Note: The materials for this article were compiled by Lynda Smith (and edited by Wise Traditions) from DrTomCowan.com; childrenshealthdefense.org; greenmedinfo.com; westonaprice.org; and Dr. Frank Shallenberger, MD, HMD.
At the end of 2020, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to two experimental coronavirus vaccines manufactured by Pfizer/BioNTech and Moderna, respectively. In late February, the FDA additionally granted EUA to Johnson & Johnson’s (J&J’s) experimental Covid injection. The EUA designation permits use of experimental drugs or vaccines during a declared public health emergency but does not signify formal FDA approval.1
In evaluating the risks and declared merits of these emergency-use injections, it is important to bear in mind who the players are. Pfizer—the second largest pharmaceutical company by revenue in 2020—has been involved in repeated consumer lawsuits for products such as Lipitor,2 Zoloft,3 Viagra4 and others. In 2009, the Justice Department ordered Pfizer to pay what was then the largest health care fraud settlement in history, over two billion dollars, to resolve criminal and civil allegations that the company had illegally promoted four of its drugs.5 At the FDA’s request, Pfizer had already pulled one of the drugs off the market after FDA concluded that its risks outweighed its benefits.6 On the day that the Pfizer Covid vaccine was released, Pfizer’s sixteen-million-dollars per-year CEO told the media that he would not take someone’s place in line to get his company’s injection.7
Until the emergency authorization of its Covid injection, Moderna, established in 2010, had “never successfully produced a medicine of any kind”8 nor managed to get any of its nine or so vaccines approved by FDA. Yet as early as February 2020, Barron’s was reporting that “bad news about the coronavirus is good news for Moderna stock.”9 In August, the investment site The Motley Fool pointed out that “The company’s insiders have made high-profile exits from their stock positions” through the sale of “tens of millions of dollars of the company’s stock. . . in a slew of pre-planned trades”; the website speculated that this could be a sign of the senior leadership’s lack of confidence in their future stock price.8
Johnson & Johnson, like Pfizer, has a decades-long history of criminality, paying out billions in settlements for drugs and products such as Risperdal, opioids, asbestos-laced baby powder and flawed hip implants.10 Journalists Richard Gale and Gary Null also note that the company has “no history whatsoever in vaccine development,” pointing out that not one of the fifty-three vaccines currently approved and licensed by the CDC “is manufactured by the nation’s leader in mouthwash and baby powder.”11 Gale and Null state: “Finally, there is a disturbing question that we have no certain answer for. How is it that a drug and household health product company, with no prior history in vaccine development, can develop and rush to market its first vaccine against a viral strain that was only identified fourteen months ago?”11
THE INJECTIONS
The Pfizer and Moderna Covid-19 injections call for administration of a two-dose series. The Moderna doses are supposed to be given one month apart,12 while Pfizer’s shots are spaced twenty-one days apart.13 J&J’s product is administered in a single shot.14 The experimental Pfizer and Moderna injections are mRNA (messenger RNA) vaccines with a “lipid nanoparticle” (LNP) carrier system, while J&J uses an adenovirus vector. No mRNA or adenoviral-vectored vaccine has ever been licensed for commercial use in Americans. Moreover, no other therapies or prophylactics on the market use the mRNA approach, despite a handful of prior efforts.6
Because they are different from licensed vaccines currently on the market, all three experimental Covid vaccines raise unique safety concerns, including risks of subsequent disease enhancement, autoimmunity, infertility and life-threatening anaphylaxis. Moreover, though their delivery systems differ, the three injections have the same goal—a goal that is completely different from that of traditional viral vaccines. As integrative physician Dr. Frank Shallenberger explained in a December letter to his patients, traditional vaccines introduce pieces of a virus (“live” or inert), as well as adjuvants such as aluminum, to stimulate an immune reaction, but an mRNA vaccine “actually injects (transfects) molecules of synthetic genetic material from non-humans [sic] sources into our cells. Once in the cells, the genetic material interacts with our transfer RNA (tRNA) to make a foreign protein that supposedly teaches the body to destroy the virus being coded for.”15 Stated another way, Dr. Tom Cowan says that “the vaccines are hijacking the protein-makeup machinery.”6 The J&J vaccine works in similar fashion, shuttling DNA (instead of RNA) into the cells to force them to manufacture coronavirus spike protein.10 As Dr. Shallenberger further explains, the “newly created proteins are not regulated by our own DNA, and are thus completely foreign to our cells”; ominously, “what they are fully capable of doing is unknown.”15
