In a large-scale observational study published on Feb. 29 in the New England Journal of Medicine (NEJM), researchers invited 800,000 people with varying levels of COVID-19 exposure and duration to take an online cognitive assessment and follow-up survey. Cognitive difficulties have been implicated in numerous syndromes following COVID-19, including long COVID, suggesting infection may have lasting effects on the mental processes of the brain.

The study’s authors hypothesized there would be measurable cognitive deficits after COVID-19 that would scale with the severity and duration of the illness. They also speculated that objective impairments in executive and memory function, especially poor memory and brain fog, would be observable in those with persistent symptoms.

Using an assessment tool for cognitive function, researchers estimated global cognitive scores among participants with a history of previous SARS-CoV-2 infection who had symptoms for at least 12 weeks—whether resolved or not—and among a control group of uninfected participants. While cognitive and memory deficits were small for people with mild infection who recovered from COVID-19 quickly, impairments were more pronounced in those with severe disease.

Greater Impairment With More Severe Disease

Of 112,964 participants who completed the survey, those who recovered from COVID-19 with symptoms that resolved in less than four weeks or by 12 weeks post-infection had similar small deficits in global cognition compared with those who had never had COVID-19.

Participants who had mild COVID-19 with resolved symptoms experienced a 3-point drop in IQ compared to uninfected participants. Those with unresolved persistent symptoms had a 6-point loss in IQ, and those with COVID-19 admitted to the intensive care unit experienced a 9-point loss in IQ. Reinfection with SARS-CoV-2 caused an additional loss in IQ of nearly 2 points compared to those who were not reinfected. An IQ, or intelligence quotient, is a number used to represent the relative intelligence of an individual.

According to the study, memory, reasoning, and executive function tasks were the strongest indicators of impaired cognitive function, and these scores correlated with brain fog symptoms reported by participants. More significant deficits were seen in those with unresolved persistent symptoms and those infected with earlier variants of the SARS-CoV-2 virus compared with those who never had COVID-19. Additionally, study participants who were hospitalized had greater deficits in cognitive function compared to those who were not hospitalized.

“By using an innovative cognitive test which has also been completed by people who did not have COVID-19, this important and well-conducted study provides the first accurate quantification of the scale of cognitive deficits in people who had COVID-19,” Maxime Taquet, a fellow in psychiatry at the National Institute for Health and Care Research at the University of Oxford, said in a statement.

Mr. Taquet said researchers found a small but obvious association between COVID-19 and cognition that was more pronounced at extremes.

“The risk of having more severe cognitive problems was almost twice as high in those who had COVID-19 compared to those who did not, and three times as high in those who were hospitalized with COVID-19,” he noted.

In an editorial published Feb. 29 in the NEJM, Drs. Ziyad Al-Aly and Clifford Rosen said the study’s results are concerning and have broad implications that require further evaluation to determine the functional impact of a 3-point loss in IQ and why one group of participants was more severely affected than another.

“Whether these cognitive deficits persist or resolve along with predictors and trajectory of recovery should be investigated. Will Covid-19-associated cognitive deficits confer a predisposition to a higher risk of Alzheimer’s disease or other forms of dementia later in life? The effects on educational attainment, work performance, accidental injury, and other activities that require intact cognitive abilities should also be evaluated,” they wrote.

Study Implications for People With Long COVID

The study’s participants were part of a larger community sample of nearly 3 million people in the Real-time Assessment of Community Transmission (REACT) study assessing SARS-CoV-2 transmission in England. Although the researchers did not say whether participants in the study had long COVID, people with long COVID frequently report persistent cognitive impairment.

There is no accepted universal definition for the condition, but the Centers for Disease Control and Prevention (CDC) broadly defines long COVID as “signs, symptoms, and conditions that continue to develop after acute COVID-19 infection” that can last for “weeks, months, or years.” The term “long COVID” also includes post-acute sequelae of SARS-CoV-2 infection, long-haul COVID, and post-acute COVID-19.

Nearly 7 percent of U.S. adults surveyed by the CDC in 2022 said they’ve experienced long COVID. Although U.S. regulatory agencies claim vaccinating against COVID-19 can reduce the risk of developing long COVID and the current paper suggests vaccination with two or more doses may provide a slight cognitive advantage, a recent paper published in the Journal of Clinical Medicine did not find a significant link between the presence of comorbidities or infection severity and the emergence of long COVID symptoms.

The NEJM study has several limitations, including reliance on subjective reporting to identify individuals with ongoing symptoms and self-selection bias. People with long COVID may have enrolled in the study, but those with more severe impairments may not have been able to participate in the survey. Additionally, certain groups were overrepresented in the study compared with the base population. Baseline cognitive data before SARS-CoV-2 infection was also unavailable, so researchers could not assess cognitive change or infer causality.

In the study published in PLOS One, researchers examined data from 487 and 371 individuals at four weeks and six months post-SARS-CoV-2 infection, respectively, to estimate the incidence, characteristics, and predictors of long COVID among patients. Long COVID symptoms were reported by 29.2 percent of participants four weeks following infection. This number dropped to 9.4 percent at six months, indicating symptoms may diminish over time.

Researchers found that the greater the severity of infection a patient had, the more likely they were to experience long COVID. The incidence of long COVID at four weeks of follow-up in those who experienced mild/moderate disease was 23.4 percent compared with 62.5 percent in those with severe cases.

At six months, the incidence of long COVID was considerably lower. For those with mild/moderate infection, only 7.2 percent reported symptoms compared with 23.1 percent in those with severe/critical cases. The most commonly reported symptom was fatigue. Other symptoms included cough, cognitive dysfunction or brain fog, and loss of taste and smell.

During the four-week follow-up, patients were more likely to experience long COVID if they had preexisting medical conditions, a higher number of symptoms during the acute phase of COVID-19 illness, if their infection was more severe or resulted in hospitalization, or if they had received two COVID-19 vaccine doses.

Although previous vaccination was associated with long COVID, the authors could not find “any interaction effect of COVID-19 vaccination and acute COVID-19 severity on causing Long COVID.”

This implies that prior vaccination “was independently associated with the occurrence of long-COVID,” cardiologist Dr. Peter McCullough explained in a recent Substack post.

How COVID-19 Vaccines May Contribute to Long COVID

Nearly 7 percent of U.S. adults surveyed in 2022 said they’ve experienced long COVID—a condition commonly thought only to be associated with SARS-CoV-2 infection. Although definitions of long COVID differ, the Centers for Disease Control and Prevention broadly defines long COVID as “signs, symptoms, and conditions that continue to develop after acute COVID-19 infection” that can last for “weeks, months, or years.” The term “long COVID” is also used to refer to post-acute sequelae of SARS CoV-2 infection (PASC), long-haul COVID, and post-acute sequelae of COVID-19.

U.S. regulatory agencies claim vaccinating against COVID-19 can reduce the risk of developing long COVID. One theory is that COVID-19 vaccines prevent severe disease, and as researchers noted in the PLOS One study, severe disease is a predictor of developing the condition. However, some research suggests the condition may be caused by an immune overreaction to the SARS-CoV-2 spike protein that COVID-19 vaccines use to induce antibodies.

One theory is that vaccination may cause some people to generate a second round of antibodies that target the first. These antibodies could function like spike protein, which targets the angiotensin-converting enzyme 2 (ACE2) receptor—a cell surface protein—and enables the virus to enter cells. Like spike protein, these “rogue antibodies” might also bind to the ACE2 receptor and disrupt ACE2 signaling, which can cause conditions associated with long COVID.

“In my practice, the most severe cases of long-COVID are in vaccinated patients who also had severe and or multiple episodes of SARS-CoV-2 infection,” Dr. McCullough wrote on X. In his recent Substack post, he said he believes long COVID symptoms are due to the retention of SARS-CoV-2 spike protein in cells and tissues after SARS-CoV-2 infection.

When people receive an mRNA COVID-19 vaccine, this produces a “massive additional load of full-length Spike protein” that can circulate in the blood for six months or longer, he wrote.

Scientists from the National Institutes of Health in 2022 conducted an observational study (posted as a preprint but never published) of 23 individuals with long COVID. Researchers found that a “variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process.”

In a February study published in the Journal of Medical Virology, researchers examined the levels of spike protein and viral RNA circulating in patients hospitalized for COVID-19 with and without long COVID. They found that spike protein and viral RNA were more likely to be present in patients with long COVID. In patients with long COVID, 30 percent were positive for spike protein and viral RNA, whereas none of the individuals without long COVID were positive for both.

