Category: Science

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Biden Pandemic COVID Politics Reprints from others. Science Uncategorized

Pfizer quietly admits it will never manufacture original FDA approved COVID vaccines Company claims it is manufacturing Comirnaty product with new formula.

Not giving the rest of the story. Getty Pictures

This article is from The Dossier.

The August 23, 2021 FDA approval of Pfizer’s Comirnaty vaccine was a cause for celebration. Marked as a turning point in the battle against COVID19, the announcement was highly publicized by the Biden Administration with the clear intention to extinguish “vaccine hesitancy” and boost uptake.

Twitter avatar for @cnnbrkCNN Breaking News @cnnbrk

President Biden says anyone who was waiting for an FDA-approved Covid vaccine should “go get your vaccination and get it today” cnn.it/3D3Q7ci

Image

 

Twitter avatar for @BridgetNasoBridget Naso @BridgetNaso

Dr. Anthony Fauci said surveys show 30% of unvaccinated Americans said if the vaccine was FDA approved they would get the shot. It was approved today and Fauci said “The time has come.”

It was celebrated as a cause for national relief, and many Americans arrived at their local pharmacies under the impression, via government and pharmaceutical propaganda, that they were receiving an FDA-approved COVID vaccine. Yet that legally distinct product, as we know it, never existed. And now we know, via Pfizer, that it will never exist.

 

For the uninitiated:

Comirnaty is a legally distinct product from the emergency use authorization (EUA) shots, and It has never made its way to market. For months on end, no such vaccine has ever become available. Those who received the “Pfizer shot(s)” have been injected with the emergency use authorization (EUA) version of the shots. See my piece in The Dossier for more info:

 
Shell Game? There remains no FDA approved COVID vaccine in the United States
I fact checked the fact checkers and couldn’t believe what I found. Despite the corporate press, Big Pharma, and the federal government telling us otherwise, it is absolutely true that there is no FDA approved COVID-19 vaccine available in the United States today. And there are no plans to make one available any time soon…

Read more

5 months ago · 241 likes · 79 comments · Jordan Schachtel

The information operation succeeded. There was indeed an FDA approved vaccine, at least on paper, but you couldn’t get it.

When originally confronted with this ordeal, Pfizer labeled this issue an inventory question that had nothing to do with the legal distinction between an experimental EUA product and an FDA-approved vaccine. Up until just weeks ago, this was the statement up on the CDC website via Pfizer:

“Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY).  At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.

At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution.  As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”

In May, Pfizer updated its statement to mention a December 2021 licensed Comirnaty product, which was granted a license four months after the highly-publicized August FDA press release.

And just last week, Pfizer finally acknowledged that its original licensed product will never be distributed. In an unreported update on the CDC website, Pfizer told the agency:

“Pfizer received initial FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename. These NDCs will not be manufactured. Only NDCs for the subsequently BLA approved tris-sucrose formulation will be produced.”

The key distinction between the originally approved formulation and the tris-sucrose formulation is that — according to manufacturers — the latter can be held for a much longer period of time outside of an ultra cold freezer. These freezers cost over $10,000 a piece and each unit uses as much energy per day as an average American household. Improper storage can render the mRNA unstable.

Notably, the clinical trials for the Pfizer shot were conducted without the modified tris-sucrose ingredient. Given the partisan nature of Pfizer, the corporate media, government health bureaucracies, and your correspondent’s lack of expertise in this area, it is unclear whether this is significant.

Another notable thing to look out for in the coming days and weeks is the possibility that the subsequently FDA approved product finally becomes available in the United States. In recent days, the CDC removed the language of “not orderable at this time” above the description of both Comirnaty and Moderna’s Spikevax.

Additionally, as reported by Uncover DC, the Defense Department appears to be in the early stages of ordering what it has interpreted as a legally required minimum of Comirnaty in order to continue its mRNA mandate of American service members.

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Science

‘Mind blowing’ ancient settlements uncovered in the Amazon

Section of the mighty Amazon River

The urban centers are the first to be discovered in the region, challenging archaeological dogma.

Freda Kreier for Nature.com

Aerial view of a forest islet in the Llanos de Moxos, Santa Ana del Yacuma, Beni, Bolivia.

Researchers uncovered ancient urban centers on forested mounds in the Bolivian Amazon Basin.Credit: Roland Seitre/Nature Picture Library

Mysterious mounds in the southwest corner of the Amazon Basin were once the site of ancient urban settlements, scientists have discovered. Using a remote-sensing technology to map the terrain from the air, they found that, starting about 1,500 years ago, ancient Amazonians built and lived in densely populated centers, featuring 22-meter-tall earthen pyramids, that were encircled by kilometers of elevated roadways.

The complexity of these settlements is “mind blowing”, says team member Heiko Prümers, an archaeologist at the German Archaeological Institute headquartered in Berlin.

“This is the first clear evidence that there were urban societies in this part of the Amazon Basin,” says Jonas Gregorio de Souza, an archaeologist at the Pompeu Fabra University in Barcelona, Spain. The study adds to a growing body of research indicating that the Amazon — long thought to have been pristine wilderness before the arrival of Europeans — was home to advanced societies well before that. The discovery was published on 25 May in Nature1.

A shift in thinking

Humans have lived in the Amazon Basin — a vast river-drainage system roughly the size of the continental United States — for around 10,000 years. Researchers thought that before the arrival of Europeans in the sixteenth century, all Amazonians lived in small, nomadic tribes that had little impact on the world around them. And although early European visitors described a landscape filled with towns and villages, later explorers were unable to find these sites.

The settlement beneath: Arial image of a site in Bolivia showing an ancient urban centre beneath dense vegetation.

Source: Ref. 1

By the twentieth century, archaeologists had yet to confirm the rumors, and argued that the Amazon’s nutrient-poor soil was unable to support large-scale agriculture, and that it would have prevented tropical civilizations — similar to those found in central America and southeast Asia — from arising in the Amazon. By the 2000s, however, archaeological opinion was beginning to shift. Some researchers suggested2 that unusually high concentrations of domesticated plants, along with patches of unusually nutrient-rich soil that could have been created by people, might indicate that ancient Amazonians had indeed shaped their environment.

The hypothesis gained steam when, in 2018, archaeologists reported3 hundreds of large, geometric mounds that had been uncovered because of deforestation in the southern Amazon rain forest. These structures hinted at ancient organized societies capable of thriving in one location for years — but direct evidence of settlements was lacking.

In 1999, Prümers began studying a set of mounds in the Bolivian part of the Amazon Basin, outside the thick rain forest. There, a multitude of tree-covered mounds rise above a lowland area that floods during the rainy season.

Previous digs had revealed that these ‘forest islands’ contained traces of human habitation, including the remains of the mysterious Casarabe culture, which appeared around AD 500. During one excavation, Prümers and his colleagues realized that they had found what looked like a wall, indicating that a permanent settlement had once occupied the area. The researchers also found graves, platforms and other indications of a complex society. But dense vegetation made it difficult for them to use conventional methods to survey the site.

