Category: FDA

Federal Court Sides With Doctors on Ivermectin Lawsuit Charging FDA Overreach

  • Published September 18, 2023
  • Federal & State Courts
Ivermectin antiparisitic drug

The Fifth Circuit Court of Appeals in New Orleans has given new life to a lawsuit brought by three doctors claiming the U.S. Food and Drug Administration (FDA) overstepped its authority and acted as a medical doctor rather than as a regulating authority in the agency’s campaign promoting a ban on the use of the drug Ivermectin in the treatment of COVID-19.1

The court’s decision overturned U.S. District Judge Jeffrey Vincent Brown’s lower court’s order dismissing the doctors’ lawsuit. Judge Brown agreed with the government that it was protected from the lawsuit due to sovereign immunity.2 Sovereign immunity provides that the government may not be sued without its consent. The purpose behind the legal doctrine of sovereign immunity is to protect the government from being forced to change policies should someone disagree with them and bring legal action.3

The medical doctors, Mary Bowden, Paul Marik, and Robert Apter, argue that the FDA’s actions of interfering with their prescribing of Ivermectin harmed their reputation caused punitive action to be taken against them, and interfered with the practice of medicine, which included pharmacies failing to fill their prescription orders for Ivermectin.

Jared Kalson, the lawyer for the plaintiffs argued:

If the government is going to label Ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out. The government engaged in a singularly effective campaign here to malign a common drug that has been used for a very long time and has been dispensed in billions of doses. It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the Ivermectin,’ I don’t understand how that would not be traceable back to the FDA.4

Court Rules “FDA Not a Physician”

The plaintiffs appealed the lower court order to the Fifth Circuit Court of Appeals. The panel of three appellate judges, including Judge Don Willet, Judge Jennifer Walker Elrod, and Judge Edith Brown Clement agreed with the plaintiffs that the FDA committed government agency overreach and allowed the doctors to proceed with their lawsuit.5

The Order read,:

FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The doctors have plausibly alleged that FDA’s posts fell on the wrong side of the line between telling about and telling to. As such, the doctors can use the APA to assert their ultra vires claims against the agencies and the officials.6

Judge Willet took issue with the FDA’s Aug. 21, 2021 Twitter post stating, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The judge wrote, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”7

How a Licensed Inexpensive Antiparasitic Drug Helped Treat COVID

Merck originally marketed Ivermectin, which was licensed in 1981, as a veterinary antiparasitic drug. By the late 1980s, Ivermectin became the most widely used antiparasitic drug in both animals and humans and has been especially useful in Africa to effectively and safely control malaria.8 9 A Nobel prize-winning drug, doctors have been prescribing Ivermectin to patients for decades.10

So how did a cheap, accessible antiparasitic become such a popular drug used to treat SARS-CoV-2 infections during the COVID pandemic?

In 2020, Australian researchers from the Biomedicine Discovery Institute (BDI) at Monash University made the discovery that Ivermectin could neutralize the novel SARS-CoV-2 virus within 48 hours. The study, a joint effort between Monash Biomedicine Discovery Institute, Monash University in Clayton, Australia, and the Peter Doherty Institute of Infection and Immunity—a joint venture between the University of Melbourne and the Royal Melbourne Hospital, both in Melbourne, Australia—found that, in vitro, the drug proved effective against a number of viruses, including HIV, dengue, influenza, and Zika. The findings suggested that just a single dose of Ivermectin could remove or significantly reduce viral RNA within 24 to 48 hours of SARS-CoV-2 .

Dr. Kylie Wagstaff, Monash Biomedicine Discovery Institute scientist and leader of the study said: “We found that even a single dose could essentially remove all viral RNA by 48 hours and that even at 24 hours there was a really significant reduction in it.”

A study was published in 2021 in the American Journal of Therapeutics providing evidence that the use of Ivermectin reduces morbidity and mortality from SARS-CoV-2 infections, including time to recovery and viral clearance.11 In addition, Ivermectin is being investigated as an option for treating certain other human viral infections like latent Epstein Barr, which can be reactivated in some individuals when they are infected with SARS-CoV-2 and lead to long COVID.12 13 14

Ivermectin Showed Antiviral Effects Against Omicron and Other Variants

Off-label use of Ivermectin has been the source of much scrutiny among many public health officials throughout and even following the pandemic. And while historically prescribed as an antiparasitic for humans and animals, the drug did show and other variants in 2022 during joint nonclinical research conducted by Japanese pharmaceutical company, Kowa Co. Ltd.15

Additionally, another study published in The Lancet in 2021 found Ivermectin to incite “antiviral activity against SARS-CoV-2 and provides insights into the type of evaluations to be considered in the assessment of antiviral drugs for the control of COVID.”16

Popular podcast host and health and wellness influencer Joe Rogan posted a video only days after the FDA urged people to stop taking the drug to prevent or treat COVID-19 to share he was taking Ivermectin after contracting the virus. He said that taking Ivermectin in conjunction with monoclonal antibodies, prednisone, azithromycin, a NAD drip, and a vitamin drip, a protocol he shared with his followers, helped him feel “great” only three days later.

FDA’s Condemnation of Ivermectin-Blocked Doctor Prescriptions for COVID Patients

Judge Willet further pointed out that Ivermectin is available in both animal and human form and that doctors have been prescribing the drug to patients for decades. However, after the FDA’s condemnation of Ivermectin as an ineffective and potentially dangerous treatment for COVID-19, pharmacies across the country began refusing to fill doctors’ prescriptions for patients.

A Department of Justice attorney, Ashley Cheumg Honold, clarified the FDA’s position to the court stating…

FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID.17

Despite the FDA’s statement that doctors have the authority to prescribe Ivermectin to treat COVID, pharmacies continue to refuse to fill prescriptions for the drug, leaving patients scrambling. Dr Bowden told The Epoch Times:

This needs to come to an end. In telling my patients what medicines they can and cannot have access to, we effectively have a large group of pharmacists practicing medicine without a license. They have no accountability for this yet they are allowed to dictate patient care. … I see it every single day. Enough is enough.18

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Click here to view References:

1 Robertson N. Federal appeals court revives lawsuit against FDA over COVID-19 ivermectin messaging. The Hill. Sept. 2, 2023.

2 Stieber Z. Judge Rules on Lawsuit Against FDA Over Ivermectin. The Epoch Times. Dec. 6, 2022.
3 What Is Sovereign Immunity? Definition and Examples. ThoughtCo.
4 Stieber Z. Judge Rules on Lawsuit Against FDA Over Ivermectin. The Epoch Times. Dec. 6, 2022.
5 Lysiak M. ‘FDA Is Not a Physician’: Appeals Court Sides With Doctors on Ivermectin for COVID-19. The Epoch Times Sept. 2, 2023.
6 Ibid.
7 Ibid. 
8 Laing R, Gillan V, Devaney E. Ivermectin – Old Drug, New Tricks? Trends Parasitol June 2017; 33(6): 463-472.
9 Foy BD, Alout H, Seaman JA et al. Efficacy and risk of harms of repeat Ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial. The Lancet 2019; 393 (10180): 1517-1526.
10 Santin AD, Scheim DE, McCullough PA et al. Invermection: a multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19. New Microbes New Infect 2021; 42.
11 Kory P, Meduri GU, Varon J et al. Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. Am J Ther 2021; 28(3).
12 Gold JE, Ikyay RA, Licht WE, Hurley DJ. Investigation of Long COVID Prevalence and its Relationship to Epstein-Barr Virus Reactivation. Pathogens 2021; 10(6).
13 Na L, Zhao L, Zhan X. Quantitative proteomics reveals a broad-spectrum antiviral property of ivermectin benefiting for COVID-19 treatment. J Cell Physiol 2021; 236(4): 2959-2974.
14 Bernal KDE, Whitehurst CB. Incidence of Epstein Barr virus reactivation is elevated in COVID-19 patients. Virus Res 2023; 334: 199157.
15 Reuters. Ivermectin shows ‘antiviral effect’ against COVID, Japanese company says. Jan. 31, 2022.
16 Krolewiecki A et al. Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial. The Lancet June 17, 2021.
17 Lysiak M. ‘FDA Is Not a Physician’: Appeals Court Sides With Doctors on Ivermectin for COVID-19. The Epoch Times Sept. 2, 2023.
18 Lysiak M. Doctor: Pharmacists Continuing to Refuse Ivermectin Prescriptions, Raising Ethical Concerns. The Epoch Times. Sept. 1, 20223.

Federal Appeals Court Revives FDA Lawsuit Regarding Anti-Ivermectin Campaign

Federal Appeals Court Revives FDA Lawsuit Regarding Anti-Ivermectin Campaign

A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images

OAN’s Brooke Mallory
11:48 AM – Monday, September 4, 2023

SEE: https://www.oann.com/newsroom/federal-appeals-court-revives-fda-lawsuit-regarding-anti-ivermectin-campaign/;

Republished below in full unedited for informational, educational, & research purposes.

A federal appeals court overturned a prior judgment on Friday, enabling a Food and Drug Administration (FDA) lawsuit involving its campaign against the use of ivermectin to treat COVID-19 to proceed.

In a lawsuit filed against the FDA last year, three different doctors asserted that the agency had overstepped its boundaries in its anti-ivermectin campaign, “acting more like a medical body than a regulator.”

A district judge had originally ruled that the lawsuit could not proceed, but in a Friday decision, the 5th Circuit Appeals judge gave the physicians new hope by remanding the matter to a lower court for reconsideration.

“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” said Judge Don Willett. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

Ivermectin is an anti-parasite drug that is frequently prescribed to horses but also occasionally prescribed to people as well. The FDA’s campaign, which featured viral posters stating “You are not a horse,” underscored the agency’s warnings that it should not be used to treat the COVID-19 virus.

“Although [the] FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use,” the agency’s recommendations stated.

While a handful of people were reportedly hospitalized and some even died from the drug, which occurs if one takes ivermectin in addition to certain other medications, many groups still welcomed it as a miracle cure and claimed to receive beneficial results for their health.

However, In 2021, a review of 14 studies on the use of ivermectin concluded that there was insufficient evidence to justify its usage, adding that “few [of the studies] are considered high quality.”

Yet, “It must be acknowledged that some of these studies were possibly intentionally designed to yield predetermined findings,” researchers maintained.

Besides COVID-19, there have also been reports from those suffering from autoimmune disorders who claim that ivermectin helped combat their negative symptoms and that they have been taking the anti-parasite drug for years.

The National Institutes of Health and the World Health Organization are two organizations that have consistently advised against using ivermectin to treat COVID-19.

The anti-ivermectin FDA campaign, according to the three doctors, damaged their doctoral reputations since they had previously encouraged the use of the drug. One doctor was expelled from medical school, and another was even suspended from working at a hospital.