In a 2023 study in the European Review for Medical and Pharmacological Sciences, researchers analyzed the serum of 81 individuals with long COVID syndrome and found viral spike protein in one patient after the infection had cleared and yielded a negative COVID-19 test, and vaccine spike protein in two patients two months after vaccination.

“This study, in agreement with other published investigations, demonstrates that both natural and vaccine spike protein may still be present in long-COVID patients, thus supporting the existence of a possible mechanism that causes the persistence of spike protein in the human body for much longer than predicted by early studies,” the authors wrote.

(The Epoch Times)—Shrimp have become the latest addition to a growing list of food sources targeted by mRNA gene therapy technology. An Israeli company seeking to bring mRNA vaccines to shrimp farming has raised $8.25 million from a group of venture capitalists to promote and improve animal health in marine species through its orally administered RNA-particle platform.

ViAqua, a biotechnology company, created an RNA-based vaccine product that uses ribonucleic acid interference (RNAi) to manipulate gene expression in shrimp. RNAi is a biological process where RNA molecules are used to inhibit gene expression or translation by neutralizing targeted mRNA molecules.

The vaccine comes in the form of a coated feed supplement designed to enhance resistance to white spot syndrome virus (WSSV)—a viral infection that causes an annual loss of about $3 billion and a 15 percent reduction in global shrimp production. ViAqua suggests RNA molecules can inhibit the expression of genes that cause disease with every meal containing its coated product.

According to a 2022 proof-of-concept study, the nanovaccine was roughly 80 percent effective in a lethal WSSV challenge model and exhibited excellent in vivo safety profiles. Yet the risks of altering gene expression in shrimp and the effects of consuming vaccinated shrimp are unknown.

“Oral delivery is the holy grail of aquaculture health development due to both the impossibility of vaccinating individual shrimp and its ability to substantially bring down the operational costs of disease management while improving outcomes,” said Shai Ufaz, CEO of ViAqua in a press release. “We are excited to bring this technology to market to address the need for affordable disease solutions in aquaculture.”

ViAqua plans to begin production in India in 2024 and believes its technology has numerous applications in aquaculture and beyond, according to their press release.

mRNA Vaccines Are Already Used in Pigs

The aquaculture industry is not the only market being targeted with mRNA vaccines. Genvax Technologies, a startup creating mRNA vaccines for animals, in 2022 secured $6.5 million in funding to develop a self-amplifying mRNA (saRNA) platform that allows for rapid development of a herd or flock-specific vaccine matched 100 percent to the circulating variant at the root of a disease outbreak.

Genvax’s technology involves inserting a specific transgene or “gene of interest” matched to the variant strain into the platform. The saRNA then generates an antibody response without requiring the whole pathogen to be matched to the circulating strain.

In April 2022, Genvax was awarded a $145,000 grant by the Foundation for Food and Agriculture Research to develop an saRNA vaccine for African swine flu (ASF) in collaboration with the U.S. Department of Agriculture. ASF is a highly contagious virus with a 100 percent swine mortality rate but has never occurred in the United States.

According to a 2022 paper published in eClinicalMedicine, saRNA technology uses lipid nanoparticles (LNPs) to encapsulate saRNA. When injected as a vaccine, the LNP encapsulation facilitates “endosomal uptake and release into the cytoplasm of target cells in vivo.” This novel technology has “significant and previously untested potential” to be used in drugs and vaccines.

Genvax isn’t the first company to harness mRNA technology in pigs. Merck, in 2018, introduced SEQUIVITY, a “revolutionary swine vaccine platform” that uses RNA particle technology to create “customized prescription vaccines against strains of influenza A virus in swine, porcine circovirus (PCV), rotavirus and beyond.”

SEQUIVITY uses electronic gene sequencing to generate RNA particles that, when injected into an animal, provide instructions to immune cells to translate the sequence into proteins that act as antigens, similar to how the COVID-19 vaccine causes the body to generate spike proteins. The idea is that the animal’s immune system, when challenged with the actual live pathogen, will recognize the antigen and elicit an immune response.

According to Merck, their RNA participle technology allows for the development of a “safe and flexible” custom swine flu vaccine in only eight to 12 weeks compared to traditional vaccines that take years to develop.

Although it is claimed vaccines utilizing RNA technology are safe and effective, studies appear to be scarce with little to no research to determine what effects consuming pork from vaccinated pigs may have on the human body.

mRNA Vaccines in Cattle Raise Concerns Among Producers

According to the National Cattlemen’s Beef Association, mRNA vaccines are currently not licensed for use in U.S. beef cattle. The vaccines are being developed to treat and prevent diseases in cattle, whose meat could make its way to the dinner table.

Ranchers-Cattlemen Action Legal Fund United Stockgrowers of America (R-CALF USA), a national, non-profit organization with more than 5,000 members dedicated to ensuring the continued profitability and viability of the U.S. cattle industry, has raised concerns over using mRNA vaccines in cattle.

In April 2023, R-CALF USA met with medical doctors and a molecular biologist regarding the status of mRNA injections in the global protein supply chain. Veterinarian Max Thornsberry reported that some researchers have found that mRNA and its coded virus could pass to humans who have consumed dairy or meat products from an mRNA-injected animal.

Mr. Thornsberry raised concerns about the full impact and unknown long-term effects of consuming meat from animals injected with mRNA vaccines and called for more extensive research. Although the United States has not yet approved an mRNA vaccine for use in cattle, the country is increasing imports of beef from other countries that either vaccinate cattle with mRNA vaccines or plan to.

“This points to the urgent need for MCOOL (mandatory country of origin labeling),” Mr. Thonsberry said. “Consumers deserve the right to choose whether to consume beef from a country where mRNA injections are being given to cattle, and the only way they can have that choice is if Congress passes MCOOL for beef.”

R-CALF USA plans to develop a policy direction for the organization at an upcoming meeting, but “strongly reinforces the need for mandatory country of origin labeling” of beef immediately so that American consumers will know if the beef they are buying comes from a country that is using the controversial mRNA technology in their cattle.

In an op-ed posted on its website, R-CALF USA CEO Bill Bullard said the organization has been attacked for its position and accused by pharmaceutical-backed publications of “fearmongering and misinformation.”

“Iowa State University researchers submitted a multi-year research project to the U.S. Department of Agriculture to test a cattle mRNA vaccine system for bovine respiratory syncytial virus (RSV) infection,” Mr. Bullard said.

“According to the submission, researchers planned to test the mRNA on cattle during the second year of the project with a completion date of 2026. It would be naïve not to assume that such a research project signals an effort to obtain approval for mRNA injections in U.S. cattle,” he added.

Mr. Bullard encouraged others not to “simply trust the pharmaceutical companies and the government” and says his organization “intends to learn the truth by continuing to disclose differing scientific findings, seeking more research into the long-term effects of mRNA injections for cattle, and demanding more transparency from pharmaceutical companies and the government.”

Meanwhile, the organization has stated it believes people have a right to know whether the meat they consume has come from animals injected with mRNA technology.

Several states have already drafted or proposed legislation seeking to require the labeling of products derived from animals administered mRNA vaccines, including Tennessee, Idaho, Arizona, Texas, and Missouri.

Sound off about this story on The Liberty Daily Substack.

Researchers with the burns unit at Concord Repatriation General Hospital in Australia saw two to four cases of SJS, or toxic epidermal necrolysis (TEN), per year prior to COVID-19. In the first six months of 2022 alone, the same burn center observed a sevenfold rise in cases.

Of the 14 reported cases, five patients had COVID-19 a month before developing SJS/TEN, and three of 14 patients received a COVID-19 vaccine one month prior. Not a single case of SJS/TEN was reported in an unvaccinated individual.

Researchers said the rarity of the condition and presence of medications known to trigger the disease make the link difficult to prove, but the rapid rise in cases since the beginning of the pandemic and vaccine rollout is “alarming.”

SJS/TEN is a severe hypersensitivity condition where the skin develops rashes, blisters, and peels forming painful areas that resemble a severe hot water burn. Mucous membranes, including the eyes, genitalia, and mouth, are often affected or severely damaged, leading to sepsis, pneumonia, infection, or death.

Although SJS and TEN were once considered separate conditions, they are now part of the same disease—with SJS representing the less severe end of the disease spectrum and TEN representing the most severe.

Medications, including epilepsy medicines, antibiotics, and anti-inflammatory painkillers, are the chief cause of SJS/TEN, but certain viruses and vaccines can also cause the condition. Due to its potentially fatal nature, SJS/TEN is considered a medical emergency, and patients are treated in burn units.

Researchers’ 3 Theories for Sudden Rise in SJS/TEN Cases

The researchers proposed three theories for the sudden increase in SJS/TEN cases.

