FDA acted Irresponsibly
Post #1523
As reported in The Defender over at the Children’s Health Defense website, the FDA understated the risk of harm from the experimental COVID injections. When people are tasked with protecting public health, you expect them to act responsibly, and to refrain from a distortion or misrepresentation of the truth, or a concealment of facts.
At the link above, a scientific study was introduced which performed a second analysis of the benefits and the harms from using Moderna mRNA-1273 shots in young adult males. Before granting approval for Moderna, FDA conducted a risk-benefit analysis, assuming 1 million young adult males get the shot. Here are details:
At top right, in Scenario 1 (dubbed “most likely” by FDA), it was estimated that giving a million males Moderna shots will put 110 of them into the hospital with myocarditis/pericarditis — vaccine-attributable myocarditis/pericarditis, or VAM/P, for short.
The middle column suggests that the shots will be 72% effective in keeping people out of the hospital from COVID — vaccine effectiveness against hospitalization, or VEH, for short. The left column suggests a projected continuation — over the next 5 months — of the exact same high incidence rates as were found in December 2021.
All 3 columns show some evidence of playing fast-and-loose with numbers. The easiest one to pick on is the left column: Why assume that December rates will persist? The authors of this re-analysis then present their own analysis, using only that data which had been available to FDA officials when those officials put their report out.
Notice how the existing estimates of harm run much higher than the “most-likely” estimate of 110 harmed per million injections which the FDA reported. For hospitalizations caused by COVID shots, the weighted average was 250 per million, more than double the estimate from FDA. The top estimate was 452 per million doses.
For the “most-likely” analysis by FDA (Scenario 1), it was conjectured that injecting a million males will prevent 4,766 hospitalizations over the course of 5 months, while only causing 110 hospitalizations due to myocarditis/pericarditis from taking those million COVID shots.
This led to a very high benefit:risk ratio (top-right value) of 43 hospitalizations prevented for each one caused, but the refined estimate after re-analysis was just 181 hospitalizations prevented, and 268 hospitalizations caused (blue highlight added):
When the researchers kept certain of FDA presumptions and reworked the FDA Scenario 1 — second green section called Scenario A — there was a supposed residual benefit to COVID shots, but it can get discounted, because of FDA’s unfounded presumption that 100% of all young males would get COVID during the next 5 months.
What kind of a slip-shod analysis presumes that 100% of people will get infected within 5 months? Even worse was that the FDA did not account for protection from prior infection, even though it would have been expected by 2022 that most young adults had had COVID:
Prior infection not only protects against future hospitalization due to COVID, but adds risk on the back-side when getting vaccinated post-infection:
This has the effect of moving both numbers in the ratio, which produces the largest impact on a benefit:risk ratio. For 70% of the young males taking Moderna after it got approved by FDA — i.e., those presumed to have had a prior COVID infection — net harm would be expected to come to them (with a minimum of 2.1x the risk):
But public policy which is expected to cause net-harm to 70% of a population should not be allowed in the future. It is bad enough that it was allowed to happen this time. The high estimate means that 7 young adult males were put into the hospital by myocarditis/pericarditis for each one kept out of the hospital for COVID.
This is an instance of the FDA officials acting irresponsibly. Let it never happen again.
Reference
[re-analysis of risk:benefit of Moderna for young males] — https://www.mdpi.com/2076-393X/14/2/165