Actualité de la semaine et invitée exceptionnelle, la biostatisticienne Christine COTTON

Key statements

• The biostatistician is the guarantor of an essai's methodology — calculating the sample size, writing the protocol, running the analyses. Doctors are not equipped to read the resulting tables; they typically call statisticians for help. ▶ 40:07
  Sources: ICH-GCP guidelines
• The 95% efficacy headline comes from a primary endpoint defined as a first occurrence of PCR-confirmed symptomatic COVID counted seven days after dose 2 — a participant-driven case definition. ▶ 44:21
  Sources: Pfizer C4591001 Protocol
• Symptoms triggered by the vaccine itself (chills, fever, diarrhea, vomiting) overlap with COVID symptoms. Doctors couldn't tell them apart, so testing was often skipped — "no test, no Covid." ▶ 46:47
  Sources: Pfizer C4591001 Protocol
• Vaccine-arm participants took antipyretics roughly 3 to 4 times more often than placebo. Suppressed symptoms meant no testing — and the headline 95% efficacy figure is therefore wrong. ▶ 47:29
  Sources: Pfizer C4591001 interim clinical study report (Dec 2020) — antipyretic use tables
• The second major problem: no antibody titre measurement at three months post-dose 2. Had Pfizer measured at that timepoint, the waning of protection would have been visible before September 2021's booster announcement. ▶ 48:50
  Sources: Pfizer C4591001 Protocol (immunogenicity schedule)
• Participants were supposed to be followed 24 months. Interim analyses leading to marketing authorization for an accelerated-development product after only three months of follow-up is, in Cotton's words, unprecedented. ▶ 49:24
  Sources: Pfizer C4591001 Protocol
• An October 2021 report on the 5-11 trial explicitly states the sample size is too small to detect myocarditis. Small samples can't surface rare serious harms — which makes post-authorization follow-up all the more crucial. ▶ 51:50
  Sources: Pfizer C4591001 pediatric (5-11 yrs) clinical study report (October 2021)
• Maddie de Garay, a 12-15 trial participant, suffered 35 adverse events and is now wheelchair-bound with a gastric feeding tube. Her serious adverse event is not in the clinical report. ▶ 52:37
  Sources: Pfizer C4591001 pediatric (12-15 yrs) clinical study report
• Senator Ron Johnson is collecting adverse-event testimony from trial victims who otherwise have no recourse, and Cotton notes there is pressure to silence such victims. ▶ 53:13
  Sources: Sen. Ron Johnson testimony series (US Senate)
• Real-world protection lasts about four months — meaning a booster every four months. The HAS December 2020 advisory already noted Pfizer was studying boosters at that time. ▶ 54:01
  Sources: HAS opinion (December 2020) on Comirnaty
• These vaccines were not designed to block transmission. HAS and ANSM both confirm transmission was not studied in the trial — anyone claiming otherwise is engaged in disinformation. ▶ 55:19
  Sources: Pfizer C4591001 Protocol; HAS opinion on Comirnaty
• A Santé publique France preprint shared on her Twitter shows the booster has no significant effect under age 80 — undercutting the pass vaccinal's stated public-health rationale. ▶ 59:50
  Sources: Santé publique France preprint (booster effectiveness)
• The Comirnaty package leaflet states pregnant women should be vaccinated only if benefits outweigh risks — i.e., case-by-case. Cotton was publicly attacked (by LREM MP Coralie Dubost) for sharing this official notice. ▶ 01:01:02
  Sources: Comirnaty SmPC / package leaflet
• Cotton's report concluded with a formal demand for suspension of the vaccine. The Quebec lawyer who commissioned the report was, ten days after pleading, ordered to undergo a psychiatric evaluation. ▶ 01:02:50
  Sources: Cotton — January 2022 expertise report

Documents cited

• Pfizer C4591001 Protocol — NEJM supplementary materials
• Pfizer C4591001 interim clinical study report (December 2020) — FDA briefing documents, Dec 2020 VRBPAC
• Pfizer C4591001 pediatric clinical study reports (12-15 yrs; 5-11 yrs, Oct 2021) — FDA briefing documents
• Comirnaty SmPC / package leaflet — EMA EPAR archive / ANSM
• HAS opinion on Comirnaty (December 2020) — Haute Autorité de Santé
• Cotton — Expertise report (January 2022) — christinecotton.com
• Santé publique France preprint (booster effectiveness) — shared on Cotton's Twitter feed

• Locate the Pfizer C4591001 5-11 yrs October 2021 clinical study report (the FDA briefing for the pediatric authorization) and capture the page where it explicitly says the sample size is too small to detect myocarditis.Cited at ~51:50 as the strongest pediatric-trial admission.

  Sources she cites in the book

  • 76 FDA — Pfizer/BioNTech BNT162b2 clinical data for adolescents (12-15 yrs) / Maddie de Garay SAE narrative, FDA media document (April 2021)
  • 74 FDA — Pfizer/BioNTech clinical report for adolescents aged 12-15 and young people under 25, FDA media document (released April 2021)
  • 123 FDA — Pfizer/BioNTech COVID-19 vaccine pediatric (6 months-4 years / under-5) clinical data, FDA media document (2022)
  • 115 FDA — Pfizer/BioNTech COVID-19 vaccine 5-11 years FDA briefing/clinical document presented to VRBPAC, FDA media document (26 October 2021)
  • 116 FDA — Pfizer/BioNTech COVID-19 vaccine 5-11 years FDA briefing/clinical document presented to VRBPAC, FDA media document (26 October 2021)
  • 117 FDA — Vaccines and Related Biological Products Advisory Committee (VRBPAC) October 26, 2021 meeting announcement
  • 118 ClinicalTrials.gov — Pfizer/BioNTech pediatric trial C4591007 (NCT04816643), registry record
• Find the Santé publique France preprint on booster effectiveness in under-80s that Cotton shared on Twitter in early February 2022; archive a copy with publication metadata.Cited at ~59:50 as undercutting the public-health rationale for the pass vaccinal.
• Capture the Comirnaty SmPC / package leaflet section on pregnancy that triggered Cotton's clash with MP Coralie Dubost.Mentioned ~01:01:02 — useful for a future entry on official labels vs public messaging.

  Sources she cites in the book

  • EMA — Comirnaty EPAR Summary of Product Characteristics / Product Information (current, undated version)
  • EMA — Comirnaty EPAR Product Information / SmPC, archived version of 24 December 2020 (via Wayback Machine)
  • 48 EMA — Pfizer Comirnaty Risk Management Plan (RMP) summary, 25 December 2020 (archived via Wayback Machine)
  • 246 HAS (Haute Autorité de Santé) — Vaccination strategy: place of the mRNA vaccine Comirnaty (BNT162b2), opinion of December 2020 (modified February 2021) ⧉ archived
  • 247 UK Government (MHRA) — Summary Public Assessment Report for Pfizer/BioNTech COVID-19 vaccine, section 3.4 Toxicology ⧉ archived
• Document the case of the Quebec lawyer who commissioned Cotton's January 2022 report and was subsequently ordered to undergo a psychiatric evaluation — verify name, date, and outcome.Cited at ~01:02:50 — Cotton presents the timing as a coincidence but flags it as troubling.

  Sources she cites in the book

  • Christine Cotton — expert report on the Pfizer/BioNTech clinical trial, completed mid-January 2022 (commissioned by Canadian lawyer Gloriane Blais for the Quebec Court of Appeal)