Recently the US Food and Drug Administration approved Sanofi's new quadrivalent meningococcal vaccine, MenQuadfi, for injection into infants between the ages of six weeks and 23 months. MenQuadfi was first approved by the FDA in 2020 for children two years and older.
The sanctioning of MenQuadfi for infants is the latest black mark in the FDA's checkered history. Like this agency's previous shameful decisions, this one provides further proof of the reckless swindle that has become standard operating procedure for all vaccine approvals.
The Mad Hatter "logic" of how the approval process works for vaccines is detailed in the 2022 book “Turtles All the Way Down: Vaccine Science and Myth.” That "logic" is incisively illustrated in the well-known anecdote from which the book draws its title:
After a lecture on cosmology and the structure of the solar system, [William] James was accosted by a little old lady.
"Your theory that the sun is the centre of the solar system, and the earth is a ball which rotates around it has a very convincing ring to it, Mr. James, but it's wrong. I've got a better theory," said the little old lady.
"And what is that, madam?" inquired James politely.
"That we live on a crust of earth which is on the back of a giant turtle."
Not wishing to demolish this absurd little theory by bringing to bear the masses of scientific evidence he had at his command, James decided to gently dissuade his opponent by making her see some of the inadequacies of her position.
"If your theory is correct, madam," he asked, "what does this turtle stand on?"
"You're a very clever man, Mr. James, and that's a very good question," replied the little old lady, "but I have an answer to it. And it's this: The first turtle stands on the back of a second, far larger, turtle, who stands directly under him."
"But what does this second turtle stand on?" persisted James patiently.
To this, the little old lady crowed triumphantly,
"It's no use, Mr. James—it's turtles all the way down."
As we will see in the remainder of the Turtles book, the "little old lady's" irrational explanation is the same line of reasoning that the FDA used to justify licensure of the MenQuadfi vaccine
For example, a quick look at the package insert for the MenQuadfi vaccine shows that the safety trial "placebo" used to establish the safety profile for MenQuadfi was the meningitis vaccine Menveo. In other words, Sanofi used another vaccine as a comparator rather than a true placebo such as saline water.
In those trials, an alarming 5.3% of infants who were injected with MenQuadfi experienced at least one serious adverse event (SAE) compared to 3.6% of infants who experienced an SAE after receiving the Menveo vaccine.
By comparing MenQuadfi's 5.3% risk profile to Menveo’s 3.6% risk profile, the FDA claimed that the "similar" SAE rates meant that the new vaccine must be "safe" simply because the placebo Menveo is assumed to be "safe."
So, in a sleight of hand as clever as a professional magician's tricks, the FDA took two risky products and compared them to one another in order to make the adverse effects to babies seem less alarming for the new vaccine. Were the FDA honest, it would have recognized the danger signals for both drugs and refused to approve either one of them!
Using the Menveo vaccine comparator turtle to stand on should have been an egregious enough act to render the MenQuadfi trial null and void. But it wasn't. The plot thickens. Upon further inspection, we discover that the Menveo safety trial was also standing on a bigger turtle below it when it was licensed. That licensure, it turns out, was based on a trial in which Sanofi’s meningococcal vaccine, Menactra, was used as the control.
Lest you think Menactra was the bottom-most turtle, think again. No, siree. The turtle Menactra stood on to earn its license was a safety trial in which Sanofi’s Menomune vaccine (discontinued in 2017) was used as the control. Menomune itself was never licensed using a proper placebo-controlled trial.
Interestingly, the FDA's Menomune package insert from 2016 admits the following:
"Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in clinical practice."
What we're left with in the FDA's regulatory universe of infinite regressions are vaccines that get approved based on comparisons with previous vaccines that got approved based on comparisons with previous vaccines that got approved based on . . . no proper tests.
Applying this turtle "logic," it's a snap to see that the MenQuadfi vaccine used as its control the Menveo vaccine, which used as its control the Menactra vaccine, which used as its control the Menomune vaccine, which was licensed without a proper placebo-controlled trial when it used Menactra as its safety trial "placebo."
All of this makes for an upside-down Vaccine Wonderland, where the circular logic of vaccines tested against one another is enough to gain certain, if not swift, FDA approval. No true placebo-controlled, double-blind studies are anywhere to be found—ever! Instead, the public is saddled with a product that has a higher risk of serious harm than the disease it's supposed to prevent.
In the words of ICAN's lead attorney, Aaron Siri:
[It's] a pyramid scheme of safety, at the bottom of which there is no baseline on which safety is being judged. Just a get-it-licensed-to-profit shell game. FDA and pharma have nothing to lose here. We, as taxpayers, will pay for all of the harms suffered and, worst of all, the children who are injected and harmed and their families will really pay for the harms.