“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” the doctors’ attorney, Jared Kelson, said in a statement. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”

One of the pro-liberty plaintiffs in the case, Mary Talley Bowen, praised the decision on Friday.

“A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny… ONWARD!” Bowen said.

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Techno-Hell: FDA Approves the Release of 2.4 Million Bioengineered Designer Mosquitoes in Florida, California

Techno-Hell: FDA Approves the Release of 2.4 Million Bioengineered Designer Mosquitoes in Florida, California

BY BEN BARTEE

SEE: https://pjmedia.com/news-and-politics/benbartee/2023/06/30/techno-hell-fda-approves-the-release-of-2-4-million-bioengineered-designer-mosquitoes-in-florida-california-n1707642;

Republished below in full unedited for informational, educational, & research purposes.

The U.S. Environmental Protection Agency has approved a British biotech firm’s application to release 2.4 million genetically altered mosquitoes into the wild as an “experimental pesticide product.”

Via NBC News:

The experimental public health effort, which still requires final approval from state regulators, follows the 2021 release of 144,000 genetically modified mosquitoes in the Florida Keys by British biotech firm Oxitec.

Oxitec said its genetically modified male, and thus non-biting, mosquitoes “find and mate with invasive female Aedes aegypti mosquitoes, mediating a reduction of the target population as the female offspring of these encounters cannot survive,” thus reducing the overall population…

Oxitec’s mosquito release — which the EPA calls an “experimental pesticide product” — can take place in a 34,760-acre area across the two states between now and April 30, 2024, when the experiment ends.

Via Oxitec’s press release announcing FDA approval (emphasis added):

Oxitec, the leading developer of biological pest control solutions, is proud to announce the publication by the U.S. Environmental Protection Agency (EPA) of its approval to conduct pilot projects of Oxitec’s safe, non-biting, Aedes aegypti mosquitoes in California and Florida. Two pilot projects were approved, one with the Delta Mosquito and Vector Control District (Delta MVCD) in California and one with the Florida Keys Mosquito Control District (FKMCD) in Florida.

This approval is an extension of the Experimental Use Permit (EUP) granted in 2020 by the EPA for a pilot project in the Florida Keys, which was successfully carried out in 2021. Alongside its in-depth scientific evaluation process was a 30-day period for public comments. The EPA reviewed and responded to each public comment before issuing its approval…

Oxitec’s safe, sustainable and targeted biological pest control technology does not harm beneficial insects* like bees and butterflies and is proven to control the disease transmitting Aedes aegypti mosquito, which has invaded communities in Florida, California and other U.S. states. In California, since first being detected in 2013, this mosquito has rapidly spread to more than 20 counties throughout the state, increasing the risk of transmission of dengue, chikungunya, Zika, yellow fever and other diseases.

We’ve seen the fruits of “experimental” regulatory approval in the context of the emergency use authorizations granted to the manufacturers of the COVID-19 shots (potentially granted under fraudulent pretexts), and they’re not pretty.

Regarding the second claim — that Oxitec’s product “does not harm beneficial insects” — there is, of course, no way to affirmatively know the long-term effects of this product on local fauna because three years is a blip on the radar in the Public Health™ domain.

The most that could honestly be said — assuming robust, good-faith studies on the ecological impacts thus far have, in fact, been conducted and Oxitec hasn’t doctored the evidence — is that, at this stage, there appear to be no adverse impacts on the local ecology.

Twelve Infants Die During Clinical Trials for FDA-Endorsed RSV Drug

BY AMBER BAKER

SEE: https://thevaccinereaction.org/2023/06/twelve-infants-die-during-clinical-trials-for-fda-endorsed-rsv-drug/;

Republished below in full unedited for informational, educational, & research purposes.

On June 8, 2023, the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously (21-0) in favor of AstraZeneca and Sanofi’s new nirsevimab (Beyfortus) monoclonal antibody drug believed to provide protection for infants from respiratory syncytial virus (RSV) disease and other lower respiratory tract infections during their first year of life.1

Citing a “favorable benefit-risk profile for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season,” AstraZeneca/Sanofi stated in a press release that the antibody may also have the potential to protect those born healthy at term or preterm, as well as with conditions that make them more susceptible to RSV disease.2

RSV is a common, typically-mild lower respiratory illness. In serious cases, the disease can lead to pneumonia or bronchiolitis, putting infants and the elderly at high risk for complications.

The RSV antibody comes on the heels of the world’s first RSV vaccine, GSK’s Arexvy, which was approved by the FDA last month for use in people 60 years of age and older. Pending final FDA approval, nirsevimab would become the first single-dose pharmaceutical intervention in the U.S. aimed at protecting babies from RSV infections through the age of two years.3

RSV Labeled a Major Public Health Threat After Unprecedented Surge in Cases

After COVID infections decreased, there was an “unprecedented” spike in RSV infections in infants that overwhelmed hospitals in 2022 and prompted pediatric health organizations to call on President Biden to declare a public health emergency after 17 states reported that more than 80 percent of their beds were full last fall.4

While some experts suggest the surge in respiratory viruses is a result of relaxing COVID-19 measures, others attribute the spike to “immunity debt,” or the idea that people’s immune systems were weakened from lack of normal, natural exposure to pathogens like RSV and influenza because of stay-at-home orders, prolonged mask-wearing, and social distancing that persisted for the better part of three years.5

The path to pharmaceutical RSV protection spans several decades, with clinical trials for an RSV vaccine ending abruptly in the 1960s after the shot unexpectedly sickened and hospitalized 80 percent of children in the trial. The inactivated virus used in the shot exacerbated the disease once trial participants caught RSV naturally, leading to two children’s deaths and researchers going back to the drawing board.6

Today, more than 60 years later, 12 infants have died during clinical trials of the new nirsevimab, two from “unknown causes” thought to be linked to sudden infant death syndrome (SIDS).7

Infant Deaths Attributed to Underlying Disease Despite Clinical Trials Requiring Healthy Participants

The other 10 infant deaths were attributed to “underlying disease.” However, according to Pfizer, clinical trials typically include healthy participants to assess the safety of the drug and any side effects, and only certain types of trials—such as those for oncology—would warrant the inclusion of sick patients versus healthy people.7 8

Before joining a clinical trial, according to the U.S. National Institutes of Health (NIH), participants must be given informed consent, as well as any information that allows the research team to determine whether or not they can participate in the study safely.9

As for the other 10 children’s deaths—attributed to a number of varying causes such as cardiac disease, a tumor, COVID, a skull fracture, pneumonia, two from gastroenteritis, and two from unknown causes—FDA official Melissa Baylor, MD said none of the deaths appeared to be related to the experimental drug nirsevimab.7

SIDS and the Importance of Black Box Warnings on Drugs

By definition, SIDS is an unexpected and unexplainable death that occurs in a “seemingly normal, healthy infant under one year of age.” In fact, nine out of 10 deaths in the study occurred around the two- and four-month mark, when well-baby visits to the pediatrician commonly precede the administration of multiple vaccines, such as the combined DTaP (diphtheria, tetanus, and acellular pertussis) in one visit, according to the U.S. Centers for Disease Control and Prevention’s (CDC) Immunization Schedule.10

Many drugs, including some routine childhood vaccinations for newborns, contain black box warnings on the manufacturer’s product inserts. A black box warning, the highest safety-related warning intended to alert the consumer to major risks of the drug, stamps the insert of any drug where trial participants died during clinical studies. Still, more often than not, as with the clinical trials of nirsevimab, the diagnosis of SIDS often overrules the occurrence of a potentially lethal drug reaction as the cause of death in an otherwise healthy infant.11

The FDA is slated to make a final decision on nirsevimab later this year. To date, the agency maintains it has not identified any safety concerns in its review of the drug.7

If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.

Click here to view References:

1 Pinsk A. A New Shot Prevents Serious Illness from RSV. Johns Hopkins Bloomberg School of Public Health Mar. 30, 2022.
2 Press Release. Nirsevimab unanimously recommended by FDA Advisory Committee for the prevention of RSV lower respiratory tract disease in infants. AstraZeneca June 8, 2023.
3 Press Release. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine. U.S. Food and Drug Administration May 3, 2023.
4 Kimball S. Children’s hospitals call on Biden to declare emergency in response to ‘unprecedented’ RSV surge. CNBC Nov. 18, 2022.
5 Christensen J. Pandemic ‘immunity gap’ is probably behind surge in RSV cases, scientists say. CNN Oct. 28, 2022.
6 Harding A. Research shows why 1960s RSV shot sickened children. Reuters Dec. 3, 2008.
7 Kimball S. FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV. CNBC June 8, 2023.
8 Reed J. Do You Have What It Takes to Join a Phase 1 Clinical Trial? Pfizer 2021.
9 U.S. National Institutes of Health. NIH Clinical Research Trials and You, The Basics. Oct. 3, 2022.
10 Sudden Infant Death Syndrome (SIDS). Boston Children’s Hospital 2012.
11 Vitamin K Injection [PACKAGE INSERT]. Novaplus 2021.

Mary Holland: FDA Withholding VAERS Data on Injuries, Deaths

BY VERONIKA KYRYLENKO

SEE: https://thenewamerican.com/mary-holland-fda-withholding-vaers-data-on-injuries-deaths/;

Republished below in full unedited for informational, educational, & research purposes.

Americans have been promised complete transparency on Covid shots safety. Yet, the nation’s top healthcare agencies are suspiciously reluctant to release the data that they use to advertise these injections as “safe.”  

Last year, Children’s Health Defense (CHD) submitted two separate-but-related FOIA requests to the U.S. Food and Drug Administration (FDA) to obtain data related to the agency’s obligatory work on analyzing the safety signals for Covid shots. When both requests were rejected, the non-profit took the agency to court.

In this interview with The New American, Mary Holland, the CHD’s president and general counsel, explains the basics of what the Vaccine Adverse Effects Reporting System (VAERS) is and how it is used to detect safety signals. It was recently uncovered that the CDC, the FDA’s sister agency that co-runs VAERS, identified more than 770 different types of adverse events that showed safety signals. The FDA must be open about the disastrous safety profile of the shots, which are long overdue for a recall, emphasized Ms. Holland.

To learn more about and support Children’s Health Defense, please click here.

Moderna Withheld Data From FDA Regulators to Get Bivalent Booster Approved

Moderna Withheld Data From FDA Regulators to Get Bivalent Booster Approved

BY BEN BARTEE

SEE: https://pjmedia.com/news-and-politics/benbartee/2023/01/15/moderna-withheld-data-from-fda-regulators-to-get-bivalent-booster-approved-n1661950;

Republished below in full unedited for informational, educational, & research purposes.