What lies beneath

By the 2010s, a technique called lidar — a remote-sensing technology that uses lasers to generate a 3D image of the ground below — had come into vogue with archaeologists. In 2012, a lidar survey of a valley in Honduras helped lead to the rediscovery of an ancient pre-Columbian city rumored to exist in the area. The jungle had completely overtaken the settlement since it was abandoned in the fifteenth century, making it all but impossible to see from the air without lidar.

Prümers and his colleagues took advantage of lidar in 2019, when they flew a helicopter equipped with the technology over six areas near sites confirmed to have been occupied by the Casarabe people. The team got more than it bargained for, with lidar revealing the size and shape of 26 settlements, including 11 the researchers hadn’t been looking for — a monumental task that would have taken 400 years to survey by conventional means, Prümers says.

Two of the urban centers each covered an area of more than 100 hectares — three times the size of Vatican City. The lidar images revealed walled compounds with broad terraces rising 6 meters above the ground. Conical pyramids made of earth towered above one end of the terraces (see ‘The settlement beneath’). People probably lived in the areas around the terraces and traveled along the causeways that connected the sites to one another.

“We have this image of Amazonia as a green desert,” Prümers says. But given that civilizations rose and thrived in other tropical areas, he notes, “Why shouldn’t something like that exist here?”

Mysteries remain

Why these settlements were abandoned after 900 years is still a mystery. Radiocarbon dating has revealed that the Casarabe disappeared around 1400.

Prümers points out that lidar images revealed reservoirs in the settlements, perhaps indicating that this part of the world wasn’t always wet — an environmental shift that might have driven people away. However, consistent pollen records reveal4 that maize (corn) was grown in the area continuously for thousands of years, indicating sustainable agricultural practices.

At the very least, the discovery of long-lost Amazonian societies “changes the general perspective people have of Amazonian archaeology”, says Eduardo Neves, an archaeologist at the University of São Paulo in Brazil. Present-day logging and farming in the Amazon Basin are almost certainly destroying important archaeological sites that have yet to be discovered, he says, but a growing interest in Amazonian archaeology could lead to the protection of vulnerable places.

These discoveries also counter the narrative that Indigenous peoples were passive inhabitants of the Amazon Basin before the arrival of Europeans. “The people who lived there changed the landscape forever,” Neves says.

Updates & Corrections

  • Correction 26 May 2022: An earlier version of this story said that there are hundreds of tree-covered mounds rising above a lowland area in the Bolivian Amazon. Some estimates suggest there are many more than that.

References

  1. Prümers, H., Betancourt, C. J., Iriarte, J., Robinson, M. & Schaich, M. Nature https://doi.org/10.1038/s41586-022-04780-4 (2022). Article  Google Scholar

  2. Neves, E. G. & Heckenberger, M. J. Annu. Rev. Anthropol. 48, 371–388 (2019). Article  Google Scholar

  3. de Souza, J. G. et al. Nature Commun. 9, 1125 (2018).Article  Google Scholar

  4. Carson, J. F. et al. Holocene 25, 1285–1300 (2015).Article  Google Scholar

Download references

 

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Opinion Science

Being Special Isn’t So Special -Mark Manson

Want your specialness recognized? Pay $79.99 for a "guaranteed" magic spell.

Don’t let attention and glory be your main motivators in life. If you can’t find pleasure in the simple or the mundane, then you won’t find it anywhere.

There’s a paradox that is stumping psychologists right now and it’s this: Over the past 50+ years, despite the standard of living rising dramatically in the western world, happiness has stayed level, while mental illnesses, anxiety disorders, narcissism, and depression have all gone up.

When you study marketing, the first thing you learn is that fear sells. If you make a person feel inadequate or inferior, they will shut up and buy something in order to feel better. A capitalist system markets to everyone constantly, therefore it promotes a society where people constantly feel inadequate and inferior.

It’s funny, a lot of people who travel to the third-world claim that people are “happier” there. They often follow it up with some banal statement about materialism and how we’d all be so much happier if we knew how to live with less.

This is completely wrong.

Poor people in developing societies aren’t happier, they’re simply less anxious and less stressed. People in the developing world don’t care how many friends you have or if you bought the latest hot item or not. They’re much more family- and community-oriented. They’re also more socially accepting and less socially anxious simply because they have to be. It’s how they survive. When you take hyper-individualistic westerners — especially ones who have killed themselves at a desk job to make a ton of money — when they’re exposed to this, they perceive it as being a “happier” or “healthier” way of life. In some ways, it is. But at the same time, it’s exactly what our system gave up to gain its abundance of material wealth.

The philosopher Alain de Botton has written about this in his book Status Anxiety. In centuries past, he says, people knew where they fit into the social order. If you were born a peasant, you knew you were a peasant. If you were born a lord, you knew you were a lord. There was no mobility or opportunity, and so there was no stress about getting ahead. You weren’t responsible for your birthright, so you accepted it and moved on.

But in a meritocratic society, something changes. In a meritocracy, if you’re poor, or you gain success and then lose it, it’s not an accident. It’s worse. It’s your fault. You’re the failure. You’re the one who lost everything. And this causes people to live shackled with a constant fear of inadequacy; all the world’s hustle and bustle motivated by a baseline status anxiety.

De Botton doesn’t argue that feudal societies or poor societies were somehow better. He simply makes the point that when a society goes from feudal and destitute to meritocratic and wealthy, the price its people pay for that increased standard of living and social mobility is an increase in stress and anxiety.

After all, the greater the opportunity one has, the greater the anxiety of somehow squandering it. Thus, we stress: we need to make better grades, to get a better job, to date more attractive people, to have cooler hobbies, to make more friends, to be more liked and more popular. Simply being content with what we have isn’t good enough anymore. In fact, for some it’s tantamount to giving up.

Today we live with more information than any other point in human history. According to Google, the internet produces as much information every two years as the rest of all of human history combined. And all of that information is theoretically instantly accessible by us all. It’s truly amazing.

But when you combine a capitalist system with an infinite flow of information, a side effect is a population who is reminded of the infinite amount of ways that it’s not good enough.

In the early 1900s, a phrase became popular, “Keeping up with the Joneses.” It described the pernicious effect of consumerism. The neighbors got a new car, so now we feel like we need a new car. Your brother-in-law landed seasons tickets to the local baseball team, so now you need season tickets. Your coworker just booked a trip to China, so now you need to travel somewhere exotic.

Now, most of us aren’t douchey enough to feel these types of envy consciously. But unfortunately the “Keeping up with the Joneses” afflicts us all, whether we realize it or not. As humans, we are unconsciously measuring ourselves up against one another constantly. It unfortunately plays a large part in how we define ourselves, whether we want it to or not.

