FDA restricts J&J’s COVID-19 vaccine due to blood clot risk

Authrsors: Associated Press

WASHINGTON (AP) — U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J’s vaccine. U.S. authorities for months have recommended that Americans starting their COVID-19 vaccinations use the Pfizer or Moderna shots instead.

FDA officials said in a statement that they decided to restrict J&J’s vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination.

J&J’s vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines.

Under the new FDA instructions, J&J’s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t receive an additional dose. J&J’s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said.

A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”

Despite the restriction, FDA’s vaccine chief Dr. Peter Marks said J&J’s vaccine “still has a role in the current pandemic response in the United States and across the global community.”

The FDA based its decision on “our safety surveillance systems and our commitment to ensuring that science and data guide our decisions

Nearly 15 million deaths associated with COVID-19, WHO says

The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned.

COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.

The New Brunswick, New Jersey-based company announced last month that it didn’t expect a profit from the vaccine this year and was suspending sales projections.

The rollout of the company’s vaccine was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas.

Additionally, regulators added warnings about the blood clots and a rare neurological reaction called Guillain-Barré syndrome.

Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 17 million Americans got the J&J shot.

Blood-clotting imbalance persists in Long COVID, research finds

Date: :August 23, 2022Source:RCSI

Summary:

New research from RCSI University of Medicine and Health Sciences has provided greater insight into the causes of Long COVID syndrome.

The findings, which further investigate the link between Long COVID and blood clotting, have been published in the Journal of Thrombosis and Haemostasis.

Long COVID syndrome is a broad collection of symptoms including shortness of breath, fatigue and reduced physical fitness that can continue for many months after initial infection with COVID-19. Understanding is limited about why these symptoms persist in some patients but not others, and the novel syndrome remains a considerable clinical challenge for both doctors and patients alike.

To gain a new understanding of what causes Long COVID, researchers at RCSI studied patients in Ireland with symptoms of Long COVID, and saw that the body’s blood-clotting and immune systems can remain tipped out of balance long after the initial infection.

The team of researchers, led by Professor James O’Donnell at the RCSI School of Pharmacy and Biomolecular Sciences with Dr Helen Fogarty as Clinical Fellow, analysed blood from 50 patients with Long COVID syndrome up to 12 weeks post infection with the COVID-19 virus. They compared the samples to ‘controls’, blood from healthy people who did not have Long COVID syndrome.

The study found that the blood of patients with Long COVID syndrome had higher levels of a blood-clotting booster called von Willebrand Factor (VWF), and lower levels of a protein that normally breaks down VWF, called ADAMTS13. Their analysis also suggests that blood vessels were still being damaged long after the initial infection, and that specific cells of the immune system were at abnormal levels in patients with Long COVID.

“In this study, we examined 50 patients with symptoms of Long COVID syndrome. We saw that, in patients with Long COVID, the normally finely tuned balance of pro- and anti-clotting mechanisms were tipped in favour of blood clotting,” said Dr Helen Fogarty, Health Research Board Irish Clinical Academic Training (ICAT) Programme Fellow and lead author on the paper. “Our analysis also suggests that abnormal clotting and disturbed immunity go hand in hand in Long COVID. Together, these findings may help explain some of the symptoms of Long COVID syndrome.”

Commenting on the study, Professor James O’Donnell said: “Extensive research has been carried on the dangerous clotting observed in patients with acute severe COVID-19 infection, and we now understand a lot more about how and why these deadly clots occur. In this study, we put the focus on Long COVID syndrome, as so much less is known about this persistent illness which is affecting millions of people worldwide.”

The study was carried out by clinical colleagues at St James’s Hospital and researchers at RCSI as part of the Irish COVID-19 Vasculopathy Study (ICVS) collaboration, which includes scientific researchers in RCSI, Trinity College Dublin and University College Dublin as well as clinical partners in St James’s, St Vincent’s and Beaumont Hospitals. The ICVS is supported by a Health Research Board COVID-19 Rapid Response award (COV19-2020-086), and a philanthropic grant from the 3M Foundation to RCSI in support of COVID-19 research.

Journal Reference:

  1. Helen Fogarty, Soracha E. Ward, Liam Townsend, Ellie Karampini, Stephanie Elliott, Niall Conlon, Jean Dunne, Rachel Kiersey, Aifric Naughton, Mary Gardiner, Mary Byrne, Colm Bergin, Jamie M. O’Sullivan, Ignacio Martin‐Loeches, Parthiban Nadarajan, Ciaran Bannan, Patrick W. Mallon, Gerard F. Curley, Roger J. S. Preston, Aisling M. Rehill, Ross I. Baker, Cliona Ni Cheallaigh, James S. O’Donnell, Niamh O’Connell, Kevin Ryan, Dermot Kenny, Judicael Fazavana. Sustained VWF‐ADAMTS‐13 axis imbalance and endotheliopathy in long COVID syndrome is related to immune dysfunctionJournal of Thrombosis and Haemostasis, 2022; DOI: 10.1111/jth.15830

Cite This Page: MLA APAChicago RCSI. “Blood-clotting imbalance persists in Long COVID, research finds.” ScienceDaily. ScienceDaily, 23 August 2022. <www.sciencedaily.com/releases/2022/08/220823095434.htm>.

Covid linked to 33-fold increase in risk of potentially fatal blood clot

Infection with virus also associated with fivefold increase in risk of deep vein thrombosis, data suggests

Authors: Linda Geddes The Guardian

Catching Covid is associated with a fivefold increase in the risk of deep vein thrombosis (DVT) and a 33-fold increase in risk of a potentially fatal blood clot on the lung in the 30 days after becoming infected, data suggests.

