Pfizer and Moderna will increase the number of children in their COVID vaccine clinical trials prior to seeking Emergency Use Authorization (EUA), after the U.S. Food and Drug Administration (FDA) told the vaccine makers the size and scope of their pediatric studies, as initially envisioned, were inadequate to detect rare side effects.
The rare side effects cited by the FDA include myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, multiple people familiar with the trials told The New York Times.
Moderna’s shot is authorized for emergency use in people 18 and up, and Pfizer’s vaccine is authorized for children as young as 12. No COVID vaccines have yet received EUA approval for children younger than 12.
Expanding the pediatric trials means thousands more children as young as 6 months old may soon be recruited and enrolled in COVID vaccine trials.
According to the Times, the FDA asked the companies to include 3,000 children in the 5- to 11-year-old group, the group for whom results were expected first.
One person, granted anonymity by the Times to speak freely, described that figure as double the original number of study participants.
Moderna researchers had intended to test the vaccine in about 7,000 children, with some as young as 6 months, according to ABC News, but the company told the news outlet today in an email they never decided on how many kids would be added to the trial.
Pfizer began testing its vaccine in children ages 5 to 11 on June 8, with those younger than 5 being included as of June 21. The study will involve up to 4,500 subjects from the U.S., Finland, Poland and Spain, according to the Wall Street Journal, which also reported the company declined to say whether the recent request from the FDA will change the timing of any authorization submissions.
Last month, Pfizer and Moderna said their vaccines for children 5 through 11 could be ready as early as September. Pfizer, which is on a faster timetable than Moderna, may be able to meet the FDA’s expectations on a bigger trial size and still file a request for expanded EUA by the end of September, the Times reported.
A federal official, who spoke to the Washington Post on the condition of anonymity because they were not authorized to speak publicly, predicted authorization of a COVID vaccine for children 5 through 11 might come by late October or early November.
The government is not expecting it will be a big problem to enroll more children because so many parents are eager to get their children vaccinated, the official said.
Heart inflammation in teens raises red flag
Moderna spokesman Ray Jordan told the Post the goal is “to enroll a larger safety database which increases the likelihood of detecting rarer events.”
According The Washington Post:
“The FDA wants to be particularly careful about the possibility of children developing myocarditis, or heart inflammation, after receiving a coronavirus vaccine. Adolescents who receive the vaccines are more likely to develop myocarditis than adults — though the risk remains small — and officials want to increase the chances that the trials will indicate whether there is increased incidence of heart inflammation in children.”
The Centers for Disease Control and Prevention in June acknowledged 1,200 cases of heart inflammation in 16- to 24-year-olds, and said mRNA COVID vaccines should carry a warning statement. The FDA followed by adding the warning.
According to the latest data available, the CDC’s Vaccine Adverse Event Reporting System has received 383 reports of myocarditis and pericarditis in vaccine recipients between the ages of 12 and 17 years old, with 379 cases attributed to Pfizer’s vaccine.
For all age groups during the same period, 1,848 cases of myocarditis and pericarditis were reported to VAERS, with 1,176 cases attributed to Pfizer, 606 cases to Moderna and 62 cases to J&J’s COVID vaccine.
The data reflects reports received between Dec. 14, 2020 and July 16, 2021. The FDA first authorized Pfizer’s vaccine for 12- to 15-year-olds in May of this year.
Despite the known cases and the FDA warning, the CDC said the benefits of the vaccine outweigh the risk.
Doctors weigh in on ill-advised rush to vaccinate kids
The authors of an op-ed published earlier this month in The BMJ argued that even if one assumes the vaccine provides protection against severe COVID, given its “very low incidence in children,” an extremely high number would need to be vaccinated in order to prevent one severe case.
Meanwhile, a large number of children with very low risk for severe disease would be exposed to vaccine risks, known and unknown, they said.
They wrote:
“In the clinical trial underlying the authorization of Pfizer-BioNTech’s mRNA vaccine in children aged 12 to 15, of the close to 1000 children who received placebo, 16 tested positive for COVID-19, compared to none in the fully vaccinated group.
