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Doctors sue CDC over childhood vax schedule, demanding proof it does more good than harm



Health and Human Services Secretary Robert F. Kennedy Jr. indicated during a congressional hearing in June that kids "get 69 to 92 jabs" by the time they are 18 years old. Now, two doctors are working to change the burden of proof from on the patients who are subjected to them, to on the government agencies that effectively demand them.

Tony Lyons, president of MAHA Action, told Blaze News that the "vaccines have never been properly tested, either individually, in groupings, or as the full schedule, so no one can honestly say that they are not linked to the chronic disease epidemic."

Two doctors backed by the advocacy group Stand for Health Freedom have filed a lawsuit against the Centers for Disease Control and Prevention challenging the agency's recommended childhood immunization schedule.

Dr. Paul Thomas and Dr. Kenneth Stoller, both of whom had their medical licenses suspended and revoked in recent years for standing up against the vaccination regime, want to flip the burden of proof on the matter.

Their complaint, filed on Aug. 15 in the U.S. District Court for the District of Columbia, notes that "America administers more vaccines than any nation on earth while producing the sickest children in the developed world. Yet CDC demands proof of harm while refusing to conduct the studies that could provide it."

"They who recommend dozens of medical interventions for millions of children must first prove that these interventions taken together result in more good than harm," the complaint says.

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Photo illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty

In their lawsuit, the doctors accuse the CDC of violating:

  • the Administrative Procedure Act by issuing de facto "binding national mandates" without required rulemaking and "by failing to consider the important aspect of cumulative vaccine safety";
  • the Fifth Amendment's Due Process Clause "by compelling medical interventions without scientific basis while punishing those who seek evidence of safety";
  • the Fifth Amendment's Equal Protection Clause by allegedly denying the medical vulnerability of certain children, treating all children as medically identical, and treating "each vaccine as if administered in a biological vacuum, ignoring cross-reactivity and cumulative burden on vulnerable immune systems"; and
  • the First Amendment by suppressing, through its contraindication framework, "medical and scientific dissent through coordinated professional retaliation."

In addition to requesting that the court affirm these accusations, the doctors seek an injunction against the CDC from maintaining any Category A recommendations for childhood vaccines.

The Advisory Committee for Immunization Practices is the federal panel that makes the vaccine recommendations that become official policy at the CDC and apply to the entire American population once adopted by the agency's director.

The panel, which was purged in June by Kennedy of all of its Biden administration appointees, organizes its vaccine recommendations into two categories: A and B.

Category A recommendations are made for all persons in an age- or a risk-factor-based group. Category B recommendations are made for individual clinical decision-making.

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Photographer: Al Drago/Bloomberg via Getty Images

Thomas and Stoller figure that until the CDC can demonstrate through "scientifically rigorous" studies that the cumulative schedule is safe, all the vaccines should be shifted into the second category.

While the ACIP's recommendations are technically advisory, they are effectively enforced as mandatory standards in most jurisdictions in the country.

'High vaccination rates don't require coercion.'

"Medical boards revoke licenses for deviation. Schools exclude children. Insurance coverage depends on compliance," the lawsuit says.

Lyons told Blaze News, "It's a mandate when children in every state can't go to school without following the schedule. It's disingenuous to claim that it's just a recommended schedule. Everyone knows that isn't true."

Reclassifying the vaccine recommendations as Category B could serve to neutralize such mandates.

Richard Jaffe, attorney for the plaintiffs, indicated that this lawsuit differs from other challenges to the CDC's vaccination schedule because rather than focus on state mandates or exemptions, it is taking the agency to task on administrative and constitutional grounds.

"We're not asking to ban vaccines," Jaffe wrote. "High vaccination rates don't require coercion. Parents make responsible choices when given honest information and medical freedom."

When pressed for comment, a representative for the CDC told Blaze News that the agency "does not discuss pending litigations."

Dorit Reiss, a vaccine policy researcher at the University of California Law, San Francisco, told Politico, "This lawsuit does not raise valid legal claims, is by plaintiffs who do not have direct injury from the schedule as a whole — the doctors lost their license for other things — and its factual basis is untrue."

"It seems more performative than anything else," added Reiss, who previously complained about the HHS scrapping its recommendation that pregnant women and kids get the COVID-19 vaccines.

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FDA blasts 'politically motivated' criticism over review of SSRI health risks during pregnancy



The U.S. Food and Drug Administration is pushing back against criticism from medical establishmentarians over the agency's willingness to take a closer look at the health risks posed by antidepressants, specifically selective serotonin reuptake inhibitors, during pregnancy.

