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.

More of the vaccinated and boosted landing in hospital with COVID-19

Authors: By Ariel Hart Zachary Hansen May 19. 2022 – The Atlanta Journal-Constitution

Doctors say it’s caused by a combination of a variant that can escape the vaccine’s effects and the most vulnerable also being the most vaccinated

As summer once again brings signs of a coming COVID-19 wave, an unusual trend has emerged: The Georgians who are fully vaccinated and boosted are increasingly winding up in the hospital with serious COVID-19 symptoms.

The phenomenon points to two changes in the unpredictable pandemic battleground more than two years in. The circulating omicron variant has become better at evading the vaccine, which was designed on the first version of coronavirus to appear in China. And the people most likely to get boosted are those who were most vulnerable to begin with: the elderly, or patients with pre-existing conditions. Despite the extra vaccine protection, those people remain the most vulnerable.

Even in light of the unexpected hospitalizations of those vaccinated and boosted, doctors say it’s still true that boosted groups are the least likely to die.

“I’ve had several older patients who have been boosted and had the vaccine,” said Dr. William Cleveland, a nephrologist in southwest Atlanta. “They get hospitalized, and they had to have some significant medical attention, but they get discharged. And I know that just because of their frailty, without having had the vaccine they would not have survived.”

The rate of hospitalizations for boosted Georgians fell again this week, but still remains higher than the rate of hospitalizations for those with only the primary vaccine series (2 shots). The fact that boosted patients’ hospitalizations nearly outstripped all others even for one week was an unprecedent moment in the pandemic. In the past, hospitalization rates for unvaccinated groups have drastically outnumbered those who have taken the vaccine — sometimes tenfold.

The trend emerged at the tail-end of the omicron variant outbreak and has accelerated over the past two months, setting off alarm bells for state public health experts already expecting a surge in cases this summer.

Dr. Eva Lee, director of the Center for Operations Research in Medicine and Healthcare at Georgia Tech, agreed that the rate of hospitalizations among boosted people was on track to outpace other populations. However, she said it’s not a sign of vaccines losing all effectiveness — it has to do with who is choosing to get boosted.

“A big part of the people that are boosted are also the ones that are really at high risk already to begin with, right?” Lee said. “But what has remained and hasn’t changed is the following: The people that are at risk remain at risk. That means the people that are immune-compromised and the people that are like the elderly people, and people who have coexisting conditions, their risk is still higher.”

Growing number of breakthroughs

Overall, the number of people hospitalized with COVID remains at or near the lowest rate since the beginning of the pandemic. But state data shows that the most protected and least protected groups are starting to find themselves fighting for their lives in Georgia hospitals at nearly the same levels.

According to Georgia Department of Public Health data, unvaccinated groups were being hospitalized due to COVID at twice the rate of other populations at the beginning of March. By the end of April, there were 1.3 hospitalizations per 100,000 vaccinated and boosted Georgians compared to 1.6 hospitalizations for every 100,000 unvaccinated Georgians.https://datawrapper.dwcdn.net/qtaSR/1/

In addition to at-risk groups being more likely to get every shot available to them, omicron and its subvariants have presented a challenge for the U.S.’s current vaccines. Breakthrough cases of less serious illness are now common, and health experts warn they are a sign of the vaccines’ waning immunity.

“Prior to Omicron we could, with a booster, assume there was well over 90-95% vaccine effectiveness vs severe disease,” Eric Topol, founder and director of the Scripps Research Translational Institute in New York, wrote in a recent column sounding the alarm for a summer surge in COVID-19 infections. “It is clear, however, from multiple reports … that this level of protection has declined to approximately 80%, particularly taking account the more rapid waning than previously seen. That represents a substantial drop-off.”

The growing number of breakthrough cases has prompted national health officials to discuss reformulating the current vaccines to specifically target omicron and its subvariants. The U.S. Food and Drug Administration has a meeting scheduled for June 28 to evaluate vaccine efficiency and composition.

Georgia hasn’t seen any noticeable uptick in COVID-19 deaths, but death reports often lag behind increasing hospitalization rates by several weeks.

While health experts are troubled by the rising hospitalization rates, they emphasize that COVID’s death toll would already be on the rise if the most at-risk Georgians weren’t vaccinated and boosted.

Surprised to still be alive

Raymond Fain knew he couldn’t risk getting COVID-19. Given he has kidney disease, the 58-year-old made sure to not only get fully vaccinated but he took a Pfizer booster shot to boot.

Just two months later, during the onslaught of the omicron variant this winter, he was shocked to be told that in spite of his vaccinations he caught COVID. What followed was a bad sickness and two rounds of hospitalization that totaled nearly a month. But at the end of it, came another surprise: He lived.

“I was sort of shocked that that disease that I caught didn’t overcome me with, the failed kidneys. You know what I’m saying?” Fain said.

Cleveland works with Fain’s doctor, both of whom have pleaded with their kidney patients to get vaccinated. Cleveland is all too familiar with kidney patients who get COVID and don’t make it. He’s heard all the excuses, and he’s ready to counter them.

“I’ve seen so much of that (kidney patients succumbing to COVID) that I do not hesitate to try to explain to my patients that I’ve just seen this too many times to to be comfortable with them saying that they are afraid,” Cleveland said.

The percentage of Georgia residents who’ve been vaccinated is among the lowest in the country — the peach state currently ranks 45th. The state’s booster adoption rate is even worse, with less than half of all fully vaccinated people choosing to get one booster dose.

There’s also a large age disparity among those getting boosted. Nearly 60% of all Georgia seniors, people 65 and older, have gotten a booster dose, but there’s a stark drop-off for younger populations. Only about 15% of 25- to 34-year-old Georgians are boosted.

The low booster adoption rate for younger people, who are less likely to be at a high risk of life-threatening infections, is an explanation for why boosted groups seem to be hospitalized at higher rates, health experts said.https://datawrapper.dwcdn.net/KYHdI/1/

“All such people need to have vaccination and booster coverage but our (Centers for Disease Control and Prevention) has failed to convey their life-saving impact from the get go…” Topol wrote in his column. “That’s why we have 31% of Americans who had had 1 booster shot whereas most peer countries are double that proportion.”

For Fain, he’s surprised he was able to pull through his severe bout with COVID and get back on his feet, but his friends and loved ones haven’t let him forget how close he was to death.

“Everybody’s going to talk to me now, they say, ‘Boy when you started, we thought you was going to get gone. You sounded so bad,’” Fain said. “Yeah, but everything is okay now. I’m strong.”

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?

Clinical update on risks and efficacy of anti-SARS-CoV-2 vaccines in patients with autoimmune hepatitis and summary of reports on post-vaccination liver injury

Authors: Ana Lleo 1Nora Cazzagon 2Cristina Rigamonti 3Giuseppe Cabibbo 4Quirino Lai 5Luigi Muratori 6Marco Carbone 7Italian Association for the Study of the LiverAffiliations expand PMID: 35410851 PMCID: PMC8958090DOI: 10.1016/j.dld.2022.03.014 Published:March 27, 2022DOI:https://doi.org/10.1016/j.dld.2022.03.014

Abstract

Patients with liver diseases, especially those with cirrhosis, have an increased mortality risk when infected by SARS-CoV-2 and therefore anti-SARS-CoV-2 vaccine has been recommended by leading Scientific Associations for all patients with chronic liver diseases. However, previous reports have shown a reduced antibody response following the full course of vaccination in immunosuppressed patients, including liver transplant recipients and several rheumatic diseases.This document, drafted by an expert panel of hepatologists appointed by the Italian Association for the Study of the Liver (AISF), aims to present the updated scientific data on the safety and efficacy of anti-SARS-CoV-2 mRNA vaccines in patients with autoimmune hepatitis (AIH). Furthermore, given the recent reports of sporadic cases of AIH-like cases following anti-SARS-CoV-2 mRNA vaccines, we summarize available data. Finally, we provide experts recommendations based on the limited data available.