Virus-Induced

The first theory is that the SARS-CoV-2 virus may induce SJS/TEN by directly binding to receptors that trigger a T-cell-mediated response. Other viruses known to cause SJS/TEN include the herpes simplex virus, Epstein-Barr virus, and influenza.

Vaccine-Induced

A second theory is that COVID-19 vaccines may directly bind to cell receptors that trigger SJS/TEN and influence the body’s T-cell immune response initiating SJS/TEN. This T-cell response peaks at seven and 28 days post-vaccination, consistent with the observed cases.

Of the three cases attributed to vaccination in the study, two patients had received an mRNA vaccine, and one received a viral vector vaccine within a month of developing SJS/TEN. Researchers identified eight other cases of SJS following COVID-19 vaccination in published literature—four were associated with mRNA vaccines, three with viral vector vaccines like AstraZeneca and Johnson & Johnson, and one with a whole virus vaccine.

According to the U.S. Vaccine Adverse Event Reporting System (VAERS), 198 cases of SJS/TEN following COVID-19 vaccination were reported between Dec. 14, 2019, and June 23, 2023. Historically, VAERS has been shown to report fewer than 1 percent of actual vaccine adverse events, which means other cases of SJS/TEN may have occurred but were unreported.

Threshold Lowering

The third theory proposed by the authors is that developing a COVID-19 infection or receiving a vaccine “primes” the immune system, lowering the threshold for a drug to trigger SJS/TEN. Without this “priming,” the drug would otherwise not cause the condition, as noted in each of the following cases:

• A 26-year-old male received two previous doses of a viral vector vaccine and one mRNA vaccine dose. After experiencing vaccine-associated symptoms, he took paracetamol and ibuprofen and developed SJS. He had previously taken both medications with no adverse effects.
• A 60-year-old female had COVID-19 six weeks before the onset of SJS/TEN. During that time, she received allopurinol for gout and experienced a reaction, despite taking the drug in the past with no ill effect. The woman had received two doses of an mRNA vaccine.
• A 45-year-old male developed a reaction to a seizure prophylaxis drug. He was diagnosed with COVID-19 four weeks before developing SJS/TEN and was triple vaccinated with an mRNA vaccine.
• A 53-year-old female received a viral vector vaccine three weeks before the onset of SJS/TEN. She was quadruple vaccinated with viral vector and mRNA vaccines and reacted to medications received for a life-threatening scleroderma complication.

Regulatory agencies in the United States and abroad have not acknowledged the potential link between SJS/TEN and COVID-19 vaccines or studied the ability of the virus or vaccine to prime the immune system. The study’s authors say more research should be done to investigate the impact viruses like SARS-CoV-2 have on immune-mediated disorders such as SJS/TEN.

Sound off about this story on the End Medical Tyranny Substack.

Article cross-posted from our premium news partners at The Epoch Times.

According to a paper published in Nature on June 22, COVID-19 mRNA vaccines, by mode and action, are gene therapy products and should adhere to different regulatory standards. Yet U.S. and European regulatory agencies have not classified COVID-19 mRNA vaccines as gene therapy products, which has allowed them to be regulated as vaccines against infectious diseases instead of being subjected to the more stringent regulation of GTPs.

Because current regulatory guidelines either do not apply, do not mention RNA therapeutics, or do not have a widely accepted definition for these products, regulatory agencies adopted a modified and accelerated approval process for COVID-19 vaccines in the form of a “rolling review.”

A rolling review is a regulatory tool typically used during a public health emergency to speed up the assessment of data for medicines or vaccines. It allows data to be reviewed as it becomes available—without the complete data package or specific controls.

This process led to broad and continuous biodistribution of mRNA COVID-19 vaccines that were not thoroughly studied and yielded tests with noncompliant results regarding purity, quality, and batch homogeneity. Manufacturers are now planning to replace classic vaccines with mRNA vaccines using the same process—starting with influenza vaccines.

Vaccines With mRNA Technology Are Gene Therapies

The Centers for Disease Control and Prevention currently defines a “vaccine” as a preparation used to stimulate the body’s immune response against diseases. However, the agency’s definition was changed in 2021 out of concern it didn’t apply to COVID-19 vaccines.

A vaccine must contain an antigen to trigger the body’s natural immune response. Pfizer and Moderna’s mRNA vaccines do not contain antigens. The active substance used to elicit an immune response in these vaccines is the mRNA—a form of nucleic acid and the genetic material of the SARS-CoV-2 virus that provides instructions to the body for producing antigens—spike proteins.

In other words, the mRNA is not the substance causing active immunization. Instead, the mRNA must be translated into protein by the cells of the person vaccinated, and that person’s immune system must produce its own antigens to trigger an immune response.

The U.S. Food and Drug Administration (FDA) states that gene therapy seeks to “modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.” Moderna’s Q2 2020 filing with the Securities and Exchange Commission acknowledged that mRNA is “considered a gene therapy product by the FDA.” In addition, BioNTech founder Ugur Sahin, in a 2014 article stated, “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy.”

According to the FDA, mRNA vaccines are comparable to the TypeIA of prodrugs—substances that, after administration, are converted in the body into pharmacologically active drugs.

This “prodrug property” could suggest that additional controls should be applied in addition to those required for vaccines. However, neither the FDA nor the European Medicines Agency (EMA) have referenced these qualifications for mRNA COVID-19 vaccines.

“With a conventional vaccine, you have the antigen, and you inject it into a person, and that is the thing that your immune system looks at and says, ‘ah ha,’ we need to make antibodies, T-cells, and other immune system components to what’s being injected,” said Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology, and experimental pathology, in an interview with The Epoch Times.

“The prime reaction of an mRNA vaccine is that it instructs the body how to make the antigen of interest. So, it’s similar to a prodrug, which is converted inside the body via metabolism and enzymes into the desired drug effect. The substance you’re injecting isn’t doing the final action; it leads to the thing that does the final action. With a prodrug, the molecule you inject does not get changed into the final molecule of the antigen, it simply provides instructions because it’s gene therapy.”

Wiseman said the FDA and EMA guidance and regulations that discuss gene therapy all define gene therapies “more or less” the same way. However, a number of years ago, the FDA decided to exclude vaccines for infectious diseases from its various guidance for unknown reasons, including vaccines made from gene therapy technology. Vaccines, in essence, were given their “own set of rules.”

However, the FDA can “change or exclude whatever they want from regulatory guidance, but it doesn’t change the biologic definition of the product,” said Wiseman. “Since Pfizer and Moderna COVID-19 vaccines meet the definition of gene therapy, they should be handled according to gene therapy guidelines.”

mRNA COVID-19 Vaccines Bypassed Essential Studies

According to the paper, because mRNA COVID-19 vaccines were not classified as gene therapy, necessary tests required for GTPs were not performed for the following:

• Genotoxicity.
• Genome integration.
• Germ-line transmission.
• Insertional mutagenesis.
• Tumorigenicity.
• Embryo/fetal and perinatal toxicity.
• Long-term expression.
• Repeated toxicity.
• Excretion in the environment, such as shedding through seminal fluid or breast milk.

“The long-term safety monitoring of GTPs is required over several years whereas, for vaccines, it is generally only carried out over a few weeks,” wrote Dr. Helene Banoun with the French Institute of Health and Medical Research in the paper. “This should not be acceptable, given the persistence of the drug product and the expressed protein.”

In addition, known results of anti-cancer therapies that use gene therapy technology and mRNA vaccines could lead us to anticipate safety and efficacy problems, she added.

In the EU, gene therapy medicinal products are required to undergo “tests or trials to evaluate the risk of genome integration and germ-line transmission, even if this integration is unlikely,” and tests and clinical trials to evaluate the risk of “insertional mutagenesis, tumorigenicity, embryo/fetal and perinatal toxicity, and long-term expression.”

EMA requires “extensive studies on both the nucleic acid and the vector particle/delivery system that includes biodistribution, dose study, potential target toxicity, the identification of the target organ to obtain biological activity, toxicity linked to the expression of structurally altered proteins.”

It is necessary to insist pharmacokinetic studies be performed to determine how the body interacts with the administered substance during the entire duration of exposure—even though they are generally not required for vaccines unless there’s a new formulation or a vaccine contains novel adjuvants or excipients (inactive substances such as preservatives).

For GTPs, shedding studies are also needed to determine excretion and dissemination in the body, and biodistribution studies are needed to assess where injected compounds—such as lipid nanoparticles, the delivery system used to deliver mRNA—travel in the body and which tissues or organs they accumulate in.