Various health organizations, including the American College of Obstetricians and Gynecologists, accused FDA Commissioner Dr. Marty Makary, his agency, and the participants in an expert panel discussion that Makary hosted last month of disseminating "inaccurate" information and of making "outlandish" claims.

'Adolescents exposed to SSRIs in utero exhibited higher anxiety and depression symptoms than unexposed adolescents.'

An FDA spokesperson defended the agency's discussions with experts on the topic, suggesting to Blaze News that the critiques of the agency's expert advisory process were "politically driven."

Dr. Jay Gingrich, professor of developmental psychology at the Columbia University Medical Center, noted during the July 21 panel discussion that while expectant mothers suffering depression have long been prescribed SSRIs, it was not until recently that any substantial research was undertaken to determine whether these drugs improved outcomes in the mothers' offspring.

JAMA Medical News confirmed that no randomized clinical trials have been undertaken, due partly to ethical concerns. Despite the absence of such trial data, 6%-8% of pregnant women are reportedly prescribed SSRIs in the United States.

After observing in rodent trials that the mice born of female mice exposed to SSRIs exhibited "stark changes in behavior" and "changes in the brain," Gingrich explored with Finnish researchers whether SSRI exposure in the womb was similarly consequential for human children and found that it was.

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Farrukh Saeed/Getty Images

A study co-authored by Gingrich and published earlier this year in the peer-reviewed journal Nature Communications provided further confirmation of negative impacts, revealing that "adolescents exposed to SSRIs in utero exhibited higher anxiety and depression symptoms than unexposed adolescents and also had greater activation of the amygdala and other limbic structures when processing fearful faces."

The study concluded that "SSRIs are a common therapeutic strategy in perinatal maternal emotional disorders, however the present cross-species data and prior studies on single species indicate that we need more mechanistic understanding of how pharmacological factors like SSRIs impact early brain development and later result in maladaptive behaviors."

'The public needs better information, and the FDA must strengthen the warnings.'

Dr. Adam Urato, chief of maternal-fetal medicine at MetroWest Medical Center in Massachusetts, told his fellow panelists that he has observed in recent years women increasingly taking antidepressants during pregnancy, in many cases thinking SSRIs "don't affect the baby or cause complications."

"These drugs alter the mom’s brain. Why wouldn't they affect the baby’s?" said Urato. "We can see it on prenatal ultrasound. The ultrasound studies show SSRI-exposed fetuses have different movement and behavior patterns. After birth the newborn babies can have jitteriness, breathing difficulties, and higher rates of admission to the neonatal intensive care unit."

"The public needs better information, and the FDA must strengthen the warnings," Urato underscored. "For example, there's currently no warning regarding preterm birth or preeclampsia. The postpartum hemorrhage warning needs to be strengthened. But perhaps the major shortcoming is that the label doesn't make clear that SSRIs alter fetal brain development."

The concerns raised by Gingrich, Urato, and the other panelists evidently ruffled some feathers at organizations that champion the use of SSRIs during pregnancy.

Steven Fleischman, president of the American College of Obstetricians and Gynecologists, rushed to complain, stating shortly after the conclusion of the panel discussion that it "was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy," adding, "Robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects.

The American College of Obstetricians and Gynecologists' current practice guidelines reportedly recommend SSRIs as a first-line pharmacotherapy for mothers between the time of conception and up until a year after the baby's birth.

Fleischman told JAMA Medical News last week that the panel may "incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need."

'Commissioner Makary has an interest in ensuring policies reflect the latest gold-standard science and protect public health.'

Marketa Wills, CEO of the American Psychiatric Association, echoed Fleischman in a July 25 letter to Makary, stating, "We are alarmed and concerned by the misinterpretations and unbalanced viewpoints shared by several of the panelists."

"The inaccurate interpretation of data, and the use of opinion, rather than the years of research on antidepressant medications, will exacerbate stigma and deter pregnant individuals from seeking necessary care," wrote Wills.

In addition to stating that "the overall evidence suggests that individuals can and should take SSRIs prior to or during pregnancy, when they are clinically indicated for treatment," Wills claimed that "recent meta-analyses have found no association between prenatal SSRI exposure and overall risk of birth defects."

The Society for Maternal-Fetal Medicine similarly complained, suggesting that the panelists made "unsubstantiated and inaccurate claims."

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Dobrila Vignjevic/Getty Images stock photo

Other groups similarly outraged by the discussion of possible downsides to drugs characterized as safe and effective include Postpartum Support International, the National Curriculum in Reproductive Psychiatry, and the Massachusetts General Hospital for Women's Mental Health.