The findings, published in the British Medical Journal on Thursday, could help explain a doubling in the incidence of, and deaths from, blood clots in England since the start of the pandemic compared with the same periods in 2018 and 2019.

They also help to put the very small increased risk of blood clots associated with Covid-19 vaccination into context. “The degree of complications associated with Covid-19 is much stronger and lasts for much longer than what we might be getting after vaccination,” said Dr Frederick Ho, a lecturer in public health at the University of Glasgow, who was not involved in the research.

“Even those people with mild symptoms who do not need to be hospitalised might have a small increase in the risk of [blood clots].”

Although previous research had suggested that catching Covid was associated with an increased risk of blood clots, it was unclear for how long this risk remained, and whether mild infections also increased people’s risk.

To address these uncertainties, Anne-Marie Fors Connolly at Umeå University in Sweden and her colleagues measured the risk of DVT, pulmonary embolism – a blood clot on the lung – and various types of bleeding, such as gastrointestinal bleeding or a burst blood vessel in the brain, in more than 1 million people with confirmed Covid infections and more than 4 million uninfected individuals.

Overall, they identified a 33-fold increase in the risk of pulmonary embolism, a fivefold increase in the risk of DVT and an almost twofold increase in the risk of bleeding in the 30 days after infection. People remained at increased risk of pulmonary embolism for six months after becoming infected, and for two and three months for bleeding and DVT.

Although the risks were highest in patients with more severe illness, even those with mild Covid had a threefold increased risk of DVT and a sevenfold increased risk of pulmonary embolism. No increased risk of bleeding was found in those who experienced mild infections.

“Pulmonary embolism can be fatal, so it is important to be aware [of this risk],” said Connolly. “If you suddenly find yourself short of breath, and it doesn’t pass, [and] you’ve been infected with the coronavirus, then it might be an idea to seek help, because we find this increased risk for up to six months.”

Ho said the results remained relevant even in the Omicron era, since current vaccines were highly effective against severe Covid but breakthrough infections were common, even after a third dose of a vaccine.

“Despite the potential for new variants of concern, most governments are removing restrictions and shifting their focus to determining how best to live with Covid. This study reminds us of the need to remain vigilant to the complications associated with even mild Sars-CoV-2 infection, including [blood clots].”

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‘Never Seen’ Before: Embalmers Finding Long, Rubbery Clots Inside Corpses Since Implementation of Covid Vaccines

By Cristina Laila September 4, 2022

Embalmers are finding long, rubbery clots inside of corpses since the implementation of Covid vaccines.

According to one Alabama embalmer who has been treating corpses for over 20 year, the strange fibrous clots emerged in May of 2021, shortly after the Covid vaccines first became available to the public.

“It wasn’t until May or June of last year that I started to say, ‘something is really different about the blood’ and then later in September, I took my first picture, since I couldn’t come out with just one piece of evidence because what if it’s just a fluke?” Alabama embalmer Richard Hirschmann told 1819 News. “Now, I have been gathering evidence and I have pictures of over 100 cases. And it’s not stopping. It’s not slowing down.”

Embalmers are finding long, rubbery clots inside of corpses since the implementation of Covid vaccines.

According to one Alabama embalmer who has been treating corpses for over 20 year, the strange fibrous clots emerged in May of 2021, shortly after the Covid vaccines first became available to the public.

“It wasn’t until May or June of last year that I started to say, ‘something is really different about the blood’ and then later in September, I took my first picture, since I couldn’t come out with just one piece of evidence because what if it’s just a fluke?” Alabama embalmer Richard Hirschmann told 1819 News. “Now, I have been gathering evidence and I have pictures of over 100 cases. And it’s not stopping. It’s not slowing down.”

The Epoch Times spoke to Richard Hirschmann and other embalmers who have all documented the same rubbery clots in corpses starting in 2021.

“In 20 years of embalming, I had never seen these white fibrous structures in the blood, nor have others in my field. In the past year, I have seen these strange clots in many different individuals, and it doesn’t seem to matter what they die of, they often have similar substances in their blood. This makes me very concerned because if something is wrong in the blood, it begs the question: is something causing people to die prematurely?” Hirschman told the Epoch Times.

Hirschmann said he has noticed that the blood in people’s bodies has changed in the last two years.

Mr. Hirschmann said he cannot confirm that the blood clots are caused by the Covid vaccines, but it is his hope that the clots are investigated.

Have all documented the same rubbery clots in corpses starting in 2021.

Several embalmers across the country have been observing many large, and sometimes very long, “fibrous” and rubbery clots inside the corpses they treat, and are speaking out about their findings.

Numerous embalmers from different states confirmed to The Epoch Times that they have been seeing these strange clots, starting from either 2020 or 2021.

It’s not yet known if the cause of the new clot phenomenon is COVID-19, vaccines, both, or something different.

The Epoch Times received videos and photos of the anomalous clots, but could not upload them due to the level of gore.

Mike Adams, who runs an ISO-17025 accredited lab in Texas, analyzed clots in August and found them to be lacking iron, potassium, magnesium, and zinc.

Adams’s lab uses inductively coupled plasma mass spectrometry (ICP-MS), triple quadrupole mass spectrometer, and liquid chromatography-mass spectrometry, usually testing food for metals, pesticides, and glyphosate.

“We have tested one of the clots from embalmer Richard Hirschman, via ICP-MS. Also tested side by side, live human blood from an unvaccinated person,” Adams told The Epoch Times.

He found that the clots are lacking key elements present in healthy human blood, such as iron, potassium, and magnesium, suggesting that they are formed from something other than blood.

Adams is joining analytic forces with more doctors and plan to invest out of their own pocket in equipment in order to further determine their composition and probable causation.

The string-like structures differ in size, but the longest can be as long as a human leg and the thickest can be as thick as a pinky finger.

