Liver injury after mRNA-based SARS-CoV-2 vaccination in a liver transplant recipient

Authors: Jérôme Dumortiera,b,⁎ Clin Res Hepatol Gastroenterol. 2022 Jan; 46(1):101743.16.  doi: 10.1016/j.clinre.2021.101743 PMCID: PMC8214934PMID: 34146727

Coronavirus disease-2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is an ongoing global pandemic of major concern, started at the end of 2019. Patients with comorbidities are at high risk of developing severe disease and this includes solid organ transplant recipients [1]. Therefore, Covid-19 vaccine is highly recommended in this population. Neverthless, immunocompromised patients, including solid organ transplant recipients, were not included in the Covid-19 vaccine large trials, especially of Pfizer/BioNTech and Moderna mRNA vaccines, and therefore, safety and efficacy data are lacking in this population. Recently, a significantly reduced immunogenicity of the mRNA SARS-CoV-2 vaccines has been reported [2,3]. Regarding the massive number of patients receiving this vaccination, identification of clinically relevant imputable side-effects of the vaccines is very difficult and therefore a major goal.

Herein we report the case of a 46-year-old male, who received the first injection of BNT162b2 mRNA vaccine 123 days after a liver transplantation for alcohol-associated liver disease. At the time of vaccination, the patient was on maintenance immunosuppression therapy with tacrolimus and mycophenolate mofetil, and liver function tests were within normal range. According to systematic biological follow-up, 12 days after vaccination, laboratory findings were as follows: AST 99 U/l (normal: 10–45), ALT 287 U/l (normal: 10–45), alkaline phosphatase (ALP) 270 U/l (normal: 38–120), gamma glutamyl transferase (GGT) 797 U/l (normal: 7–65), total bilirubin 9 mmol/l (normal: 0–20). The patient was totally asymptomatic. Serum HBsAg, anti-HBs, anti-HBc IgM, anti-HAV IgM, anti-HEV IgM, EBV-DNA (PCR), CMV-DNA (PCR), antinuclear antibody, anti-smooth muscle antibody, and anti-liver kidney microsomal antibody were negative. The patient did not consume alcohol on a regular or irregular basis. Other than immunosuppressive treatments included only aspirin. Abdominal Doppler ultrasound was normal. The diagnosis of liver damage related to vaccination was considered and no further investigation was performed, including no liver biopsy. Similarly, no modification of immunosuppressive regimen was done. The second vaccine injection was contra-indicated. Biological evolution was rapidly favourable. One month after initial biological liver injury, laboratory findings were as follows: AST 19 U/l (normal: 10–45), ALT 24 U/l (normal: 10–45), ALP 117 U/l (normal: 38–120), GGT 101 U/l (normal: 7–65), total bilirubin 8 mmol/l (normal: 0–20).

We report herein the case of a liver transplant recipient who presented mild liver injury probably due to the first injection of BNT162b2 mRNA vaccine. Evolution was spontaneously favourable. Perturbation of liver function tests was transitory, but detected because of regular systematic (monthly) biological follow-up, less than one year after transplantation. In this context, such diagnosis must be considered together with more usual cause of liver graft injury, such as rejection, in face of significant liver function test abnormalities. Moreover, in the absence of severe liver injury, deleterious manoeuvres (diagnostic or therapeutic) must be ovoid and close biological follow-up performed. The most intuitive expected toxicity of mRNA vaccine (but also all vaccines) is related to immune activation. Therefore, benign and common reported symptoms include soreness, fatigue, myalgia, headache, chills, fever, joint pain, nausea, muscle spasm, sweating, dizziness, flushing, feelings of relief, brain fogging, anorexia, localized swelling, decreased sleep quality, itching, tingling, diarrhoea, nasal stuffiness and palpitations [4]. The flip side of the possibly beneficial adjuvant inflammation, however, is potential toxicity of the mRNA vaccines. And remember that this type of vaccine has also been evaluated as an anti-cancer treatment. With the Covid-19 vaccines, we are using this new type of vaccine for the first time on a very large scale. From preliminary animal and human studies on previous mRNA vaccines, the clinical adverse effects have included myopathy (caused by mitochondrial toxicity), lipodystrophy, lactic acidosis, pancreatitis, liver steatosis, and nerve damage and some were severe [5]. A better understanding of the toxicity of Covid-19 vaccines, particularly mRNA vaccines, can only be based on comprehensive reporting of even apparently mild cases. These cases will be more easily identified in special populations under close clinical and biological surveillance, such as transplant patients, as reported in our patient. Perhaps these patients are also at greater risk.Go to:

Footnotes

Conflicts of interest and sources of funding: None to declare.

Author contributions: J.D. clinically managed the patient and wrote the manuscript.Go to:

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How the Pfizer-BioNTech COVID-19 vaccine affects human liver cells

Authors: Lund University MARCH 10, 2022 Medical Xpress

A recent study from Lund University in Sweden on how the Pfizer-BioNTech COVID-19 vaccine affects human liver cells under experimental conditions, has been viewed more than 800,000 times in just over a week. The results have been widely discussed across social media—but the results have in many cases been misinterpreted. Two of the authors, Associate Professor Yang de Marinis (YDM) and Professor Magnus Rasmussen (MR), share their views.

How did this study come about?

YDM: A previous study from MIT has indicated that the SARS-CoV-2 virus mRNA can be converted to DNA and integrated into the human genome. Indeed, about 8 percent of human DNA comes from viruses inserted into our genomes during evolution. Does the Pfizer-BioNTech mRNA vaccine get converted to DNA or not? This has been the question our study aims to answer.

What did your study conclude?

YDM: This study does not investigate whether the Pfizer vaccine alters our genome. Our publication is the first in vitro study on the conversion of mRNA vaccine into DNA, inside cells of human origin. We show that the vaccine enters liver cells as early as six hours after the vaccine has been administered. We saw that there was DNA converted from the vaccine’s mRNA in the host cells we studied.

MR: These findings were observed in petri dishes under experimental conditions, but we do not yet know if the converted DNA is integrated into the cells’ DNA in the genome—and if so, if it has any consequences.

Why liver cells and why the specific dose?

YDM: About 18 percent of the vaccine accumulates in the liver just 30 minutes after the vaccine is injected in mice as reported by Pfizer in EMA assessment report, and therefore we chose to study liver cells. This also explains the choice of vaccine concentrations in our study, something we specifically address in the paper, which are 0.5–2% of the injection site concentration.

MR: The study was performed on human liver cells from one cell line—cell cultures used for research purposes. It is a good tool when studying molecular and cellular processes, they are easy to research, and since the cell lines are easily accessible, studies often start with various cell lines.

What are key limitations of the study?

MR: One should consider that cell lines differ from cells in living organisms, and therefore it is important that similar investigations are also studied in humans.

It is important to bear in mind that the liver cells in this study are more genetically unstable than our own liver cells.

YDM: One of the limitations of our study is that we don’t know if what we observed in this cell line could also happen in cells of other tissue types, and this needs to be addressed in follow-up studies.

The study has received a lot of media attention, what are your thoughts on that?

MR: We understood that the study would attract attention, but we think it is self-evident that this type of research should be pursued. We have a new vaccine, and it needs to be tested in cell and animal models and also in humans, in various ways. The result might be surprising, but it is also a bit surprising that such studies do not seem to have been carried out before.

YDM: The attention of the media and the general public reflects a concern among some regarding new vaccine technologies. This in itself motivates the need for further studies.

Based on this study, is there any reason to not get vaccinated?

MR: There is no reason for anyone to change their decision to take the vaccine based on this study.

What are the next steps in this research?

