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[DEBRIEF] La biostatisticienne Christine Cotton sur l'efficacité du vaccin anti-COVID Pfizer

Michèle Rivasi · YouTube · Watch ▶

📅 2022-05-02🎙️ Michèle Rivasi (MEP, Europe Écologie Les Verts) — post-OPECST debrief📺 Michèle Rivasi — YouTube channel⏱ 49 min
“On the basis of the December 2020 evidence, no authorization should have been granted for these products — three months' follow-up is insufficient, efficacy is biased, and the benefit-risk ratio is, plainly, false.”

Key statements

  • Cotton was heard in camera by the OPECST (French Parliamentary Office for Scientific and Technological Assessment) following a 33,000-signature petition on COVID-vaccine adverse events. The hearing brought together deputies and senators across the political spectrum. ▶ 03:07
    Sources: OPECST hearing transcript (in camera, 2022); French Senate petition on COVID-vaccine adverse events (2022)
  • The 95% headline corresponds to only 0.84% absolute reduction in symptomatic-PCR-confirmed COVID. Recasting the same data as an absolute-risk difference makes the result look very different. ▶ 09:24
    Sources: Pfizer C4591001 interim clinical study report (Dec 2020)
  • Vaccine-group participants used antipyretics more often than placebo; participants self-reported symptoms; PCR testing was triggered only by symptom reporting. No symptoms → no test → no COVID counted as a success for the vaccine. ▶ 10:33
    Sources: Pfizer C4591001 interim clinical study report (Dec 2020) — antipyretic use tables
  • Neutralizing antibody titres were already declining two months after dose 2 by December 2020 — visible in both the preclinical macaque data and the human Phase 1-2. Pfizer chose to take no further measurement, so the December 2020 dossier did not show the decline. ▶ 13:05
    Sources: Pfizer preclinical macaque study; Pfizer C4591001 Protocol (immunogenicity schedule)
  • France's HAS, in December 2020, noted that Pfizer was already studying a booster. The progression from 2 → 3 → 4 doses, with the US now discussing a fifth, was therefore pre-known, not discovered later. ▶ 14:28
    Sources: HAS opinion on Comirnaty (December 2020)
  • Maddie de Garay (Pfizer 12-15 trial, Cincinnati site) suffered vomiting, nausea, memory loss; is wheelchair-bound and fed by gastric tube. None of this appears in the clinical report. Cotton learned of the case through Sen. Ron Johnson's victim-testimony hearings. ▶ 17:48
    Sources: Maddie de Garay testimony to Sen. Ron Johnson; Pfizer C4591001 (12-15 yrs) clinical study report
  • Across the adult, adolescent, and 5-11 reports, there is no statistically significant effect on severe cases — there were too few severe cases in the trial to demonstrate one. The official narrative that the vaccine "prevents severe disease" is therefore not supported by the registration trials. ▶ 18:06
    Sources: Pfizer C4591001 interim clinical study report (Dec 2020); Pfizer pediatric trial reports (12-15 yrs, 5-11 yrs)
  • Pregnant women, immunocompromised patients, patients with comorbidities (diabetes, COPD), and those over 75 with sufficient power were not studied in the trial — yet were the first vaccinated. Co-administration with the flu vaccine was authorized despite no interaction study. ▶ 21:59
    Sources: Pfizer C4591001 interim clinical study report (Dec 2020); Comirnaty Risk Management Plan (Dec 2020, EMA)
  • The December 2020 OPECST report itself records that on the first day of UK vaccination, severe allergic reactions occurred, and that people carrying an adrenaline pen should not be vaccinated. That warning was disregarded by French policy. ▶ 28:26
    Sources: OPECST report (December 2020) on COVID-19 vaccination
  • At 6-month follow-up the trial shows 15 deaths in the vaccine arm and 14 in placebo, with 2 COVID deaths in placebo and 1 in vaccine — no statistically meaningful effect on COVID mortality, and no effect on total mortality. ▶ 35:02
    Sources: Pfizer C4591001 6-month follow-up clinical study report
  • If this trial is accepted, it is the end of 30-40 years of reliable clinical research. McKinsey, in a self-congratulatory article, says the next target is 100-day vaccines — Cotton notes that 325-day vaccines already produced this much harm. ▶ 39:44
    Sources: McKinsey article on accelerated vaccine development (2022); ICH-GCP guidelines

Documents cited

  • Pfizer C4591001 interim clinical study report (December 2020) — FDA briefing documents, Dec 2020 VRBPAC
  • Pfizer C4591001 6-month follow-up clinical study report — FDA briefing documents
  • Pfizer pediatric trial reports (12-15 yrs, 5-11 yrs) — FDA / EMA submission archives
  • Comirnaty Risk Management Plan (December 2020, EMA) — EMA EPAR archive
  • HAS opinion on Comirnaty (December 2020) — has-sante.fr archive
  • OPECST report on COVID-19 vaccination (December 2020) — Assemblée nationale / Sénat archive
  • Maddie de Garay testimony to Sen. Ron Johnson — Sen. Ron Johnson public events
  • ANSM pharmacovigilance reports — ansm.sante.fr
  • McKinsey article on accelerated vaccine development (2022) — McKinsey.com — health-industry briefing

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