Breaking news, the FDA has identified a myocarditis safety signal in vaccinated children under 17.

This study included 3 017 352 enrollees aged 5 to 17 years. Of the enrollees across all 3 databases, 1 510 817 (50.1%) were males, 1 506 499 (49.9%) were females, and 2 867 436 (95.0%) lived in an urban area.
In the primary sequential analyses, a safety signal was observed only for myocarditis or pericarditis after primary series vaccination with BNT162b2 in the age group 12 to 17 years across all 3 databases.

In the dose-specific analyses, a signal was detected after dose 2 in all definitions of the outcome myocarditis or pericarditis in the age groups 12 to 15 years and 16 to 17 years from all data partners.

Twenty-seven of these cases (73.0%) were confirmed as true cases of myocarditis or pericarditis, of which 25 patients were male, and 19 were hospitalized with a mean length of hospital stay of 2.8 days (median, 2 days). The mean time from vaccination to presentation for care for myocarditis or pericarditis was 6.8 days (median, 3 days).


Here's the study: https://jamanetwork.com/journals/jamapediatrics/fullarticle/2805184
JAMA Pediatr. Published online May 22, 2023. doi:10.1001/jamapediatrics.2023.1440

Also, as an aside, you may want to look up if your county / state is doing full data sharing with the FDA. Another conspiracy theory came true.
At the time of analysis, claims data from Optum and CVS Health were additionally supplemented with vaccination data from participating local and state immunization information systems (eTable 1 in Supplement 1).5

Trust the science.

Safe and effective.

Better 18 months late than never?

Jack wagons.

I wonder what caused the abrupt shift in admitted issues.

Just last month, this was a conspiracy theory and evil Florida was promoting dangerous misinformation.
https://www.cdc.gov/media/releases/2023/p0313-letter.html

Just 2 years ago, the UK was recommending that children under 17 not get boosted.
https://www.theguardian.com/society/2021/aug/07/jcvi-largely-opposed-to-covid-vaccination-for-children-under-16
https://www.pbs.org/newshour/world/uk-opts-not-to-vaccinate-most-under-18-against-covid-19
https://fee.org/articles/england-refuses-to-offer-covid-shots-to-kids-under-12-while-us-cities-mandate-them-who-s-right/

Just a thought, but it starts with D and ends with onald Trump.

Before long, this will be 100% his vaccine. If he wins the primary, I can basically assure you they will flood the public with stories of how toxic the vaccine is and how rushed it was, hanging it all on the neck of Trump.

From perusing their risk windows, it looks like something's fucky. They're hilariously short. Seizures is only 0-1 day.

https://bestinitiative.org/wp-content/uploads/2022/12/C19-Active-Monitoring-Protocol-Addendum-2022.pdf

All I did was skim it though; I'm not going to pull sources and compare to what other countries found as the average delta between adverse effects.
I'm pretty sure the mean time period for adverse effects (based on vaers data) is ~45 days.

The time of emotion driven major lawsuit payouts has passed. Now is the time for expensive medical treatments to save these poor innocent children. It is time to reap the monetary rewards of their evil

How many is 3?017?352

Is that supposed to be 3,017,352?

Unless your kid was an immunocompromised cancer patient, I can’t see any reason why you would have even considered it.

Healthy kids have a statistical zero chance of death or serious problems from covid, which has been known since well before the vaccines even got approved for them. There’s literally no benefit, before you even reach the risk side. And the risks were completely unknown early on.

Nobody is safe!!

"NOBODY IS SAFE!" #COVID19 pic.twitter.com/GeRfWm8jce

Matt Orfalea  (@0rf) May 20, 2023

What..What….WHAT? Trust the science

Do you have a link OP?

nvm. Found it.

No, it’s the new math. The’ question mark’ is the place holder for Derf.

Now the FDA is helping to expose the conspiracy.  We're through the looking glass here, people.

Here's who to call and bitch to; all I did was copy paste.
It's not my fault they're retards and have hidden characters for the spaces instead of commas.

> Published Online: May 22, 2023. doi:10.1001/jamapediatrics.2023.1440

> Corresponding Author: Steven A. Anderson, PhD, MPP, Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 ([email protected]).

