The Canadian Covid Care Alliance (CCCA) critically analyzed the Pfizer COVID-19 vaccinations clinical trial reports in a new video report. They criticized the lack of a control group, calculations focused on relative risk instead of absolute risk, failure to check for early signs of adverse events, and the choice of endpoints for the study. TrialSite has previously reported on adverse events caused by the Pfizer vaccines as well as numerous positive looks—for example, numerous health systems report substantially lower COVID-19 death rates among vaccinated persons.
Undoubtedly not a feature in any mainstream news, The CCCA, a group of over 500 Canadian healthcare professionals, has released “The Pfizer Inoculations for COVID-19 – More Harm than Good” (PDF of the video available here). This video breaks down various reports released by Pfizer, investigates the data published, and concludes that the approved Pfizer vaccines cause harm to the public. What are the main concerns expressed by this Canadian group? Do they look at the problem objectively? While raising purported problems, do they showcase the benefits of the vaccine?
Control group cut after two months
A Dec. 2020 report summarized two months’ data from the Pfizer vaccine clinical trials. It states that in the 43,500 participants, divided into vaccine and placebo groups, the vaccine had 95% efficacy seven days after the second dose.
It should be noted that this 95% indicates relative risk reduction: 8 out of 18,200 vaccinated participants and 162 out of 18,300 placebo recipients contracted COVID-19. The risk of contracting COVID-19 in the placebo group was 0.88%, reduced to 0.04% in the vaccination group. Therefore, the absolute risk reduction of the vaccine came to 0.84%.
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The trials were blinded, meaning that participants were not informed whether they were in the vaccine or placebo group. Phase 3 of the blinded trial was supposed to run until May 2023. However, after only two months of data collection in 2020, Pfizer un-blinded the study and offered the placebo group the opportunity to receive the vaccine and continue the trials in the vaccinated group. This meant that, as of early 2021, there was no longer a control group to measure the effectiveness or safety of the vaccines.
Participant deaths “not related” to vaccine
A Nov. 2021 report evaluated six months of clinical data from the Pfizer vaccine trials. This report showed 91.3% efficacy of the vaccines (relative risk reduction), but also revealed an increase in illness and death amongst the vaccinated group. A table of adverse events, included in the supplementary material of the report (Table S3), evidences an increase in adverse events in almost every category.
The CCCA also draws attention to the fact that the deaths in trial participants were inadequately addressed. According to the study, “During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received the BNT162b2 after unblinding died”. The study reported that none of these deaths were related to the BNT162b2 vaccine.
Biased from the start?
The Pfizer COVID-19 vaccines were developed, tested, and administered within one year, whereas vaccines are usually developed over five to ten years, according to CCCA. Phases II and III of the trials were combined, and the vaccine received Emergency Use Authorization (EUA) after 2 months of these trials. The trials were then un-blinded, but Phase III trials are still ongoing until 2023.
COVID-19 affects those over 75 years of age more severely, however, those over 75 years represented only 4.3% of trial subjects (refer to Section 11.4 Geriatric Use). Only 21% of participants had comorbidities, even though 95% of people who have died from COVID-19 had comorbidities.
The Pfizer trials also only focused on individuals who had never contracted COVID-19. The CCCA claims that to have data on natural and vaccine-induced immunity, Pfizer should have included those that have recovered from COVID-19 and received the vaccine, as well as those who have recovered from COVID-19 but remained unvaccinated. Pfizer only looked at symptomatic adverse events. Despite testing blood for antibodies after vaccination, they did not perform tests for biomarkers of pre-symptomatic disease, like inflammation, cardiac damage, hypoxia, or autoimmune disease.
Endpoints “Biggest Mistake” of the Pfizer Trials
According to the CCCA, the “biggest mistake” of the Pfizer trials included use of the wrong endpoints. The trials should have focused on mortality, illness, and spread, not hospitalizations.
