Article by Lyn Redwood, RN, MSN from Children’s Health Defense.
The National Institute of Allergy and Infectious Diseases (NIAID) announced the trial April 7, one day after researchers in the UK published a study confirming polyethylene glycol (PEG), a compound in the two vaccines, caused the anaphylactic reaction experienced by a woman who received the Pfizer vaccine.
However, a close look at the NIAID trial guidelines reveals the study excludes individuals most likely to experience allergic reactions to the vaccines — those with PEG allergies and autoimmune disorders.
UK study focused on 52-year-old woman
On April 6, researchers from the Department of Allergy and Oncology at Cambridge University Hospitals and the National Health Service Foundation Trust in Cambridge, UK, published a research letter in Clinical and Experimental Allergy. The letter — “Polyethylene Glycol (PEG) Is a Cause of Anaphylaxis to the Pfizer/BioNTech mRNA COVID-19 Vaccine” — confirmed PEG as the culprit in the increasing number of reports of anaphylaxis following administration of the Pfizer and Moderna mRNA vaccines.
The UK researchers conducted a series of skin prick allergy tests on a 52‐year‐old woman who required immediate medical attention after receiving the Pfizer COVID‐19 vaccine. The woman developed throat constriction and a cough followed by loss of consciousness.
The woman told researchers she previously experienced allergic reactions and hives to multiple products including shampoos, conditioners and shower gels containing PEG, and immediate burning of the mouth with toothpastes and mouthwash containing PEG. Prior to her vaccination she was not known to be allergic to PEG.
Under medical supervision, the woman underwent skin prick allergy testing to test the Pfizer vaccine excipients (inert compounds, PEG and polysorbate 80) and the AstraZeneca COVID‐19 vaccine). All skin prick testing for allergy was negative, with the exception of PEG.
The researchers reported that 12 minutes after PEG skin testing the patient developed a systemic reaction with widespread pruritus (itching), urticaria (hives) and coughing with throat constriction. Her blood pressure dropped resulting in the need for emergency treatment with intramuscular adrenaline, intravenous chlorpheniramine and hydrocortisone. Her blood pressure then improved but coughing persisted, with a drop in oxygen saturation to 85%. This resulted in the need for a second dose of intramuscular adrenaline.
The investigators concluded for the first time that PEG allergy was responsible for a severe COVID-19 vaccine anaphylaxis. They recommended for patients with suspected or proven PEG allergy, mRNA vaccines containing PEG should be avoided, as should vaccines containing polysorbate 80 which is structurally similar to PEG and present in other COVID vaccine formulations.
The rapidly developed and currently distributed COVID-19 mRNA vaccines rely on a new nanoparticle-based carrier system that utilizes PEG. The lipid nanoparticles (LNPs) carrier system used in the Pfizer and Moderna COVID-19 vaccines to facilitate the delivery of the mRNA into the cell is pegylated — meaning coated with PEG. Coating the lipid nanoparticle with PEG keeps it from being broken down in the body after injection.
U.S. study designed to exclude individuals most likely to experience anaphylactic reaction
“The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines … The information gathered during this trial will help doctors advise people who are highly allergic or have a mast cell disorder about the risks and benefits of receiving these two vaccines. However, for most people, the benefits of COVID-19 vaccination far outweigh the risks.”
The research is no small undertaking. The NIAID study will enroll 3,400 adults ages 18 to 69 years at up to 35 academic allergy research centers nationwide.
The research is designed only to “estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and if the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD compared to a non-atopic population.”
There is no mention of trying to determine what specific ingredient in the mRNA vaccines is causing the allergic reactions, which are hardly rare. In the U.S., 24,841 cases of anaphylaxis following COVID vaccines were reported between Dec. 14, 2020, and April 16 to the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System. Of those, 43% of the reports were attributed to Pfizer’s vaccine, 47% to Moderna and 10% to the Johnson & Johnson vaccine (which contains polysorbate 80, but not PEG).