How many times have we been treated, in the era of the New Normal, to exasperated corporate media hacks complaining about “misinformation” pushed by “conspiracy theorists” regarding the COVID-19 mRNA gene therapies deceptively marketed as “vaccines”?

As it turns out, the biggest purveyor of misinformation is the pharmaceutical industry, followed closely by the government and corporate media.

Via CNN:

The pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year when [FDA] advisers discussed whether the shot should be authorized and made available to the public…
That data suggested the possibility that the updated booster might not be any more effective at preventing Covid-19 infections than the original shots.

Specifically, Moderna hid data on actual infection rates among patients who were administered the original booster and those who got the bivalent “vaccine.” The reason is obvious: The data showed that the original booster resulted in fewer infections than the bivalent version, which clearly wouldn’t be good news for sales.

Related: Judicial Watch Releases Damning New Information on the Moderna Vaccine

1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected.

Research released by the New England Journal of Medicine found that “boosting with new bivalent mRNA vaccines targeting both the BA.4–BA.5 variant and the D614G strain did not elicit a discernibly superior virus-neutralizing peak antibody response as compared with boosting with the original monovalent vaccines.”

In English, that means they don’t work as promised.

So…

When will Moderna get its Twitter account suspended for promulgating dangerous misinformation?

When will the White House collude to censor Moderna’s free speech?

When will Moderna’s licenses to create drugs get suspended, the way doctors were threatened with having their medical licenses suspended for spreading COVID “misinformation”?

When will CNN begin conducting ambush interviews of Moderna executives, as they do with defenseless independent practitioners like Dr. Mercola who challenge big pharma orthodoxy?

FDA approves OMICRON booster shots for babies, children

BY CAROLYN HENDLER, J.D.

SEE: https://thevaccinereaction.org/2023/01/fda-approves-u-s-babies-and-young-children-to-get-omicron-covid-booster-shots/;

Republished below in full unedited for informational, educational, & research purposes.

In early December 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer/BioNTech and Moderna/NIAID mRNA Covid-19 shots to include administration of the Omicron Covid booster shots to children as young as six months old. The action allows everyone over the age of six months to get the newest booster shot.1

The FDA made the decision to authorize the vaccination of infants and very young children just three days after Pfizer submitted an application to the regulatory agency for the Omicron BA.4/BA.5-Adapted Bivalent Covid vaccine.2

The bivalent Covid booster, which contains the original strain of the SARS-COV-2 virus along with spike proteins from the BA.4 and BA.5 variants of the Omicron strain, was approved for children five years of age and older on Oct. 12, 2022.3 FDA commissioner Robert Califf, MD said:

More children now have the opportunity to update their protection against Covid-19 with a bivalent Covid-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so–especially as we head into the holidays and winter months where more time will be spent indoors.4>

COVID Vaccination Uptake Has Been Slow Among Babies and Young Children

Omicron Covid booster shot uptake is limited because it is only available to infants and children who have received both doses of the original Covid shots developed by Pfizer and Moderna. Children who have already received three doses of the original Pfizer Covid shot are not eligible for the booster.

U.S. Centers for Disease Control and Prevention (CDC) officials have reported that less than five percent of children aged two to four and only three percent of children and babies under the age of two have received the original Covid shots.5 Therefore, there is not much demand for Omicron booster shots among very young children. Meanwhile, 32 percent of children aged five to 11 years are fully vaccinated against Covid.6

Yale School of Medicine pediatrician Leslie Sude, MD said:

While a significant proportion of the population was not eligible for vaccination, there was still the opportunity for widespread circulation of COVID among children, who could then keep transmitting it to older people. And as long as the virus spreads from person to person, the virus can keep changing and evolving into new variants.7

However, Dr. Sude’s comment conflicts with CDC director Rochelle Walensky’s acknowledgment that getting a Covid shot does not prevent infection with and transmission of the SARS-CoV-2 virus to others. Dr. Walensky stated:

 Our vaccines are working exceptionally well … but what they can’t do anymore is prevent transmission.8

Covid Shot Study Data Not Peer Reviewed or Published

The FDA and a committee of independent vaccine experts relied on data provided by the vaccine manufacturers when extending the EUA for the bivalent Omicron Covid booster shot to infants and very young children. The data presented by vaccine manufacturers have not been peer-reviewed or published.9

When extending the EUA status of the Moderna Covid booster shot to babies and young children, the FDA relied on a clinical study looking at the immune response of adults to the Moderna product.  The FDA also compared a clinical study looking at the immune response of 56 children aged 17 months through five years after getting the full dose series of the original Covid shots plus the booster dose to a study examining the immune response of 300 young adult participants, who received the two-dose original Moderna Covid shot. The FDA concluded that the immune response of infants and very young children were comparable to the immune response in young adults.10

The FDA also looked at a clinical study examining the safety of a single dose Moderna Covid booster shot in 145 children aged six months through five years old. The study showed the common side effects in babies 17 through 36 months old were irritability/crying, sleepiness, and loss of appetite. Previous clinical trials showed the common side effects in this age group to also include fatigue, muscle pain, headache, joint pain, nausea/vomiting, and chills.11

The third dose of the monovalent Pfizer Covid shot will no longer be used in very young children and will, instead, be replaced with the booster dose. The FDA relied on efficacy data previously submitted by the drug manufacturer in individuals aged six months through four years old, 16 years and older, and adults aged 55 years and up who received the original two-dose series of shots, the monovalent booster as well as the bivalent booster dose.12

The safety of the Pfizer Covid booster shot for children aged six months through five years old was determined by looking at safety data from a clinical study of the bivalent booster shot in participants aged 55 years and older; clinical trials looking at the safety of the primary vaccine series in children six months and older with the monovalent booster, as well as safety data from clinical trials and post-marketing safety data of the booster shot in participants five years and older.

Even though the safety data presented did not include the bivalent Covid booster shot, the FDA concluded the previous trials and studies on the monovalent booster were relevant to the approval process of the bivalent Omicron version due to the fact the same manufacturing process was used to make both versions of the shot.13

If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.

Click here to view References:

1 Gumbrect J. Children as young as 8 months can now receive an updated COVID-19 vaccine. CNN Dec. 9, 2022.
2 Pandolfo C. FDA authorizes bivalent COVID-19 booster shots for children under 5. Fox News Dec. 8, 2022.
3 Cáceres M, Fisher BL. FDA Authorizes COVID Bivalent Shots for Children as Young as Five Years Old. The Vaccine Reaction Oct. 17, 2022.
4 Gumbrect J. Children as young as 8 months can now receive an updated COVID-19 vaccine. CNN Dec. 9, 2022.
5 Pandolfo C. FDA authorizes bivalent COVID-19 booster shots for children under 5. Fox News Dec. 8, 2022.
6 MacMillan C. COVID-19 Vaccines for Kids Under 5; What Parents Need To Know. Yale Medicine Dec. 12, 2022.
7 Ibid.
8 Stykes E. CDC Director: Covid vaccines can’t prevent transmission anymore. MSN Jan 10, 2022.
9 MacMillan C. COVID-19 Vaccines for Kids Under 5; What Parents Need To Know. Yale Medicine Dec. 12, 2022.
10 News Release. Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. U.S. Food and Drug Administration Dec. 8, 2022.
11 Ibid.
12 Ibid.
13 Ibid.

Nuremberg II: Mass-murder trials could commence after midterms for the vaccine-pushing genocidal maniacs Fauci, Walenski and more

Image: Nuremberg II: Mass-murder trials could commence after midterms for the vaccine-pushing genocidal maniacs Fauci, Walenski and more

BY S.D. WELLS

SEE: https://www.naturalnews.com/2022-11-15-nuremberg-ii-mass-murder-trials-could-commence-after-midterms.html;

Republished below in full unedited for informational, educational, & research purposes.

(Natural News) The Covid crimes are years in the making and more than a handful of vaccine manufacturers and promoters could be on trial soon for mass murder and conspiracy to commit genocide. Senator Rand Paul puts Dr. Anthony Fauci at the forefront of the whole plandemic brigade since Fauci lied and DID help fund gain-of-function research that led directly to the (Wuhan Flu) virus outbreak in humans across planet Earth. Already those who planned and propagated the scamdemic are begging for forgiveness, knowing that Nuremberg II trials are coming, sooner or later, for them. There are too many people involved in this mass murder scheme, but the ones at the top should be tried first.

Anthony “Fraudulent” Fauci is the King of Misinformation when it comes to anything related to Covid-19

Fauci flip-flopped on mask-wearing, social distancing, lockdowns, medications, vaccinations, and just about every piece of “advice” that spewed from his mouth for the past two years. Back and forth he went, talking about mandates that were vital to ‘flattening the curve’ and saving lives, when, come to find out, most of his advice is responsible for killing millions, if not billions, of people. Then he wrote a book on it all so he can further pad his rich pockets from the whole scamdemic, that’s ongoing and may never end. That’s why Fauci is the King of Misinformation. Then there’s Bill Gates, Peter Daszak, Dr. Walenski, and their scamdemic-planning cohorts at the regulatory agencies, and those who literally invested in the pandemic and made a fortune also.

Turns out the masks cause bacterial infections in the mouth, throat, and lungs, leading to worsened cases of Covid and pneumonia. Turns out that the #1 recommended drug in hospitals for Covid patients is remdesivir, which decimates kidney function, and all the leading doctors, CDC, and FDA “experts” know it. Turns out lockdowns and ‘virtual learning’ destroys children’s cognitive AND social development. Oops.

Fauci swore up and down that the vaccines were safe and effective, but they cause myocarditis, pericarditis, severe inflammation, and strange rubbery vascular clots that lead to SADS (Sudden Adult Death Syndrome).

It’s time to try the Covid-19 criminals for their crimes of murder and conspiracy to commit murder

Most of the people taking direct orders from Adolf Hitler in Nazi Germany were GUILTY of mass murder, not just “taking orders.” They saw firsthand the concentration death camps and they knew, at least to some extent, the genocide of Jews that was taking place. Hitler was also exterminating anyone with autism, handicaps, deformations, or senility. Today, depopulation agendas are rooted in “vaccination” agendas instead of gas chambers. The only difference is the victims are slowed and walked into their own demise by their own choice, after being conned and brainwashed by fear and CDC-scripted MSM propaganda.

Dr. Rand Paul is on the record stating, “To arrive at the truth, the U.S. government should admit that the Wuhan Virology Institute was experimenting to enhance the coronavirus’s ability to infect humans.” The Jews in WWII were not “subhuman,” and the vaccinated masses now are not supposed to be slated for execution either, but the clot shots are setting up this mass tragedy we are seeing take place, under the media’s radar.

