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Les essais cliniques de Pfizer sont-ils frauduleux ? Avec Christine Cotton

Sud Radio · Dailymotion · Watch ▶

📅 2022-02-24🎙️ André Bercoff (host)📺 Sud Radio⏱ 18 min
“The famous 95% in December 2020 is wrong. I can't say if it was 75, 70, 53, 45 — but it is wrong. In 23 years of my career, I've never seen a trial of this mediocrity. When that's the case, you suspend the product.”

Key statements

  • Cotton examined Pfizer's own source documents: the C4591001 protocol, the clinical study reports for the 16+, 12-15, and 5-11 populations, and the EU Risk Management Plan — a document the manufacturer itself prepares for products requiring real-world surveillance. ▶ 01:10
    Sources: Pfizer C4591001 Protocol; Pfizer C4591001 clinical study reports; Comirnaty Risk Management Plan
  • The 95% headline of December 2020 is wrong, due to methodological biases that favor the vaccine. Cotton cannot say whether the true figure is 75, 70, 53, or 45 — only that it is not 95. ▶ 02:39
    Sources: Pfizer C4591001 interim clinical study report (Dec 2020)
  • The protocol did not schedule an antibody titre measurement at three months post-dose 2 — only at six months. A three-month titre would have shown the waning protection that Pfizer only acknowledged before the CDC in September 2021. ▶ 04:04
    Sources: Pfizer C4591001 Protocol (immunogenicity schedule)
  • The HAS December 2020 opinion explicitly notes no demonstrated efficacy on transmission. Pfizer was already studying a booster at that same moment — implying they knew protection wouldn't last. ▶ 05:18
    Sources: HAS opinion on Comirnaty (December 2020); Pfizer booster sub-study (Dec 2020 amendment)
  • Maddie de Garay, a participant in the 12-15 trial, suffered 35 adverse events and is now wheelchair-bound with a gastric feeding tube. The clinical study report reduced this to "abdominal pain." ▶ 06:23
    Sources: Pfizer C4591001 pediatric (12-15 yrs) clinical study report
  • Populations excluded from the trial — pregnant women, immunocompromised, comorbid patients, co-administration with other vaccines — are formally flagged in the Risk Management Plan for close real-world monitoring. They were vaccinated anyway. ▶ 07:41
    Sources: Comirnaty Risk Management Plan (December 2020, EMA)
  • In 23 years of clinical-trial work, Cotton says she has never seen a trial of such mediocre quality — GCP violations, methodological biases everywhere — and that this invalidates the headline results. The proper response is to suspend the product. ▶ 08:48
    Sources: ICH-GCP guidelines
  • Cotton refuses to argue real-world efficacy in over-65s on top of biased trial results — GCP exists to prevent exactly this kind of post-hoc reasoning. The ICH framework is designed to minimize the risk of authorizing a product that harms the public. ▶ 10:33
    Sources: ICH-GCP guidelines
  • The Ventavia case (whistleblower Brook Jackson, three centers documented in the BMJ) shows poorly-monitored patient follow-up. With ~150 trial centers, Cotton calls for an independent audit — not one performed by Pfizer itself. ▶ 15:12
    Sources: Ventavia whistleblower case (BMJ, Thacker, November 2021)
  • Cotton submitted her report — alongside the patient-association Verity (which collects adverse-event reports including serious cases up to death) — to France's ANSM and was awaiting a response. ▶ 17:31
    Sources: Cotton — Expertise report (January 2022); Verity association adverse-event collection

Documents cited

  • Pfizer C4591001 Protocol — NEJM supplementary materials
  • Pfizer C4591001 clinical study reports (16+, 12-15, 5-11) — FDA briefing documents and EMA EPAR archive
  • Comirnaty Risk Management Plan (December 2020) — EMA EPAR archive
  • HAS opinion on Comirnaty (December 2020) — Haute Autorité de Santé
  • Ventavia whistleblower case (Thacker, BMJ 2021) — BMJ 2021;375:n2635
  • Cotton — Expertise report (January 2022) — christinecotton.com
  • ICH-GCP guidelines — International Council for Harmonisation

Research follow-ups

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