Now imagine that there are two million Joneses to keep up with, and suddenly you have the internet.

This isn’t an argument against capitalism. And it’s definitely not an argument against the internet. I’m simply making observations and stating facts. In today’s world, it is impossible to not be reminded of how somebody, somewhere, is doing something that is much cooler than you, and be reminded of it constantly.

In a bitter irony, through open-sourcing information, the internet has also open-sourced inadequacy and insecurity.

One example: The whole “Make Money from Home, Travel the World” thing that Tim Ferriss started over a decade ago. Truth be told, it’s an extreme lifestyle that is probably not emotionally sustainable in the long-term, and likely doesn’t suit most people’s personalities. Most people who give it a go end up giving it up after a few years, including Ferriss himself.

Yet if you look around online, you’d think the concept cures cancer or something. I have probably half a dozen people who pop onto my Facebook newsfeed all the time going on about the merits of creating your own career path, following your passion, building a personal brand, living off the grid, doing something crazy and then blogging about it. Ironically, I think many of the people saying this stuff are still living at home with their parents and not making any money. It’s almost like they’re trying to convince themselves more than anyone else.

I’m special. I’m unique. I’m doing something different. Look at me. I’m different, right?

Everybody I know who actually lives this way generally shuts up about it because they find talking about it too much alienates people back home. Being special is nice, but that’s not where our real needs get met. It’s not a sufficient metric for our overall well-being.

If everyone quit their desk job and tried to monetize a blog about quilting or created an app that counts how many times you pass gas each day, the economy would come to a standstill. Some people are wired to be loners and eccentrics. And others are wired for routine. Some enjoy taking risks. Some like stability.

There’s something admirable about finding satisfaction in the simple, everyday pleasures of life, and it’s becoming harder and harder to do. We’re bombarded every day: here’s the brave soldier who saved a school bus full of kids with nothing but a crowbar and fishing line; here’s the 30-something billionaire who is going to cure aging so we can all live forever; here’s the 12-year-old who can play Stravinksy’s Rite of Spring on seven different instruments with her feet.

The implication is always the same: What have YOU done lately?

Oh, you flossed today? Way to go, you lazy sack of shit. Now let me just retweet that real quick.

If you can’t find pleasure in the simple or the mundane, then you won’t find pleasure anywhere.

As they say, wherever you go, there you are. Being special isn’t so special. You will still feel frustrated. You will still feel lonely. You will still feel like you could have done more.

Don’t sell yourself out for the sake of attention and false glory. Not that attention and glory are wrong, but they should not be prime motivators that drive your life.

Instead, focus on simplicity. On nuance. Slow down. Breathe. Smile. You don’t need to prove anything to anybody. Including yourself. Think about that for a minute and let it sink in:

You don’t have to prove anything to anybody, including yourself.

Categories
Back Door Power Grab Biden Pandemic Corruption COVID Drugs Science

That OTHER Global COVID Summit

COVID-19 vaccine maker says it's time to jab up.

17,000 physicians and medical scientists make a plea to restore scientific integrity and end the national emergency

While global bureaucrats were meeting on May 12, 2022 at a summit hosted by President Biden to discuss how to “turn vaccines into vaccinations,” and how to increase demand for unwanted injections, another COVID summit was taking place.

The alternate summit focused on some big questions: Why have patients been denied life-saving medical treatments? Why are we not researching the damage being caused by the injections? Why are medical professionals still being censored by media companies, Big Tech and their own institutions?

The group known as the Global COVID Summit represents 17,000 physicians and medical scientists from all over the world who have signed on to a declaration based on the following ten foundational principles:

1.    We declare and the data confirm that the COVID-19 experimental genetic therapy injections must end.

2.    We declare doctors should not be blocked from providing life-saving medical treatment.

3.    We declare the state of national emergency, which facilitates corruption and extends the pandemic, should be immediately terminated.

4.    We declare medical privacy should never again be violated, and all travel and social restrictions must cease.

5.    We declare masks are not and have never been effective protection against an airborne respiratory virus in the community setting.

6.    We declare funding and research must be established for vaccination damage, death and suffering.

7.    We declare no opportunity should be denied, including education, career, military service or medical treatment, over unwillingness to take an injection.

8.    We declare that first amendment violations and medical censorship by government, technology and media companies should cease, and the Bill of Rights be upheld.

9.    We declare that Pfizer, Moderna, BioNTech, Janssen, Astra Zeneca, and their enablers, withheld and willfully omitted safety and effectiveness information from patients and physicians, and should be immediately indicted for fraud.

10.  We declare government and medical agencies must be held accountable.

Read more and watch the entire summit here or watch an in-depth interview with some of the Global COVID Summit doctors here.

With dozens of previously healthy young athletes literally dropping dead after getting jabbed, and hundreds of people seriously ill after getting jabbed, the Biden regime has now approved it for children — statistically the LEAST likely to contract Covid-19 — as young as FIVE years old.

WHY?

Categories
Science

Supermassive black hole at center of Milky Way seen for first time — Science Corner

The first image of Sagittarius A*, the black hole at the center of our galaxy. Credit: Event Horizon Telescope Collaboration

An image of the supermassive black hole at the center of the Milky Way has been captured, giving the first direct glimpse of the turbulent heart of our galaxy.

The black hole itself, known as Sagittarius A*, pronounced “Sagittarius A-Star,” cannot be seen because no light or matter can escape its gravitational grip. But its shadow is traced out by a glowing, fuzzy ring of light and matter that is swirling on the precipice at close to the speed of light before its eventual plunge into oblivion.

The image was captured by the Event Horizon telescope (EHT), a network of eight radio telescopes spanning locations from Antarctica to Spain and Chile, which produced the first image of a black hole, in a galaxy called Messier 87, in 2019.

Prof Sera Markoff, an astrophysicist at the University of Amsterdam and co-chair of the EHT Science Council, said: “The Milky Way’s black hole was our main target, it’s our closest supermassive black hole and it’s the reason we set out to do this thing in the first place. It’s been an 100-year search for these things and so scientifically it’s a huge deal.”

The image provides compelling proof that there is a black hole at the center of the Milky Way, which had been the working assumption of mainstream astronomy. But a minority of scientists had continued to speculate about the possibility of other exotic objects such as boson stars or clumps of dark matter.

“I’m personally happy about the fact it really drills home the fact that there is definitely a black hole at the center of our galaxy,” said Dr Ziri Younsi, a member of the EHT collaboration who is based at University College London. “It’s a turbulent, chaotic and quite violent environment. It made me think, ‘Wow, we’re quite lucky to live at the edge of the galaxy actually.’”

To the untrained eye, the latest image might appear similar to that of M87, which is 55m light years from Earth, but the observations are already giving entirely new scientific insights. And, Younsi said, there was an emotional, as well as purely scientific, value in finally seeing the enigmatic object about which our home galaxy revolves. “It’s another doughnut, but it’s our doughnut,” he said.