Though many of the mass murderers from WWII only got 4 to 7 years in federal prison for their crimes, at least they were found guilty and served time. Justice must be served again, for WWIII is underway, and just because the plandemic masterminds are not using guns and bombs to kill millions, they are using weapons of mass destruction (biological weapons or B-WMDs).

Support Dr. Rand Paul as he moves forward with the goal of bringing justice to these pandemic-spreading criminals. Bookmark Vaccines.news to your favorite independent websites for updates on the next wave of Fauci-funded Covid-19 that Biden says is coming to America soon.

Sources for this article include:

MSN.com

NaturalNews.com

ConservativeBrief.com

Civil rights sell-out: Biden State Department gives law enforcement, intelligence agencies unrestricted access to personal data on millions of Americans

Image: Civil rights sell-out: Biden State Department gives law enforcement, intelligence agencies unrestricted access to personal data on millions of Americans

BY ETHAN HUFF

SEE: https://www.naturalnews.com/2022-11-11-biden-state-department-access-personal-data.html;

Republished below in full unedited for informational, educational, & research purposes.

(Natural News) The personal data of more than 145 million Americans are being indiscriminately handed over by the Biden regime’s State Department to various law enforcement and intelligence agencies for illegal and unconstitutional probing, according to a letter sent from Sen. Ron Wyden (D-Ore.) to Secretary of State Antony Blinken.

Without any proper legal due process or apparent oversight, Biden’s State Department is reportedly pulling private information from people’s passport applications without their knowledge or consent and passing it off to other government agencies. Wyden’s letter is part of an ongoing investigation into Operation Whistle Pig, a wide-ranging leak investigation launched by a Border Patrol agent and several of his supervisors at the U.S. Customs and Border Patrol’s National Targeting Center.

“I write to express serious concern that the Department of State is providing law enforcement and intelligence agencies with unfettered access to personal data, originally collected through passport applications, of the more than 145 million Americans with a passport,” Wyden’s letter reads.

It adds that “the breadth of this access highlights the potential for other abuses. In a July 13, 2022, briefing for my office, State Department officials confirmed that 25 other federal agencies have access to the Department’s database of passport applications.” (Related: In April, Biden’s State Department issued a memo claiming that covid “most likely” escaped from a lab in Wuhan, China.)

The Biden regime is an unlawful and unconstitutional regime

Among the data being collected from Americans and passed from the federal government to law enforcement and intelligence groups are names, addresses, birth dates, biometric data like fingerprints and facial images, email addresses, phone numbers, gender, race, Social Security numbers, and other private information.

“The [State] Department’s mission does not include providing dozens of other government agencies with self-service access to 145 million Americans’ personal data,” Wyden’s letter goes on to state.

“The Department has voluntarily taken on this role, and in doing so, prioritized the interests of other agencies over those of law-abiding Americans. While there is a legitimate role for the use of this information by law enforcement, the current unregulated system of interagency access to millions of Americans’ records goes far beyond what a reasonable person would expect or tolerate.”

There is no legal requirement that the State Department provide any of this information upon request, except through a normal legal process such as a subpoena or court order. In this case, there is none of that present, which means the Biden regime is committing an unconstitutional act.

It remains unknown the level to which each of the 25 law enforcement and intelligence agencies on the dole has access to said data. Some may only have access to a small amount of it while others have full access – we just do not know because there is no transparency.

Wyden also alleges that a Border Patrol agent misused government databases to pursue a rogue leak investigation into a news reporter and her relationship with a congressional staffer. The Department of Homeland Security’s (DHS) Office of Inspector General (OIG) launched a probe into these allegations, as well as into the work of said Border Patrol agent.

What the OIG investigation has uncovered thus far as part of a more than 500-page unredacted report forms the basis of the Operation Whistle Pig investigation, which you can learn more about at this link.

“Abuses of this access came to light through a report of an investigation by the Department of Homeland Security Office of Inspector General (OIG) into activities at Customs and Border Protection (CBP),” a letter about the investigation states.

Want to keep up with the latest nest about the Biden regime? Visit Corruption.news.

Sources for this article include:

Yahoo.com

NaturalNews.com

Yahoo.com

 

WINNING: Request Granted to Depose Fauci and Other Biden Officials in Censorship Lawsuit

BY STACEY LENNOX

SEE: https://pjmedia.com/news-and-politics/stacey-lennox/2022/10/22/winning-request-granted-to-depose-fauci-and-other-biden-officials-in-censorship-lawsuit-n1639033;

Republished below in full unedited for informational, educational, & research purposes.

Today, District Court Judge Terry Doughty granted the National Civil Liberties Alliance’s (NCLA’s) requests for depositions in the censorship lawsuit, State of Missouri ex rel. Schmitt, et al. v. Biden, et al. Earlier interrogatories in this lawsuit identified 45 federal officials from the Department of Homeland Security, the Cybersecurity and Infrastructure Security Agency, the CDC, Dr. Fauci’s NIAID, the Office of the Surgeon General, and others who communicated with social media companies about “misinformation” and censorship.

Now, the plaintiffs will have the opportunity to depose a total of eight Biden officials. The following officials will be required to give depositions: NIAID Director and White House Chief Medical Advisor Dr. Anthony Fauci; former White House Press Secretary Jennifer Psaki; FBI Supervisory Special Agent Elvis Chan; Surgeon General Vivek Murthy; CDC Chief of the Digital Media Branch Carol Crawford; and Acting Coordinator of the State Department’s Global Engagement Center Daniel Kimmage. The plaintiffs will need to select one of the individuals from the following pairs to depose: Deputy Assistant to the President and Director of White House Digital Strategy Rob Flaherty OR former White House Senior COVID-19 Advisory Andrew Slavitt; and CISA Director Jen Easterly OR CISA official Lauren Protentis.

Jenin Younes, Litigation Counsel at NCLA, and the legal team based the deposition requests on the information obtained in the interrogatories. The plaintiffs believe those named have specific individual details by virtue of their position. For example, CDC Chief of the Digital Media Branch Carol Crawford leads the agency’s digital media activities. Interrogatory responses revealed Crawford was holding regular “Be On the Lookout” meetings with staff from the social media companies. In these meetings, attendees reviewed specific social media posts containing “misinformation.”

In the case of Dr. Anthony Fauci, the plaintiffs seek specific underlying information regarding some communications that are already public. Younes cited the email exchange between Fauci and former NIH Director Dr. Francis Collins discussing a takedown of the authors of the Great Barrington Declaration and NCLA clients Drs. Jayanta Bhattacharya and Martin Kulldorff. Fauci also did not complete or sign his own interrogatory as is customary.

Related: Shocking Details Emerge on How Biden’s White House Colluded With Social Media Companies to Censor Americans

Judge Doughty noted this breach of custom in his ruling (emphasis added): “Lastly, Plaintiffs argue that Dr. Fauci’s credibility has been in question on matters related to supposed COVID-19 ‘misinformation’ since 2020. Specifically, the Plaintiffs state that Dr. Fauci has made public statements on the efficacy of masks, the percentage of the population needed for herd immunity, NIAID’s funding of ‘gain-of-function’ virus research in Wuhan, the lab-leak theory, and more. Plaintiffs urge that his comments on these important issues are relevant to the matter at hand and are further reasons why Dr. Fauci should be deposed. Plaintiffs assert that they should not be required to simply accept Dr. Fauci’s ‘self-serving blanket denials’ that were issued from someone other than himself at face value. The Court agrees.”

According to Younes, the lawsuit seeks declaratory and injunctive relief. None of the plaintiffs are seeking a financial award. “The plaintiffs want the court to declare it is a First Amendment violation for the government to be involved in the social media companies’ viewpoint discrimination.” While the case centers on censorship of information related to COVID-19, such a declaration could have broad-reaching implications for censorship of information on other issues in the public square.

Based on continued disclosures in discovery, it has become clear that the federal censorship enterprise is enormous and far-reaching. The plaintiffs’ Second Amended Complaint names 67 defendants, spanning at least eleven federal agencies and sub-agencies. The decision orders that the depositions get completed in the next 30 days. The defendants can appeal to the Fifth Circuit Court, which may cause a delay.

Recently, the Fifth Circuit has ruled on some meaningful cases. It is the court that struck down President Biden’s vaccine mandate. In NetChoice v. Paxton, it also stayed an injunction against a Texas law that prohibits social media companies with more than 50 million users from engaging in viewpoint censorship by removing it or hiding it. The law also restricts email providers from preventing email transmission under most circumstances. It makes exceptions for content that is obscene, illegal, or that contains malicious code. And it requires covered platforms to provide detailed reports about their content moderation policies.

“For the first time, Dr. Fauci and seven other federal officials responsible for running an unlawful censorship enterprise will have to answer questions under oath about the nature and extent of their communications with tech companies,” Younes declared. “We look forward to learning more about just how far these government actors went in ensuring that Americans heard only one perspective about Covid-19: the government’s.”

Covid-jabbed kids 4,423% more likely to DIE than unvaccinated children, official government data show

BY ETHAN HUFF

SEE: https://www.naturalnews.com/2022-10-12-covid-vaccines-children-death-government-data.html;

Republished below in full unedited for informational, educational, & research purposes.

(Natural News) Just hours before Boris Johnson announced his resignation as prime minister of the United Kingdom back in July, an official government report was released showing that children “vaccinated” for the Wuhan coronavirus (Covid-19) are 45 times more likely to die from any cause than unvaccinated children with natural immunity.

Further, that same report revealed that fully vaccinated kids are 137 times more likely than their unvaccinated counterparts to die from “covid.” This disturbing little factoid flies in the face of everything we have been told for the past several years about how the jabs supposedly protect against the alleged virus.

The U.K.’s Office for National Statistics (ONS) put forth the data in a report called “Deaths by Vaccination Status, England, 1 January 2021 to 31 May 2022.” You can read it for yourself at this link.

The Exposé deserves credit for poring through the ONS data to figure all this out. After all, the government presents it with minimal fanfare and in such a way as to make it difficult to fully ascertain.

One would think that if “saving lives” was truly the goal here that revelations such as these would be all over the news and flowing from the lips of politicians. Instead, we get nothing but silence or flat-out denial about the facts. (Related: Evidence also exists to suggest that Pfizer is secretly adding heart attack pharmaceuticals to the child version of its mRNA [messenger RNA] shot.)

ONS caught trying to disguise “horrific” mortality rates among covid-jabbed kids

In this case, The Exposé figured out that the ONS once again tried to disguise the reality that children who get injected with Fauci Flu shots are a ticking time bomb for sudden death. 

The ONS has done this many times throughout the scamdemic, hiding the truth in its voluminous datasets that are continually manipulated to make it more difficult to suss out the truth.