Could tiny blood clots cause long COVID’s puzzling symptoms?

Scientists debate evidence for a micro-clot hypothesis that has some people pursuing potentially risky treatments

Authors: Cassandra Willyard Nature 608, 662-664 (2022)doi: https://doi.org/10.1038/d41586-022-02286-7

When Lara Hawthorne, an illustrator in Bristol, UK, began developing strange symptoms after having COVID-19, she hoped that they weren’t due to the virus. Her initial illness had been mild. “I’ve been triple vaccinated. I felt quite protected,” she says. But months later, she was still sick with a variety of often debilitating symptoms: earaches, tinnitus, congestion, headaches, vertigo, heart palpitations, muscle pain and more. On some days, Hawthorne felt so weak that she could not get out of bed. When she finally saw her physician, the diagnosis was what she had been dreading: long COVID.

Unable to find relief, she became increasingly desperate. After reading an opinion piece in The Guardian newspaper about how blood clots might be to blame for long COVID symptoms, Hawthorne contacted a physician in Germany who is treating people with blood thinners and a procedure to filter the blood. She hasn’t heard back yet — rumour has it that people stay on the waiting list for months — but if she has the opportunity to head there for these unproven treatments, she probably will. “I don’t want to wait on my health when I’m feeling so dreadful,” she says.

Researchers are baffled by long COVID: hundreds of studies have tried to unpick its mechanism, without much success. Now some scientists, and an increasing number of people with the condition, have been lining up behind the as-yet-unproven hypothesis that tiny, persistent clots might be constricting blood flow to vital organs, resulting in the bizarre constellation of symptoms that people experience.

Heart disease after COVID: what the data say

Proponents of the idea (#teamclots, as they sometimes refer to themselves on Twitter) include Etheresia Pretorius, a physiologist at Stellenbosch University in South Africa, and Douglas Kell, a systems biologist at the University of Liverpool, UK, who led the first team to visualize micro-clots in the blood of people with long COVID. They say that the evidence implicating micro-clots is undeniable, and they want trials of the kinds of anticoagulant treatment that Hawthorne is considering. Pretorius penned the Guardian article that caught Hawthorne’s attention.

But many haematologists and COVID-19 researchers worry that enthusiasm for the clot hypothesis has outpaced the data. They want to see larger studies and stronger causal evidence. And they are concerned about people seeking out unproven, potentially risky treatments.

When it comes to long COVID, “we’ve now got little scattered of bits of evidence”, says Danny Altmann, an immunologist at Imperial College London. “We’re all scuttling to try and put it together in some kind of consensus. We’re so far away from that. It’s very unsatisfying.”

Cascade of clots

Pretorius and Kell met about a decade ago. Pretorius had been studying the role of iron in clotting and neglected to cite some of Kell’s research. When he reached out, they began chatting. “We had a Skype meeting and then we decided to work together,” Pretorius says. They observed odd, dense clots that resist breaking down for years in people with a variety of diseases. The research led them to develop the theory that some molecules — including iron, proteins or bits of bacterial cell wall — might trigger these abnormal clots.

Blood clotting is a complex process, but one of the key players is a cigar-shaped, soluble protein called fibrinogen, which flows freely in the bloodstream. When an injury occurs, cells release the enzyme thrombin, which cuts fibrinogen into an insoluble protein called fibrin. Strands of fibrin loop and criss-cross, creating a web that helps to form a clot and stop the bleeding.

Under a microscope, this web typically resembles “a nice plate of spaghetti”, Kell says. But the clots that the team has identified in many inflammatory conditions look different. They’re “horrible, gunky, dark”, Kell says, “such as you might get if you half-boiled the spaghetti and let it all stick together.” Research by Kell, Pretorius and their colleagues suggests that the fibrin has misfolded1, creating a gluey, ‘amyloid’ version of itself. It doesn’t take much misfolding to seed disaster, says Kell. “If the first one changes its conformation, all the others have to follow suit”, much like prions, the infectious misfolded proteins that cause conditions such as Creutzfeldt–Jakob disease.

Long-COVID treatments: why the world is still waiting

Pretorius first saw these strange, densely matted clots in the blood of people with a clotting disorder2, but she and Kell have since observed the phenomenon in a range of conditions1 — diabetes, Alzheimer’s disease and Parkinson’s disease, to name a few. But the idea never gained much traction, until now.

When the pandemic hit in 2020, Kell and Pretorius applied their methods almost immediately to people who had been infected with SARS-CoV-2. “We thought to look at clotting in COVID, because that is what we do,” Pretorius says. Their assay uses a special dye that fluoresces when it binds to amyloid proteins, including misfolded fibrin. Researchers can then visualize the glow under a microscope. The team compared plasma samples from 13 healthy volunteers, 15 people with COVID-19, 10 people with diabetes and 11 people with long COVID3. For both long COVID and acute COVID-19, Pretorius says, the clotting “was much more than we have previously found in diabetes or any other inflammatory disease”. In another study4, they looked at the blood of 80 people with long COVID and found micro-clots in all of the samples.

So far, Pretorius, Kell and their colleagues are the only group that has published results on micro-clots in people with long COVID.

But in unpublished work, Caroline Dalton, a neuroscientist at Sheffield Hallam University’s Biomolecular Sciences Research Centre, UK, has replicated the results. She and her colleagues used a slightly different method, involving an automated microscopy imaging scanner, to count the number of clots in blood. The team compared 3 groups of about 25 individuals: people who had never knowingly had COVID-19, those who had had COVID-19 and recovered, and people with long COVID. All three groups had micro-clots, but those who had never had COVID-19 tended to have fewer, smaller clots, and people with long COVID had a greater number of larger clots. The previously infected group fell in the middle. The team’s hypothesis is that SARS-CoV-2 infection creates a burst of micro-clots that go away over time. In individuals with long COVID, however, they seem to persist.

