COVID-19
Report Shows Politics Trumped Science on U.S. Vaccine Mandates
From the Frontier Centre for Public Policy
By Lee Harding
If you thought responsible science drove the bus on the pandemic response, think again. A December 2024 report by the U.S. House of Representatives Select Subcommittee, Coronavirus Pandemic shows that political agendas made regulatory bodies rush vaccine approvals, mandates, and boosters, causing public distrust.
“After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward” praised the Trump administration’s efforts to speed up vaccine development. By contrast, the report said presidential candidate Joe Biden and vice-presidential candidate Kamala Harris undermined public confidence.
“[W]hy do we think the public is gonna line up to be willing to take the injection?” Joe Biden asked on September 5, 2020. This quote appeared in a Politico article titled “Harris says she wouldn’t trust Trump on any vaccine released before [the] election.”
The House report noted, “These irresponsible statements eventually proved to be outright hypocrisy less than a year later when the Biden-Harris Administration began to boldly decry all individuals who decided to forgo COVID-19 vaccinations for personal, religious, or medical reasons.”
Millions of doses of COVID-19 vaccines were administered beginning in December 2020 under an Emergency Use Authorization. This mechanism allows unapproved medical products to be used in emergency situations under certain criteria, including that there are no alternatives. The only previous EUA was for the 2004 anthrax vaccine, which was only administered to a narrow group of people.
By the time vaccines rolled out, SARS-CoV-2 had already infected 91 million Americans. The original SARS virus some 15 years prior showed that people who recovered had lasting immunity. Later, a January 2021 study of 200 participants by the La Jolla Institute of Immunology found 95 per cent of people who had contracted SARS-CoV-2 (the virus behind COVID-19) had lasting immune responses. A February 16, 2023 article by Caroline Stein in The Lancet (updated March 11, 2023) showed that contracting COVID-19 provided an immune response that was as good or better than two COVID-19 shots.
Correspondence suggests that part of the motivation for full (and not just emergency) vaccine approval was to facilitate vaccine mandates. A July 21, 2021, email from Dr. Marion Gruber, then director of vaccine reviews for the Food and Drug Administration (FDA), recalled that Dr. Janet Woodcock had stated that “absent a license, states cannot require mandatory vaccination.” Woodcock was the FDA’s Principal Deputy Commissioner at the time.
Sure enough, the FDA granted full vaccine approval on August 23, 2021, more than four months sooner than a normal priority process would take. Yet, five days prior, Biden made an announcement that put pressure on regulators.
On August 18, 2021, Biden announced that all Americans would have booster shots available starting the week of September 20, pending final evaluation from the FDA and the U.S. Centers for Disease Control and Prevention (CDC).
Some decision-makers objected. Dr. Marion Gruber and fellow FDA deputy director of vaccine research Dr. Philip Krause had concerns regarding the hasty timelines for approving Pfizer’s primary shots and boosters. On August 31, 2021, they announced their retirements.
According to a contemporary New York Times article, Krause and Gruber were upset about Biden’s booster announcement. The article said that “neither believed there was enough data to justify offering booster shots yet,” and that they “viewed the announcement, amplified by President Biden, as pressure on the F.D.A. to quickly authorize them.”
In The Lancet on September 13, 2021, Gruber, Krause, and 16 other scientists warned that mass boosting risked triggering myocarditis (heart inflammation) for little benefit.
“[W]idespread boosting should be undertaken only if there is clear evidence that it is appropriate,” the authors wrote. “Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.”
Regardless, approval for the boosters arrived on schedule on September 24, 2021. CDC Director Dr. Rochelle Walensky granted this approval, but for a wider population than recommended by her advisory panel. This was only the second time in CDC history that a director had defied panel advice.
“[T]his process may have been tainted with political pressure,” the House report found.
Amidst all this, the vaccines were fully licensed. The FDA licensed the Comirnaty (Pfizer-BioNTech) vaccine on August 23, 2021. The very next day, Defense Secretary Lloyd Austin issued a memo announcing a vaccine mandate for the military. Four other federal mandates followed.
“[T]he public’s perception [is] that these vaccines were approved in a hurry to satisfy a political agenda,” the House report found.
The House report condemned the dubious process and basis for these mandates. It said the mandates “ignored natural immunity, … risk of adverse events from the vaccine, as well as the fact that the vaccines don’t prevent the spread of COVID-19.”
