https://christinecotton.fr/english_expertise_updated
This document has been used in complaints against French health authorities, a legal action for abuse of power against the ANSM (French National Agency for Medicines and Health Products Safety), and a criminal complaint for aggravated deception and administering a substance without consent.
This report demonstrates that the population has not received the product tested into the clinical trial with the 95% efficacy so touted by politicians, journalists, and TV doctors, and that, at the time it was authorized, there were no results on efficacy and satefty.
It highlights incomplete results, multiple risks and missing information, as well as numerous methodological problems and even fraud that invalidate all the results.
If you don't have the courage to read it in its entirety, at least read the conclusion, which is unequivocal. This product is the biggest scandal in the history of the pharmaceutical industry: lies, mass manipulation, refusal to acknowledge the victims…
In the future, be vigilant.
Abstract:
This report evaluates the methodological practices and clinical data from the mRNA COVID- 19 vaccine trials sponsored by Pfizer, focusing on Good Clinical Practice (GCP), efficacy, and safety outcomes. It has been established by examining
- the pivotal study clinical reports on adults over 16 years of age (December 2020 -interimanalysis at 3 months, New England Journal of Medecine publication - six-month interimanalysis, July 2023 – final analysis)
- the trial results in the adolescent population aged 12 to 15 years (April 2021),
- the trial results in children aged 5 to 11 years (October 2021)
- the trial results regarding hildren aged 6 months to less than 5 years (June 2022)
- the results on third dose or booster (September 2021)
- the results from trials on bivalent vaccines,
- the trial results involving pregnant women,
- the successive Risk Management Plans,
- the publicly released database of the pivotal trial due to a court ruling,
- the Periodic Safety Update Reports (PSURs) …
The report highlights incomplete results (efficacy on transmission, asymptomatic cases,mortality not tested and not statistically proven), multiple risks, missing information regarding both efficacy, safety and immunogenicity data (protection conferred by antibodies).It demonstrates multiple methodological bias and major violations to GCP across allclinical trials that invalidate the conclusions regarding efficacy, safety, and immunogenicity
(...)
The conclusions are as follows:
16.5 Regarding immunogenicity
The duration of protection is discussed in Section 4.7 of the Clinical Review Memorandum for the Biologics License Application (BLA) dated August 23, 2021, by Drs. Susan Wollersheim and Ann Schwartz.
The FDA conducted a quantitative benefit-risk assessment through a model evaluating the benefits of preventable COVID-19 cases through vaccination, hospitalizations, ICU admissions, and deaths, as well as the risks of excess cases of myocarditis/pericarditis, hospitalizations, and vaccination-related deaths. This analysis was performed for groups stratified by age and sex combinations (12-15 years, 16-17 years, 18-24 years, and 25-29 years).
From this modeling, the most likely scenario predicted a vaccine protection duration of 6 months.
Illustration 261 : August 23, 2021 BLA Clinical Review Memorandum – Risk-Benefit Assessmen
It has been acknowledged since May 2021 that the protection provided by the vaccine
would not exceed six months.
The measurement of neutralizing antibodies presented in the report from December 10, 2020,
already indicated a decline in immunity to below two months after the second dose.
As of September 22, 2021 10 , Pfizer publicly admitted to a decline in antibodies six to eight
months after the second dose. This decline could have been observed earlier if the interim
analysis had been conducted after six months instead of the two-month median, as permitted
by the FDA's Emergency Use Authorization. Additionally, if the trial had included visits
between one month and six months after the second dose, it would have seemed prudent,
especially for such an innovative vaccine.
(...)
In December 2020, the opinion of the HAS indicated that a booster was already planned. Itproved quite convenient not to measure antibodies at three months, as this would have hinderedthe Emergency Use Authorization in the United States and the conditional marketing authorization in Europe. Who would authorize a vaccine whose protection does not exceed six months? No one.
The design of the trial allowed for the avoidance of measuring antibodies beyond two months after the second dose, contributing to the concealment of their decline, which wasforeseeable based on studies in macaques, and which was confirmed in the followingmonths.
This represents a serious oversight, if not a methodological fraud, that proved to be quite convenient, as no authorization would have been granted for a vaccine whose protection lasts only four to five months. This lack of measurement also facilitated the administration of boosters, as well as the fourth, fifth, sixth, and seventh doses, among others.
16.6 Regarding safety
In all the clinical reports presented—the report from December 10, the report from April 2021,the report from October 2021, and the report from June 2022—the results were based on a median follow-up time of two months (with 50% of participants followed for less than two months and a maximum follow-up of four months).
The total duration of the clinical trial was planned to be two years, as indicated in the memorandum signed by Marion Gruber, Director of the Office of Vaccines Research and Review (OVRR) of the FDA, dated December 11, 2020.
(...)
This follow-up period was authorized by the new regulations issued urgently by the U.S. Foodand Drug Administration in October 2020 ("Emergency Use Authorization for Vaccines to Prevent COVID-19"11 )) and contradicts the recommendations of the World Health Organization from 2010 12 regarding vaccines, which advocated for a one-year follow-up to conclude efficacy and six months to properly assess safety in order to obtain valid and reliable results.
