Pfizer C4591001 / Roux case — fraud timeline

Augusto Roux receives first dose at 18:50 hs at Hospital Militar Central (Polack's site). Trial Subject ID: 12312982. Roux signed IC v30-JUN-2020 at 17:36 (same act, no witness — site judged non-vulnerable).

Roux receives second dose. Begins symptoms (shortness of breath, chest pain) on the way home.

Roux is hospitalized at Hospital Alemán with right paracardiac radio-opacity. PCR for SARS-CoV-2 negative; chest CT without alterations. The site's own clinical record (F19, Dr. Ivonne Name 16 Sept 2020) interprets the clinical picture as "síndrome febril secundario a reactogenicidad severa relacionada al producto en investigación" — severe reactogenicity RELATED to the investigational product.

IECS site classification: AE RELATED to IP. Dr. Ivonne Name (Matrícula 100.079) records in Roux's Eventos Adversos HC that the 12-14 Sept Hospital Alemán event was "síndrome febril secundario a reactogenicidad severa relacionada al producto en investigación". Negative SARS-CoV-2 PCR is acknowledged. This is the original site classification — later overridden by Pfizer (see 2020-10-07 row).

Audio recording — Polack, 22:32 (Hospital Militar context).

Pfizer records Roux's withdrawal from VACCINATION + FOLLOW-UP same day (per Pfizer SDTM safety narrative F20). Reason: "WITHDRAWAL BY SUBJECT". Same date Pfizer's AE record for "severe anxiety" begins (23:00) — later classified by Pfizer to FDA as "NOT RELATED / OTHER: constitutive features". Roux himself reports leaving the trial on 8 October 2020 (per F16 / Lucesole), so the 23-Sept date is Pfizer's own internal recording of withdrawal, not Roux's account.

Real-time sponsor and hospital awareness of Roux's post-dose event. Contemporaneous WhatsApp exchanges with Andrea Szyferman of the "Arg Vacuna COVID" / Pfizer iTrials follow-up channel, and emails involving Hospital Alemán Infectology and the trial/research team, document Roux's post-second-dose fever, abnormal liver studies, pulmonary findings, hospitalization, and pending follow-up. Hospital Alemán records and epicrisis materials are transmitted to the trial contact. The Hospital Alemán physician advises the research team to record the case and avoid interfering with independent medical follow-up. A later CIREC / Hospital Militar FOIA response (Aug 2021) confirms an AE related to the investigational product had been reported with "favorable evolution." Establishes that Pfizer/iTrials and the Hospital Militar trial structure were aware of Roux's situation in real time.

Roux files complaint with ANMAT (via "ANMAT Responde") — serious adverse event requiring hospitalization, requests withdrawal from the protocol and unblinding.

ANMAT's second GCP inspection begins — complaint-driven (the Roux complaint).

Virtual meeting: ANMAT ↔ Polack (PI) ↔ Pfizer sponsor. ANMAT instructs Pfizer to perform the unblinding for Roux.

Pfizer (the sponsor) requests Roux's adverse-event term be reclassified. Site staffer María Alejandra Neira (Matrícula 126.934) records in Roux's Eventos Adversos HC at 20:21: "Por solicitud del Sponsor se actualiza termino de evento adverso a Enfermedad COVID. Se envia formulario de seguimiento de EAS." — "At the sponsor's request the adverse-event term is updated to 'COVID disease'." On 09 Oct further refined to "Sospecha de enfermedad COVID-19" (Suspected COVID-19 disease), with a note acknowledging the PCR was negative. This is the smoking-gun reclassification that allowed Pfizer's FDA-facing narrative (F20) to label Roux's event "Suspected COVID-19 / NOT RELATED" despite the negative PCR — overriding Dr. Name's original "severe reactogenicity RELATED to IP" classification of 16 Sept.