A resolution the equivalent of seeing a bagel on the moon was required to bring it into focus.

Despite being local in astronomical terms (still 26,000 light years away) observing SgrA* turned out to be more challenging than anticipated and the team has spent five years analyzing data acquired during fortuitously clear skies across several continents in April 2017. Sagittarius A* is more than a thousand times smaller and less massive than M87*, meaning a resolution the equivalent of seeing a bagel on the moon was required to bring it into focus.

Its size means dust and gas is orbiting it in a matter of minutes, rather than weeks, so the image was constantly changing from one observation to the next. Markoff compared the challenge to trying to capture a puppy chasing its tail using a camera with a slow shutter speed. And the scientists had to peer through the galactic plain, meaning radiation from all the intervening stars had to be filtered out. Some combination of these factors – and possibly some extreme black hole phenomenon – explain the bright blobs in the image.

“We didn’t anticipate how evasive and elusive it would be,” said Younsi. “It was really a tough picture to take – it’s hard to overstate that.”

Four million times more massive than our Sun.

The EHT picks up radiation emitted by particles within the accretion disc that are heated to billions of degrees as they orbit the black hole at close to the speed of light, before vanishing into the central vortex. The blotchy halo in the image shows light bent by the powerful gravity of the black hole, which is four million times more massive than our Sun.

The latest observations are already giving intriguing hints about the nature of our own black hole. Simulations based on the data hint that our black hole’s angle of rotation is not neatly aligned with the galactic plain, but is off-kilter by about 30 degrees. The observations also suggest that SgrA* is in a dormant state, in contrast with some black holes, including M87, which feature vast, powerful jets that blast light and matter from the black hole’s poles into intergalactic space. “If a big star fell in, which would happen every 10,000 years, that would wake it up for a short amount of time and we’d see things brighten up,” said Markoff.

Ultimately, scientists hope that observing these competing processes in black holes – gobbling up nearby material versus blasting it outwards into space – could help answer a chicken-and-egg style question about the evolution of galaxies.

“It’s an open question in galactic formation and evolution. We don’t know which came first, the galaxy or black hole,” said Prof Carole Mundell, an astrophysicist at the University of Bath who is not part of the EHT collaboration.

“From the technology perspective it’s mind-blowing that we can do this,” she said of the latest images.

The EHT team’s results are being published on Thursday in a special issue of the Astrophysical Journal Letters.

Categories
Biden Pandemic COVID Science

Better Late Than Never

Four positive signs we’re seeing as we move into year 3 of this pandemic

Here we are in May 2022. We made it through the “winter of death.” The springtime birds are singing, the sun is shining and we’re feeling hopeful… So let’s briefly take stock of how things are looking, shall we?

1)    The FLCCC and CDC found something to agree on

It took a while. A lot longer than any of us thought it would, in fact. And although it wasn’t how we imagined it might go, and certainly not how we suggested, the Centers for Disease Control recently came to a bold conclusion — one the FLCCC has been championing all along: “Early treatment works.”

Let’s be clear and completely transparent. The CDC didn’t recommend FLCCC protocols, nor are the treatments they recommend ones that FLCCC endorses.

Still, we agreed on something: COVID is treatable. Let’s take our wins where we can.

2)    States are starting to push back

Legislatures in 30 states – 60% of the country — have now proposed bills either putting limits on the authority of health boards to punish doctors who promote alternative treatments, or explicitly enabling the promotion of those treatments.

As Drs. Kory and Marik say, the federal public health agencies have been captured by Big Pharma, so our only hope is in individual states fighting back. And state legislators will only do that if they hear the voice of the people — i.e., you!

Let’s have a look at some recent advances:

This doesn’t mean you can roll right into a pharmacy in Nashville or Nashua and grab some ivermectin off the shelf just yet, but after two years of a near-daily struggle just to be allowed to treat COVID, these are small victories.  Thanks to the dedication, sacrifice and hard work of many people around this country, change is beginning to manifest — slowly but surely.

Thank you for reading The FLCCC Alliance Community. This post is public so feel free to share it.

3)    Mainstream media are inventing new reasons why ivermectin works

Wendy Zukerman hosts a podcast called ‘Science Vs’ and she recently devoted an episode to what she calls “the wild and bizarre tale of … ivermectin.”

Of the 82 studies from around the world that have now looked at IVM and COVID, Zukerman focused on just two – the now discredited Elgazzar paper and the recently released and highly suspicious TOGETHER trial.

Here’s the conclusion her podcast came to:

“Ivermectin didn’t work”

We all know that’s not true. Even the TOGETHER trial’s principal investigator, Edward Mills, knows it’s not true:

“I advocate that, actually, there is a clear signal that IVM works in COVID patients, just that our study didn’t achieve significance. I really don’t view our study as negative… I think if we had continued randomizing a few hundred more patients, it would have likely been significant.”

According to Zukerman, having a nice doctor like Pierre Kory, who gives you a drug they really believe will work, maybe just makes you feel better. Hear her out:

She cites a previous episode of her own show from 2019 on placebos to back this up.

Another podcaster suggests some people were going to get better from COVID anyway, so doctors who get results by prescribing ivermectin can’t really claim the drug is having an effect. He explains:

If it’s true that a lot of people will have a mild case and recover on their own, then it’s hard to understand why vaccines should be mandatory and why people should be encouraged to take an expensive medicine like Paxlovid with its many drug-drug interactions. But that’s a topic for another time.

Other people who still struggle to “explain” the effectiveness of ivermectin, demonstrated in study after study, put it down to the fact that many of those studies were conducted in places where people are infected with worms.

Or, it could just be that ivermectin works for COVID… Go figure.

4)    There is a growing understanding of how clinical trials can be corrupted or designed to fail

Thanks to the tireless work of researchers and investigators like Alexandros Marinos, Phil Harper, Steve Kirsch, Pierre Kory, Flavio Cadegiani and many others, people are gaining a better view into the inner workings of clinical trials and medical journals.

Sadly, what’s being revealed is not a pretty sight.

The story of how Andrew Hill was likely coerced into changing the conclusions of his meta-analysis on ivermectin, and the many ways in which the much-touted TOGETHER trial was based on bad science, are now well documented.

Will this awareness change anything? Maybe, maybe not. As a society, we may have become indifferent to the truth if that truth threatens to shatter our illusions. But as a group of people with a moral conscience, the FLCCC will not stop exposing lies when we see them. We will not stop encouraging critical thinking. We will not stop pursuing solutions for a better world.

For over two years, the members of the FLCCC have endured assaults on our character, integrity, personal and professional reputations, and livelihoods. We have had ample opportunity to turn and walk away, to acquiesce, to give in.

But we didn’t.

We will never give up on our patients. We will never give up on fighting for safe, science-based solutions to one the greatest medical challenges we have ever faced.

