Covid : où en sont les chiffres en 2023 ?

Key statements

• The 95% efficacy figure announced in December 2020 covered only mild and moderate PCR-confirmed COVID cases counted from 7 days after dose 2 — not asymptomatic cases, not excluded populations such as pregnant women, not patients with comorbidities. ▶ 05:46
  Sources: Pfizer C4591001 interim clinical study report (Dec 2020)
• In December 2020 there was no proven efficacy on severe cases. Cotton repeats that antibodies were not measured, in her view deliberately, to avoid showing they were declining. ▶ 06:16
  Sources: Pfizer C4591001 interim clinical study report (Dec 2020)
• Transmission was not studied in the trial. All of this could be known from the clinical-trial protocol from October 2020 onward — health agencies have known since the beginning because they hold the protocols. ▶ 06:52
  Sources: Pfizer C4591001 Protocol
• The leaked Pfizer-South Africa contract (signed April 2021) declares that the product had "completed" Phase 2-3 clinical trials. This is impossible: the Phase 3 trial began in July 2020 and was designed to last two years, so it could not have been completed by April 2021. ▶ 07:39
  Sources: Leaked Pfizer-South Africa supply contract (April 2021)
• By April 2021 the adolescent (12-15) clinical study report stated in black and white, on page 38, that the unknowns for adolescents were the same as for adults: duration of protection, efficacy in at-risk subgroups, efficacy on symptomatic cases, long-term effects, mortality, and transmission — all unknown. ▶ 08:19
  Sources: Pfizer C4591001 adolescent (12-15) clinical study report (April 2021)
• Results were released after a maximum of three months of follow-up, with 50% of participants followed for less than two months — yet authorizations were granted in December 2020 for elderly and immunocompromised people who had no demonstrated efficacy in the clinical report. ▶ 09:44
  Sources: Pfizer C4591001 interim clinical study report (Dec 2020)
• The Haute Autorité de Santé still recommends co-administering the Pfizer vaccine with the flu vaccine despite there being no clinical trial — no interaction study has ever been performed. ▶ 11:14
  Sources: Comirnaty Risk Management Plan (EMA)
• At the moment the Pfizer vaccine was authorized with its 95% headline, the manufacturing chain had just been changed (Process 2). The product administered to the public is not the product of the clinical trial. The EMA had voiced major reservations because the integral mRNA content of the commercial product was lower than in the trial product. ▶ 12:11
  Sources: Pfizer C4591001 Protocol (Process 2 amendment); EMA assessment report (Comirnaty)
• EudraVigilance (EMA) shows 1.2 million reported cases for the first monovalent Pfizer vaccine alone, with 25% serious. With a conservative 10-fold under-reporting factor, that would mean 12 million sick people in Europe. Cotton cites a 2006 publication co-signed by a French pharmacovigilance leader estimating under-reporting could require multiplying some serious cases by 100. ▶ 16:51
  Sources: EudraVigilance (EMA adverse-event database); 2006 French pharmacovigilance publication (Jean-Ville Bérat et al.)
• Documented risks were known and included in the Risk Management Plan: initially anaphylaxis (later removed), myocarditis/pericarditis, and disease enhancement where the vaccine fatigues the immune system instead of protecting. Cotton asks where the favorable benefit/risk ratio could possibly be found — "On the Moon? Certainly not on Earth." ▶ 17:51
  Sources: Comirnaty Risk Management Plan (EMA)

Documents cited

• 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)
• Leaked Pfizer-South Africa supply contract (April 2021) — Health Justice Initiative (S. Africa) disclosure
• EMA assessment report (Comirnaty) — Process 2 mRNA integrity reservations — EMA EPAR archive
• EudraVigilance (EMA) — adverse-event database — adrreports.eu
• 2006 French pharmacovigilance under-reporting publication (Jean-Ville Bérat et al.) — Peer-reviewed pharmacology journal
• ANSM February 2023 vaccine efficacy update (45% / 56% / 75% figures cited by host) — ansm.sante.fr

• Locate page 38 of the Pfizer C4591001 adolescent (12-15) clinical study report (April 2021) where the listed unknowns appear in black and white: duration of protection, efficacy on at-risk populations, efficacy on symptomatic cases, long-term effects, mortality, transmission.Cited at 08:19 — flagship documentary evidence that the unknowns persisted into the pediatric authorization.

  Sources she cites in the book

  • 74 FDA — Pfizer-BioNTech COVID-19 Vaccine, adolescent (12-15) clinical/EUA review document (released to the public April/May 2021)
  • 76 FDA — Pfizer-BioNTech COVID-19 Vaccine, adolescent (12-15) clinical/EUA review document (2021)
  • 79 PHMPT — Complaint, de Garay v. FDA (filed 11 Oct 2022), hosted at phmpt.org ⧉ archived
  • 83 CCNE (French National Consultative Ethics Committee) — opinion on ethical issues of COVID-19 vaccination in children and adolescents, 8 June 2021 ⧉ archived
• Archive the EMA assessment report passages flagging Process 2 mRNA-integrity reservations / major objections, and link them to the Process 2 amendment in the C4591001 protocol.Cotton states at 12:11 that EMA reservations are "all documented" — locating the EPAR passage gives the archive a durable citation.

  Sources she cites in the book

  • 299 EMA — Comirnaty EPAR public assessment report (CHMP assessment report, 19 February 2021)
  • 296 NEJM — C4591001 study protocol, supplementary appendix to Polack et al. (NEJMoa2034577), Dec 2020 ⧉ archived
  • 296 NEJM — Polack et al., Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (NEJMoa2034577), Dec 2020 ⧉ archived
  • 297 EMA — press release 'Cyberattack on EMA – update 5'
  • 298 EMA — press release 'Cyberattack on EMA – update 4'
  • 300 The BMJ — rapid response by Joshua Guetzkow to BMJ 2022;378:o1731 ⧉ archived
• Find and cite the 2006 French pharmacovigilance under-reporting publication co-signed by Marie-Josèphe (Jean-Ville) Bérat, including the figure that some serious adverse events should be multiplied by 100.Cited at 17:12 as the empirical basis for Cotton's 10×–100× under-reporting multiplier.

  Sources she cites in the book

  • 38 PubMed — Jonville-Béra et al., 2006 French pharmacovigilance article on vaccine adverse events (PMID 16343870)
• Cross-reference the ANSM February 2023 efficacy update (45% post-primovaccination, 56% after 3rd dose, 75% after 4th–5th doses, decaying to 22% at 6 months) with Cotton's commentary; add to the Archive Index sources.Bercoff reads the ANSM figures in the intro (~03:30); they frame the entire interview as the 95% / 4.25% / 45% reality check.