The Food and Drug Administration’s advisery panel unanimously recommended on Wednesday that very young children be given mRNA Covid shots. The FDA panel’s move all-but-guarantees that the agency will authorize regimens of two-to-three shots for a cohort that is at statistically no risk from Covid-19.
“Outside advisers to the Food and Drug Administration voted unanimously on Wednesday to recommend that the agency authorize the Moderna and Pfizer-BioNTech coronavirus vaccines for very young children, a move that could clear the way for regulators to authorize both pediatric vaccines on an emergency basis later this week,” the New York Times reported.
“Pfizer’s three-dose vaccine would cover children 6 months through 4 years old, while Moderna two-dose vaccine would be for children 6 months through 5 years old,” the Times added. “States have already ordered millions of doses. Depending on what regulators do, White House officials have said administration of doses could start in earnest on Tuesday.”
“The F.D.A. has said that clinical trial data from the companies shows that each vaccine met the criteria for safety and effectiveness in the age group,” the Times noted.
The New York Times did not note, however, that there are major serious questions about Pfizer’s clinical trial data.
Dr. Vinay Prasad noted that the trial data show “horrifically poor vaccine efficacy.”
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Vaccine efficacy against symptomatic disease must count any case that occurs after randomization
That's how trials work
The Pfizer documents suggest horrifically poor vaccine efficacy 👇 pic.twitter.com/1Gl2AXUxs5
— Vinay Prasad, MD MPH 🎙️📷 (@VPrasadMDMPH) June 14, 2022
Pfizer used an invalid ‘control group’ to come up with a bogus ’80 percent efficacy’ figure.
As shown by the Pfizer trial, the control group was not inoculated members of the pool of 4,526 participants within the same age cohort of 6 months through 4 years, but rather 170 randomly selected members of Pfizer’s previous adult clinical trial for ages 16 to 25 years.
Even worse, the comparison between the groups was for a selectively biased, tiny window that occurred after the third shot. Covid analyst Alex Berenson noted that this statistical sleight-of-hand.
Here’s what the Food and Drug Administration and Pfizer did; they only counted cases after the THIRD mRNA dose.
But of the 375 Sars-Cov-2 infections in the trial, 365 occurred before the third dose. Only 10 occurred after the third dose.
Yes, you are reading that right. The efficacy figure is based on 3 PERCENT OF ALL THE INFECTIONS IN THE TRIAL. (Which is why the confidence intervals are so large.)
The highlighted data are provided below showing where the ’80 percent’ efficacy rate comes from:
Indeed, you can see a negative efficacy rate between dose one to dose two, showing that it increases chances a child will get Covid. As Daniel Horowitz of Conservative Review noted:
[T]here were many more total COVID cases in the trial group than placebo group – 225 in trial and 150 in placebo (among those 6 months to 2 years old, it was 98-58 trial vs. placebo; among 2 <5 it was 127-92). Thus, as witnessed by real-world experience, there is straight-up negative efficacy for several periods of time that will outweigh any isolated period of illusory efficacy.
What the FDA panel doesn’t state is that nearly all children have had Covid-19 already. Critically, according to CDC data from February, 74.2% of “children and adolescents had serologic evidence of previous infection with SARS-CoV-2, with approximately one third becoming newly seropositive since December 2021.”
The elephant in the room is that children who were previously infected have natural immunity that has been shown to be more robust than vaccinated immunity. The CDC’s own data has borne this out to be the case.
The shot regimen being authorized for children is for an Omicron variant that is both generally mild and virtually defunct in the population. The New York Times effectively admits this in its selectively reported piece on the development.
Thus, the FDA is already contemplating recommending that children receive a booster shot right after they get the regime of ‘vaccines.’
Both the vaccines that the committee considered on Wednesday appear significantly less effective against symptomatic infection than the adult vaccines when they were introduced. The F.D.A. attributes that Omicron being far more adept at evading the vaccines’ defenses against infection than the original version of the virus.
Given the waning of protection observed among adult recipients and the virus’s rapid evolution, regulators have said children who would get Pfizer’s and Moderna’s vaccines would most likely require a booster. That would mean Pfizer’s vaccine, developed with the German firm BioNTech, could wind up as four doses, while Moderna’s could be three.
Since healthy children are at a miniscule risk from Covid-19, regardless of the variant, and indeed, the coronavirus has been shown to be less risky to this age group than the seasonal flu, this is subjecting the most vulnerable among us to ‘vaccines’ that have failed to stop the spread and even to thwart infection.
Indeed, ‘fully vaccinated’ and boosted Dr. Anthony Fauci was reported to have been infected with Covid-19 on the same day that the FDA panel made its recommendation to give the shots to very young children.
Despite being nearly worthless at protecting very young children, there are real risks that come in the form of serious adverse events. As Horowitz points out in Pfizer’s data, the great majority of children had a reaction from the shots that is comparable to the symptoms of the virus itself.
On the surface, Pfizer’s own report is an indictment of the shot’s safety. Table 21 on page 42 states that 61% of babies 6 months to 2 years old experienced a “systemic reaction within 7 days.” This means that it’s not just irritation of the injection site but something more along the lines of fever, chills, or muscle aches. Right off the bat, that should be disqualifying, because that is the upper bounds of discomfort the kids would suffer from the virus anyway. The only rebuttal to this is that almost as many placebo group patients experienced such reactions. But that in itself should be an indication there is something fraudulent with the placebo group. It’s understandable for even a saline injection to cause irritation at the injection site, but “systemic” reactions?
The bottom line is that the FDA, CDC, Pfizer, and Moderna appear desperate to inject even small babies with multiple rounds of the novel mRNA shots, despite the mortality and hospitalization risk being close to nil and the shots failing to stop the spread of the virus.
There is an ulterior motive at hand: Big Pharma apparently seeks to cover its own needle tracks by eliminating the control group.