1. 2022 AISF recommendation on anti-SARS-CoV-2 vaccines for patients with known autoimmune hepatitis

Patients with chronic liver diseases (CLD), especially those with cirrhosis, have an increased mortality risk when infected by SARS-CoV-2 [[1]]. One of the largest international studies currently available, showed an observed mortality of 32% in patients with cirrhosis compared to 8% in those without [[2]]. Therefore, the European Association for the Study of the Liver (EASL) has recommended vaccination against SARS-CoV-2 for all patients with CLD [[3]]. Although contrasting data have been published, patients with AIH with or without cirrhosis under immunosuppressive therapy represent an at-risk category of developing severe COVID-19 when infected [[4],[5]]. Therefore, based on the data available, the benefit of anti-SARS-CoV-2 vaccination outweighs the potential risk for disease exacerbation in AIH.Although the registration trials of mRNA vaccines enrolled patients with CLD (217 patients in Pfizer trial and 196 patients in Moderna trial), subjects under immunosuppressive therapy were excluded. A recent study by Thuluvath and colleagues found that 75% of patients with CLD without cirrhosis and 77% of patients with cirrhosis had adequate antibody response to anti-SARS-CoV2 vaccines [[6]]. The authors included 233 patients with CLD with 61 being affected by immune mediated liver diseases, including AIH, primary biliary cholangitis, and primary sclerosing cholangitis. Also 62 patients were liver transplant (LT) recipients, 79 had cirrhosis, and 92 had CLD without cirrhosis. Antibody levels were undetectable in 11 patients who had LT, 3 with cirrhosis, and 4 without liver cirrhosis. LT and treatment with two or more immunosuppressive drugs were associated with poor antibody responses. However, only 3 patients out of 18 with undetectable antibody were AIH patients on immunosuppression (2 on prednisone plus mycophenolate mofetil (MMF) and 1 on prednisone plus azathioprine).Reports have shown a reduced antibody response following the full course of vaccination in liver transplant recipients [[7]]. It has also been formerly demonstrated that specific drugs (i.e. methotrexate, abatacept, and rituximab) reduced the immune response to influenza or pneumococcal vaccines in a number of different rheumatic diseases [8910]. The efficacy of anti-SARS-CoV-2 vaccination in preventing COVID-19 in patients with AIH on immunosuppressive therapies [[11],[12]], as well as the risk of disease reactivation after anti-SARS-CoV-2 vaccination, have been poorly investigated. Similarly, cellular immunity to SARS-CoV-2 in AIH patients has not been studied.The American College of Rheumatology (ACR) has recently proposed a guidance [[13]] suggesting a short-term withdrawal of methotrexate, JAK inhibitors, abatacept, and MMF, and deferral of rituximab and cyclophosphamide infusion if possible before anti SARS-Cov-2 vaccination, according to rheumatic disease activity. However, there is no solid evidence as to whether it is appropriate or not to suspend or reduce the dose of immunosuppressive drugs immediately before or following the administration of the vaccine in AIH patients. Importantly, this strategy may be potentially associated with an increased risk of AIH reactivation particularly dangerous in patients with cirrhosis. Of interest, high doses of MMF and rituximab remain independent predictors of failure to develop an antibody response after vaccination in rheumatic diseases [[14]]; however, no data are available in AIH. At the present time, the available data do not justify withdraw or reduction of immunosuppression before or immediately after vaccination in patients with AIH.Finally, no clear evidence of reactivation of AIH after anti-SARS-CoV-2 vaccination has been reported in the literature. Interestingly, the presence of significant fibrosis at the liver histology of a small number of newly diagnosed AIH following anti-SARS-CoV-2 vaccination might suggest the possibility of disease reactivation [151617]. However, until new multicenter studies are available there is no current indication for routine testing of transaminases levels in AIH patients after vaccination.

2. 2022 aisf recommendation on autoimmune hepatitis like onset following anti-SARS-CoV-2 vaccination

The COVID-19 pandemics has necessitated the development and registration of several vaccines in record time. The monitoring for safety, side effect and efficacy is ongoing in the post-marketing surveillance. Recent reports inform on the possible occurrence of immune mediated hepatitis or AIH-like disease in predisposed individuals. Autoimmunity is widely accepted to develop in genetically predisposed individuals and some polymorphisms have been identified in AIH [[18]]; unfortunately, they are not yet of clinical use and cannot be of help to identify individuals at risk.Considering that 58% of the world population has received at least one dose of anti-SARS-CoV-2 vaccine, with 9.2 billion doses been administered globally, it is unclear whether this is a pure coincidence rather than a causality.The fact that someone developed immune-mediated acute hepatitis after vaccination does not necessarily mean that this was caused by the vaccine.The European Medicine Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has recently started an assessment following the very small number of cases reported after vaccination with Spikevax and Comirnaty (known as Moderna and Pfizer vaccines, respectively) in the medical literature and EudraVigilance (www.ema.europa.eu). Further data and analyses have been requested from the marketing authorization holder to support the ongoing assessment by PRAC. Given the small number of cases currently reported, the issue seems to be rare; however, specific studies should be performed to define the number and severity of cases.At the time these recommendations are drafted, 17 reports have been published in the medical literature that overall include 31 cases of suspected AIH-like triggered by the vaccine (Table 1). Patients were more often women (F:M 21:10), age ranging from 32 to 89 years old (median 58 years). In eleven cases a pre-existent autoimmune condition (i.e., seven Hashimoto thyroiditis, one primary biliary cholangitis, two rheumatoid arthritis, one systemic lupus erythematosus) is reported. Two patients had experienced COVID-19 infection before the vaccine. All except four presented with an acute onset of AIH-like with jaundice. All patients underwent liver biopsy and in six of them fibrosis was already present, which might suggest that they had a previous liver disease, possibly an undiagnosed AIH. All were treated with steroid therapy, and all improved the liver function tests (LFTs), although details on the biochemical response are not thoroughly reported.Table 1Cases of suspected AIH triggered by the vaccine reported in the literature.

