COVID Vaccine Clinical Trials Doomed to Fail; Fatal Design Flaw; NY Times Opinion Piece Exposes All Three Major Clinical Trials
Or do the vaccine manufacturers have a devious trick up their sleeves?
PART ONE: THE FAILURE
Peter Doshi, associate editor of the medical journal BMJ, and Eric Topol, Scripps Research professor of molecular medicine, have written a devastating NY Times opinion piece about the ongoing COVID vaccine clinical trials.
They expose the fatal flaw in the large Pfizer, AstraZeneca, and Moderna trials.
September 22, the Times: “These Coronavirus Trials Don’t Answer the One Question We Need to Know”:
“If you were to approve a coronavirus vaccine, would you approve one that you only knew protected people only from the most mild form of Covid-19, or one that would prevent its serious complications?”
“The answer is obvious. You would want to protect against the worst cases.”
“But that’s not how the companies testing three of the leading coronavirus vaccine candidates, Moderna, Pfizer and AstraZeneca, whose U.S. trial is on hold, are approaching the problem.”
“According to the protocols for their studies, which they released late last week, a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick. That’s not what these trials will determine.”
This means these clinical trials are dead in the water.
The trials are designed to show effectiveness in preventing mild cases of COVID, which nobody should care about, because mild cases naturally run their course and cause no harm. THERE IS NO NEED FOR A VACCINE THAT PREVENTS MILD CASES.
Now let’s go deeper. Read the next section from the Times piece, and then I’ll make comments.
“The Moderna and AstraZeneca studies will involve about 30,000 participants each; Pfizer’s will have 44,000. Half the participants will receive two doses of vaccines separated by three or four weeks, and the other half will receive saltwater placebo shots. The final determination of efficacy will occur after 150 to 160 participants develop Covid-19…”
Here’s how it works. The vaccine companies are looking for a total of 150 (mild) COVID cases to occur, combined, in the two groups; those receiving the placebo and those receiving the vaccine. How would that happen? The researchers believe ‘the coronavirus is spreading everywhere and it will pounce on some of the volunteers in the clinical trial.’
Let’s say that, during the trial, 100 people receiving the placebo develop mild COVID-19, and only 50 people receiving the vaccine develop mild COVID.
The vaccine companies would say, ‘We just proved the vaccine is 50% effective in preventing COVID, and that’s all we need to do, in order to win authorization from the FDA. Release the vaccine. Inject the world.’
The irrelevant outcomes for 150 people equal ‘let’s shoot up seven billion people.’ That’s staggering.
But it gets even worse. The magic number of 150 COVID cases? How is a COVID case defined? The authors of the Times piece have the answer:
“In the Moderna and Pfizer trials, even a mild case of Covid-19 — for instance, a cough plus a positive lab test — would qualify and muddy the results. AstraZeneca is slightly more stringent but would still count mild symptoms like a cough plus fever as a case.”
But wait. The NY Times itself recently published an article stating that up to 90% of US COVID cases could very well be false positives—in other words, not cases at all. Why? Because the diagnostic PCR test, as it is performed by many labs, is too sensitive. It registers ‘positive for COVID’ when it shouldn’t.
So, in these vaccine clinical trials, the whole process of determining that ‘150 people developed COVID-19’ is completely unreliable, useless, absurd, and nonsensical.
Other than that, the clinical trials are perfect. Yes, perfectly ridiculous.
There is much more in the Times opinion piece, but I’ll leave it there.
“So the magic number is 150? That’s the number that will decide the immediate fate of the planet?”
“And these 150 people, who you say develop COVID-19…you really can’t confirm that because the definition of a COVID case is so vague and the PCR test is so unreliable.”
“And come to think of it, the people receiving the vaccine in the clinical trials could develop symptoms indistinguishable from COVID-19, as a result of the effects of the vaccine.”
“Yes, that’s right.”
“But you’re very confident in the success of the vaccine.”
“I have to be confident. If we’re exposed as incompetent frauds, our bottom line will take a huge hit.”
“Thank you, sir. And that’s tonight’s news. Make sure you take the vaccine, everyone. It’s vital. This is Fred J Clown, for CBS-NBC-ABC-CNN-FOX-PBS-AP-Reuters and all official news sources East, West, North, and South. The News, brought to you by Venom-X-2, a medicine that has only 463 adverse effects. Ask your doctor if Venom is right for you.”