The mandates robbed people of their livelihoods, “hollowed out our healthcare and education workforces, reduced our military readiness and recruitment, caused vaccine hesitancy, reduced trust in public health, trampled individual freedoms, deepened political divisions, and interfered in the patient-physician relationship,” the report continued.
The same could be said of Canadian vaccine mandates, as shown by the National Citizen’s Inquiry hearings on COVID-19. Unfortunately, an official federal investigation and a resulting acknowledgement do not seem forthcoming. Politicized mandates led to profits for vaccine manufacturers but left “science” with a sullied reputation.
Lee Harding is a Research Fellow for the Frontier Centre for Public Policy.
From the Brownstone Institute
An explosive new study conducted within the US Food and Drug Administration’s (FDA) own laboratory has revealed excessively high levels of DNA contamination in Pfizer’s mRNA Covid-19 vaccine.
Tests conducted at the FDA’s White Oak Campus in Maryland found that residual DNA levels exceeded regulatory safety limits by 6 to 470 times.
The study was undertaken by student researchers under the supervision of FDA scientists. The vaccine vials were sourced from BEI Resources, a trusted supplier affiliated with the National Institute of Allergy and Infectious Diseases (NIAID), previously headed by Anthony Fauci.
Recently published in the Journal of High School Science, the peer-reviewed study challenges years of dismissals by regulatory authorities, who had previously labelled concerns about excessive DNA contamination as baseless.
The FDA is expected to comment on the findings this week. However, the agency has yet to issue a public alert, recall the affected batches, or explain how vials exceeding safety standards were allowed to reach the market.
The Methods
The student researchers employed two primary analytical methods:
- NanoDrop Analysis – This technique uses UV spectrometry to measure the combined levels of DNA and RNA in the vaccine. While it provides an initial assessment, it tends to overestimate DNA concentrations due to interference from RNA, even when RNA-removal kits are utilised.
- Qubit Analysis – For more precise measurements, the researchers relied on the Qubit system, which quantifies double-stranded DNA using fluorometric dye.
Both methods confirmed the presence of DNA contamination far above permissible thresholds. These findings align with earlier reports from independent laboratories in the United States, Canada, Australia, Germany, and France.
Expert Reaction
Kevin McKernan, a former director of the Human Genome Project, described the findings as a “bombshell,” criticizing the FDA for its lack of transparency.
“These findings are significant not just for what they reveal but for what they suggest has been concealed from public scrutiny. Why has the FDA kept these data under wraps?” McKernan questioned.
CSO and Founder of Medicinal Genomics
While commending the students’ work, he also noted limitations in the study’s methods, which may have underestimated contamination levels.
“The Qubit analysis can under-detect DNA by up to 70% when enzymes are used during sample preparation,” McKernan explained. “Additionally, the Plasmid Prep kit used in the study does not efficiently capture small DNA fragments, further contributing to underestimation.”
In addition to genome integration, McKernan highlighted another potential cancer-causing mechanism of DNA contamination in the vaccines.
He explained that plasmid DNA fragments entering the cell’s cytoplasm with the help of lipid nanoparticles could overstimulate the cGAS-STING pathway, a crucial component of the innate immune response.
“Chronic activation of the cGAS-STING pathway could paradoxically fuel cancer growth,” McKernan warned. “Repeated exposure to foreign DNA through COVID-19 boosters may amplify this risk over time, creating conditions conducive to cancer development.”
Adding to the controversy, traces of the SV40 promoter were detected among the DNA fragments. While the authors concluded that these fragments were “non-replication-competent” meaning they cannot replicate in humans, McKernan disagreed.
“To assert that the DNA fragments are non-functional, they would need to transfect mammalian cells and perform sequencing, which wasn’t done here,” McKernan stated.
“Moreover, the methods used in this study don’t effectively capture the full length of DNA fragments. A more rigorous sequencing analysis could reveal SV40 fragments several thousand base pairs long, which would likely be functional,” he added.
Regulatory Oversight under Scrutiny
Nikolai Petrovsky, a Professor of Immunology and director of Vaxine Pty Ltd, described the findings as a “smoking gun.”
“It clearly shows the FDA was aware of these data. Given that these studies were conducted in their own labs under the supervision of their own scientists, it would be hard to argue they were unaware,” he said.
Nikolai Petrovsky, Professor of Immunology and Infectious Disease at the Australian Respiratory and Sleep Medicine Institute in Adelaide
Prof Petrovsky praised the quality of work carried out by the students at the FDA labs.