ReferenceVaccinePatient’s characteristicsClinical presentation and laboratory dataTherapyOutcome
Age, genderAutoimmune comorbiditiesPrevious COVID-19 infectionOther comorbidities
Avci & Abasiyanik [15]mRNAPfizer/BioNTech,1 month before61, FHashimoto thyroiditisYes, mild, 8 months beforeHypertensionAcute icteric ANA, ASMA, hyper-IgG, fibrosis F2,Prednisolone + azathioprine add-on35 days follow-up, mild transaminases and bilirubin
Bril et al. [16]mRNAPfizer/BioNTech,7 days before35, FNot reportedNoGestational hypertension and cesarian section 3 months beforeAcute icteric, normal IgG, no fibrosisPrednisone 20 mg/day50 days follow-up, transaminases normalization
Cao et al. [17]Inactivated whole-virion SARS-CoV2 (Coronavac)57, FNot reportedNoNot reportedAcute icteric, pruritus IgG slight elevation, ANA+, Fibrosis F2Methylprednisolone, UDCA + azathioprine add-on5 months follow-up, no relapse
Clayton-Chubb et al. [23]ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca), 26 days before36, MNoNoHypertension, laser eye surgery 2 weeks beforeAcute, sub-icteric, asymptomatic, ANA+, normal IgG, no fibrosisPrednisolone 60 mg/day24 days, normalization of bilirubin, marked reduction of ALT
Garrido et al. [24]mRNA Moderna, 2 weeks before65, FNoNoPolycythemia vera under PEG-IFNAcute icteric severe, ANA, hyper-IgG, no fibrosisPrednisolone 60 mg/day1 month, improvement of LFTs and IgG normalization
Ghielmetti et al. [25]mRNA-1273, 7 days before63, MNoNo, unknown but anti-cardiolipin+Type 2 diabetes, ischemic heart diseaseAcute icteric, hyper-IgG, ANA+, AMA+ (different from PBC) APCA+, no fibrosisPrednisone 40 mg/day, rapidly tapered14 days follow-up
Goulas et al. [26]mRNA Moderna, 2 weeks before52, FNoNoAcute icteric, ANA+, ASMA+, hyper-IgG, no fibrosis reportedPrednisolone 50 mg/day, azathioprine add-onUnknown
Londono et al. [27]mRNA Moderna, 7 days after the II dose41, FNot reportedNoHormonal therapy for premature ovarian failureAcute icteric, ANA, ASMA, anti-SLA/LC+, hyper-IgG, no fibrosisPrednisone 1 mg/KgNormalization of LFTs
Palla et al. [28]mRNAPfizer/BioNTech 1 month after II dose40, FSarcoidosisTransaminases 3–4 x ULN fluctuation, ANA+, hyper-IgG, active hepatitis, fibrosis with septaPrednisolone 40 mg/dayTransaminases decline after 7 days of prednisolone
Rela et al. [29]ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca), 20 days before38, FNo (hypothyroidism?)NoHypothyroidismAcute icteric, ANA+, IgG mildly elevated, multiacinar hepatic necrosis, no fibrosisPrednisolone 30 mg/day and tapering after 4 weeks1 month of follow-up normal LFTs
ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca), 16 days before62, M2 episodes of jaundice resolved with native medicationAcute severe AIH, autoantibodies negative, mild fibrosisPrednisolone 30 mg/day + plasma exchange 5 cyclesPersistent cholestasis → death in 21 days for economic constraints regarding liver transplantation
Rocco et al. [30]Pfizer/BioNTech 1 week before (II dose)89, FHashimoto thyroiditisNoPrevious acute glomerulonephritis, pravastatin and low-dose aspirin for primary preventionAcute icteric, ANA+, hyper-IgG, no fibrosisPrednisone 1 mg/Kg/day and tapering3 months of follow-up, progressive improvement
Tan et al. [31]mRNA Moderna, 6 weeks before56, FNot reportedNoRosuvastatinAcute icteric, ANA+, ASMA+, hyper-IgG, also eosinophil, early fibrosisBudesonide1 week of follow-up
Tun et al. [32]mRNA Moderna, 3 days before (I dose) and 2 days before (II dose)47, MNot reportedNoNot reportedAcute icteric, ANA+ hyper-IgG, rapidly resolved and then reappeared 2 days after the II dose, minimal fibrosisPrednisolone 40 mg/day2 weeks of follow-up PT normalized
Vuille-Lessard et al. [33]mRNA Moderna, 3 days before76, FHashimoto thyroiditisYes, 3 months before (mild disease)Prior urothelial carcinomaAcute icteric, hyper-IgG, ANA+, ASMA+, ANCA+, steatosis, active AIH, fibrosis not evaluablePrednisolone 40 mg/day + azathioprine add-on 2 weeks after4 months follow-up: LFTs normalization after 4 weeks, stop azathioprine and 6 weeks after no relapse
Suzuki Y et al. [34]mRNA Pfizer/BioNTech 10 days before (II dose)80, FNot reportedNot reportedGastroesophageal reflux esophagitisAcute icteric, ANA+, hyper-IgGPrednisone at an initial dose of 0.8 mg/kg/day, then tapered to 10 mg/week50 days of follow-up: transaminases normalization
mRNA Pfizer/BioNTech 4 days before (II dose)75, FNot reportedNot reportedDyslipidemiaAcute icteric, ANA+, AMA +, hyper-IgGPrednisone at an initial dose of 1 mg/kg/day, then tapered to 10 mg/week105 days of follow-up: transaminases normalization
mRNA Pfizer/BioNTech 7 days before (I dose)78, FPrimary biliary cholangitisNot reportedNoAcute, ANA+, AMA+, hyper IgGPrednisone at an initial dose of 0.6 mg/kg/day, then tapered to 10 mg/week103 days of follow-up: transaminases normalization
Torrente et al. [35]ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca), 3 weeks before49, FHypothyroidism (?), ANA+NoHypothyroidism treated with levothyroxineAcute AIH, ANA+, hyper-IgG, no fibrosisPrednisone 30 mg/day then tapering and azathioprine add-onTransaminases decrease after 2 weeks
Rigamonti C et al. [36]mRNAPfizer/BioNTech, 7 patientsmRNA Moderna, 2 patientsChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca),3 patientsmedian age 62 years (range 32–80)6 F, 6 M3 thyroiditis,2 rheumatoid arthritis,1 systemic lupus erythematosus10 acute onset,8 jaundice,8 positive autoantibodies (6 ANA, 1 SMA, 1 LKM-1)Prednisone / prednisolone +/- azathioprinemedian follow-up 3 months: 58% complete biochemical response
Efe C et al. [37]mRNAPfizer/BioNTech, 1 patient53, MNoneNot reportedNoneAcute icteric hepatitis, no ANA, hyper-IgG, no fibrosisprednisolone (40 mg/day) and plasma exchangeLiver transplantation

Adverse effects of the vaccine are possible, and abnormal liver function tests following vaccination represent an important clinical issue. AIH is a relatively rare, chronic immune-mediated liver disease, which develops in genetically predisposed individuals following environmental triggers; viral infections and drug exposures have been suggested to trigger the disease, but not definitive evidence is available [[19],[20]]. AIH-like onset after vaccination – other than anti-SARS-CoV-2 – has been also previously reported [[21]]. However, even if it can be speculated that the vaccines can disturb self-tolerance and trigger autoimmune responses through cross-reactivity with host cells, it might be hard to definitively state that AIH is induced by a vaccine. Considering the reported AIH-like cases following SARS-CoV-2 vaccination, timing of occurrence of acute hepatitis from vaccination in some of them is very short (less than 7 days), suggesting that a dysregulation of immune system has already occurred before vaccination in those cases. So far, given the availability of only observational literature without a structured collection of AIH-like cases after anti-SARS-CoV-2 vaccines, no definitive conclusions can be drawn. There is a need for population-based studies to gather data on the incidence, severity, and clinical features of anti-SARS-Cov-2 vaccination-induced AIH under the umbrella of the national and European Scientific Societies.In the meantime, while intensive vaccination against SARS-CoV-2 continues, healthcare providers should include the diagnosis of AIH triggered by vaccines in the differential diagnosis in cases of acute hepatitis of unexplained etiology and manage them as drug-induced AIH or AIH-like liver injury as recommended by current guidelines [[22]].

3. RECOMMENDATIONS

*These recommendations will be reviewed periodically as further information becomes available.

  • •AIH patients should receive anti-SARS-CoV-2 vaccination consistent with the age restriction of the local approval. In Italy, as recommended by the Italian Ministry of Health for all immunosuppressed patients, mRNA vaccines should be used. Based on the data for the mRNA vaccines available, there is no preference for one vaccine over another.
  • Patients with AIH are suggested to undergo vaccination when the disease activity is controlled by immunosuppressive therapy. To date there are no data available to establish variations on the interval between doses of anti-SARS-Cov2 vaccine.
  • There is no current evidence to recommend suspension or reduction of immunosuppressive drugs in AIH patients before or immediately after anti-SARS-CoV-2 vaccination.
  • The risk of AIH flare or disease worsening following anti-SARS-Cov-2 vaccination has not been assessed to date and specific studies are required before defining a line of recommendation. Based on available data routine testing of transaminases levels in AIH patients after vaccination could be suggested in selected patients although the timing needs to be defined.
  • •Testing of antibody levels for IgM and/or IgG to spike or nucleocapsid proteins to assess immunity to SARS-Cov2 after vaccination in AIH patients is not recommended, nor to assess the need for vaccination in an unvaccinated AIH patients.
  • Patients with new acute onset of liver injury following anti-SARS-Cov-2 vaccine should be managed as suggested by current guidelines and known clinical algorithms, including the indication to liver biopsy. Considering the lack of evidence currently available to exclude drug induced AIH in this setting, immunosuppressive therapy should be carefully considered and used if AIH diagnosis is confirmed; long-term immunosuppressive therapy needs to be assessed on a patient-by-patient basis.
  • Patients with newly diagnosed AIH or AIH flare after anti-SARS-Cov-2 vaccine should be consider for vaccine booster; however, the timing of the booster could be personalised based on the disease activity and ongoing therapy and discussed case-by-case with an expert center in autoimmune liver diseases.
  • Given the limited number of cases compared to the number of vaccinated subjects, extended testing of transaminases level after vaccination in the general population is not sustainable nor suggested.
  • EMA’s PRAC encourages all healthcare professionals and patients to report any cases of autoimmune hepatitis and other adverse events in people after vaccination.

Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance

Authors: Katherine E. Fleming-Dutra, MD1Amadea Britton, MD1,2Nong Shang, PhD1et al May 13, 2022 JAMA. Published online May 13, 2022. doi:10.1001/jama.2022.7493

Key Points

Question  Does the estimated effectiveness of 2 doses of the BNT162b2 COVID-19 vaccine against symptomatic SARS-CoV-2 Omicron variant infection (based on the odds ratio for the association of prior vaccination and infection) wane rapidly among children and adolescents, as has been observed for adults?

Findings  In a test-negative, case-control study conducted from December 2021 to February 2022 during Omicron variant predominance that included 121 952 tests from sites across the US, estimated vaccine effectiveness against symptomatic infection for children 5 to 11 years of age was 60.1% 2 to 4 weeks after dose 2 and 28.9% during month 2 after dose 2. Among adolescents 12 to 15 years of age, estimated vaccine effectiveness was 59.5% 2 to 4 weeks after dose 2 and 16.6% during month 2; estimated booster dose effectiveness in adolescents 2 to 6.5 weeks after the booster was 71.1%.

Meaning  Among children and adolescents, estimated vaccine effectiveness for 2 doses of BNT162b2 against symptomatic infection decreased rapidly, and among adolescents increased after a booster dose.Abstract

Importance  Efficacy of 2 doses of the BNT162b2 COVID-19 vaccine (Pfizer-BioNTech) against COVID-19 was high in pediatric trials conducted before the SARS-CoV-2 Omicron variant emerged. Among adults, estimated vaccine effectiveness (VE) of 2 BNT162b2 doses against symptomatic Omicron infection was reduced compared with prior variants, waned rapidly, and increased with a booster.

Objective  To evaluate the association of symptomatic infection with prior vaccination with BNT162b2 to estimate VE among children and adolescents during Omicron variant predominance.

Design, Setting, and Participants  A test-negative, case-control analysis was conducted using data from 6897 pharmacy-based, drive-through SARS-CoV-2 testing sites across the US from a single pharmacy chain in the Increasing Community Access to Testing platform. This analysis included 74 208 tests from children 5 to 11 years of age and 47 744 tests from adolescents 12 to 15 years of age with COVID-19–like illness who underwent SARS-CoV-2 nucleic acid amplification testing from December 26, 2021, to February 21, 2022.

Exposures  Two BNT162b2 doses 2 weeks or more before SARS-CoV-2 testing vs no vaccination for children; 2 or 3 doses 2 weeks or more before testing vs no vaccination for adolescents (who are recommended to receive a booster dose).

Main Outcomes and Measures  Symptomatic infection. The adjusted odds ratio (OR) for the association of prior vaccination and symptomatic SARS-CoV-2 infection was used to estimate VE: VE = (1 − OR) × 100%.

Results  A total of 30 999 test-positive cases and 43 209 test-negative controls were included from children 5 to 11 years of age, as well as 22 273 test-positive cases and 25 471 test-negative controls from adolescents 12 to 15 years of age. The median age among those with included tests was 10 years (IQR, 7-13); 61 189 (50.2%) were female, 75 758 (70.1%) were White, and 29 034 (25.7%) were Hispanic/Latino. At 2 to 4 weeks after dose 2, among children, the adjusted OR was 0.40 (95% CI, 0.35-0.45; estimated VE, 60.1% [95% CI, 54.7%-64.8%]) and among adolescents, the OR was 0.40 (95% CI, 0.29-0.56; estimated VE, 59.5% [95% CI, 44.3%-70.6%]). During month 2 after dose 2, among children, the OR was 0.71 (95% CI, 0.67-0.76; estimated VE, 28.9% [95% CI, 24.5%-33.1%]) and among adolescents, the OR was 0.83 (95% CI, 0.76-0.92; estimated VE, 16.6% [95% CI, 8.1%-24.3%]). Among adolescents, the booster dose OR 2 to 6.5 weeks after the dose was 0.29 (95% CI, 0.24-0.35; estimated VE, 71.1% [95% CI, 65.5%-75.7%]).

Conclusions and Relevance  Among children and adolescents, estimated VE for 2 doses of BNT162b2 against symptomatic infection was modest and decreased rapidly. Among adolescents, the estimated effectiveness increased after a booster dose.Introduction

In December 2021 and January 2022, the spread of the SARS-CoV-2 Omicron variant led to the highest rates of COVID-19 cases among children 5 to 15 years old1 and the highest rate of pediatric hospitalizations (age ≤17 years) with COVID-19 to this point in the pandemic.2,3 Randomized trials of the BNT162b2 mRNA COVID-19 vaccine (Pfizer-BioNTech), the only COVID-19 vaccine authorized for use in children and adolescents 5 to 15 years of age, were conducted before the emergence of the Omicron variant and demonstrated high efficacy of 2 doses against COVID-19 (100% and 91% among those aged 12-15 and 5-11 years, respectively).4,5 The US Food and Drug Administration issued Emergency Use Authorization for BNT162b2 (2 doses of 30 μg) for those aged 12 to 15 years on May 10, 2021,6 and for those aged 5 to 11 years (2 doses of 10 μg) on October 29, 2021.7 Evidence that estimated vaccine effectiveness (VE) waned over time among adults and adolescents8 contributed to a recommendation on January 5, 2022, for a booster (30-μg dose) 5 months or more after the second dose for adolescents 12 to 15 years old.9

Observational studies in adults documented lower protection from mRNA vaccines against the Omicron variant compared with the Delta variant and rapid waning of protection.10,11 However, observational estimates of VE among children 5 to 11 years old and adolescents 12 to 15 years old during Omicron variant predominance are lacking but needed to inform COVID-19 vaccine policy and use of nonpharmaceutical interventions in these age groups. The objectives of this analysis were to use the odds ratio (OR) for the association of prior vaccination and symptomatic infection to estimate BNT162b2 VE during Omicron variant predominance of (1) 2 doses among children 5 to 11 years old and adolescents 12 to 15 years old over time since the second dose and (2) 3 doses among adolescents 12 to 15 years old.Methods

This activity was determined to be public health surveillance as defined in 45 CFR §46.102(l) (US Department of Health and Human Services [HHS], Title 45 Code of Federal Regulations, §46 Protection of Human Subjects); thus, it was not submitted for institutional review board approval and informed consent was not needed.Data Source

Data from the Increasing Community Access to Testing (ICATT) platform were used. ICATT is an HHS program that contracts with 4 commercial pharmacy chains to facilitate drive-through SARS-CoV-2 testing nationally.8,10,12,13 No-cost testing is available to anyone regardless of symptom or exposure status, and sites were selected to address COVID-19 health disparities by increasing access in racially and ethnically diverse communities and areas with moderate to high social vulnerability based on the Social Vulnerability Index (SVI).14 During the analysis period, contracted pharmacy chains used different versions of the registration questionnaire and not all captured data on booster doses. This analysis was, therefore, limited to a single chain, which collected data on booster doses and provided 82% of tests platform-wide for children and adolescents aged 5 to 15 years during the analysis period.

When registering for SARS-CoV-2 testing, individuals or parents/guardians of minors answered a questionnaire (available in English or Spanish) to self-report demographic information (including race and ethnicity selected from fixed categories, shown in the Table), COVID-19–like illness symptoms (fever, cough, shortness of breath, recent loss of sense of smell or taste, muscle pain, fatigue, chill, headache, sore throat, congestion or runny nose, vomiting, or diarrhea; reported to HHS as asymptomatic or symptomatic with ≥1 symptom), and vaccination status.10 Race and ethnicity were collected as part of the HHS COVID-19 laboratory reporting requirements.15 Self-reported COVID-19 vaccination data included number of doses received up to 4, and for each dose, vaccine product and month and year received. For doses reported in the same month or the month before test registration, the registrant was asked whether the most recent dose was administered at least 2 weeks before the test date. Reporting of vaccination status was neither mandatory nor verified. Test registrants were also asked to self-report underlying health conditions, including immunocompromising conditions (defined in the questionnaire as “immunocompromising medications, solid organ or blood stem cell transplant, HIV, or other immunocompromising conditions”), and whether they had previously tested positive for SARS-CoV-2 (within 90 days and/or >90 days before test registration); answers were not verified.