RISKS OF EXAGGERATED IMMUNE REACTIONS
One major concern voiced by some scientists and physicians is the potential for the coronavirus vaccines to function as a Trojan horse, laying the groundwork for a phenomenon known as antibody-dependent enhancement (ADE)16 or “pathogenic priming.”17 In an unheeded December 4 letter to the director of the FDA’s Center for Biologics Evaluation and Research (CBER), Children’s Health Defense Chairman Robert F. Kennedy Jr. cited ADE as a key reason to be cautious about approving the mRNA injections.18
Scientists warning about ADE include the former head of respiratory research at Pfizer, Dr. Michael Yeadon, and Dr. Wolfgang Wodarg, a lung specialist and former head of the German public health department. On December 1, the two experts filed a petition with the European Medicines Agency urging the agency to pause the phase three trials of the Pfizer vaccine.19 Among the various reasons cited, the two highlighted the problem of ADE, alluding to studies documenting ADE in humans,20 non-human primates21 and ferrets22 in connection with the coronaviruses linked to severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
Their petition stated: “If ADE occurs in individuals, their response to the virus can be worse than their response if they had never developed an antibody in the first place. This can cause a hyperinflammatory response, a cytokine storm, and a generally dysregulation of the immune system that allows the virus to cause more damage to our lungs and other organs of our body. . . . There are many studies that demonstrate that ADE is a persistent problem with coronaviruses in general, and in particular, with SARS-related viruses.”19
In his letter to the FDA,18 Mr. Kennedy also pointed out that the Covid-19 vaccine trials were not designed to detect ADE.23 Moreover, although it is impossible to know what proportion of the U.S. population might suffer ADE after receiving a Covid-19 vaccine, individuals with preexisting autoimmune diseases—estimated at fifteen to twenty-four million Americans24— could be especially vulnerable. A leading surgeon, Dr. Hooman Noorchashm, has written letters to the FDA questioning the wisdom of vaccinating the millions of Americans who have already had Covid-19, arguing that the elderly, frail and those with serious cardiovascular comorbidities, in particular, are “at risk of being harmed by a dangerous exaggerated immune response triggered by the COVID vaccine.”25
AUTOIMMUNE RISKS
Dr. Cowan observes that the vaccine trials did not rule out whether the new genetic material the injections will insert into human bodies are the same (homologous) as other genetic sequences in the body. If homologous sequences are present, the body will be “taught” to attack itself.6
In support of this possibility, Cowan cites information presented in an Off-Guardian article (titled “COVID19 – Evidence of global fraud”) describing something called the Basic Local Alignment Search Tool (BLAST).26 A BLAST search is a way to search the compiled genetic data bank for all human and microbial sequences.
A search for one of the SARS-CoV-2 sequences (called the RdRp sequence) being used in the PCR test to diagnose the presence of the coronavirus reveals that there are ninety-nine human genetic sequences with a 100 percent sequence-identity match to the RdRp SARS-CoV-2 sequence.26 Another sequence (called the ORF1ab sequence) used in the PCR test returns ninety results with a 100 percent sequence-identity match. In addition, as BLAST reveals, there are ninety-two microbes identical to the ORF1ab sequence and one hundred microbes identical to the RdRp sequence. As the Off-Guardian’s Iain Davis concludes, “Whenever we check the so-called unique genetic markers for SARS-CoV-2. . . we find complete or high percentage matches with various fragments of the human genome. This suggests that the genetic sequences, which are supposed to identify SARS-CoV-2, are not unique.”26 (By implication, this means that PCR testing for the SARS-CoV-2 virus has no scientific validity, as it is not testing for any sequence that is unique to any virus.)
