FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation

[connda]

FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation

Trust the experts!  No problem.  Get your shots and your 7th and 8th boosters.  Safe and Effective.
Caveat:  The CNN article totally defends Covid vaccinations, so no worries. Rare heart inflammation are probably fake news, innit?

 

https://edition.cnn.com/2025/05/21/health/fda-covid-vaccine-warning-heart-inflammation

[illisdean]

Yeah, "trust the experts", the only thing you can trust is that the experts and Biden are/was lying.

 

 

 

[Magictoad]

It doesn't worry me. I just want to know where I can get the vaccine in Pattaya?

[impulse]

Anyone interested should follow Sen Ron Johnson's current Senate investigation into the "safe and effectives".  Just hitting the wingnut sites now.

 

Snippet of their coverage, based on released documents:

 

In February 2021, Israeli health officials warned the CDC of “large reports of myocarditis, particularly in young people” following Pfizer injections, just two and a half months after the vaccine received emergency use authorization.

 

By April, the CDC was already reviewing myocarditis data from Israel and the Department of Defense. But instead of alerting the public, they stayed quiet.

 

[blaze master]

2 weeks to flatten the curve.

[save the frogs]

16 hours ago, connda said:

Rare heart inflammation are probably fake news, innit?

 

It could be fake news. Either deliberate or botched up bad science or botched up reporting. 

 

It is extremely difficult to discern fake from real news in this day and age. A formidable task. Hence we are all lost and confused to varying degrees. 

 

There could be fake news on both sides of any agenda, causing even more confusion. 

 

You can hardly believe anything that you don't experience personally. 

 

I had 2 shots because I thought employers would check for it. Then they didn't. I hope to avoid any further shots. But I'm not convinced of any of these alleged risks. 

 

[impulse]

41 minutes ago, save the frogs said:

You can hardly believe anything that you don't experience personally. 

 

I had 2 shots because I thought employers would check for it. Then they didn't. I hope to avoid any further shots. But I'm not convinced of any of these alleged risks. 

 

I had 2 shots and my health and quality of life took a nosedive the day after my 2nd Pfizer.

 

But I don't extrapolate that to the billions of shots that were administered.  For that, we have to depend on honest analysis of millions or even billions of records.  Honesty which has been sorely lacking, for many reasons.  Mostly CYA and greed.

 

[save the frogs]

11 hours ago, impulse said:

 

I had 2 shots and my health and quality of life took a nosedive the day after my 2nd Pfizer.

 

But I don't extrapolate that to the billions of shots that were administered.  For that, we have to depend on honest analysis of millions or even billions of records.  Honesty which has been sorely lacking, for many reasons.  Mostly CYA and greed.

 

 

Yeah, good luck getting an honest analysis of billions of records.

 

I don't even trust people's personal anecdotes on AN. Sorry, unless I meet actual people in my daily life and notice a significant pattern, I'm not buying a story from some random dude on AN claiming his health deteriorated after the jab.

 

Honesty is ... a lonely word.

 

 

[impulse]

17 minutes ago, save the frogs said:

Yeah, good luck getting an honest analysis of billions of records.

 

The data is there, scattered across hundreds or thousands of databases around the world.  And now there's someone at HHS that actually wants to analyze it.  With help from some database geniuses.

 

Believe me, don't believe me.  I could care less.  But what motive would I have for lying about my 2nd Pfizer?  Contrast that with the "experts" who count on Big Pharma to pay for their research.  Whether directly, or indirectly.

 

[save the frogs]

11 hours ago, impulse said:

But what motive would I have for lying about my 2nd Pfizer?

 

Perhaps no motive to lie.

But maybe you "believe" whatever ailment is connected to the jab, when it's coincidental that it happened around the same time.  

 

[TallGuyJohninBKK]

Cutting through the continuing Trump Admin / RFK Jr. anti-vax nonsense, here's what you need to understand about COVID vaccines and very rare, typically short-term cases of myocarditis (heart inflammation), mainly in young men.