Nasal swabs were self-collected at drive-through sites and tested for SARS-CoV-2 either onsite with the ID Now (Abbott Diagnostics Scarborough Inc) rapid nucleic acid amplification test (NAAT) or at contracted laboratories using laboratory-based NAAT (TaqPath COVID-19 Combo Kit [Thermo Fischer Scientific Inc] or COVID-19 RT-PCR Test [Laboratory Corporation of America]). Deidentified questionnaire data, specimen collection date, test type, test result, and testing site location and census tract SVI14 were reported to HHS with an approximate 3-day lag.Study Design

A test-negative, case-control analysis16 was conducted to estimate BNT162b2 VE against symptomatic infection. This analysis used rapid and laboratory-based NAATs from children and adolescents aged 5 to 15 years reporting 1 or more symptoms tested at the pharmacy chain from December 26, 2021, to February 21, 2022 (data downloaded February 22, 2022). The unit of analysis was tests, because unique identifiers for individuals were not available. Cases were defined as those with positive SARS-CoV-2 NAAT results, and controls were those with negative NAAT results. Tests from children and adolescents meeting any of the following criteria were excluded: indeterminate test results, missing assay type, reported an immunocompromising condition (because COVID-19 vaccine recommendations differ for these individuals),9 unknown vaccination status, vaccine product other than BNT162b2, receipt of 1 vaccine dose or receipt of the second or third dose within 2 weeks of the test date, vaccination before the month of the recommendation by the Advisory Committee on Immunization Practices (for children 5-11 years, November 2021; for adolescents 12-15 years, May 2021 for the primary series and January 2022 for the booster dose),9,17,18 receipt of more than the authorized number of doses for nonimmunocompromised individuals (>2 for children 5-11 years, >3 for adolescents 12-15 years), receipt of a third dose less than 4 months after the second dose (for adolescents 12-15 years),9 or inconsistent vaccination information (eg, reported vaccine receipt but missing dose dates, reported no vaccine receipt but doses reported).Exposure

The exposures of interest were 2 BNT162b2 doses for children 5 to 11 years old and 2 or 3 BNT162b2 doses for adolescents 12 to 15 years old. Cases and controls were considered unvaccinated if tests were from children and adolescents who received no COVID-19 vaccine before the SARS-CoV-2 test. Cases and controls were considered vaccinated with 2 or 3 doses if tests were from children and adolescents who reported receiving the second or third dose 2 weeks or more before their SARS-CoV-2 test.Outcome

The outcome measure was symptomatic SARS-CoV-2 infection determined by positive NAAT result in a person reporting COVID-19–like illness.Statistical Analysis

Associations between symptomatic SARS-CoV-2 infection and BNT162b2 vaccination were estimated by comparing the odds of prior vaccination with 2 or 3 doses (exposed) vs no vaccination (unexposed) in cases vs controls using multivariable logistic regression. The OR was used to estimate VE, where VE = (1 – OR) × 100%. Logistic regression models were adjusted for calendar day of test (continuous variable), race, ethnicity, sex, testing site region, and testing site census tract SVI (continuous variable).14 Tests with missing sex and site census tract SVI were not included in adjusted analyses. Unknown race and ethnicity were coded as categorical levels within each variable to retain those tests in regression models.

Adjusted OR and corresponding VE of 2 doses were estimated by age group (5-11 years and 12-15 years) and month since the second dose. Because only vaccination month and year but not exact calendar dates of each dose were reported, month since the second dose was calculated as the difference between the month and year of testing and the month and year of the second vaccine dose (at least 2 weeks after the second dose). The range of possible days after the second dose for month 0 was 14 to 30 days; month 1, 14 to 60 days; month 2, 30 to 90 days; month 3, 60 to 120 days, and so on (assuming 30 days per month). Because of potential imprecision of month since vaccination based on calendar month of vaccination and testing rather than exact dates, a simulation analysis (of scenarios with rapid vs slow vaccine uptake and varying date of vaccine introduction) and an analysis of previously published data from this platform8 were conducted to compare VE estimates using this approach with those with exact number of days since the second dose (eAppendix in the Supplement).

The maximum difference between calendar month of SARS-CoV-2 test and calendar month of the second dose was 3 months for children 5 to 11 years old (tested during February 2022 and second dose received in November 2021) and 9 months for adolescents 12 to 15 years old (tested during February 2022 and second dose received in May 2021). However, VE was not calculated for the last month since the second dose (month 3 for children and month 9 for adolescents) because the number of possible days since the second dose was limited in the last month. This was a result of both the timing of vaccine authorization (children became eligible for second doses in late November 202118 and adolescents in late May 202117) and by the timing of the end of the study period (test dates were only included through February 21, 2022) (eAppendix in the Supplement). For adolescents 12 to 15 years of age, the maximum possible time after a booster was 6.5 weeks (tested February 21, 2022, and booster dose received after recommendation by the Advisory Committee on Immunization Practices on January 5, 2022).9

To assess the effect of reported prior SARS-CoV-2 infection on estimated 2-dose VE (by age group and month since the second dose), 3 sensitivity analyses were conducted. The first analysis included only tests from individuals without any reported prior SARS-CoV-2–positive test result. The second analysis included only tests from individuals without reported prior SARS-CoV-2–positive test result within 90 days, because a recent prior positive test result could have been due to prolonged NAAT positivity,19 multiple tests within the same illness episode (eg, confirming an at-home test), or reinfection with a different variant in the setting of Omicron variant emergence. The third analysis included only tests from individuals without reported prior SARS-CoV-2–positive test result more than 90 days prior to the test date, because prior SARS-CoV-2 infection provides infection-induced immunity in both vaccinated and unvaccinated individuals.20

The adjusted OR and corresponding VE of 3 doses among adolescents 12 to 15 years old were estimated overall (ie, not by month since the second dose) due to the short timeframe (6.5 weeks) since booster recommendation.

Statistical analyses were performed in R (version 4.1.2; R Foundation) and SAS (version 9.4; SAS Institute Inc). OR and VE estimates were presented with 95% CIs. To compare the waning pattern for estimated VE since the second dose between children and adolescents, an interaction term between age group (5-11 vs 12-15 years) and month after the second dose (for months 0, 1, and 2) was added to the model; a likelihood ratio test comparing the models with and without the interaction term was used to evaluate the interaction. Two-sided P values comparing the magnitude of the association of vaccination and infection between the 2 age groups and across study months were estimated; a P value less than .05 was considered significant. Because of the potential for type I error due to multiple comparisons, findings should be interpreted as exploratory.Results

A total of 121 952 tests from children and adolescents aged 5 to 15 years at 6897 sites across 49 states (all states except North Dakota), Washington, DC, and Puerto Rico, met inclusion criteria (Figure 1), including 53 272 cases (43.7%) and 68 680 controls (56.3%). The median age among individuals with included tests was 10 years (IQR, 7-13); 61 189 (50.2%) were female, 75 758 (70.1%) were White, and 29 034 (25.7%) were Hispanic/Latino. Among 74 208 included tests from children 5 to 11 years old, 58 430 (78.4%) were from unvaccinated children and 15 778 (21.3%) from those vaccinated with 2 doses. Among 47 744 included tests from adolescents 12 to 15 years old, 24 767 (51.9%) were from unvaccinated adolescents, 22 072 (46.2%) from those vaccinated with 2 doses, and 905 (1.9%) from those with booster doses.