We will be here when others see the light and decide to come join us. We won’t even complain (much) if others try to co-opt our ideas and take credit for them. Treating patients and saving lives is in our DNA and will always come before divisive politics and crony capitalism.

Our goal is simple: developing affordable COVID-19 treatments powered by safe, off-patent, repurposed drugs. All are welcome to join. And if you can’t get behind that, then may we politely ask that you at least get out of the way?

Categories
Child Abuse COVID How sick is this? Reprints from others. Science

Did Pfizer Know that Paxlovid will NOT Work in the Vaccinated?

Original Here:

To start:

  • Pfizer likely knew that Paxlovid did not work in the vaccinated, and removed them from the EPIC-SR trial
  • Paxlovid was not AT ALL tested on children in both trials, but the FDA approved it for children anyway.

Introduction

You can skip this introduction and head straight into the next section if you are familiar with the Paxlovid story. Briefly, I wrote the following article on April 13, pointing out that the Internet is full of stories of Paxlovid-treated patients relapsing and having Covid re-emerge on Day 10 of their illness.

Igor’s Newsletter
Paxlovid, “Snake Oil” of the 21st Century?
Paxlovid is a combination of a protease inhibitor Nirmatrelvir and a HIV medication Ritonavir. At $895, it is definitely going to be a moneymaker for Pfizer. But how well does it work for the patients? This is what we all heard: The first study, that lasted for four weeks only, reported amazing success and “89% prevention of severe symptoms”. That first s…

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18 days ago · 267 likes · 235 comments · Igor Chudov

Much has happened since then (not all related to my post, of course). So much noise was made that the US government got interested!

Brian Mowrey wrote five excellent articles looking at the biomolecular mechanisms of why Paxlovid would not work and some aspects of the trial. Jessica Rose also wrote a Paxlovid article, looking at Paxlovid and bringing her highly relevant experience as a former HIV researcher. Peter Nayland Kust brought up the above story Federal Government is forced to urgently look into Paxlovid not working. Darby Shaw straight out asked, correctly, whether Paxlovid is a danger to the vaccinated. Much noise was also made on Twitter, including by yours truly, before Twitter suspended me.

Hundreds of stories are all over Twitter and Reddit. This one from yesterday 4/30/22:

Pfizer Purposely Excluded Vaccinated People from Trials. It had a Reason!

Two Pfizer trials for Paxlovid (High Risk and Standard Risk) had long lists of patients to exclude. Some, like HIV patients with complicated problems, are understandably excluded.

But why did Pfizer decide to exclude vaccinated people from the trials? That decision seems crazy since Pfizer intended to ”vaccinate the world” and have everyone vaccinated. So, considering that Pfizer knew about “breakthrough infections,” why did it decide to ban vaccinated people from both trials if it expected that most people would be vaccinated? Seems strange to exclude most people from being potential customers, no?

Well, it looks like Pfizer knew more than it disclosed. (hat tip, Dr. Buzz)

Twitter avatar for @jpogue1Jason Pogue @jpogue1

@DrToddLee @ASPphysician @boulware_dr Looks like someone quietly removed vaccinated high risk patients from EPIC-SR.

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April 17th 2022

16 Retweets

Actually, Pfizer did NOT want to exclude the vaccinated from at least one trial, EPIC-SR, from the start. In the beginning, EPIC-SR allowed vaccinated people with comorbidities. Original Epic-SR exclusion read:

Has received or is expected to receive any COVID-19 vaccine, except for participants with an underlying medical condition associated with an increased risk of developing severe illness from COVID-19. Participants with these conditions who are fully vaccinated are considered to be at lower risk of developing severe disease and are therefore considered eligible.

So, according to the above, vaccinated patients with comorbidities were considered “standard risk” and were in the trial.

However, between March 9 and April 5 of 2022, Pfizer decided to change the criteria and excluded ALL vaccinated people:

What made Pfizer change this criterion? My speculative answer is that Pfizer knew that Paxlovid did not work in the vaccinated. Having failed to hit the target when it came to vaccinated people, Pfizer decided to remove them from the trial and “move the target,” so to speak. This way, the EPIC-SR study would end up being a “success,” technically.

They removed their main target market — the vaccinated — from the trial, to make sure that the trial looks good. Then Pfizer turned around and asked the FDA to sell the drug to the very people whom they consciously excluded from the trial.

Despite intentionally removing and ignoring vaccinated people in both trials, Pfizer asked for and received FDA approval for all patients, vaccinated or not. So now, Pfizer gets $895 per treatment course and makes a lot of money. Does this treatment benefit vaccinated patients? You decide.

Paxlovid was not tested in Children; FDA Approved Paxlovid for Kids Anyway

It gets worse. Both EPIC-HR and EPIC-SR excluded children under 18.

Despite not having tested Paxlovid for kids at all in these clinical trials, FDA authorized Paxlovid for children:

 

I am slightly puzzled by this. I mean, surely the FDA cares for our children, right? So wouldn’t it want to ask Pfizer to at least test Paxlovid for children? Of course, it is just a few million dollars for Pfizer. Not a big deal. But testing on children was not done at all, and the FDA recommended Paxlovid for children anyway.

Mind you, Paxlovid is not a little harmless vitamin pill. It is a repackaged HIV/AIDS medication blocking certain liver functions, combined with a radically novel protease inhibitor affecting intricate intracellular processes. Who knows how Paxlovid affects growing kids going through puberty? I surely do not know, but does anyone else?

Categories
Biden Pandemic COVID Reprints from others. Science

You make the call. Vaccinated Up to 15X MORE LIKELY Than Unvaxxed to Develop Heart Inflammation Requiring Hospitalization: Peer Reviewed Study That’s what happens when you listen to a guy who hasn’t practiced medicine since the 80’s

The heart that gets infected may be your own. Photo by Tobi Oshinnaike on Unsplash

You can find the links and the original articles here.

The whole article can be found here.

From the *peer-reviewed study, which was published by the Journal of the American Medical Association (JAMA):

Question  Is SARS-CoV-2 messenger RNA (mRNA) vaccination associated with risk of myocarditis?

Findings  In a cohort study of 23.1 million residents across 4 Nordic countries, risk of myocarditis after the first and second doses of SARS-CoV-2 mRNA vaccines was highest in young males aged 16 to 24 years after the second dose. For young males receiving 2 doses of the same vaccine, data were compatible with between 4 and 7 excess events in 28 days per 100 000 vaccinees after second-dose BNT162b2, and between 9 and 28 per 100 000 vaccinees after second-dose mRNA-1273.

Meaning  The risk of myocarditis in this large cohort study was highest in young males after the second SARS-CoV-2 vaccine dose, and this risk should be balanced against the benefits of protecting against severe COVID-19 disease.

