Posted on 11/03/2023 9:52:06 AM PDT by SeekAndFind
(NOTE: I asked the FDA for comment for this article before noon on Thursday. The agency has missed my deadline of noon Friday to respond. mRNA shots are still promoted to children, so the fact they may cause seizures is an urgent public health issue. I have decided to publish the article now, including my questions to the FDA in it. When they respond I will update.)
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Young children had a significantly elevated risk of seizures and convulsions after receiving mRNA Covid jabs, Food and Drug Administration scientists have found.
The FDA researchers quietly released the finding , which comes from an analysis of insurance claims databases, earlier this week. The FDA and Centers for Disease Control did not meet a deadline on questions if CDC knew of the finding before it advised kids to receive more mRNA Covid boosters last month.
The FDA did not quantify the risk or severity of the seizures in the paper. But the published data suggest the risk appears to be about 1 in 2,500 completed vaccinations within a week of a shot. Older kids also had increased risk, though it did not hit statistical significance.
The CDC’s push for more mRNA for young kids was already controversial, since most countries no longer make Covid boosters available to children (or most healthy adults). The seizure finding will only increase the scrutiny CDC faces.
The “signal” - as researchers call the finding of elevated seizure risk - occurred in children aged 2-4 who received the Pfizer mRNA Covid shot and 2-5 who received the Moderna jab. (The age difference comes because Pfizer and Moderna offer different regimens of shots with different age limits to young kids.)
The researchers reported 72 seizures and convulsions in children in those age ranges after the first two doses of either Pfizer of Moderna. Most seizures came along with fevers, they wrote.
They found the seizures occurred after mRNA shots from both companies, increasing the odds the finding is a real risk, not a chance artifact.
The data also show a trend towards more seizures in children who received the Moderna shots, which contain more mRNA than the Pfizer jabs. Epidemiologists call that a dose-response relationship, and it is also evidence the finding is real.
In addition, the risk appeared highest in the day after children received the shots and persisted for up to a week, as far as the researchers tracked it. The fact the risk was highest soonest after the shots is still more evidence that the link is real.
Young children sometimes have seizures spontaneously or while running high fevers.
But when the researchers compared the normal background number of seizures with the 72 they saw, they found a difference that was unlikely to be due to chance.
The researchers found another 40 seizures in children under age 2, and 161 more in children and teenagers 5-17, though far more older kids received shots, so the relative risk in them was was lower.
In a similar analysis released in May that did not cover the youngest kids , the researchers found an elevated seizure risk in older children and teenagers, with the risk especially notable in children 5-11. But the risk did not reach statistical significance, meaning it could have been a chance finding.
The new analysis was published Sunday as a “preprint,” a non-peer-reviewed paper, or the Medrxiv server. It lacks certain crucial data.
Notably, the researchers did not include either the overall number of jabs or the number of completed vaccinations given to children 2-4 (or 2-5 for Moderna). They also did not include the background rates they used. So calculating either absolute or relative risk ratios with precision is impossible.
However, they did report the total number of jabs given to kids under 5, which was roughly 850,000, including about 140,000 second Moderna jabs and 100,000 third Pfizer jabs. Two Moderna jabs and three Pfizer shots are required for a complete mRNA regimen in young kids.
Thus the total number of completed vaccinations in all kids under five in the database was about 240,000. Most of those went to kids in the 2-5 range. The 72 seizures thus come off a base of 175,000 to 200,000 completed vaccinations, for a rate of 1 seizure per 2,500 vaccinations.
(Again, if and when FDA or CDC responds to my questions, I will update the article.)
Ping this to anyone interested
FDA: OOPS!
Hearken to us,
exDemMom
Scientist with
great aplomb!
By the power of
Calculus™! we implore
your aid!
Help, help, we’re being
misinformed™!
the FDA knew this, and that all the mice
used for testing also died.
the FDA therefore mandated it for children
and pregnant women.
the FDA administrators belong in GITMO to get
the justice they deserve.
That’s not all ping.
IBTFR$$sD
LMAO
only very urgent to the brainwashed masses who trusted the gov and gave their kids the shot.
Anything that COVID could do, the jab can do better.
Plenty of purebloods like me got wrecked by COVID. It’s infuriating that the jab was foisted on so many people.
😂
You misspelled *hell*.
The FDA stamp of approval has not only become meaningless to me, it’s quickly becoming the kiss of death for medicines and drugs.
