FDA Detects Serious Safety Signal for Covid Vaccine Among Kids
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According to a new federally funded study, which just came out of the FDA, children between the ages of 12 to 17 who took the Pfizer vaccine face an elevated risk of heart inflammation, with the elevated risk being present just seven days post-vaccination.
Now, everybody already kind of knew that.
However, according to the FDA researchers who are conducting this study, the number of myocarditis and pericarditis events that they found in this particular age group met the threshold for something that's known as a safety signal, as defined by the CDC. To be specific, this study was published earlier this week over in the pages of JAMA, which is the Journal of the American Medical Association.
And here is what the FDA wrote as a summary of their findings.
Quote, Now, this was what's known as a retrospective study, meaning that these FDA researchers, they looked at the historical data in three separate commercial databases.
Those databases, just for your reference, are the CVS Health database, the second one was HealthCore, which is owned by Anthem Blue Cross Blue Shield, the insurance company, and then the third one was Optum, which is a subsidiary of the United Health Group, which is another insurance company.
And these researchers, they took this data and they limited their inquiry to only children aged 5 to 17 who received the Pfizer vaccine sometime between December 11th of 2020, when the vaccine was first cleared by the FDA, all the way up until the middle part of 2022.
Furthermore, they were specifically digging through this large dataset in order to see whether any of the 20 different health problems that they were looking for were experienced at a higher rate by those who took the vaccine.
Now, the types of conditions that they were specifically screening for were We're problems like myocarditis, pericarditis, things like Bell's palsy, appendicitis, anaphylaxis, seizures, heart attacks, strokes, and so on and so forth.
There were 20 things in total that they were looking for.
However, as we mentioned earlier, what the study says they found was that among the 20 different conditions, only the numbers for myocarditis and pericarditis met the threshold to be labeled as a CDC safety signal.
And just in terms of definitions, just so we're all on the same page, here's how the CDC defines a safety signal.
Quote, unusual or unexpected patterns of adverse events following vaccination.
Now, in terms of these specifics, after combing through these three commercial databases, well, here's what the FDA researchers actually discovered.
And by the way, as a short aside, I hope that if you appreciate content like this, you take a super quick moment to smash those like and subscribe buttons, and maybe even leave a little comment below as well in order to tickle the YouTube algorithm and have this video reach ever more people.
Now, back to the study.
Here's what the researchers discovered after digging through those three different databases.
They found 89 cases among 12 to 15 year olds, 64 cases among 16 to 17 year olds, and 30 cases among children age 5 to 11.
Furthermore, If we take a look at the table that was provided as a part of this study, you can see it up on screen for yourself, and for reference, this is table number two, it breaks down for us the different adverse reactions, how many of each reaction was detected in each different database, as well as the RR, which is the incidence ratio rate.
For reference, the RR number basically tells you how much more often this occurred within the population that's being studied As compared to the historical precedent.
So basically, a higher RR number means that the adverse event was happening much more.
Here's how specifically it's defined on the NIH website: "When a treatment has an RR greater than 1, the risk of a bad outcome is increased by the treatment.
When the RR is less than 1, the risk of a bad outcome is decreased, meaning that the treatment is likely to do good.
Meaning, the higher the RR number, the worse." And so with all that as the preface, if we go back to the chart and look at this CVS data for, let's say, anaphylaxis, we'll find RR numbers that hover between 3.5 all the way up to 4.7.
That means that, on average, the kids experience anaphylaxis about that much more than you would expect just by looking at the historical precedent.
Then if we scroll down that chart towards the bottom, we get to myocarditis.
And we'll see that the RR numbers there get pretty high.
Depending on which data set you're looking at, as well as which age group you're looking at, the number of myocarditis cases ranges from about three times more than average, all the way up to almost 30 times more than the historical average.
And by the way, if you'd like to dig through this entire table, or if you'd like to read the whole study in its entirety, I'll throw all those links.
They'll be down in the description box below.