Abstract

Importance  Reports of myocarditis after SARS-CoV-2 messenger RNA (mRNA) vaccination have emerged.

Objective  To evaluate the risks of myocarditis and pericarditis following SARS-CoV-2 vaccination by vaccine product, vaccination dose number, sex, and age.

Design, Setting, and Participants  Four cohort studies were conducted according to a common protocol, and the results were combined using meta-analysis. Participants were 23 122 522 residents aged 12 years or older. They were followed up from December 27, 2020, until incident myocarditis or pericarditis, censoring, or study end (October 5, 2021). Data on SARS-CoV-2 vaccinations, hospital diagnoses of myocarditis or pericarditis, and covariates for the participants were obtained from linked nationwide health registers in Denmark, Finland, Norway, and Sweden.

Exposures  The 28-day risk periods after administration date of the first and second doses of a SARS-CoV-2 vaccine, including BNT162b2, mRNA-1273, and AZD1222 or combinations thereof. A homologous schedule was defined as receiving the same vaccine type for doses 1 and 2.

Main Outcomes and Measures  Incident outcome events were defined as the date of first inpatient hospital admission based on primary or secondary discharge diagnosis for myocarditis or pericarditis from December 27, 2020, onward. Secondary outcome was myocarditis or pericarditis combined from either inpatient or outpatient hospital care. Poisson regression yielded adjusted incidence rate ratios (IRRs) and excess rates with 95% CIs, comparing rates of myocarditis or pericarditis in the 28-day period following vaccination with rates among unvaccinated individuals.

Results  Among 23 122 522 Nordic residents (81% vaccinated by study end; 50.2% female), 1077 incident myocarditis events and 1149 incident pericarditis events were identified. Within the 28-day period, for males and females 12 years or older combined who received a homologous schedule, the second dose was associated with higher risk of myocarditis, with adjusted IRRs of 1.75 (95% CI, 1.43-2.14) for BNT162b2 and 6.57 (95% CI, 4.64-9.28) for mRNA-1273. Among males 16 to 24 years of age, adjusted IRRs were 5.31 (95% CI, 3.68-7.68) for a second dose of BNT162b2 and 13.83 (95% CI, 8.08-23.68) for a second dose of mRNA-1273, and numbers of excess events were 5.55 (95% CI, 3.70-7.39) events per 100 000 vaccinees after the second dose of BNT162b2 and 18.39 (9.05-27.72) events per 100 000 vaccinees after the second dose of mRNA-1273. Estimates for pericarditis were similar.

Conclusions and Relevance  Results of this large cohort study indicated that both first and second doses of mRNA vaccines were associated with increased risk of myocarditis and pericarditis. For individuals receiving 2 doses of the same vaccine, risk of myocarditis was highest among young males (aged 16-24 years) after the second dose. These findings are compatible with between 4 and 7 excess events in 28 days per 100 000 vaccinees after BNT162b2, and between 9 and 28 excess events per 100 000 vaccinees after mRNA-1273. This risk should be balanced against the benefits of protecting against severe COVID-19 disease.

 

Categories
Biden Pandemic Child Abuse Drugs Science

TAKE THAT, KARENS! Heart Inflammation More Prevalent Among Vaccinated Than Unvaccinated: Study

Not giving the rest of the story. Getty Pictures
via AP
By Zachary Stieber for EPOCH TIMES April 22, 2022

Heart inflammation requiring hospital care was more common among people who received COVID-19 vaccines than those who did not, according to a new study of tens of millions of Europeans.

Rates of myocarditis or pericarditis, two types of heart inflammation, are above the levels in an unvaccinated cohort, pegged at 38 per 100,000 after receipt of a second dose of a vaccine built on messenger RNA (mRNA) technology in males aged 16 to 24—the group studies have shown are most at risk of the post-vaccination condition—researchers with health agencies in Finland, Denmark, Sweden, and Norway found.

“These extra cases among men aged 16–24 correspond to a 5 times increased risk after Comirnaty and 15 times increased risk after Spikevax compared to unvaccinated,” Dr. Rickard Ljung, a professor and physician at the Swedish Medical Products Agency and one of the principal investigators of the study, told The Epoch Times in an email.

Comirnaty is the brand name for Pfizer’s vaccine while Spikevax is the brand name for Moderna’s jab.

Rates were also higher among the age group for those who received any dose of the Pfizer or Moderna vaccines, both of which utilize mRNA technology. And rates were elevated among vaccinated males of all ages after the first or second dose, except for the first dose of Moderna’s shot for those 40 or older, and females 12- to 15-years-old.

Researchers pulled data from national health registers, analyzing 23.1 million people aged 12 or older. The analysis was of data from Dec. 27, 2020, to incidence of myocarditis or pericarditis, or the end of the study time period, which was Oct. 5, 2021.

“The risks of myocarditis and pericarditis were highest within the first 7 days of being vaccinated, were increased for all combinations of mRNA vaccines, and were more pronounced after the second dose,” researchers wrote in the study, which was published by the Journal of the American Medical Association following peer review.

Moderna and Pfizer did not respond to requests for comment.

Some previous studies have indicated that the risk of heart inflammation is higher from the companies’ vaccines, or certain doses of the vaccines, than from COVID-19 itself.

Others have concluded the opposite, including a recent non-peer-reviewed study from the U.S. Centers for Disease Control and Prevention, though that is one of the papers that has estimated a higher rate of post-vaccination heart inflammation.

Authorities in the United States and many European countries continue recommending vaccination for virtually every eligible person, regardless of age, health condition, or prior infection.

The Nordic countries, however, halted use of Moderna’s vaccine in 2021 for youth and young adults due to concerns over post-vaccination heart inflammation.

Ljung said he could not answer whether the results mean some people should consider only a single dose, or no doses, of a COVID-19 vaccine because the Swedish Medical Products Agency doesn’t give those types of recommendations.

In a press release promoting the study, researchers said that occurrence of the heart inflammation is “very rare” and claimed that “the benefits of these vaccines to reduce the risk of severe COVID-19 and death outweigh the risks of side effects.”

Dr. Peter McCullough, the chief medical adviser for the Truth for Health Foundation and a cardiologist who is seeing patients with post-vaccination heart inflammation, disagreed.

The benefits of the vaccines in no way outweigh the risks.

“In cardiology we spend our entire career trying to save every bit of heart muscle. We put in stents, we do heart catheterization, we do stress tests, we do CT angiograms. The whole game of cardiology is to pervert preserve heart muscle,” McCullough told The Epoch Times. “Under no circumstances would we accept a vaccine that causes even one person to stay sustain heart damage. Not one. And this idea that ‘oh, we’re going to ask a large number of people to sustain heart damage for some other theoretical benefit for a viral infection,’ which for most is less than a common cold, is untenable. The benefits of the vaccines in no way outweigh the risks.”