PART TWO: THE DEVIOUS TRICK
Now I’m going to go over the vital information again, but this time I’m going to show you how…
The vaccine companies can use the fatal flaw in their protocol design to…
Actually win approval of their COVID vaccine.
Stick with me. This is big.
Only 150 people are needed to make the major clinical trials of a COVID vaccine look like a success.
Out of 30,000 volunteers in a trial, researchers are waiting for 150 people to “come down with COVID-19.” MILD cases. They assume this will happen because they believe the coronavirus is everywhere, and it’ll infect their volunteers.
Of course, their definition of a mild case of COVID-19 is meaningless. Cough plus fever, and a positive PCR test. The test spits out false positives like a rigged slot machine, and the visible symptoms could result from flu, polluted air, or too many candy bars.
Nevertheless, the researchers are waiting for a total of 150 people to “catch a mild case of COVID.” When that number is reached, everything stops.
Now comes the big moment. How many of those 150 COVID cases occurred in the group that received the vaccine, and how many in the group that received the placebo shot of salt water?
Let’s say only 50 COVID cases occurred in the vaccine group, and 100 in the placebo group. The researchers pop champagne corks. They say, “Look, the vaccine is 50% effective at preventing COVID, and that’s all we need to win authorization from the FDA.”
BUT suppose 70 cases occurred in the vaccine group and 80 in the placebo group? No good. No good at all. No way to call the vaccine effective.
Now comes the “reshaping of the data.”
HERE WE GO.
The researchers say, “Wait. Thirty of the COVID cases in the vaccine group were REALLY just adverse reactions to the vaccine. They weren’t cases of COVID. You see, the vaccine can cause symptoms that are indistinguishable from mild COVID. Cough, fever, chills. ACTUALLY, there were only 40 cases of COVID in the vaccine group. Half as many as in the placebo group. The vaccine IS 50% effective. We don’t really need to wait until we have a total of 150 COVID cases. We’re good. We’re golden. We can get authorization from the FDA right now to shoot up everybody in America!”
Vaccine manufacturers HAVE KNOWN ALL ALONG that they could pull this trick.
Why leave things to chance?
Why risk a few hundred billion dollars of profit on a random distribution of mild COVID cases among the volunteers in their clinical trials?
There is yet a further devious twist. The New York Times article I just analyzed torpedoed the vaccine manufacturers for designing their trial protocols to prevent MILD cases of COVID. Why?
Because no one needs a vaccine that can do that. Mild cases are not a problem or a threat. They cure themselves quickly. No vaccine is necessary in the first place.
BUT the definition of a mild COVID case is EXACTLY what the vaccine manufacturers needed. It enabled them to hatch a plan, to make sure they didn’t fail.
They could pawn off a MILD case of COVID on a vaccine reaction. They could fake that without causing ripples. The FDA would say, “The vaccine reactions aren’t serious. All right, no problem. We’ll approve this vaccine for emergency use.”
However…If the manufacturers designed their clinical trial protocol to prevent serious cases of COVID, they would be waiting to see 150 cases of really sick people to occur. That might never happen.
If it did happen, and the manufacturers had to pull their devious switcheroo trick and blame the vaccine for some of these SERIOUS cases…
They would have to tell the FDA that their vaccine was causing life-threatening pneumonia; and the FDA, under a lot of scrutiny these days, would find it very difficult to overlook that.
FDA: “We can’t approve this vaccine. It could cause a few million cases of dire pneumonia…”
The vaccine companies didn’t make a titanic stupid mistake in their protocol design. In gearing the protocol to prevent MILD COVID cases, they did what they did on purpose. It allows them to “reshape their data” and win FDA approval for their vaccine.
These companies have no intention of failing, starting over, and spending a year recruiting 30,000 new volunteers. They want success and money now. They want to win the race.
And they could win, if the truth isn’t known and shared widely.
The author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX, Jon Rapport was a candidate for a US Congressional seat in the 29th District of California. He maintains a consulting practice for private clients, the purpose of which is the expansion of personal creative power. Nominated for a Pulitzer Prize, he has worked as an investigative reporter for 30 years, writing articles on politics, medicine, and health for CBS Healthwatch, LA Weekly, Spin Magazine, Stern, and other newspapers and magazines in the US and Europe. Jon has delivered lectures and seminars on global politics, health, logic, and creative power to audiences around the world.
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