I followed the links and read the abstract of the original study. The findings are not conclusive.
However, the study should not be ignored, as it is a legitimate study. It’s not the typical pro- or anti-vax propaganda we normally see.
What really bothers me is that all legitimate anti-vax studies are buried by the mainstream media. Folks have the right to hear all sides of the issue. And that’s sure not what we’re getting.
And as a side note, I mistrusted mRNA vaccines from the get-go. This study reinforces my decision to avoid them.
Crimes-Against-Humanity BUMP
My daughter-in-law got her little kids vaccinated out of spite. The little boy collapsed at school. He almost died. They don’t know what was wrong. They still claimed they don’t know. I know.
☠️
Poison
A thread on this study was published several days ago and I already went through a step-by-step analysis of why it is only posted on a pre-print server and will almost certainly not be published in the peer-reviewed medical/scientific literature.
I wish FR had a more user-friendly search function. I'd just repost my earlier analysis if I could.
The authors of the study report communicate over and over (without using the exact words) that the finding of increased seizure was most likely an artifact resulting from how they analyzed the data. They compared the rate of seizures between vaccinated children and the background incidence of seizures of children in the same age group.
When they compared seizure rates in vaccinated children to the 2020 background rate, they saw a slight increase in the vaccinated group which they only described as "meeting the statistical threshold." But when they compared the vaccinated children to the background rate in 2022, there was no difference:
However, in a post-hoc sensitivity analysis, the seizures/convulsions signal was sensitive to background rates selection and was not observed when 2022 background rates were selected instead of 2020 rates.
No one else has ever found an association between Covid vaccines and seizures, further indicating that the finding is an artifact:
The seizures/convulsions signal in children aged 2-4/5 years has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines.
The authors themselves say that no conclusion should be made from this study and that the finding must be confirmed in future, more carefully designed studies:
The new seizures/convulsions signal observed in our study should be interpreted with caution and further investigated in a more robust epidemiological study.
They stressed that background rates of seizures were lower in 2020 than they were in 2022. The significance of this is that since the FDA issued the EUA for pediatric Covid vaccines in July 2022, the comparison of occurrence of seizures in vaccinees should be made against the 2022 background, not the 2020 background. As the authors point out, viruses known to cause seizures were circulating in 2022:
However, seizures/convulsions rates in this age group in 2022 were twice as high as 2020 rates. There could be a couple of potential reasons for elevated outcome rates in 2022 compared to 2020. First, there was an increased incidence of respiratory infections (influenza and respiratory syncytial virus) which are shown to be associated with febrile seizure in younger children, during the study period (mid-2022 to mid-2023) compared to 2020. Second, in 2020, there were likely fewer emergency department visits for seizure-related events compared to 2022 because of COVID-19 pandemic healthcare resource limitations.
The paper contains absolutely no information about the statistical tests used or mention P values, confidence intervals, or any of the other statistical measures that are included in scientific papers. They do not define what they mean by "statistical threshold for a signal," which is not a general scientific term which would be widely understood within the scientific community. Furthermore, the authors repeatedly used language indicating that they consider that the "seizure signal" was a spurious result. If they had found something they thought was concerning, they would have said so in the report. I'd be surprised if this ever made it through peer-review to be published even in a low-impact medical journal; I question whether it has been submitted to a journal at all.
This study was funded by the FDA. It looks to me like it was written up and posted on the pre-print server to show whoever at the FDA authorized the funding that they did do the funded work (and didn't just spend the funds on office parties or whatever).
Oops, I made an error here.
I said that the study authors did not describe the statistical tests used to detect the “statistical threshold” signals. However, they do mention using the “Poisson Maximized Sequential Probability Ratio Test (PMaxSPRT) to detect statistical signals” with no further explanation or details about the actual signals detected, ranges, or error rates.
That's called a 'rising secular trend' and can be indicative of systemic errors (you ignored an important variable, such as, THE CLOT SHOTS are responsible and are contaminating the background level) or maybe just global warming as another SCIENTIFIC paper told us would lead to rising heart attack rates, and which you declined to discuss with me just the other day.
My FR search works.
But oh, snap! According to you I don't know how to post html hyperlinks in-thread, even though I'd just done so in some of my replies to you earlier this week. Save me, Science-gurl! I risk being MISINFORMED!
Can you tell me why any child should have gotten a Covid19 vaccine?
Any…. Child.
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