A Key to Long Covid Is Virus Lingering in the Body, Scientists Say

Virus remaining in some people’s bodies for a long time may be causing longer-term complications, recent research suggests

Authors:  Sumathi Reddy Sept. 8, 2022 The Wall Street Journal

The virus that causes Covid-19 can remain in some people’s bodies for a long time.  A growing number of scientists think that lingering virus is a root cause of long Covid.

New research has found the spike protein of the SARS-CoV-2 virus in the blood of long Covid patients up to a year after infection but not in people who have fully recovered from Covid. Virus has also been found in tissues including the brain, lungs, and lining of the gut, according to scientists and studies 

The findings suggest that leftover reservoirs of virus could be provoking the immune system in some people, causing complications such as blood clots and inflammation, which may fuel certain long Covid symptoms, scientists say. 

A group of scientists and doctors are joining forces to focus research on viral persistence and aim to raise $100 million to further the search for treatments. Called the Long Covid Research Initiative, the group is run by the PolyBio Research Foundation, a Mercer Island, Wash., based nonprofit focused on complex chronic inflammatory diseases. 

“We really want to understand what’s at the root of [long Covid] and we want to focus on that,” says Amy Proal, a microbiologist at PolyBio and the initiative’s chief scientific officer. Dr. Proal has devoted her career to researching chronic infections after developing myalgic encephalomyelitis/chronic fatigue syndrome, an illness that shares similar symptoms with long Covid, in her 20s.  She has mostly recovered now but has symptoms she manages.

Three long Covid patients, frustrated at the lack of answers and treatments, have helped connect researchers. 

“Long Covid is this really incredible emergency,” says Henry Scott-Green, one of the patients, a 28-year-old in London who says brain fog, extreme fatigue and other debilitating long Covid symptoms prevented him from resuming full-time work as a product manager, though he plans to return soon. “We’re really trying to run really efficiently and cut out as many layers of bureaucracy as possible.”

So far, the group says it has received a pledge of $15 million from Balvi, an investment and direct giving fund established by Vitalik Buterin, the co-creator of the cryptocurrency platform Ethereum. een says debilitating long Covid symptoms have prevented him from resuming full-time work.

Among the strongest evidence of viral persistence in long Covid patients is a new study by Harvard researchers published Friday in the journal of Clinical Infectious Diseases. Researchers detected the spike protein of the SARS-CoV-2 virus in a large majority of 37 long Covid patients in the study and found it in none of 26 patients in a control group.

Patients’ blood was analyzed up to a year after initial infection, says David R. Walt, a professor of pathology at Brigham and Women’s Hospital in Boston and Harvard Medical School and lead researcher of the study. Dr. Walt isn’t currently involved with the long Covid initiative. 

A year after infection, some patients had levels of viral spike protein that were as high as they did earlier in their illness, Dr. Walt says. Such levels long after initial infection suggest that a reservoir of active virus is continuing to produce the spike protein because the spike protein typically doesn’t have a long lifetimehe adds.

Dr. Walt plans to test antivirals such as Paxlovid or remdesivir to see if the drugs help clear the virus and eliminate spike protein from the blood.  He says it’s possible that for some people, the normal course of medication isn’t enough to clear the virus. Such cases may require “a much longer exposure to these antivirals to fully clear,” says Dr. Walt.

One of the research group’s goals is to find a way for people to identify whether they continue to have the virus in their bodies. There is no easy way to determine this now. 

Long Covid patients experience such a wide range of long-term symptoms that scientists think there is likely more than one cause, however. Some cases may be fueled by organ damage, for instance. 

Yet consensus is growing around the idea that lingering virus plays a significant role in long Covid. Preliminary research from immunologist Akiko Iwasaki’s laboratory at Yale University documented T or B cell activity in long Covid patients’ blood, suggesting that patients’ immune systems are continuing to react to virus in their bodies. Dr. Iwasaki is a member of the new initiative. 

In a 58-person study published in the Annals of Neurology in March, University of California, San Francisco researchers also found SARS-CoV-2 proteins circulating in particles in long Covid patients’ blood, especially in those with symptoms such as fatigue and trouble concentrating.

Now, the group is completing a study using imaging techniques and tissue biopsies to detect persistent virus or reactivation of other viruses in tissue. It also is looking at T-cell immune responses in tissues and whether they correlate with symptoms. 

Some people may harbor the virus and don’t have long-term symptoms, says Timothy Henrich, an associate professor of medicine at UCSF involved with the study and a member of the long Covid initiative. For others, lingering virus may produce problems.

“I think there’s a real amount of mounting evidence that really suggests that there is persistent virus in some people,” says Dr. Henrich.

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.

New ivermectin study shows 92% lower chance of COVID death

Protection increases with increased usage of politically charged drug

Authors: Art Moore WND News Center

A large study on the impact of using ivermectin as a prophylaxis for COVID-19 found that regular users of the drug experienced up to a 92% reduction in mortality compared to those who did not.

Brazilian research scientist Dr. Flavio A. Cadegiani said via Twitter that his study in his home country showed a “dose-response effect,” meaning that “the more you used, the more protection you had.”