Virtual interview ANMAT ↔ Roux. Same day Polack inscribes a "severe anxiety / constitutive nature" diagnosis into Roux's site record — three weeks after Roux's hospitalization for bilateral pneumonia. The Hospital Militar trial record (F23) shows Polack describing Roux as displaying "considerable exaltation, suspicion, intense anxiety and anger," including alleged concerns about a conspiracy between Hospital Alemán, Hospital Militar, and the sponsor — yet the file contains no psychiatric examination, mental-health consultation, validated assessment, or formal diagnosis supporting that characterization. Earlier trial records (Visits 1 and 2) had classified Roux as a healthy eligible participant with no psychiatric exclusion criteria. This gaslit diagnosis is the centerpiece cited by the later ANMAT/EMA reply (F11) and the 2025 ANMAT Legal Opinion (F14); the blind was broken the next day (9 Oct 2020), confirming Roux had received two 30 mcg doses of BNT162b2.

Pfizer S.R.L. formal written response to ANMAT — argues against unblinding on participant request (would "set a worrying precedent" and "put the integrity of the overall study at risk"), then agrees to unblind Roux specifically. Polack notifies Roux of his study-arm assignment.

ANMAT inspection minutes signed (IF-2020-69589916). The Buenos Aires City Ministry of Health audit summary; the curator's note: "everything known about the deceased appears in various texts of the audit; that audit is fatal."

Pfizer SDTM generates Roux's FDA-facing Safety Narrative at 10:49 GMT. Subject C4591001-1231-12312982. Pfizer's narrative classifies Roux's severe anxiety as "NOT RELATED / OTHER: constitutive features" (adopting Polack's reframe) and the 9-Sept hospitalization as "Suspected COVID-19 / NOT RELATED / OTHER: unknown" (post-Pfizer-requested-reclassification from F19). Omits the pericardial effusion, the cyclic-tachycardia chronic state, and the negative SARS-CoV-2 PCR. Released through PHMPT v. FDA under the Pittman order (FDA-CBER-2021-5683-0221408 et seq).

ANMAT transmits the GCP-inspection summary to EMA — the F11 report ("The inspection process has not been finished yet…"). First documented ANMAT→EMA correspondence on the Roux complaint, confirmed in the EMA's 28 Jan 2026 access-to-file letter (Documents 6 and 7 both begin with this date).

ANMAT↔EMA Inspection-team follow-up exchange on the Roux case (second documented EMA↔ANMAT email per Document 6).

Roux files a healthcare-fraud complaint with U.S. HHS-OIG. The complaint (generated 3 Feb / 2 Mar 2021) reports the Pfizer-BioNTech trial case (BNT162b2, C4591001) to the U.S. Department of Health and Human Services, Office of Inspector General, alleging alteration or misclassification of clinical-trial results. Identifies 9 Sept 2020 as the activity date and references prior reports already made to FDA, NIH/Ombudsman, VAERS, and the U.S. Department of Justice (initial prior reporting 3 Nov 2020). HHS-OIG issues a confirmation receipt 21 March 2021; a separate fax transmission to HHS-OIG is successfully completed 25 March 2021.

Further ANMAT↔EMA exchange on the Roux case (Document 6).

EMA internal handling of Roux's direct complaint begins. EMA Inspection Team summary email: "EMA has received a complaint by a subject enrolled at the site in Argentina where the study C4591001 is being conducted… The complaint is about the fact that the AEs developed by him after his vaccination were not carefully assessed/reported… and is mentioning other possible AEs (including deaths) not reported at the site." Rapporteur asked to assess impact.

EMA opens three parallel lines of inquiry on the Roux complaint within a 10-day window:

1. Scientific-reviewer track — Eudralink (EMA's secure document-transfer system) to the Rapporteurs (the lead scientific reviewers responsible for the BNT162b2 marketing authorization), 30 May. In essence: "this complaint may affect what you've already approved — please look."

2. Sponsor track — Eudralink to Pfizer (MAH = Marketing Authorization Holder), 1 June, then sustained back-and-forth on 2, 4, 5, 6, 7, and 8 June (Document 4). In essence: "Pfizer, explain yourself; here are our follow-up questions."

