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La vérité sur les essais Pfizer - Le Zoom - Christine Cotton - TVL

Chaîne officielle TVL · YouTube · Watch ▶

📅 2023-10-11🎙️ Élise Blaise (TVL host)📺 TVL (TV Libertés) — Le Zoom⏱ 33 min
“I've never in my life as a biostatistician — since 1995 — seen a trial with methodology of this mediocrity. Never.”

Key statements

  • The South Africa Pfizer contract shows the state assuming the risk of ordering a product whose long-term tolerability and efficacy were not really known. ▶ 00:48
    Sources: Leaked Pfizer-South Africa supply contract (April 2021)
  • Page 8 of the South Africa contract states the product had "completed" Phase 2-3 clinical trials. This is impossible: the trial began July 2020 and was scheduled to run for two years. The April 2021 adolescent clinical study report listed all the key information as still missing — transmission, mortality, symptomatic cases, long-term protection and tolerability. ▶ 01:22
    Sources: Leaked Pfizer-South Africa supply contract (April 2021); Pfizer C4591001 adolescent (12-15) clinical study report (April 2021)
  • The European Commission's contract with Pfizer has not been seen by the public. MEPs were apparently shown it but were not allowed to keep a copy — "a vast masquerade," with redacted passages and (Cotton jokes) maybe even an electronic signature alongside the von der Leyen-Bourla SMS. ▶ 02:30
    Sources: EU Advance Purchase Agreements (Pfizer/BioNTech)
  • Since 1995 Cotton has never worked with anyone but competent professionals respecting Good Clinical Practice. A biostatistician is by definition incorruptible: they sign the clinical report and engage their responsibility on the results. ▶ 03:06
    Sources: ICH-GCP guidelines
  • Pfizer began Phase 1 in April 2020, Phase 3 in July 2020, recruited about 44,000 participants and reported in November 2020 with the famous 95% efficacy — measuring only mild and moderate PCR-confirmed COVID cases counted from 7 days after dose 2. ▶ 07:03
    Sources: Pfizer C4591001 Protocol; Pfizer C4591001 interim clinical study report (Dec 2020)
  • Phase boundaries were not respected: Phase 2 began before Phase 1 was finished; Phase 3 began before Phase 2 was finished; the interim analysis was done after only three months of follow-up, with 50% of participants (about 18,000 people) followed for less than two months. Cotton: "Is that enough hindsight for tolerability?" ▶ 08:45
    Sources: Pfizer C4591001 Protocol; Pfizer C4591001 interim clinical study report (Dec 2020)
  • The FDA gave Pfizer "a freeway" by changing the vaccine analysis guidelines to allow results after only three months of follow-up — unprecedented. Cotton asks why three months and not four: "Maybe at four months they would have measured the antibodies, and seen that they only last four months — so the vaccine couldn't be approved." ▶ 11:06
    Sources: FDA Guidance on Development and Licensure of Vaccines to Prevent COVID-19 (June 2020)
  • The pre-clinical monkey publication already showed antibodies rising and then falling. Olivier Véran's predecessor Jérôme Salomon publicly warned (France Info) that one should not place too much hope in the Pfizer vaccine because antibodies last only a few months — then disappeared from public communication. ▶ 12:19
    Sources: Pfizer-BioNTech pre-clinical macaque immunogenicity publication
  • Cotton wrote in January 2022 that the methods used in the Pfizer trial cannot guarantee that the results are reliable and faithful to GCP; she presented this to the OPECST (April 2022) and the ANSM (July 2022, behind closed doors). The ANSM told her the primary endpoint was "accepted by every health agency in the world" — leaving, in Cotton's words, three possibilities: mass stupefaction, mass incompetence, or deliberate choice to put a defective product on the market. ▶ 17:12
    Sources: Cotton — Expertise of the Pfizer C4591001 trial (January 2022); Cotton OPECST hearing (April 2022); Cotton ANSM hearing (July 2022, closed)
  • Multiple doses were planned from the start: by December 2020 Pfizer was already studying a booster. Antibodies were not measured — Cotton's reading is so they could not be shown to fall. When the public noticed waning at six months, the pre-planned booster was "pulled out of a hat." ▶ 18:22
    Sources: Pfizer booster sub-study (Dec 2020 amendment to C4591001)
  • Serious adverse events are missing from the clinical reports on adults and adolescents — Cotton has spoken to trial-injured participants who suffered severe harm that was never reported. "This is not OK by Good Clinical Practice: in a center, you have someone half-dying and the recruiting doctor doesn't report them." ▶ 21:03
    Sources: Pfizer C4591001 clinical study reports (adult + adolescent)
  • Maxime, age 22, died about 5-6 hours after his first injection while at table with his in-laws. The autopsy claims to find no allergy trace on the injection arm — but in fact examined the other arm, where the adrenaline shot used to try to resuscitate him had been administered. ▶ 22:38
    Sources: Maxime autopsy report (cited in book)
  • "Lucie" was given a vaccine her GP had "kept aside" because the friend-GP couldn't otherwise use the dose within the half-hour — and the GP refused to file a pharmacovigilance report. Cotton: doctors who don't report adverse events are committing a grave breach; pharmacovigilance signals cannot be calculated correctly if reports never reach the system. ▶ 24:00
    Sources: French pharmacovigilance reporting obligations
  • Cotton's prediction: a time will come when it is not anonymous victims dying in obscurity but "daughters of police officers, wives of judges" — then the case dismissals will be revisited. ▶ 27:15

Documents cited

  • Leaked Pfizer-South Africa supply contract (April 2021) — Health Justice Initiative (S. Africa) disclosure
  • Pfizer C4591001 Protocol — NEJM supplementary materials
  • Pfizer C4591001 interim clinical study report (December 2020) — FDA briefing documents, Dec 2020 VRBPAC
  • Pfizer C4591001 adolescent (12-15) clinical study report (April 2021) — EMA / FDA submissions (court-released)
  • EU Advance Purchase Agreements (Pfizer/BioNTech) — European Ombudsman OI/4/2022/PB
  • FDA Guidance on Development and Licensure of Vaccines to Prevent COVID-19 — FDA CBER, June 2020
  • Cotton — Expertise of the Pfizer C4591001 trial (January 2022) — christinecotton.com
  • OPECST hearing of Christine Cotton (April 2022) — Assemblée nationale / Sénat OPECST

Research follow-ups

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