He observed that people who use ivermectin regularly every 15 days for at least six to eight weeks had up to a 92% reduction in mortality.

Cadegiani conducted a previous study of drug that evaluated whether its use could impact COVID-19 infection and mortality rates.

Last fall, esteemed epidemiologist Dr. Harvey Risch of Yale Medical School was among scientists and physicians who said in Senate testimony that thousands of lives could have been saved if treatments such as ivermectin and hydroxychloroquine had not been suppressed.

In April, after noticing that the word ivermectin was trending on Twitter amid Elon Musk’s move to buy the company, the FDA reprised its disingenuous “horse dewormer” smear of the drug as a treatment for COVID-19.

“Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19,” said a post on the FDA’s Twitter account.

The reference to horses played on the explosion last fall of media articles and social media posts mocking people who treated COVID-19 with the drug as ignorant rubes who were sneaking into farms or patronizing Tractor Supply stores in quest of “horse dewormer.”

During the pandemic, Twitter and other social media platforms censored positive mention of ivermectin and hydroxychloroquine despite the countless testimonies and dozens of studies from around the world showing the drugs to be effective in treating COVID-19.

A follow-up FDA post said: “Also, a reminder that a study showed it didn’t actually work against COVID.”

Dr. Pierre Kory, who has testified to the Senate of the effectiveness of ivermectin against COVID-19, fired back.

“You are not a horse, you are not a cow, you are Big Pharma’s ass,” he tweeted.

The FDA, he wrote, was “messaging BS” by citing “one corrupt study” while ignoring 82 trials, including 33 randomized controlled trials with 129,000 patients from 27 countries that show “massive benefits” of ivermectin in treating COVID-19.

“Stop lying man, people are dying,” he wrote, adding the hashtag “earlytreatmentworks.”

In an article published in April for the Brownstone Institute, Kory wrote that it’s “a tried-and-true tactic with effective and dastardly results” for “Big Pharma and other well-financed interests” to sponsor purportedly impartial medical trials “aimed at discrediting cheaper generic alternatives.’

“Ignoring the flaws in the methodology, the media runs wild with the desired narrative, which is amplified by a well-orchestrated public relations effort,” he wrote.

Kory cited as an example the newly reported clinical trial from Brazil known as “TOGETHER,” which he said ostensibly aimed at studying the effectiveness of ivermectin to treat COVID.

Among the flaws was the lack of explicit exclusion criteria for trial participants on ivermectin, meaning both trial groups had access to the same drug.  Further, the treatment window was set for only three days, which didn’t allow for adequate dosing, and the trial was conducted during the massive gamma variant surge, which was one of the most virulent and deadly COVID variants.

“The dosage of the trial was far lower than everyday Brazilian clinicians were prescribing patients at the time to match the strength of the strain,” Kory pointed out.

“In spite of these and other readily apparent shortcomings, the nation’s leading media gobbled up the results. ‘Ivermectin Didn’t Reduce Covid-19 Hospitalizations in Largest Trial to Date’ blared the Wall Street Journal, while a New York Times headlined announced, ‘Ivermectin Does Not Reduce Risk of Covid Hospitalization, Large Study Finds.’”

Meanwhile, social media platforms stifled conversations while California pushed potentially precedent-setting legislation to punish doctors “who dare question phony studies,” threatening loss of a medical license.

A similar study of ivermectin “of far larger size, conducted by investigators without any conflicts of interest, found the drug led to massive reductions in Covid infection, hospitalization and mortality—yet it received virtually no media coverage.”

Kory said that ending “this cycle of perpetual disinformation requires revamping our dysfunctional drug approval process.”

“An independent board free of pharma industry conflicts must be established to oversee trials for re-purposed medicines,” he said. “Recommendations should be based on trials designed by impartial experts and actual results, not the desired ones, and policymakers or prescribers who ignore the findings should be held accountable.”

And academia and the regulatory agencies must be reminded, he said, “that observational trials data – wherein a sample of population who take a drug are compared to those who do not – is equally valid at informing policy.”

“Randomized controlled trials can yield useful information, but their complexity, costs, and delays to treatment lead to errors and effectively shut out low-cost drugs from the approval process, regardless of their efficacy,” he said.

Medical experts question Paxlovid study on symptoms in people under 65

Authors: Bart Jones August 27, 2022 Newsday

Some medical experts on Long Island are disputing a new study that said Paxlovid did not help relieve COVID-19 symptoms in people under 65.

Pfizer’s COVID-19 pill appears to provide little or no benefit for younger adults, while still reducing the risk of hospitalization and death for high-risk seniors, according to a large study published Wednesday.

The results from the 109,000-patient Israeli study are likely to renew questions about the U.S. government’s use of Paxlovid, which has become the go-to treatment for COVID-19 due to its at-home convenience.

But two leading infectious disease specialists on Long Island said they had seen the opposite — Paxlovid did help people in various age groups.

“I don’t think that’s really correct,” Dr. Sharon Nachman, chief of the division of pediatric diseases at Stony Brook Children’s Hospital, said of the study. “I do think that those that were under 65 and have taken Paxlovid have actually done quite well with it.”