“Given this low incidence, the fact that COVID-19 is generally asymptomatic or mild in children, and the high rate of adverse events in those vaccinated (e.g. in Pfizer’s trial of 12-15 year olds, 3 in 4 kids had fatigue and headaches, around half had chills and muscle pain, and around 1 in 4 to 5 had a fever and joint pain), a comparison of quality-adjusted life-years in the trial would very much favor the placebo group.”
Doctors for COVID Ethics, an EU-based international alliance of hundreds of concerned doctors and scientists, said COVID vaccines are not only “unnecessary and ineffective,” but also “dangerous for children and adolescents.”
Three of the group’s founding signatories — Dr. Michael Palmer (Canada), Dr. Sucharit Bhakdi, (Germany) and Stefan Hockertz, Ph.D. (Germany) — assembled in one document powerful expert evidence that highlights the Pfizer vaccine’s “catastrophically bad” safety profile in both adults and adolescents.
In an open letter to the EU’s Medicines and Healthcare Products Regulatory Agency, more than 40 doctors, medics and scientists in the UK said children are more vulnerable to the potential long-term effects of COVID vaccines.
Vaccinating kids for COVID is “irresponsible, unethical and unnecessary,” they said.
The letter warned against vaccinating people under 18 because evidence shows the virus poses almost no risk to healthy children. The risk of death from COVID in healthy children is 1 in 1.25 million, the authors wrote.
COVID vaccines, however, are linked to strokes due to cerebral venous thromboses in people under 40 — a finding that “led to the suspension of the Oxford-AstraZeneca children’s trial,” the authors said.
The doctors wrote:
“Children have a lifetime ahead of them, and their immunological and neurological systems are still in development, making them potentially more vulnerable to adverse effects than adults.”
According to the latest available data for 12- to 17-year-olds, between Dec. 14, 2020 and July 16, 2021, VAERS received a total of 14,494 reports of adverse events related to COVID vaccines, including 871 rated as serious and 17 deaths.
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I am sure everyone agrees with the FDA that we have to kill all the children with vaccines to find out if they are safe for children.
http://www.strike-the-root.com/3/herman/herman10.html#:~:text=%27We%20had%20to%20destroy%20the%20village%20to%20save,My%20Lai%20%2C%20where%20approximately%20500%20unarmed%20
And anyone who works with children
Who are these parents that will enroll their children in this study?
Have we as a society become so numb to our children we blithely just stick whatever we are told into them?
It’s bad enough children are being used as pawns in the whole transgender ideology, trotted out at every BLM rally, and being taught to fear their fellow playmates and teachers as the very epitome of death, now we are just going to sacrifice them on the Vaccine Altar of Baal.
Pregnant women won’t even drink a cup of coffee or eat a tuna sandwich, but by all means, inject some concoction with zero long -term safety data into yourself because the super honest, never wrong, always ethical pharmaceutical companies say it’s ok. I mean, don’t worry about the fact that they are shielded from liability. If your little bun in the oven exits stage left before its time, you can always try again, or maybe just not have any. You know, global warming. Or climate change. Something like that. Ask Bill Gates he knows.
As we go full speed ahead into our own Logan’s Run, with some shades of an upcoming Soylent Green thrown in, anyone with more than two brain cells to rub together surely must be having some kind of doubt about all of this? Surely? Or have a vast majority of the population just decided to stop thinking altogether? That seems like a much more likely scenario. The New America. Please leave your brain at the door.
Pup – I think you are giving the younger generations too much credit for being able to think for themselves. Most of them were raised in some type of institution (day care, pre-school, kindergarten, K-12) for the first 18 years of their lives. A good portion went on to an additional 4-6 years of advanced indoctrination.
They have been programmed that government is good and would never lie to them, cheat them or have them do something that is not in their best interest.
Oh I know….but even the supposedly genetic “maternal instinct” is eroded now?
When I was pregnant with my son I remember my OBGYN telling me to avoid pretty much all medications. ALL. She never once recommended I take a flu shot. She said “eat right, sleep as much as you can and need to, take your prenatal vitamins, avoid coffee and shellfish, you’ll be fine”
You are a woman???