> Conflict of Interest Disclosures: Dr Amend reported equity or stocks from Optum outside the submitted work. Ms Kline reported working on grants, subcontracts, or contracts from Harvard Pilgrim Health Care Institute, Brown University (National Institute on Aging, IMPACT Collaboratory), Reagan Udall Foundation for the FDA, Academy of Managed Care Pharmacy’s Biologics and Biosimilar Collective Intelligence Consortium (BBCIC), TherapeuticsMD, REACHnet (Louisiana Public Health Institute), IQVIA, Pfizer, HealthCore, and Patient-Centered Outcomes Research Institute as an employee of CVS Health and reported stock or stock options from CVS Health. Dr Beachler is an employee of HealthCore who has previously contracted with Pfizer for separate projects. Dr Seeger reported stock or stock options in UnitedHealth Group. Dr Harris reported other from Harvard Pilgrim Health Care Institute, Reagan Udall Foundation for the FDA, and Academy of Managed Care Pharmacy’s BBCIC and stock or stock options in CVS Health outside the submitted work. Ms Song reported equity or stocks from Optum outside the submitted work. Dr McMahill-Walraven reported working on grants, subcontracts, or contracts from Harvard Pilgrim Health Care Institute, Brown University (National Institute on Aging, IMPACT Collaboratory), Reagan Udall Foundation for the FDA, Academy of Managed Care Pharmacy’s BBCIC, TherapeuticsMD, REACHnet (Louisiana Public Health Institute), IQVIA, Pfizer, Janssen, HealthCore, Patient-Centered Outcomes Research Institute, National Evaluation System for Health Technology Coordinating Center, and Harvard Pilgrim HealthCare Institute as an employee of CVS Health and reported stock or stock options from CVS Health. Ms Cooper reported other from Harvard Pilgrim Health Care Institute, Brown University (National Institute on Aging, IMPACT Collaboratory), Reagan Udall Foundation for the FDA, Academy of Managed Care Pharmacy’s BBCIC, TherapeuticsMD, REACHnet (Louisiana Public Health Institute), IQVIA, Pfizer, HealthCore, and Westat as an employee of CVS Health outside the submitted work. Ms Clifford reported stock or stock options in UnitedHealth Group. No other disclosures were reported.

> Funder/Support: The US Food and Drug Administration provided funding for this study.

If so, that would mean a 99.9991% chance of not getting myocarditis and would be way safer than the virus statistically, even in healthy young people.

Wtf is a safety signal?

Unless getting covid increases your chances of getting myocarditis, too.   We need to see the stats on that too, to make a true comparison.


The unknown (and unknowable at the time) nature of the risks at the time is why I don't fault anyone for choosing either path.   Their body, their risk to take.

Cry more

If mRNA vaccines for COVID were introduced by Pastuer & this effective, he would have been taken to the Guillotine & vaccines would have taken 300 years to gain any credibility.

It isn’t science if you don’t show all the data—it’s propaganda.

“We’ll just do the controls later…who’s gonna know….? Derp”

Risk of death or serious illness in healthy kids is a statistical zero (see, e.g., JHU/Makary’s analysis).

Risks of vaccine - still unknown and evolving.

Tag for later.

Can someone dumb this down for those of us who aren't doctors?

Incredible


What an authoritarian shit hole this nation has become.

Ya know, this is one thing he doesn’t own.

The administrative roll-out was a success, which he can take credit for.

No way he should be expected to understand, or be held accountable for, the actual results of the vaccine itself.

BNT162b2 is the Pfizer vaccine.  The article talks about 153 cases out of over 3 million kids age 12-17.  That is 0.005% that developed myocarditis or pericarditis for any reason.  The study goes on to claim that proves the vaccines are safe for kids.

Conclusions and Relevance  Among 20 health outcomes that were monitored in near real time, a safety signal was identified for only myocarditis or pericarditis. Consistent with other published reports, these results provide additional evidence that COVID-19 vaccines are safe in children.

Based on the data, almost no children out of several million had bad outcomes.

I’m not sure people here understand these results.

Here's some learning for you: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6055643/
TLDR, you look at any and all datasets you have available and try to spot any trends to identify possibly risks and adverse effects without having to wait 3+ years for actual causational trials to be completed.  
IDEALLY, you leave the windows open for as long as possible to bias capturing any issues, instead of arbitrarily missing some.