“We haven’t seen that much relapse of COVID in that population and we’ve certainly not seen those who took Paxlovid coming to the hospital with COVID and being sick,” she said. “The vast majority infected it did help.”

“Sometimes when you do a study you have to be careful how you ask the question and who you ask it of, because that may skew what you are able to interpret from the results,” she added.

Dr. Bruce Hirsch, an infectious disease specialist at Northwell Health, said he agreed that Paxlovid had helped many patients of different age groups.

“Paxlovid really improves clinical well-being within two or three days of taking the medicine,” he said.

“The younger people are doing OK anyway” for the most part when they get infected with the Omicron variant, he added, “but I have seen people who are younger feel better faster with Paxlovid.”

The Biden administration has spent more than $10 billion purchasing the drug and making it available at thousands of pharmacies through its test-and-treat initiative.

The researchers found that Paxlovid reduced hospitalizations among people 65 and older by roughly 75% when given shortly after infection. That’s consistent with earlier results used to authorize the drug in the United States and other nations.

But people between the ages of 40 and 65 saw no measurable benefit, according to the analysis of medical records.

The findings reflect the changing nature of the pandemic, in which the vast majority of people already have some protection against the virus due to vaccination or prior infection. For younger adults, in particular, that greatly reduces their risks of severe COVID-19 complications. The Centers for Disease Control and Prevention recently estimated that 95% of Americans 16 and older have acquired some level of immunity against the virus.

“Paxlovid will remain important for people at the highest risk of severe COVID-19, such as seniors and those with compromised immune systems,” said Dr. David Boulware, a University of Minnesota researcher and physician, who was not involved in the study. “But for the vast majority of Americans who are now eligible, this really doesn’t have a lot of benefit.”

A spokesman for Pfizer declined to comment on the results, which were published in the New England Journal of Medicine.

The U.S. Food and Drug Administration authorized Paxlovid late last year for adults and children 12 and older who are considered high risk due to conditions like obesity, diabetes and heart disease.

“Game-changer” Paxlovid turns into pandemic enigma

Authors: Arielle Dreher Axios September 2, 2022

Paxlovid, once hailed as a “game-changer” for its ability to treat COVID-19 infections at home, is becoming one of the pandemic’s biggest enigmas.

The intrigue: There’s growing concern about the link between Pfizer’s antiviral pill and COVID rebound, in which patients test positive or have symptoms days after a course of the drug is completed. President Biden, First Lady Jill Biden and NIAID Director Anthony Fauci have each relapsed.

  • The FDA has asked Pfizer to investigate whether a second five-day course of the drug will prevent the virus from returning.
  • Pfizer executives in May suggested patients who can’t clear the virus with the first course should take more, Bloomberg reported.

The big picture: Paxlovid use surged over the summer, with as many as one-third of reported coronavirus cases treated with the drug.

  • But uncertainty over what’s causing the relapses, and whether the drug helps younger patients, is making some people wary of taking the treatment, physicians say.
  • At least part of the problem is that people are not routinely tested after taking Paxlovid, which makes it hard to establish how often rebound happens or why the virus lingers in some people, Leana Wen, an emergency physician and a professor at George Washington University, told CNN.
  • A large study of more than 109,000 people in the New England Journal of Medicine concluded the drug significantly reduced hospitalizations and deaths among patients aged 65 and older but that there was no evidence of benefit in younger adults.
  • The prospect of reinfection shouldn’t discourage older or high-risk patients from taking the pills, said Yale infectious diseases specialist Scott Roberts.
  • “Rebound is almost always more mild than initial course,” Roberts told Axios.
  • Paxlovid could have the added benefit of warding off long COVID, or symptoms that linger beyond the first 30 days after testing positive, and studies to determine this are underway.

But availability of the drug could change before clear answers emerge.

  • The Biden administration has only bought enough pills to supply Paxlovid through the middle of next year, after which it will transition to the commercial market, HHS Assistant Secretary for Preparedness and Response Dawn O’Connell wrote in a blog post on Tuesday.

Between the lines: COVID rebound has also been observed in people who have not taken Paxlovid, and some experts believe it might be a natural course of the infection to see symptoms ebb, then return.

  • COVID’s course “is not a purely linear process; it waxes and wanes a little bit,” said Jonathan Li, a Harvard Medical School researcher and co-author of a pre-print that found high levels of rebound in people who hadn’t been treated with the drug.

State of play: The CDC recommends Paxlovid for those over the age of 50, and for those with medical conditions like lung or heart disease that makes them high-risk, although the drug’s emergency authorization covers anyone 12 years old and up.

  • Research in Clinical Infectious Diseases found the drug remains effective for vaccinated people who contract COVID-19, reducing emergency room visits by lowering the risk of complications like lower respiratory tract infection and cardiac arrhythmia.
  • Beyond the Pfizer study requested by the FDA, a clinical trial of immunocompromised people is evaluating if Paxlovid should be used for five, 10 or 15 days.