If you are interested in seeing the methodology that was used to retrace the ONS’ steps in trying, but failing, to hide the risks associated with covid jabs for children, you can do so at The Exposé website.

In a nutshell, the ONS failed to provide the death rate per 100,000 children and teenagers in its dataset, even though this information was provided for all other adult age groups contained in the same dataset.

How The Exposé was able to break through the deception was by piecing together other information that was provided to calculate what that figure would have been had the ONS provided it directly as it did for all the adult age groups.

“… all we need to do is divide each vaccination group’s ‘person-years’ by 100,000, and then divide the number of deaths among each vaccination group by the answer to the previous equation, to work out the mortality rates by vaccination status,” The Exposé explains.

The resulting figures, the outlet further maintains, “reveal that unvaccinated children are much less likely to die of Covid-19 than children who have had the Covid-19 injection.”

“Based on Pfizer’s vaccine efficacy formula, this data reveals that the Covid-19 injections are now proving to have negative effectiveness against death among children,” we also now know.

In the comments, someone wrote that this is hardly a surprise since Big Pharma and the governments it controls have been targeting children for many decades with their deadly injections.

“‘Murder them while they are young!’ is the motto of the evil ones,” this person wrote before then offering a blessing to the victims across time. “Eternal life blessings for Yahweh’s saints!”

The latest news about Chinese Virus injections can be found at ChemicalViolence.com.

Sources for this article include:

Expose-News.com

ONS.gov.uk

NaturalNews.com

Lives and Liberty Lost by Order of the Deep State~Freedom, innovation, progress, opportunity, and choice — all on the Left’s chopping block.

BY JONATHAN EMORD

SEE: https://www.frontpagemag.com/lives-and-liberty-lost-by-order-of-the-deep-state/;

Republished below in full unedited for informational, educational, & research purposes.

Three-quarters of all federal law is not enacted by those we elect but by the unelected heads of over 200 government departments, agencies, and bureaus.  Under our Constitution, only Congress has the power to make laws (Art. I: “All legislative Powers herein granted shall be vested in a Congress of the United States . . .”), and yet, through a deliberate circumvention of the Constitution, federal agencies have for over one hundred and forty years created, enforced, adjudicated, and punished parties for violating laws Congress never enacted.  Indeed, as Professor Philip Hamburger explains, the administrative state is largely indistinguishable from the dreaded Courts of Star Chamber and High Commission that the Founding Fathers condemned for their abuses and constitutionally prohibited.

The Administrative State makes decisions that sacrifice individual liberty and property, but also even human life—all without adherence to constitutional limits on government power.  A single example can illustrate the point.  For over sixty years, to protect drug companies from competition, the FDA has maintained a blanket ban on information associating nutrients with disease risk reduction, thus giving drug companies a monopoly on therapeutic claims.  Under that ban, the FDA prohibited Americans from receiving at the point-of-sale information associating 800 micrograms of folic acid in dietary supplements with a reduction in the risk of neural tube defects (e.g., spina bifida and anencephaly).  That ban was held unconstitutional in Pearson v. Shalala in 1999, but for at least two decades before the Court ruled, FDA’s censorship resulted in an estimated 2,500 preventable NTDs each year and countless NTD-related abortions.  FDA continues to censor numerous nutrient-disease claims that, if allowed, would save lives.

Consider just a few more examples of the unconstitutional power and abuses visited upon us by the Administrative State.  The Founding Fathers were very familiar with general warrants and believed them antithetical to individual liberty; they prohibited them in the Fourth Amendment.  Prohibited, general warrants are nevertheless used every day by federal administrative agencies, a flagrant violation of the Fourth Amendment.  In Stanford v. Texas, the Supreme Court explained that “[v]ivid in the memory of the newly independent Americans were these general warrants known as writs of assistance under which officers of the Crown had so bedeviled the colonists.”  Justice Potter Stewart wrote for a unanimous Court that Americans were entitled to “’ be secure in their persons, houses, papers, and effects from intrusion and seizure by officers acting under the unbridled authority of a general warrant.”  Yet every day, general warrants are issued by federal agencies, like the FTC, the EPA, and the BLM, acting without a federal court order and commanding Americans to produce all manner of the most sensitive financial records and documents entirely on suspicion and without ever having to prove probable cause.

As early as 1895, in Coffin v. United States, the Supreme Court made unequivocal that those accused by the government were entitled to a presumption of innocence.  Yet every day the Administrative State presumes those it accuses to be guilty until they prove themselves innocent.  Moreover, the Fifth Amendment right against self-incrimination is ignored in the administrative law context, such that routinely individuals accused by agencies are ordered to provide testimony against themselves.

It is a cardinal constitutional principle, articulated well by Madison in Federalist No. 47, that the prosecutor not also be the judge because impartial justice is impossible when the very official seeking conviction of the accused is also the one with legal authority to decide the dispute.  Madison wrote: “The accumulation of all powers, legislative, executive, and judiciary, in the same hands, whether of one, a few, or many, and whether hereditary, self-appointed, or elective, may justly be pronounced the very definition of tyranny.”  And yet, when administrative law judges decide a case, their decisions are but recommendations to the agency heads, the very heads who ordered the prosecution in the first place.  That leads to biased decision-making.  Indeed, former FTC Commissioner Joshua D. Wright explained that in his agency’s history, he could not find a single instance in which the accused was ever found innocent of the wrongdoing charged by the FTC:  Every time FTC accuses, it holds the accused guilty!

Under the Sixth and Seventh Amendments, every American is entitled to a jury trial before the government imposes a penalty (a restriction on his or her liberty or a command that he or she pay the government money or forfeit property).  And yet, when administrative agencies impose huge fines, discontinue any enterprise, or deny the accused the right to advertise, label a product, or market a good or service, the party affected is denied the right to a trial before an impartial jury of peers.

These are among many violations of constitutional rights that take place across the United States as Administrative Agencies enforce their rules which Congress never passed into law.  There are thousands of Americans who have lost their jobs, lost their businesses, lost their livelihoods, and, indeed, lost their liberty and lives because of government agencies depriving Americans of constitutional rights to achieve politically preferred outcomes.  The Deep State has swallowed not just political enemies but honest, hard-working Americans in virtually every field of endeavor.  Freedom, innovation, progress, opportunity, and choice have all been put on the chopping block by the voracious regulatory state that now dominates and controls America.

Until we limit law-making to Congress, as the Constitution requires, and until we end Administrative Agency rights violations, we will never enjoy that liberty that is our birthright as citizens of our constitutional republic.  An updated version of a bill I wrote with Norm Singleton for Ron Paul years ago would help solve the problem.  Called the Congressional Responsibility and Accountability Act, it would prohibit any administrative agency proposed rule from taking effect unless passed into law by Congress, and it would sunset every existing regulation within three years unless passed into law by Congress.  Add to that a requirement that agencies bring charges before independent federal courts, elimination of administrative law courts, and demand for de novo judicial review of all agency actions, and we would be well on our way to restoring the constitutional rights protections taken from us by the Administrative State.

Reprinted From Townhall.

FDA Withholds Autopsy Results of Those Who Died After COVID Shots

BY MARCO CACERES

SEE: https://thevaccinereaction.org/2022/10/fda-withholds-autopsy-results-of-those-who-died-after-covid-shots/;

Republished below in full unedited for informational, educational, & research purposes.

The U.S. Food and Drug Administration (FDA) has refused a Freedom of Information Act (FOIA) request to release the autopsy results of people whose deaths were reported to the Vaccine Adverse Event Reporting System (VAERS) after receiving a COVID-19 shot. The FOIA request was submitted by The Epoch Times newspaper.1

“VAERS is a centralized vaccine reaction reporting system that was among the safety provisions secured by parents of DPT (diphtheria-pertussis-tetanus) vaccine injured children in the National Childhood Vaccine Injury Act (NCVIA) of 1986,” explains Barbara Loe Fisher, co-founder-and-president-of the National Vaccine Information Center (NVIC). It is jointly operated by the FDA and U.S. Centers for Disease Control and Prevention (CDC).2 3

According to The Epoch Times, the FDA declined to release any autopsy reports of VAERS deaths, even redacted copies, citing FOIA section (8) (A) which allows federal agencies to withhold information from the public if an agency “reasonably foresees that disclosure would harm an interest protected by an exemption,” with the exemption being “personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.”1 4

FDA Refusal to Provide Autopsy Info Attributed to Concerns Over Personal Privacy

The FDA reportedly also cited federal law that blocks the release of “personnel, medical and similar files the disclosure of which constitutes a clearly unwarranted invasion of personal privacy.”1 4

One possible reason for the FDA’s reluctance is that neither officials at the FDA nor at the CDC have found (or at least openly admitted)  a “causal association” between the COVID shots and the post-COVID vaccination deaths reported to VAERS. A study published last year in the journal Clinical and Experimental Vaccine Research stated:

These regulatory agencies have not found a causal association, and there is no reason to state that the COVID-19 vaccine causes death. Data from the VAERS and available clinical information (death certificates, autopsies, and medical records) does not establish cause and effect between deaths and reported deaths. Deaths following vaccination equated to deaths caused by vaccines are irresponsible, misleading and scientifically inaccurate.5

To release autopsy reports of people who died after receiving COVID shots might lead to uncomfortable questions about the conclusions reached by FDA and CDC officials and raise the specter of a national re-evaluation and lots of second opinions regarding the safety of the shots.

That does not appear to be a conversation these and other public health officials at the helm of government agencies like the National Institutes of Health (NIH) and, specifically, the National Institute of Allergy and Infectious Diseases (NIAID), appear anxious to have.

Those responsible for operating these federal agencies, not to mention countless doctors, scientists, and politicians around the country, have staked their reputations on assuring the American public that the COVID shots do not cause harm, much less death. Why indeed would they want to investigate and give space to a conversation by asking legitimate questions and offering dissenting views?

More Deaths After COVID Shots Reported in VAERS Than Any Other Vaccine

It must already be difficult enough having to acknowledge the 16,516 deaths in the U.S. reported to VAERS after COVID vaccinations as of Sept. 14, 2022.1

Still, it is a public conversation that should be allowed to take place. After all, it is no minor thing that, as Fisher notes, “There have been more deaths reported to VAERS following COVID-19 vaccinations than for any other federally recommended vaccine since VAERS became operational in 1990.”2

All of the FDA’s stated concerns about protecting privacy seem rather bogus, as the autopsy results sought through the FOIA request could be released with personal information blacked out. “The personal information could easily be redacted without losing the potential learnings from [the] autopsy,” said Kim Witczak, a drug safety advocate who serves as an adviser to the FDA.1

Besides, Witczak logically points out:

If someone submits their experience to VAERS they want and expect to have it investigated by the FDA. This includes autopsy reports. Autopsies can be an important part of postmortem analysis and should be done especially with increased deaths following COVID-19 vaccination.1

Why is transparency on this issue such a stumbling block for the FDA?