It’s logical to assume, says Cowan, that the genetic sequences identified as part of the coronavirus—sequences homologous to human genetic sequences—are in the coronavirus vaccines as well. The response to these as well as to other potential genetic sequences included in the vaccines could be either an acute inflammatory reaction or, later in life, the development of an autoimmune disease.6
RISKS TO FERTILITY
The vaccines are expected to produce antibodies against spike proteins of SARS-CoV-2. However, as Drs. Yeadon and Wodarg stated in their December petition to the European Medicines Agency, spike proteins also contain proteins homologous to syncytin-1, which is “responsible for the development of a placenta in mammals and humans and is therefore an essential prerequisite for a successful pregnancy.”19
According to Yeadon and Wodarg, the possibility that a vaccine against SARS-CoV-2 could trigger an immune reaction against syncytin-1—thereby preventing the formation of a placenta—has not been ruled out. The vaccine clinical trials were too short and were not designed to assess this outcome. Such an immune reaction could cause infertility “of indefinite duration” in vaccinated women. Drs. Yeadon and Wodarg also caution that “it could take a relatively long time” for a “noticeable number of cases of post-vaccination infertility” to become evident.19
RISKS OF POLYETHYLENE GLYCOL AND POLYSORBATES
In his letter to patients regarding the Covid vaccines, Dr. Shallenberger explained that there are many unknowns surrounding mRNA vaccination.15 For example, Shallenberger calls attention to the presence of a synthetic substance called polyethylene glycol (PEG) in the vaccines:
“The mRNA molecule is vulnerable to destruction. So, in order to protect the fragile mRNA strands during insertion into our DNA, they are coated with PEGylated lipid nanoparticles. This coating hides the mRNA from our immune system, which ordinarily would kill any foreign material injected into the body. PEGylated lipid nanoparticles have been used in several different drugs for years.”15
In fact, PEGs and/or PEGylated lipid LNPs are used in numerous drugs27 as well as in cosmetics28 and even food.29 And although the J&J Covid-19 vaccine does not contain PEG, it does include polysorbate 80, an ingredient structurally similar to PEG.30
Studies have found that PEGylated LNPs can induce allergic reactions, including anaphylaxis.31,32 Researchers have also grown increasingly aware that individuals who are hypersensitive to PEG may cross-react to polysorbate 80, with PEG hypersensitivity functioning as the “mechanism” for the polysorbate reactions.30,33 Because the vaccine clinical trials excluded people with a history of severe allergic reactions, no safety signal was reported in the clinical trials.34 Immediately after the launch of the Pfizer-BioNTech Covid-19 vaccine in the UK, however, media outlets began reporting severe anaphylactic reactions post-injection.35,36 According to Reuters and other news outlets, the FDA and others instantly suspected that PEG could be the culprit.34,37,38
A 2016 study in Analytical Chemistry,39 summarized by Children’s Health Defense, “reported detectable and sometimes high levels of anti-PEG antibodies (including first-line-of-defense IgM antibodies and later-stage IgG antibodies) in approximately 72% of contemporary human samples and about 56% of historical specimens from the 1970s through the 1990s.”40 The investigators, who admitted that the findings were unexpected, also reported that 8 percent of the samples displayed especially elevated anti-PEG IgG antibody levels.39 Extrapolated to the U.S. population of three hundred thirty million intended eventually to receive Covid-19 vaccines, over twenty-six million Americans could have the extremely high anti-PEG antibody levels most strongly associated with adverse effects.
Moderna is well aware of the safety risks associated with PEG and other aspects of its mRNA technology.40 In Moderna’s 2018 corporate prospectus, the biotech company specifically acknowledged the potential for its proprietary PEGylated LNPs to produce systemic reactions, stating, “Certain aspects of our investigational medicines may induce immune reactions from either the mRNA or the lipid as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events.”41
PEG has also been a suspected carcinogen since at least the 1980s.42 Researchers who question its biocompatibility have issued warnings about PEGylated particles’ ability to “enhance tumor growth.”43
CANCER RISKS
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is the purportedly “independent” panel that licenses new vaccines as “safe and effective.” VRBPAC is also the group that authorized the Pfizer, Moderna and J&J vaccines for emergency use.44,45,46
In a December article illustrating VRBPAC’s questionable independence and integrity, Robert F. Kennedy Jr. described how the committee unanimously agreed to allow adult human cancer cells into vaccines a decade ago.47 The FDA also allows vaccine manufacturers to use human fetal cell lines.48 Both types of cells have cancer risks.