What they’re saying: “The consensus by the vast majority of people caring for COVID patients is that the rebound is not really a side effect of Paxlovid, it is more that are we really treating people for long enough or not?” Sarju Ganatra, a cardiologist at Lahey Hospital and co-author of the Clinical Infectious Diseases study, told Axios.

Yes, but: “This is where having a well-designed, well-controlled study helps us understand disease better, and this is the challenge of anecdotal reports. Without a control, it’s really hard to know what’s actually happening,” said Kara Chew, an infectious disease physician at University of California Los Angeles.

The bottom line: Paxlovid remains an important tool to keep some people out of the hospitals, especially with the highly contagious Omicron variant still circulating and many people not staying current on boosters, experts said.

  • Isolation will also be critical as long as enough people are experiencing COVID rebound and stay infectious beyond the five-day isolation period recommended by the CDC.

Pfizer Vaccine Whistleblower Responds To Motion To Dismiss False Claims Suit

Authors: Alex Giordano via The Epoch Times AUG 27, 2022 

Pfizer cannot use the government as a shield from liability for making false claims about its COVID-19 vaccine, lawyers for a whistleblower argued in response to Pfizer’s motion to dismiss a False Claims Act lawsuit.

Respondents claim fraudulent certifications, false statements, doctored data, contaminated clinical trials, and firing of whistleblowers can be ignored based on the theory that they contracted their way around the fraud,” lawyers for Brook Jackson, who worked as regional director at one of the clinical trials used to develop the Pfizer vaccine, wrote in their Aug. 22 response.

“A drug company cannot induce the taxpayers to pay billions of dollars for a product,” they countered, “that honest data would show poses more risks than benefits, and that ignores the actual contract and the law itself.”

Jackson’s lawsuit alleges that Pfizer and two of its subcontractors violated the False Claims Act by providing bogus clinical trial results to garner the FDA approval of its COVID-19 vaccine.

Under federal law, individuals can sue on behalf of the government and win treble damages if they can prove an individual or company deliberately lied to the government.

One of Jackson’s attorneys, Warner Mendenhall, told The Epoch Times that the payout could be as much as $3.3 trillion.

It would be enough to bankrupt Pfizer,” Mendenhall said.

Mendenhall, whose law firm has won multimillion-dollar False Claims Act cases, based his estimates on the more than $2 billion the U.S. government has paid Pfizer for more than 100 million doses of its COVID-19 vaccine.

In motions to dismiss the lawsuit, Pfizer and its subcontractors argued that besides Jackson’s allegations being false, the government, not a private citizen, can initiate a False Claims Act complaint and that the lawsuit against them should, therefore, be dismissed.

“The Relator may not pursue the claims against Pfizer without the Government first pursuing them in an administrative proceeding,” Pfizer’s motion states.

The companies also argued that the FDA was well aware of Jackson’s claims for at least two years before the lawsuit was filed against them and that it publicly responded to Jackson’s allegations by expressing the agency’s “full confidence” in the data used to support the vaccine.

However, Mendenhall said a false claims action is independent of the government’s knowledge and that Jackson only has to prove Pfizer and its subcontractors presented fraudulent information to the FDA.

Jackson was third in command of the clinical trials conducted by Ventavia Research Group as part of Pfizer’s application for emergency use authorization of its COVID-19 vaccine. She was there for only 18 days before being fired by Ventavia after reporting what she called “absolute mayhem” and an utter disregard for safety protocols and federal regulations in developing the vaccine.

Jackson has submitted over 400 exhibits as part of her complaint. Jackson said that a former Taco’s cashier was among those tasked with injecting patients with the experimental jab. She alleged that the trial staff falsified patient signatures on informed consent paperwork. And she has described a daily mess of unsanitary conditions.

Jackson also responded for the first time to Pfizer’s characterization of her as an anti-vaccine, anti-government individual out for money as vengeance for her firing.

Jackson has worked on a long list of government-run clinical trials for vaccines and said she is pro-vaccine. She pointed out that her children have had all their childhood vaccines and that her entire family gets the flu vaccine yearly. Jackson received the COVID-19 vaccine as soon as it was available and was initially one of its biggest cheerleaders.

While she is seeking compensation for her termination as part of her actions against Pfizer and the other companies, Jackson said she plans to donate any money she receives under her legal action against the companies to those injured by the vaccine.

As far as I’m concerned, it’s blood money,” she said. “The world should be disgusted by what went on here with the shameful actions behind this dangerous vaccine.”

Omicron’s Mutations Impaired Vaccine Effectiveness, CDC Says

Authors: Madison Muller  August 25, 2022 Bloomberg

Almost 40% of people hospitalized in the US with the Covid subvariant that circulated this spring were vaccinated and boosted, highlighting how new strains have mutated to more readily escape the immunity offered by current shots.

The findings from scientists at the US Centers for Disease Control and Prevention underscore the importance of having Covid shots that are better at targeting omicron subvariants. 

From the end of March through May, when the omicron BA.2 and BA.2.12.1 subvariants were dominant in the US, weekly hospitalization rates increased for all adults — with those over 65 hit the hardest. Even so, the total number of hospitalizations remained much lower than when the delta variant was rampant last fall. 