An FDA spokesperson told Blaze News, "The claim that the FDA’s expert advisory process is 'one-sided' or politically driven is insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels."

"FDA expert panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and individual experts may offer their recommendations for regulatory action," continued the spokesperson. "This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight, thoroughly considering evolving science and consumer health."

The spokesperson noted that "Commissioner Makary has an interest in ensuring policies reflect the latest gold-standard science and protect public health" and stated that suggesting "his engagement on women’s health signals a desire to manipulate outcomes is politically motivated and undermines the serious work being done to improve care for millions of women."

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Blood clots, neurological disorders, and swollen hearts: Multinational study on COVID vaccines paints a damning picture



Those skeptical of the assertion that COVID-19 vaccines were altogether safe and effective — a claim long advanced by once-trusted government agencies, pharmaceutical companies, and the media amidst a historic censorship campaign targeting dissenters and critics — appear to have had their doubts once again validated.

A damning new peer-reviewed multinational study examining data from nearly 100 million people has not only affirmed the well-documented link between the COVID-19 vaccines and increased risk of heart conditions but has also highlighted troubling links between the AstraZeneca, Moderna, and Pfizer vaccines and medical conditions such as Guillain-Barré syndrome, brain and spinal cord inflammation, Bell's palsy, and convulsions.

The study was conducted by the Global COVID Vaccine Safety Project — a Global Vaccine Data Network initiative supported by both the Centers for Disease Control and Prevention and the Department of Health and Human Services — and published last week in the esteemed journal Vaccine, the official journal of the Japanese Society for Vaccinology.

Lead author Kristýna Faksová of the Department of Epidemiology Research at the Danish State's Serum Institute was joined by researchers from various other countries including Argentina, Australia, Canada, Finland, New Zealand, and Scotland in assessing whether there was a greater risk of 13 neurological, blood, and heart-related medical conditions occurring following the receipt of a COVID-19 vaccine.

According to the observed versus expected rates study, which included data on 99 million people vaccinated against SARS-CoV-2 across eight countries, "the risk up to 42 days after vaccination was generally similar to the background risk for the majority of outcomes; however, a few potential safety signals were identified."

"Bell's palsy had an increased OE ratio after a first dose of [Pfizer's] BNT162b2 and [Moderna's] mRNA-1273," said the study. "There were also increased OE ratios for febrile seizures following a first and second dose of mRNA-1273 ... and for generalized seizures following first mRNA-1273 dose and fourth BNT162b2 dose."

The researchers observed a trend of Guillain-Barré syndrome and cerebral venous sinus thrombosis — a type of blood clot in the brain — cases after viral vector vaccines such as the Oxford-AstraZeneca COVID-19 vaccine, which Canada and European nations ditched in spring 2021 over reports of dangerous blood clots.

The researchers specifically found a "statistically significant increase in GBS cases within 42 days after a first ChAdOx1 dose." Whereas they expected to find 76 GBS "events," they found well over twice as many.

The University of Auckland, which hosts the Global Vaccine Data Network, noted that the researchers found possible "safety signals for transverse myelitis (inflammation of part of the spinal cord) after viral vector vaccines and acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after viral vector and mRNA vaccines."

However, the paper cautioned that "although some case reports have suggested a possible association between COVID-19 vaccination and ADEM, there was no consistent pattern in terms of vaccine or timing following vaccination, and larger epidemiological studies have not confirmed any potential association."

The study did however confirm previously established safety signals for myocarditis and pericarditis following mRNA vaccination, highlighting "significantly higher risks of myocarditis following the first, second and third doses of BNT162b2 and mRNA-1273 as well as pericarditis after the first and fourth dose of mRNA-1273, and third dose of ChAdOx1, in the 0–42 days risk period."

According to the study, "Potential underreporting across countries may have led to an underestimation of the significance of potential safety signals" for viral vector and mRNA vaccines alike.

"The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals," Faksová said in a statement. "Single sites or regions are unlikely to have a large enough population to detect very rare signals."

The researchers claimed that the "safety signals identified in this study should be evaluated in the context of their rarity, severity, and clinical relevance."

Additionally, they noted the "overall risk–benefit evaluations of vaccination should take the risk associated with infection into account, as multiple studies demonstrated higher risk of developing the events under study, such as GBS, myocarditis, or ADEM, following SARS-CoV-2 infection than vaccination."

Blaze News reported earlier this month that a peer-reviewed study published Jan. 24 in the Springer Nature Group journal Cureus suggested the COVID-19 vaccines were a rushed product with an "unacceptable harm-to-reward ratio."

