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When lack of safety equals safety
New FDA study claims to show covid vaccines are safe for children even though the study shows significant increase in serious heart conditions
I was contacted by both the Epoch Times and the Children’s Health Defence (CHD) to comment on this FDA article that appeared this week.
Some of my comments and those of other colleagues are included in both the Epoch Times article and the CHD article, but not all the problems we raised are included.
For the record, here are the full set of comments we made.
I said:
I’ve had a quick look through it.
The conclusion that “these results provide additional evidence that COVID-19 vaccines are safe in children” is pretty ludicrous given the fact that a) they show the safety signal for myocarditis and pericarditis is very strong (and is likely underestimated given some obvious weaknesses of the study); and b) the lack of any benefits of the vaccine to children of this age since they are at no risk from covid and (as others studies show) are actually more likely to get covid with the vaccine.
Issues about the study:
There is a clear ‘healthy user’ bias (or other systemic bias like misclassification or under-reporting of outcomes) in the sample and analysis methods as can be seen for the conditions excluding myocarditis, pericarditis and anaphylaxis. Unless the vaccine has magical health benefits why would incidence of things like bells palsey and appendicitis be so much lower in the vaccinated? In fact, the authors admit that they were unable to follow up extensively on the outcomes.
I don’t like the fact that, where number of outcomes is “<11”, the exact number is not provided.
Given that the types of outcome are inevitably going to be rare in children I’m a bit concerned that the separation into 3 age groups is diluting the results. For example, I suspect that if the groups were combined there could be a significant safety signal for Anaphylaxis based on the reported risk ratios for the 12-15 and 16-17 groups.
There may be conflicts of interest among the authors.
Dr Scott Mclachlan said:
The “risk window” for some events seems arbitrarily too short.
It feels to me that all they are really giving us is “myocarditis” - likely because we already know (and they already admit to) that one. For everything else it just feels like they tried to hide the noise in the numbers.
Another bias is that they included patients on an insurance plan (who are therefore more likely to have a higher socioeconomic status because their parents are employed and therefore provided with or able to afford expensive health insurance). I think the outcome numbers would be vastly different in a group of children whose parents are not as well off.
It is also retrospective (health records) based. I don’t believe they declare what happens when a parent loses their job (and therefore their health plan) and the child ceases to be an active health plan member. I have seen studies out of Optum and Kaiser Permanente in California and Boston in the past where they assume the health plan member had no reaction simply because nothing was written in their health record, but it was assumed they were still a member - sometimes in error. In America this is an incorrect assumption because if you can’t afford to attend the Health Plan doctor, you have to go to a community clinic or the doctor funded by your new health plan provider. That whole “the absence of something is not proof it didn’t happen” thing springs to mind.
Prof Josh Guetzkow said:
I agree with Norman that the main weakness of this design is the comparison they are doing. They are comparing a highly select group of child and adolescent insured vaccine recipients to a historical baseline population consisting of everyone in the relevant age group who were insured. But the people who get vaccinated tend to be healthy, sometimes much healthier, than others. The Nature paper on increases in POTS after vaccination showed this very clearly because the baseline risk values for the unvaccinated were many times higher than for the vaccinated group.
Amazingly, this limitation isn't even mentioned in the article!
I also agree with Scott that the risk windows are rather short and arbitrary. Narcolepsy is a perfect example: the narcolepsy cases following the Swine Flu vaccine in 2009 took months to manifest and be diagnosed. If this was the same then you wouldn't expect to see the incidence increase 42 days after jabbing.
Another thing that is arbitrary are the ratios they establish that would trigger a signal. This is in the protocol of the study, Table 5 page 15: https://bestinitiative.org/wp-content/uploads/2022/12/C19-Active-Monitoring-Protocol-Addendum-2022.pdf
Why, for example, is the ratio for appendicitis 1.09, for DVT it's 1.25 and for GBS it's 2.38 (for the .5-4 year olds)? That means that in order for a 'safety signal' to trigger, you'd need a ratio of 2.38 the incidence rate of GBS among vaccinated compared to expected pre-COVID 'background' rate and the ratio would need to be statistically significant. Oh but wait a second! Why don't the authors include sequential test results for GBS in their study? It's in the protocol. They have the background rates. So why no comparison to background rates? The same can be said of some of the other AEs for which there is only descriptive results. You can triangulate between the study protocol (linked above), the published tables (especially in the supplement) and the protocol for establishing background rates to see exactly which ones should have a sequential comparison but instead are only descriptive.(MIS-C is an exception since that is a new diagnosis developed after COVID started.)
Also, according to the protocols, they are supposed to have some 'negative case' controls -- AEs that would be unrelated to vaccination but could detect other differences, like care-seeking. Why aren't those results reported?
Finally, I think the idea that they look at only 20 very specific AEs then declare them safe upon not finding anything is very myopic. There are many different ICD 10 codes for blood clots or strokes, for example, but here they look at very specific ones like DVT. What might they find if they looked at, for example, a broader range of blood clot diagnoses grouped together?
Also (and related), they say in the protocol that they would add AEs to look at based on signals identified from other sources. What about all the concerning safety signals identified by the CDC for these age groups?
When lack of safety equals safety
The FDA are liars. It has been clear for over 2 years that the shots are unnecessary in children, ineffective in any case, and very, very dangerous. It is not possible to explain their malfeasance as incompetence.