The overall number of hospitalizations is an important point, said Abraar Karan, an infectious disease doctor at Stanford University.

“When you look at who’s hospitalized, it’s much more likely that they will have been vaccinated because so many people are vaccinated now,” Karan said. “The real comparison is how many hospitalizations do we have now versus in the past when people were not vaccinated or not up-to-date with boosters.”

CDC scientists found that vaccines and boosters did a better job of keeping people with delta infections out of the hospital than those with later variants. Effectiveness decreased slightly with the BA.1 variant, then changed significantly with BA.2 — with a much greater share of hospitalized adults who had been vaccinated with at least one booster. 

Read more: Retiring Fauci expected Covid to be ‘behind us’

Immunity from vaccines starts to wane within six months, so staying up-to-date with shots is key to being fully protected. Fewer than half of Americans have gotten a booster shot.

Adults with at least two booster shots fared better than other people when BA.2 was dominant. The majority of those admitted to the hospital also had at least one underlying condition. Unvaccinated adults were more than three times as likely to be hospitalized, but breakthrough infections still represented a significant number of the severe Covid cases, the data show.

US regulators have pushed Moderna Inc., Pfizer Inc. and BioNTech SE to expedite development of omicron-specific boosters for a September rollout. The drugmakers this week submitted early data to the US Food and Drug Administration seeking emergency clearance for updated shots that target the BA.4 and BA.5 virus strains. Scientists and vaccinemakers are already beginning to look toward next-generation shots that may provide longer-lasting protection against more variants. 

The new report’s findings also indicate that along with vaccination, other pharmaceutical and non-pharmaceutical measures should be used by those at highest risk of getting Covid. That includes easy access to therapeutics such as Pfizer’s antiviral drug Paxlovid and Gilead Sciences’ remdesivir, as well as AstraZeneca’s Evusheld for immunocompromised people. Scientists also note that wearing a mask can help guard the wearer from getting sick.  

Though the number of Covid deaths is the lowest it has been since last July, the US continues to see hundreds of deaths each day from Covid, CDC data show.

Vascular and organ damage induced by mRNA vaccines: irrefutable proof of causality

Authors: Michael Palmer, MD and Sucharit Bhakdi, MD August 19, 2022 Popular Science

This article summarizes evidence from experimental studies and from autopsies of patients deceased after vaccination. The collective findings demonstrate that

  1. mRNA vaccines don’t stay at the injection site by instead travel throughout the body and accumulate in various organs,
  2. mRNA-based COVID vaccines induce long-lasting expression of the SARS-CoV-2 spike protein in many organs,
  3. vaccine-induced expression of the spike protein induces autoimmune-like inflammation,
  4. vaccine-induced inflammation can cause grave organ damage, especially in vessels, sometimes with deadly outcome.

We note that the damage mechanism is which emerges from the autopsy studies is not limited to COVID-19 vaccines only but is completely general—it must be expected to occur similarly with mRNA vaccines against any and all infectious pathogens. This technology has failed and must be abandoned.

While clinical case reports (e.g. [1,2]) and statistical analyses of accumulated adverse event reports (e.g. [3,4]) provide valuable evidence of damage induced by mRNA-based COVID-19 vaccines, it is important to establish a causal relationship in individual cases. Pathology remains the gold standard for proof of disease causation. This short paper will discuss some key findings on autopsy materials from patients who died within days to several months after vaccination. For context, some experimental studies are briefly discussed as well.

1. Most of the evidence presented here is from the work of pathologist Prof. Arne Burkhardt, MD

  • Dr. Burkhardt was approached by the families of patients deceased after “vaccination”
  • Autopsy materials were examined by standard histopathology and immunohistochemistry
  • Based on the findings, most deaths were attributed to “vaccination” with a high to very high degree of likelihood

Prof. Burkhardt is a very experienced pathologist from Reutlingen, Germany. With the help of his colleague Prof. Walter Lang, he has studied numerous cases of death which occurred within days to several months after vaccination. In each of these cases, the cause of death had been certified as “natural” or “unknown.” Burkhardt became involved only because the bereaved families doubted these verdicts and sought a second opinion. It is remarkable, therefore, that Burkhardt found not just a few but the majority of these deaths to be due to vaccination.

While all four major manufacturers of gene-based vaccines were represented in the sample of patients studied by Burkhardt and Lang, most patients had received an mRNA vaccine from either Pfizer or Moderna. Some of the deceased patients had received both mRNA- and viral vector-based vaccines on separate occasions.

2. Pfizer’s own animal experiments show that the vaccine quickly distributes throughout the body

In order to cause potentially lethal damage, the mRNA vaccines must first distribute from the injection site to other organs. That such distribution occurs is apparent from animal experiments reported by Pfizer to Japanese authorities with its application for vaccine approval in that country [5]. Rats were injected intramuscularly with a radioactively labelled model mRNA vaccine, and the movement of the radiolabel first into the bloodstream and subsequently into various organs was followed for up to 48 hours.