Dalton has also found that fatigue scores seem to correlate with micro-clot counts, at least in a few people. That, says Dalton, “increases confidence that we are measuring something that is mechanistically linked to the condition”.

In many ways, long COVID resembles another disease that has defied explanation: chronic fatigue syndrome, also known as myalgic encephalomyelitis (ME/CFS). Maureen Hanson, who directs the US National Institutes of Health (NIH) ME/CFS Collaborative Research Center at Cornell University in Ithaca, New York, says that Pretorius and Kell’s research has renewed interest in a 1980s-era hypothesis about abnormal clots contributing to symptoms. Pretorius, Kell and colleagues found amyloid clots in the blood of people with ME/CFS, but the amount was much lower than what they’ve found in people with long COVID5. So clotting is probably only a partial explanation for ME/CFS, Pretorius says.

Micro-clot mysteries

Where these micro-clots come from isn’t entirely clear. But Pretorius and Kell think that the spike protein, which SARS-CoV-2 uses to enter cells, might be the trigger in people with long COVID. When they added the spike protein to plasma from healthy volunteers in the laboratory, that alone was enough to prompt formation of these abnormal clots6.

Bits of evidence hint that the protein might be involved. In a preprint7 posted in June, researchers from Harvard University in Boston, Massachusetts, reported finding the spike protein in the blood of people with long COVID. Another paper8 from a Swedish group showed that certain peptides in the spike can form amyloid strands on their own, at least in a test tube. It’s possible that these misfolded strands provide a kind of template, says Sofie Nyström, a protein chemist at Linköping University in Sweden and an author of the paper.

Micrographs of platelet poor plasma of a healthy volunteer showing few microclots,and post-COVID-19 infection showing microclots
Micro-clots (green) in a study participant before SARS-CoV-2 infection (left four panels) and in the same person after they developed long COVID (right four panels).Credit: E. Pretorius et al./Cardiovasc. Diabetol. (CC BY 4.0)

A California-based group found that fibrin can actually bind to the spike. In a 2021 preprint9, it reported that when the two proteins bind, fibrin ramps up inflammation and forms clots that are harder to degrade. But how all these puzzle pieces fit together isn’t yet clear.

If the spike protein is the trigger for abnormal clots, that raises the question of whether COVID-19 vaccines, which contain the spike or instructions for making it, can induce them as well. There’s currently no direct evidence implicating spike from vaccines in forming clots, but Pretorius and Kell have received a grant from the South African Medical Research Council to study the issue. (Rare clotting events associated with the Oxford–AstraZeneca vaccine are thought to happen through a different mechanism (Nature 596, 479–481; 2021).)

Raising safety concerns about the vaccines can be uncomfortable, says Per Hammarström, a protein chemist at Linköping University and Nyström’s co-author. “We don’t want to be over-alarmist, but at the same time, if this is a medical issue, at least in certain people, we have to address that.” Gregory Poland, director of the Mayo Clinic’s vaccine research group in Rochester, Minnesota, agrees that it’s an important discussion. “My guess is that spike and the virus will turn out to have a pretty impressive list of pathophysiologies,” he says. “How much of that may or may not be true for the vaccine, I don’t know.”

Dearth of data

Many researchers find it plausible and intriguing that micro-clots could be contributing to long COVID. And the hypothesis does seem to fit with other data that have emerged on clotting. Researchers already know that people with COVID-19, especially severe disease, are more likely to develop clots. The virus can infect cells lining the body’s 100,000 kilometres of blood vessels, causing inflammation and damage that triggers clotting.

Those clots can have physiological effects. Danny Jonigk, a pathologist at Hanover Medical School in Germany, and his colleagues looked at tissue samples from people who died of COVID-19. They found micro-clots and saw that the capillaries had split, forming new branches to try to keep oxygen-rich blood flowing10. The downside was that the branching introduces turbulence into the flow that can give rise to fresh clots.

How common is long COVID? Why studies give different answers

Several other labs have found signs that, in some people, this tendency towards clotting persists months after the initial infection. James O’Donnell, a haematologist and clotting specialist at Trinity College Dublin, and his colleagues found11 that about 25% of people who are recovering from COVID-19 have signs of increased clotting that are “quite marked and unusual”, he says.

What is less clear is whether this abnormal clotting response is actually to blame for any of the symptoms of long COVID, “or is it just, you know, another unusual phenomenon associated with COVID?” O’Donnell says.

Alex Spyropoulos, a haematologist at the Feinstein Institutes for Medical Research in New York City, says the micro-clot hypothesis presents “a very elegant mechanism”. But he argues that much more work is needed to tie the lab markers to clinical symptoms. “What’s a little bit disturbing is that these authors and others make huge leaps of faith,” Spyropoulos says.

Jeffrey Weitz, a haematologist and clotting specialist at McMaster University in Hamilton, Canada, points out that the method Pretorius’s team is using to identify micro-clots “isn’t a standard technique at all”. He adds: “I’d like to see confirmation from other investigators.” Micro-clots are difficult to detect. Pathologists can spot them in tissue samples, but haematologists tend to look for markers of abnormal clotting rather than the clots themselves.

Other, larger studies of long COVID have failed to find signs of clotting. Michael Sneller, an infectious-disease specialist, and his colleagues at the NIH in Bethesda, Maryland, thoroughly examined 189 people who had been infected with SARS-CoV-2, some with lingering symptoms and some without, and 120 controls12. They did not specifically look for micro-clots. But if micro-clots had been clogging the capillaries, Sneller says, they should have seen some evidence — tissue damage in capillary-rich organs such as the lungs and kidneys, for example. Micro-clots might also damage red blood cells, leading to anaemia. But Sneller and his colleagues found no signs of this in any of the lab tests.