Categories
Child Abuse COVID Drugs Science

Protect your kids: Persistent Cardiac MRI Findings in a Cohort of Adolescents with post COVID-19 mRNA vaccine myopericarditis —Actual science

Not giving the rest of the story. Getty Pictures

By:Jenna Schauer, MD  Sujatha Buddhe, MD, MS  Avanti Gulhane, MD, DNB, FSCMR Sathish Mallenahalli Chikkabyrappa, MD Yuk Law, MD Michael A. Portman, MD et al for The Journal of Pediatrics

Published:March 25, 2022 DOI:https://doi.org/10.1016/j.jpeds.2022.03.032
Abbreviations:

Late gadolinium enhancement (LGE), Coronavirus disease of 2019 (COVID-19), Nonsteroidal anti-inflammatory drugs (NSAIDs), Intravenous immunoglobulin (IVIG), Left ventricle (LV), Left ventricular ejection fraction (LVEF), Global Longitudinal Strain (GLS)

Myopericarditis, , has emerged as an important adverse event following COVID-19 mRNA vaccination, particularly in adolescents

Patients typically exhibit chest pain and an elevated serum troponin level in the days following the COVID-19 mRNA vaccine. They usually are hemodynamically stable, and symptoms and cardiac biomarkers normalize within a few days cardiac magnetic resonance studies, when performed early, frequently demonstrate abnormalities such as edema and late gadolinium enhancement (LGE), meeting Lake Louise Criteria for diagnosing myocarditis noninvasively ,

In classical myocarditis LGE can be predictive of a poor outcome

Little is known about the prognostic value or expected evolution of these CMR abnormalities associated with post-COVID-19 mRNA vaccine myopericarditis. In this case series we report the evolution of CMR imaging compared with initial, acute phase, CMR in our cohort of patients with myopericarditis post COVID-19 mRNA vaccine.

Methods

This case review includes patients younger than 18 years of age presenting to Seattle Children’s Hospital with chest pain and elevated serum troponin level from April 1, 2021 to January 7, 2022 within one week of receiving the second dose of the Pfizer COVID-19 mRNA vaccine. Institutional Review Board approval was obtained. All patients were evaluated by a pediatric cardiologist, underwent ECG and echocardiogram, and were admitted for observation with telemetry, serial troponin measurements, and repeat cardiac testing as needed. All patients underwent CMR within 1 week of initial presentation and had repeat CMR imaging at 3-8 months follow up. CMR was performed on a 1.5 T Siemens scanner. CMR analysis was performed using CVI42 (version 5.11.4, Circle Cardiovascular Imaging Inc., Alberta Canada). Patients were excluded if they did not undergo CMR or did not have a follow up CMR. Initial and follow up CMR data for each patient were reviewed and compared using paired Student t-test. Statistical significance was defined as a p < 0.05. Statistical analysis was performed using SPSS 27 (SPSS Inc., Chicago, IL).

Results

A total of 35 patients with the diagnosis of myopericarditis associated with Pfizer COVID-19 mRNA vaccine are followed at our institution. Twelve patients were excluded as they never had CMR due to delayed presentation after initial symptoms resolved or admission to other centers. Six patients were excluded as they did not have a follow up CMR, either because they followed up out of state or a study is still pending. One patient was excluded as initial CMR was performed 3 weeks after presentation. Sixteen patients who had both acute phase and follow-up CMR available for review comprised the final cohort. This group had a median age of 15 years (range, 12-17), were mostly male (n=15, 94%), white and non-Hispanic (n= 14, 88%). One patient was Asian and one patient was American Indian. Median time to presentation from the second dose of the Pfizer COVID-19 mRNA vaccine was 3 days (range 2-4 days). All patients had chest pain. The most common other presenting symptoms were fever (n=6, 37.5%) and shortness of breath (n=6, 37.5%). All patients had elevated serum troponin levels (median 9.15 ng/mL, range 0.65-18.5, normal < 0.05 ng/mL). Twelve patients had c- reactive protein (CRP) measured with median value 3.45 mg/dL, range 0-6.5 mg/dL, normal < 0.08 mg/dL.
Ten (62.5%) patients had an abnormal electrocardiogram (ECG), with the most common finding being diffuse ST segment elevation. All patients had an echocardiogram on admission; 14/16 patients had normal left ventricular (LV) systolic function; two patients demonstrated mildly reduced LV systolic function with no dilation. Left ventricular ejection fraction (LVEF) for these two patients was 45% and 53% (normal > 55%). Median left LVEF was 59% (range 45-69%). No patients had pericardial effusion.

The initial CMRs were performed within 1 week of presentation (median 2, range 0-7 days). All were abnormal; all showed evidence of edema by T2 imaging and 15/16 had LGE in a patchy subepicardial to transmural pattern with predilection for the inferior LV free wall. Distribution of LGE can be seen in Figure 1. LV regional wall motion abnormalities were noted in 2 patients. CMR median LVEF% was 54%, range 46-63%. CMR LVEF was mildly decreased in 7 patients. CMR global longitudinal strain (GLS%) measurements were abnormal in 12 patients (median -16.1%, range -13.2% to -18.1%, normal <-18%).

Figure thumbnail gr1

Figure 1Distribution of Late Gadolinium Enhancement (LGE) in American Heart Association Myocardial Segments Figure shows segment with number of patients and percent of cohort.

All patients were treated with nonsteroidal anti-inflammatory drugs (NSAIDs): 75% (n=12) received scheduled dosing (mostly, 10 mg/kg ibuprofen every 8 hours) with the remaining 4 receiving NSAIDs as needed for pain. The median time from vaccination to NSAID initiation was 2.5 days (range 0-4 days) and from symptom onset to NSAID initiation was 1 day (range 0-4 days). The two patients who presented with echocardiographic LV dysfunction were treated with intravenous immunoglobulin (IVIG) plus a corticosteroid per our institutional pathway for treatment of myocarditis

One additional patient received IVIG without corticosteroids. Median hospital length of stay was 2 days (range 1-4 days) with no ICU admission and no significant morbidity or mortality. All patients had resolution of chest pain and down-trending serum troponin level prior to discharge.

All patients underwent follow up CMR at 3-8 months after their initial study (median 3.7 months, range 2.8-8.1 months). The results are compared in Table I. Follow up CMR LVEF (57.7 ±2.8%) was significantly improved from initial (54.5 ± 5.5%, p < 0.05), and none of the patients had regional wall motion abnormalities. LVEF by echocardiogram was normal for all patients at the time of follow up. Eleven patients (68.8%) had persistent LGE, although there was a significant decrease in the quantifiable LGE% (8.16± 5.74%) from the initial study (13.77± 8.53%, p <0.05). Cardiac edema resolved in all but one patient. GLS% remained abnormal in most patients (75%, mean -16.4 ± 2.1%) at follow up without significant change from the initial study (-16.0 ± 1.7, p = 0.6). Examples of initial and follow up CMR images are shown in Figure 2. The patient who received IVIG alone and one patient who received IVIG plus corticosteroid had resolution of LGE, and the other had persistence of LGE.