After assessing Pfizer and Moderna’s COVID-19 vaccine documents obtained by attorney Aaron Siri through the Freedom of Information Act, Wiseman noted many studies listed in nonclinical summaries that should have been performed but were not.

“Several studies should have been done but weren’t done because they fell under the auspices of vaccines. But if you read the guidelines, it doesn’t say these studies are unnecessary, just that circumstances may deem them unnecessary,” Wiseman said. “We need laws for products that say you can’t just exclude them from regulations because you feel like it—because they are still gene therapies,” he said.”We are hijacking the machines of our bodies to produce spike proteins in an uncontrolled, undefined way—there are too many things we don’t know about.”

Article cross-posted from our premium news partners at The Epoch Times.

Sound off about this story on my End Medical Tyranny Substack.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website.

The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,447,520 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and Oct. 21, 2022, to the Vaccine Adverse Event Reporting System (VAERS).

VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S. The data included a total of 31,696 reports of deaths and 263,462 serious injuries, including deaths, during the same time period.

There were a total of 5,435 reports of adverse events following the new COVID-19 bivalent booster as of Oct. 21, 2022. The data included a total of 45 deaths and 280 serious injuries. As of Oct. 27, 22.8 million people have received the updated bivalent booster dose.

Of the 31,696 reported deaths, 20,252 cases are attributed to Pfizer’s COVID-19 vaccine, 8,599 cases to Moderna, 2,752 cases to Johnson & Johnson (J&J) and no cases yet reported for Novavax.

Excluding “foreign reports” to VAERS, 887,564 adverse events, including 14,920 deaths and 92,482 serious injuries, were reported in the U.S. between Dec. 14, 2020, and Oct. 21, 2022.

Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.

Of the 14,920 deaths reported as of Oct. 21, 7% occurred within 24 hours of vaccination and 15% occurred within 48 hours of vaccination.

In the U.S., 632 million COVID-19 vaccine doses had been administered as of Oct. 19, including 376 million doses of Pfizer, 238 million doses of Moderna and 19 million doses of J&J.

Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed. Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.

VAERS data from Dec. 14, 2020, to Oct. 21, 2022, for 6-month-olds to 5-year-olds show:

• 4,482 adverse events, including 187 cases rated as serious and 8 reported deaths.
• 5 reports of myocarditis and pericarditis (heart inflammation).
  The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.
• 27 reports of blood clotting disorders.
• 46 reports of seizures.

VAERS data from Dec. 14, 2020, to Oct. 21, 2022, for 5- to 11-year-olds show:

• 14,938 adverse events, including 701 rated as serious and 29 reported deaths.
• 47 reports of myocarditis and pericarditis.
• 71 reports of blood clotting disorders.
• 183 reports of seizures.

VAERS data from Dec. 14, 2020, to Oct. 21, 2022, for 12- to 17-year-olds show:

• 40,045 adverse events, including 4,358 rated as serious and 129 reported deaths.

According to the CDC, “VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.”

• 269 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death.
• 1,336 reports of myocarditis and pericarditis with 1,167 cases attributed to Pfizer’s vaccine.
• 301 reports of blood clotting disorders with 278 cases attributed to Pfizer.
• 27 cases of postural orthostatic tachycardia syndrome (POTS) with all cases attributed to Pfizer’s vaccine.

VAERS data from Dec. 14, 2020, to Oct. 21, 2022, for all age groups combined, show:

• 16% of deaths were related to cardiac disorders.
• 53% of those who died were male, 42% were female and the remaining death reports did not include the gender of the deceased.
• The average age of death was 72.
• As of Oct. 21, 8,608 pregnant women reported adverse events related to COVID-19 vaccines, including 5,027 reports of miscarriage or premature birth.
• Of the 16,555 cases of Bell’s Palsy reported, 73% were attributed to Pfizer vaccinations, 22% to Moderna and 5% to J&J.
• 3,040 reports of Guillain-Barré syndrome.
• 10,100 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
• 4,844 reports of myocardial infarction.
• 43,699 reports of blood-clotting disorders. Of those, 29,940 reports were attributed to Pfizer, 9,849 reports to Moderna and 3,820 reports to J&J.
• 24,438 cases of myocarditis and pericarditis with 18,514 cases attributed to Pfizer, 5,459 cases to Moderna and 417 cases to J&J.
• 70 cases of Creutzfeldt-Jakob disease with 57 cases attributed to Pfizer, 12 cases to Moderna and 1 case to J&J.
• 564 cases of POTS with 418 cases attributed to Pfizer, 125 cases to Moderna and 21 cases to J&J.

Children’s Health Defense (CHD) asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.

CDC pressured FDA to authorize COVID boosters without clinical trials

The CDC pressured U.S. regulators to clear COVID-19 boosters without clinical trial data, according to emails obtained by Judicial Watch.

CDC officials relayed to counterparts at the FDA in early August 2021 that they wanted authorization for Moderna and Pfizer boosters, as data began showing that the vaccines weren’t working as well as initially promoted.

The conversation took place on a call that was described by Dr. Phil Krause, a top FDA official, to several other FDA workers. On that call, the CDC “evidently stated” they would assemble all the data they were aware of on third dosing in the immunocompromised setting and send it to the FDA in hopes they would authorize a third dose for those with compromised immune systems under Emergency Use Authorization.

All COVID-19 vaccines were authorized only for emergency use at that time. No boosters had been authorized and no clinical data were available for a third vaccine dose. Less than two weeks later, the FDA authorized boosters for certain people, including immunocompromised persons.

The agency said “a thorough review of the available data” concluded the group “may benefit” from a third dose. The only data cited on efficacy were from two studies, one conducted by French researchers and another by Canadian researchers. Pfizer and Moderna hadn’t completed any clinical trials.

FDA slow-walked studies on COVID vaccine safety signals in elderly

The FDA took more than a year to follow up on a potential increase in serious adverse events in elderly people who received Pfizer’s COVID-19 vaccine, according to an investigative report published Tuesday by The BMJ.

According to The BMJ, in July 2021, the FDA “quietly disclosed” the findings of a potential increase in four types of serious adverse events in elderly people who had received a Pfizer COVID-19 vaccine: acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia, and pulmonary embolism.

The FDA disclosure lacked specific details, such as the magnitude of the increased potential risk, and the agency said it would “share further updates and information with the public as they become available.”

The FDA did not alert physicians or the public, via a press release or any other means, The BMJ investigator said.

Eighteen days later, the FDA published a study planning document that outlined a protocol for a follow-up epidemiological study for investigating the matter more thoroughly.

According to the BMJ, the recondite technical document disclosed the unadjusted risk ratio estimates originally found for the four serious adverse events, which ranged from 42% to 91% increased risk.

More than a year later, the status and results of the follow-up study are unknown. The BMJ report also alleged the FDA has not “publicly acknowledged other published observational studies or clinical trial reanalyses reporting compatible results.”

CDC knew COVID shots could cause myocarditis in young males months before telling the public

Two months after COVID-19 vaccines were rolled out to the U.S. public, a statistically significant vaccine safety signal for myocarditis in males ages 8 to 21 appeared in the CDC’s VAERS database, but CDC officials waited another three months before alerting the public, according to a new study.

The study, “Delayed Vigilance: A Comment on Myocarditis in Association with the COVID-19 Injections,” by Karl Jablonowski, Ph.D., and Brian Hooker, Ph.D., P.E., was published on Oct. 17 in the International Journal of Vaccine Theory, Practice, and Research.

In their study, Jablonowski and Hooker recorded and analyzed the increasing incidence of myocarditis as it progressively became a statistically significant “signal” in VAERS.

In an interview with The Defender, Hooker said the paper shows a “strong, statistically significant vaccine adverse event ‘signal’ for myocarditis in males 8 to 21 years of age was seen on the VAERS database as early as Feb. 19, 2021, just two months after the release of the COVID-19 vaccine to the U.S. public.”

Yet, instead of sounding the alarm, “CDC officials buried the connection between COVID-19 vaccination and myocarditis until May 27, 2021,” Hooker added. “By this date, over 50% of the eligible U.S. population had received at least one mRNA COVID-19 vaccine.”

All age groups at higher risk of myocarditis death after COVID vaccines

People of all ages are at higher risk of death from heart inflammation after COVID-19 vaccination compared with the typical occurrence of myocarditis death, according to a new preprint study.

Researchers in Japan analyzed deaths caused by myocarditis, a form of heart inflammation, where the myocarditis set in within 28 days of vaccination. Thirty-eight deaths fit the definition, about half of which were diagnosed by autopsy and or biopsy, with the others being determined through tools such as blood tests and electrocardiograms.

