Where to begin with the absurd benefit-risk analysis by the US Food and Drug Administration (FDA) for Pfizer’s COVID-19 mRNA “vaccine” in children ages 5-11? (FDA) for Pfizer’s COVID-19 mRNA “vaccine” in children ages 5-11?
Let’s start with my credibility. I studied statistics for a year at one of America’s top liberal arts colleges (Swarthmore). I studied statistics for a year at UC Berkeley, a #1 ranked master’s program in policy analysis. And I have a PhD in political economy from one of the best universities in the world (University of Sydney). (See Attachment 1 at the End).
Because my research is on corruption in the pharmaceutical industry, I have been reading scientific studies on vaccines almost daily for the past five years. Earlier in my career, I worked professionally to analyze shoddy cost-benefit analyses prepared by companies trying to obtain tax breaks, contracts, and other concessions from local governments.
Suffice it to say, I have studied risk-benefit analysis in depth and am better able than most to read one of these documents. The FDA’s risk-benefit analysis for Pfizer’s vaccine for children ages 5-11 is one of the sloppiest documents I have ever seen….
Let’s start from the beginning:
1. The rates of COVID-19 in children 5-11 years old are so low that there were ZERO cases of severe COVID-19 and ZERO cases of death from COVID, either in the treatment group (n=1,518) or in the control group (n=750).
Therefore, any claims in the press that the Pfizer vaccine is “90% effective” in children are meaningless, as they refer to mild cases from which children generally recover quickly (and then have robust broad-spectrum immunity).
So there is literally no emergency in this population for which an Emergency Use Authorization (EUA) can be requested. Pfizer’s application should be denied out of hand if the FDA truly followed the science and its own rules. We will return to this issue below.
2. Pfizer’s clinical trial in children was intentionally inadequate to hide the harms.
This is a well-known trick of the pharmaceutical industry. (Pfizer manipulated it by importing data from another study, but that other study monitored adverse effects for only 17 days, so the new data contaminated rather than clarified the results.)
In short, if the rate of certain adverse outcomes in children as a result of this vaccine is 1 in 5,000, and the trial enrolled only 1,518 children in the treatment group, it is unlikely that this particular harm would be detected in the clinical trial. Voila “Safe and Effective.”
3. Pfizer enrolled only “participants aged 5 to 11 years with no evidence of prior SARS-CoV-2 infection.”
Does Pfizer’s mRNA injection nullify natural immunity and leave you worse off than if you do nothing, as these UK government data show?
Pfizer is not aware why children with prior SARS-CoV-2 infection were excluded from this study. This was intentional. Polluters have learned not to ask questions they don’t want answers to, lest they face their own smoking gun in a future lawsuit.
This is according to an analysis by Alex Berenson:
“The British find that the vaccine impairs the body’s ability to form antibodies after infection not only against the spike protein, but also against other parts of the virus. Specifically, vaccinated people do not appear to make antibodies against the nucleocapsid protein, the envelope of the virus, which is a critical part of the response in unvaccinated people.”
“This means that vaccinated people are much more susceptible to mutations of the spike protein, even if they have already been infected once (or probably even several times) and have recovered. This also means that the virus probably selects mutations that are just that way, because it can infect a large susceptible population. And it’s probably even more evidence that vaccines can interfere with the development of robust long-term immunity after infection.”
4. Did Pfizer lose contact with 4.9% of its clinical trial participants?
The FDA risk-benefit document states, “Of the participants in Cohort 1, 95.1% had safety follow-up ≥2 months after Dose 2 at the time of the data stop on September 6, 2021.” So what happened to the 4.9% who did not have safety follow-up 2 months after Dose 2?
Were they in the treatment group or the control group? We don’t know because Pfizer won’t say. Given the small size of the study, the results could be confounded if 4.9% of participants were not followed up.
5. The follow-up period was intentionally too short.
This is another well-known trick of the pharmaceutical industry to disguise the harm. Cohort 1 was apparently followed for two months, while Cohort 2 was monitored for adverse events for only 17 days.
Many vaccine harms, including cancer and autoimmune diseases, take much longer to appear. As the old saying goes, “You can do it fast or you can do it right, but you can’t have it both ways.” Pfizer made a quick decision.
6. The benefit-risk model created by the FDA only considers one known harm of Pfizer’s mRNA injection: myocarditis.
But we know that the real-world harms of Pfizer’s mRNA injection go far beyond myocarditis and include anaphylaxis, Bell’s palsy, heart attack, thrombocytopenia/low platelet count, permanent disability, shingles, and Guillain-Barré syndrome, to name a few.
Cancer, diabetes, endocrine system disorders, and autoimmune diseases may come later. But the FDA doesn’t care about any of that because it has a vaccine to sell, so it just ignores all of those factors in its model.
7. Pfizer intentionally eliminates the control group as quickly as possible by vaccinating all the children who originally received the placebo.
They claim they are doing this for “ethical reasons.” But everyone knows that Pfizer’s real goal is to eliminate any comparison group so that there can be no long-term safety studies.
Eliminating the control group is a criminal act, and yet Pfizer, Moderna, Johnson & Johnson, and AstraZeneca do this as standard practice with approval from the FDA and the Centers for Disease Control and Prevention.
8. Given all this, how could the FDA claim that this vaccine has any benefit?
You’d better sit down for this part, because it has it all! Here’s the key sentence:
“The vaccine’s efficacy was determined by immune bridging 50% of neutralizing SARS-CoV-2 antibody titers (NT50, SARS-CoV-2 mNG microneutralization assay).”
Wait, let me explain. ZERO cases of severe COVID-19 occurred in the clinical trial in children aged 5-11 years. Therefore, Pfizer and the FDA simply ignored any actual health consequences (they had to, because there is no emergency, so the lawsuit is moot).