Included tests were more frequently rapid NAAT (66.3%) than laboratory-based NAAT (33.7%), and controls were more often tested by rapid NAAT than cases (70.5% vs 60.2% for children; 71.5% vs 60.8% for adolescents) (Table). Cases vs controls were more often tests from persons from the South Atlantic region (27.6% vs 22.3% for children; 27.9% vs 23.7% for adolescents). Report of prior positive SARS-CoV-2 test result within 90 days of the test date was more common among cases than controls (22.0% vs 13.0% for children; 21.1% vs 15.5% for adolescents), while report of a positive test result more than 90 days before the test date was less common among cases than controls (4.9% vs 11.1% for children; 6.5% vs 13.4% for adolescents).

Among children 5 to 11 years old, the adjusted OR for symptomatic infection for tests performed during month 0 after the second dose was 0.40 (95% CI, 0.35-0.45; estimated VE, 60.1% [95% CI, 54.7%-64.8%]) and during month 2 after the second dose was 0.71 (95% CI, 0.67-0.76; estimated VE, 28.9% [95% CI, 24.5%-33.1%]) (Figure 2). For adolescents 12 to 15 years old, the adjusted OR during month 0 after the second dose was 0.40 (95% CI, 0.29-0.56; estimated VE, 59.5% [95% CI, 44.3%-70.6%]), during month 2 after the second dose was 0.83 (95% CI, 0.76-0.92; estimated VE, 16.6% [95% CI, 8.1%-24.3%]), and was no longer significantly different from 0 during month 3 after the second dose (OR, 0.90 [95% CI, 0.82-1.00]; estimated VE, 9.6% [95% CI, −0.1% to 18.3%]). Estimated VE was not significantly different between children and adolescents during months 0 and 1 after the second dose, but estimated VE in children was significantly higher than in adolescents during month 2 (P value for month 0: .99; month 1: .40; month 2: .01; and for months 0-2 combined: .06).

The simulation analysis showed that estimated VE waning curves that used either the exact number of days or calculated months since the second dose were in close agreement in scenarios with rapid and slow vaccine uptake and vaccine introduction on day 1 and day 16 of month 0 (eFigures 1-2 in the Supplement). The analysis of previously published data from this platform showed estimated monthly VE waning curves aligned well with daily VE waning curves (eFigures 3-4 in the Supplement).

Sensitivity analyses limited to those without any prior SARS-CoV-2–positive test result (eFigure 5 in the Supplement), without prior SARS-CoV-2–positive test result within 90 days of test date (eFigure 6 in the Supplement), and without prior SARS-CoV-2–positive test result more than 90 days prior to test date (eFigure 7 in the Supplement) yielded estimated VE at month 0 of 60.4% to 66.4% among children 5 to 11 years old and 58.3% to 64.3% among adolescents 12 to 15 years old. These were similar to the main analysis results that did not take prior infection into account. However, estimated VE in the sensitivity analyses was somewhat more sustained over time relative to the main analysis, particularly for the model limited to tests from individuals without any reported prior infection (estimated VE among children was 39.8% during month 2; among adolescents, estimated VE was significantly different from 0 until month 7) and the model limited to tests from those without infection within 90 days (estimated VE among children was 39.8% at month 2; among adolescents, estimated VE was significantly different from 0 until month 5).

Among adolescents, the adjusted OR for a booster dose 2 to 6.5 weeks after the dose was 0.29 (95% CI, 0.24-0.35; estimated VE, 71.1% [95% CI, 65.5%-75.7%]).Discussion

This analysis estimated BNT162b2 VE among children 5 to 11 years old and adolescents 12 to 15 years old with COVID-19–like illness tested for SARS-CoV-2 using NAAT at drive-through US pharmacy sites from December 26, 2021, to February 21, 2022. It found the estimated VE of the BNT162b2 2-dose primary series against symptomatic infection with the Omicron variant was modest and decreased over time since vaccination in both age groups, similar to the pattern observed in adults during Omicron variant predominance.10 A booster dose was associated with increased protection against symptomatic infection in adolescents.

Previous analyses among adults have shown lower estimated VE against the Omicron variant than against the Delta variant and waning of mRNA vaccine protection against symptomatic infection, regardless of predominant variant.8,10,11 A recent analysis from the same testing platform as this analysis demonstrated the estimated VE of the 2-dose BNT162b2 primary series against symptomatic Omicron infection among adults 18 years or older was 42% at 2 to 4 weeks after the second dose. This decreased to not significantly different from 0 by 3 months after the second dose.10 In this analysis, the estimated VE against symptomatic infection among adolescents 12 to 15 years old also was not significantly different from 0 during month 3 after the second dose. Among children 5 to 11 years old, the duration of protection could only be assessed up through month 2 since the second dose, and continued monitoring will be important.

Among adolescents 12 to 15 years old, the estimated VE against symptomatic infection increased after a booster dose. This finding is consistent with data on adults from this platform and from other studies among adults and adolescents during Omicron variant predominance, which provide evidence of increased protection following mRNA vaccine booster dose.10,21,22 Given the well-established pattern of waning mRNA VE after 2 doses and early evidence of waning of booster dose protection in adults,22 monitoring the duration of protection from booster doses in adolescents will be important. Booster doses may be needed to optimize protection against symptomatic infection with the Omicron variant in children 5 to 11 years old as well.

Children aged 5 to 11 years receive a lower-dose formulation (10 μg) of BNT162b2 than adolescents and adults (30 μg), and limited observational data are available on VE with the 10-μg dose. In this analysis, the similar starting VE among children and adolescents and slower waning seen in children than adolescents suggest the 10-μg dose performed as well or better in children than the 30-μg dose in adolescents. These findings are consistent with the phase 2-3 trial in which immunogenicity of the 10-μg dose among children 5 to 11 years old, as measured by geometric mean titers of neutralizing antibodies 1 month after the second dose, was not significantly different from that generated by 30 μg in persons 16 to 25 years old.4 Furthermore, recent studies indicate estimated 2-dose BNT162b2 VE is similar among children 5 to 11 years old and adolescents 12 to 15 years old against any Omicron infection with or without symptoms (31% and 59%, respectively, with overlapping CIs)23 and against emergency department and urgent care visits due to COVID-19 (51% among children 5-11 years vs 45% among adolescents 12-15 years, with overlapping CIs).21

Prior SARS-CoV-2 infection may influence estimated VE in various ways. Unvaccinated persons with prior infection may have infection-induced immunity, which could bias VE estimates toward the null, whereas vaccinated persons with prior infection may have higher levels of protection than those with vaccination alone.20 Additionally, the proportion of the population with prior infection and how protective prior infection from a previous variant is against currently circulating variants can also influence estimated VE. The sensitivity analysis including only children and adolescents without any reported prior infection showed that waning of estimated VE was less pronounced than in the main analysis, which may provide the clearest picture of protection provided by vaccination. However, prior SARS-CoV-2 infection is increasingly common; the estimated SARS-CoV-2 infection–induced antibody seroprevalence among US children 0 to 17 years old who had blood specimens tested at commercial laboratories (for reasons unrelated to COVID-19) was 45% in December 2021.24 Although history of SARS-CoV-2 infection was self-reported in this analysis and is an imperfect measure, 27% of tests were from persons reporting prior infection. Thus, inclusion of tests from persons with prior infection may more accurately reflect vaccine performance under current conditions in the US.

Although estimated VE against symptomatic infection waned quickly in this analysis, vaccine protection against symptomatic infection is harder to achieve than protection against severe disease. For mRNA vaccines including BNT162b2, estimated VE against severe disease and hospitalization has been higher and waned more slowly than estimated VE against infection among adolescents and adults during Delta predominance25 and Omicron predominance.21,22 While estimated VE against symptomatic infection is an important end point to inform nonpharmaceutical intervention policy decisions and can provide an early warning signal of declining VE, estimated VE against severe disease is needed for children and adolescents during Omicron variant predominance.Limitations

This analysis is subject to several limitations. First, vaccination status was self-reported, which may lead to misclassification. Second, approximately 12% of tests were from people who did not report vaccination status, and 8% had missing symptom data. Exclusion of these tests may have biased results. Third, vaccination dose dates were provided as month and year rather than exact calendar date, which could affect the estimated VE over time through imprecise classification of months since vaccination. A simulation analysis and an analysis of previously published data from this platform8 (eAppendix in the Supplement) suggested that the magnitude and patterns of estimated VE over time would be similar when estimated by day or month since second dose and additionally would be robust to different speeds of vaccine uptake and timing of vaccine authorization.