The J&J and Oxford/AstraZeneca Covid vaccines—both of which use adenovirus vectors—propagate their adenovirus using human fetal cell lines, meaning, says Kennedy, that “the final vaccine products will contain cellular debris and DNA fragments from these cells.”47 J&J’s fact sheet for the health care providers who are administering its vaccine confirms this fact, stating that each dose of vaccine “may. . . contain residual amounts of host cell proteins. . . and/or host cell DNA.”49 Other adenovirus-vectored Covid vaccines using human fetal cell lines in the production stage include four U.S. vaccines under development or in phase one trials (Altimmune, ImmunityBio, Vaxart and the University of Pittsburgh), China’s CanSino Biologics vaccine and the Gamaleya Sputnik V vaccine in Russia.50 Pfizer and Moderna tested their mRNA vaccines using fetal cells but claim that there is no fetal cell debris or DNA in their final products.50
The J&J vaccine relies on a cell line called PER.C6 (a proprietary cell line derived from the eyeball of a healthy fetus aborted at 18 weeks), while the Oxford/AstraZeneca injection (authorized for emergency use outside the U.S.) relies on the more widely used HEK293T cell line (derived from the kidney cells of an aborted fetus). Children’s Health Defense recently explained that production of “continuous” or “immortalized” cell lines of this type requires artificial manipulation of the original cells, which “is accomplished by introducing chemical exposures or rendering them cancerous,” a process that “introduces genetic changes into the cells.”10 Children’s Health Defense goes on to explain the risks:
“A senior FDA official warned over two decades ago about the inherent risks of using continuous cell lines for vaccine development, noting that such cell lines, ‘by definition’ have abnormalities, and worriedly acknowledging their ‘potential for growing tumors in laboratory animals.’ An FDA document published in late 2020 shows that these issues are far from resolved; explicitly referring to cell lines such as PER. C6 and HEK293T, the FDA author states: ‘The use of tumorigenic and tumor-derived cells is a major safety concern’ and observes that the cell lines contain ‘latent’ or ‘quiet’ threats that ‘might become active under vaccine manufacturing conditions.’”10
Referring to these challenges, the senior FDA official unnecessarily added, “It’s very important to assure that these things are safe before they are given to people.”51
LONG-TERM RISKS
The FDA authorized the three Covid injections for emergency use on the basis of abbreviated clinical trial results. No long-term safety studies have been conducted on any of these vaccines, and if placebo group participants start getting the injections after six months, as the manufacturers hope, the opportunities for meaningful long-term comparisons “will be lost.”52 At the December 10 FDA/VRBPAC meeting to review the Pfizer vaccine, “less than 2.1% of the safety study cohort had been followed for over three months as of the Nov. 14 cutoff date,” a period of time “inadequate to determine any long-term effects of the vaccine.”52
Additionally, Children’s Health Defense points out: “Only 2.1% and 1.8% of the study cohort included patients 75 years old and older with pre-existing medical conditions, for the vaccinated and the placebo groups, respectively. There were only 41 total African Americans older than 75 in both arms of the Pfizer vaccine study. These are insufficient samples on which to base broad recommendations for these very important and vulnerable segments of the population.”52
Moderna’s preliminary clinical trial data suggested that participants in the vaccine group were more likely to experience systemic adverse events—clinical-trial lingo for “difficult side effects”—after the second dose. Participants in all three companies’ clinical trials reported reactions such as high fever, chills, muscle pains and headaches, and some reported severe reactions requiring hospitalization.53 This was the case even though the clinical trial participants were in excellent health, as trial participants usually are—screened out if they have pre-existing chronic health issues such as asthma, allergies or autoimmune diseases. Thus, at the time that the FDA granted its emergency use authorizations, there were no data on the effects of the injections in populations weighed down by chronic health problems.
At an October FDA meeting, the director of CBER’s Office of Biostatistics & Epidemiology presented a “working list” of twenty-one “possible adverse event outcomes” from Covid vaccines (see Figure 1). The list—labeled “draft” and “subject to change”—included Guillain-Barré syndrome, brain swelling, muscle weakness and paralysis, convulsions and seizures, stroke, narcolepsy, shock, heart attack, autoimmune disease, arthritis and joint pain, multisystem inflammatory syndrome in children and death.54 The adverse event reports that have been pouring in since the experimental vaccines’ rollout—reports of deaths, allergies, Bell’s palsy, convulsions and cardiac problems, among many others—are provocative checkmarks for many of the items on the FDA’s list.55
CAPTURED REGULATORS, FLEECED TAXPAYERS
Unfortunately, the American people cannot trust regulators to look out for their interests. As Dr. Cowan states, though “We would especially hope that the FDA, entrusted to examine and review pharmaceutical products, has the highest standards of integrity,” the FDA and sister agencies that are supposed to protect the public “have acted in ways that do not engender trust.”6
In an article describing “the cavalier, ignorant and astonishingly unethical deliberations” that took place during a 2012 VRBPAC meeting—the meeting where attendees agreed to allow use of human tumor cells in vaccines— Robert F. Kennedy Jr. shares several quotes that illuminate the FDA’s appalling track record:47
Len Lutwalk (FDA scientist): “If the American people knew some of the things that went on at the FDA, they’d never take anything but Bayer aspirin.”
