Moderna's Safety Signal
433.3% higher rate of Croup 160% higher rate of RSV and higher rates of Hospitalization in babies that got the shot.
As I shared before, I have read all of Moderna’s Data Package for the FDA meeting about approving 6 month old vaccines for Children.
It was a pretty mind numbing read yall. And I am formally trained to read stuff like this. Pfizer docs were released last night, so I am writing this with key takeaways and examples, not detailed quoting of every instance the stuff occurs in the document.
When I read the Moderna Data Package, at first I thought “Well at least the tried to do a science experiment.” See my post on what Science is here if you haven’t yet, because science actually does matter in all of this stuff. It matters a LOT.
Since there are a bunch of really great articles that have already been written on the Moderna data package, I will break it down in terms of what are the top 4 things I would want to know about Moderna’s Document as a Parent, focusing on stuff that I haven’t really seen talked about too much, assuming that they are going to rubber stamp this farse at oversite on Tuesday and Wednesday, then mention 2 really great articles.
Babies that got the shot got sick with dangerous infections at higher rates than the babies that didn’t get their shot. Rates of 433% croup, 160% RSV in the youngest group.
Moderna showed us higher rates of hospitalizations in the kids that got their shot.
Moderna’s experiment for efficacy wasn’t actually focused primarily around vaccine efficacy, but laboratory blood tests.
The plan to BOOST THOSE BABIES!!!!
Babies that got Moderna’s shot got sick with dangerous infections at higher rates than the babies that didn’t get their shot.
Moderna’s safety study caught a signal of increased rates of RSV, non Covid Pneumonias, and Croup in the babies that got the Moderna products. They reported Increased rates of Serious adverse events in the study group of young children (events requiring hospitalizations or severely limiting ones ability to do whatever is expected that you do every day).
Small increases in rates add up when you multiple it out by a million kids. This is very very troubling to me because Croup, RSV and NonCovid Pneumonias are 3 things that actually do cause serious illness and death in young children under age 5. See James Roguski’s substack for more on that. I don’t understand their excuses for the increased rate between the study arm and placebo arm. Frankly it is appears to be a concerning safety finding that could be a signal of a larger problem. There is a signal in the safety of the Moderna product and these higher rates of infection and Severe adverse events. Instead the FDA and Moderna try to talk their way out of the problem. They say that the adverse events were determined to be unrelated… because they are infections. They say lots of kids get sick and the study happened at the time of the year when kids were getting sick. The say that the signal is small and probably its just a fluke so don’t worry about it. The truth is that this study is not designed with a large enough number of participants to actually determine if the products are safe or not, or if the products are causative of this signal. These signals are supposed to be further investigated before we role out for use in the population at large.
PDF Page 93. Moderna uses the excuses below. In the youngest babies that they injected, the rate of croup was 433% in the treatment group of as compared to placebo. The rate of RSV was160% in the treatment group as compared to the placebo. The rate of pneumonia was also elevated. Same trend on the 2-5 year olds. It looks like there could be a similar trend on the older children also, but those studies had extended follow-up and they offered the vaccines to the placebo group when Pfizer shot became available. All I can say is that while the signal isn’t present in older kids, they failed to show that the safety signal was NOT present in older kids, and that is what safety studies are supposed to do.
Moderna showed us higher rates of hospitalizations in the kids that got their shot.
This one really goads me, because the justification to authorize that is used is wholly based on reducing hospitalizations, and they presented a data package with increased hospitalizations in the study arm. When one looks at the rates of serious adverse events, these are events that require hospitalization, the rates were increased in the treatment groups verses the controls, but the individual cases were disregarded as unrelated to vaccination by the investigators. Lets look at what this means for hospitalizations in the youngest babies that they injected with their products: more 6 month old through 23 month olds where hospitalized in the experimental group than in the control group. Those occurrences are disregarded because the investigators determined that the hospitalizations were not related. How could they determine that for most of these things? pdf page 96 has a graph on this:
They said only 1 event was related, because they decided that there was no way that someone that had the shot could have an increased rate of infections. The way I read the chart only 1 event should be considered related, the baby that had a foreign body.
Once again… “The Investigators did not consider either event to be related to vaccination”
Here’s one of the tough the many tough question we all should be asking: How could the investigators really know whether these events involving autoimmune and infectious events that occurred at slightly higher rates in the study group that the placebo group where related to the vaccination?
How can we assume that a product prevents hospitalization when more children were hospitalized for severe adverse events in the study groups than in the control groups?
How can anyone say that this product is safe to use in babies?
Moderna’s experiment for efficacy wasn’t actually focused primarily around vaccine efficacy, but laboratory blood tests.
It was designed to check it’s product for antibodies and adverse effects in babies and younger children. The trial did show that the Moderna products was able to make antibodies. But it also showed that despite making antibodies those antibodies did a very poor job in preventing COVID19 in the real world. Even though the vaccines were demonstrated to not really work well, the conclusion says that the vaccines were still effective, because they were as effective in the study as the other vaccines that are already approved were against Omicron in the real world. So let me ask you: How effective were the already authorized vaccines against Omicron in your experience?
BOOST THOSE BABIES!!!!
The maximal expected protection is 5 months, and the plan from the get go is going to include boosters. Many children in the studies got boosters, within 6 months of receiving their second shot. The published plan is to push a booster 4-6 months after your baby receives the second dose. Conveniently the real world efficacy studies did not appear to consider the boosters efficacy.
Here are 2 substacks that I found helpful on the matter:
Check out James Roguski’s substack post about the moderna document. I have been in communication with James as we tried to put our thoughts together. If he hasn’t published his take on the Moderna document yet he will be soon. James focuses on the legal and regulatory requirements and how Moderna has utterly and completely failed in even coming close to meeting those legal and regulatory requirements, even as loose as they are since the COVID19 emergency status.
I like Jessica Rose’s take on the Moderna document because she sums up exactly what I was thinking as I read the document: Moderna has a shot that doesn’t work and they needed to really quick whip up a safety data package. I thought it was interesting that she suspects that Placebo may have been something besides saline. I was surprised by the high rates of Systemic Adverse Effects in Placebo groups in the Studies that are discussed by Moderna. I would like to know why they saw such unexpectedly high rates of SAEs in the Placebo groups.
I am a fan of @Jessica Rose since she co authored a peer reviewed study with Peter McCullough about myocarditis post MRNA Vaccine that was then simply removed from Elsevier without explanation. There were no questions about the appropriateness of the methodology. Her paper was not retracted, it was removed. As I recall, Elsevier didn’t notify the authors and didn’t provide a reason. Elsevier did not provide an abstract or the document in any form. They simply made it go away. Perhaps it is a coincidence that the FDA and Pfizer were able to do a much more favorable job of benefit risk analysis of the Pfizer product for 5-11 children in the FDA VRBPAC meeting a few weeks latter after the paper was removed from the scientific record. At the meeting Pfizer’s Products remained quite safe and effective as far as published literature was concerned.
(I guess that Pfizer is No Fair to more people than just its competitors)
Dr Rose has since posted the myocarditis paper on her substack for those who are interested to see what type of scientific research gets removed from publication if it is inconvenient to Federal and Corporate interests in the USA today.
What to do? If its before 11:59PM ET on June13th you can still post comment on the federal register.
Also contact your representative and encourage them to get involved.
I will let yall know after I looked at Pfizer’s data package for 6month old through 4 year olds.
-AnthonyAPRN