Le désastre sanitaire ne fait que commencer I Christine Cotton

Key statements

• Transmission was never studied in the registration trial. ▶ 03:57
  Sources: Pfizer C4591001 Protocol
• Results were provided after only a three-month interim follow-up, even though the trial was designed to last two years. Safety beyond three months therefore could not be asserted. ▶ 04:01
  Sources: Pfizer C4591001 Protocol; Pfizer C4591001 interim clinical study report (Dec 2020)
• From December 2020 onward, the Pfizer trial's primary endpoint counted only mild and moderate PCR-confirmed COVID cases, measured 7 days after dose 2. Had cases been counted by anti-nucleocapsid serology, efficacy would have been roughly 50%, not 95%. ▶ 04:25
  Sources: Pfizer C4591001 interim clinical study report (Dec 2020)
• The December 2020 report shows no demonstrated effect on severe cases and no demonstrated effect on participants over 75 years of age. "It is written in the reports." ▶ 04:55
  Sources: Pfizer C4591001 interim clinical study report (Dec 2020)
• The same flawed methodology was reused without adjustment for the 11-15, 5-11, and 6-month-to-4-year trials, including authorization of 3-4 doses in infants whose COVID mortality risk is extremely low. ▶ 05:45
  Sources: Pfizer pediatric trial reports (12-15 yrs, 5-11 yrs, 6 months-4 yrs)
• ICH Good Clinical Practice standards — the same standards her CRO was repeatedly audited against by Ipsen and the FDA — are not respected in the COVID trials. ▶ 06:55
  Sources: ICH-GCP guidelines
• The leaked Pfizer-South Africa contract (signed April 2021) declared the Phase 2-3 clinical trials "completed" — impossible, since the protocol called for two years of follow-up. If the underlying results are false, the liability shield in those contracts may be void. ▶ 09:21
  Sources: Leaked Pfizer-South Africa supply contract (April 2021)
• The vaccine administered to the public is not the vaccine of the clinical trial: the manufacturing chain (Process 2) was changed, with the new process tested per protocol on only 250 patients per batch. mRNA integrity of the rolled-out product is lower than in the trial product, and independent vial analyses show DNA impurities. ▶ 13:31
  Sources: Pfizer C4591001 Protocol (Process 2 amendment); Pfizer C4591001 trial database (FOIA / court-released)
• The December 2020 EU Risk Management Plan formally records gaps for pregnant women, immunocompromised patients, and co-administration with other vaccines (no interaction study) — at the moment of authorization. ▶ 16:30
  Sources: Comirnaty Risk Management Plan (Dec 2020, EMA)
• A Moderna SEC filing acknowledges these products are gene therapies that were classified as vaccines to accelerate development — bypassing the additional animal and human testing a gene therapy would have required. ▶ 22:44
  Sources: Moderna SEC 10-K / S-1 filing (gene-therapy classification)
• At an FDA / CDC public meeting on 22 October 2020, regulators presented a long list of adverse events to actively monitor: Guillain-Barré, transverse myelitis, encephalitis, myocarditis/pericarditis, anaphylaxis, stroke, thrombocytopenia, disseminated intravascular coagulation, autoimmune disease, and more. The harms were anticipated before rollout. ▶ 26:31
  Sources: FDA VRBPAC meeting (22 Oct 2020) — adverse events of special interest slide deck
• Trial participants who suffered serious adverse events were ignored: Brian Dressen (AstraZeneca), Augusto Roux (Pfizer adult arm, Argentina, nearly died), Maddie de Garay (Pfizer adolescent arm, 35 serious adverse events, testified to Senator Ron Johnson). ▶ 31:16
  Sources: Augusto Roux medical file; Maddie de Garay testimony to Sen. Ron Johnson
• After Cotton posted her January 2022 report to LinkedIn, the post was visited (in two days, before LinkedIn closed her account) by 133 lawyers and by people from the US State Department, French National Gendarmerie, Ministry of the Armed Forces, Ministry of the Interior, Apple, the WHO, Thales, Airbus, and various state agencies. ▶ 32:43
  Sources: Cotton — January 2022 expertise report (LinkedIn post)