YDM: More research is needed. Data, especially data from vaccinated humans, will hopefully sort out the question marks. Whether our results are true for other cell types in humans, or if they are specific to mRNA vaccines, are among many questions for further research.

About the study:

In a lab environment, i.e., in petri dishes, the researchers added Pfizer BioNTech’s vaccine to a cell line that originally came from a human liver tumor.

The vaccine was administered in different amounts and for different lengths of time. Cells that received no vaccine at all were used for control purposes. The researchers then investigated how different gene expressions in the cells changed over time. A gene that the researchers studied produces the protein LINE-1.

“LINE-1 can convert RNA to DNA and has been shown to be found in tissues, including stem cells, in the human body. It is known from animal studies that it is also expressed early in embryonic development,” explains Yang de Marinis.

Dr. Robert Malone: ‘Rotten to the Core’ FDA Knew COVID Vaccines Could Spur Viral Reactivation, But Said Nothing

Authors:  Debra Heine May 17, 2022

American Greatness

The Food and Drug Administration (FDA) was aware early on that the COVID vaccines could spur viral reactivation of diseases like the varicella-zoster virus (shingles) in some people, but chose not to disclose it, according to renowned vaccinologist and physician Dr. Robert Malone.

“They knew about the viral reactivation,” Malone declared during a recent panel discussion hosted by Del Bigtree with fellow Global COVID Summit physicians Dr. Ryan Cole, and Dr. Richard Urso.

Malone, the original inventor of mRNA and DNA vaccination technology, explained that he had been “very actively engaged” with senior personnel at the FDA in the Office of the Commissioner when the vaccines were being rolled out. The group, he noted, included Dr. William DuMouchel, the Chief Statistical Scientist for Oracle Health Sciences.

“We were talking by Zoom on a weekly or twice a week basis,” he said, regarding the early data on what risks were associated with vaccines.

“This is the group that first discovered the signal of the cardiotoxicity, the doctor continued. “They also knew at that time—one of them actually had the adverse event early on of shingles. They knew that the viral reactivation signal—which the CDC has never acknowledged—was one of the major known adverse events.”

Malone told the panel that it was a mistake to assume that the CDC and FDA—because they stayed silent—were unaware of the risk of viral reactivation associated with the vaccines.

“They absolutely did know, and they did not acknowledge it. It’s another one of those things that is inexplicable,” he said.

Malone pointed out that there are supposed to be strict rules in place for clinical researchers developing “these types of products.”

“You have to characterize where it goes, how long it sticks around, and how much protein it makes, or what the active drug product is. None of that stuff was done very well. It wasn’t done rigorously, and there was a series of misrepresentations about what the data were,” he said. “And the thing is, the FDA let them get away with it. They did not perform their function. They’re supposed to be independent gatekeepers.”

Normally, he pointed out, the FDA pays close attention to the the process, and if there are any red flags, the research is halted.

“What happened here is the regulatory bodies gave the pharmaceutical industry a pass,” Dr. Malone said, adding that Big Pharma also “misrepresented key facts about their product.”

“On the basis of that, average docs just assumed that this was something that it wasn’t. They assumed that this was a relatively benign product that didn’t stick around in the body. All of that is false,” he said.

“Many of us have been wracking our brains as you have to understand how this could possibly happen, why it’s possibly happening, and why is our regulatory apparatus, which we as physicians had all come to assume had a function that actually did the job that we could believe in and trust, and what we find out now is the whole house of cards is rotten to the core,” Malone concluded.

On May 11, the Global COVID Summit, a symposium of 17,000 other physicians and medical scientists from around the world, released its fourth declaration demanding that the state of medical emergency be lifted, scientific integrity restored, and crimes against humanity addressed.

COVID policies imposed over the past two years “are the culmination of a corrupt medical alliance of pharmaceutical, insurance, and healthcare institutions, along with the financial trusts which control them,” the signatories declare. “They have infiltrated our medical system at every level, and are protected and supported by a parallel alliance of big tech, media, academics and government agencies who profited from this orchestrated catastrophe.”

This “corrupt alliance” continues, they state,  “to advance unscientific claims by censoring data, and intimidating and firing doctors and scientists for simply publishing actual clinical results or treating their patients with proven, life-saving medicine.”

“These catastrophic decisions came at the expense of the innocent, who are forced to suffer health damage and death caused by intentionally withholding critical and time-sensitive treatments, or as a result of coerced genetic therapy injections, which are neither safe nor effective,” the signatories said.

The Centers for Disease Control and Prevention (CDC) on Friday released new data showing a total of 1,261,149 reports of adverse events following COVID-19 vaccines that were submitted between Dec. 14, 2020, and May 6, 2022, to the Vaccine Adverse Event Reporting System (VAERS).

According to the data, there was a total of 27,968 reports of deaths in that time frame, and 228,477 serious injuries.

Despite these alarming safety signals, the FDA on Tuesday approved of a booster dose of the Pfizer-BioNTech COVID-19 shot for children 5 through 11 years of age, even though research shows that the shots provide no benefit to children, and can, in fact, cause serious adverse effects and death.

New Study Finds mRNA Vaccines Actually Hurt Long-Term Immunity to Covid Compared to the Unvaccinated

Authors:  Jim Hoft Published May 19, 2022  The Gateway Pundit

A new study conducted by scientists from the National Institutes of Health (NIH) and Moderna Inc. showed that mRNA vaccines hurt the long-term immunity to Covid-19 after contracting infection compared to unvaccinated people.

Researchers performed a placebo-controlled vaccine efficacy trial published at medRxiv last month, to evaluate anti-nucleocapsid antibody (anti-N Ab) seropositivity in Moderna vaccine efficacy after Covid-19 infection.

“To evaluate for evidence of prior infection in a person with a history of COVID-19 vaccination, a test that specifically evaluates anti-N should be used. Past infection is best determined by serologic testing that indicates the presence of anti-N antibody,” according to the CDC.

The study analyzed data from 1,789 participants (1,298 placebo recipients and 491 vaccine recipients) with Covid-19 infection at 99 sites in the US during the blinded phase (through March 2021).

The study concludes that anti-nucleocapsid antibody (anti-N Abs) may have lower sensitivity in patients vaccinated with Moderna who become infected. The study also mentioned that the anti-N Ab response in unvaccinated persons has been reported to be durable, with half-life estimates ranging from 68 to 283 days.

Among the participants with confirmed Covid-19 illness, only 21 out of 52 (40%) of people who received the Moderna shots had antibodies compared to the placebo recipients, 605 out 648 (93%).

Unvaccinated people are much more likely to develop broad antibody immunity after Covid infections than people who have received mRNA shots, a new study shows.

Researchers already knew that many vaccinated people do not gain antibodies to the entire coronavirus after they are infected with Covid.

Unvaccinated people nearly always gain antibodies to the nucleocapsid protein, which covers the virus’s core of RNA, as well as its spike protein, which allows the virus to attack our cells. Vaccinated people often lack those anti-nucleocapsid antibodies and only have spike protein antibodies.

The researchers examined the development of anti-nucleocapsid antibodies in people who had been part of Moderna’s clinical trial and were infected with Covid. As they expected, the scientists found that the vaccinated people were far less likely to develop the anti-nucleocapsid antibodies. Only 40 percent of people who received the shots had antibodies, compared to 93 percent of those who did not.

But they then went a step further. Because the infected people had been in the trial, their viral loads had been precisely measured when they were found to have Covid. So the researchers were able to compare vaccinated and unvaccinated people who had the same amounts of virus in their blood.

Once again, they found that unvaccinated people were far more likely to develop anti-nucleocapsid antibodies than the jabbed. An unvaccinated person with a mild infection had a 71 percent chance of mounting an immune response that included those antibodies. A vaccinated person had about a 15 percent chance.