3. Internal-pharmacovigilance track — EMA Inspection Team ↔ EMA EudraVigilance team on 3–4 June, checking whether Pfizer had failed to report SUSARs (Suspected Unexpected Serious Adverse Reactions) from the Argentine site (Document 5). EudraVigilance is EMA's central database of adverse-event reports across the EU — i.e., they were verifying whether the Argentine site had silently missed mandatory reports.

Criminal complaint filed: CFP 003060/2021 (filed 2 June 2021) — National Federal Criminal and Correctional Court No. 4 of the Federal Capital. Charges include incompatible negotiations (Art. 265), active bribery, and abuse of authority / violation of public duties (Art. 248). Complainant: De Marchi and others; Roux later admitted as private prosecutor (querellante). This case is the federal criminal investigation pending before Judge Ariel Lijo, concerning alleged irregularities in the Argentine government's COVID-19 vaccine procurement decisions during the pandemic. Public reporting and the Federal Prosecutor's Office state that Judge Lijo ordered investigative statements from former officials and business figures, including Hugo Sigman, in connection with alleged delays or irregularities in the Pfizer vaccine negotiations and the possible benefit to other vaccine business interests.

David Healy clinical letter on Roux, co-signed by Dr. Gemma Torrell (family medicine, Barcelona) and Prof. Joan-Ramon Laporte (Spanish pharmacovigilance). Conclusion: Roux had a significant vaccine-linked injury; "Dr Polack and colleagues attempted to characterize Mr. Roux's problems as not linked to the vaccine and indeed attempted to claim that he had a mental illness." Reviews scans, Hospital Alemán records, the four overlapping Historia Clínica documents, and Roux's outreach to EMA/Pfizer/FDA/Anmat/OIG-HHS/NIH/German regulator.

Roux files Law 27,275 ("Pedido al Presidente") public-information request to President Alberto Fernández — invoking the Personal-Data Protection Law (25,326).

EMA changes its sharing posture with ANMAT after consulting Roux about which documents/records EMA may share with ANMAT (Document 9). The 2026 EMA access letter records: "Following the exchange of correspondence with you in October 2022, the Agency did not provide to ANMAT any documentation regarding your report."

Healy, Roux & Dressen publish "The coverage of medical injuries in company trial informed consent forms" in International Journal of Risk & Safety in Medicine (Vol 34, Issue 2) — three-trial analysis (paroxetine Study 329, Pfizer BNT162b2, AstraZeneca) of misleading consent-form language about medical-injury coverage. The article identifies Augusto Germán Roux as the 2020 Pfizer-BioNTech trial participant in Argentina and analyses the mismatch between independent medical records and Pfizer's trial / regulatory records. Received 6 Jul 2022; accepted 18 Jan 2023.

DW TV Español interview with Roux. Roux discusses on the international news outlet: the case of an allegedly unreported death, confidential military-related agreements that should have been signed by the Ministry of Health rather than the Ministry of Defense, underreporting and misclassification of adverse events (including his own), and the prior suspension of the Hospital Militar Ethics Committee by an Official Gazette resolution. Spanish version exceeded 154,000 YouTube views and was rebroadcast by television channels in Spain, the United States, and Latin America.

EMA exhausts the ANMAT route. EMA Inspection Team emails ANMAT 4 July 2023 and 4 August 2023 (Document 7); on 25 August 2023, the EMA team confirms internally that ANMAT has not responded and agrees to close case EI 2021-09 "as we have exhausted all routes for additional information."

EMA officially closes Roux's reporting case EI 2021-09. The decision is stated in the EMA's 28 Jan 2026 access-to-file letter: the closure rests on (a) regulatory remit, (b) "the absence of feedback received from ANMAT," and (c) GCP compliance of the site confirmed by relevant documentation.