“The irony is striking,” he remarked. “These students performed essential work that the regulators failed to do. It’s not overly complicated—we shouldn’t have had to rely on students to conduct tests that were the regulators’ responsibility in the first place.”
The Australian Therapeutic Goods Administration (TGA), which has consistently defended the safety of the mRNA vaccines, released its own batch testing results, claiming they met regulatory standards. However, Prof Petrovsky criticised the TGA’s testing methods.
“The TGA’s method was not fit for purpose,” he argued. “It didn’t assess all the DNA in the vials. It only looked for a small fragment, which would severely underestimate the total amount of DNA detected.”
Implications for Manufacturers and Regulators
Now that DNA contamination of the mRNA vaccines has been verified in the laboratory of an official agency and published in a peer-reviewed journal, it becomes difficult to ignore.
It also places vaccine manufacturers and regulators in a precarious position.
Addressing the contamination issue would likely require revising manufacturing processes to remove residual DNA, which Prof Petrovsky explained would be impractical.
“The only practical solution is for regulators to require manufacturers to demonstrate that the plasmid DNA levels in the vaccines are safe,” Prof Petrovsky stated.
“Otherwise, efforts to remove the residual DNA would result in an entirely new vaccine, requiring new trials and effectively restarting the process with an untested product.”
Now the onus is on regulators to provide clarity and take decisive action to restore confidence in their oversight. Anything less risks deepening the scepticism of the public.
Both the US and Australian drug regulators have been approached for comment.
Republished from the author’s Substack
Author
Our immune systems are supposed to fight viruses. Now they invite them round for tea. It’s all down to IgG4…
Have you heard about the IgG4 antibody switch? It’s been glossed over in official discussions about Covid-19 ‘vaccines’, but it’s the elephant in the room. Let’s break it down and explore why this may matter more than we’re being told.
The antibody switch: what’s the big deal?
Our immune system is like a well-trained army, with different types of antibodies serving as its soldiers. Among them, IgG antibodies are the frontline warriors, designed to neutralize viruses and protect us from infections. But here’s the catch: not all IgG antibodies are created equal. Think of IgG4 antibodies as the peacekeepers of the immune system. They’re not fighters like the other IgG subclasses—they’re more about tolerance, calming things down. They’re certainly not about launching an attack.
Now, here’s where it gets interesting (and worrying).
Studies have shown that repeated Covid-19 mRNA injections—especially after the second dose or booster—cause the body to switch from producing the more effective IgG3 antibodies to producing IgG4. Essentially, the immune system is shifting toward tolerance rather than attack.
Sounds harmless, right? Well, not so fast. Here’s a look at what this shift might mean:
1. More Covid-19 infections
Imagine your immune system being rewired to tolerate the virus instead of fighting it. That’s essentially what the IgG4 switch could entail. A study from the Cleveland Clinic found a troubling trend: the more Covid-19 vaccine doses a person received, the higher their risk of getting infected. This isn’t what we were promised with “safe and effective,” is it? The IgG4 antibodies might be making the body less effective at dealing with the virus, leaving vaccinated individuals more susceptible to reinfections.
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2. The potential for worse outcomes
IgG4 antibodies are great if you’re dealing with allergies, as they help the body tolerate allergens. But when it comes to fighting a virus like SARS-CoV-2, this tolerance could backfire. Instead of neutralizing the virus, the immune system might let it hang around longer, potentially leading to more severe disease outcomes. It’s like inviting a burglar into your house and offering them tea instead of calling the police.
3. The risk of other conditions
This shift to IgG4 isn’t just about Covid-19. It could open the door to other IgG4-related diseases (known as IgG4-RD). These are a group of conditions where the immune system starts attacking various organs, causing inflammation and fibrosis (thickening or scarring of tissues). Examples include autoimmune pancreatitis, kidney disease, and even conditions affecting the lungs or brain. There have been reports of individuals developing these conditions after receiving the mRNA vaccines. Coincidence? Maybe. But it’s enough to warrant serious investigation.
Below is a list of IgG4-related diseases (IgG4-RD) and other pathologies associated with elevated IgG4 levels that could also be related to IgG4 rising after mRNA injections:
- Type 1 Autoimmune Pancreatitis (AIP): Chronic inflammation of the pancreas, often presenting with abdominal pain, jaundice, or weight loss. It is one of the most common manifestations of IgG4-RD.
- Sialadenitis (Mikulicz’s Disease): Enlargement of the salivary and lacrimal glands, leading to dry mouth and eyes. This is a classic presentation of IgG4-RD in the head and neck region (Stone et al., 2012).