The first thing to note is that the labelled vaccine shows up in the blood plasma after a very short time—within only a quarter of an hour. The plasma level peaks two hours after the injection. As it drops off, the model vaccine accumulates in several other organs. The fastest and highest rise is observed in the liver and the spleen. Very high uptake is also observed with the ovaries and the adrenal glands. Other organs (including the testes) take up significantly lower levels of the model vaccine. We note, however, that at least the blood vessels will be exposed and affected in every organ and in every tissue.

The rapid and widespread distribution of the model vaccine implies that we must expect expression of the spike protein throughout the body. For a more in-depth discussion of this biodistribution study, see Palmer2021b.

3. Expression of viral proteins can be detected with immunohistochemistry

While the distribution of the model vaccine leads us to expect widespread expression of the spike protein, we are here after solid proof. Such proof can be obtained using immunohistochemistry, which method is illustrated in this slide for the vaccine-encoded spike protein.

If a vaccine particle—composed of the spike-encoding mRNA, coated with lipids—enters a body cell, this will cause the spike protein to be synthesized within the cell and then taken to the cell surface. There, it can be recognized by a spike-specific antibody. After washing the tissue specimen to remove unbound antibody molecules, the bound ones can be detected with a secondary antibody that is coupled with some enzyme, often horseradish peroxidase. After another washing step, the specimen is incubated with a water-soluble precursor dye that is converted by the enzyme to an insoluble brown pigment. Each enzyme molecule can rapidly convert a large number of dye molecules, which greatly amplifies the signal.

At the top right of the image, you can see two cells which were exposed to the Pfizer vaccine and then subjected to the protocol outlined above. The intense brown stain indicates that the cells were indeed producing the spike protein.

In short, wherever the brown pigment is deposited, the original antigen—in this example, the spike protein—must have been present. Immunohistochemistry is widely used not only in clinical pathology but also in research; it could readily have been used to detect widespread expression of spike protein in animal trials during preclinical development. However, it appears that the FDA and other regulators never received or demanded such experimental data [6].

4. Expression of spike protein in shoulder muscle after vaccine injection

This slide (by Dr. Burkhardt) shows deltoid muscle fibres in cross section. Several (but not all) of the fibres show strong brown pigmentation, again indicating spike protein expression.

While the expression of spike protein near the injection site is of course expected and highly suggestive, we would like to make certain that such expression is indeed caused by the vaccine and not by a concomitant infection with the SARS-CoV-2 virus. This is particularly important with respect to other tissues and organs which are located far away from the injection site.

5. Coronavirus particles contain two prominent proteins: spike (S) and nucleocapsid (N)

To distinguish between infection and injection, we can again use immunohistochemistry, but this time apply it to another SARS-CoV-2 protein—namely, the nucleocapsid, which is found inside the virus particle, where it enwraps and protects the RNA genome. The rationale of this experiment is simple: cells infected with the virus will express all viral proteins, including the spike and the nucleocapsid. In contrast, the mRNA-based COVID vaccines (as well as the adenovirus vector-based ones produced by AstraZeneca and Janssen) will induce expression only of spike.

6. Infected persons express the nucleocapsid protein (and also the spike protein)

This slide simply illustrates that the method works: lung tissue or cells from a nasal swab of a person infected with SARS-CoV-2 stain positive for nucleocapsid expression, whereas cultured cells exposed to the vaccine do not (but they stain strongly positive for the spike protein; see inset at the top right of Slide 3).

7. Injected persons express only the spike protein, which implicates the vaccine

Here, we see immunohistochemistry applied to heart muscle tissue from an injected person. Staining for the presence of spike protein causes strong brown pigment deposition. In contrast, only very weak, non-specific staining is observed with the antibody that recognizes the nucleocapsid protein. The absence of nucleocapsid indicates that the expression of the spike protein must be attributed ot the vaccine rather than an infection with SARS-CoV-2.

We will see shortly that the strong expression of spike protein in heart muscle after vaccination correlates with significant inflammation and tissue destruction.

8. Expression of spike protein within the walls of small blood vessels

We see spike protein expression in arterioles (small arteries; left) as well as in venules (small veins) and capillaries (right). Expression is most prominent in the innermost cell layer, the endothelium. This makes the endothelial cells “sitting ducks” for an attack by the immune system.

9. Endothelial stripping and destruction of a small blood vessel after vaccination

We now turn to the evidence of immune attack on the endothelial cells which produce the spike protein. On the left, a normal venule, delimited by an intact endothelium and containing some red blood cells and few white blood cells (stained blue) inside.

The image on at the centre shows a venule that is being attacked and destroyed by the immune system. The outline is already dissolving, and the spindle-shaped (and swollen) endothelial cells have peeled off from the vessel wall. Furthermore, we see lymphocytes—the small cells with dark, round nuclei and with very little cytoplasm around them; a single lymphocyte (at much higher magnification) is shown on the right.