The four most urgent questions about long COVID

Kell and Pretorius argue that just because this study didn’t find any evidence of micro-clots doesn’t mean they aren’t there. One of the key issues with long COVID is that “every single test comes back within the normal ranges”, Pretorius says. “You have desperately ill patients with no diagnostic method.” She hopes that other researchers will read their papers and attempt to replicate their results. “Then we can have a discussion,” she says. The ultimate causal proof, she adds, would be people with long COVID feeling better after receiving anticoagulant therapies.

There is some limited evidence of this. In an early version of a preprint, posted in December 2021, Kell, Pretorius and other researchers, including physician Gert Jacobus Laubscher at Stellenbosch University, reported that 24 people who had long COVID and were treated with a combination of two antiplatelet therapies and an anticoagulant experienced some relief13. Participants reported that their main symptoms resolved and that they became less fatigued. They also had fewer micro-clots. Pretorius and Kell are working to gather more data before they try to formally publish these results. But other physicians are already using these medications to treat people with long COVID. Some are even offering a dialysis-like procedure that filters fibrinogen and other inflammatory molecules from the blood. To O’Donnell, such treatment feels premature. He accepts that some people with long COVID are prone to clots, but leaping from a single small study to treating a vast number of people is “just not going to wash in 2022 in my book”, he says. Sneller agrees. “Anticoagulating somebody is not a benign thing. You basically are interfering with the blood’s ability to clot,” he says, which could make even minor injuries life-threatening.

Kell says he’s tired of waiting for a consensus on how to treat long COVID. “These people are in terrible pain. They are desperately unwell,” he says. Altmann understands that frustration. He gets e-mails almost daily, asking: “Where are the drug trials? Why does it take so long?” But even in the midst of a pandemic, he argues, researchers have to follow the process. “I’m not rubbishing anybody’s data. I’m just saying we’re not there yet,” he says. “Let’s join up the dots and do this properly.”

References

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Opinions | How long covid reshapes the brain — and how we might treat it

Authors: Wes Ely August 25, 2022 The Washington Post

The young man pulled something from behind both ears. “I can’t hear anything without my new hearing aids,” said the 32-year-old husband and father. “My body is broken, Doc.” Once a fireman and emergency medical technician, he’d had covid more than 18 months before and was nearly deaf. He was also newly suffering from incapacitating anxiety, cognitive impairment and depression. Likewise, a 51-year-old woman told me through tears: “It’s almost two years. My old self is gone. I can’t even think clearly enough to keep my finances straight.” These are real people immersed in the global public health catastrophe of long covid, which the medical world is struggling to grasp and society is failing to confront.

As such stories clearly indicate, covid is biologically dangerous long after the initial viral infection. One of the leading hypotheses behind long covid is that the coronavirus is somehow able to establish a reservoir in tissues such as the gastrointestinal tract. I believe the explanation for long covid is more sinister.

The science makes it increasingly clear that covid-19 turns on inflammation and alters the nervous system even when the virus itself seems to be long gone. The virus starts by infecting nasal and respiratory lining cells, and the resulting inflammation sends molecules through the blood that trigger the release of cytokines in the brain. This can happen even in mild covid cases. Through these cell-to-cell conversations, cells in the nervous system called microglia and astrocytes are revved up in ways that continue for months — maybe years. It’s like a rock weighing down on the accelerator of a car, spinning its engine out of control. All of this causes injury to many cells, including neurons. It is past time we recognized this fact and began incorporating it into the ways we care for those who have survived covid.

For too long, the mysteries of long covid led many health-care professionals to dismiss it as an untreatable malady or a psychosomatic illness without a scientific basis. Some of this confusion comes down to the stuttering cadence of scientific progress. Early in the pandemic, autopsy findings from patients who died of covid “did not show encephalitis or other specific brain changes referable to the virus” as one report noted. Patients with profound neurological illnesses resulting from covid-19 had no trace of the virus in the cerebrospinal fluid encasing their brains.

These studies left most medical professionals mistakenly convinced that the virus was not damaging the brain. Accordingly, we narrowed our focus to the lungs and heart and then scratched our heads in wonder at the coma and delirium found in more than 80 percent of covid ICU patients. A robust study from the Netherlands showed that at least 12.5 percent of covid patients end up with long covid three months afterward, yet because “brain fog” wasn’t identified until later in the pandemic, these investigators didn’t include cognitive problems or mental health disorders in the data they collected. Thus, this otherwise beautifully executed study almost certainly underestimated the rate of long covid.

Since the early days of the pandemic, we’ve learned a great deal about the neurological effects of SARS-CoV-2. Earlier this year, the UK Biobank neuroimaging study showed that even mild covid can lead to an overall reduction in the size of the brain, with notable effects in the frontal cortex and limbic system. These findings help explain the profound anxiety, depression, memory loss and cognitive impairment experienced by so many long-covid patients.

new study published in the Lancet of more than 2.5 million people matched covid-19 patients with non-covid patients to determine the rate of recovery from mental health complaints and neurological deficits like the depression and brain fog in my own patients. What it revealed is partly encouraging and partly devastating: The anxiety and mood disorders in long covid tend to resolve over months, while serious dementia-like problems, psychosis and seizures persist at two years.

4 Ways COVID Leaves Its Mark on the Eye

Authors: Reena Mukamal American College of Opthalmology

An analysis of 121 patients dating back to the beginning of the pandemic unveils COVID’s most common effects on the eye. Share this information and remember: Widespread vaccination is key to ending the pandemic.

How does COVID reach the eyes?

