
4 See, e.g., https://www.bmj.com/content/373/bmj.n1244 (Peter Doshi) (last visited 8/27/2021); 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-ethics-
11623689220 
(Aaron 
Kheriaty 
and 
Gerard 
V. 
Bradley) 
(last 
visited 
8/27/2021); 
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-anti-
science/ (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) 
(last 
visited 
8/27/2021); 
https://ebm.bmj.com/content/early/2021/08/08/bmjebm-2021-111735 (Sarah Tanveer, Anisa Rowhani-Farid, 
Kyungwan Hong, Tom Jefferson, Peter Doshi) (last visited 8/27/2021); https://www.arcdigital.media/p/medical-
ethicist-sues-the-university (Justin Lee) (last visited 8/27/2021). 
5  See, e.g., https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-
covid-19-vaccine/ (Peter Doshi) (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/ 
(Peter 
Doshi) 
(last 
visited 
8/27/2021). See also https://www.re-check.ch/wordpress/en/covid-certificate/ (Catherine Riva and Serena Tinari) (last 
visited 8/27/2021). 
6
 See 
https://www.andrewbostom.org/2021/06/why-collegiate-covid-19-vaccine-mandates-are-lysenkoist-anti-
science/ (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-ratio-
of-covid-19-vaccination-of-very-low-covid-19-risk-12-to-17-year-olds-with-pfizers-emergency-use-authorization-
only-mrna-vaccine/ (Andrew Bostom) (last visited 8/27/2021). 
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Recognizing the urgency to inform the public concerning the data and information 
underlying a licensed vaccine, the Code of Federal Regulations expressly provides that “[a]fter a 
license has been issued, the following data and information in the biological product file are 
immediately available for public disclosure unless extraordinary circumstances are shown: (1) All 
safety and effectiveness data and information…” 21 C.F.R. § 601.51(e) (emphasis added).  The 
FDA’s own regulations thus expressly recognize the importance of having the data and information 
relied upon to license a vaccine “immediately available for public disclosure.”  Id.  The FDA’s 
regulation not only supports the need for expedited treatment under FOIA but is also an 
independent legal basis that requires expedited treatment of this request. 
This policy is not surprising given the FDA’s commitment to transparency and its entire 
program to assure transparency, because a lack of transparency erodes the confidence the medical 
and scientific community and the public have in the conclusions reached by the FDA.8  There is 
an 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 
Vaccine10 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 treatment 
of this request.  
First, there is an ongoing, public national debate regarding the adequacy of the data and 
information, and analyses of same, relied upon by the FDA to license the Pfizer Vaccine.  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 is more than sufficient for 
licensure.   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.”11  Peter Marks, the director of FDA’s Center for Biologics Evaluation and 
Research, made similar remarks, stating that 
[The FDA’s] scientific and medical experts conducted an incredibly 
thorough and thoughtful evaluation of [the Pfizer Vaccine]. We 
 
8 https://www.fda.gov/about-fda/transparency (last visited 8/27/2021). 
9 The FDA explains in its guidance materials that the clinical trials relied upon for approval are typically “1 to 4 years” 
(https://www.fda.gov/patients/drug-development-process/step-3-clinical-research) and the duration of clinical trials 
should “reflect the product and 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 (last 
visited 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 
(last 
visited 
8/27/2021). 
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evaluated scientific data and information included in hundreds of 
thousands of pages, conducted our own analyses of [the Pfizer 
Vaccine’s] safety and effectiveness, and performed a detailed 
assessment of the manufacturing processes, including inspections of 
the manufacturing facilities[.]12 
Peter Marks further stated that “although [the FDA] approved [the Pfizer Vaccine] expeditiously, 
it was fully in keeping with [the FDA’s] existing high standards for vaccines in the U.S.”13 
President Biden also stated that the FDA’s approval meets the “gold standard.”14 Even prior to 
FDA approval of the Pfizer Vaccine, government officials, public health authorities, and medical 
professionals repeatedly claimed that COVID-19 vaccines are “safe and effective.”15 
 