If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.

Click here to view References:

1 Stieber Z. EXCLUSIVE: FDA Withholding Autopsy Results on People Who Died After Getting COVID-19 Vaccines. The Epoch Times Sept. 30, 2022.
2 Fisher BL. More Deaths Reported to VAERS Following COVID-19 Vaccinations Than for Any Other Vaccine. The Vaccine Reaction July 11, 2021.
3 TVR Staff. Only One Percent of Vaccine Reactions Reported to VAERS. The Vaccine Reaction Jan. 9, 2022.
4 The United States Department of Justice. THE FREEDOM OF INFORMATION ACT, 5 U.S.C. § 552.
5 Lamptey E. Post-vaccination COVID-19 deaths: a review of available evidence and recommendations for the global population. Clin Exp Vaccine Res September 2021; 10(3): 264–275.

GOVERNMENT CENSORSHIP: Biden White House officials and multiple federal agencies coordinated with FACEBOOK & Big Tech to censor Americans and cover up government crimes

Image: GOVERNMENT CENSORSHIP: Biden White House officials and multiple federal agencies coordinated with Big Tech to censor Americans and cover up government crimes

BY LANCE D. JOHNSON

SEE: https://www.naturalnews.com/2022-09-04-biden-officials-coordinated-with-big-tech-censor-americans.html;

Republished below in full unedited for informational, educational, & research purposes.

(Natural News) Not only did the Federal Bureau of Investigations (FBI) coordinate with Mark Zuckerberg to censor reports on Biden family crimes in the leadup to the 2020 election, but the pre-appointed Biden regime also coordinated with Facebook and Twitter to censor individuals who posted about crimes committed by the CDC and Anthony Fauci.

According to newly released internal emails from Facebook and Twitter, the Biden regime coordinated with Big Tech to restrict the speech of individual Americans. This blatant violation of the First Amendment was uncovered by Attorneys General Eric Schmitt (MO) and Jeff Landry (LA). These revelations prove that the Biden regime is a fascist government, in violation of the U.S. Constitution.

At least 45 Biden officials worked with Big Tech to silence Americans

More than one federal agency reached out to Facebook and Twitter employees, instructing the social media giants to flag specific information as “misinformation.” This vast censorship enterprise included at least 45 identified federal employees. The Department of Homeland Security (DHS), the Cybersecurity and Infrastructure Security Agency (CISA), the National Institutes of Allergy and Infectious Disease (NIAID), the Centers for Disease Control (CDC), Health and Human Services (HHS), the U.S. Election Assistance Commission, and the Office of the Surgeon General were all involved. These agencies repeatedly pressured Facebook and Twitter to censor specific topics, and they even directed the platforms to suppress speech using official, government-approved narratives.

“We have already received a number of documents that clearly prove that the federal government has an incestuous relationship with social media companies and clearly coordinate to censor freedom of speech, but we’re not done,” said Schmitt in a joint statement. “The Department of Justice is cowering behind executive privilege and has refused to turn over communications between the highest-ranking Biden Administration officials and social media companies. That’s why, yesterday, we asked the Court to compel the Department of Justice to produce those records. We’re just getting started – stay tuned.”

CDC worked regularly with Facebook to control speech

A CDC official coordinated monthly meetings with Facebook employees to deploy “debunking” strategies. Facebook employees waited for official CDC narratives to be crafted before they went ahead and censored Americans with this “debunking” strategy. These “debunking strategies” were used to protect public health officials who were causing serious harm throughout society (e.g., Anthony Fauci). One White House Official coordinated with Facebook to take down parody accounts that exposed Anthony Fauci.

Instead of working on ways to improve public health, the CDC spent its resources on conducting regular “be on the lookout” calls. CDC employees surveilled social media to find messages that they wanted to censor. Most of the censored speech was speech that held the government accountable for all the fraud, deception, and malice they were causing as part of their covid-19 response.

Twitter was also in on these crimes, and even scheduled meetings with Biden White House officials to identify “vaccine misinformation.” Almost all of this “vaccine misinformation” from a year ago was either proven true at the time or would eventually be proven true. YouTube provided communications about content moderation that was directed by eleven federal officials, including officials with the Census Bureau and the White House.

The U.S. Surgeon General’s office devised a “misinformation health advisory” in July of 2021 and worked with a senior Facebook official to implement its conditions throughout social media. In the email, the Facebook official acknowledged Meta’s compliance with the speech directives. “I know our teams met today to better understand the scope of what the White House expects from us on misinformation going forward.” That same Facebook official discussed numerous steps to censor freedom of speech with HHS officials.

For more on the feds' collusion with Big Tech, check out Censorship.News.

Sources include:

Zerohedge.com

AGO.MO.gov

The FDA KNEW: 44% of pregnant women miscarried following covid vaccination but shots were given emergency authorization anyway

BY ETHAN HUFF

SEE: https://www.naturalnews.com/2022-08-18-fda-knew-44percent-women-miscarriage-covid-vaccination.html;

Republished below in full unedited for informational, educational, & research purposes.

(Natural News) In making the decision to grant emergency use authorization (EUA) to Wuhan coronavirus (Covid-19) “vaccines,” the U.S. Food and Drug Administration (FDA) knew full well at the time that nearly half of all pregnant women would end up miscarrying as a result of the injections.

The latest Pfizer document drop shows that 44 percent of all pregnant women who participated in Pfizer’s mRNA (messenger RNA) jab trials ended up losing their unborn babies. To the FDA, this still constitutes a “safe and effective” drug. (Related: A Wisconsin doctor who worshipped covid injections suffered a miscarriage after getting hers.)

After these women lost their children, Pfizer tried to claim that the deaths had nothing to do with its shots. The FDA apparently took Pfizer’s word for it and proceeded to authorize, and later approved, the injections as a remedy for the Fauci Flu.

The thousands upon thousands of pages of documents that Pfizer and the FDA tried to conceal for 75 years demonstrate a shocking pattern of intentional deceit by the two entities. Both Pfizer and the FDA have been working overtime to try to withhold the truth from the public – but that truth is now coming out.

Big Pharma and the FDA are LIARS

Unfortunately for the millions of women who already took the jabs, the damage is already done. Many have already learned the hard way that Operation Warp Speed is really just Operation Death Speed, including for unborn babies.

The women who participated in the Pfizer trial all took between one and four injections of Pfizer’s mRNA concoction. Forty-two received the drug immediately while eight received a placebo initially followed by the real drug later.

By March 31, 2021, all of the pregnant women in the trial – 50 in total – had taken at least one dose of Pfizer’s BNT162b2 experimental injection. The following explains how Pfizer knowingly hid the disastrous results.

“Pfizer notes the miscarriages as serious adverse events (SAEs) with ‘moderate’ (2) or ‘severe’ (3) toxicity ratings. However, all the miscarriages were reported as being unrelated to the trial vaccine – i.e., having ‘Other’ causes – and marked as ‘Recovered/resolved’ adverse effects. To reiterate, not only does Pfizer deny any vaccine-related causality and assert the losses of life had other causes, but it also categorizes losing a baby as a ‘resolved adverse effect’ – like a headache that went away.”

In other words, the loss of a pregnancy is just collateral damage – a “side effect” that quickly got “resolved” once the babies died. This is how Pfizer operates, by the way: just hide the truth, recategorize it, or flat-out lie about it – and the FDA does the exact same thing.

By April 1, the FDA was fully aware of the fact that a “significant percentage” of pregnant women who get jabbed for the Fauci Flu suffer “abortion spontaneous.” Even so, the agency proceeded to do nothing, allowing many more pregnant women to take the shots.

The FDA “failed in its duty to study the data and investigate what basis Pfizer had for marking the fetal deaths as unrelated to the vaccine and having ‘Other’ causes,” reports explain.

The FDA also failed to at least tell the public that there is a serious risk involved for unborn babies who are exposed to covid shots via their mothers. Without that information, notes the Daily Clout, “women were not able to give informed consent for receiving Pfizer’s mRNA COVID vaccine.”

To say that the FDA failed implies that it simply made a mistake, which is not the case. The corrupt federal agency lied on behalf of Pfizer by withholding the truth from the public, which is a crime against humanity as well as a dereliction of duty.

More stories like this one can be found at ChemicalViolence.com.

Sources for this article include:

UndercoverDC.com

NaturalNews.com

DR. Mercola: Drug industry is trying to use Congress to take over supplements and regulate them out of existence

Image: Mercola: Drug industry is trying to use Congress to take over supplements and regulate them out of existence

BY LANCE D. JOHNSON

SEE: https://www.naturalnews.com/2022-07-22-mercola-drug-industry-using-congress-regulate-supplements-out-of-existence.html;

republished below in full unedited for informational, educational & research purposes:

(Natural News) Health freedom is under attack in a new way. Illinois Senator Richard Durbin (D) is the sponsor of a new regulatory proposal -the Dietary Supplement Listing Act of 2022. This regulatory nightmare would give the pharmaceutical industry (FDA) more control over nutritional supplements, allowing the Food and Drug Administration to regulate many out of existence.

Under the new legislation, nutritional, food-based, and herbal supplements would be required to undergo the same pre-market approval process as drugs – limiting access and driving up the cost of some of the most basic nutrients and superfoods.

Drug industry seeks to destroy NAC, B6, CBD and much more

Dr. Joseph Mercola warns that the Dietary Supplement Listing Act of 2022 would allow the drug industry to take over supplements and regulate them out of existence. In the past, he said, “the drug industry and the U.S. Food and Drug Administration have tried to ban certain supplements, including vitamin B6 and N-acetylcysteine (NAC), by reclassifying them as new drugs.” The latest hostile takeover of supplements would ensure that millions of Americans are unable to take care of their health in the most basic, fundamental ways.

This legislation would allow the FDA to reclassify certain supplements as “new drugs.” Supplement companies will not be able to afford millions of dollars in new regulatory fees that will be required to get their products approved by the FDA. If passed, this will drive small supplement manufacturers out of business, allowing the drug companies to continue buying them up. Right now, fourteen mega corporations – including the likes of Pfizer, Nestle, and Bayer – control more than one hundred of the most popular supplements on the market. For example, Nestle Health Science has bought up Garden of Life, Vital Proteins, Wobenzym, Persona Nutrition, Nuun, Orthica, Pure Encapsulations, Douglas Laboratories, Genestra, Minami, AOV, Klean Athlete, Bountiful, and its smaller brands Solgar, Osteo Bi-Flex, Puritan’s Pride, Ester-C, and Sundown. Once the drug companies control these products, the formulas are often adulterated and manufactured with fillers and synthetic chemicals.