- Retroperitoneal Fibrosis: Thickening and fibrosis of the tissue behind the peritoneum, which can lead to ureteral obstruction and kidney damage (Stone et al., 2012).
- Riedel’s Thyroiditis: A rare form of thyroiditis involving fibrosis of the thyroid gland. It can present as a hard, fixed thyroid mass that mimics malignancy (Stone et al., 2012).
- Küttner’s Tumor (Chronic Sclerosing Sialadenitis): Affects the submandibular glands, causing enlargement and fibrosis, often mistaken for a tumor (Stone et al., 2012).
- IgG4-Related Sclerosing Cholangitis: Involves the bile ducts, often associated with autoimmune pancreatitis. Can lead to jaundice and bile duct obstruction (Stone et al., 2012).
- IgG4-Related Ophthalmic Disease: Involves orbital inflammation and can cause proptosis (bulging eyes), double vision, or orbital masses (Stone et al., 2012; Uchida et al., 2022).
- IgG4-Related Aortitis and Periaortitis: Inflammation of the aorta and surrounding tissues, which may lead to aneurysms or vascular complications (Stone et al., 2012).
- IgG4-Related Kidney Disease: Includes tubulointerstitial nephritis and other renal manifestations, leading to kidney dysfunction or masses (Stone et al., 2012; Uchida et al., 2022).
- IgG4-Related Lung Disease: Pulmonary involvement, presenting with inflammatory pseudotumors, interstitial pneumonia, or pleural thickening (Stone et al., 2012).
- IgG4-Related Lymphadenopathy: Enlargement of lymph nodes that may mimic lymphoma (Stone et al., 2012).
- IgG4-Related Skin Disease: While less common, presents as various cutaneous lesions, including plaques or nodules (Stone et al., 2012).
- IgG4-Related Prostatitis: Enlargement of the prostate, causing lower urinary tract symptoms (Stone et al., 2012).
- IgG4-Related Hypophysitis: Involves inflammation of the pituitary gland, leading to hormonal imbalances such as adrenal insufficiency or diabetes insipidus (Stone et al., 2012).
- IgG4-Related Pachymeningitis: Inflammation of the dura mater (the outer membrane covering the brain and spinal cord), leading to headaches, cranial nerve palsies, or other neurological symptoms (Stone et al., 2012).
That’s not all. There are potentially broader implications of elevated IgG4 levels that we must consider:
- Repeated infections. Elevated IgG4 levels may impair the immune system’s ability to clear infections, as IgG4 is less effective at neutralizing pathogens (Aalberse, 2009; Irrgang, 2021).
- Autoimmune diseases. Elevated IgG4 levels may contribute to autoimmune processes, where the immune system attacks its own tissues (Watad, 2021).
- Cancer risks. Chronic inflammation caused by IgG4-related conditions may increase the risk of certain malignancies. While not directly caused by IgG4, this link warrants further research (Uchida, 2022).
- Idiopathic Interstitial Lung Disease. Chronic inflammation and fibrosis in the lungs may lead to respiratory symptoms, further complicating the clinical picture (Stone, 2012).
- Systemic Vasculitis. Inflammation of blood vessels associated with IgG4-RD can cause systemic complications and end-organ damage (Stone, 2012).
Why isn’t this being talked about?
Good question. The IgG4 switch is a complex phenomenon, and scientists are still trying to figure out its full implications. However, one thing is clear: this isn’t a simple black-and-white issue as the long-term effects of repeated mRNA shots are only now coming into focus.
Health agencies like the CDC and WHO argue that the benefits of vaccination outweigh the risks. But should we ignore potential red flags, especially when they involve changes to our immune system long term? Especially in populations that had virtually no risk from Covid-19 (i.e. children)? Absolutely not.
The science isn’t settled – but nor is this speculation
Elevated IgG4 levels are documented. Multiple studies confirm that repeated mRNA injections lead to a significant increase in IgG4 antibodies (Irrgang et al., 2021). This isn’t speculation—it’s a fact.
Case reports suggest a link. Individuals have developed IgG4-related diseases shortly after getting injected (Uchida et al., 2022). While these cases are rare, as not many practitioners have linked the Covid 19 gene therapy to a certain pathology, they highlight a potential connection that needs further investigation.