The chart that should worry the vaccinated: the yellow line shows the odds that an unvaccinated person will develop anti-nucleocapsid antibodies to Sars-Cov-2, stratified by viral load. The blue line shows the same odds for a person who received an mRNA shot.

An unvaccinated person has an almost 60 percent chance of developing antibodies even with an extremely mild infection; a vaccinated person needs almost 100,000 times as much virus in his blood to have the same chance.

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As the Gateway Pundit previously reported, a new report released earlier this year by the Centers for Disease Control and Prevention (CDC) revealed that unvaccinated people who recovered from COVID-19 were better protected than those who were vaccinated and not previously infected during the recent delta surge.

The researchers evaluated the data from 1.1 million Covid-19 cases among adults in California and New York (which account for 18% of the U.S. population) from May 30 to Nov. 20, 2021.

“When looking at the summer and fall of 2021, when Delta became predominant in this country, however, surviving a previous infection now provided greater protection,” CDC epidemiologist Benjamin Silk said.

The study confirmed something that we’ve known for a long time that “natural immunity” acquired through previous infection of COVID is more potent than experimental vaccines.

Latest CDC Data Shows FULLY Vaccinated Children Have Higher Covid Infection Rates Than Unvaccinated Children

Authors:  Julian Conradson Published May 18, 2022  The Gateway Pundit

As the Biden Administration green-lights another experimental jab of mRNA for 5-11-year-olds, the latest CDC data reveals children of that age have a higher Covid infection rate than their unvaccinated peers. In other words, kids who are jabbed are more likely to catch Covid, which also means the vaccinated are spreading the virus more than the unvaccinated.

So, these kids must take their boosters… Must be that dang science again.

According to the latest CDC data, children aged 5-11 have been contracting Covid at a higher rate if they have been fully vaccinated since February, which is the first time the agency recorded more vaccinated Covid cases than unvaccinated.

On Feb. 12, the CDC reported a weekly case rate among fully vaccinated children aged 5-11 of 250.02 per 100,000, compared to 245.82 among the unvaccinated children in the same age group.

Although the vaccines were billed as and promised to be ‘effective,’ they definitely aren’t living up to being anything close to it. Since February, the infection rate among vaccinated children remained higher through the third week of March, which is the latest available data published – and things are trending in the wrong direction.

As of March, the difference in the case rates has nearly doubled, with the most recent numbers showing a -11 gap (36.23 per 100,000 [vaxxed] / 26.98 per 100,000[unvaxxed]).

The breakdown of the case rate for 5-11-year-olds between Feb. and Mar. is as follows:

February 19: 136.61 per 100,000 [vaxxed] / 120.63 per 100,000[unvaxxed]

February 26: 71.81 per 100,000 [vaxxed] / 61.52 per 100,000[unvaxxed]

March 5: 56.67 per 100,000 [vaxxed] / 40.61 per 100,000[unvaxxed]

March 12: 42.56 per 100,000 [vaxxed] / 28.75 per 100,000[unvaxxed]

March 19: 36.23 per 100,000 [vaxxed] / 26.98 per 100,000[unvaxxed]

The Biden Administration and the FDA authorized the experimental vaccine for children in this age group in November of 2021. In just three short months, enough children had become vaccinated and the case rate flipped. Any protection the jab provided quickly wore off, making the fully vaccinated children more susceptible to and more likely to spread the virus than the unvaccinated.

In all, there are over 28 million children aged 5-11 in the United States. Unfortunately, a whopping ~8 million of them (or 28.8%) have been fully vaccinated already, according to the Mayo Clinic. Not only is the virus proven to be effectively non-lethal for children, especially ones of this young age (99.995% or higher recovery rate), but the experimental vaccine has proven to have negative effectiveness – aka higher infection rate – across multiple age groups.

In addition to the poor results, the mRNA vaccine has been directly linked to serious and life-threatening side effects that have become prevalent in the wake of its rollout. Most concerningly of which – myocarditis – is popping up at an unprecedented rate in otherwise healthy children and young people all across the world. According to heart experts like Dr. Peter McCullough, who is the most published Cardiologist in the world, “an extraordinary number of young individuals that are going to have permanent heart damage” because of this experimental jab. 

Keep in mind, Fauci, Biden, and the rest of the tyrannical public health bureaucracy just Ok’d boosters for 5-11-year-olds. Considering everything that’s publicly available, let alone what the federal government has compiled, this is beyond criminal. How much more data is needed to pull these shots off the market?

Autoimmune hepatitis after SARS-CoV-2 vaccine: New-onset or flare-up?

Authors: Enver Avci 1Fatma Abasiyanik 2

Autoimmune 2021 Dec;125: 102745. doi: 10.1016/j.jaut.2021.102745  Epub 2021 Nov 11. PMID:  34781161PMCID: PMC8580815DOI: 10.1016/j.jaut.2021.102745

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been reported to trigger several autoimmune diseases. There are also recent reports of autoimmune diseases that develop after SARS-CoV-2 vaccines. Autoimmune hepatitis is a polygenic multifactorial disease, which is diagnosed using a scoring system. A 61-year-old woman presented with malaise, fatigue, loss of appetite, nausea and yellow eyes. She had a Pfizer/BioNTech BNT162b2 mRNA vaccine a month ago. Her physical examination revealed jaundice all over the body, especially in the sclera. The laboratory tests showed elevated liver enzymes and bilirubin levels. Antinuclear antibody and anti-smooth muscle antibody were positive and immunoglobulin G was markedly elevated. The liver biopsy revealed histopathological findings consistent with autoimmune hepatitis (AIH). The patient was diagnosed with AIH and initiated on steroid therapy. She rapidly responded to steroid therapy. A few cases of AIH have been reported after the COVID-19 vaccine so far. Although the exact cause of autoimmune reactions is unknown, an abnormal immune response and bystander activation induced by molecular mimicry is considered a potential mechanism, especially in susceptible individuals. As intensive vaccination against SARS-CoV-2 continues, we would like to emphasize that clinicians should be cautious and consider AIH in patients presenting with similar signs and symptoms.

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CDC: No Documents Supporting Claim Vaccines Don’t Cause Variants

Authors:  Zachary Stieber May 13, 2022 The Epoch Times

The Centers for Disease Control and Prevention (CDC) says it does not have documents backing its claim that COVID-19 vaccines do not cause variants of the virus that causes COVID-19.

The CDC’s website calls it a myth that the vaccines cause variants.

“FACT: COVID-19 vaccines do not create or cause variants of the virus that causes COVID-19. Instead, COVID-19 vaccines can help prevent new variants from emerging,” the website states.

“New variants of a virus happen because the virus that causes COVID-19 constantly changes through a natural ongoing process of mutation (change). As the virus spreads, it has more opportunities to change. High vaccination coverage in a population reduces the spread of the virus and helps prevent new variants from emerging,” it also says.

The Informed Consent Action Network (ICAN), a nonprofit, asked the CDC in Freedom of Information Act requests for documentation supporting the claim.

In one request, the group asked for “All documents sufficient to support that COVID-19 vaccines do not create or cause variants of the virus that causes COVID-19.”

Another requested “All documents sufficient to support that the immunity conferred by COVID-19 vaccines does not contribute to virus evolution and the emergence of variants.”

The CDC has now responded to both requests, saying a search “found no records responsive” to them.

The first response came in January (pdf); the second came on May 4 (pdf).

If the CDC is making declaratory statements, the agency should have documents supporting them, Aaron Siri, an attorney representing ICAN, told The Epoch Times.

