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The document, posted on the FDA website, is titled, “Vaccines and Related Biological Products; Advisory Committee Meeting; FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine.” [1]
It is dated December 10, 2020. The date tells us that all the information in the document is taken from the Pfizer clinical trial, based on which the FDA authorized the vaccine for public use.
A key quote is buried on page 42: “Among 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 [who received a saltwater shot].”
Those shocking numbers have never seen the light of day in news media.
The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than a placebo shot—the standard for FDA Emergency Use Authorization.
The FDA document also states: “Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group.”
That’s explosive. Right after vaccination, 409 people who received the shots became “suspected COVID cases.” This alone should have been enough to stop the clinical trial altogether. But it wasn’t.
It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days post vaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.
What does “suspected cases” mean?
It can only mean these people all displayed symptoms consistent with the definition of COVID-19, but they’re unconfirmed cases because…their PCR tests were negative, not positive.
However, if their tests were negative, why would they be called “suspected cases” instead of “NOT CASES”?
Something is wrong here. The FDA is hedging its bets, muddying the waters, obscuring facts.
By FDA/CDC rules, a case of COVID-19 means: a person has tested positive, period.
That’s the way cases are counted.
originally posted by: Raggedyman
a reply to: Nexttimemaybe
While I have no intention of ever getting the shot, I think you have raised a very fair point
originally posted by: Raggedyman
While I have no intention of ever getting the shot, I think you have raised a very fair point