Pfizer/BioNTech seek full FDA approval for their Covid-19 vaccine

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Jon Rappaport has a great article today.


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.

To make all this clear, I need to back up and explain the theory of the vaccine clinical trial.

The researchers assumed the SARS-CoV-2 virus was spreading everywhere in the world, and during the clinical trial, it would descend on some volunteers.

The billion-dollar question was: how many people receiving the vaccine would become infected, vs. how many people in the placebo group?

If it turned out that FAR FEWER people getting the vaccine became infected with SARS-CoV-2, the vaccine would be hailed as a success. It protected people against the virus.

But as you can see from the numbers above, that wasn’t the case at all.

So now we come to the vital weasel-phrase in the FDA document I just quoted: “suspected but unconfirmed COVID-19 [cases].”

“Well, you see, we can’t say these were ACTUAL COVID-19 cases. Maybe they were, maybe they weren’t. They’re in limbo. We want to keep them in limbo. Otherwise, our clinical trial is dead in the water, and we’ll never get approval for the vaccine.”

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.

These thousand-plus volunteers in the Pfizer clinical trial were either COVID-19 cases or they weren’t. Which is it?

The official response to that question is obvious: the FDA decided to throw the data from all those “suspected cases” in the garbage and ignore them. Poof. Gone.
 
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David PS

David PS

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This is more great news.
 

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