The Dietary Supplement Listing Act of 2022 has already been introduced to the US Senate and referred to the Committee on Health, Education, Labor, and Pensions. It is expected to become a part of the FDA’s Safety Landmark Advancements Act. Daniel Fabricant, Ph.D. president and CEO of the Natural Products Association, warned, “Last time I checked, dietary supplements are not drugs, biologics or medical devices, so why Congress or anyone supporting nongermane legislation that will only add costs to consumers who are doing all they can to stay healthy is extremely troubling.”

Big Pharma trying to control, distort, eliminate the very God-given substances that help the body heal

The FDA has been writing warning letters to supplement companies, telling them not to market N-Acetyl-Cysteine (NAC) for any health issues. NAC has been used as a remedy to help the body synthesize glutathione, strengthening the immune system. The FDA threatened Amazon to stop selling NAC products after learning about the public’s interest in NAC for combating infections.

This is just the tip of the spear. In 2007, Medicure Pharma manufactured a synthetic version of vitamin B6, for which they owned a drug patent. Medicure Pharma called the vitamin MC-1 and used it to treat inadequate blood flow.

That year, Medicure Pharma called on the FDA to target any dietary supplement manufacturer that used vitamin B6 in their formula. Medicure Pharma argued that any product that contained pyridoxal 5?-phosphate was guilty of selling an “adulterated” product under the Federal Food, Drug and Cosmetic Act, article 402(f). The drug company had already entered MC-1 into the drug bank and believed they had exclusive rights to manufacture the synthetic B6 vitamin – no competition allowed. However, various whole food vitamin manufacturers used the natural form of vitamin B6 (pyroxidine) and refused to acquiesce to the Medicure Pharma and the drug industry. When a pharmaceutical company turns a vitamin into a synthetic drug, they are able to jack up the price and market it as theirs.

Under the new regulatory proposal, drug companies would be able to legally get away with this fraud with just about any natural vitamin or phytochemical. This will inevitably destroy health food stores and push basic food-based supplements into the pharmacy, where drug companies can control the price and limit access.

The Natural Products Association urges everyone to contact their representatives to oppose this threat to our health and freedom.

Sources include:

TheBurningPlatform.com

Congress.gov

NaturalNews.com

NCBI.NLM.NIH.gov

NPANational.org

Scientists Leaving CDC, FDA, NIH Due to “Bad Science,” Political Pressure

BY VERONIKA KYRYLENKO

SEE: https://thenewamerican.com/scientists-leaving-cdc-fda-nih-due-to-bad-science-political-pressure-from-biden/;

republished below in full unedited for informational, educational & research purposes:

America’s top healthcare agencies are facing an alarming rate of resignations. “Low morale” and “bad science” practiced by the agencies and caused by the political pressure from the Biden administration are the primary factors that make even top-level employees call it quits.

Last week, Dr. Marty Makary, a top public-health expert at Johns Hopkins University and a medical advisor to Virginia Governor Glenn Youngkin; and Dr. Tracy Beth Høeg, an epidemiologist affiliated with the Florida Department of Health, posted an article in which they quoted doctors and scientists at the top levels of the U.S. National Institute of Health (NIH), the U.S. Food and Drug Administration (FDA), and the U.S. Centers for Disease Control and Prevention (CDC) on their dreadful work conditions. The latter said they felt “variously frustrated, exasperated, and alarmed about the direction of the agencies to which they have devoted their careers.”

The article reads,

“It’s like a horror movie I’m being forced to watch and I can’t close my eyes,” one senior FDA official lamented. “People are getting bad advice and we can’t say anything.”

Support for masking in schools, school closures, and the authorization of experimental gene therapeutics against Covid (aka “vaccines”) for children four and under were among the major decisions made by the federal agencies that undermined personnel’s morale.

From the very onset of the pandemic, all of the agencies ostensibly responsible for sound healthcare policies have been mired in controversy for inconsistent and confusing messaging and for decision-making that was at odds with the available science. The high-profile employees of the agencies say the root cause is that politics is driving science, and not the other way around.

The result of the pressure is what Makary and Høeg call “bad science,” when the top decision-makers deliberately “use weak or flawed data to make critically important public health decisions.”

Per the article,

“There’s been a large amount of turnover. Morale is low,” one high level official at the CDC told us. “Things have become so political, so what are we there for?” Another CDC scientist told us: “I used to be proud to tell people I work at the CDC. Now I’m embarrassed.”

This is the agency whose goal is to “increase the health security of our nation” by “conducting critical science and providing health information that protects our nation against expensive and dangerous health threats.” In the end, it is the CDC that makes public health recommendations based on research done internally and by its sister agencies, the FDA and the NIH.

Those two are experiencing a state of affairs that is not much better.

At the NIH, doctors and scientists complain to us about low morale and lower staffing: The NIH’s Vaccine Research Center has had many of its senior scientists leave over the last year, including the director, deputy director and chief medical officer. “They have no leadership right now. Suddenly there’s an enormous number of jobs opening up at the highest-level positions,” one NIH scientist told us.

The NIH is responsible for biomedical and public health research and works to find the best ways to apply the findings “to enhance health, lengthen life, and reduce illness and disability.”

Then, there’s the FDA, which is presumably working to ensure the safety of medical products — including vaccines — and food to “protect public health.”

Discussing the FDA’s decision to recommend the Moderna and Pfizer Covid shots for young children and the overall detrimental impact of the botched pandemic policies supported by the FDA that hurt children, one official told the authors, “I can’t tell you how many people at the FDA have told me, ‘I don’t like any of this, but I just need to make it to my retirement.’”

Yet many chose to leave rather than be a part of the travesty, with the decision to vaccinate all American children being the last straw. They say that the data provided by Pfizer, for example, was “extremely weak” and “inconclusive,”

Referring to Pfizer’s vaccine efficacy in healthy young children, one high-level CDC official — whose expertise is in the evaluation of clinical data — joked: “You can inject them with it or squirt it in their face, and you’ll get the same benefit.”

Moderna’s efficacy data was just as bad, added Makary and Høeg.

If the shots were simply ineffective, that would only be a part of the issue. Yet the shots are not just associated with a stunning number of adverse events and deaths in children, they irreparably disrupt the natural development of their innate immune systems. When that ultimate defense mechanism is undermined, any infectious disease may kill children. The constant reinfection of vaccinated people, including little ones, is also associated with an increased risk of cancer, as explained to The New American by world-class vaccinology and immunology expert Dr. Geert Vanden Bossche.

Despite unacceptably low data quality, the agencies moved forward with the recommendation that all children in America, up to 75 percent of whom have acquired natural immunity against Covid as a result of previous infection, be immunized with the experimental shots. Both Pfizer and Moderna vaccines are considered “investigative,” i.e., experimental, and are administered under the Emergency Use Authorization (EUA).

“That slap in the face of science may explain why only 2% of parents of children under age five have chosen to get the Covid vaccine, and 40% of parents in rural areas say their pediatricians did not recommend the Covid vaccine for their child,” noted the doctors.

The doctors also point out that employees are being “muzzled” against open dissent and feel uncomfortable discussing the scientific observations that go against the official internal narrative. Makary further cited FDA staffers, who complained that “You get labeled based on what you say. If you talk about it you will suffer, I’m convinced,” and, “If you speak honestly, you get treated differently.” 

Makary and Høeg conclude that the result of the healthcare agencies’ caving into political pressure is crumbling public trust in “public health itself” with “potentially disastrous consequences.”

FDA Authorizes Novavax Covid Shot to Increase Vax Rate, Biden Buys 3.2 Million Doses

BY VERONIKA KYRYLENKO

SEE: https://thenewamerican.com/fda-authorizes-novavax-covid-shot-to-increase-vax-rate-biden-buys-3-2-million-doses/;

republished below in full unedited for informational, educational & research purposes:

Trying to convince some 100 million unvaccinated Americans to get a Covid shot, U.S. federal regulators have just authorized another Covid vaccine called Novavax. The reasoning behind the move is that if a person is hesitant to take gene-editing mRNA vaccines from Pfizer and Moderna or vector-based Johnson & Johnson, he or she would probably find a vaccine that uses moth cells to grow the most toxic part of the virus — spike protein — a “safer” option.

Commenting on the Emergency Use Authorization (EUA) for Novavax, FDA Commissioner Robert M. Califf said, “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

Despite such claims, FDA-authorized Covid vaccines already in use are associated with more than 1.3 million adverse events and more than 29,000 deaths. Those numbers, apparently, are not significant, and the FDA’s sister agency, the U.S. Centers for Disease Control and Prevention (CDC), does not even evaluate them. Moreover, the FDA has been sued to release all documents that it was supposed to review prior to granting full approval to Pfizer-BioNTech. The agency refused, saying it needed at least 75 years to release the documents it reviewed within nine months, although the judge gave the regulators until August 2022 to make them public. Analysis of the data presented to the FDA revealed that the shots are ineffective at preventing Covid and were clinically shown to cause a wide range of severe adverse reactions, including for pregnant women and their babies. Then, there are FDA documents explicitly showing more than 40,000 adverse reactions and 1,200 deaths linked to the Pfizer shot in just two and a half months of its being administered to the public. Yet the FDA finds nothing troubling about that.

Back to Novavax. How does it work?

According to the FDA,

The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.

Novavax describes the steps in the creation of its investigational vaccines, including those for Covid.

An “investigational” medical product means that it is experimental and “is being studied to see if your disease or medical condition improves while taking it,” according to the FDA.

The Washington Post produced an instructional video on how Novavax uses moth cells to create its coronavirus vaccine.

The narrator describes how researchers at Novavax “hijack the ovaries of the fall armyworm” and infect them with a genetically-modified baculovirus (a type of insect virus) to contain SARS-CoV-2 spike protein.” Then, just like human cells, moths’ cells produce spike proteins and then antigen proteins, so “the match is perfect,” explained the president of research and development of Novavax, Gregory Glenn, in the video.

Speaking with The New American in July of 2021, Dr. Richard Fleming warned against using Novavax, arguing that the spike protein is an actual biological weapon.

Regarding the safety of the shot, it is linked to the increased risk of myocarditis (inflammation of the heart muscle), pericarditis (inflammation of the lining outside the heart), injection-site reactions (pain, redness, swelling, itching), general side effects (fatigue, joint pain, vomiting, muscle pain, etc.), and allergic reactions, according to the FDA. There are no long-term safety studies of the shots. Some of the participants were observed for just four months.