The responses are “very troubling,” Siri said. “I thought the CDC was a data-driven organization, that they made their decisions based on the studies and the science and the data.”

The CDC did not respond to a request for comment.

ICAN has been one of the more prolific requesters of information from the CDC during the pandemic. Many requests have yielded information. Others have not.

In this case, the CDC should act to ensure continued public trust, Siri says.

“Remove the language or provide the evidence,” he said. “There obviously are going to be instances where recommendations from the CDC might prove helpful or useful. And I think they do a disservice to everybody by hurting their own credibility by making statements that they either don’t have support or won’t produce the support for.”

Scientists outside the CDC have also said that vaccines can help prevent new variants.

“As more people get vaccinated, we expect virus circulation to decrease, which will then lead to fewer mutations,” the World Health Organization says on its site.

But many of the claims relied on the vaccines being able to stop infection from the CCP (Chinese Communist Party) virus, which causes COVID-19. The vaccines are increasingly unable to do so, particularly against the newest dominant strain, Omicron.

Dr. Geert Vanden Bossche, a virologist, is among those who say that the vaccines themselves are behind new variants.

“All COVID-19 vaccines fail in blocking viral transmission, especially transmission of more infectious variants. This is a huge problem as viral transmission is now increasingly taking place among healthy people in general and vaccinees in particular (as their S-specific Abs do not sufficiently neutralize S variants),” Vanden Bossche says on his website. “The resulting suboptimal S-directed immune pressure serves as a breeding ground for even more infectious variants.”

Exclusive: Pilots Injured by COVID Vaccines Speak Out: ‘I Will Probably Never Fly Again’

Authors: MICHAEL NEVRADAKIS  MAY 8, 2022 The Epoch Times Originally Published Children’s Defense Fund

In interviews with The Defender, pilots injured by COVID-19 vaccines said despite a “culture of fear and intimidation” they are compelled to speak out against vaccine mandates that rob pilots of their careers — and in some cases their lives.

As a commercial pilot, Bob Snow had long looked forward to seeing his daughter follow in his footsteps by helping her learn to fly an airplane.

However, having received the COVID-19 vaccine “under duress,” this dream is no longer a possibility for Snow.

“I will probably never fly again,” Snow said in a video he made about his story. “I was hoping to teach my daughter to fly. She wants to be a pilot. That will probably never happen, all courtesy of the vaccine.”

Snow is one of a growing number of pilots coming forward to share stories of injuries they experienced after getting a COVID-19 vaccine.

Some of these accounts are “hair-raising and deeply disturbing,” according to Maureen Steele, a paralegal and head of media relations for the John Pierce Law Firm.

The firm represents U.S. Freedom Flyers (USFF), an organization opposing vaccine and mask mandates for pilots and airline staff, in a series of legal actions against the U.S. Federal Aviation Administration (FAA) and several airlines.

Josh Yoder, a pilot with a major commercial airline, Army combat veteran and former flight medic, is a co-founder of USFF.

In a recent interview with The Defender, Yoder said the FAA has been aware of cases of pilots suffering vaccine injuries since at least December 2021, when the California-based Advocates for Citizens’ Rights hand-delivered an open letter to the FAA, major airlines and their insurers.

Yoder said USFF “has received hundreds of phone calls from airline employees who are experiencing adverse reactions post COVID-19 vaccination,” describing the stories as “heartbreaking.”

According to Yoder, the warnings contained in the letter, including testimony by “world-renowned experts,” were “completely ignored,” adding that “we are now beginning to see the consequences.”

This is leading an increasing number of pilots to “come forward to expose the truth regarding these toxic injections,” Yoder said.

The Defender recently reported on a series of reports that have been submitted to the Vaccine Adverse Event Reporting System, or VAERS, involving pilots who sustained severe injuries and side effects following the COVID-19 vaccine.

Congressional testimony from Cody Flint, an agricultural pilot who has logged more than 10,000 flight hours, was included in this letter.

“The FAA has created a powder keg and lit the fuse,” Flint said in an interview with The Defender.

“We are now seeing pilots experiencing blood clots, myocarditis, pericarditis, dizziness and confusion at rates never seen before. Pilots are losing their careers and having to call in sick or go on medical leave from medical issues developing almost immediately after vaccination.”

Vaccine-Injured Pilots Share Stories With the Defender

Several pilots, including Bob Snow, shared their stories with The Defender in a recent series of interviews.

Snow, a captain with a major U.S. airline, told The Defender he received the Johnson & Johnson COVID-19 vaccine on Nov. 4, 2021, “as a result of an unambivalent company mandate to receive the vaccine or be terminated.”

According to Snow, he “began experiencing issues a little over two months” after receiving the vaccine. Due to a history of gastroenteritis, he underwent an endoscopy and an abdominal CT scan.

The results of the endoscopy were normal and Snow was awaiting the results of the CT scan when he suffered cardiac arrest on April 9, immediately after landing at Dallas-Forth Worth International Airport.

As Snow described it:

“I was very lucky to have collapsed when and where I did, as the aircraft was shut down at the gate post-flight and care was immediately provided.

“There was absolutely no warning preceding my collapse in the cockpit. It was literally as if someone ‘pulled the plug.’”

After receiving CPR and AED (automated external defibrillator) shocks to be revived, Snow spent almost a week in the hospital, where he was diagnosed with having sustained sudden cardiac arrest (SCA).

Medical studies indicate survival rates for out-of-hospital SCA cases are estimated at 10.8% to 11.4%.

Snow said:

“Needless to say, that’s not an encouraging number and I feel very, very lucky to have survived.

“Had this happened in a hotel, in flight, at home or almost anywhere else, I do not believe I would be here right now.”

Snow said prior to this incident, he had “no history of prior significant cardiac issues,” based on two EKGs (electrocardiograms) per year for each of the previous 10 years — none of which, according to Snow, “provided any indication of incipient issues that might lead to cardiac arrest.”

“I have no known family history to indicate a predisposition to developing significant cardiac issues at this point in my life,” Snow added.

Snow has been recuperating at home since April 15, while awaiting more tests that will provide a prognosis for his long-term survival.

However, it is likely that he will never fly again in any capacity.

Snow said, “[f]or now, it appears my flying career — indeed, likely all flying as a pilot —  has come to a rapid and unexpected conclusion as SCA is a red flag to FAA medical certification.”

This, according to Snow, has resulted “in a significant loss of income and lifestyle,” adding that he has a college student and high school student at home and a non-working spouse who relied on his livelihood.

‘Last Thing I Remember Is . . . Praying I Would Make It’

Like Snow, Cody Flint had no prior medical history to indicate he was at risk.

“I have been extremely healthy my whole life with no underlying conditions,” said Flint, adding:

“As a pilot that held a second-class medical [certification], I was required to get a yearly FAA flight physical to show I was healthy enough to safely operate an airplane.

“I have renewed my medical every year since I was 17. The last FAA medical I received was on January 19, 2021. The medical showed I was perfectly healthy just 10 days before receiving the COVID-19 vaccine.”

Flint got his first (and only) dose of the Pfizer COVID-19 vaccine on Feb. 1, 2021. He told The Defender:

“Within 30 minutes, I developed a severe burning headache at the base of my skull and blurred vision. After a few hours, the pain was constant, but didn’t seem to be getting worse. I thought the pain would go away, eventually. It did not.”

Two days later began his seasonal job as an agricultural pilot, which typically runs from February to October of each year, Flint said.

He said:

“Approximately one hour into my flight, I felt my condition starting to rapidly decline and I was developing severe tunnel vision. I pulled my airplane up to turn around to head home and immediately felt an extreme burst of pressure in my skull and ears.”

