The Case of the Damning FDA Memos
A first look at ICAN's release of Pfizer/BioNTech's Covid shot EUA data
On July 21, 2025, the Informed Consent Action Network (ICAN) announced that it had secured the release of over 600,000 pages of Emergency Use Authorization (EUA) data used by the US Food and Drug Administration (FDA) to authorize and approve Pfizer-BioNTech’s COVID-19 vaccine (BNT162b2), following a successful lawsuit, culminating in a late 2024 court ruling.
These documents, now publicly available on ICAN’s website, are part of a broader release of over 1.6 million pages, including data from the vaccine’s licensure in August 2021 and the earlier EUA in December 2020.
This report builds on my prior investigative work analyzing thousands of FDA documents released following the Public Health and Medical Professionals for Transparency (PHMPT) lawsuit, which focused on the biological product file submitted by Pfizer for the full approval of its COVID-19 vaccine in August 2021.
I was one of the initial researchers to uncover and analyse the damning data hidden within Pfizer’s Pregnancy & Lactation Cumulative Review, Interim-Narrative-Sensitive document (3000+ pages), and Cumulative Analysis of Post-Authorization Adverse Event Reports document, among others.
Both ICAN and PHMPT’s lawsuits sought to make public the FDA’s data on the Pfizer-BioNTech’s COVID-19 shot, asserting that transparency is critical for public trust and independent analysis, given the global administration of billions of doses of this experimental gene-based product that was mandated in several countries.
My preliminary review of ICAN’s EUA data reveals several irregularities, outlined below with references to key documents and downloadable sources. This report focuses on four critical issues: manufacturing oversight gaps, missing Bell’s palsy data, clinical trial site deficiencies, and the exclusion of unconfirmed COVID-19 cases.
The last-minute request for manufacturing oversight
On December 10, 2020, one day before the FDA granted EUA for the Pfizer-BioNTech COVID-19 vaccine, Ramachandra Naik, Ph.D., a primary reviewer at the FDA’s Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review, sent an email to Pfizer’s Elisa Harkins Tull requesting a document clarifying the relationship between Pfizer, Inc. and BioNTech Manufacturing GmbH.
How could the FDA’s CBER, at such a critically late-stage, lack clarity on the relationship between Pfizer and BioNTech?
Concerningly, the request also sought last-minute clarification on how Pfizer was “assuring oversight of the aspects of the manufacturing process conducted by BioNTech and any other entity responsible for any aspect of manufacturing.”
This damning email raises red flags about the vaccine’s quality control and consistency, as well as pointing to significant gaps in regulatory scrutiny.
Clearly, significant oversight failures by Pfizer, BioNTech, and regulators concerning manufacturing have emerged since the rollout, including the mRNA integrity, DNA contamination and batch-specific adverse event scandals, which I have previously reported on.
The mRNA integrity scandal only came to light due to a data leak from the European Medicines Agency. Leaked EMA emails and confidential documents, dated November 10-25, 2020, revealed that the mRNA integrity in Pfizer/BioNTech’s commercial vaccine batches fell to as low as 55%, compared to 78% in clinical trial batches. Despite regulators, including the FDA, being aware of these significant concerns, EUA was granted just weeks later.
The missing information for the Bell’s palsy cases
The email dated December 8, 2020, from Captain Michael Smith of the Center for Biologics Evaluation & Research (CBER) to two Pfizer employees, urgently requesting the missing information on four participants from Pfizer-BioNTech COVID-19 vaccine phase III trial (study C4591001), who reported facial palsy (Bell’s palsy) is noteworthy for several reasons. Firstly, the email requesting Pfizer for a response “ASAP” was sent just three days before EUA was granted. This points to the intense rush in reviewing Pfizer’s submissions and raises serious questions over the trial’s data integrity.
Notably, it took eight months after EUA was granted, for Bell’s palsy to be added as a listed side effect in the August 23, 2021, prescribing information following the FDA’s full approval of the vaccine, overseen by CBER (the FDA division responsible for overseeing biologics, including vaccines). The package insert, under the “Postmarketing Experience” section, lists Bell’s palsy as a reported adverse event based on post-authorization data. Yet, CBER was aware of this reported side effect from the earlier clinical trial data but decided not to include it as a potential side effect on the original Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers on December 11, 2020.
However, the Bell’s palsy cases were disclosed in the FDA’s December 10, 2020, briefing document for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting- two days after Captain Mike Smith’s email request to Pfizer.
The briefing document noted four cases of Bell’s palsy among the vaccinated group (out of ~21,720 clinical trial participants) and none in the placebo group. Despite this adverse event of special interest, the FDA concluded: “The observed frequency of reported Bell’s palsy in the vaccine group is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time.”