People respond in different ways to COVID-19 infections. While some people develop mild to severe respiratory problems, others experience no symptoms at all. Pink eye remains the most common sign of COVID in the eyes of children and adults.

Doctors are still learning how COVID affects the eyes. But it’s clear that some people with COVID experience inflammation throughout their body. This inflammation can cause blood clots to form. These clots may travel through the body and reach the veins, arteries and blood vessels of the eye.

COVID’s effects on the retina

The new study suggests that few people with COVID will develop eye problems. But when those problems occur, they can range from mild to vision-threatening. Many of these problems affect the retina — a light-sensing layer of cells in the back of the eye that plays a key role in your vision.

Here are four of the most common eye problems that may develop after COVID infection, according to the new analysis.

1. “Cotton wool” spots

When blood clots prevent nutrients from getting to the retina, the tissue in the retina begins to swell and die. If the doctor examines your eye closely using optical coherence tomography, this area looks white and fluffy like cotton wool (shown in the image above). These spots do not typically affect a person’s vision.

2. Eye stroke (also called retinal artery occlusion)

Blood clots in the arteries of the retina can block the flow of oxygen, causing cells to die. This is known as a retinal artery occlusion, or eye stroke. The most common symptom of an eye stroke is sudden, painless vision loss.

3. Retinal vein occlusion

When a vein in the retina becomes blocked, blood can’t drain out like it should. The buildup of blood raises pressure levels inside the eye, which can cause bleeding, swelling and fluid leaks. People with this complication can develop blurry vision or even sudden, permanent blindness.

4. Retinal hemorrhage

This occurs when blood vessels in the retina start bleeding. It is sometimes caused by a retinal vein occlusion. A hemorrhage can lead to blind spots and gradual or sudden loss of vision.

Am I at risk of eye complications from COVID?

Very few people with COVID will experience serious eye-related complications. But certain people are more likely than others to develop these problems. People with the following conditions are at greatest risk:

When eye problems occur, they tend to develop within 1 to 6 weeks of experiencing COVID symptoms.

These problems have developed in people who were very sick with COVID as well as people who were apparently healthy and lacked symptoms.

Although this is the largest study to date on COVID’s impact on the retina, researchers only examined information from 121 patients. Doctors are continuing to explore how often eye problems affect people with COVID, and how to prevent these conditions.

How to protect your eyes during COVID-19

If you develop symptoms of COVID and notice changes in your vision, schedule an appointment with an ophthalmologist right away.

To protect your eyes and your overall health, be sure to wear a face mask around other people, wash and sanitize your hands frequently and get vaccinated against COVID-19. The potential complications of the disease far outweigh any complications from the vaccine.

Doctors Criticize Fauci For Saying COVID Vaccines Induce ‘Only Temporary’ Menstrual Irregularities

Authors: Enrico Trigozo Epoch Times August 6, 2022

Dr. Anthony Fauci’s recent comments on menstrual irregularities met with serious rebuttal from gynecologists, who say COVID-19 vaccines should not have been injected into pregnant women without adequate safety testing.

Well, the menstrual thing is something that seems to be quite transient and temporary, that’s one of the points,” Fauci said in an appearance on Fox News on July 25, upon being asked about the effect of vaccines on menstrual cycles.

“We need to study it more,” Fauci added.

Fauci is the director of the National Institute of Allergy and Infectious Diseases (NIAID) and has been a frontman for COVID vaccine information in the United States.

Dr. Christiane Northrup MD, a former fellow in the American College of Obstetricians and Gynecologists, remarked to The Epoch Times on Fauci’s comments: “Unfortunately the menstrual problems we are seeing are far from transient and temporary. Many women have been bleeding daily or having heavy, irregular, painful periods for an entire year. And some of these are well past menopause. Something is way off here. ”

Dr. James Thorp is an extensively published 69-year-old physician MD board-certified in obstetrics and gynecology, as well as maternal-fetal medicine, who has been practicing obstetrics for over 42 years.

The significant and dramatic changes in menstrual patterns occurring after COVID-19 vaccines should not be marginalized. It is indicative of major adverse effects on women of reproductive age. The stakeholders claimed that the vaccine would remain at the injection site in the deltoid muscle. This was misinformation. The lipid nanoparticles (LNP’s) are now known to be distributed throughout the entire body and to be concentrated in the ovaries, according to at least two studies. Schadlich and colleagues demonstrated concentration of the LNP’s in ovaries of different mouse species and Wistar rats, in vivo, in vitro and by sophisticated microscopic imaging in 2012,” he told The Epoch Times.

A lipid nanoparticle is an extremely small particle, a fat-soluble membrane that is the cargo of the messenger RNA.

Pfizer’s Internal Documents

Pfizer’s internal documents, obtained via the Freedom of Information Act, show a 118-fold increase in the concentration of LNPs from the time of injection to 48 hours.

“The LNP’s are known to include toxic substances including polyethylene glycol and pseudo-uridinated mRNA. The limited number of ovum in the ovaries (about 1 million) are exposed to potentially toxic substances and could potentially have catastrophic effects on human reproduction,” Thorp said.  

The stakeholders claimed that the pseudo-uridinated mRNA could not be reverse transcribed into the human DNA. This was misinformation,” he added, referring to a Swedish study published in February 2022 that concluded that Pfizer’s COVID-19 vaccine is able to enter human liver cells and is converted into DNA.

Thorp and former Pfizer VP Michael Yeadon believe that the medical industrial complex had unequivocal evidence on the vaccine’s danger in pregnant women.

This is proven not only by VAERS but also by Pfizer’s own internal document ‘Pfizer 5.3.6 post-marketing experience” Thorp said.

Within the first 90 days of trials, there were 1,223 deaths, multiple severe adverse effects, and a 45 percent complication rate in pregnancy cases (274) that occurred in vaccinated mothers (124).