What is even more concerning about this study is that according to ClinicalTrials.gov, the study excludes the exact people who are likely to have allergic and anaphylactic reactions to the vaccines.
In other words, the study excludes anyone with: a history of a severe reaction to any component of the Pfizer or Moderna COVID vaccines; contact dermatitis with confirmed patch test reaction to PEG or Doxil® (a PEG-containing drug); autoimmune or other disorders requiring systemic immune modulators; and/or or acute urticaria (hives) within 28 days of being enrolled in the study.
It is important to note that in the clinical trials for these vaccines, the drug makers also excluded individuals with a history of severe allergic reactions, which is one explanation for why these adverse events were not recognized prior to Emergency Use Authorization.
Past studies highlight potential risk of PEG allergies
A landmark 2016 study published in Analytical Chemistry reported detectable and sometimes high levels of anti-PEG antibodies in approximately 72% of contemporary human samples and about 56% of historical specimens from the 1970s through the 1990s.
Of the 72% with PEG IgG antibodies, 8% had anti-PEG IgG antibodies greater than 500ng/ml., which is considered extremely elevated and a potential risk for severe allergic reactions. The authors of that study concluded that “…sensitive detection and precise quantitation of anti-PEG Ab levels in a clinical setting will be essential to ensuring the safe use of PEGylated drugs in all target patient populations going forward.”
According to a 2017 study, “screening and monitoring the anti-PEG abs in blood before and during the treatment with PEG-containing drugs are of particular importance to provide safety and maintain therapeutic efficacy. The generation of anti-PEG abs can accelerate the clearance of PEGylated therapeutics, thus reducing therapeutic efficacy. Moreover, the existence of anti-PEG abs threatened patient safety with anaphylaxis and other reactions.”
In January 2019, the U.S. Department of Health and Human Services, U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research issued a guidance document, “Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody (ADA) Detection: Guidance for Industry.”
The document cites research which specifically addresses the need to “adequately understand the risk of anti-drug antibodies … in products with modifications such as pegylation” and states that “information on immune responses observed during clinical trials, particularly the incidence of anti-drug antibodies induction or any implications of ADA responses affecting pharmacokinetics, pharmacodynamics, safety, or efficacy is crucial for any therapeutic protein product development program.”
It is mystifying how a never-before-utilized vaccine technology that contained a synthetic, nondegradable and increasingly controversial polymer (PEG) — known to be associated with adverse immune responses and the development of anti-drug antibodies — was allowed to bypass the bedrock of pharmaceutical development, which is immunological testing.
Children’s Health Defense warned FDA on PEG allergies last year
On Sept. 25, 2020, Robert F. Kennedy Jr., Children’s Health Defense chairman and chief legal counsel, sent a letter to FDA Director Steven Hahn and Peter Marks, director of the Center for Biological Evaluation and Research, with a copy to Fauci, in which Kennedy voiced concerns about the use of PEG in the Moderna COVID vaccine trials, due to the development of anti-PEG antibodies and also because in recent years, PEG has come under increasing scrutiny.
In the letter to the FDA, Children’s Health Defense recommended additional steps be taken to reduce the risk of exposing trial participants to a substance to which up to 72% of the U.S. population may have pre-existing antibodies that could result in life-threatening allergic responses and decreased efficacy of the vaccine.
The recommended steps included:
- Pre-screening trial participants for the presence and titers of anti-PEG antibodies
- Using such data to characterize the potential association and impact of anti-PEG antibodies on adverse reactions in the trial
- Identifying the level of anti-PEG antibody titers that preclude safe administration of the vaccine in the absence of secondary measures to address the anti-PEG immune response
- Measuring the impact of the anti-PEG immune response on vaccine efficacy
Unfortunately, the FDA and National Institutes of Health (NIH) refused to consider our science- based recommendations which could have prevented the anaphylactic response to the vaccine experienced by the 52 year old woman and by thousands of others.