The study noted that the kinds of serious adverse events that would be factored into a risk-benefit comparison "have often been wrongly ascribed to COVID-19 rather than to the COVID-19 mRNA vaccinations."

"Misattributions of SAEs to COVID-19 often may be due to the amplification of adverse effects when mRNA injections are followed by SARS-CoV-2 subvariant infection," said the study. "Injuries from the mRNA products overlap with both [post-acute COVID-19 syndrome] and severe acute COVID-19 illness, often obscuring the vaccines' etiologic contributions."

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Biden admin's latest vaccine push falls on deaf ears, with majority indicating they will not get the COVID-19 shot



The Biden administration has implored Americans in recent weeks to get yet another COVID-19 booster. A new poll has revealed that the majority of Americans have no interest in complying. This is especially true of Republicans.

Moderna, whose profits in recent years have been driven by COVID-19 vaccine sales, claimed in August that an early study showed its latest vaccine to be effective against the so-called "Eris" and "Fornax" subvariants. Pfizer similarly alleged that the shot it developed with BioNTech has demonstrated neutralizing activity against the Eris subvariant, at least in mice, reported Reuters.

On Sept. 12, eight days after the double-vaccinated and twice-boosted first lady Jill Biden came down with COVID-19 yet again, the Centers for Disease Control and Prevention recommended that everyone 6 months and older take the updated COVID-19 vaccines.

The CDC further claimed that the "benefits of COVID-19 vaccination continue to outweigh any potential risks" and that "serious reactions after COVID-19 vaccination are rare."

Eighty-year-old President Joe Biden, who last caught COVID-19 in July 2022, got an updated booster on Sept. 22 and encouraged all Americans to do likewise.

The latest Kaiser Family Foundation COVID-19 Vaccine Monitor poll revealed last week that 52% of U.S. adults don't feel much like following the president's lead.

According to the poll, 33% of respondents said they would "definitely not get" the vaccine and another 19% indicated they would "probably not get" the vaccine.

Conversely, 23% of adults indicated they "definitely" plan to get the vaccine and another 23% suggested they will "probably" get it.

And 94% of respondents who never received a vaccine indicated they'd likely hold fast. Only 1% indicated with any certainty they'd cave now, years after America achieved herd immunity.

When it comes to children, it appears most parents won't roll the dice.

According to the KFF, "Most parents say they will not get their child the new COVID-19 vaccine including six in ten parents of teenagers (those between the ages of 12 and 17), and two-thirds of parents of children ages 5 to 11 (64%) and ages 6 months to 4 years old (66%)."

Over half of parents of children aged five and younger gladly admitted to neither giving their child the COVID-19 vaccine nor intending to do so in the future.

A key predictor of vaccine uptake appears to be political affiliation.

Whereas 69% of Democrats indicated they would probably or definitely get the latest shot, the same was true of only 25% of Republican respondents. On the flip side, 29% of Democrats expressed resistance, whereas 76% of Republicans indicated they would not get the booster.

It appears that Democrats continue to let COVID-19 concerns dictate their lives; 58% of Democratic respondents indicated they changed their behavior to "be more COVID-conscious." Only 19% of Republicans did likewise.

There may be a link between uptake and confidence in vaccine safety and medical authorities. After all, 84% of Democrats believe the vaccines are safe. Only 36% of Republicans think likewise.

And 88% of Democratic respondents indicated they trust the CDC, and 86% said they trust the U.S. Food and Drug Administration. For Republicans, the corresponding trust levels were 40% and 42%, respectively.

As has been true throughout the pandemic, a much smaller share of Republicans (24%) than Democrats (70%) expect to get the new COVID-19 vaccine \u2013 a 46 percentage point gap, according to our latest COVID-19 Vaccine Monitor poll. https://t.co/u1INw3bC6o
— KFF (@KFF) 1696169707

According to the CDC's COVID-19 tracker, only 1.8% of emergency department visits between Sept. 17 and Sept. 23 were diagnosed as having the virus.

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'There's something going on': Scientists acknowledge the severity of 'long vax' as well as their reluctance to pursue research that might furnish skeptics with a 'sensational headline'



Science, the peer-reviewed academic journal of the American Association for the Advancement of Science, has just published damning admissions substantiating fears about COVID-19 vaccines that would have up until recently been verboten to express online.

Just as there is allegedly "long COVID," in which persons who contracted the virus suffer various symptoms long after they should have recovered, the American medical establishment now appears comfortable admitting there is similarly "long vax."

After the obligatory claim that COVID-19 vaccines have saved lives, Science correspondents Gretchen Vogel and Jennifer Couzin-Frankel noted that COVID-19 vaccines aren't just causing side effects, such as "abnormal blood clotting and heart inflammation," but have been linked to "a debilitating suite of symptoms that resembles Long Covid."