Pfizer researchers tried to answer, declaring, “Do people who take the vaccines test positive for COVID-19 less often?” Their test answered “yes”, so the worldwide rollout of the vaccines commenced. Although the vaccines were not tested for reduction of transmission, COVID-19 vaccine passes are being used in many countries to reduce transmission
Testing Failures and Subjective Testing
According to the CCCA, the Pfizer trials only tested symptomatic participants for COVID-19, meaning that potential asymptomatic infections were missed. This failure to test everyone further biased the study while infusing subjectivity. There were also 166 participants (80 vaccinated, 86 placebo) ‘lost to follow-up’, meaning they could not be contacted (Table 3). The much-cited relative risk reduction figure of 95% may have fallen significantly if these participants were still included in the data.
The calculations also ignored “suspected, but unconfirmed cases,” where participants showed COVID-19 symptoms but were never tested: 1,596 in the vaccinated group, and 1,816 in the placebo group (page 42). If, for instance, all these individuals had COVID-19, then the relevant risk reduction would have been only 19%.
According to the CCCA, the FDA will not grant EUA to any vaccine with a risk reduction below 50%.
12–15-Year Old Adolescent Trial
Researchers published a report on the safety and efficacy of the Pfizer vaccine in children in May 2021. The study looked at 2260 participants aged 12 – 15, split into vaccinated and placebo groups. No participants in the vaccinated group contracted COVID-19, and 18 tested positive in the placebo group.
Among the vaccinated children, there was one serious adverse event reported: 12-year-old Maddie de Garay was hospitalized within 24 hours of receiving her second Pfizer dose. She experienced gastroparesis, nausea and vomiting, erratic blood pressure, memory loss, brain fog, headaches, dizziness, fainting, seizures, verbal and motor tics, lost feeling from the waist down, lost bowel and bladder control, and lost her ability to eat. Since then, she has been wheelchair-bound and fed via a tube. The FDA described Maddie’s injuries as “functional abdominal pain” (Page 30).
The CCCA believes that the FDA has abandoned the crucial health care principle “First, do no harm.” They claim that the FDA is aware that the vaccine may increase the risk of myocarditis in children but is still pushing for children to be vaccinated. They also state that those being vaccinated do not have appropriate informed consent based on their interpretation of the risk-benefit analysis. Parents are not aware of the limitation of a Pfizer study in kids aged 5 to 11. These limitations include “the lack of longer-term follow-up to assess the duration of immune responses, efficacy, and safety,” and “This study was also not powered to detect potential rare side effects of [the Pfizer vaccine} in 5-to-11-year-olds.” (See Discussion)
Rising incidence of heart issues and deaths in young people
In Canada, Ontario Public Health reported an increase of heart issues in young people between Dec. 2020 and Sept. 2021. There is also a rising awareness and increased reporting of professional athletes collapsing with health issues. Of course, this isn’t proof of any association let alone causation.
Israel’s Real Time News reported 21 FIFA players collapsing on the pitch in 2021 – five times the normal annual rate. Again, this news is used by vaccine critics, but no proof of association or causation is provided.
On Nov. 17, 2021, the FDA released documents ordered by a court to satisfy a Freedom of Information request by a group called the Public Health and Medical Professionals for Transparency. The group requested access to data used by the FDA to approve Pfizer’s COVID-19 vaccinations. The Post Marketing Pharmacovigilance Report submitted by Pfizer to the FDA showed over 1,200 deaths, and 25,000 nervous system adverse events.
Evidence of Conflict of Interest?
The authors of the Pfizer reports have a clear conflict of interest, with 84% of the authors either connected to Pfizer or BioNTech The founders of BioNTech, Ugur Sahin and Ozlem Tureci, were also the main authors of the six-month report. Since the rollout of the vaccines, the BioNTech stock value has increased by $9 billion.
Concerningly, since the rollout of the COVID-19 vaccines worldwide, the Centers for Disease Control and Prevention (CDC) changed the definition of “vaccine” on their website. It was “A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting that person from that disease.” It was changed to “A preparation that is used to stimulate the body’s immune response against diseases.” There is no more mention of protection or immunity.
Ethical Considerations Regarding Unblinding
An opinion piece published in Frontiers in Public Health on Jun. 24, 2021 discussed the ethical considerations regarding unblinding participants. The authors offer an opposing view to the CCCA, as they argue that participants who received a placebo should be unblinded and offered the vaccine once the efficacy of the vaccine has been proven.