Site #1125’s missing adverse event data
In addition to specific adverse events like Bell’s palsy, the EUA data reveal broader issues with clinical trial data integrity, particularly at certain trial sites. The screenshot below is taken from a December 2, 2020, memo sent by Captain Michael Smith to Pfizer’s Elisa Harkins detailing significant issues identified during an FDA inspection of site number 1125, one of the 153 clinical trial sites. It was issued shortly after an FDA inspection and barely a week before the VRBPAC meeting- where EUA was granted the next day.
The memo raises concerns about missing data in subject source documents, which should have been collected via subject eDiaries through the TrialMax app (designed to capture real-time subject data).
The missing information, particularly toxicity grading (assessing the severity of adverse effects), respiratory treatment, and hospitalization data for COVID-19 illness visits, highlights critical gaps in monitoring COVID-19 severity during Pfizer’s pivotal trial. It is also serves as further evidence of incomplete source data, which can obscure safety signals and affect the assessment of vaccine effectiveness.
Furthermore, the FDA’s request for Pfizer to report similar issues at other U.S. sites suggests that site #1125’s problems may not have been isolated but an indicator of widespread failure in data capture.
According to a report in the The BMJ, only “nine of the trial’s 153 sites were inspected,” with limited data verification due to the trial’s ongoing status.
Whistleblower, Brook Jackon, a former regional director at Ventavia Research Group (a Pfizer contractor) reported to The BMJ that “the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.”
After repeatedly notifying Ventavia of these problems, Jackson emailed a complaint to the FDA on September 25, 2020. Ventavia fired her later the same day.
My March 2022 interview of Jackson for Trial Site News detailed further claims, including improper vaccine storage, mislabeled lab specimens, fabricated informed consent signatures, and untested potentially COVID-19-positive participants due to supply shortages.
The 2449 subjects who missed Dose 2
The screenshot below is taken from a telephone conversation record (conducted via WebEx) of the November 25, 2020, teleconference between Pfizer and the FDA’s CBER. It summarizes 12 dataset-related questions from Captain Smith’s November 24 email. In particular, two issues stand out: the 2,449 subjects who missed their second dose and the exclusion of over 3,000 unconfirmed COVID-19 cases.
It is notable that close to 2500 subjects missed their second vaccination in the EUA database, including recent enrolees and withdrawals. This raises questions about participants’ reasons for not completing the vaccination schedule.
The exclusion of over 3,000 unconfirmed COVID-19 cases
The screenshot below is taken from the same telephone conversation record between Pfizer and the FDA’s CBER. Pfizer’s response to CBER’s question 5 states that over 3,000 subjects reported potential COVID-19 symptoms prompting nucleic acid amplification test (NAAT) swabs but were not confirmed as meeting the primary endpoint case flag (CDECASE), defined as a PCR-confirmed COVID-19 case with symptoms occurring at least 7 days after the second dose.
These unconfirmed cases were recorded as efficacy assessment data in Case Report Forms (CRFs) rather than adverse events (AEs) or serious adverse events (SAEs), unless deemed unusually intense, frequent, or vaccine-related by investigators.
If the exclusion of over 3,000 unconfirmed cases (roughly 8% of the core safety population, 37,586) included vaccine-related symptoms, misclassification as non-SAEs could have skewed the vaccine’s efficacy by undercounting events leading to an inflated 95% estimate based on the alleged 162 cases in the placebo group (n=21,728), versus 8 cases in the vaccine group (n=21,720).
Notably, when “CBER asked about viral load and PCR cycle threshold, Pfizer replied that the viral load endpoint is in the protocol and they would have to ask their lab personnel about the PCR question.”
It is highly relevant what PCR cycle threshold was used by Pfizer’s lab personnel- given that higher PCR cycle thresholds (Ct values) increase the likelihood of false positives and lower ones increase the likelihood of false negative cases.
The fact that CBER inquired about the PCR cycle threshold highlights a critical gap in oversight, as they were unaware of the value used, and, unbelievably, Pfizer did not know either, needing to consult with their lab personnel to provide an answer.
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I truly appreciate all of the hard work you have done to provide this information. Early on I became aware of the irregularity of Pfizer being allowed EUAs in December of 2020 when in March of 2020 NIH published (on PubMed) research indicating hydroxychloroquine was effective against the SARS-CoV-2 virus, and in June of 2020's Journal of Antibiotics, research was published indicating ivermectin was effective against the virus. That they are being allowed to continue operating under EUAs when the "emergency" was declared over a year or more ago is obscene. Makary's FDA should have pulled those on Day1.
Thank you for this!