Flint initially considered landing on a nearby highway, unsure he’d make it back to the airstrip, but chose not to so as not to put the public in danger.

Instead, according to Flint:

“The last thing I remember is seeing our airstrip from a few miles out and praying I would make it.

“Later, my coworkers told me I landed and immediately stopped my plane. They described me as being unresponsive, shaking and slumped over in my seat … I do not remember landing or being pulled from the plane.”

Flint said various doctors, including his longtime hometown doctor, refused to consider that his recent COVID-19 vaccination caused his symptoms. Instead, he was prescribed Meclizine for vertigo and Xanax for panic attacks.

According to Flint, doctors told him he would be “completely better within two days.” But two days later, Flint “could barely walk without falling over.”

Seeking a second opinion, Flint visited the Ear & Balance Institute in Louisiana, where he was diagnosed with left and right perilymphatic fistulas (a lesion in the inner ear), and highly elevated intracranial pressure due to swelling in his brainstem.

As Flint described it, “[m]y intracranial pressure had risen so high that it caused both of my inner ears to ‘blow out.’” Doctors told him this is usually caused by major head trauma.

“Obviously, I did not have head trauma,” said Flint. “What I did have, though, was an unapproved and experimental ‘vaccine’ just two days prior to suffering this bodily damage.”

“My doctors [at the Ear & Balance Institute] clearly stated my health issues were a direct result of a severe adverse reaction to the Pfizer COVID-19 vaccine,” he added.

Flint says he now cannot receive renewed medical certification from the FAA due to the injuries he sustained, the physical condition he is currently in and “the fact that I will be on the FAA-unapproved medicine Diamox for the foreseeable future.”

Like Snow, Flint believes “it is … highly unlikely that I’ll ever be able to fly again,” adding, “On most days, I am too dizzy to even safely drive a vehicle.”

Greg Pierson, like Snow and Flint, shared a similar story. A commercial pilot with a major U.S. airline that is also a federal contractor, he was mandated to get vaccinated.

Pierson told The Defender:

“I felt extremely pressured to consider getting vaccinated, even though I am adamant against any mandates that violate personal freedom choices.

“I did research and consulted several medical professionals regarding the associated risks.

“I have never had a flu shot in my lifetime, so this was not something I wanted to do. I reluctantly received the first dose of the Pfizer vaccine on August 26, 2021.”

For Pierson, the onset of symptoms was almost immediate, beginning “approximately 14 hours” after receiving the vaccine, when he experienced “an extremely erratic and highly elevated heart rate.”

Pierson visited a local emergency room, where he was diagnosed with atrial fibrillation. His condition was stabilized and he was soon discharged, though he remained on medication to help his heart return to a normal rhythm.

While Pierson says he has not experienced any further episodes, he nevertheless still has not been cleared to return to the cockpit.

“I successfully passed all the required protocols to re-obtain my certification that will allow me to return to work,” he said, adding the FAA has had his records and test results since Feb. 16, but he still hasn’t received a determination.

“I have been on disability since this occurrence, and combined with the leave, the personal and financial impacts have been significant,” Pierson said.

Pierson also described a similar experience to that of Flint, regarding the attitudes of some medical professionals regarding the possibility that his condition was brought on by the COVID-19 vaccine.

“When I brought the subject up to the ER cardiologist, that it was obvious what triggered my onset, she simply stated ‘s*it happens,’” Pierson said.

Widow Describes Husband’s Last Days

Snow, Flint and Pierson are fortunate in that they have managed to survive, even if their flying careers are in jeopardy.

But other pilots have not been so lucky.

American Airlines pilot Wilburn Wolfe suffered a major seizure following his COVID-19 vaccination, which cost him his life. Fortunately, Wolfe was not on duty when his seizure hit.

Claudia Wolfe, his widow, shared her late husband’s story with The Defender.

Wolfe, a former Marine just a few years from retirement, “was definitely against getting this vaccine but was put in the position to take it or lose his job as a captain,” Claudia Wolfe said.

He received the Johnson & Johnson vaccine on Nov. 9, 2021.

Claudia Wolfe told The Defender:

“[The] first 10 days were without any event … [on] day 11, it started with a migraine-like headache which got better that afternoon after taking a couple of aspirin.

“Unfortunately, the migraine came back and he was hoping that it’s nothing else but a migraine.

“On November 22, 13 days after the COVID vaccine, he had a seizure. When paramedics arrived and my husband came out of the seizure, he was paralyzed on his right side, arm and leg, and was taken to the emergency room.”

At the emergency room, a CT scan showed he was experiencing brain bleeding, and he was admitted into intensive care. There, according to Claudia Wolfe, “he continued to have convulsions on his right hand … shortly after he was admitted, he had another seizure and doctors decided to sedate him and put him on a ventilator.”

“That was the last time I talked to my husband, before the seizure in the ICU,” Claudia Wolfe said.

Wolfe never regained consciousness and died on Nov. 26, 2021 — only 17 days after receiving the COVID-19 vaccine. Even if he had survived, he likely would not have been able to work as a pilot again.

As Claudia Wolfe explained:

“Doctors told me that he couldn’t work as a pilot anymore because he would have to be on seizure medication.

“But as the bleeding continued to spread I was told that he probably would not recognize me or his family and he probably would need a 24-hour facility to help him.

“This man was so strong and never needed a doctor, he was never sick enough to need one, and [he] just had a physical a couple months prior for his job as a pilot.”

Pilots Describe Culture of Fear and Reluctance to Come Forward

Pilots who spoke to The Defender described a culture of intimidation that has led to many of their colleagues fearing professional or personal consequences if they speak publicly about injuries following COVID-19 vaccination.

According to Yoder, “Many pilots and other airline employees capitulated to the tactics of threats, harassment and intimidation perpetrated by the very companies they serve.”

Yoder described airlines, as well as aviation industry unions, as “state actors” illegally “working in lockstep with the U.S. government” to “enforce unconstitutional mandates via a culture of fear.”

Snow told The Defender several of his colleagues shared stories of vaccine injuries with him:

“Since my SCA I have heard from several other airline personnel regarding potential vaccine injuries up to and including cardiac issues (chest pain and myocarditis).

“Many crewmembers are very reluctant to divulge potential significant health issues for fear of losing their FAA medical certification and, potentially, their careers.”

According to Snow, such fear exists “due to both concern for one’s career and also the fear of being portrayed as a vaccine skeptic.”

“There seems to be genuine reluctance on the part of corporations, businesses, government and the medical community in general to acknowledge the potential for COVID vaccine injury,” Snow said.

Claudia Wolfe also shared her experience, stating that following her husband’s death, she learned “of others that died after the COVID vaccine,” adding that “not many talk about it or believe this vaccine can harm or kill you.”

Pierson also expressed concerns, telling The Defender, “Some things I have stated publicly could have consequences in this regard.”

This culture of intimidation appears to extend beyond just accusations of being a “vaccine skeptic.”

Steele described incidents of airline employees’ non-work and online activities seemingly being monitored by their employers, who are then using this as a justification to question or harass those employees.

“I believe the airlines have people on staff that must be trolling the social media of employees and when they find a conservative, or someone they believe to be, they attack,” Steele said.

Steele said female employees appear to be particular targets of the airlines, as they “appear to be isolated and intimidated for hours on end.”

Flint connected incidents such as those described above to political interests, telling The Defender the FAA approved COVID-19 vaccines for pilots just two days after the U.S. Food and Drug Administration (FDA) issued its first Emergency Use Authorization (EUA) for such vaccines, on Dec. 10, 2020.