Here's a little snippet of history: https://www.nytimes.com/1976/10/13/archives/swine-flu-prograrm-is-halted-in-9-states-as-3-die-after-shots.html
Safety Signal was:
two weeks after they began nationally, after the deaths of three elderly persons who received the vaccine yesterday at a clinic in Pittsburgh.
All three patients are known to have had heart disease, health officials said. and autopsies showed that two died of heart attacks.
No Evidence Shots Caused Them
At a news conference at the agency's headquarters in Atlanta, Dr. David J. Sencer, director of the center, said there was no evidence to suggest that the deaths had been caused by the vaccinations. Further, he said he knew of no reason for other communities to suspend their programs.

In response:
In nine states, however, health officials shut down swine flu vaccination programs until information about the Pittsburgh deaths could be clarified. These are Maine, Vermont, Illinois, Wisconsin, Virginia, Louisiana, Texas, New Mexico and Alaska.
The New York City health authorities, meanwhile, pressed ahead with the immunization program, as did those in New Jersey and Connecticut. But New York State officials asked upstate areas to delay using any of the vaccine from the batch used in Pittsburgh. [Page 53].

153 out of 3 million isn’t that concerning.

Then again, neither is the virus, in the first place, for kids with no or minimal co-morbidities. So “no benefit” means we needn’t even reach the “how much risk” side of the equation.

and how many had bad results from covid that werent immune compromised already?

Someone didn't read the JAMA article. Their conclusion is the vaccines are safe and effective for children ages 3-17.

Effective at what? Modest relative reduction of an absolute risk of “statistical zero,” for a very limited period of time?

The entire exercise for kids who aren’t obese chemo patients is microscopic mathematical masturbation. It literally doesn’t matter for 99.9999% of kids, the virus is a total non-issue for them.

You don't actually expect these people to read articles before they post them do you?

Don't worry, someone will be along shortly to call you a shill for pointing this out.

Not disagreeing at all.

More a reflection of both how biased and dishonest the media enterprise is. That will be the main talking point.

LOL.

That's not how safety signals work. It simply means it's hit their arbitrary decision point for real research.
If you were actually curious about their validity, or even possible relative risk, you'd have read their methodology that I so helpfully linked.
Alternatively, you could have just looked at the divergence in guidance between the US and UK and ask why other countries have decided the risk isn't worth the reward, but the US hasn't.
We're over 2 years behind some countries.

First time?
You must be new to reading papers. I'm no longer phased by conclusions that are directly contradicted by the data sets. They seem to know ain't nobody got time to read dat shit.

Nm

This is the correct answer.

I just presented factual details from the study you posted.  I didn't imply any interpretation or try to explain anything.  Not sure what you are going on about.  

The study you posted said "Of the 153 cases of myocarditis or pericarditis among children aged 12 to 17 years" and "These results provide additional evidence for the safety of the COVID-19 vaccines in the pediatric population."  I just repeated it here in plain English.

You're literally sitting here, saying that the FDA's own procedures for identifying safety signals is invalid and it's a giant nothing burger.
If that's the standard, I'm happy to roll with that, but for fucks sake, what counts as valid then?

Corresponding Author: Steven A. Anderson, PhD, MPP, Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 ([email protected]).

Trust the government.  They're here to help.

No fucking shit

I bet those pharmaceutical companies are glad it was only trial doses so they could not be sued.

C'mon, man!!! The Vax Covidians say that kids have been suffering from myocarditis since there have been kids!!!

You are 100% correct.
I said this when they deemed Operation Derp Speed a "success".
When it ALL GOES SIDEWAYS, they will blame Trump.

You're the only one making that claim, you're arguing against something I've never claimed.
You're also using this kind of research incorrectly, as you generally can't use such non-rigourous data for anything definitive. Hence the method, as that's where you find all sorts of interesting and unique deal breakers preventing any real analysis past identifying a safety signal.

You can keep harping on whatever you want, but that's where we're currently at.

FDA has identified a safety signal as of a few weeks ago.
Current guidance is to continue vaccinating children.
Other Countries identified the same safety signal in 2021 and stopped recommending boosters for their youth.

All of these are unambiguous facts.

Well at least it stopped people from getting infected, and stopped person-to-person transmission.  

Suckers.

I thought that all vaccines did that to one extent or another.

and that it is short lived...

If you go to the ER and you have myocarditis or Paricarditis they will ask if you have recently received any vaccinations.

But I am not a Dr. or Nurse.

Next time around, it will be even worse. And people will lap it up.

The simpler and more pertinent fact is there was no reason (and still isn’t) to vaccinate kids in the first place.

You can’t produce relative reduction in risk in a population that has a statistical zero risk to begin with.

It’s all so tiresome.