The 2012 study, mentioned by Thorp earlier, says that after testing with different mouse species and Wistar rats, “a high local accumulation of nanoparticles, nanocapsules and nanoemulsions in specific locations of the ovaries was found in all animals.”

Yeadon believes that the pharmaceutical industry “definitely knew,” since 2012, that the lipid nanoparticles would accumulate in the ovaries of women that took the vaccines.

“No one in the industry or in leading media could claim ‘they didn’t know about these risks to successful pregnancy,’” Yeadon told The Epoch Times in April.

Study: Kids with COVID more likely to develop blood clots

Authors: David Olsen August 6, 2022 Newsday

Children who test positive for COVID-19 are much more likely to develop blood clots and cardiac problems weeks after their infection, compared with kids who did not contract the virus, a newly released study found.

The study, published Thursday by the Centers for Disease Control and Prevention, also found significantly higher rates of kidney failure and diabetes in those infected with the virus.

“A lot of the things they’re reporting are things that we’re seeing,” said Dr. Howard Balbi, chief of pediatric infectious diseases at Good Samaritan Hospital in West Islip.

Many of the kids who develop complications a few weeks after infection, including some who ended up in intensive care, initially had mild or no COVID-19 symptoms, he said.

WHAT TO KNOW

  • Children who tested positive for the coronavirus were significantly more likely to develop blood clots, cardiac problems, kidney failure and diabetes than kids who did not, a newly released CDC study found.
  • Long Island doctors said the study backs up what they’ve been seeing in hospitals. Many of the children who later developed complications initially had only mild COVID-19 or no symptoms at all, one pediatrician said.
  • Even though children are less likely to get severe COVID-19 than adults, the study shows that a small number of kids will develop serious health conditions, doctors say.

Dr. Andrew Handel, a pediatric infectious disease specialist at Stony Brook Children’s Hospital, said the study’s results “confirm our suspicions.”

“We know that most children who get COVID do not have severe infections from it,” he said. “But a small portion of these children are going to go on to have permanent organ damage as a result of the infection.”

The study is the largest ever in the United States on “post-COVID-19” effects on children, defined as symptoms and conditions four or more weeks after infection. CDC researchers examined medical records of more than 3.1 million children and adolescents, from infants to 17-year-olds, a quarter of whom had tested positive for the coronavirus and the rest who had not. The children were followed for between 60 days and a year.

Kids who had COVID-19 were twice as likely to have blood clots or lung-artery blockages caused by blood clots. They also were twice as likely to have cardiomyopathy, a disease of the heart muscle, or myocarditis, an inflammation of the heart muscle.

Last year, the CDC warned of rare cases of myocarditis among adolescent and young-adult males who received the Pfizer-BioNTech and Moderna vaccines. Some parents interviewed by Newsday and other media outlets said fear of myocarditis was a factor in not getting their children vaccinated.

But a CDC study released in April found that COVID-19 is far more likely than coronavirus vaccines to cause myocarditis, even among young males. The new study reiterates that COVID-19 is a greater myocarditis threat, Handel said.

In addition, he said, “What we’ve seen anecdotally in clinic [at Stony Brook] but also in research itself is that the myocarditis that kids get from the vaccine tends to be much, much, much less severe than when they experience it as a result of the infection itself. Generally, when kids get myocarditis after getting vaccinated, they can have some mild symptoms that usually just resolve on their own within a day or two. But myocarditis that you get with COVID infection itself can be devastating.”

COVID-19 causes inflammation, so it’s not surprising that the inflammation can continue for a longer period of time in some kids, said Dr. Mundeep Kainth, a pediatric infectious disease specialist at Cohen Children’s Medical Center in New Hyde Park.

“There is definitely already a known risk for that for anybody with COVID,” she said.

Children with COVID-19 also were about 1.3 times more likely to have kidney failure and roughly 1.2 times more likely to develop type 1 or type 2 diabetes or have issues with taste or smell, the study found.

The rate of malaise and fatigue among kids who had COVID-19 was only 1.05 times higher.

Studies have found that fatigue is the most common symptom of adults with “long COVID,” which the CDC defines as symptoms lasting at least three months after first contracting the virus.

Handel said he’s not surprised the rates of fatigue among kids aren’t higher.

“The symptoms that go along with what we’re calling long COVID — fatigue, body aches, difficulty thinking and maybe some psychiatric symptoms — those are really much less common in children for reasons that we don’t quite understand,” he said.

Kainth said the lower rates of fatigue also are probably because kids in general are more active than adults on average, and less likely to be fatigued.

Even so, Balbi said, multiple parents have told him that even though their kids who had gotten infected may not have severe post-COVID symptoms, “To quote the parent, ‘They’re just not themselves four months later. … They’re not back to normal. They’re not as active, they’re not as interested in doing things.’ ”

Researchers cautioned that the study was not representative of the U.S. pediatric population. About 70% of the kids were enrolled in Medicaid managed care. In addition, the analysis was based on medical records — meaning the children in the study who did not contract the coronavirus “were seeking medical care,” Kainth said. “These were not completely healthy kids.”

If healthier children had been part of the study, there may have been an even larger gap between kids who had COVID-19 and those who had not, she said.