Fourth, person-level identifiers were not available; therefore, the unit of analysis was tests, not individuals. The analysis was restricted to symptomatic children and adolescents tested within a 2-month timeframe, likely reducing the number of individuals contributing multiple tests. Fifth, these data are from children and adolescents who sought testing at ICATT sites and may not be generalizable to the US population. Nonetheless, these data represent a large sample of children and adolescents 5 to 15 years old tested at 6897 sites nationally. Sixth, primary series vaccine coverage among children 5 to 11 years old and booster coverage among adolescents 12 to 15 years old remained low in the US during the time of this study.26 Children who received the primary series and boosted adolescents may differ in meaningful and unmeasured ways from unvaccinated children and unboosted adolescents.

Seventh, due to the short time (6.5 weeks) since adolescents 12 to 15 years old were recommended for a booster dose, this analysis was unable to estimate booster VE over time in adolescents. Eighth, this analysis includes both rapid and laboratory-based NAAT. While there may be slight variation in the sensitivity of assays performed at different laboratories, NAAT, including rapid NAAT, is the most sensitive method available for detection of SARS-CoV-2 infection.27 Simulations of the effect of test sensitivity on influenza VE estimates using the test-negative design suggest that estimated VE remains relatively stable over a range of test sensitivity from 80% to 100%.28Conclusions

Among children and adolescents, estimated VE for 2 doses of BNT162b2 against symptomatic infection was modest and decreased rapidly. Among adolescents, the estimated effectiveness increased after a booster dose.

References1.Centers for Disease Control and Prevention. COVID data tracker: COVID-19 weekly cases and deaths per 100,000 population by age, race/ethnicity, and sex. Accessed January 20, 2022. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime

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Pfizer Jab In Young People Only 20% Effective After 60 Days, 0% After 5 Months

Authors:  Zachary Stieber May 14, 2022 The Epoch Times

The Pfizer COVID-19 vaccine turned negatively effective after five months, according to a new study

The Pfizer COVID-19 vaccine turned negatively effective after five months, according to a new study.

Researchers with the U.S. Centers for Disease Control and Prevention (CDC) analyzed test results from sites across the United States and determined that the vaccine was 60 percent effective two to four weeks after 12- to 15-year-olds got the second of the two-dose primary regimen.

But the effectiveness, measured against symptomatic illness, quickly plummeted, hitting 20 percent around month two and zero around month five.

After that, recipients in the age group were more likely to be infected by the disease caused by the CCP (Chinese Communist Party) virus, also known as SARS-CoV-2, the virus causes COVID-19.

Vaccine effectiveness “was no longer significantly different from 0 during month 3 after the second dose,” the researchers wrote in the study, which was published by the Journal of the American Medical Association.

Pfizer, its partner BioNTech, and the CDC didn’t respond to requests for comment.

The analyzed tests were performed between Dec. 26, 2021, and Feb. 21, 2022. Some 47,700 tests among 12- to 15-year-olds were included, with about half being unvaccinated. The testing data was on the Increasing Community Access to Testing, a program funded by the U.S. Department of Health and Human Services that contracts with pharmacy chains to perform drive-through testing. The testing data was supplemented by information in questionnaires filled out by adults with the adolescents.

Limitations of the study included vaccination being self-reported.

The study was funded by the U.S. government.

The study also found that vaccine effectiveness against symptomatic infection plunged quickly for those 5 to 11 years old, starting at 60 percent but hitting 23 percent just one month later.

One way to combat the negative effectiveness, researchers said, was to get a booster dose.

Of the 906 12- to 15-year-olds who got a third, or booster, dose, the effectiveness was measured at 71 percent two to six weeks after receipt.

Other studies, though, show that the protection from a booster, like that from the primary regimen, quickly wanes.

“Given the well-established pattern of waning mRNA VE after 2 doses and early evidence of waning of booster dose protection in adults, monitoring the duration of protection from booster doses in adolescents will be important,” researchers said.

Both the Pfizer and Moderna vaccines are built on messenger RNA (mRNA) technology. VE refers to vaccine effectiveness.

In another study published by the same journal on May 13, New York researchers reported the gap of infection and hospitalization risk between unvaccinated and vaccinated youth narrowing over time, with vaccinated 5- to 11-year-olds being infected at a rate of 62 per 100,000 and unvaccinated being infected at a rate of 70 per 100,000.

That was an incidence rate ratio of 1.1; the rate ratio for 12- to 17-year-olds was 2.

The protection also waned considerably against hospitalization over time, researchers found.

They said that the findings support “efforts to increase vaccination coverage in children and adolescents.”

A Case of Hepatotoxicity After Receiving a COVID-19 Vaccine

Authors: Muath M. AlqarniAmmar Z. FaloudahAmjad S. AlsulaihebiHassan K. HalawaniAbdulmajeed S. Khan Published: December 16, 2021  DOI: 10.7759/cureus.20455


Abstract

The coronavirus disease 2019 (COVID-19) has led to a global health crisis. Its clinical manifestations are well-documented, and severe complications among patients who survived the infection are being continuously reported. Several vaccines with well-established efficacies and excellent safety profiles have also been approved. To date, few side effects of vaccines have been reported. Drug-induced hepatotoxicity is an extremely rare side effect of these vaccines, with few reported instances. In this case report, we describe a patient who experienced hepatotoxicity after receiving the COVID-19 vaccine from Pfizer BioNTech.

Introduction

The coronavirus disease 2019 (COVID-19) has caused an unprecedented global health crisis. Its most common symptoms include fever, cough, fatigue, and myalgia. Rarely, patients may develop an acute respiratory distress syndrome or multiple organ failure [1]. Other conditions, such as liver injury, may occur. Various factors can lead to liver injury, including severe inflammatory responses, severe hypoxia, drug-induced liver injury (DILI), and worsening of pre-existing metabolic conditions [2]. The manifestations of liver injury vary from elevated serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin to hepatic dysfunction in severe cases [3]. In May 2020, the Pfizer‐BioNTech COVID‐19 vaccine received emergency authorization for use among adolescents aged 12-15 years [4]. Clinical trials have demonstrated that its efficacy in this age group may be as high as 100%. The vaccine’s side effects are typically mild and non-life-threatening, including headache, fatigue, myalgias, and chills [5]. However, there have been reports on extremely rare yet life-threatening side effects, such as anaphylactic shock, deep venous thromboembolism, and pulmonary embolism [1,6].

Case Presentation

A 14-year-old female, not known to have any chronic illnesses, presented to the emergency department with epigastric pain, diarrhea, nausea, and vomiting for the past four days. Three days prior to her current presentation, the patient received the second dose of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine. The patient denied the use of any pharmaceutical, herbal, or recreational drugs. Upon arrival to the emergency room, the patient had a temperature of 36.9°C, a pulse rate of 128 bpm, a blood pressure of 90/63 mmHg, a respiratory rate of 18 rpm, and oxygen saturation of 97% on room air. On physical examination, the patient was conscious, oriented, and had a Glasgow coma scale (GCS) score of 15/15. In addition, she had mild epigastric tenderness and jaundice. No signs of chronic liver disease were evident.

On the first day of admission, vital signs returned to normal after resuscitation with intravenous fluids. The patient’s urine was dark as observed after urinary catheter insertion. The hematology panel showed Leukopenia, neutropenia, and lymphopenia among others as seen in Table 1. Biochemical and coagulation profile workups are shown in Table 2. Abdominal ultrasound was unremarkable except for a minimal rim of free fluid in the pelvic cavity. Along with conservative treatment, the patient was started on N-acetylcysteine, lactulose, and Vitamin K. In addition, ceftriaxone was given as an empirical antibiotic. On the second day, the results of AST, ALT, and alkaline phosphatase decreased, yet remained abnormally high (Figures 12).

