Absolute risk, simply explained, is “the likelihood that an outcome will occur.” Relative risk “compares the risk of a health event … among one group with the risk among another group.”
Pfizer told the FDA that eight (of approximately 22,000) volunteers in its vaccine group developed a PCR-confirmed case of COVID-19, versus 162 of 22,000 volunteers in the placebo group. Moderna reported a similar spread — five out of 15,000 in the vaccine group versus 90 out of 15,000 in the placebo group.
When one does the math, the Pfizer clinical trial numbers showed: “The risk reduction in absolute terms [was] only 0.7%, from an already very low risk of 0.74% [in the placebo group] to a minimal risk of 0.04% [in the vaccine group].” (Dividing 0.7 — the difference between the two groups — by 0.74 is the mathematical calculation that produced the touted “95% effective” number).
Although the eight versus 162 PCR-confirmed COVID cases in the Pfizer trial may sound like a big difference to the casual reader, Peter Doshi subsequently alerted the public to the fact that Pfizer skewed its analysis by excluding more than 3,400 individuals with non-PCR-confirmed symptoms of COVID — individuals split almost evenly across the vaccine and placebo groups.
Excluding “suspected” cases of COVID because they didn’t meet the PCR threshold:
All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed COVID-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbers were dwarfed by a category of disease called “suspected COVID-19”—those with symptomatic COVID-19 that were not PCR confirmed. According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”
Excluding all kinds of critical data from their public report:
an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic. There is a clear need for data to answer these questions, but Pfizer’s 92-page report didn’t mention the 3410 “suspected COVID-19” cases. Nor did its publication in the New England Journal of Medicine. Nor did any of the reports on Moderna’s vaccine. The only source that appears to have reported it is FDA’s review of Pfizer’s vaccine.
Suspiciously high numbers of “protocol deviations” for Pfizer:
Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals: 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.) What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group?
Why did they do all this statistical manipulation and why are they hiding so much data from the public, you ask?
With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing COVID-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set by regulators.