The immune response Is complex. The IgG4 switch might be the immune system’s way of adapting to repeated exposure to the spike protein in the vaccines. But this adaptation could come with unintended consequences, including reduced vaccine efficacy and heightened risk of certain diseases. And the most important question is the duration of this fact which we will only know in a decade.
More studies are needed. The science is evolving, and more research is needed to fully understand the implications of this antibody switch. For now, it’s clear that this isn’t a one-size-fits-all situation.
What can we do?
As individuals, the best thing we can do is stay informed. Ask questions if asked to be vaccinated: demand transparency, and weigh the risks and benefits of any medical intervention.
If you yourself have been affected by any of the pathologies above, even months or years after the Covid injections, ask your healthcare providers to assess a potential association. You can test for Covid antibodies (when over 1000 BAU, it is reasonable to assume that you are still producing spike proteins after the injections). You can also get tested for IgG4s (for Covid and generally), for spike proteins (in serum, immune cells, exosomes, body fluids) or for mRNA (in serum, exosomes or any body fluid).
For policymakers and health agencies, it’s crucial to continue monitoring these injections’ long-term effects and be honest about potential risks. Ignoring the elephant in the room won’t make it go away.
Final thoughts
The IgG4 switch is an alarming consequence of repeated Covid-19 mRNA vaccinations. The evidence so far suggests that this phenomenon could have significant implications for immunity, vaccine efficacy, and long-term health. It’s time to have an open, honest conversation about those ‘trade-offs’—and to keep the spotlight on the elephant in the room. This is certainly another red flag for the continuation of the Covid 19 gene therapy and adds to the calls for a moratorium of this technology. Especially considering further promotion of mRNA technologies in the US, Europe, and Russia, we urgently need independent scientists to gather at a roundtable with those pushing for even more use. The World Council for Health has repeatedly called for a moratorium on the technology. This is just the latest, essential piece we’re adding to the puzzle.
References
Aalberse, R. C., Stapel, S. O., Schuurman, J., & Rispens, T. (2009). Immunoglobulin G4: an odd antibody. Clinical & Experimental Allergy, 39(4), 469-477. https://doi.org/10.1111/j.
Bergamaschi, C., Terpos, E., Rosati, M., Angel, M., Bear, J., Stellas, D., … & Felber, B. K. (2021). Systemic IL-15, IFN-γ, and IP-10/CXCL10 signature associated with effective immune response to SARS-CoV-2 in BNT162b2 mRNA vaccine recipients. Cell Reports, 36(6), 109504. https://doi.org/10.1016/j.
Uchida, K., Ito, S., Nakamura, Y., Hoshino, Y., Abe, Y., Ito, T., … & Okazaki, K. (2022). IgG4-related disease after BNT162b2 COVID-19 mRNA vaccination: A case report. Vaccine, 40(22), 3079-3082. https://doi.org/10.1016/j.
Irrgang, P., Gerling, J., Kocher, K., Lapuente, D., Steininger, P., Habenicht, K., … & Überla, K. (2021). Class switch towards non-inflammatory, spike-specific IgG4 antibodies after repeated SARS-CoV-2 mRNA vaccination. medRxiv. https://doi.org/10.1101/2022.
Kang, C. K., Kim, M., Lee, S., Kim, G., Choe, P. G., Park, W. B., … & Oh, M. D. (2022). Longitudinal analysis of SARS-CoV-2 specific antibody responses after COVID-19 vaccination. Journal of Korean Medical Science, 37(4), e35. https://doi.org/10.3346/jkms.
Lozano-Ojalvo, D., Camara, C., Lopez-Granados, E., Nozal, P., Del Pino-Molina, L., Bravo-Gallego, L. Y., … & Paz-Artal, E. (2021). Differential effects of the second SARS-CoV-2 mRNA vaccine dose on T cell immunity in naive and COVID-19 recovered individuals. Cell Reports, 36(8), 109570. https://doi.org/10.1016/j.
Perugino, C. A., AlSalem, S. B., Mattoo, H., Della-Torre, E., Mahajan, V., Ganesh, G., … & Stone, J. H. (2021). Identification of galectin-3 as an autoantigen in patients with IgG4-related disease. Journal of Allergy and Clinical Immunology, 147(2), 736-745. https://doi.org/10.1016/j.
Stone, J. H., Zen, Y., & Deshpande, V. (2012). IgG4-related disease. New England Journal of Medicine, 366(6), 539-551. https://doi.org/10.1056/
World Health Organization (WHO). (2023). COVID-19 vaccines: safety surveillance manual.
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