The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) routinely violate their own standards and the fundamental norms of science when reviewing Emergency Use Authorizations (EUA) and Biologics License Applications from pharmaceutical companies that wish to introduce a new vaccine.
The FDA publishes a 242-page book called Communicating Risk and Benefits: An Evidence-Based User’s Guide. The guide states that absolute risk, relative risk and number needed to treat (NNT) are all necessary for proper decision-making.
Yet the recent FDA risk-benefit assessment in connection with the Pfizer EUA application for children 5 to 11 described only relative risks in an older population and ignored absolute risk and NNT altogether.
Similarly, the CDC’s “Guidance for Health Economics Studies Presented to the Advisory Committee on Immunization Practices (ACIP)” describes 21 items every health economics study in connection with vaccines must do. In four separate places, the CDC guidance document mentions the importance of coming up with a number needed to vaccinate (NNTV).
The FDA and CDC work hand-in-hand to review vaccine safety. Yet the FDA’s risk-benefit analysis violated at least half of the 21 CDC standards and never once estimated an NNTV. Because the FDA failed to provide an NNTV, I will attempt to provide it here.
First a little background and context. The NNT in order to prevent a single case, hospitalization, ICU admission or death is a standard way to measure the effectiveness of any drug. It’s an important tool because it enables policymakers to evaluate tradeoffs between a new drug, a different existing drug, or doing nothing.
In vaccine research, the equivalent term is number needed to vaccinate (NNTV), sometimes also written as NNV) in order to prevent a single case, hospitalization, ICU admission or death (those are four different NNTVs that one could calculate).
The pharmaceutical industry hates talking about NNTV, and they hate talking about NNTV even more when it comes to COVID-19 vaccines because the NNTV is so high that this vaccine could not pass any honest risk-benefit analysis.
Indeed about a year ago, I innocently asked on Twitter what the NNTV is for coronavirus vaccines. A swarm of Pharma trolls rushed in to attack me and a Pharma goon published a hit piece on me outside of Twitter to punish me for even asking the question. That lets me know that I’m directly over the target.
Of course none of the Pharma trolls ever provide an estimate of the NNTV for COVID shots — their goal is to impede any honest scientific debate. Various health experts have calculated an NNTV for COVID vaccines:
- Ronald Brown, a health economist in Canada, estimated that the NNTV to prevent a single case of coronavirus is between 88 and 142.
- Pediatrician Allan Cunningham calculated the NNTV to prevent a single case at 256.
- In the best study to date, German and Dutch researchers (Walach, Klement, and Aukema, 2021), using a large (500,000 person) data set from a field study in Israel, calculated an NNTV for the Pfizer mRNA shot at between 200 and 700 to prevent one case of COVID. They went further and figured out that the “NNTV to prevent one death is between 9,000 and 100,000 (95% confidence interval), with 16,000 as a point estimate.”
You can see why the pharmaceutical industry wants to avoid talking about this number. One would have to inject a lot of people to see any benefit, and the more people who are injected, the more the potential benefits are offset by the considerable side-effects associated with the shots.
Furthermore, the NNTV to prevent a single case is not a very meaningful measure because most people, particularly children, recover on their own (or even more quickly with ivermectin if treated early). The numbers that health policymakers should really want to know are the NNTV to prevent a single hospitalization, ICU admission, or death.
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But with the NNTV to prevent a single case already so high, and with significant adverse events from coronavirus vaccines averaging about 15% nationwide, Pharma and the FDA dare not calculate an NNTV for hospitalizations, ICU admissions, and deaths — because then no one would ever take this product (and they would lose $93 billion in annual revenue).
Increased all-cause mortality in the Pfizer clinical trial of adults
Pfizer’s 6-month clinical trial in adults showed alarming increases in all-cause mortality in the vaccinated. On that basis, Pfizer’s initial EUA application should have been rejected and the Independent Review Board should have rejected Pfizer’s application to conduct clinical trials in children.
In Pfizer’s 6-month clinical trial in adults there was one death from COVID-19-related illness out of about 22,000 participants in the vaccine (“treatment”) group, and two deaths from COVID-19-related illness out of 22,000 in the placebo group (see Table s4). It would appear that 22,000 shots prevented one death from COVID so one might assume an NNTV of 22,000? Not so fast.
When one looks at all-cause mortality, there were 15 deaths in the treatment group and 14 deaths in the placebo group. Efficacy against COVID was declining by 6% every month (see p. 7), so at the 6-month point Pfizer ended the trial and offered the vaccine to everyone in the placebo group.
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Once Pfizer’s mRNA shot was available to everyone (what’s called the “open-label period”) three more people from the treatment group and two original placebo recipients who elected to receive the Pfizer mRNA shot died. So in all, there were 20 deaths in the treatment group and 14 deaths in the placebo group.