Instead of designing a study that excludes the most likely culprit causing these reactions, we call on FDA and NIH to instead do the studies recommended by their own guidance document, as Children’s Health Defense recommended in September 2020 and which should have been done as part of the clinical trials.
Big Pharma’s Five Major Minions that Everyone, Vaxxed or Unvaxxed, Must Oppose
This is not an “anti-vaxxer” article, per se. It’s a call for everyone to wake up to the nefarious motives behind vaccine mandates, booster shots, and condemnation of freedom.
The worst kept secret in world history SHOULD be that the unquenchable push for universal vaccinations against Covid-19 has little if anything to do with healthcare and everything to do with Big Pharma’s influence over the narrative. Unfortunately, that secret has stayed firmly hidden from the vast majority of people because of the five major minions working on behalf of Big Pharma.
What’s even worse is the fact that Big Pharma’s greed is merely a smokescreen to hide an even darker secret. We’ll tackle that later. First, let’s look at the public-facing ringleaders behind the vaccine push, namely Big Pharma. But before we get into their five major minions, it’s important to understand one thing. This is NOT just an article that speaks to the unvaccinated. Even those who believe in the safety and effectiveness of the vaccines must be made aware of agenda that’s at play.
Let’s start with some facts. The unvaccinated do NOT spread Covid-19 more rampantly than the vaccinated. Even Anthony Fauci acknowledged the viral load present in vaccinated people is just as high as in the unvaccinated. This fact alone should demolish the vaccine mandates as it demonstrates they have absolutely no effect on the spread of the disease. But wait! There’s definitely more.
This unhinged push to vaccinate everyone defies science. Those with natural immunity may actually have their stronger defenses against Covid-19 hampered by the introduction of the injections which fool the body into creating less-effective antibodies. Moreover, the push to vaccinate young people is completely bonkers. The recovery rate for those under the age of 20 is astronomical. Children neither contract, spread, nor succumb to Covid-19 in a statistically meaningful way. What they DO succumb to more often than Covid-19 are the adverse reactions to the vaccines, particularly boys.
All of this is known and accepted by the medical community, yet most Americans are still following the vaccinate-everybody script. It requires pure cognitive dissonance and an overabundant need for confirmation bias to make doctors and scientists willingly go along with the program. Yet, here we are and that should tell you something.
Before I get to the five major minions of of Big Pharma, I must make the plea for help. Between cancel culture, lockdowns, and diminishing ad revenue, we need financial assistance in order to continue to spread the truth. We ask all who have the means, please donate through our GivingFuel page or via PayPal. Your generosity is what keeps these sites running and allows us to expand our reach so the truth can get to the masses. We’ve had great success in growing but we know we can do more with your assistance.
Who does Big Pharma control? It starts with the obvious people, the ones who most Americans believe are actually behind this push. Our governments at all levels as well as governments around the world are not working with Big Pharma. They are working for Big Pharma. Some are proactive as direct recipients of cash. Others may oppose Big Pharma in spirit but would never speak out because they know anyone who does has no future in DC.
This may come as a shock to some, but it’s Big Pharma that drives the narrative and sets the agenda for the “experts” at the CDC, FDA, WHO, NIH, NIAID, and even non-medical government organizations.
Most believe it’s the other way around. They think that Big Pharma is beholden to the FDA for approval, but that’s not exactly the case. They need approval for a majority of their projects, but when it comes to the important ones such as the Covid injections, Big Pharma is calling the shots. They have the right people in the right places to push their machinations forward.
That’s not to say that everyone at the FDA is in on it. Big Pharma only needs a handful of friendlies planted in leadership in order to have their big wishes met. We have seen people quitting the FDA in recent weeks for this very reason. The same can be said about the other three- and five-letter agencies. Too many people in leadership have been bribed, bullied, or blackmailed into becoming occasional shills for the various Big Pharma corporations. Some have even been directly planted by Big Pharma. That’s the politics of healthcare and science that drives such things as Covid-19 “vaccines.”
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JD Rucker – EIC