Documents cited

• Pfizer C4591001 Protocol — NEJM supplementary materials
• Pfizer C4591001 interim clinical study report (December 2020) — FDA briefing documents, Dec 2020 VRBPAC
• Comirnaty EU Risk Management Plan (December 2020) — EMA EPAR archive
• Pfizer C4591001 trial database (court-released) — Court orders following FOIA / PHMPT litigation
• Leaked Pfizer-South Africa supply contract (April 2021) — Health Justice Initiative (S. Africa) disclosure
• Moderna SEC filing referencing gene-therapy classification — SEC EDGAR
• FDA VRBPAC meeting (22 October 2020) — adverse-event monitoring slides — FDA / CDC public materials, available on the FDA YouTube channel
• Christine Cotton — Expertise report (January 2022 version) — christinecotton.com
• Andrew Bridgen — UK Parliament speech on excess mortality (Dec 2023) — Hansard

• Locate the page(s) in the Pfizer C4591001 December 2020 interim report (or FDA briefing document) that show no demonstrated efficacy in participants over 75 years of age. Cotton says "it is written in the reports" — the FOIA'd / court-released Pfizer documents and the December 2020 FDA VRBPAC briefing should both contain this. Capture page numbers and add to the archive.Cotton states this twice for emphasis at ~02:00 of the Cercle Aristote interview. The flagship FOIA-able citation.

  Sources she cites in the book

  • 30 FDA — William Gruber (Pfizer) VRBPAC presentation slides for BNT162b2, FDA meeting of 10 December 2020 (efficacy results by age group)
  • 32 VIDAL (vidal.fr) — COMIRNATY vaccine page, February 2021 (Wayback Machine archive, captured 25 Feb 2021)
  • 192 French National Assembly / OPECST — information report 'The Covid-19 Vaccine Strategy' (l15b3695), 15 December 2020
• Find and link the leaked Pfizer-South Africa supply contract (April 2021) that declares Phase 2-3 clinical trials "completed." Likely the Health Justice Initiative disclosure.Cited at ~08:47 as proof that contracts were signed on impossible claims about trial completion.

  Document located

  • Health Justice Initiative (South Africa) — redacted Pfizer/South Africa COVID-19 vaccine supply agreement (released Sept 2023)
• Find the Moderna SEC filing (10-K or S-1) that classifies mRNA products as gene therapies. Cotton references it as the smoking-gun reclassification document.Cited at ~19:30 — the smoking gun for the vaccine-vs-gene-therapy reclassification argument.

  Sources she cites in the book

  • 295 Moderna, Inc. — Annual Report Form 10-K for fiscal year ended 31 December 2019 (filed with U.S. Securities and Exchange Commission, EDGAR) ⧉ archived
• Archive the FDA VRBPAC 22 October 2020 adverse-events-to-monitor slide deck (the list of Guillain-Barré, encephalitis, myocarditis, etc.) — available on the FDA YouTube channel.Cited at ~19:30 as proof harms were anticipated before rollout.

  Sources she cites in the book

  • 91 FDA YouTube channel — video recording of the VRBPAC public meeting broadcast live 22 October 2020
  • 92 FDA — full transcript of the VRBPAC meeting of 22 October 2020
  • 93 FDA — Tom Shimabukuro (CDC) presentation slides, VRBPAC meeting 22 October 2020 (Preliminary list of VAERS AEs of special interest)
  • 94 FDA — Steve Anderson (FDA CBER) presentation slides, VRBPAC meeting 22 October 2020
• Locate the Pfizer C4591001 protocol section limiting Process 2 manufacturing validation to 250 patients per batch.Central to the "product administered is not the product tested" argument (~11:20).

  Sources she cites in the book

  • 296 NEJM — Pfizer/BioNTech C4591001 clinical study protocol (supplementary appendix to Polack et al., NEJMoa2034577, December 2020) ⧉ archived
  • 299 EMA — Comirnaty EPAR public assessment report (CHMP assessment report, 19 February 2021)
  • 300 BMJ — rapid response by Joshua Guetzkow on the Pfizer manufacturing-process change (bmj.o1731) ⧉ archived