Instead, Pfizer switched to looking for antibodies in the blood. In general, antibodies are a poor indicator of immunity. And the antibodies in the blood of these 5-11 year olds tell us nothing, because there were no cases of severe COVID-19 in this study either (none in the treatment group, none in the control group).
They came up with an “immune bridge.” Pfizer looked at antibody levels in blood tests from another study involving people ages 16 to 25, calculated the antibody level that appears to be protective in that population, then calculated how many children ages 5 to 11 had similar antibody levels in their blood, and then suggested a figure for how many cases, hospitalizations, ICU admissions, and deaths in the 5-to-11-year-old population could be prevented by this vaccine in the future, based on antibody levels and health outcomes in the 16-to-25-year-old population.
If your head hurts from this tortured logic, it should, because such chicanery is unprecedented in a risk-benefit analysis.
Then, when the FDA uses this tortured logic at the beginning of its briefing paper, all the calculations derived from it are completely wrong. Not just wrong, but absurdly and criminally wrong.
The whole game boils down to Table 14 on page 34 of the FDA’s risk-benefit document. And here the red flags come fast and furious.
9. The FDA model does not assess the benefit of vaccine protection until six months after completion of the two doses.
It also assumes that the vaccine’s effectiveness remains constant during this period. This is problematic for several reasons.
First, reducing mild cases in children is not a desired clinical outcome. As Dr. Geert Vanden Bossche notes, mass vaccination causes children to produce more infectious variants. He said:
“Young, healthy people should definitely not be vaccinated, as this would only erode their protective innate immunity against coronaviruses (CoV) and other respiratory viruses.”
“Their innate immunity is normally/naturally highly protective and provides a kind of herd immunity in the sense that it attenuates infectious CoV pressure at the population level, whereas mass vaccination makes them carriers of more infectious variants.”
“Children/adolescents who contract the disease usually become mildly to moderately ill and continue to contribute to herd immunity by developing broad and long-lasting immunity.”
“If you’re vaccinated and get infected, you can also develop lifelong immunity, but why risk vaccination, especially if you’re young and healthy?”
For one thing, there’s the risk of possible side effects, and for another, there’s an increased risk that your vaccine antibodies will no longer be functional, even though they still bind to the virus, increasing the likelihood of ADEs or even severe disease … “
Second, we know that the vaccine’s efficacy is negative in the month after the first dose because it inhibits the immune system and begins to decline after four months, so all FDA estimates of the vaccine’s efficacy are inflated.
Third, myocarditis caused by these vaccines is likely to develop over the years. Robert Malone, the inventor of the mRNA technology, points out that the FDA admits that children will be injected twice a year forever (hence the six-month time frame in the FDA’s risk-benefit model).
But the risks of “adverse events such as cardiomyopathy will be cumulative.” Therefore, any model that considers only a six-month time frame obscures the true rate of adverse events.
10.The FDA / Pfizer play fast and loose with their estimates of myocarditis.
First, they estimate “excess” (read: caused by injections) myocarditis using data from the private “Optum health claims database” instead of the public Vaccine Adverse Event Reporting System (VAERS) (see page 32).
Therefore, it is impossible for the public to verify their claims. Then, when it comes time to calculate how many children with vaccine-induced myocarditis need to be hospitalized and treated in the ICU, they use the Vaccine Safety Data Link (see page 33). Why switch to another database for these estimates? Finally, they do not explain how the “excess” myocarditis deaths were calculated, so they simply reported 0.
The FDA estimates that for every 1 million dually vaccinated children ages 5-11, there will be 106 additional cases of myocarditis. There are 28,384,878 children ages 5-11, and the Joe Biden administration wants to vaccinate them all with Pfizer’s mRNA vaccines and has already purchased enough doses to do so (although only one-third of parents want their children vaccinated with this vaccine).
So if the Biden administration gets its way, 106 cases of excessive myocarditis per 1 million x 28.38 million people would result in 3,009 cases of excessive myocarditis after vaccination, if Pfizer’s vaccine is approved.
And over the course of several years, many of these children will die. Dr. Anthony Hinton (“Consultant surgeon with 30 years’ experience in the NHS”) points out that the mortality rate for myocarditis is 20% after two years and 50% after five years.
So the FDA has it exactly backwards: they want to prevent mild COVID in children, which reduces herd immunity, and simply lie about the dangers of myocarditis.
I have taken the liberty of correcting FDA Table 14 with actual real-world data and stretching it to 5 years. Here’s what that looks like:
A study by Harvard Pilgrim Healthcare for the US Department of Health and Human Services estimates that VAERS captures only 1% of actual vaccine injuries. Steve Kirsch has created a sophisticated model that puts the underreporting factor for COVID-19 vaccine deaths at 41 (so multiply the above numbers by 41). (See Attachments 2 and 3 at the End.)
And myocarditis is just one of many possible outcomes of COVID-19 vaccination. Dr. Jessica Rose recently calculated an undercount of 31 for all serious adverse events following vaccination.
Pfizer’s vaccine defies an honest benefit-risk assessment with respect to its use in children aged 5-11 years. The FDA’s risk-benefit analysis for Pfizer’s mRNA vaccine in children aged 5-11 years is of poor quality. A twisted logic (that would be rejected by any proper academic journal) was used to reach a predetermined conclusion that is not scientifically sound.
The FDA briefing paper is a work of fiction and should be immediately withdrawn. If the FDA continues with this grotesque charade, it will cause irreparable harm to children, and FDA leadership will one day be charged with crimes against humanity.
1. FDA Briefing Document
2. Grant Final Report
3. Public Health Policy Initiative (PHPI)