Lymphocytes are the backbone of the specific immune system—whenever antigens are recognized and antibodies are produced, this is done by lymphocytes. Also among the lymphocytes we find cytotoxic T cells and natural killer cells, which serve to kill virus-infected cells—or ones that look to them as if infected, because they have been forced to produce a viral protein by a so-called vaccine.

A crucial function of the endothelium is to prevent blood clotting. Thus, if the endothelium is damaged, as it is in this picture, and the tissues beyond it make contact with the blood, this will automatically set off blood clotting.

10. A crack in the wall of the aorta, lined by clusters of lymphocytes, leading to aortic rupture

On the left, a section through the wall of an aorta. This picture is taken at an even lower magnification than the one before; the lymphocytes now appear as just a cloud of tiny blue specks. To the left of this blue cloud, we see a vertical crack running through the tissue. Such a crack is also visible macroscopically in the excised specimen of an aorta shown on the right.

The aorta is the largest blood vessel of the body. It receives the highly pressurized blood ejected by the left ventricle of the heart, and it is thus exposed to intense mechanical stress. If the wall of the aorta is weakened by inflammation, as it is here, then it may crack and rupture. Aortic rupture is normally quite rare, but Prof. Burkhardt found multiple cases in his limited number of autopsies. Some of the affected aortas were also shown to have expressed the spike protein.

11. Healthy heart muscle tissue, and lymphocytic myocarditis

In Slide 7, we saw that heart muscle cells strongly expressed the spike protein after vaccine injection. Here, we see the consequences. The picture on the shows a sample of healthy heart muscle tissue, with regularly oriented and aligned heart muscle fibres. On the right, we see a heart muscle sample from one of the autopsies. The muscle fibres are disjointed and disintegrating, and they are surrounded by invading lymphocytes. Burkhardt found myocarditis in multiple of his deceased patients.

12. Lymphocytic infiltration and proliferative inflammation in lung tissue

On the left, we see healthy lung tissue, with air-filled spaces (the alveoli), delimited by delicate alveolar septa with embedded, blood-filled capillaries. We also see some larger blood vessels.

On the right hand side, we see lung tissue overrun by lymphocytes. The air-filled spaces have largely disappeared and been filled with scar (connective) tissue. This vaccine-injected patient would obviously have had very great trouble breathing.

Lymphocytic infiltration, inflammation and destruction were also observed in many other organs, including the brain, the liver, the spleen, and multiple glands. However, instead of illustrating them all, we will conclude the pathological evidence with another immunohistochemistry result, which strikingly shows the long duration of spike protein expression.

13. Vaccine-induced expression of spike protein in a bronchial biopsy nine months after vaccination

The slide shows a sample of bronchial mucous membrane, from a patient who is alive but has suffered respiratory symptoms ever since being vaccinated. We see several cells in the uppermost cell layer that strongly express spike protein—and this even nine months after his most recent vaccine injection! While this is indeed the most extreme case of long-lasting expression, there is evidence both from Burkhardt’s autopsies and from published studies on blood samples [7] or lymph node biopsies [8] to indicate that expression does last several months.

14. The Pfizer vaccine mRNA gets copied (“reverse-transcribed”) into DNA and inserted into the cellular genome

The official mRNA vaccine narrative maintains that the modified mRNA contained in the vaccine will not be replicated in vivo; expression of the spike protein should therefore cease once the injected RNA molecules have been degraded.

The limited experimental studies available [9,10] suggest that the injected modified mRNA should be degraded within days to a few weeks of the injection. This is obviously difficult to square with the observed long-lasting expression; in some form or other, the genetic information appears to be perpetuated in vivo.

A recent experimental study from Sweden [11] has shown that human-derived cells can copy the Pfizer mRNA vaccine into DNA and then insert it into their own chromosomal DNA. The image shows the key evidence from this study. The cells were exposed to the vaccine for the lengths of time indicated. Cellular DNA was then isolated, and inserted DNA copies of the vaccine mRNA detected by PCR amplification of a fragment 444 base pairs (bp) in length.

All samples labelled with “BNT” had been treated with the vaccine, and they all show a PCR product of the expected length, as is evident from comparison to a DNA fragment length standard (“L”). Samples labelled with “Ctrl n” were controls: Ctrl 1– 4 contained DNA from cells not incubated with vaccine, Ctrl 5 contained RNA (not DNA) from vaccine-treated cells; Ctrl 6 contained the same but was additionally treated with RNAse, which step was also performed in the purification of DNA samples. As expected, none of the control samples contain the PCR product.

Considering Aldén’s observation of DNA insertion in every single experimental sample, it seems highly likely that this will also occur in vivo. Beyond providing a plausible mechanism for perpetuating the expression of spike protein, DNA insertion also poses risks of genetic damage, leading to cancers and leukemias.

15. Summary

The evidence presented here clearly demonstrates a chain of causation from vaccine injection to

  • rapid distribution of the vaccine through the bloodstream,
  • widespread spike protein expression, prominently in blood vessels, and
  • autoimmune-like inflammation and organ damage.

Vaccine-induced vascular damage will promote blood clotting, and clotting-related diseases such as heart attack, stroke, lung embolism are very common in the adverse events databases [4,12].