On the other hand, numerous public health officials, media outlets, journalists, scientists, 
politicians, public figures, and others with large social or media platforms have publicly raised 
questions regarding the sufficiency of the data and information, the adequacy of the review, and 
appropriateness of the analyses relied upon to license the Pfizer Vaccine, including a number of 
the scientists and journalists that are members of PHMPT.  For example, on June 1, 2021, a group 
of 27 clinicians, scientists, and patient advocates, including PHMPT members Peter Doshi, senior 
editor for The BMJ and associate professor of pharmaceutical health services research at the 
University of Maryland School of Pharmacy,16 and Peter A. McCullough, professor of medicine 
at Texas A&M College of Medicine, filed a Citizen Petition17 with the FDA, claiming that the 
available evidence for licensure of the Pfizer Vaccine “is simply not mature enough at this point 
to adequately judge whether clinical benefits outweigh the risks in all populations.”18  Separately, 
Peter Doshi has publicly questioned the lack of transparency regarding the vaccine approval 
process19 which Peter Marks publicly disputed.20 Andrew Kheriaty, professor of psychiatry at UCI 
 
12 Id. 
13 Id. 
14
 https://www.cbsnews.com/news/biden-address-covid-19-vaccine-pfizer-fda-approval-watch-live-stream-today-
2021-08-23/ (last visited 8/27/2021). 
15 See, e.g., https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-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-of-
pfizers-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-covid-
19-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-covid-
19-vaccine/ (last visited 8/27/2021); https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-
effective-vaccines-we-need-more-details-and-the-raw-data/ (last visited 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/ 
(last 
visited 8/27/2021). 
20
 https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/ 
(last 
visited 8/27/2021). 
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School of Medicine, Director of the Medical Ethics Program at UCI Health,21 and a member of 
PHMPT, has also questioned the FDA’s approval process.  For example, in an article published in 
the Wall Street Journal, Dr. Kheriaty questioned the need for student vaccination requirements 
based on, among other things, a review22 by the FDA’s Vaccines 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, arguing 
that it is “essential” for the FDA to, among other things, “make the data generated by clinical trials 
and supporting documents submitted to the FDA by developers available to the public[.]” 24  
PHMPT incorporated by reference, as if cited and fully set forth herein, any and all articles, media, 
and publications regarding or reflecting the public discussion, discourse and debate regarding the 
Pfizer Vaccine, including all matters related to the licensure of this product. 
Given this widespread and ongoing public debate, the medical and scientific community 
and the public has an immediate need to review the data and information underlying the licensure 
of the Pfizer Vaccine.  Public disclosure of this information will inform this ongoing public debate.  
Releasing this data should also confirm the FDA’s conclusion and thus increase confidence in the 
safety and efficacy of the Pfizer Vaccine. The FDA should produce the data and information 
necessary 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 and 
information underlying the licensure of the Pfizer Vaccine because, over the objections of many, 
this product is being mandated to individuals across the country by the federal government,25 local 
 
21 https://www.aaronkheriaty.com/bio (last visited 8/27/2021). 
22 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-processing-
effective-oct-1 
(last 
visited 
8/27/2021); 
https://apnews.com/article/business-health-coronavirus-pandemic-
coronavirus-vaccine-4cf7451267919302de4a7b591508e80c (last visited 8/27/2021); https://www.forbes.com/
sites/joewalsh/2021/08/09/us-military-will-require-covid-vaccinations-by-mid-september/?sh=78defacd6c9f 
(last 
visited 8/27/2021); https://www.whitehouse.gov/briefing-room/statements-releases/2021/07/29/fact-sheet-president-
biden-to-announce-new-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/ 
(last 
visited 8/27/2021).  
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governments, 26 public and private employers, 27 universities, 28 schools, 29 and various other 
institutions,30 and many are expected to follow suit.31  At the federal level, legislation was recently 
introduced that would require COVID-19 vaccines for air travel into or out of the United States32 
and the Pentagon has mandated the COVID-19 vaccines for all military personnel.33  At the state 
 