Researchers then took the vaccinated mortality rate and compared it with the death from myocarditis rate from the general population before the pandemic, in the years 2017 to 2019.

Using data provided by the Japanese government, the researchers observed an increased myocarditis mortality rate ratio in the SARS-CoV-2 vaccinated population compared with the general population during the three years pre-COVID-19 pandemic era, especially in young adults.

An increased risk was also observed in the middle-aged (40s) and elderly vaccinated populations.

Even estimating the lowest level of the effect, the risk of COVID-19 vaccination on myocarditis death would be at least four times higher than the unadjusted mortality risk, the researchers said. There are also signs that some post-vaccination deaths aren’t reported properly, they added.

Recent studies identify new concerns related to COVID vaccines and organ transplants

Recent studies identified a new concern related to the failure of transplanted kidneys and other organs: COVID-19 vaccination.

In one study, published in September in Transplant Infectious Disease, researchers cataloged acute organ rejection within a week or two of COVID-19 vaccination in five individuals who had received kidney, liver or heart transplants six to 18 months earlier.

In August, Japanese researchers reported rejection of corneal grafts — which ordinarily have a high success rate — in COVID-19 vaccine recipients, occurring from one day to six weeks post-vaccination.

Noting literature that documents transplant rejection in association with other vaccines such as influenza, hepatitis B, tetanus and yellow fever, the Japanese authors expressed worry about what “the projected societal shift towards a more frequent vaccination schedule” portends for transplant recipients.

Concerns about the impact of COVID-19 jabs on people with existing transplants are important, but another pressing-yet-unaddressed issue is what happens when an unvaccinated person receives a transplanted organ from someone who received a COVID-19 vaccination.

Woman injured by Gardasil vaccine shares how COVID shots injured her mother and ended the life of her grandmother

In 2012, when she was 20 years old, Rochelle was so injured by Merck’s Gardasil vaccine that she had to give up her pre-med studies.

Ten years later, her mother was injured by Moderna’s COVID-19 vaccine, and shortly after, her grandmother died just a few weeks after getting her second dose of Pfizer’s vaccine.

In an exclusive interview with The Defender, Rochelle, now 30, shared her story, and her mother and grandmother’s stories. Rochelle told The Defender that her father, grandfather and brother all became doctors, and her mother, Marcia, was a nurse.

Rochelle’s mother received both doses of the Moderna vaccine in the spring of 2021. Adverse events followed soon after the first dose and she was diagnosed with polymyalgia rheumatica (PMR), which her doctor said was induced by the vaccine.

Marcia’s PMR “caused severe inflammation throughout her body,” leading to “spontaneous tendon ruptures and a lower back disc herniation,” said Rochelle. In addition, “she tore her thumb tendon just by moving her hand normally and required urgent surgery to repair it.”

Rochelle said her mother will need several surgeries for complete tendon tears in her shoulder, and may potentially need spine surgery to repair her herniated disc. She is also on medication and for a long time, could not perform basic tasks.

What happened to Rochelle after getting the Gardasil human papillomavirus, or HPV, vaccine, and her mother, Marcia, after getting the COVID-19 vaccine was bad enough — but not as bad as what happened to Rochelle’s grandmother. After receiving her second Pfizer vaccine, Jean lost her ability to communicate, her health declined severely and within a few weeks, she was dead.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

The preprint, accepted for publication in a peer-reviewed journal, involved 314 participants ages 13-18 who were healthy and without abnormal symptoms after receiving their first vaccine dose.

Participants with a history of cardiomyopathy, tuberculous pericarditis or constrictive pericarditis and severe allergic reaction to the COVID-19 vaccine were excluded from the study. Although the study included 314 adolescents, 13 were excluded from the findings as they were “lost to follow-up.”

Of the 301 remaining participants, 202 (67.1%) were male.

Researchers found that 18% of the 301 teens analyzed had an abnormal electrocardiogram, or EKG after receiving their second dose of Pfizer, 3.5% of males developed myopericarditis or subclinical myocarditis, two were hospitalized and one was admitted to the ICU for heart problems.

Cardiovascular adverse events observed during the study included tachycardia (7.64%), shortness of breath (6.64%), palpitation (4.32%), chest pain (4.32%) and hypertension (3.99%).

Fifty-four adolescents had abnormal electrocardiograms after vaccination, three patients had minimal pericardial effusion with findings compatible with subacute myopericarditis and six patients experienced mitral valve prolapse.

Myocarditis is inflammation of the heart muscle that can lead to cardiac arrhythmia and death. According to the National Organization for Rare Disorders, myocarditis can result from infections, but “more commonly the myocarditis is a result of the body’s immune reaction to the initial heart damage.”

Pericarditis is inflammation of the tissue surrounding the heart that can cause sharp chest pain and other symptoms. According to the study, the most common symptom was chest pain, followed by chest discomfort, fever and headache.

Three patients between the ages of 13 and 18 reported chest pain and biomarkers were evaluated. All three reported the symptoms within 24-48 hours of receiving the second dose of Pfizer.

Four patients had no symptoms but had elevated biomarkers. All patients were male and had abnormal electrocardiograms, particularly sinus tachycardia. The clinical course was mild in all cases.

The majority of the participants (257/301 or 85.38%) had no underlying diseases prior to being vaccinated.

As part of the study, participants received a diary card to record cardiac symptoms. Those who developed side effects from the vaccine could call the principal investigator and be transferred to a medical team at the Hospital for Tropical Diseases for assessment.

If the participant developed abnormal EKG, echocardiographic findings or increased cardiac enzymes, the principal investigator scheduled patients for follow-up per the study’s protocol and for day 14 lab assessments.

Individuals were monitored with laboratory tests including cardiac biomarkers, ECG and echocardiography at three clinical visits — baseline, day 3, day 7 and day 14 after receiving the second dose of the Pfizer BioNTech COVID-19 vaccine.

The diagnostic criteria for myocarditis were classified as either probable cases or confirmed cases and were based on clinical symptoms and medical tests.
The researchers concluded the clinical presentation of myopericarditis after vaccination was “usually mild,” with all cases fully recovering within 14 days and recommended adolescents receiving mRNA vaccines be monitored for side effects.

Dr. Tracy Høeg, an epidemiologist, in a tweet said the study is “unique & impressive because of the extensive workup both pre and post vaccination” as the study could “detect pre-existing cardiac abnormalities.”

This study is unique & impressive because of the extensive workup both pre and post vaccination, it could detect pre-existing cardiac abnormalities
In this (albeit) small cohort, they deemed the cases "mild" pic.twitter.com/GJBPpYdl4q

— Tracy Høeg, MD, PhD (@TracyBethHoeg) August 9, 2022

Independent journalist Jordan Schachtel noted in a tweet the cardiac events witnessed during the study occurred after only one shot of Pfizer, as children with heart conditions had been excluded.

Adolescents post Pfizer:

"most common cardiovascular effects were tachycardia (7.64%), shortness of breath (6.64%), palpitation (4.32%), chest pain (4.32%), & hypertension (3.99%). 7 participants (2.33%) exhibited at least one elevated cardiac biomarker."

That's after ONE SHOT.

— Jordan Schachtel @ dossier.today (@JordanSchachtel) August 10, 2022

According to the most recent data from the Vaccine Adverse Event Reporting System (VAERS), from Dec. 14, 2020, to July 29, 2022, there were 1,292 reports of myocarditis and pericarditis in the 12-17 age group.

Of the 1,292 reports, 1,145 cases were attributed to Pfizer’s COVID-19 vaccine.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,379,438 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and Aug. 5, 2022, to the Vaccine Adverse Event Reporting System (VAERS). That’s an increase of 7,964 adverse events over the previous week.

VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.

The data included a total of 30,162 reports of deaths — an increase of 181 over the previous week — and 251,075 serious injuries, including deaths, during the same time period — up 1,959 compared with the previous week.

Of the 30,162 reported deaths, 19,462 cases are attributed to Pfizer’s COVID-19 vaccine, 8,038 cases to Moderna, 2,613 cases to Johnson & Johnson (J&J) and no cases yet reported for Novavax.

Excluding “foreign reports” to VAERS, 854,084 adverse events, including 13,972 deaths and 87,488 serious injuries, were reported in the U.S. between Dec. 14, 2020, and Aug. 5, 2022.

Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.

Of the 13,972 U.S. deaths reported as of Aug. 5, 7% occurred within 24 hours of vaccination, 15% occurred within 48 hours of vaccination and 54% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.

In the U.S., 604 million COVID-19 vaccine doses had been administered as of Aug. 3, including 357 million doses of Pfizer, 228 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).

Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.

Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.

VAERS data from Dec. 14, 2020, to Aug. 5, 2022, for 6-month-olds to 5-year-olds show:

• 2,975 adverse events, including 140 cases rated as serious and 5 reported deaths.
• 4 reports of myocarditis and pericarditis (heart inflammation).
  The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.
• 20 reports of blood clotting disorders.
• 38 reports of seizures.

VAERS data from Dec. 14, 2020, to Aug. 5, 2022, for 5- to 11-year-olds show:

• 13,364 adverse events, including 620 rated as serious and 22 reported deaths.
• 45 reports of myocarditis and pericarditis.
• 64 reports of blood clotting disorders.
• 169 reports of seizures.

VAERS data from Dec. 14, 2020, to Aug. 5, 2022, for 12- to 17-year-olds show:

• 32,945 adverse events, including 4,189 rated as serious and 118 reported deaths.
  According to the CDC, “VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.”
• 268 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 94% of cases attributed to Pfizer’s vaccine.
• 1,304 reports of myocarditis and pericarditis with 650 cases attributed to Pfizer’s vaccine.
• 298 reports of blood clotting disorders with 275 cases attributed to Pfizer.
• 26 cases of postural orthostatic tachycardia syndrome (POTS) with all cases attributed to Pfizer’s vaccine.

VAERS data from Dec. 14, 2020, to Aug. 5, 2022, for all age groups combined, show:

• 20% of deaths were related to cardiac disorders.
• 55% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
• The average age of death was 73.
• As of Aug. 5, 12,010 pregnant women reported adverse events related to COVID-19 vaccines, including 4,801 reports of miscarriage or premature birth.
• Of the 16,124 cases of Bell’s Palsy reported, 75% were attributed to Pfizer vaccinations, 23% to Moderna and 4% to J&J.
• 2,881 reports of Guillain-Barré syndrome, with 66% of cases attributed to Pfizer, 20% to Moderna and 17% to J&J.
• 9,884 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
• 4,663 reports of myocardial infarction.
• 42,180 reports of blood-clotting disorders in the U.S. Of those, 28,921 reports were attributed to Pfizer, 9,445 reports to Moderna and 3,754 reports to J&J.
• 23,535 cases of myocarditis and pericarditis with 17,890 cases attributed to Pfizer, 5,226 cases to Moderna and 399 cases to J&J.
• 64 cases of Creutzfeldt-Jakob disease with 51 cases attributed to Pfizer, 12 cases to Moderna and 1 case to J&J.
• 493 cases of POTS with 375 cases attributed to Pfizer, 109 cases to Moderna and 21 cases to J&J.

Children’s Health Defense (CHD) asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.

New CDC COVID guidance ditches distinctions between vaccinated and unvaccinated

The CDC on Thursday issued sweeping new recommendations as part of the agency’s efforts to overhaul its COVID-19 guidance.

“This guidance acknowledges that the pandemic is not over, but also helps us move to a point where COVID-19 no longer severely disrupts our daily lives,” the CDC’s Greta Massetti said in a press release.

Here are the biggest changes to the CDC’s guidance:

• Unvaccinated people now have the same guidance as vaccinated people.
• Those who are exposed to the virus are no longer required to quarantine regardless of vaccination status.
• Students may stay in class even if they’ve been exposed to COVID-19.
• Six-foot social distancing is no longer recommended.
• Contact tracing and routine surveillance testing of symptomatic people are no longer recommended in most settings.

According to The New York Times, the CDC has been working for months on the new guidance which builds on previous guidance issued in February that reduced isolation times for those who get COVID-19.

The agency said it is making changes to its guidance now because “vaccination and prior infections have granted many Americans some degree of protection against the virus, and treatments, vaccines and boosters are available to reduce the risk of severe illness.”

According to The National Law Review:

“The CDC’s focus on individual responsibility, the removal of distinctions between vaccinated and unvaccinated, the removal of quarantine recommendations and the discussion of mask wearing as an individual responsibility are good news for employers who are considering relaxing COVID-19 workplace requirements.

“This likely will not be the last we hear from the CDC on this topic. Indeed, the CDC stated that it intends to issue more specific guidance for settings such as healthcare, congregate living, and travel.”

Pfizer vaccine efficacy in teens wanes 27 days after second dose

A study published Aug. 8 in The Lancet showed the effectiveness of the Pfizer-BioNTech COVID-19 vaccine against symptomatic infection among adolescents “rapidly declined over time,” waning from just 27 days after the second dose.

Researchers analyzed data from 503,776 COVID-19 tests of 2,948,538 adolescents — ages 12-17 — in Brazil from Sept. 2, 2021, to April 19, 2022, and 127,168 tests of 404,673 adolescents in Scotland from Aug. 6, 2021, to April 19, 2022.

The study showed vaccine efficacy began to decline 27 days after the second dose for both countries, plummeting to 5.9% (95% CI 2.2–9.4) in Brazil and dropping to 50.6% (95% CI 42.7–57.4) in Scotland at 98 days after adolescents received the second dose.

While protection against symptomatic COVID-19 dropped dramatically in both countries less than one month after the second dose, protection against severe illness — defined as hospitalization or death within 28 days — remained above 80% in Brazil from 28 days to 98 days and beyond.

The authors sought to assess protection against severe illness in Scotland but were unable to do so because so few cases of severe COVID-19 in adolescents in Scotland were reported during the time of the study.

The authors concluded that “two doses are insufficient to sustain protection against symptomatic disease” in adolescents and recommended more research be done on the need for booster doses.

‘Stunning’ link between Pfizer vaccine and myocarditis in teens, study shows

A preprint study conducted during Thailand’s national COVID-19 vaccination campaign showed what one physician described as a “stunning” association between myocarditis and the Pfizer-BioNTech vaccine.

The study analyzed 301 participants ages 13-18 who were healthy and without abnormal symptoms after receiving their first vaccine dose. Participants with a history of cardiomyopathy, tuberculous pericarditis or constrictive pericarditis and severe allergic reaction to the COVID-19 vaccine were excluded from the study.

Researchers found that 18% of the 301 teens analyzed had an abnormal electrocardiogram, or EKG after receiving their second dose of Pfizer, 3.5% of males developed myopericarditis or subclinical myocarditis, two were hospitalized and one was admitted to the ICU for heart problems.

Cardiovascular adverse events observed during the study included tachycardia (7.64%), shortness of breath (6.64%), palpitation (4.32%), chest pain (4.32%) and hypertension (3.99%).

Fifty-four adolescents had abnormal electrocardiograms after vaccination, three patients had minimal pericardial effusion with findings compatible with subacute myopericarditis and six patients experienced mitral valve prolapse.

All patients were male and had abnormal electrocardiograms, particularly sinus tachycardia. Researchers said the clinical course was mild in all cases.

Military using ‘Comirnaty’ vaccine produced at facility not approved by FDA

In an exclusive interview with The Defender, a U.S. Coast Guard (USCG) service member alleged the U.S. Department of Defense (DOD) is administering COVID-19 vaccines from vials of Pfizer’s Comirnaty-labeled vaccines that are not produced in a facility approved by the FDA.

Lt. Chad R. Coppin, in a July 30 declaration submitted to Sen. Ron Johnson (R-Wis.) under penalty of perjury, detailed his personal investigation into the availability and origin of Comirnaty-labeled COVID-19 vaccine vials at U.S. military facilities.

Coppin relayed his concerns in an interview with The Defender, as did Holly Freincle, the wife of a U.S. military service member stationed at Fort Detrick, Maryland, who corroborated Coppin’s claims that Comirnaty-labeled vaccine vials are appearing at military service facilities.

Until now, the DOD has claimed the Pfizer-BioNTech COVID-19 vaccine, administered under Emergency Use Authorization, is “interchangeable” with the fully licensed Pfizer Comirnaty vaccine — which until recently, was said to be unavailable at military facilities.

In his July 30 declaration, Coppin, who has served with the USCG since March 2002, reported that after a long period of unavailability, the “Comirnaty” vaccine began to appear at U.S. military facilities in June.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.

The data included a total of 29,790 reports of deaths — an increase of 155 over the previous week — and 247,686 serious injuries, including deaths, during the same time period — up 1,010 compared with the previous week.

Of the 29,790 reported deaths, 19,236 cases are attributed to Pfizer’s COVID-19 vaccine, 7,917 cases to Moderna, 2,584 cases to Johnson & Johnson (J&J) and no cases yet reported for Novavax.

Excluding “foreign reports” to VAERS, 848,094 adverse events, including 13,805 deaths and 86,604 serious injuries, were reported in the U.S. between Dec. 14, 2020, and July 22, 2022.

Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.

Of the 13,805 U.S. deaths reported as of July 22, 7% occurred within 24 hours of vaccination, 15% occurred within 48 hours of vaccination and 54% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.

In the U.S., 601 million COVID-19 vaccine doses had been administered as of July 20, including 355 million doses of Pfizer, 227 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).

Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.

Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.

U.S. VAERS data from Dec. 14, 2020, to July 22, 2022, for 6-month-olds to 5-year-olds show:

• 2,429 adverse events, including 81 cases rated as serious and 3 reported deaths.
• 4 reports of myocarditis and pericarditis (heart inflammation).
  The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.
• 15 reports of blood clotting disorders.
• 23 reports of seizures.

U.S. VAERS data from Dec. 14, 2020, to July 22, 2022, for 5- to 11-year-olds show:

• 12,232 adverse events, including 313 rated as serious and 9 reported deaths.
  The most recent reported death involves a 9-year-old girl (VAERS I.D. 2377304) from California who died two weeks after receiving her first dose of Pfizer’s COVID-19 vaccine. The child experienced abdominal pain, sore throat and chest pain during the 2-3 days before she died, according to the VAERS report, which did not indicate any pre-existing conditions.
• 24 reports of myocarditis and pericarditis.
• 47 reports of blood clotting disorders.
• 101 reports of seizures.

U.S. VAERS data from Dec. 14, 2020, to July 22, 2022, for 12- to 17-year-olds show:

• 32,835 adverse events, including 1,849 rated as serious and 44 reported deaths.
• 62 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 97% of cases attributed to Pfizer’s vaccine.
• 657 reports of myocarditis and pericarditis with 645 cases attributed to Pfizer’s vaccine.
• 165 reports of blood clotting disorders with all cases attributed to Pfizer.
• 20 cases of postural orthostatic tachycardia syndrome (POTS) with all cases attributed to Pfizer’s vaccine.

U.S. VAERS data from Dec. 14, 2020, to July 22, 2022, for all age groups combined, show:

• 20% of deaths were related to cardiac disorders.
• 54% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
• The average age of death was 73.
• As of July 22, 5,670 pregnant women reported adverse events related to COVID-19 vaccines, including 1,772 reports of miscarriage or premature birth.
• Of the 3,623 cases of Bell’s Palsy reported, 51% were attributed to Pfizer vaccinations, 40% to Moderna and 8% to J&J.
• 900 reports of Guillain-Barré syndrome, with 42% of cases attributed to Pfizer, 30% to Moderna and 27% to J&J.
• 2,293 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
• 1,743 reports of myocardial infarction.
• 14,254 reports of blood-clotting disorders in the U.S. Of those, 6,378 reports were attributed to Pfizer, 5,112 reports to Moderna and 2,718 reports to J&J.
• 4,273 cases of myocarditis and pericarditis with 2,619 cases attributed to Pfizer, 1,450 cases to Moderna and 188 cases to J&J.
• 14 cases of Creutzfeldt-Jakob disease with 8 cases attributed to Pfizer, 5 cases to Moderna and 1 case to J&J.
• 270 cases of POTS with 165 cases attributed to Pfizer, 87 cases to Moderna and 17 cases to J&J.

Children’s Health Defense (CHD) asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.

Woman develops rare acute kidney failure after first Pfizer dose

A woman developed a rare case of acute kidney renal failure — linked to antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) — a few days after receiving her first dose of Pfizer-BioNTech’s COVID-19 vaccine.

According to a case study published July 18 in Nephron, a previously healthy 47-year-old woman presented to a primary care clinic for bilateral flank pain, generalized weakness and bilateral lower extremity swelling that started three days after her first Pfizer shot.

AAV is a group of diseases characterized by the destruction and inflammation of small vessels. The condition occurs when neutrophils attack small and medium vessels of the body, which can affect several organs, such as the kidney, stomach, intestine and lungs.

This case adds to previous reports suggesting COVID-19 vaccines may, in rare instances, promote the development or worsening of autoimmune diseases, such as AAV, from their silent state, according to Patricia Inacio, Ph.D., who summarized the report for ANCA Vasculitis News.

“Rarely, autoimmune processes have been described post-vaccination. AAV is an example of an autoimmune disease that can be induced or flared up from a silent state by COVID-19 vaccines,” the authors concluded. “A high index of suspicion regarding the presence of an autoimmune renal process is needed whenever a recently COVID-19-vaccinated individual presents for acute kidney injury.”

43% of parents ‘definitely’ won’t vaccinate young kids for COVID

According to survey results released Tuesday, 43% of U.S. parents of children under 5 will “definitely not” give their child a COVID-19 vaccine amid concerns the vaccine poses a greater risk to kids than the virus.

The survey, published by the Kaiser Family Foundation, found that 27% of parents said they would “wait and see,” while another 13% said they would have their children vaccinated only if required to do so for school or childcare.

Even parents who were vaccinated against COVID-19 said they would not give permission for their youngest children to get vaccinated.

When asked why they will not vaccinate their eligible child under 5 “right away,” parents cited “concerns about the newness of the vaccine and not enough testing or research, concerns over side effects and worries over the overall safety of the vaccines.”

CDC used flawed data to justify authorizing COVID-19 vaccines for kids

A CDC official used data from a flawed preprint study that exaggerated the risk of death for children from COVID-19 in her presentations to CDC and FDA advisors who were responsible for recommending Pfizer and Moderna’s vaccines for infants and young children.

The study, first published May 25 on the medRxiv preprint server, was authored by a group of U.K. researchers. On June 28, the authors published a revised version of the study, after critics questioned some of their original findings.

“It’s really disturbing that data this poor made its way into the meetings to discuss childhood COVID and that it took me less than a few minutes to find a major flaw (and then I found many more as I looked deeper),” said Kelley K, who was the first to point out some of the study’s flaws on her website COVID-Georgia.com.

After learning of Kelley’s analysis, The Defender reviewed the original preprint, confirmed Kelley’s findings and uncovered additional flaws in the original preprint and also in the June 28 revised version.

CHD demands D.C. schools rescind COVID vaccine mandate

Robert F. Kennedy, Jr., chairman and chief legal counsel for CHD, in a letter to the superintendent of the District of Columbia school system threatened to sue the school district unless it rescinds its recently announced COVID-19 vaccine mandate for students ages 12 and up.

State Superintendent of Education Christina Grant announced on July 19 that student immunization requirements for the upcoming 2022-2023 school year will include the COVID-19 vaccine for all students who are of an age for which there is a vaccine fully approved by the FDA now that the FDA has fully approved the Pfizer-BioNTech vaccine for individuals 12 to 15 years old.

D.C. law requires students in all area schools, including private, parochial and independent schools, to be fully compliant with mandated vaccinations, unless they have an approved exemption. The law also requires schools to verify immunization certification for all students.

The requirement was detailed in a law the D.C. Council approved last year and is the first legislation of its kind in the region.

Although courts have upheld many childhood vaccination requirements for licensed and approved vaccines, no court has ever upheld a mandate for schoolchildren for an Emergency Use Authorization vaccine, according to Kennedy.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.

The data included a total of 29,460 reports of deaths — an increase of 187 over the previous week — and 243,466 serious injuries, including deaths, during the same time period — up 1,566 compared with the previous week.

Of the 29,460 reported deaths, 19,066 cases are attributed to Pfizer’s COVID-19 vaccine, 7,770 cases to Moderna and 2,563 cases to Johnson & Johnson (J&J).

Excluding “foreign reports” to VAERS, 842,576 adverse events, including 13,604 deaths and 85,731 serious injuries, were reported in the U.S. between Dec. 14, 2020, and July 8, 2022.

Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.

Of the 13,604 U.S. deaths reported as of July 8, 15% occurred within 24 hours of vaccination, 19% occurred within 48 hours of vaccination and 58% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.

In the U.S., 597 million COVID-19 vaccine doses had been administered as of July 6, including 353 million doses of Pfizer, 225 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).

Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.

Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.

U.S. VAERS data from Dec. 14, 2020, to July 8, 2022, for 6-month-olds to 5-year-olds show:

• 2,105 adverse events, including 71 cases rated as serious and 3 reported deaths.
• 4 reports of myocarditis and pericarditis (heart inflammation).
  The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.
• 13 reports of blood clotting disorders.
• 19 reports of seizures.

