Tag Archives: Pfizer vaccine trial

With Pfizer Likely to Get FDA Approval Monday It’s Worth Remembering Pfizer and Moderna Lost The Clinical Trial Control Group Testing Vaccine Efficacy and Safety, by sundance

You can’t conduct a randomly controlled trial if you “decontrol” the control group before the trial is complete. From sundance at theconservativetreehouse.com:

According to the New York Times and multiple media outlets, Pfizer is expected to get full FDA approval today.  “The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.” (read more)  With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:

The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine.  However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated.  Almost all the control group were then given the vaccine.

Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues.  Without a control group there is nothing to compare the vaccinated group against.  According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:

(Via NPR) […] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.  “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots. (read more)

Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost under the auspices of  “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.

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Why the number ‘3’ may make you rethink Covid hysteria, by Simon Black

Simon Black makes strong points about Covid hysteria using the date from the Pfizer vaccine trial. From Black at sovereignman.com:

Yesterday I promised to explain why the number three is among the most compelling data points discovered so far in Covid-19 research.

And it’s something that you most likely won’t see in the mainstream media, even though the data is right there in the FDA’s research.

Covid has clearly been THE most heavily researched topic of 2020. Google Scholar shows roughly 90,000 scientific studies and academic papers on SARS-CoV-2 and COVID-19 that were published this year, which is a great testament to how quickly researchers can mobilize.

Many of these studies, however, were limited in nature. They were small-scale, involving only a handful of test subjects. Or they relied upon data from numerous, disparate sources, which introduced a lack of uniformity into the experiment.

But late last week, the FDA published its analysis of the Pfizer/BionTech COVID-19 vaccine trial results, called BNT162b2.

And the results are extremely valuable:

1- The study was very large, involving tens of thousands of people;

2- The participants came from all walks of life and highly diverse genetic compositions;

3- The rules and protocols were completely uniform across the entire experiment.

This is quite rare. Of the nearly 90,000 COVID-19 studies this year, very few meet these criteria.

Perhaps more importantly, there was no funny arithmetic involved, like how the government and media tend to count anyone who sets foot in a hospital or mortuary as Covid-related.

I told you yesterday that the vaccine results are very promising: only 8 people out of 20,033 who received two full doses of the vaccine ended up testing positive for COVID-19.

And perhaps even better, ZERO out of the 805 subjects over the age 75 (who received the vaccine) tested positive for COVID.

So Pfizer has clearly done something extraordinary here.

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