Former New York Times investigative reporter Alex Berenson broke the news about the bad outcomes for the vaccinated in the Pfizer clinical trial in adults. Twitter banned Berenson for life for posting Pfizer’s own clinical trial data.
Pfizer learned its lesson with the adult trial, so when the drugmaker conducted a trial of its mRNA vaccine in children ages 5 to 11 it intentionally made it too small (only 2,300 participants) and too short (only followed up for 2 months) in order to hide harms.
Estimating an NNTV in children ages 5 to 11 using Pfizer’s own clinical trial data
All of the NNTV estimates above are based on data from adults. In kids the NNTV will be even higher — the lower the risk, the higher the NNTV to prevent a single bad outcome.
Children ages 5 to 11 are at extremely low risk of death from coronavirus. For instance, in a meta-analysis combining data from five studies, Stanford researchers Cathrine Axfors and John Ioannidis found a median infection fatality rate (IFR) of 0.0027% in children ages 0-19. In children ages 5 to 11, the IFR is even lower.
Depending on the study one looks at, COVID is slightly less dangerous or roughly equivalent to the flu in children. So how many children would need to be injected with Pfizer’s mRNA shot in order to prevent a single hospitalization, ICU admission, or death?
Let’s examine Pfizer’s EUA application and the FDA’s risk-benefit analysis. By Pfizer’s own admission, there were zero hospitalizations, ICU admissions, or deaths in the treatment or control group in their study of 2,300 children ages 5 to 11.
NNTV is calculated by dividing 1 by the Absolute Risk Reduction. But there was no risk reduction in hospitalizations, ICU admissions, nor death. So if one remembers grade school math, 1/0 is “undefined” since one cannot divide by zero.
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This means one could vaccinate every child age 5 to 11 in the U.S. and not prevent a single hospitalization, ICU admission, or death from coronavirus — according to Pfizer’s own clinical trial data as submitted to the FDA.
Estimating an NNTV and risk-benefit model in children ages 5 to 11 using limited available data
It appears Pfizer was not even trying to conduct a responsible clinical trial of its mRNA shot in kids ages 5 to 11. Pfizer submitted an EUA application to the FDA showing no health benefit in children ages 5 to 11 and the FDA’s Vaccines and Related Biologics Products Advisory Committee approved it anyway, 17 – 0 with 1 abstention.
So the vaccine juggernaut marches on. Yet, the original question remains. If one wanted to develop a responsible NNTV and risk-benefit model using the limited real world data that is available, what might that look like?
Over time, others will develop a much more sophisticated estimate — for example, Walach, Klement, & Aukema (2021) estimated an NNTV for three different populations based on “days post dose”.
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But for our purposes here I believe there is an easier way to come up with a ballpark NNTV estimate for children ages 5 to 11. We can do that by asking: “What is the maximum number of deaths from COVID-19-related illness that might be prevented if all children in this age group were vaccinated, and how many lives would be lost as a result of side effects from injecting that many kids?”
It’s admittedly an unconventional approach. But given Pfizer’s data is unusable, the FDA is ignoring the question, the CDC is making up numbers (see update below), and shots are going in arms as we speak, I feel compelled to try to come up with a best guess under the circumstances.
Here’s the benefits model:
- As of Oct. 30, the CDC stated 170 children ages 5 to 11 have died of COVID-related illness since the start of the pandemic. (That represents less than 0.1% of all coronavirus-related deaths nationwide even though children that age make up 8.7% of the U.S. population).
- The Pfizer mRNA shot only “works” for about six months (it increases risk in the first month, provides moderate protection in months two through four and then effectiveness begins to wane, which is why all of the FDA modeling only used a 6-month time-frame). So any modeling would have to be based on vaccine effectiveness in connection with the 170 / 3 = 57 children who might otherwise have died of COVID-related illness during a six-month period.
- At best, the Pfizer mRNA shot might be 80% effective against hospitalizations and death. That number comes directly from the FDA modeling (p. 32). I am bending over backwards to give Pfizer the benefit of considerable doubt because again, the Pfizer clinical trial showed no reduction in hospitalizations or death in this age group.
- So injecting all 28,384,878 children ages 5 to 11 with two doses of Pfizer, which is what the Biden administration wants to do, would save, at most, 45 lives (0.8 effectiveness x 57 fatalities that otherwise would have occurred during that 6-month time period = 45).
- So then the NNTV to prevent a single fatality in this age group is 28,384,878 / 45 = 630,775 . But it’s a two-dose regimen, so if one wants to calculate the NNTV per injection the number doubles to 1,261,550. It’s literally the worst NNTV in the history of vaccination.
If you inject that many children, you certainly will have lots and lots of serious side effects, including disability and death. So let’s look at the risk side of the equation.