As I have written before, Danger is my middle name. I remember eating sushi and cold cuts during pregnancy.
You seem genuinely surprised I am a woman.
I didn’t eat sushi but I vaguely remember bologna. Bad morning sickness for a long time kept me away from a lot of things.
Stucky thought I was a dude, too. We need to curse more. Or less. Not sure.
I swear quite a bit in most of my posts depending on he subject matter.
You need to swagger, stick your thumbs in your waistbands and spit alot. Roll your shoulders and wax nostalgic on cars, guns, and complain about women having the right to vote.
Cursing is irrelevant. I have a filthy mouth and they know I’m female…they didn’t at first.
Our granddaughter has 4 girls and makes sure they all get the prescribed shots on time. Her “maternal instinct” is telling her to vaccinate to protect her babies. that is the way she was brought up and that is the way she is bringing up her daughters. I wish there were more pediatricians like Dr. Farella in Houston. She is not anti-vax, but she is skeptical about giving experimental gene therapy to little ones.
Polio was a real danger when I was a kid and we all got our shots, because we all knew someone who had had it and was crippled. We all got the TB shot because there were TB hospitals all over the country full of people sick with the disease and we all got diphtheria and tetanus shots. Other than that, we did not have the full shot regimen the kids go through today. Everyone got measles, mumps and chicken pox. Our Mothers used to make sure all of the kids got it at the same time so it we could get better and carry on. It was accepted because they were not too dangerous for kids.
Hey Billy, you go test out the showers first……
Mengele was a lightweight compared to these guys.
He and Goebbels laid the foundation and they have built a mighty tower on it.
I wish you and sleezeball above would just stop it. Mengele and Goebbels were nice guys just doing their jobs. Every business owner would die to have such dedicated employees.
They were just following orders.
Darling liebchen, you’re going to have to remember to put the /s after your comments. Too many just do not understand satire…or irony nor do they even possess a rudimentary sense of humor.
Of course, you are 100% correct. There are a number of Dummies here whose sarc-o-meter has decayed into a useless heaping pile of rust.
OTOH, not including the old /s leads to some amazing shitfests … and, hate … towards me.
This amuses me.
It’s all over, folks.
Yep, I’m back to there’s-no-hope mode. It’s Wednesday, after all. That’s the most depressing article posted his week.
Look, if parents are willing to have their own children jabbed with an experimental gene-therapy protocol, one that alters their child’s immune system for life, and for which long-term side effects are completely unknown … and all that to “cure” a disease for which children have a 99.99% recovery rate …… then this nation is fucked six ways to Sunday!
There will be no revolution. No uprising.
We will never get back to normal.
It’s all over.
This may very well be the final test run before mandating that every American be jabbed. —- “Look at those dumb fucking sheep, Herr Fauchi! They don’t even give a shit about us forcing them to jab their own children! We should be able to get our Fuck You Get Jabbed Act passed 535 – 0 !!! We won!! hahahaha. “
Supposedly 3.5% of dissenters that act on it are all that is needed for a successful rebellion/overthrow of a government.
I do believe that they are overplaying their cards right about now with the vaccine mandates for government employees and healthcare workers everywhere.
Mothers will fight to the death before their children get injected with a poison. We do not need a majority.
You wait and see. Things will change and people will rise up. I expect it to be in a warmer season, and with the summer almost over this year and people still lulled into a coma due to some things that have reopened temporarily, I bet things will turn violent in the summer of 2022.
We are looking for a property in Idaho to get out of the Northeast. Better late than never.
I agree to a point. Most parents I have talked to are adamant against these vaccines. I know last year when His Lord High Baker tried to mandate the flu vaccine there was a ton of push back and he reversed his policy and made it seem like it was his idea.
Massachusetts. The land of the “independent”. Laughable.
Being a son of Massachusetts, from a family that has been there for centuries; what has happened to that once great commonwealth is profoundly saddening
Good. Don’t bother coming to the southern tip of the Appalachians. The northeast seems to be moving here.
But be careful, isn’t Kamala from I-da-ho?