Drummond Rennie (deputy editor of the Journal of the American Medical Association): “The FDA, by spinelessly knuckling under to every whim of the drug companies, has thrown away its high reputation, and in doing so, forfeited our trust.”
Ronald Kavanaugh, PhD (pharmacist who reviewed medications for FDA from 1998- 2008): “While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. . . . If we asked questions that could delay or prevent a drug’s approval—which of course was our job as drug reviewers—management would reprimand us, reassign us, hold secret meetings about us or worse. . . . [I]f you found issues that would make you turn down a drug, you could be pressured to reverse your decision, or the review would then be handed off to someone who would simply copy and paste whatever claims the company made in the summary document. . . . I believe I also have documentation of falsification of documents, fraud, perjury and widespread racketeering, including witnesses tampering and witness retaliation.”
Moreover, while Covid vaccines have benefited from generous U.S. taxpayer support,56-57 their manufacturers are legally immune from lawsuits for any harms that the injections may cause. The Public Readiness and Emergency Preparedness (PREP) Act declaration that designated Covid-19 as a public health emergency also immediately indemnified vaccine makers.58 Manufacturers of licensed vaccines recommended for children have also enjoyed freedom from liability since the passage of the 1986 National Childhood Vaccine Injury Act (NCVIA). Unfortunately, the NCVIA legislation may very well apply to Covid-19 vaccines if they graduate from being experimental to being licensed.
SIDEBAR
SOME RECENT WINS
Good news! For the first time ever, this legislative session saw the introduction of more good vaccine bills than bad! In various states, a total of two hundred forty-five vaccine bills were introduced—including a whopping one hundred forty-nine good ones (and ninety-six bad ones).
As of March 9, 2021, seventeen good bills died in committee. Two Utah bills passed both the House and Senate and have been sent for enrolling (that is, to be signed by the governor). These bills are UT HB 233, which ensures vaccine exemptions for college students, and UT HB 308, which prohibits government entities from requiring emergency use Covid-19 vaccines.
The Weston A. Price Foundation is tracking a small number of bills that have passed out of committee. In addition, a handful of good bills have passed either the Senate or the House, but not yet both. These include:
- Idaho: HB 140, which passed the House on February 23, 2021, prohibits the state from contracting with companies that discriminate based on vaccination status.
- Kansas: SB 273 prohibits the governor from directing or permitting mandatory vaccination during a declared emergency. The bill passed the Senate on March 1.
- Montana: SB 332 prohibits requiring foster families to undergo vaccination as a condition of participating in the program. The bill has passed the Senate and went to the House on March 1.
- Montana: HB 334 strengthens vaccine medical exemptions and provides privacy protections. It passed the House on February 27 and transferred to the Senate.
On other fronts:
- In early to mid-March, the governors of six states—Iowa, Mississippi, Montana, North Dakota, Texas and Wyoming— lifted their states’ mask mandates. Texas and Mississippi also gave the green light for businesses to operate at 100 percent capacity.
- Alabama’s governor plans to let the state’s mask mandate expire in April.
- Governors in states such as Louisiana and Michigan loosened restrictions on bars, restaurants and other businesses.
Many thanks to all of you who took action and contacted your legislators!
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- Johnson J. “Taking taxpayers for a ride”: Moderna to charge $32 to $37/dose for Covid-19 vaccine developed entirely with public funds. Common Dreams, Aug. 5, 2020. https://www.commondreams.org/news/2020/08/05/taking-taxpayers-ride-moderna-charge-32-37dose-covid-19-vaccine-developed-entirely.
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- https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Spring 2021
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Bert byers says
I have followed the Westin a price folks for a long time and feel that you are usually right on however, this time you are missing the mark. This is a worldwide pandemic and as of now July 2021, it is been proven that the vaccines effectiveness way outweigh any risk associated with them. I urge you for the good of all, to update your stance on the COVID -19 vaccination program.
MARCUS WILLIAMS says
Are you offering any FACTUAL evidence as to WHY they should change their stance, or are you making an emotional appeal?