Here’s the risk model:
- Because the Pfizer clinical trial has no usable data, I have to “immuno-bridge” from the nearest age group. To be clear, I do not believe that immuno-bridging is a valid way to calculate these numbers. But since the FDA used immuno-bridging to estimate benefits, then I will also use it to show harms.
- 31,761,099 people (so just about 10% more people than in the 5 to 11 age bracket) ages 12 to 24 have received at least one coronavirus shot.
- The COVID vaccine program has existed for only 10 months and younger people have had access only more recently (children 12 to 15 have had access for five months — since May 10) — so we’re looking at roughly the same observational time period as modeled above.
- During that time, there are 128 reports of fatal side effects following coronavirus mRNA injections in people 12 to 24. (That’s through Oct. 31. There is a reporting lag though, so the actual number of reports that have been filed is surely higher).
- With potentially deadly side effects including myocarditis and pericarditis disproportionately impacting youth it is reasonable to think that over time, the rate of fatal side effects from mRNA shots in children ages 5 to 11 might be similar to those in ages 12 to 24.
- Kirsch, Rose, and Crawford (2021) estimate the Vaccine Adverse Event Reporting System undercounts fatal reactions by a factor of 41, which would put the total fatal side effects in this age-range at 5,248. Kirsch et al. represent a conservative estimate because others have put the underreporting factor at 100.
- Death is just one of a multitude of possible adverse events that are reported following vaccination. Dr. Jessica Rose recently calculated an underreporting factor of 31 for all severe adverse events following vaccination.
Simply put, the Biden administration plan would kill 5,248 children via Pfizer mRNA shots in order to save 45 children from dying of coronavirus. For every one child saved by the shot, another 117 would be killed by the shot.
The Pfizer mRNA shot fails any honest risk-benefit analysis in children ages 5 to 11. Even under the best circumstances, estimating NNTV and modeling risk vs. benefits is fraught.
In the current situation, with a new and novel bioengineered virus, where Pfizer’s data are intentionally underpowered to hide harms, and the FDA, CDC, and Biden administration are doing everything in their power to push dangerous drugs on kids, making good policy decisions is even more difficult.
The Biden Administration, the FDA, and the CDC claim they “follow the science” and yet they violate their own standards and scientific norms in order to exaggerate the benefits and hide the harms from vaccines.
The FDA refused to calculate an NNTV, not because it forgot, but because agency officials knew the number and corresponding side effects are so high it would destroy the case for mRNA vaccines in children this age.
Update: CDC finally mentions NNTV, but …
Toward the end of the six-hour CDC’s Advisory Committee on Immunization Practices (ACIP) Nov. 2 meeting where the committee voted to recommend Pfizer’s EUA vaccine for children 5 – 11, there was finally a mention of NNTV. It was on slide 36 of a presentation by CDC official Dr. Sara Oliver. Unfortunately the CDC estimate was untethered from reality. I’ll explain:
Then she claimed the NNTV to prevent a single hospitalization is between 2,213 and 8,187. This is dishonest and a violation of scientific norms. NNTV is calculated by dividing 1 by the Absolute Risk Reduction. There was no Absolute Risk Reduction in hospitalizations in the Pfizer clinical trial in kids 5 to 11, because no one was hospitalized in either the treatment or control group. 1/0 is “undefined” not 8,187.
Oliver made no estimate of NNTV to prevent a single COVID-19-related death because that is also undefined (again, there were no COVID-related deaths in the treatment or placebo group in the trial so the absolute risk reduction was zero).
Oliver also did not model injuries or deaths from the vaccine (she immuno-bridged from an older age group to show benefits but ignored the reported harms from the vaccine in the older age group).
I should also note that my estimates of NNTV were based on CDC data showing 170 deaths from COVID-19-related illness in kids ages 5 to 11 over the last 18 months (I got the number directly from the CDC COVID tracking website). However at the ACIP meeting, the CDC said the number of children in this age group who have died of COVID-19-related illness is 94.
If 94 is the correct number (over an 18 month period) then the NNTV will be even higher. Again the calculation is based on a 6-month period (so 94 / 3 = 31). And the Pfizer vaccine, at best, is only 80% effective (so 31 x .8 = 24.8 = maximum number of COVID fatalities that might be prevented in that age group in that time period). So then the NNTV to prevent a single death from COVID-19 related illness in this age group would be 28,384,878 / 24.8 = 1,144,552. But it’s a two-dose regimen, so if one wants to calculate the NNTV-per-injection the number doubles to 2,289,103.
I imagine that at most, half of American parents will be foolish enough to inject this toxic product into their kids. At a 50% uptake rate, the ACIP decision to approve the Pfizer shot will likely kill 2,624 children via adverse reactions in order to potentially save 12 from COVID-19-related illness.
Now you know why the CDC did not release the meeting materials prior to the ACIP meeting — they could not stand up to any public scrutiny.
This article was originally published on Substack.
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