 

According to the following report, young men are are 7 to 11 times more likely to get myocarditis from COVID infections than from COVID vaccines, and the vaccine-related kind is typically milder and more short-term that people usually recover from relatively quickly and completely than the COVID infection-related kind.

 

In short, the myocarditis risk is absolutely greater from COVID the infection than it is from COVID vaccination.

 

 

 

 

PS - the above report also completely rebuts and debunks the Republicans' claim posted above that there was some kind of "cover-up" over the myocarditis issue during the Biden administration. That's covered in the first opening part of the above video report.

 

"The Unbiased Science Podcast, hosted by Dr. Jessica Steier and Dr. Sarah Scheinman, is devoted to objective, critical appraisal of available evidence on science & health-related topics relevant to listeners’ daily lives. Dr. Steier is a public health scientist with expertise in public health policy, data science, and research study design. ... Dr. Scheinman is a neurobiologist with expertise in basic science, preclinical, and translational biomedical research."

 

 

 

[TallGuyJohninBKK]

Myocarditis complications more common after COVID infection than vaccination, 18-month data suggest

August 27, 2024

 

A study today in JAMA suggests that hospitalized patients—primarily previously healthy young men—have considerably fewer cardiovascular sequelae by 18 months if they develop myocarditis after COVID-19 mRNA vaccination than after COVID-19 infection.

 

French researchers mined data from the French National Health Data System on all 4,635 residents aged 12 to 49 years hospitalized for myocarditis, or inflammation of the heart muscle, from December 2020 to June 2022. 

...

Low rates of myocarditis after vaccination with mRNA COVID-19 vaccines have been reported, mainly in young adults after receipt of their second dose, the vast majority with a favorable outcome.

 

(more)

 

https://www.cidrap.umn.edu/covid-19/myocarditis-complications-more-common-after-covid-infection-vaccination-18-month-data

 

 

[TallGuyJohninBKK]

What we know about the safety, efficacy of mRNA vaccines amid recent scrutiny

Vaccines using mRNA technology have been studied for decades, experts say.

 

May 23, 2025

...

"The FDA, in asking the vaccine companies to expand their warning labels, cited “new safety information” -- data from one of the agency’s safety surveillance systems and a study published in October that followed people who developed myocarditis linked to COVID vaccines.

 

[Dr. Peter Chin-Hong, a professor of medicine and infectious disease specialist at the University of California, San Francisco] said the risk of myocarditis is much higher after COVID-19 compared to after vaccination, and that contracting COVID itself is higher.

 

“The risk of COVID is much higher in general. If you look at it, 22 to 31 cases per million [among] 18 to 29 years old as an example,” he said. “At the time when these vaccines are used very often in that group, [myocarditis risk] is 1,500 per million. So, you're talking about 22 to 31 per million versus 1,500 per million.” [emphasis added]

 

https://abcnews.go.com/Health/safety-efficacy-mrna-vaccines-amid-recent-scrutiny/story?id=122068940

 

 

[TallGuyJohninBKK]

How do we know these vaccines are safe, especially in the long term?

"Hundreds of millions of people in the U.S. have gotten mRNA vaccines, and billions of doses have been administered worldwide. That has allowed researchers to scour for side effects too rare to show up in a 30,000-person clinical trial, or that might appear after more than a few months.

 

“The number of people that could be evaluated for the vaccine and [adverse] reactions was enormous, much larger than we’ve ever been able to do,” said Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program.

...

That was how researchers first saw hints that mRNA Covid-19 vaccines were linked with a slightly increased risk of inflamed heart muscle, or myocarditis, in younger adults, particularly young men. A 2022 study reported that the Pfizer and Moderna vaccines led to an additional 22 and 31 myocarditis cases, respectively, for every million 18- to 29-year-olds in the U.S. Most of these rare cases were mild and didn’t cause more than brief chest pain. By comparison, SARS-CoV-2 infection causes myocarditis at much higher rates than vaccination, with the CDC reporting 150 cases per 100,000 Covid-19 patients. [emphasis added]

 

(more)

 

STAT

(STAT delivers trusted and authoritative journalism about health, medicine, and the life sciences)

https://archive.ph/fTkmP