"You see one or two patients and you wonder if it’s a coincidence," Dr. Anne Louis Oaklander, neurologist and researcher at Harvard Medical School, told the journal. "But by the time you’ve seen 10, 20. .... Where there's smoke, there's fire."

Vogel and Couzin-Frankel suggested that symptoms of vaccine fallout "can include persistent headaches, severe fatigue, and abnormal heart rate and blood pressure. They appear hours, days, or weeks after vaccination and are difficult to study. But researchers and clinicians are increasingly finding some alignment with known medical conditions."

One of these conditions is reportedly small fiber neuropathy, whereby "nerve damage can cause tingling or electric shock-like sensations, burning pain, and blood circulation problems."

Another is postural orthostatic tachycardia syndrome (POTS), which can manifest as "muscle weakness, swings in heart rate and blood pressure, fatigue, and brain fog."

The National Institutes of Health noted in December 2022 that researchers examining linkages between COVID-19 vaccines and "uncommon side effects" had found "a slight increase in the number of people who have experienced postural orthostatic tachycardia syndrome (POTS) following vaccination."

Some patients are reportedly unfortunate enough to suffer "features of one or both conditions."

Peter Marks, director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research, which oversees vaccines, told the journal, "We can't rule out rare cases" where vaccines have triggered small fiber neuropathy or POTS and further stressed the importance of health care providers taking "seriously the concept [of] a vaccine side effect."

However, Marks appears to be worried that admitting vaccines are hurting people in the long term could give rise to a "sensational headline" that would, as Vogel and Couzin-Frankel phrased it, "mislead the public."

The article alludes to the German health minister's recent acknowledgement that COVID-19 vaccines, which were similarly de facto mandatory in his country, have been shown to result in long-term consequences.

Karl Lauterbach, the minister in question, reportedly told Christian Sievers of the ZDF Heute Journal that what has happened to people affected by vaccine injuries "is absolutely dismaying and every single case is one too many. I honestly feel very sorry for these people. There are severe disabilities, and some of them will be permanent," adding "1 in 10,000 is the frequency of serious side effects."

DW reported that the Paul Ehrlich Institute, the German Federal Institute for Vaccines and Biomedical Drugs, "has registered 333,492 cases of suspected harmful vaccination side effects and 50,833 suspected cases of serious side effects since the start of the vaccination campaign: a reporting rate of 1.78 per 1,000 vaccine doses."

Vogel and Couzin-Frankel stressed that researchers studying the long-term fallout of the vaccines, such as Harlan Krumholz, a cardiologist at Yale University, are worried about "undermining trust."

Krumholz reportedly indicated he was initially reluctant to "dive in" for fear of bringing to light truths that might be seized upon by vaccine critics.

Notwithstanding his reservations, Krumholz said, "I’m persuaded that there’s something going on” with these side effects. "It’s my obligation, if I truly am a scientist, to have an open mind and learn if there’s something that can be done."

Krumholz and Yale immunologist Akiko Iwasaki have started a post-vaccination study called LISTEN, for Listen to Immune, Symptom and Treatment Experiences Now, reported the New York Post.

They are attempting to "understand long COVID, post-vaccine adverse events and the corresponding immune responses by collecting information about symptoms and medical history from participants."

Theirs is not the only show in town, however.

Researchers at Cedars-Sinai Medical Center analyzed a health database of nearly 300,000 people in Los Angeles, all of whom had received at least one COVID-19 shot.

"They found that within 90 days after a shot, the rate of POTS-related symptoms was about 33% higher than in the 3 months before; 2581 people were diagnosed with POTS-related symptoms after vaccination, compared with 1945 beforehand," Vogel and Couzin-Frankel indicated.

Some researchers suspect that the SARS-CoV-2 spike protein, delivered by the vaccines, may be responsible for "long vax," as it may instigate an immune overreaction and destabilize ACE2 signaling.

Although the specifics of how precisely the vaccines are upending some patients' lives are presently being worked out, Lawrence Purpura, an infectious disease specialist at Columbia University, is certain about the consequences.

Postvaccination illness is "a long, relentless disease," said Purpura.

In recent years, amid a broader effort to censor down vaccine skepticism, the Biden White House has pressured social media companies to silence those who raised concerns about the short- and long-term effects of COVID-19 vaccines, including Tucker Carlson.

While curbing dissenting views and squelching expressions of concern, the Biden administration imposed vaccine mandates, knowing full well there were "breakthrough" infections despite COVID-19 vaccination, contrary to how they were sold to the public.

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