Table 1Covid Vaccine-Associated Myopericarditis Findings in 16 patients
Initial (Mean±SD)Follow up (Mean±SD)P value
Echocardiographic LVEF %59.4±6.062.6±2.8<0.05
Electrocardiogram

Abnormal

Normal

10 (62.5%)

6 (37.5%)

Peak Serum Troponin (ng/mL)9.0± 5.2
CMR LVEF %54.5 ± 5.557.7 ±2.7<0.05
CMR LGE % (n=15*)13.5± 8.37.7 ± 5.7<0.001
CMR global longitudinal strain % (n=15*)-16.0 ± 1.7-16.4 ± 2.10.5
*Initial source images were not available for reanalysis for one patient.
LVEF% = LV ejection fraction
LGE %= percentage of late gadolinium enhancem
ent
CMR = Cardiac MRI
Figure thumbnail gr2
Figure 2CMR images from 3 days after admission of a 16-year-old male who presented to emergency room with chest pain and elevated troponin 3 days after receiving Pfizer COVID-19 mRNA vaccine. Initial CMR. 1a and 1b. subepicardial to midmyocardial LGE in inferior and inferolateral LV wall from base to apex (arrows). 1c shows T2 hyper-intensity in similar segments, consistent with edema. 1d, 1e and 1f. Follow up CMR 4.4 months later. LGE still persistent but decreased from 26% to 19.84% (arrows), LVEF remained stable at 58%. There is improved T2 hyperintensity.
Eight patients (5 of whom had persistent LGE) underwent 24-hour cardiac rhythm monitoring, all of which studies were normal. Six patients, all with persistent LGE, underwent exercise tests, all of which were normal. Four patients complained of intermittent chest pain at follow up with no identifiable abnormality on evaluation; no therapy or intervention was required. No patient received heart failure medication.

DISCUSSION

We previously reported 15 patients with clinically suspected SARS-CoV-2 mRNA vaccine induced myopericarditis. All patients had an abnormal CMR, with edema and or LGE in addition to clinical symptoms and troponin elevation, and some had abnormal ECG or echocardiogram

We have since established a clinical protocol for serial CMR performance in these patients consistent with the 2021 American Heart Association (AHA) statement that stressed the risk of sudden cardiac death, particularly with exercise, while active inflammation is present.

our patients were restricted from exercise on discharge. Repeat CMR was performed within 3-6 months to guide next clinical decision-making steps; timing was modified in some individuals based on scanner accessibility and safety precautions during the COVID-19 pandemic. Although symptoms were transient and most patients appeared to respond to treatment (soley with NSAIDS), we demonstrated persistence of abnormal findings on CMR at follow up in most patients, albeit with improvement in extent of LGE.
CMR has increasingly been identified as an important diagnostic tool for myocarditis given its ability to identify subclinical injury and fibrosis by markers of LGE and edema. CMR also has been utilized in longitudinal follow up of patients with myocarditis to help therapeutic management, although exact screening protocols remain controversial
The presence of LGE is an indicator of cardiac injury and fibrosis and has been strongly associated with worse prognosis in patients with classical acute myocarditis. In a meta-analysis including 8 studies, Yang et al found that presence of LGE is a predictor of all cause death, cardiovascular death, cardiac transplant, rehospitalization, recurrent acute myocarditis and requirement for mechanical circulatory support]Similarly, Georgiopoulos et al found presence and extent of LGE to be a significant predictor of adverse cardiac outcomes in an 11 study meta-analysis
The persistence of LGE over time and its prognostic value is less well established. Malek et al found that in a cohort of 18 patients with myocarditis, nearly 70% had persistent CMR changes at a median follow-up time of 7 months Dubey et al found similar findings in their cohort of 12 pediatric patients, with persistence of LGE in all patients despite resolution of edema.
Prognostic meaning of LGE in vaccine associated myopericarditis requires further study.
Strain analysis by CMR also has been shown to have prognostic utility in myocarditis even in the setting of normal LV functionStrain testing can be performed without use of contrast material and can be particularly useful in situations where contrast administration is challenging or contraindicated. Notably, in our cohort, though there was significant reduction in LGE at follow up, abnormal strain persisted for the majority of patients at follow up.
This study has certain limitations. Patients who did not seek medical attention during acute illness or did not present with significant symptoms and require hospitalization were not captured, and their disease course may be different. Incomplete CMR data on other patients precludes extrapolation of our CMR findings to all who experienced mRNA vaccine-related myopericarditis. In addition, follow-up CMR timeframes varied from patient to patient making it difficult to predict the timing of CMR changes over time. the total number of patients reported is small, limiting ability to draw conclusions about the effect of treatment modalities or to generalize regarding outcomes of vaccine-associated myopericarditis.
In a cohort of adolescents with COVID-19 mRNA vaccine-related myopericarditis, a large portion have persistent LGE abnormalities, raising concerns for potential longer-term effects. Despite these persistent abnormalities, all patients had rapid clinical improvement and normalization of echocardiographic measures of systolic function. For patients with short acute illness, no dysfunction demonstrated by echocardiogram at presentation and resolution of symptoms at follow up, return to sports was guided by normalization of CMR alone. In patients with persistent CMR abnormalities we performed exercise stress testing prior to sports clearance per myocarditis recommendations We plan to repeat CMR at 1 year post-vaccine for our cohort to assess for resolution or continued CMR changes.
The CDC notes that even though the absolute risk for myopericarditis following mRNA COVID-19 vaccine is small, the relative risk is higher for particular groups, including males 12-39 years of age.

Some studies have suggested that increasing the interval between the first and second dose may reduce the incidence of myopericarditis in this population

These data led to an extension in CDC recommended dosing interval between dose 1 and dose 2 to 8 weeks. Further follow up assessment and larger multicenter studies are needed to determine the ultimate clinical significance of persistent CMR abnormalities in patients with post COVID-19 vaccine myopericarditis

Uncited reference

REFERENCES

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    The Journal of Pediatrics. 2021; https://doi.org/10.1016/j.jpeds.2021.12.025

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Footnotes

No funding was received for this research

The authors declare no conflicts of interest.

Abstract

We describe the evolution of Cardiac MRI (CMR) findings in 16 patients, 12-17 years of age, with myopericarditis after the second dose of the Pfizer mRNA COVID-19 vaccine. Although all patients showed rapid clinical improvement, many had persistent CMR findings at 3-8 month follow up.

Figures

  • Figure thumbnail gr1
    Figure 1Distribution of Late Gadolinium Enhancement (LGE) in American Heart Association Myocardial Segments

    . Figure shows segment with number of patients and percent of cohort.

          • Figure thumbnail gr2
            Figure 2CMR images from 3 days after admission