“I thought to myself, how could the FAA analyze the data and determine it was safe for pilots in just two days, when it took the FDA months to go over the trial data?” Flint said.

Flint said that was an especially jarring development, in light of the increased risk that pilots and cabin crew face:

“I was also extremely curious to know how the FAA is so certain that this vaccine will be safe for pilots when it’s obvious that Pfizer did not do a trial solely on pilots to find out if it would cause some of the serious health problems that immediately started to show up once the mass vaccination campaign [began].”

In the process, Flint stated, the FAA violated its own regulations.

Under the Guide for Aviation Medical Examiners: Pharmaceuticals (Therapeutic Medications) Do Not Issue – Do Not Fly, the FAA has a long-standing rule that states:

“FAA requires at least one year of post-marketing experience with a new drug before consideration for aeromedical certification purposes. This observation allows time for uncommon, but aeromedically significant, adverse reactions to manifest themselves.”

Flint said it “became painfully obvious” the FAA issued this guidance based not on science or safety, but political reasons.

“Why did the FAA abandon its own rules by encouraging pilots to take a brand-new experimental drug?” Flint asked. “This action by the FAA was totally unprecedented and extremely dangerous.”

Providing an example of such danger, Flint said, “it is now widely reported that mRNA COVID-19 vaccines can cause blood clots,” adding that several peer-reviewed studies going back more than a decade “show pilots are approximately 60% more likely to experience blood clots due to the ‘nature of the job.’”

Supporting this assertion, on May 5, the FDA announced that it would restrict who could receive doses of the Johnson & Johnson COVID-19 vaccine, due to the risk of blood clots.

Pierson also believes politics are at play in the medical community, telling The Defender even his longtime doctor told the FAA, in paperwork aimed at restoring Pierson’s suspended medical certification, that “it is impossible for the vaccine to have caused” his condition, though “he could not provide any explanation for an alternative hypothesis” — a stance Pierson characterized as “medical malpractice.”

Such politics are also found in professional organizations within the aviation industry, according to Pierson, who described his experience with one such entity:

“I approached the medical division of ALPA, the Air Line Pilots Association, to which I am a member, and presented them with data to substantiate my concerns.

“It was initially seemingly a concerned, open dialogue, which quickly was dismissed at the highest levels.”

Legal Actions to Follow Against the FAA, Federal Agencies, Airlines

The USFF, according to Yoder, is currently pursuing several legal actions related to the vaccine injuries that pilots and air staff are increasingly reporting.

He told The Defender:

“The U.S. Freedom Flyers have always taken a strong stance against the threats of government and corporate totalitarianism.

“We are filing massive, individual plaintiff lawsuits against the FAA, DOT [U.S. Department of Transportation] and commercial airlines to hold them accountable for the criminal and civil atrocities they’ve committed against our members.

“We will not rest until justice is served and constitutional American freedom is restored.”

Steele added:

“We are teeing up lawsuits for all the major airlines, with thousands of potential plaintiffs on our plaintiff lists.

“We also are going to be holding the FAA and the [U.S. Department of Transportation] accountable for their part in this atrocity.”

Steele said USFF “will be seeking retribution and restitution for these crimes against humanity,” mirroring remarks made by Pierson, who described the actions taken in the name of the pandemic as “nothing short of the highest crimes against humanity ever.”

According to Steele, unions are, in part, responsible for the injuries being sustained by pilots and other employees, as a result of their acceptance of vaccine mandates.

“Unfortunately the unions — from all industries — have let their members down,” Steele told The Defender. “They simply are rolling over and are in bed with the state and the corporations.”

Flint, in turn, assigned a significant amount of blame to the federal agencies:

“The FAA has failed at its duties in the most spectacular fashion, causing pilots to lose their lives, livelihoods and careers.

“The federal government, including the FAA, has not helped one single person injured by the COVID-19 vaccine.

“They [the federal agencies] have not publicly acknowledged there is a problem. They haven’t even so much as adjusted their ‘guidance’ to prevent this from happening in the future.”

Are Passengers at Risk From Pilot Vaccine Mandates?

When Snow suffered cardiac arrest, it occurred only a few minutes after he had landed a commercial airliner, full of passengers, at one of the most heavily trafficked airports in the U.S.

This begs the question: Are passengers — and the public at large — at risk due to potential adverse effects that may impact vaccinated pilots during flight?

According to Pierson, there is indeed a risk of a “catastrophic” incident:

“I became an outspoken critic of the vaccines after my injury, and due to becoming much more knowledgeable of all the potential health and safety risks from the vaccines.

“It became very clear to me that the implications of having an immediate, severe adverse reaction could be catastrophic if actively piloting an aircraft.”

Flint believes such a disaster may be an inevitability.

“It is only a matter of time before a pilot has a medically significant event from an adverse reaction to this [COVID-19] vaccine and crashes an airliner, killing a few hundred American citizens in the process.”

He added:

“When will the FAA finally do the right thing by trying to adhere to its own mission statement, which is ‘to provide the safest, most efficient aerospace system in the world’?

“How many more pilots have to die or be severely injured before the FAA acknowledges the horrible and dangerous problem it has created?”

In addition to the risk of a disaster involving casualties among passengers and the general public, the difficulties that pilots are experiencing as a result of vaccine-related adverse reactions are creating other disruptions for the airline industry and the flying public, such as flight cancellations and delays.

Yoder described this as a “ripple effect”:

“Vaccine mandates are having a ripple effect in the aviation industry that will continue for years to come.

“Pilot shortages were a concern pre-mandate, [and] have now been amplified due to early retirements and medical disqualification due to certain adverse vaccine reactions which prohibit pilots from maintaining medical certification.”

Pilots, Advocates Describe Importance of Speaking Out

The pilots, legal professionals and advocates who spoke to The Defender all expressed their hope that by speaking out and sharing their stories and experiences, they will make a difference.

Snow said:

“I hope to shine the spotlight on the potential for significant safety issues that exist within the airlines, commercial vehicles/transportation, and other safety-sensitive work that might be affected by [the] sudden onset of health issues that could be attributed to the COVID vaccines.

“It is in our collective best interest that real research and data analysis be undertaken to address this potentially dangerous situation.

“Why is there such a reluctance to investigate these EUA COVID vaccines which are still being aggressively marketed to, if not outright forced upon, the global public?”

Snow went on to discuss the history of unsafe drugs and therapies that had initially received FDA approval and the importance of “clinical and scientific studies to evaluate the possibility of injuries and deaths” instead of “parroting the marketing mantra ‘safe and effective.’”

Flint described the FAA’s handling of the issue as “one of the most glaring instances of incompetence and corruption I have ever witnessed,” adding that “the Pfizer COVID-19 vaccine has taken nearly everything from myself and my family … my health and my career have been taken from me.”

He added that due to his inability to fly, he is facing mounting debt and unpaid taxes, with an income “20% of what it was before vaccination.”

Steele, who also organized the People’s Convoy, expressed her view that “[t]he only way to push back on the government and corporate overstep is demanding accountability … to hold these policymakers unequivocally accountable.”

She specifically referenced the importance of pursuing legal claims, telling The Defender:

“The only way to ensure it never happens again is to hit them in the pocketbook … In doing so, the awarded damages will also assist the victims of these policies that have been so grievously harmed.”

Yoder described the resistance he has observed to such private and government mandates, saying that “Americans have rallied in defiance to the totalitarian dictators dubbed ‘government,’” adding that “American patriots will never succumb to totalitarianism.”

Steele drew upon her experience with the People’s Convoy to share her own observation of wide public opposition to such mandates, while expressing a message of hope:

“My greatest takeaway and the most refreshing finding on the Convoy was that patriotism is alive and well in our great country.

