Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to

or

Pfizer Vaccine Clinical Trials Poorly Designed From the Start, Analysis Shows
The Canadian COVID Care Alliance assembled a presentation that demonstrates how Pfizer’s purported randomized placebo-controlled, double-blinded study veered away from methodologies that would have definitively answered questions about the vaccine’s safety and efficacy.
By
Madhava Setty, M.D.
Here are a few key points from the CCCA presentation:
Initial data demonstrated a high relative risk reduction of infection yet this amounted to an absolute risk reduction of only 0.84%. It is the absolute risk reduction that determines the risk-benefit ratio required to make informed decisions around inoculation.
Early unblinding: Several months before publishing six-month observational results Pfizer opted to offer its product to those participants who received the placebo. By eliminating nearly all participants in the placebo wing Pfizer effectively closed the curtain on its experiment because long-term comparisons can no longer be made.
All-cause mortality and morbidity, the only sensible outcomes to use in determining efficacy and risk, were not considered. Indeed, all-cause mortality was higher in the vaccinated group after six months.
Severe adverse events outnumbered cases of severe COVID prevented after six months of observation.
Trial participants were not reflective of the most vulnerable members of our population — more than 50% of people dying from COVID are 75 years of age or older. This age group made up only 4.4% of trial participants. Also, 95% of those who have died from COVID had one or more comorbidities. Nearly 80% of trial participants had none.
Not every trial participant was tested for COVID. Asymptomatic or paucisymptomatic (presenting few symptoms) cases were missed.
Questions regarding unblinding and data integrityThe CCCA presentation also resurrects a puzzling observation mentioned in a briefing document Pfizer submitted only to the FDA’s Vaccine and Related Biologic Products Advisory Committee (VRBPAC) of the FDA, but nowhere else — including the widely cited summary of the trial reported in New England Journal of Medicine.
According to the document, 3,410 participants were suspected from their clinical presentation of having COVID but they were excluded from efficacy calculations because a diagnosis could not be confirmed through PCR testing.
The CCCA presentation presumes this large group of participants was never tested. The wording in the VRBPAC briefing document is indeed vague, stating the participants were “not PCR-confirmed” in one sentence and “unconfirmed” in another.
Assuming Pfizer’s investigators followed their study protocol, these participants were in fact tested. Yet that forces us to accept that more than 3,400 participants who had symptoms of COVID were suffering from other illnesses, not COVID.
In other words, there were 3,580 participants who clinically presented with COVID (3,410 suspected and 170 confirmed). Of these, more than 95% tested negative. This is difficult to accept in a group where clinical suspicion is high.
However, with no further testing by the investigators, we are left to accept these numbers as reported.
Note: The a pdf download of the CCCA briefing deck is at the the following link. Draw your own conclusions.
Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to

or
