“I do think it’s a relatively close call – it’s really going to be a question of what the prevailing conditions are but we’re never going to learn about how safe this vaccine is unless we start giving it.”
In the end, it wasn’t really a close call at all, and no one really thought it would be. After all, government health officials in the United States, the United Kingdom, Israel, and other countries have been talking about the “urgent need” to start vaccinating children as young as five for weeks now, if not longer.
But the words above, spoken by FDA advisor Dr. Eric Rubin of Harvard University, succinctly and chillingly summarized the decision of the FDA to grant emergency use approval (EUA) to Pfizer BioNTech’s coronavirus “vaccine” for children between the ages of five and eleven. “We’re never going to learn about how safe it is until we give it.”
The substance was originally tested on around 43,000 people in its Phase III trials before the FDA approved it, first with a EUA and then with full approval. The trial for the 5 – 11 age group, however, had just 2,250 children enrolled.
Pfizer actually acknowledged that the small size of the sample group could be seen as problematic, commenting that the study was “not large enough to detect any potential risks of myocarditis associated with vaccination.” Myocarditis is a particularly worrying side effect as it is already known to disproportionately affect younger “vaccine” recipients.
However, Pfizer reassured themselves, and apparently the FDA too, that since data from Israel had shown that “rare” post-vaccination myocarditis peaks between the ages of 16 and 19 and was lower in the 12 to 15 age group, for children younger than 12, the rate was certain to be even lower.
There it is. FDA's revised EUA for Pfizer. Once again, approving the shot for everyone in the age 5-11 group, without ANY test results showing a benefit for prior survivors of Covid (a large subgroup). Same as other age groups. https://t.co/HgNbRsIrMw pic.twitter.com/oqW1VDiJ3r
— FoiaFan (@15poundstogo) October 31, 2021
Sure enough, no cases of either myocarditis or pericarditis were found in the study following the second dose. Researchers found that the “vaccine” was “well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” with the most common side effects being pain at the injection site, fatigue, headache, chills, and fever a day or two after the second dose.
Accounts of the meeting of FDA advisors discussing whether or not to recommend the child-size dose report that the panel spent “hours” discussing the risks of myocarditis to young children. In the end, all but one panel member voted in favor; the exception abstained.
Commenting on the vote, Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said that cardiovascular side effects were far more common as a result of COVID infection than as a result of the “vaccine.”
“Myocarditis is always serious,” he said, in an astonishing admission after months of health officials playing down the “mild,” “light,” or “transient” cases of myocarditis that have been noted all over the world, wherever COVID “vaccines” have been injected.
Then he doubled back, making one wonder which part of his statement was true: “The good news is that this is generally transient, short-lived, self-resolving. It’s not like a viral myocarditis, which is much more serious. And it’s extremely rare—it’s one in 40,000. Remember also, the virus infection, COVID-19, is associated with myocarditis. The infection causes myocarditis far more commonly, in roughly 2.5% of people that get it.”
However, “extremely rare – one in 40,000” cannot be discounted as an almost unknown phenomenon when we’re discussing millions of children being injected.
“Infection causes myocarditis far more… in roughly 2.5% of people that get it” – but it does not cause myocarditis in “2.5% of the people who get it.” It may cause myocarditis in 2.5% of the people who tested positive with COVID symptoms, because that’s what one key research study looked at, but no one knows how common myocarditis is as a result of plain-old COVID infection, simply because most people, and certainly the overwhelming majority of children, don’t show symptoms and never even find out they contracted the virus.
When it comes to injecting spike protein instructions into children’s bodies, however, there are no uncertainties regarding exposure.
So, no myocarditis cases in the study – but how many cases of COVID cropped up in the study, out of such a small cohort of children? Of the around 2,250 children enrolled, 16 cases of COVID were noted in the “dummy shot” group as opposed to 3 in the test group. Pfizer concluded that their shot is 90.7% effective against symptomatic cases, which might have been good news if any of the symptomatic cases had been serious, or even moderately-serious, but they weren’t. Not a single serious case of COVID was reported in the entire study cohort, which is really no surprise at all considering what we already know about how dangerous COVID is for children.
Given that Pfizer was looking for FDA approval, however, and not reassurance that kids aren’t at risk, they had to “get creative,” as Dr. Toby Rogers writes. What they did was something called “immuno-bridging,” which extrapolates the results of another study to the cohort in the study under consideration, and draws (in)appropriate conclusions. In this particular case, what they were looking for was evidence that Comirnaty for kids gives significantly enhanced immunity to COVID, so they looked at antibody levels in the 5 to 11 age group, compared them to antibody levels in the 16 to 25 age group in another study, and concluded that kids’ Comirnaty is effective.
According to Rogers, who has spent a significant chunk of his professional life investigating risk-benefit analyses in the pharma industry, “such chicanery is unprecedented.”
That didn’t deter the FDA, whose scientists created statistical models showing that the kids’ shot would prevent around 220 hospitalizations for every million children injected (assuming that contagion rates remained at their current levels, which is quite an assumption to make). They also guessed that myocarditis as a result of the shot would cause around 58 hospitalizations per million shots, so from there to the triumphant conclusion that the shot is worth the risk wasn’t a long road to travel.
“When the virus first came into this country, children accounted for a little less than 3% of cases. Now they account for 27%,” Paul Offit noted. “In part because this is much more transmissible, and in part because they are a susceptible group” because they’re unvaccinated. What he didn’t note was that such figures are really irrelevant, given the fact that most cases that come to light are so light that they are barely noticeable.
So how is it that the Kaiser Family Foundation found that in August and September, COVID was the sixth leading cause of death for children aged 5 to 14, and the seventh leading cause of death for children between the ages of 1 and 4? That’s actually quite a simple question to answer – it’s easy, if you lump all “cancers” into one category, all “heart disease” into another, and so forth.
And it quite neatly diverts attention from the fact that around 600 children under the age of 18 have died from COVID since the “pandemic” began, and that in the 5 to 11 age group, there have been less than 100 deaths. Furthermore, according to federal tracking, nearly 70 percent of children in this age group who have been hospitalized for COVID in the United States have other serious comorbidities, and it is safe to assume that a similar statement can be made regarding mortality figures.
“This is an age group that deserves and should have the same opportunity to be vaccinated as every other age,” said panel member Dr. Amanda Cohn of the Centers for Disease Control and Prevention.
Dr. Jay Portnoy of Children’s Mercy Hospital in Kansas City, Missouri, said despite receiving over 4,000 emails urging him to vote against the vaccine, he was persuaded by the data “showing it works.” Portnoy said he also was representing “parents I see every day in the clinic who are terrified of sending their children to school. … They need a voice also.”
Dr. James Hildreth of Meharry Medical College said he ultimately voted in favor of the vaccine “to make sure that the children who really need this vaccine — primarily Black and brown children in our country — get it.”
“If all goes well, and we get the regulatory approval and the recommendation from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November,” Dr. Anthony Fauci told ABC last week. “If you look at the data that’s been made public and announced by the company, the data look good as to the efficacy and the safety.”
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