Now, because of a lack of resources, a lack of time, as well as some legal constraints, the researchers behind the study were not actually able to dig deeper into the specifics of all the different cases they were able to uncover.
However, apparently, they were able to look into some of them.
And here's what they wrote they found.
Of the 153 cases of myocarditis or pericarditis among children aged 12 to 17 years, medical record review was conducted for a sample of 37 cases whose records were obtainable.
27 of these cases, or 73%, were confirmed as true cases of myocarditis or pericarditis, of which 25 patients were male, which, for your reference, is about 92% male.
19 were hospitalized with a mean length of hospital stay of 2.8 days.
The mean time from vaccination to presentation for care for myocarditis or pericarditis was 6.8 days.
Meaning that the elevated risk for myocarditis was present within seven short days post-vaccination.
However, given that this is a typical government-funded study, well, here's how the overall conclusion was written.
This cohort study monitored 20 health outcomes in near real time and identified a safety signal only for myocarditis or pericarditis, which was consistent with other published reports.
These results provide additional evidence for the safety of the COVID-19 vaccines in the pediatric population.
And so, in short, the study found an elevated risk of serious inflammation of the myocardium, with the conclusion ultimately being that this is additional evidence for how safe the COVID vaccine is in the pediatric population.
That's very cool.
Now, we here at the Epoch Times, we did reach out to the FDA official who was listed as this particular study's corresponding author, asking him for some additional citations regarding the safety claim, but we have yet to hear back.
Regardless, like any good study, this one had several limitations, and I'll briefly mention them in passing.
For one, this analysis was not stratified by gender, and so it was only when the researchers took that extra step that we mentioned earlier and dug through some of the medical records that they were able to obtain that they learned that it was affecting about 92% boys over girls.
Then there's also the question of the window of time that the FDA chose to study post-vaccination.
Here's an analysis of this report that describes this potential limitation.
Quote, The shortest risk window was just one day for anaphylaxis or severe allergic shock.
Some others were just one week.
The rest were 28 days or 42 days.
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Now, for their part, in terms of how the FDA decides which windows to study, they actually have a protocol sheet, you can see it up on your screen, where they lay out how, essentially, they've decided to select the risk windows based on earlier pre-pandemic studies.
However, outside of just the window of time, there's also the question of general underreporting.
When asked to comment on this new study from the FDA, here's what cardiologist Dr.
Dr. Peter McCullough told us here at the Epoch Times, quote, My concern is that these data represent a gross underreporting of the frequency and severity of COVID-19 vaccine-induced myocarditis.
Now, Dr.
McCullough then did give us some other examples of some other studies, but just to be safe, because we publish this episode here on the YouTube platform, well, I will refrain from going into those examples here.
Because, well, as you likely know, what can easily happen is that some latte-sipping 20-year-old over in Silicon Valley who's never even touched any of these studies, well, he could interpret some of the other examples that Dr.
McCullough gave us as grounds to just censor this episode, which is the reality that we live with.
However, having said that, I will also mention that earlier in the week, I had the chance to sit down and speak with a woman named Nikki Holland.
And two years ago, like millions of other people across the country, Nikki Holland took the Moderna vaccine.
She actually got it in a drive-thru window near where she worked.
She just rolled out her hand out of her window and got the shot.
But sadly, just three short days later, she became paralyzed, debilitated, and became unable to either eat or breathe properly, with many of these problems persisting to this very day, which is again two full years later.
But just like most people in her condition, Nikki was marginalized by the medical community and ignored by the media.
However, now she's actually fighting back.
And she's suing the federal government, meaning the Biden administration, for government-sponsored censorship.
If you'd like to check out that awesome interview between myself and Nikki, you can do so over on Epic TV, our no-censorship video platform.
The link to it will be right there at the very, very, very top of the description box below.
Just click on that link and you can head on over to Epic TV and watch that interview right away.
And then, until next time, I'm your host, Roman from the Epoch Times.