Thank you for blogging on this.
The testimonies of post-jab heart damage in children are just piling up. Here's one I transcribed just the other day:
Dr. Chris Shoemaker and Dan Hartman in Honour of Sean Hartman
Filmed September 3, 2022, at a rally before a vigil march in Toronto, Canada
clip
https://drshoemakercovidtruth.com/hot-topics/
Full-length video from Free Speech Media
"No More Shots, Let's Follow Denmark's Lead! 09/03/22"
https://rumble.com/v1ijlnz-no-more-shots-lets-follow-denmarks-lead-090322.html
(in the full-length video the transcript starts at 8:58)
TRANSCRIPT
DR. CHRIS SHOEMAKER: I'm proud of my last name but I'm also proud of the fact that almost all of my patients and almost all of the mothers and fathers of my patients, you know, call me Dr. Chris. So I can be called either, there are my two names, Chris is my first name, Shoemaker is my last name, and it's a real honor to be here with everybody.
Well, ah, in the very near future I'd like to ask a wonderful man to come forward and stand with me. His name is Dan Hartman. He's here in the crowd. I would welcome him coming up to be with me in the next couple of minutes or seconds. And it is at this time that we will put a face to the sadness of what vaccine injury is.
Vaccine injury, when given to people who don't need it, and no one under the age of 18 needed this shot, no one. And they were all likely to have bad things happen because their immune system is so strong at that age. That's the reason that Denmark has canceled the shot for the future. If this dear gentleman and family had been living in Denmark, to be honest, his son would be alive because there is no mandating of the shot for children in Denmark. They could get them, but they were not mandated for activities, social, physical education or otherwise.
Smart people other there in Denmark. Morons over here in Canada. Morons! Who don't know that you should not vaccinate babies and children.
[clapping]
And I pass the microphone to my dear friend Dan Hartman. God bless you, Dan.
DAN HARTMAN: Thank you, Doctor Chris.
DR. CHRIS SHOEMAKER: Great honor. [inaudible]
DAN HARTMAN: My boy loved hockey. It was his whole life. He was playing ever since he was a little kid. It's all he ever thought about. It was his love and passion. To keep playing hockey, he had to get a vaccine. Sean's biggest fear in life was needles. He was terrified of them. And if he would have had the choice, he wouldn't have taken a needle.
On August 25th, he got vaccinated. On August 29th he went to the hospital, to emergency. He had brown circles around his eyes, he was vomiting, had a very sore shoulder, and a rash. And the doctor sent him home with the medical equivalent of Advil. He didn't do a d-dimer test,* he didn't do a tropanin test.** I filed a complaint against this doctor with the CPSO*** for not doing his job. Two little blood tests that he could have done that might have saved my son's life. They found him not guilty.
So he went to hockey on August, on September 26th. Went to play hockey with his friends. On the morning of September 27th he was, he was found dead on the floor beside his bed. My perfectly healthy son, who had no underlying conditions, was gone.
They did an autopsy and the cause of death was unascertained. Sorry, we don't know why he died.
I want to know why my son isn't here. He was perfectly healthy. There was nothing wrong with him. He faced his biggest fear, which was needles, and it took his life. And I want someone to tell me the damned truth, why my son isn't alive anymore.
This man next to me has been a doctor for over 45 years, he's worked in emergency for 25 years, so when you needed his help, you went and saw a man like this. You trusted him. So now the world needs to trust what he's saying because he's just trying to help. And that's what a doctor does.
My days are absolute torture now. I just cry 15 times a day. And it's hard to even exist. I want the truth about these vaccines.
Every other country in the world is admitting to vaccine deaths. Not Canada. I haven't heard of one.
Is that what we're going to do? We're just going to pretend it's not killing anybody? Really?
If someone could say, I'm sorry, Mr. Hartman, your son died from the vaccine, then I can grieve my son. But not until that day.
Thank you, doctor.
[clapping]
DR. CHRIS SHOEMAKER [taking the microphone]: Based on the medical history, I can say to you, your son was killed by the vaccine. Immediate symptoms within 48 hours of the shot, including symptoms of thrombosis or hemolysis, the fact that marks under the yes, something was going on with his hematologic system and the only thing that had happened was 48 hours before, he got a toxic shot.
I'm so sorry. We're here with you and with all the vaccine injured. Love to you all.
[clapping]
Thank you Dan.
5:33
[END]
# # #
TRANSCRIBER'S NOTES:
For more about Dr. Chris Shoemaker visit https://drshoemakercovidtruth.com/
* "A D-dimer test is a simple blood test that can help your healthcare provider determine if you may have a blood clotting condition. If you have a high level of D-dimer in your blood, your provider may have you undergo further blood tests and/or imaging procedures to determine a diagnosis."
See: https://my.clevelandclinic.org/health/diagnostics/22045-d-dimer-test
**"A troponin test looks for certain types of the protein troponin, in your bloodstream. Those types of troponin only occur in heart muscle cells and only enter your blood because of heart muscle damage. That makes troponin invaluable in diagnosing heart attacks and other heart-related problems." See: https://my.clevelandclinic.org/health/diagnostics/22770-troponin-test
*** College of Surgeons and Physicians of Ontario
https://www.cpso.on.ca/en