26  See, e.g., https://www.cnn.com/2021/08/12/us/san-francisco-vaccine-requirement/index.html (last visited 
8/27/2021); https://www1.nyc.gov/site/doh/covid/covid-19-vaccines-keytonyc.page (last visited 8/27/2021); 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-mandatory-
for-all-employees/ (last visited 8/27/2021); https://abcnews.go.com/Health/wireStory/walmart-mandates-vaccines-
workers-headquarters-79177220 (last visited 8/27/2021); https://www.kpbs.org/news/2021/aug/17/encinitas-covid-
19-vaccine-negative-test-employees/ (last visited 8/27/2021); https://www.cnbc.com/2021/08/09/covid-vaccine-
mandates-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-and-
corporate-employees (last visited 8/27/2021). 
28 See https://universitybusiness.com/state-by-state-look-at-colleges-requiring-vaccines/ (last visited 8/27/2021). See 
also, e.g., https://www.nbcnews.com/health/health-news/colleges-universities-covid-vaccination-mandates-facing-
pushback-n1273916 (last visited 8/27/2021); https://www.colorado.edu/covid-19-updates/covid-19-vaccination (last 
visited 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-requirements-
2021-2022-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-school-
district-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-up-
get-vaccine-or-face-weekly-testing.html (last visited 8/27/2021); https://www.mercurynews.com/2021/08/19/la-
county-school-district-mandates-covid-vaccines-for-k12-kids-others-soon-may-follow/ (last visited 8/27/2021). 
30  See, e.g., https://www.reuters.com/world/us/new-york-city-mandates-covid-19-vaccine-public-school-teachers-
staff-mayor-2021-08-23/ (last visited 8/27/2021); https://www.cbsnews.com/news/california-covid-vaccine-teachers-
mandate/ (last visited 8/27/2021); https://www.nytimes.com/2021/08/18/us/washington-state-teacher-vaccine-
mandate.html (last visited 8/27/2021); https://www.governor.ny.gov/news/governor-cuomo-announces-covid-19-
vaccination-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/Mayor-
Hancock-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-lawmakers-
grapple-with-statewide-covid-19-vaccine-mandate (last visited 8/27/2021). 
32  https://www.congress.gov/bill/117th-congress/house-bill/4980?q=%7B%22search%22:%5b%224980%252 (last 
visited 8/23/2021). 
33
 https://thehill.com/policy/defense/568996-pentagon-to-mandate-covid-19-vaccine-for-military 
(last 
visited 
8/23/2021). 
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level, legislation has been introduced to require COVID-19 vaccines for all post-secondary 
students,34 all state employees, 35 and even for all citizens of the state.36  As explained by Dr. 
Anthony Fauci, “a flood” of vaccine mandates will follow FDA approval of a COVID-19 vaccine37 
and President Biden is actively encouraging “companies in the private sector to step up the vaccine 
requirements[.]”38  During a time when COVID-19 vaccine mandates are being implemented over 
the objection of those that have questions about the data and information supporting the safety and 
efficacy of the Pfizer Vaccine, and individuals with these questions are being expelled from 
employment, school, transportation, and the military, the public has an urgent and immediate need 
to have access to this data.  PHMPT incorporates 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 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 the 
operations or activities of the government[.]”  Specifically, disclosure of the requested information 
will immediately address the ongoing public debate about the safety and efficacy of the Pfizer 
Vaccine and the clinical trials underlying the FDA’s approval of same. The information PHMPT 
requests will not contribute to any commercial activities.  
 
Note that if only portions of a requested file are exempted from release, the remainder must 
still be released. We therefore request that we be provided with all non-exempt portions which are 
reasonably segregable or can be deidentified.  We further request that you describe any redacted, 
deleted, or withheld material in detail and specify the statutory basis for the denial as well as your 
reasons for believing that the alleged statutory justification applies.  Please also separately state 
your reasons for not invoking your discretionary powers to release the requested documents in the 
 
34   See New York bill S6495 available at https://www.nysenate.gov/legislation/bills/2021/S6495 (last visited 
8/27/2021). 
35 See, e.g., https://www.nj.com/coronavirus/2021/08/murphy-orders-vaccination-requirement-for-all-nj-state-
workers-including-at-public-colleges.html (last visited 8/27/2021). 
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/ 
(last 
visited 8/27/2021). 
37  https://www.usatoday.com/story/news/health/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-full-approv
al/5513121001/ (last visited 8/27/2021). 
38
 https://www.msn.com/en-us/news/us/biden-urges-private-companies-to-implement-covid-19-vaccine-require
ments-following-pfizer-e2-80-99s-fda-approval/ar-AANEcYs?ocid=uxbndlbing (last visited 8/27/2021). 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 to 
announce vaccine mandates for their employees”) (last visited 8/23/2021); https://www.msn.com/en-us/news/us/now-
that-a-covid-19-shot-is-fully-approved-employer-mandates-are-rolling-in-but-will-vaccination-rates-in-the-us-go-up
/ar-AANGDTy?ocid=uxbndlbing  (last visited 8/23/2021); https://news.yahoo.com/surgeon-general-vivek-murthy-
says-205530053.html (quoting the Surgeon General referring to vaccine mandates as “reasonable”) (last visited 
8/23/2021). 
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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 date 
of your receipt of this letter.  Failure to respond in a timely manner shall be viewed as a denial of 
this 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.  Thank 
you 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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