The reduced observation period for participants does not allow for an assessment of long-term safety, which is mentioned in Pfizer/BioNTech's Comirnaty Risk Management Plan since December 2020 in chapter SVII.3.2, "Presentation of the Missing Information".
The long-term safety profile remains UNKNOWN to this day. Serious adverse effects have not been reported in the database. The safety results provided in the reports from December 2020 and April 2021 are therefore erroneous.
Case of Augusto Roux, a lawyer at the High Court of Justice in Buenos Aires: aparticipant in the trial in Argentina, he experienced serious adverse effects afterreceiving his second dose, including pericarditis, which was diagnosed as vaccine-related. The pericarditis was not reported and does not appear in the database or thereport. Other effects were reclassified as potential COVID cases by the sponsor, eveninventing convenient psychiatric disorders to discredit Mr. Roux's allegations of fraudwith health agencies.
Augusto Roux contacted the FDA, EMA, and other regulatory bodies, which refrainedfrom examining his case with the seriousness it warranted. He has opened a criminalinvestigation in Argentina against Fernando Polack, the principal investigator at theArgentine site, for falsification of public documents and neglect of a person.
Case of Maddy de Garay, a 15-year-old participant in the adolescent trial: she sufferedfrom over thirty adverse effects after receiving the vaccine. Her condition continued todecline rapidly and ultimately necessitated the continuous use of a feeding tube and awheelchair. The de Garay family received no attention from Pfizer or the FDA. In thereport submitted to health authorities for the approval of the vaccine for adolescentsged 12 to 15 years, only one serious adverse effect was listed: "functional abdominalpain."
The de Garay family requested information regarding their daughter's participation in the clinical trial through legal channels and has been heard multiple times by U.S.senators.
Regarding deaths, a crucial point since they allow for the evaluation of the vaccine's efficacy in cases of death due to COVID-19 as well as the product's safety, it is noted tha the number of deaths in the vaccinated group significantly exceeds the number of deaths in the placebo group (85 deaths in the vaccinated group from the onset of the study, 62 deaths among participants who received the placebo followed by the vaccine, and 23 deaths in the placebo group).
An examination of the Case Report Forms containing publicly available participant data reveals delays, errors, and concealment of deaths, despite the laboratory's awareness of these issues in the December 2020 report.
Among the four unreported deaths for the vaccine, two participants aged 58 and 63 died from cardiac arrest within three months following the second dose. In two instances, there were data entry errors, with the dates of death entered into the computerized system set up for data collection later corrected through correction requests.
Centers are obligated to report serious adverse effects to the laboratory within 24 hours, making these delays or persistent data entry errors regarding death dates during such significant interim analysis completely unusual, as data managers and pharmaco vigilance staff are particularly vigilant regarding death reporting.
These issues constitute a serious breach that undermines the tolerance results, as in December 2020, there were not two deaths in the vaccinated group as indicated in the report, but six,including three from cardiac arrest, which casts suspicion on all provided results.
This analysis was confirmed by Dr. Jeyanthi Kunadhasan in her correspondence with the Australian Therapeutic Goods Administration (TGA). These exchanges, sent and made public on behalf of the Australian Medical Professional Society (AMPS), consist of an initial letter dated March 21, 2024, the response from the professor of the Health Products Regulation Group at the TGA dated March 27, 2024, and the response from the professor of the AMPS dated March 27, 2024.
These findings corroborate our investigations within the database and the participant notebooks made public throughout 2023. Four deaths are missing in the vaccinated group and one death in the placebo group. Therefore, the reporting rate for deaths is 33% in the vaccinated group and 80% in the placebo group (four reported deaths out of five).
By adding deaths that occurred a few days after the data freeze date for the December 2020 interim analysis, we must include three additional fatal cardiac issues (atherosclerosis/hypertensive heart disease, cardiopulmonary arrest, congestive heart failure) among men aged 84, 53, and 54 years.
Regarding children aged 5 to 11 years, the small sample size did not allow for the detection of myocarditis, which was nonetheless identified in adolescents aged 12 to 15 years. The estimation of the risks of myocarditis/pericarditis was based on "predictions."
"Based on this information, it is reasonable to predict that the rates of post-vaccination myocarditis will likely be even lower in children aged 5 to <12 years than those observed inadolescents aged 12 to 15 years."
Risk assessment must rely on evidence, not predictions.
Based on the elements outlined above, we can conclude that the methods employed to identify adverse effects (trial design, timing of scheduled visits, absence of visits between one mont hafter the second dose and six months after the second dose, method of reporting adverse effects,participant follow-up by the investigative site, duration of participant follow-up during interim analyses, and the number of participants in analyses involving younger populations) lead to an underestimation of the number of adverse effects, rendering the tolerance results unreliable.
The unreported deaths indicate a manifest fraud aimed at concealing the product's toxicity.
This also highlights the risk taken by health agencies in granting authorization for such an innovative product based on an interim analysis with only three months of follow-up. Since the data are not finalized, the results presented are largely incomplete, if not false.
¿Tuvo conocimiento la vacunada en su consentimiento informado del riesgo comunicado a las autoridades de los Estados miembros por EMA el 22 de abril de 2021?