U.S. VAERS data from Dec. 14, 2020, to July 8, 2022, for 5- to 11-year-olds show:

• 11,868 adverse events, including 305 rated as serious and 8 reported deaths.
  The latest reported death (VAERS I.D. #2359520) occurred in an 11-year-old boy from Texas who received two doses of Pfizer’s COVID-19 vaccine. According to his report, the boy died 54 days after his second dose from “COVID-19 infection resulting in Hemorrhagic myocarditis and death.”
• 24 reports of myocarditis and pericarditis.
• 46 reports of blood clotting disorders.
• 100 reports of seizures.

U.S. VAERS data from Dec. 14, 2020, to July 8, 2022, for 12- to 17-year-olds show:

• 32,609 adverse events, including 1,845 rated as serious and 44 reported deaths.
• 62 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 97% of cases attributed to Pfizer’s vaccine.
• 656 reports of myocarditis and pericarditis with 644 cases attributed to Pfizer’s vaccine.
• 166 reports of blood clotting disorders with all cases attributed to Pfizer. VAERS reported 167 cases of blood clotting disorders in the 12- to 17-year-old age group last week.
• 20 cases of postural orthostatic tachycardia syndrome (POTS) with all cases attributed to Pfizer’s vaccine.

U.S. VAERS data from Dec. 14, 2020, to July 8, 2022, for all age groups combined, show:

• 20% of deaths were related to cardiac disorders.
• 54% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
• The average age of death was 73.
• As of July 8, 5,643 pregnant women reported adverse events related to COVID-19 vaccines, including 1,765 reports of miscarriage or premature birth.
• Of the 3,624 cases of Bell’s Palsy reported, 51% were attributed to Pfizer vaccinations, 40% to Moderna and 8% to J&J.
• 900 reports of Guillain-Barré syndrome, with 42% of cases attributed to Pfizer, 30% to Moderna and 27% to J&J.
• 2,291 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
• 1,736 reports of myocardial infarction.
• 14,200 reports of blood-clotting disorders in the U.S. Of those, 6,348 reports were attributed to Pfizer, 5,088 reports to Moderna and 2,717 reports to J&J.
• 4,263 cases of myocarditis and pericarditis with 2,612 cases attributed to Pfizer, 1,448 cases to Moderna and 187 cases to J&J.
• 14 cases of Creutzfeldt-Jakob disease with 8 cases attributed Pfizer, 5 cases to Moderna and 1 case to J&J.
• 269 cases of POTS with 165 cases attributed to Pfizer, 86 cases to Moderna and 17 cases to J&J.

Children’s Health Defense (CHD) asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.

FDA authorizes Novavax COVID-19 vaccine

The FDA on Wednesday granted Emergency Use Authorization (EUA) to the Novavax COVID-19 vaccine for adults 18 and over.

The EUA is for a two-dose primary series targeting the original Wuhan SARS-CoV-2 virus — limiting the vaccine’s use, as about two-thirds of Americans already have completed a primary series of either the Pfizer, Moderna or J&J vaccines.

The CDC still needs to sign off on the Novavax vaccine before pharmacies and other healthcare providers can start administering the product.

The Biden administration on Monday announced a deal with Novavax to purchase 3.2 million doses of the vaccine contingent on both the FDA and CDC signing off on the new shot.

The Novavax vaccine relies on a protein-based technology used for decades, leading some media outlets to portray it as a “traditional” vaccine compared with other COVID-19 vaccines that use newer technologies — which might make it appeal to unvaccinated people who are allergic to components of the mRNA vaccines, or just skeptical of the newer technologies.

But according to Dr. Meryl Nass, an internist with a special interest in vaccine-induced illnesses, chronic fatigue syndrome and toxicology, the media’s portrayal of Novavax as a more traditional vaccine is not accurate.

Nass, a member of the CHD scientific advisory committee, pointed out that the Novavax shot contains a novel adjuvant, Matrix-M, “so it is not really an old-fashioned shot.”

Nass raised safety concerns specific to the adjuvant, while others voiced concerns about Novavax being linked to heart inflammation and blood clots, and the fact that the vaccine was designed for use against the original Wuhan strain of SARS-CoV-2 — not the Omicron variants that are dominant today.

FDA quietly grants full approval of Pfizer Comirnaty vaccine for adolescents

In a move CHD President Mary Holland called “head-spinning,” the FDA on July 10 granted full approval of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine for adolescents 12 through 15 years old.

In an FDA press release, the agency said full approval of Comirnaty follows a “rigorous analysis and evaluation of the safety and effectiveness data,” and the Pfizer-BioNTech vaccine “has been, and will continue to be authorized for emergency use in this age group since May 2021.”

Pfizer’s press release announcing the approval said the Comirnaty vaccine has been available under EUA since May 2021 for the adolescent age group.

Yet, Comirnaty is not available in the U.S for any age group and is not the same formula as the Pfizer-BioNTech vaccine currently authorized under EUA and being distributed as a “fully approved” vaccine.

Latest Pfizer data dump reveals more vaccine injuries, deaths

Pfizer-BioNTech COVID-19 vaccine documents released in July by the FDA reveal three more reports of deaths among vaccine trial participants and further instances of Pfizer downplaying serious adverse events sustained by participants and listing the injuries as “not related” to the vaccine.

Of the approximately 80,000 pages released this month, a 3,611-page “confidential” document contains information about clinical trial participants who died, sustained adverse events during the trial or contracted COVID-19 during the trial.

In all three cases of reported deaths, the investigator ruled out the possibility that the deaths were related to Pfizer’s vaccines.

One instance pertains to a 56-year-old white female who suffered cardiac arrest within two months of her second Pfizer dose. The second reported death involves a 60-year-old white male who received one dose of the vaccine and died within three days of atherosclerotic disease. The participant’s death was attributed to a “suspected” cause, while the possibility that it was vaccine-related in any way was dismissed.

The third death was listed under the section in the document where trial participants withdrew. A 72-year-old man developed vasovagal syncope after receiving the vaccine, was transferred to the intensive care unit and then withdrawn from the study. He died three days after being withdrawn.

According to the documents, investigators attributed the vaccine to serious adverse events in four cases, however, Pfizer disagreed with the investigators’ conclusions in three out of the four cases.

FDA colluded with Moderna to bypass COVID vaccine safety standards

According to Alexandra Latypova, an ex-pharmaceutical industry executive, documents obtained from the U.S. Department of Health and Human Services on Moderna’s COVID-19 vaccine suggest the FDA and Moderna colluded to bypass regulatory and scientific standards used to ensure products are safe.

After analyzing 699 pages of studies and test results “supposedly used by the FDA to clear Moderna’s mRNA platform-based mRNA-1273, or Spikevax,” Latypova told The Defender she believes U.S. health agencies are lying to the public on behalf of vaccine manufacturers and subverting the regulatory and scientific standards of drug safety testing.

“They accepted fraudulent test designs, substitutions of test articles, glaring omissions and whitewashing of serious signs of health damage by the product, then lied to the public on behalf of the manufacturers,” she said.

Latypova disclosed six findings from her assessment of Moderna’s documents raising serious questions about the safety and efficacy of the company’s COVID-19 vaccine, as well as conflicts of interests that she says allowed Moderna to sidestep drug development standards.

Tennis champ Djokovic has ‘no plans’ to get vaccinated as US Open tournament nears

Tennis champion Novak Djokovic, who last weekend won his fourth straight title at Wimbledon, said he has no plans to get vaccinated in order to bypass restrictions to enter the U.S. in August for the US Open.

Djokovic said he doesn’t think an exemption is “realistically possible.” It’s just a matter of whether or not the U.S. removes the requirement in time for him to attend the tournament, he said.

U.S. COVID-19 vaccination requirements for foreigners bar Djokovic’s entry into the country where he would normally compete at the US Open.

Serbia’s Djokovic, 35, has been dominant at Wimbledon for the past couple of years, according to Tennis World USA. He is regarded by some as the world’s greatest tennis player ever.

Phillies catcher will miss two-game series in Canada rather than comply with vaccine mandate

Phillies catcher J.T. Realmuto said he refuses to get vaccinated against COVID-19, even it if means missing Philadelphia’s two-game series against the Toronto Blue Jays this week.

Players who have not been vaccinated against COVID-19 are not allowed to enter Canada due to the country’s restrictions. In addition, players will not be paid for the games they miss as part of Major League Baseball’s new collective bargaining agreement.

Realmuto will lose about $262,000 for missing the series, which he called “a little bit of money,” the Philadelphia Inquirer reported. Realmuto signed a five-year, $115.5 million contract with the Phillies in January 2021.

Realmuto said he is a 31-year-old professional athlete who had COVID-19 several times with mild symptoms. After speaking with doctors, he didn’t think he needed it and wasn’t going to get vaccinated just because he was told to.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.