“The American people have had it with the nonsense with the overstepping, with the ‘PC police,’ the degrading of morality in our country. They are simply over it and looking for actionable items that they can do.

“They want to see accountability. They want to see our country restored … It is important for people to know they are absolutely not alone. In fact, we are the majority.”

Liver injury following SARS-CoV-2 vaccination: A multicenter case series

Authors: Hersh Shroff,1,∗Sanjaya K. Satapathy,2James M. Crawford,3Nancy J. Todd,4 and Lisa B. VanWagner1 J Hepatol. 2022 Jan  10.1016/j.jhep.2021.07.024 PMCID: PMC8324396PMID:  34339763

In response to the COVID-19 pandemic, two novel mRNA-based vaccinations against the SARS-CoV-2 virus have been manufactured and distributed in an unprecedented fashion. In light of their rapid uptake, providers must remain vigilant in their monitoring of new adverse events. In early 2021, multiple providers, communicating on AST LICOP and AASLD online forums, shared strikingly similar experiences with patients who presented with liver injury following COVID-19 vaccination with no other clear precipitants. Given the pattern, we report herein on a multicenter cohort of patients with liver injury following COVID-19 vaccination. No personally identifiable information or protected health information was collected for any patient. The series was reviewed by the Northwestern University IRB and deemed not to be human subjects research.

Our cohort includes 16 total patients (Table 1 ) aged 25 to 74, who presented between 5 to 46 days following their first vaccine dose (Pfizer: 12, Moderna: 4). Notably, 75% of patients (12/16) presented after their second vaccine dose.

Table 1

Patient characteristics.

CaseAge, sexLiver disease historyTiming of presentation (days)aPattern of injuryPeak lab valuesRelevant work-up (medications, labs, imaging)Biopsy findingscTreatmentRecovery status
ALT (U/L)ALP (U/L)Bili (mg/dl)INR (ratio)Inflammation severityd, locationCellular pattern of inflammationCholestasisd and bile duct featuresFibrosis
Pfizer vaccine
146, MNAFLD, prior
DILI (due to amoxicillin)
10Hep5941973.91.3ASMA 1:40
Other autoimmune and viral serologies negative
ERCP with new severe sclerosing cholangitis
+
Portal
No interface hepatitis
Mixed infiltrate+
Mild ductular proliferation
Focal portal and peri-portalEndoscopic biliary dilationRecovering
261, FNone34Hep2,3311603.71.3Received nitrofurantoin 3 months prior
ASMA 1:160, other autoimmune and viral serologies negative
+
Portal and lobular
No interface hepatitis
Lymphocytes and plasma cellsNone
Normal bile ducts
NoneOral prednisoneRecovering
361, MNone31Hep7652302.61.2Ibuprofen x 3 days
Autoimmune and viral serologies negative
+
Portal and lobular
No interface hepatitis
LymphocytesNone
Normal bile ducts
NoneNoneFully recovered
471, MHCV (treated);
Compensated cirrhosis
27Chol1013671.7UnkNone performedNo biopsy performedNoneRecovering
574, FExtramedullary hematopoiesis of unknown significance on prior liver biopsy27Hep1,7793911.11.0ANA 1:640, other autoimmune serologies negative
Viral serologies negative
No biopsy performedNoneFully recovered
673, MAIH (treated)b6Hep8131140.7UnkNone performedNo biopsy performedOral prednisoneRecovering
725, FNone24Hep6354652.81.0Ibuprofen x 2 days
ANA 1:640, ASMA 1:20; viral studies negative
No biopsy performedNoneRecovering
861, FNone42Hep1,7352871.51.1ANA 1:320, other autoimmune serologies negative
EBV viral load 78, VZV IgM+/IgG+
Hepatic steatosis on imaging
++/+++
Portal
No interface hepatitis
Mixed infiltrateNone
Neutrophilic peri-cholangitis
NoneOral prednisoneRecovering
937, FNone29Hep>5,0001442.85.5Autoimmune and viral serologies negativeNo biopsy performedNAC infusionFully recovered
1033, FAIH (treated)b
Compensated cirrhosis
28Hep173462.11.1None+/++
Portal and lobular with interface hepatitis
Lymphocytes and plasma cellsNone
Normal bile ducts
CirrhosisOral prednisoneFully recovered
1168, MAIH (treated)b
Compensated cirrhosis
19Hep245550.91.1Imaging with new diagnosis of solitary HCC++
Portal and lobular with interface hepatitis
Mixed with plasma cellsNone
Normal bile ducts
CirrhosisOral prednisoneRecovering
1270, FPrior biliary stricture after cholecystectomy41Mixed961400.5UnkNoneNo biopsy performedNoneRecovering
Moderna vaccine
1366, FAIH (treated)b5Hep1,1993525.91.1Received shingles vaccine 3 months earlier
Viral serologies negative
+++
Portal and lobular with interface hepatitis and central perivenulitis
Plasma cellsNone
Normal bile ducts
NoneOral prednisoneRecovering
1468, FNone15Hep2,367176252.2Autoimmune and viral serologies negative
E. Coli UTI treated with ceftriaxone (after ALI onset)
+++
Portal and lobular
Interface hepatitis not reported
UnknownNone
Severe bile ductular reaction
NoneIV steroids,
NAC infusion
Recovering
1559, FNone31Hep86936714.72.4Tylenol several days per week for preceding year
ANA 1:640, IgG 1,750 other autoimmune serologies negative
EBV VCA IgM+, IgG+
Other viral markers negative
+++
Portal and lobular
No interface hepatitis
LymphocytesNone
Ductular reaction
NoneIV steroidsRecovering
1665, MNone46Mixed2,6642,52222.31.2Taking Tylenol/Norco for 4 days prior to presentation due to recent knee surgery
ANA 1:1,240, ASMA 1:40, IgG normal
Viral serologies negative
+
Portal
No interface hepatitis
Lymphocytes+++
Occasional bile duct injury
NoneNoneRecovering

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AIH, autoimmune hepatitis; ALI, acute liver injury; ALP, alkaline phosphatase; ALT, alanine aminotransferase; ANA, anti-nuclear antibodies; ASMA, anti-smooth muscle antibodies; Bili, bilirubin; DILI, drug-induced liver injury; EBV, Epstein-Barr virus; HCC, hepatocellular carcinoma; INR, international normalized ratio; NAC, N-acetylcysteine; NAFLD, non-alcoholic fatty liver disease; UTI, urinary tract infection; VCA, viral capsid antigen.aIn relation to first dose of vaccine.bNo medication changes for over 6 months with normal preceding labs.cBiopsy findings are reported based on each institution’s written report. Biopsies were not independently reviewed.dSeverity of inflammatory infiltrate and cholestasis graded as follows: +, minimal or mild; ++, moderate; +++, severe/extensive.

Six patients had a history of chronic liver disease, including 4 (#6, 10, 11, 13) with autoimmune hepatitis (AIH) in treated remission (i.e., no medication changes or abnormal labs for a minimum of 6 months). Three patients had cirrhosis: 2 patients with AIH (#10 and 11) and 1 with previously treated HCV (#4).

The majority (13/16) of cases demonstrated a hepatocellular pattern of liver injury (peak alanine aminotransferase: 96 to >5,000 U/L). Of the remaining 3 cases, 1 (#4) was cholestatic and 2 (#12, 16) were mixed. Acute liver injury (ALI, defined as international normalized ratio [INR] >1.5) occurred in 3 patients (#9, 14, and 15; INR range 2.2 to 5.5); no patients developed acute liver failure.