Regulators estimated that the new shot was 90.4-percent effective in preventing mild, moderate, or severe Covid. The figure was lower for those over the age of 65, standing at 78.6 percent. It is not clear how long this immunity lasts, or whether additional doses will be required to maintain this level of protection.

Additionally, unlike the mRNA-based competitor vaccines, Novavax is much more forgiving in terms of storage and does not require storage in subfreezing temperatures. It is also said to have a longer shelf life.

The shot comes in 10-dose vials, which suggests that it would be challenging to get a consistent quantity of the antigen and adjuvant across the 10 different draws from the vial.

The FDA’s advisory panel on vaccines, the Vaccines and Related Biological Product Advisory Committee (VRBPAC), endorsed the use of Novavax on June 7.

There are still unanswered questions regarding the studies showing that the Matrix-X adjuvant is safe. It was mentioned during the discussion that there are studies ongoing in West Africa to estimate the safety, though they are not yet concluded. Gregory Glenn told NBC Chicago that each such adjuvant particle is “basically a soap bubble. It’s made of stuff that you find in root beer.” That may be, but is it safe to mix with moth-produced proteins and inject it into humans?

It also is not clear whether the shot produces sterilizing immunity (meaning, the recipient does not get infected with Covid), and whether it protects against omicron (it was not yet circulating during the clinicals and is not listed on the company’s presentation slides).

When considering taking Novavax, one should be aware that there have been unexplained irregularities during the trials that are described here.

According to Novavax, even before the FDA formally authorized the short, the Biden administration had placed an order for 3.2 million doses of the new shot. However, it won’t be available until the CDC’s Advisory Committee on Immunization Practices (ACIP) approves it. Currently, the committee is scheduled to meet July 19.

Physicians Sue FDA Over “Crusade” Against Ivermectin

Physicians Sue FDA Over “Crusade” Against Ivermectin

BY RAVEN CLABOUGH

SEE: https://thenewamerican.com/physicians-sue-fda-over-crusade-against-ivermectin/;

republished below in full unedited for informational, educational & research purposes:

Three physicians have filed a lawsuit against the U.S. Food and Drug Administration (FDA) this month for the agency’s “crusade” against ivermectin as a treatment for Covid-19. The lawsuit contends the FDA “unlawfully interfered” with the doctors’ ability to practice medicine by directing the public, health professionals, and patients not to use ivermectin.

The Epoch Times reports that Drs. Robert L. Apter, Mary Talley Bowden, and Paul E. Marik filed the lawsuit with the U.S. District Court, Southern District of Texas, Galveston Division. In addition to the FDA, the suit names the U.S. Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra, and Acting FDA Commissioner Robert Califf. The physicians are represented by Boyden, Gray & Associates, a Washington, D.C.-based law firm.

According to the lawsuit, the FDA acted outside of its authority, which is limited to approving drugs and drug labeling.

“The FDA generally cannot ban particular use of human drugs once they are otherwise approved and admitted to the market, even if such use differs from the labeling — commonly referred to as “off-label” use,” the lawsuit reads. “The FDA also cannot advise whether a patient should take an approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient relationship. Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is — and always has been — reserved to states.”

The lawsuit specifically cites an FDA publication titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and several tweets from the FDA discouraging the use of ivermectin as examples of FDA interference.

One such tweet includes a photo of a doctor with a horse beside an image of a doctor with a patient. The tweet reads, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

The tweet is intentionally misleading, as ivermectin has, in fact, been approved by the FDA for human use. Newsmax reported that though ivermectin was developed in the 1970s as a treatment for parasitic diseases in livestock, it became hailed as a “wonder drug” and received approval for human use against diseases such as river blindness. The Epoch Times observed it has been used widely since 1987, even earning William Campbell and Satoshi Omura the 2015 Nobel Prize in Physiology or Medicine for their research on the drug.

The plaintiffs contend that the FDA’s unlawful interference in the practice of medicine creates a dangerous precedent that will “metastasize to other circumstances, destroying the carefully constructed statutory wall between federal and state regulatory powers, and between the FDA and the professional judgment of health professionals.”

The plaintiffs have seen first-hand the dangers that this interference can create.

“Doctors are increasingly employees of entities that look to the FDA for guidance and enforce standards accordingly,” the lawsuit argues.

As such, despite the plaintiffs’ extensive academic and professional credentials, all of which are outlined in the lawsuit, they all faced disciplinary action for treating their patients with ivermectin.

Dr. Apter, despite his 99.8-percent success rate in treating Covid-19 patients, was referred to the Washington Medical Commission and Arizona Medical Board for disciplinary proceedings for prescribing ivermectin as part of his Covid treatment, The Epoch Times report.

Apter asserted in a press release that the FDA’s treatment of ivermectin has resulted in disciplinary actions against doctors and inhibited physician freedom to treat patients according to their best judgment, resulting in more deaths and serious disabilities. He adds the FDA’s interference has been so overreaching that even pharmacies have refused to fill ivermectin prescriptions.

Like Apter, plaintiff Dr. Mary Bowden also successfully treated Covid-19 patients with ivermectin before being forced to resign by her employer, Houston Methodist Hospital.

Bowden told The Defender that she initially supported the widespread vaccines for Covid until she noticed the prevalence of breakthrough cases and adverse reactions to the vaccine.

“If I hadn’t seen that firsthand,” she said, referring to the adverse reactions, “I would still think the vaccine was the way to go.”

Prompted by the realization that the vaccines were not the answer to the pandemic, Bowden created her own Covid protocol, which includes ivermectin, vitamins C and D, quercetin, zinc, and black seed oil. She said the results were excellent.

Similarly, Dr. Paul Marik developed a Covid-19 Management Protocol for the Eastern Virginia Medical School (EVMS) in Norfolk, Virginia, where he worked from 2009 to 2021. Dr. Marik also served as director of the intensive care unit at Sentara Norfolk General Hospital until he was forced out of both positions for promoting the use of ivermectin to treat Covid-19.

Marik contends that the FDA’s attempt to stop the use of ivermectin for Covid has “led to innumerable hospitalizations and deaths, and caused extreme distress for patients, their families, and health professionals.”

The plaintiffs’ successes in treating Covid-19 with ivermectin are not unique to them. Studies continue to show the drug is associated with lower Covid-19 death rates, but ivermectin continues to be demonized by the FDA and the mainstream media.

Despite the evidence that ivermectin is a viable treatment for Covid-19, the plaintiffs contend the lawsuit is not about the drug’s effectiveness, but about “who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.”

The lawsuit argues the FDA acted in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), which expressly states that nothing in the FDCA “shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device for any condition or disease within a legitimate health care practitioner-patient relationship.”

The plaintiffs are asking the court to hold the FDA’s actions unlawful, issue declaratory relief declaring the Defendants’ actions unlawful, and issue declaratory relief declaring that the FDA cannot interfere with the practice of medicine. The lawsuit also asks for injunctive relief enjoining all defendants from engaging in such actions as to interfere with the practice of medicine and issue statements or directives dictating the off-label use of ivermectin. Plaintiffs are also seeking attorney fees and allowable costs, and any further relief “to which they are justly entitled at law and in equity.”

The Unbelievable Reason for the FDA’s Delayed Response to the Formula Crisis

You're Not Going to Believe the Reason for the FDA's Delayed Response to the Formula Crisis

BY RICK MORAN

SEE: https://pjmedia.com/news-and-politics/rick-moran/2022/05/26/youre-not-going-to-believe-the-reason-for-the-fdas-delayed-response-to-the-formula-crisis-n1601089;

republished below in full unedited for informational, educational & research purposes:

Last October, a conscientious whistleblower at Abbott Nutrition wrote a letter directly to the interim chief of the FDA, acting Commissioner Janet Woodcock, and others. He claimed there were serious problems at the company’s Sturgis, Mich. plant.

But the current head of the agency, FDA Commissioner Robert Califf, will testify before a congressional committee today that the top levels of the agency weren’t aware of the whistleblower’s report because of “mailroom issues.”

Dozens of infants are currently being hospitalized because the specialty formula they depend on to survive is out of stock.

And the FDA had “mailroom issues.”

Politico:

Up until now, however, FDA officials declined to comment on why it took months between the first report of a bacterial infection linked to the plant last September, their inspection this winter, which turned up a range of food safety problems, and the recall. But the new details aren’t likely to tamp down the criticism of the agency, rather, they are already fueling further outrage from lawmakers.

“The FDA, at every step of this process, dropped the ball,” Rep. Rosa DeLauro (D-Conn.), chair of the House Appropriations Committee, told POLITICO in an interview about the new details revealed in the testimony. “It put infants at risk.”

It actually gets worse. Despite getting the first reports of probable contamination in January, the Sturgis plant wasn’t shut down until mid-February. Even before then, there were internal discussions at the FDA about potential supply disruptions. This was critical because the Abbott plant supplies half the infant formula in the United States for the WIC program — the government food program for infants being raised mostly by single mothers.

Related: Wait, What? HALF of Infants in the U.S. Are on WIC?!

The FDA timeline laid out in the prepared testimony acknowledges the FDA didn’t hold interagency discussions about potential supply chain disruptions until Feb. 14, three days before the Abbott Nutrition plant at the center of the current shortages shut down and issued a formula recall. And the agency didn’t notify the Agriculture Department, which oversees a critical federal nutrition program that purchases about half of the nation’s infant formula, about potential disruptions until a week before the Abbott plant shut down. The program, known as WIC, serves 1.2 million infants from low-income families. Abbott supplies nearly half of all infant formula provided through WIC state contracts.

Why did it take the FDA until the end of January to begin its inspection of Abbott’s Sturgis plant, despite receiving warnings last fall? The FDA blames the staff at Sturgis for delaying their inspection because of COVID-19 staffing issues.

And despite parents screaming for more formula for the first two weeks in May (when the issue finally became news), it wasn’t until May 16 that the government reached an agreement with Abbott to reopen its Sturgis plant.

The White House is playing dumb and trying to deflect media attention toward the FDA.

The White House has also ducked questions about its own timeline in responding to the recall and ensuing shortages. Asked by POLITICO about when the FDA told the White House of the issues at the Sturgis plant and any concerns about potential shortages, a senior administration official said they would not comment on “internal communications.” “The recall became public on February 17 and we certainly have been very public about our activity in this space since then,” the official added.

What should have been a small, temporary supply disruption has become a national crisis because of the incompetence of the Biden administration and the general stupidity of big government. The media has already advanced the narrative that this isn’t Biden’s fault, that it was shortages caused by the pandemic, and that the company is at fault for running an unsanitary plant.

But the very regulations and procedures set up by the government to deal with a crisis like this failed in a spectacular fashion. And that’s on Biden.

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