Augusto Roux files criminal case CFP 1035/2024 (filing document dated 17 March 2024). Currently before Federal Judge Daniel E. Rafecas at the Federal Criminal and Correctional Court No. 3, Secretariat No. 6. Defendants named explicitly: Dr. Fernando Pedro Polack (ITRIALS / Hospital Militar Central), Dra. Alejandra Gurtman (Pfizer), and Dra. Nélida Agustina Bisio (ANMAT). Charges: Art. 292 CPN (falsedad ideológica), Art. 293 CPN (falsificación documental), Art. 295 CPN (issuance of false medical certificate — because the documents are signed by licensed physicians), Art. 106 CPN (abandono de personas y omisión de auxilio, for Polack and Bisio), Art. 249 CPN (incumplimiento de los deberes de funcionario público, for Bisio). Roux files in his own right and as his own legal counsel (Tomo 137 Folio 57 C.P.A.C.F.). The filing annexes Hospital Militar Central + Hospital Alemán clinical histories, ICON CRF records, and citations to international press (France Soir, Epoch Times, DW, Die Welt, BILD) and the Healy-Roux-Dressen academic paper. Distinct docket from CFP 003060/2021 (the procurement-irregularities case before Judge Lijo). In this same case, on 8 May 2026 Judge Rafecas ordered Hospital Militar Central to produce the clinical-trial documentation — see F21.

Independent psychological evaluation of Roux by Lic. Inés Lucesole (M.N. 20.048), commissioned to confirm or rule out the "constitutive psychiatric severe-anxiety illness" that Polack inscribed in Roux's site record on 8 Oct 2020 (F04). Battery: clinical interviews + Bender + graphic techniques (HTP, "Person in the Rain") + Desiderative test. Directly refutes the gaslit Polack diagnosis cited by ANMAT and EMA in their later replies.

ANMAT Legal-Affairs Directorate issues Dictamen Jurídicos (IF-2025-98988124). Findings: Roux is innocent of administrative accusations made against him; Polack committed irregularities but ANMAT says it cannot act on them; ANMAT itself was not impartial (the decision-maker was subordinate to the very person under investigation — the then-Administrator of ANMAT).

Roux files an Article 7(4) appeal under EU Regulation 1049/2001 to EMA (ASK-286563 confirmatory application) for access to documents on the conduct of C4591001 in Argentina, EMA's supervision, ANMAT inspection records transmitted to EMA, participant safety, and the completeness/accuracy/reliability of the clinical data underpinning the EU marketing authorisation.

EMA delivers full access-to-file response to Roux (EMA/22564/2026, signed by Evdokia Korakianiti, Human Medicines Division). Releases ten redacted-document bundles (Documents 1-10) covering: ANMAT inspection summary transmittal (Nov 2020), EMA↔Pfizer 2021 correspondence, EMA EudraVigilance SUSAR check at the Argentine site, EMA↔Roux clarifications, and the run-up to the Sept 2023 closure. Letter formally confirms: "the absence of feedback received from ANMAT" was a basis for closing the case.

Federal Judge Daniel E. Rafecas (Argentine Federal Criminal Court No. 3, Sec. 6) orders Hospital Militar Central to produce Roux's clinical-trial records for CFP 1035/2024 — the criminal case against POLACK, FERNANDO PEDRO Y OTROS for FALSEDAD IDEOLÓGICA, FALSIFICACIÓN DE DOCUMENTOS PÚBLICOS, EXPEDICIÓN DE CERTIFICADO MÉDICO FALSO (Art. 295) and ABANDONO DE PERSONAS. This is important because Judge Rafecas specifically requested, in digital format: Roux's clinical-trial medical record; all clinical data forms prepared in connection with his participation; all records concerning any follow-up performed by the investigator and his team after Roux left the trial; and all informed-consent forms signed by him. The court also instructed Hospital Militar Central that, if the documents are not held there, it must state where they are currently located. Distinct docket from the earlier CFP 003060/2021 — this is a newer criminal proceeding naming Polack et al. as defendants. Oficio Judicial DEO N° 23017441, digitally signed by Albertina A. Caron, 8 May 2026 11:36 ART.