Adverse effects of COVID-19 vaccines and measures to prevent them

Authors: Kenji Yamamoto Virol J. 2022; 19: 100. Published online 2022 Jun 5. doi: 10.1186/s12985-022-01831-0 PMCID: PMC9167431PMID: 35659687

Abstract

Recently, The Lancet published a study on the effectiveness of COVID-19 vaccines and the waning of immunity with time. The study showed that immune function among vaccinated individuals 8 months after the administration of two doses of COVID-19 vaccine was lower than that among the unvaccinated individuals. According to European Medicines Agency recommendations, frequent COVID-19 booster shots could adversely affect the immune response and may not be feasible. The decrease in immunity can be caused by several factors such as N1-methylpseudouridine, the spike protein, lipid nanoparticles, antibody-dependent enhancement, and the original antigenic stimulus. These clinical alterations may explain the association reported between COVID-19 vaccination and shingles. As a safety measure, further booster vaccinations should be discontinued. In addition, the date of vaccination should be recorded in the medical record of patients. Several practical measures to prevent a decrease in immunity have been reported. These include limiting the use of non-steroidal anti-inflammatory drugs, including acetaminophen to maintain deep body temperature, appropriate use of antibiotics, smoking cessation, stress control, and limiting the use of lipid emulsions, including propofol, which may cause perioperative immunosuppression. In conclusion, COVID-19 vaccination is a major risk factor for infections in critically ill patients.

COVID Vaccines Increase Adverse Events and Weaken The Immune System

The coronavirus disease (COVID-19) pandemic has led to the widespread use of genetic vaccines, including mRNA and viral vector vaccines. In addition, booster vaccines have been used, but their effectiveness against the highly mutated spike protein of Omicron strains is limited. Recently, The Lancet published a study on the effectiveness of COVID-19 vaccines and the waning of immunity with time [1]. The study showed that immune function among vaccinated individuals 8 months after the administration of two doses of COVID-19 vaccine was lower than that among unvaccinated individuals. These findings were more pronounced in older adults and individuals with pre-existing conditions. According to the European Medicines Agency’s recommendations, frequent COVID-19 booster shots could adversely affect the immune response and may not be feasible [2]. Several countries, including Israel, Chile, and Sweden, are offering the fourth dose to only older adults and other groups rather than to all individuals [3].

The decrease in immunity is caused by several factors. First, N1-methylpseudouridine is used as a substitute for uracil in the genetic code. The modified protein may induce the activation of regulatory T cells, resulting in decreased cellular immunity [4]. Thereby, the spike proteins do not immediately decay following the administration of mRNA vaccines. The spike proteins present on exosomes circulate throughout the body for more than 4 months [5]. In addition, in vivo studies have shown that lipid nanoparticles (LNPs) accumulate in the liver, spleen, adrenal glands, and ovaries [6], and that LNP-encapsulated mRNA is highly inflammatory [7]. Newly generated antibodies of the spike protein damage the cells and tissues that are primed to produce spike proteins [8], and vascular endothelial cells are damaged by spike proteins in the bloodstream [9]; this may damage the immune system organs such as the adrenal gland. Additionally, antibody-dependent enhancement may occur, wherein infection-enhancing antibodies attenuate the effect of neutralizing antibodies in preventing infection [10]. The original antigenic sin [11], that is, the residual immune memory of the Wuhan-type vaccine may prevent the vaccine from being sufficiently effective against variant strains. These mechanisms may also be involved in the exacerbation of COVID-19.

Some studies suggest a link between COVID-19 vaccines and reactivation of the virus that causes shingles [1213]. This condition is sometimes referred to as vaccine-acquired immunodeficiency syndrome [14]. Since December 2021, besides COVID-19, Department of Cardiovascular Surgery, Okamura Memorial Hospital, Shizuoka, Japan (hereinafter referred to as “the institute”) has encountered cases of infections that are difficult to control. For example, there were several cases of suspected infections due to inflammation after open-heart surgery, which could not be controlled even after several weeks of use of multiple antibiotics. The patients showed signs of being immunocompromised, and there were a few deaths. The risk of infection may increase. Various medical algorithms for evaluating postoperative prognosis may have to be revised in the future. The media have so far concealed the adverse events of vaccine administration, such as vaccine-induced immune thrombotic thrombocytopenia (VITT), owing to biased propaganda. The institute encounters many cases in which this cause is recognized. These situations have occurred in waves; however, they are yet to be resolved despite the measures implemented to routinely screen patients admitted for surgery for heparin-induced thrombocytopenia (HIT) antibodies. Four HIT antibody-positive cases have been confirmed at the institute since the start of vaccination; this frequency of HIT antibody-positive cases has rarely been observed before. Fatal cases due to VITT following the administration of COVID-19 vaccines have also been reported [15].

As a safety measure, further booster vaccinations should be discontinued. In addition, the date of vaccination and the time since the last vaccination should be recorded in the medical record of patients. Owing to the lack of awareness of this disease group among physicians and general public in Japan, a history of COVID-19 vaccination is often not documented, as it is in the case of influenza vaccination. The time elapsed since the last COVID-19 vaccination may need to be considered when invasive procedures are required. Several practical measures that can be implemented to prevent a decrease in immunity have been reported [16]. These include limiting the use of non-steroidal anti-inflammatory drugs, including acetaminophen, to maintain deep body temperature, appropriate use of antibiotics, smoking cessation, stress control, and limiting the use of lipid emulsions, including propofol, which may cause perioperative immunosuppression [17].

To date, when comparing the advantages and disadvantages of mRNA vaccines, vaccination has been commonly recommended. As the COVID-19 pandemic becomes better controlled, vaccine sequelae are likely to become more apparent. It has been hypothesized that there will be an increase in cardiovascular diseases, especially acute coronary syndromes, caused by the spike proteins in genetic vaccines [1819]. Besides the risk of infections owing to lowered immune functions, there is a possible risk of unknown organ damage caused by the vaccine that has remained hidden without apparent clinical presentations, mainly in the circulatory system. Therefore, careful risk assessments prior to surgery and invasive medical procedures are essential. Randomized controlled trials are further needed to confirm these clinical observations.

In conclusion, COVID-19 vaccination is a major risk factor for infections in critically ill patients.

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