In addition to autoimmune-like inflammation, other disease mechanisms, including prion-mediated CNS degeneration [13], aberrant vascular protein deposition (amyloidosis) [14,15], and lipid nanoparticle toxicity [16], are plausible but require further study and corroboration. Overall, these vaccines can no longer be considered experimental—the “experiment” has resulted in the disaster that many medical doctors and scientists predicted from the outset [17]. The vaccination must be stopped, and all approvals and authorizations of their use must be revoked.

References

  1. Bozkurt, B. et al. (2021) Myocarditis With COVID-19 mRNA Vaccines. Circulation 144:471-484
  2. Ehrlich, P. et al. (2021) Biopsy-proven lymphocytic myocarditis following first mRNA COVID-19 vaccination in a 40-year-old male: case report. Clinical research in cardiology official journal of the German Cardiac Society 110:1855-1859
  3. Rose, J. and McCullough, P.A. (2021) A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products. Current problems in cardiology p. 101011
  4. Shilhavy, B. (2022) 43,898 Dead, 4,190,493 Injured Following COVID Vaccines in European Database of Adverse Reactions.
  5. Anonymous, (2020) SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary statement of the pharmacokinetic study [English translation].
  6. Latyopva, A. (2022) Did Pfizer Perform Adequate Safety Testing for its Covid-19 mRNA Vaccine in Preclinical Studies? Evidence of Scientific and Regulatory Fraud.
  7. Bansal, S. et al. (2021) Cutting Edge: Circulating Exosomes with COVID Spike Protein Are Induced by BNT162b2 (Pfizer-BioNTech) Vaccination prior to Development of Antibodies: A Novel Mechanism for Immune Activation by mRNA Vaccines. J. Immunol. 207:2405-2410
  8. Röltgen, K. et al. (2022) Immune imprinting, breadth of variant recognition and germinal center response in human SARS-CoV-2 infection and vaccination. Cell (preprint)
  9. Andries, O. et al. (2015) N1-methylpseudouridine-incorporated mRNA outperforms pseudouridine-incorporated mRNA by providing enhanced protein expression and reduced immunogenicity in mammalian cell lines and mice. J. Control. Release 217:337-344
  10. Pardi, N. et al. (2018) Nucleoside-modified mRNA vaccines induce potent T follicular helper and germinal center B cell responses. J. Exp. Med. 215:1571-1588
  11. Aldén, M. et al. (2022) Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line. Curr. Issues Mol. Biol. 44:1115-1126
  12. Anonymous, (2021) OpenVAERS.
  13. Perez, J.C. et al. (2022) Towards the emergence of a new form of the neurodegenerative Creutzfeldt-Jakob disease: Twenty six cases of CJD declared a few days after a COVID-19 “vaccine” Jab. ResearchGate (preprint)
  14. Charnley, M. et al. (2022) Neurotoxic amyloidogenic peptides in the proteome of SARS-COV2: potential implications for neurological symptoms in COVID-19. Nat. Commun. 13:3387
  15. Nyström, S. and Hammarström, P. (2022) Amyloidogenesis of SARS-CoV-2 Spike Protein. J. Am. Chem. Soc. 144:8945-8950
  16. Palmer, M. and Bhakdi, S. (2021) The Pfizer mRNA vaccine: Pharmacokinetics and Toxicity.
  17. Bhakdi, S. et al. (2021) Urgent Open Letter from Doctors and Scientists to the European Medicines Agency regarding COVID-19 Vaccine Safety Concerns.

What, Exactly, Is ‘Paxlovid Mouth’ and How Do You Get Rid of It?

The Covid-19 antiviral drug can leave a foul taste. The afflicted are scouring for remedies online.

Authors: Alex Janin Aug. 16, 2022 Wall Street Journal

Jeanette Witten recently rummaged through her pantry for Red Hots, the cinnamon-flavored candy.

The 56-year-old in Montclair, N.J., was looking for a reprieve from a persistent residual taste—“like your mouth is just clenched around a grapefruit rind”—that came after she took Paxlovid, Pfizer’s antiviral drug to treat Covid-19. 

Ms. Witten is one of many people who have scouted remedies for what is informally known as Paxlovid mouth, a taste that can linger for as long as you take the drug. Patients who have taken Paxlovid have described it as sun-baked trash-bag liquid, a mouthful of dirty pennies and rotten soymilk. They have tried to erase the taste with salves from cinnamon to milk to pineapple. They are also trading strategies online. 

Pfizer spokesperson acknowledged the side effect, called dysgeusia, and pointed to a study that found the symptom occurred 5.6% of the time people took the drug. The study was funded by Pfizer and published in the New England Journal of Medicine. The company said most patients’ dysgeusia symptoms were mild.

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The culprit is likely ritonavir, a part of the drug that is used to boost levels of antiviral medicines, doctors say. Ritonavir has a known association with dysgeusia. It is a small price to pay given the nearly 90% reduction in hospitalization and death among those at risk for severe disease from Covid-19, say doctors and people who have taken the medication. 

But it’s still hard for many patients to stomach.

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.