Patient #1 was diagnosed with “new” sclerosing cholangitis via endoscopic retrograde cholangiopancreatography on this presentation; however, on chart review, he presented with drug-induced liver injury (DILI) (amoxicillin) two years earlier, at which time a magnetic resonance cholangiopancreatography showed subtle non-diagnostic biliary findings, raising the possibility of undiagnosed primary sclerosing cholangitis. At the time of presentation, the DILI was long-since resolved, and the current presentation appears to represent an ALI event in a patient with pre-existing cholangitis. Patient #2 had been prescribed a 3-day course of nitrofurantoin approximately 90 days prior to presentation. The scenario was deemed atypical for nitrofurantoin toxicity (particularly the short exposure and clinical presentation). Patients #3 and #7 used ibuprofen immediately following the second vaccine dose (2 to 3 days total, unknown total doses); patient #15 reported chronic acetaminophen use (3-4 grams for several days per week over the preceding year); and patient #16 had knee surgery 3 days prior to presentation and used alternating acetaminophen and acetaminophen-hydrocodone for a total of 4 days. None of these were deemed likely to be causative given the time frame and short exposures. No patient displayed laboratory evidence of viral hepatitis, and all patients tested negative for COVID-19 infection. While 7 of the 12 patients without previously known AIH had at least 1 positive autoimmune marker at the time of presentation, only 1 (#15) met IAIHG simplified criteria for “probable” AIH (anti-nuclear antibody 1:640, elevated IgG to 1,750 mg/dl, and biopsy “compatible” with AIH).1

Out of 16 patients, 10 underwent liver biopsy (Table 1). All exhibited portal inflammation (60% graded as moderate or severe). Five cases demonstrated a significant plasma cell component (of whom #10, 11, and 13 had pre-existing AIH and displayed interface activity), all of whom received prednisone. Cholestasis and bile duct reaction, though variably present, were only prominent in 1 case (#16) with severe cholestasis and minimal inflammation. Excluding patients with known cirrhosis (n = 3), significant fibrosis was not seen in any patient.

Out of 16 patients, 10 required hospitalization. In total, 6 of 16 patients required no treatment. Of the 10 who received treatment, 2 (#9, 14; both with ALI) received N-acetylcysteine infusions, and 8 (see Table 1) received steroids. Patient #1, newly diagnosed with sclerosing cholangitis, underwent biliary dilatation. Importantly, all patients recovered or were recovering from the acute event at the time of assembling our cohort.

We acknowledge that our series of patients with hepatic injury following mRNA-based COVID-19 vaccination contains retrospective and observational data without adjudication. Thus, our report is not structured to evaluate potential causality. In our patients with prior drug exposure (amoxicillin; nitrofurantoin; non-steroidal anti-inflammatory drugs, acetaminophen), the exposures were either too short or the presentations highly atypical (by laboratory data or histopathology) to be attributed solely to the medication. Thus, DILI is not readily implicated in this patient series, although it cannot be wholly excluded. We also consider unlikely direct hepatotoxicity from SARS-CoV-2 mRNA vaccines, noting the strong safety profile for delivery of lipid nanoparticle mRNA vaccines to human tissues.2 Rather, vaccine-induced immune-mediated hepatitis is a known phenomenon,3 , 4 and other autoimmune events (e.g., AIH, ITP) have been reported following COVID-19 vaccination.5 , 6 It is plausible that a similar mechanism is occurring here, whereby the host immune response directed against the COVID-19 spike protein triggers an aberrant, autoimmune-like hepatic condition in predisposed individuals. Many questions still remain. In particular, should patients at higher risk of hepatic autoimmunity (e.g., existing AIH, post-liver transplant) undergo pre-emptive laboratory monitoring post-vaccination? Will there be safety concerns for these patients if booster doses are recommended in the future?

We emphasize that our intent is not to promote vaccine hesitancy. The overwhelming benefits of these and other highly efficacious vaccines in the setting of a global pandemic greatly surpass any potential risk of liver injury that may exist. We simply aim to share a clinical scenario that has been observed independently by multiple providers at various institutions, with the hope that as vaccine uptake continues to increase, our shared experience can help in early recognition, further study, and management of potential adverse events.Go to:

Financial support

L.V.W. is supported by the National Heart, Lung and Blood Institute grant K23HL136891.Go to:

Authors’ contributions

Hersh Shroff (conceptualization, methodology, visualization, writing original draft, writing review and editing). Sanjaya K. Satapathy (visualization, resources, writing review and editing). James M. Crawford (visualization, resources, writing review and editing). Nancy J. Todd (resources, writing review and editing). Lisa B. VanWagner (conceptualization, methodology, resources, supervision, visualization, writing review and editing).Go to:

Data availability statement

Data and study materials will not be made available to other researchers.Go to:

Conflict of interest

The authors disclose no conflicts of interest.

Please refer to the accompanying ICMJE disclosure forms for further details.Go to:

Acknowledgements

We acknowledge the following individuals for assistance in contributing cases and reviewing the manuscript: Juan Pablo Arab (Pontificia Universidad Católica de Chile); Timea Csak (Northwell Health), Winston Dunn and Beth Floyd (University of Kansas); R. Todd Frederick (California Pacific Medical Center); Alexander Lemmer (Piedmont Healthcare); Benedict Maliakkal (Ascension Medical Group); Atoosa Rabiee (Washington DC VA Medical Center); and Priyanka Singh (Northwell Health).Go to:

Footnotes

Author names in bold designate shared co-first authorship

Supplementary data to this article can be found online at https://doi.org/10.1016/j.jhep.2021.07.024.Go to:

Supplementary data

The following is the supplementary data to this article:Multimedia component 1:Click here to view.(1.4M, pdf)Go to:

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FDA limits use of J&J vaccine over rare blood clots

Authors:  PETER SULLIVAN – 05/05/22 THE HILL

The Food and Drug Administration (FDA) on Thursday announced that it is limiting the authorization for the Johnson & Johnson COVID-19 to people who cannot or will not get other versions of the vaccine, citing the risk of rare blood clots.  

The authorization for the J&J vaccine, also known as the Janssen vaccine, is now limited to people for whom the Pfizer or Moderna vaccines “are not accessible or clinically appropriate,” or “who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.” 

That is, people can still get the J&J vaccine if they are allergic to the mRNA vaccines from Pfizer or Moderna, or if personal concerns with the other vaccines mean they would otherwise go without any inoculation.  

The agency said it was making the decision after “conducting an updated analysis, evaluation and investigation of reported cases” of the blood clots, which “warrants limiting the authorized use of the vaccine.” 

Importantly, the Pfizer and Moderna vaccines do not carry the same risks of blood clots, given they use a different technology than the Johnson & Johnson vaccines.  

Blood clots also remain rare among J&J recipients. The FDA has identified 60 confirmed cases of the blood clots following receipt of the J&J vaccine and nine deaths, it said. That is about three cases of blood clots for every million J&J vaccines administered, and 0.48 deaths per million doses of the J&J vaccine. 

The blood clots are formally known as thrombosis with thrombocytopenia syndrome (TTS).  

This is not the first time that the risk has affected distribution of the vaccine. Regulators caused shockwaves, and some controversy, early last year, when they paused the administration of the J&J vaccine for several days to allow time to investigate the blood clots.  

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” said Peter Marks, a top FDA official. “We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the [authorization].” 

The J&J vaccine already had far lower usage than the Pfizer or Moderna vaccines. About 18 million doses have been administered, according to the Centers for Disease Control and Prevention, compared to more than 200 million for Moderna and more than 300 million for Pfizer.  

In making its decision, the FDA noted the availability of other vaccines from Pfizer and Moderna, “which provide protection from COVID-19 and have not been shown to present a risk for TTS.”