Unfortunately too many of them forget why they are leaving and try to turn their new home into the Utopia they left behind.
Perzactly.
Machinist…any truth that Kamala-Mala and Obozo have purchased property in Knob Lick ?
I dunno, ask Ghost.
Or, ask anybody from KY.
Remember if it’s not from KY, it ain’t Bourbon.
The folks in Knob Lick won’t put up with them long.
I got out of the northeast 10 years ago this month. Landed in Texas (DFW countryside) and have not regretted a moment. If Texas holds, and I believe it will with a Governor Allen West, consider this nice warm climate as well as Idaho. Should Texas fall, a possibility for sure, I’ll take the cold back and head in the same direction.
There is a silver lining to Texas becoming the next California, if such a transition is eminent. Our property values are rocketing upward currently and will make future relocation, if necessary, rather easy. Many Californians are selling small million dollar “postage stamp” homes for amazingly beautiful properties here. Owning a popular ice cream shop, I get to meet many of them and the vast majority are very glad to have left the left coast and it’s politics behind.
“You wait and see. Things will change and people will rise up.”
It’s happening here…! There are still some honestly frightened people walking around with masks on, but the majority are DONE with that nonsense. Thank God!
My son moved to Austin last year. I realize this is NOT representative of Texas in general, but the rot seems to be spreading, as much as it is allowed.
I wonder when the famous politeness of the Texas cowboy will end. Soon I hope, for the sake of us all.
Austin is truly Texas swamp… Oh, but the hill country surrounding the area, absolutely stunning!!! Wildflowers and deer everywhere! I’ll retire there in the middle of nowhere and raise Labrador Retrievers someday… 🤠
I happen to be in Austin for a few days taking care of business. It’s disappointing. It feels like Colorado minus the mountains and comfortable climate.
Drove through the hill country. Wow! Beautiful and peaceful. Your retirement plan sounds ideal, GCP.
Isn’t it wonderful!?!?! Have you been to Fredericksburg or Gruene by any chance? Well worth the drive on some scenic country back roads.
Here’s hoping the dream comes true! Let me know if you’ll be in or around the DFW area, I’ll buy you an ice cream… 😁
(Contact info only a click away!)
Fucking pervert.
Don’t do it Abigail. DON’T!! Or, at least bring pepper spray. Or,bring a Satanic Bible.
GCP…yes, it really is wonderful. I did drive through Fredericksburg and Gruene…very pretty. I’ll plan to come back in the fall and spend a weekend in the area at a Bed & Breakfast. I’ll reach out to you if I’m ever in the DFW area. Thanks for the offer.
Stucky…I carry and know how to shoot. Plus, I’m a good judge of character.
Better visit quick. The Hill Country is being overdeveloped and the beauty is rapidly becoming strip malls and housing developments. Gruene is a joke, what were beautiful rapids between cypress trees is now wall to wall tube rentals and the surrounding areas around Greune are subdivisions and doctor’s offices and little shops that barely hang on.
Say it ain’t so… please! Last time we were there not two years ago it was still charming as any groovy little town ever was! What a shame. Like such a place needs offices? It’s the small shops that create the cool atmosphere!
How’s the “outback” countryside? Getting expensive I imagine… Hopefully in a few years there will be some ranch land available in East West Nowhere to disappear into.
If not, perhaps the American Redoubt is where I’ll be heading. I’m hoping a governor Allen West will help us Texans make a true stand. There are precious few people I get behind politically, but AW is a warrior first and I’d like to see him replace Abbott big time.
Yeah, that’s not so. That will never be so.
Dr. Josef Mengele III is over-seeing the children trials. He’s especially interested in twins…just like Epstein .
Neither are as interested in children as Zhou Xi Den
There used to be a catchphrase…” Release The Kraken ” .
For the unvaccinated the Gooberment will use the term, “Release The Karens ” .
Suffer the little children.
Great idea , obviously not enough Americans are dead or dying from the vaccine so let’s get the youngest of our population sick or dying before they start actively breeding that should clear the deck for Biden’s illegals to take over as good socialists members of Obama’s new America
La Nuevo Orden Mundial