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On Dec. 2, Britain\u2019s Medicines and Healthcare Products Regulatory Agency (MHRA) became the first in the world to approve a\u00a0COVID-19<\/a>\u00a0vaccine developed by Germany\u2019s BioNTech and\u00a0Pfizer<\/a>.<\/p>\n A mass vaccination campaign that targeted frontline workers to receive the vaccine began on Dec. 8. Within 24 hours of launching the campaign,\u00a0MHRA acknowledged<\/a>\u00a0two reports of anaphylaxis and one report of a possible allergic reaction.<\/p>\n Reuters<\/a>\u00a0reported late yesterday afternoon that an investigation into the\u00a0anaphylactic reactions<\/a>\u00a0by MHRA has identified\u00a0polyethylene glycol<\/a>, or PEG, as the likely culprit.<\/p>\n Imperial College London\u2019s Paul Turner, an expert in allergy and immunology who has been advising the MHRA on its revised guidance, told Reuters: \u201cThe ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk.\u201d<\/p>\n It was also reported that PEG, which helps to stabilize the shot,\u00a0is not in other types of vaccines<\/a>.<\/p>\n The statements by Turner that \u201cPEG is not in other types of vaccines\u201d and that people with allergies to \u201cjust one medicine should not be at risk\u201d are a failed attempt to provide false assurances and are patently untrue.<\/p>\n Moderna<\/a>, Pfizer\/BioNTech and Arcturus Therapeutics COVID vaccines all utilize a never-before-approved messenger RNA (mRNA) technology, an experimental approach designed to turn the body\u2019s cells into viral protein-making\u00a0factories<\/a>. This technology involves the use of lipid nanoparticles (LNPs) that\u00a0encapsulate<\/a>\u00a0the mRNA to protect them from degradation and promote cellular uptake.<\/p>\n The LNP formulations in the three COVID-19 mRNA vaccines are \u201cPEGylated,\u201d meaning that the vaccine nanoparticles are coated with a synthetic, non-degradable and\u00a0increasingly controversial<\/a>\u00a0PEG.<\/p>\n COVID mRNA vaccines<\/a>\u00a0are not the only vehicle for PEG involvement in COVID-19 vaccine production. Researchers at Germany\u2019s Max Planck Institute report developing a process for COVID-19 vaccine production to purify virus particles at \u201chigh yield.\u201d The process involves\u00a0adding PEG<\/a>\u00a0to a virus-containing liquid\u00a0and passing the liquid through membranes.<\/p>\n On Sept. 25, Robert F. Kennedy, Jr., chairman and chief legal counsel for Children\u2019s Health Defense (CHD),\u00a0notified<\/a>\u00a0the Steven Hahn, director of the U.S. Food and Drug Administration (FDA), Dr. Peter Marks director of FDA\u2019s Center for Biologics Evaluation and Research and Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, of the serious and possibly life-threatening anaphylactic potential of PEG.<\/p>\n CHD received the following\u00a0response<\/a>\u00a0from the FDA, on Dec. 2, but has not yet received a response from Fauci.<\/p>\n In earlier communications with Moderna scientists regarding the controversial use of PEG in the company\u2019s COVID-19 vaccine due to the potential for life-threatening anaphylaxis and need for pre-screening for PEG antibodies prior to vaccine administration, they insisted that the existence of PEG antibodies was purely hypothetical and underserving of concern:<\/p>\n \u201cPre-screening populations based on hypothesized biomarkers, such as anti-PEG antibodies, is not a strategy currently employed in our clinical trials.\u201d<\/p>\n Given the recent evidence of PEG anaphylaxis in Pfizer mRNA vaccine recipients, I wonder if FDA and vaccine manufacturers will now reconsider their position.<\/p>\n An extensive\u00a0review of PEG<\/a>\u00a0therapeutics, published in 2013, documented adverse effects of PEGylation and questioned the wisdom behind the continued use of PEG in drug development. The authors concluded that \u201cthe accumulating evidence documenting the detrimental effects of PEG on drug delivery make it imperative that scientists in this field break their dependence on PEGylation.\u201d<\/p>\n The statement by Turner that \u201cpeople with a known allergy to just one medicine should not be at risk,\u201d is also not true.<\/p>\n A\u00a02018 study<\/a>, \u201cImmediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized\u201d reports there are more than 1,000 products, including prescription drugs, that contain PEG. (See chart below for detailed descriptions of PEG containing drugs.)<\/p>\n The decision to allow people with other medication allergies to receive vaccines that utilize PEG in the manufacturing or delivery of the vaccine is a very risky proposition \u2014 especially given that Pfizer\u00a0has said<\/a>\u00a0people with a history of severe adverse allergic reactions to vaccines or the candidate\u2019s ingredients were excluded from their late stage trials.<\/p>\n We have no idea what the incidence of allergy or anaphylactic reactions will be once Pfizer begins global distribution of the vaccine, without such exclusions.<\/p>\n A\u00a02016 study<\/a>\u00a0reported detectable and sometimes high levels of anti-PEG antibodies in approximately\u00a072% of contemporary human samples<\/a>\u00a0and about 56% of historical specimens from the 1970s through the 1990s.\u00a0The population\u2019s\u00a0increased exposure<\/a>\u00a0to PEG-containing products since the 1990\u2019s makes it natural to assume that anti-PEG antibodies will continue to be widespread.<\/p>\n As approval of PEGylated mRNA vaccines for COVID-19 occurs, the uptick in exposure to injected PEG products will be unprecedented and potentially disastrous.<\/p>\n While four out of five doctors regularly prescribe PEGylated drugs, only\u00a0one out of five<\/a>\u00a0are aware of the potential for anti-PEG antibody responses. And only a third even know that PEG is in the drugs that they are prescribing.<\/p>\n A Vanderbilt University researcher agrees that there is a widespread\u00a0lack of recognition<\/a>\u00a0that PEG hypersensitivity is possible, much less that it manifests on a regular basis. While it has been recommended to screen patients for anti-PEG antibody levels \u201cprior to administration of therapeutics containing PEG<\/a>\u201d such testing is currently only available in research settings.<\/p>\n In a declaration effective Feb. 4, the Secretary of Health and Human Services invoked the\u00a0Public Readiness and Emergency Preparedness Act<\/a>\u00a0(PREP Act<\/a>) and declared Coronavirus Disease 2019 (COVID-19) to be a public health emergency warranting liability protections for covered countermeasures, including vaccines.<\/p>\n The fact that the FDA has abdicated its responsibility for assuring the safety of COVID vaccines to vaccine\u00a0 manufacturers means we are on our own to study the science, and weigh the benefits and risks of all drugs and vaccines.<\/p>\n CHD will continue to monitor this important safety issue in an effort to keep you well informed on the science and public policies surrounding COVID-19 vaccine development.<\/p>\n Descriptions of PEG containing drugs:<\/strong><\/p>\n![\"\"](\"https:\/\/childrenshealthdefense.org\/wp-content\/uploads\/rfkjr_hahn_marks_sept_25.jpg\")
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