DateWhite blood cellsNeutrophilsLymphocytesPlateletsTotal bilirubinDirect bilirubin
09/08/20211.670.9 (53.9%)0.68 (40.7%)107121.186.1
10/08/20211.220.58 (47.6%)0.56 (45.9%)107117.981.1
11/08/20211.080.37 (34.3%)0.66 (61.1%)101156.694.3
12/08/20211.250.49(39.2%)0.69 (55.2%)101179.6106.8
13/08/20211.090.53(48.6%)0.53 (48.6%)86213.4122.2
14/08/20211.000.52 (52.0%)0.45 (45.0%)87231.6154.0
15/08/20211.380.72 (52.2%)0.60 (43.5%)83291.4187.5
Table 1: Trend of the complete blood counts and bilirubin

Normal ranges: White blood cells: 4-10 x 109/L, Neutrophils: 2-7×103/µL (40%-75%), Lymphocytes: 1-3.5×103/µL (20%-45%), Platelets: 150-400×103/µL, Total bilirubin: 0-21 µmol/L, Direct bilirubin: 0-3.4 µmol/L

DateProthrombin timeAPTTinternational normalized ratioPotassiumSodium  Ammonia  Creatine  
09/08/202157.953.24.615.53134162.136
10/08/202148.81749.9485.463.97125211.89
11/08/202134.83253.1093.6913.86132156.420
12/08/202125.03050.6022.5163.4113938.826
13/08/202123.93264.2092.3884.6513780.451
14/08/202123.647.51.813.44133125.716
15/08/202115.37142.2981.4293.3313132.511
Table 2: Trends of the chemical and coagulation profiles

Abbreviations: APTT: Activated Partial prothrombin time, INR: international normalized ratio

Normal ranges: Prothrombin time: 11-13 seconds, Partial prothrombin time 28-40 seconds, INR: 0.9-1.2, Potassium: 3.5-5.1 mmol/L, Sodium: 136-145 mmol/L, Ammonia: 11-51 µmol/L

AST-and-ALT-trends
Figure 1: AST and ALT trends

Normal ranges: AST – Aspartate transaminase (0-40 U/L), ALT – Alanine transaminase (0-41 U/L)

Alkaline-phosphatase-and-albumin-trends
Figure 2: Alkaline phosphatase and albumin trends

Normal ranges: Albumin: 39.7-49.4 mmol/L, Alkaline phosphate: 35-104 mmol/L

On the fourth day, the patient became agitated and non-responsive, when assessed, her GCS score dropped to 8/15. Consequently, she was transferred to the intensive care unit, where she was intubated. Consultations from gastroenterology, infectious disease, neurology, and hematology departments were requested. Following this, a wide range of infectious, immunological, and toxicological tests were ordered (Tables 3,4). Nevertheless, all the results were unremarkable. To rule out structural brain pathologies, a brain computed tomography without contrast was performed. A suspicious hypodense lesion in the right temporal lobe was identified. However, the findings from the brain magnetic resonance imaging were unremarkable.

TestResult
Blood culture and sensitivity Negative
Cytomegalovirus immune globulin M (CMV IgM)Negative
Indirect Coombs testNegative
Direct Coombs testNegative
Hepatitis A virus immune globulin M (HAV IgM)Negative
Hepatitis C virus antibodies (enzyme immunoassays) Negative
Hepatitis B surface antigen (HBsAg)Negative
Urine culture and sensitivityNegative
human immunodeficiency virus serology (HIV)Negative
Stool Culture and sensitivityNegative
Chikungunya PCRNegative
Alkhurma virus PCRNegative
Dengue virus PCRNegative
Dengue virus serotypeNegative
Dengue virus IgGNegative
Dengue virus nonstructural protein 1 (NS1)Negative
Dengue virus IgMNegative
Rift valley fever PCRNegative
Anti-Smooth Muscle Antibody (ASMA)Negative
Antinuclear Antibodies (ANA)Negative
Anti-Liver-Kidney Microsomal Antibody (LKM)Negative
Table 3: Immunologic and infectious work-up for liver disease

Abbreviations: Ig: immunoglobulin, PCR: polymerase chain reaction

Name of the tested substanceResult
ParacetamolNegative
Salicylic acidNegative
Narcotic alkaloids and its derivativesNegative
BenzodiazepinesNegative
Barbituric acidNegative
Tricyclic antidepressants Negative
Organophosphorus pesticidesNegative
EthanolNegative
Table 4: Urine and blood toxicology panel

The patient’s level of consciousness returned to normal by the seventh day, her liver enzyme levels continued to decline, and her symptoms have resolved. Afterward, she was transferred to a liver transplant center for further investigation and management.

Discussion

DILI is the most common cause of acute liver injury in developed countries [7]. Its presentation ranges from an incidental elevation of liver enzymes to outright acute liver failure [8]. There are two types of DILI: idiosyncratic and intrinsic. The most common type of which is the intrinsic type that has a short latency period and is dose-dependent. An example of an offending agent in this type is acetaminophen. Contrarily, the idiosyncratic type is less common and has a longer latency. A few examples of idiosyncratic drugs are amoxicillin, nonsteroidal anti-inflammatory drugs, and isoniazid [9]. In our case, we hypothesized the type of DILI to be idiosyncratic, due to the short latency period.

The diagnosis of DILI is made by identifying a relationship between drug exposure and the onset of liver disease. It is important to exclude any infectious, autoimmune, or other forms of liver disease. A thorough medical history and a high clinical suspicion are the basis for a correct diagnosis. A recovery following withdrawal from an offending agent may indicate DILI [10]. A diagnostic criterion that can be utilized in diagnosing DILI is the Rousse Uclaf Causality Assessment Method of the Council of International Organization of Medical Science (RUCAM/CIOMS) [11]. This criterion was applied to our patient’s case, and a total of 6 was calculated, indicating that DILI is probable.

Currently, there is no effective treatment for DILI other than discontinuing the offending drug and providing patients with supportive measures until their condition improves [12]. The exception is acetaminophen intoxication in which an antidote can be used in management, namely N-acetylcysteine. Early transfer of patients with idiosyncratic DILI to tertiary liver centers is important. Liver transplantation increases overall survival from 27.8% to 66.2% [13]. Withholding the transplantation can result in infection, brain damage, organ failure, and even death [14].

There have been three reports of patients having hepatic failure, with one case being acute, after receiving the Pfizer/BioNTech BNT162b2 mRNA vaccine in the United Kingdom between September 12, 2020 and September 4, 2021. Moreover, there have been 17 reported cases of liver injury, with two cases being drug-induced [15]. The possible side effects of the COVID-19 vaccines on the liver are not limited to one type. Two case reports suggested that the ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca) may trigger acute autoimmune hepatitis [16]. Mann et al. reported a case of a 61-year-old female who developed generalized weakness and low-grade fever after receiving the second dose of Pfizer/BioNTech BNT162b2 mRNA vaccine. The patient had an ALP of 207 µ/L, total bilirubin of 6.2 mg/dL, direct bilirubin of 3.9 mg/dL, a WBC of 17 x 109, and AST of 37 U/L. All laboratory workup and imaging to investigate possible etiologies were unremarkable. As compared to our case, there were significant differences in age group, initial presentation, and degree of liver injury [17].

Prior to her recent presentation, our patient had no chronic illnesses. Given that her history, physical examination, and laboratory workups were unremarkable, the patient’s clinical picture was attributed to hepatotoxicity secondary to the Pfizer/BioNTech BNT162b2 mRNA vaccine, the only pharmacological agent that she was exposed to before her current presentation.

Conclusions

This is a case of hepatotoxicity in a 14-year-old patient that occurred after receiving the second dose of the Pfizer/BioNTech BNT162b2 mRNA vaccine. The exhaustive clinical and laboratory evaluation failed to establish any other plausible etiology besides the vaccine. The purpose of this report is to raise awareness of this uncommon but potentially life-threatening side effect.


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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.”