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RFK, Jr. and CHD Take Action on Safety Concerns over Moderna’s COVID Vaccine
by the Children’s Health Defense Team [2]
On August 26, Children’s Health Defense (CHD) wrote a letter to Dr. Jerry Menikoff [3], Director of the Department of Health and Human Services’ Office of Human Research Protection (OHRP), asking for an investigation into serious safety concerns with the COVID-19 vaccine being developed by Moderna.
Moderna’s version of the vaccine, championed by Dr. Anthony Fauci and funded with $500 million in taxpayer dollars [4] through Dr. Fauci’s National Institute of Allergy and Infectious Diseases, contains polyethylene glycol (PEG), a molecule to which approximately 72% of the American population have antibodies and 8% have highly elevated levels of antibodies [5].
People who have pre-existing PEG antibodies could experience life-threatening anaphylaxis [6] if injected with PEG-containing substances such as the Moderna COVID vaccine. Additionally, antibodies to PEG can both decrease the effectiveness of the vaccine and increase the risk of side effects [7].
CHD board chair Robert F. Kennedy, Jr. also wrote a personal letter to Dr. Fauci [8] emphasizing that these serious safety concerns must be addressed, urging that trial participants be advised of the unique risks associated with PEG. Now in Phase III clinical trials [9], the Moderna vaccine may not be in compliance with guidelines for the Protection of Human Subjects, specifically:
- 45 CFR 46.116(b) (2) that requires [10] a description of any reasonably foreseeable risks or discomforts to the subject.
- 45 CFR 46-111(a) (1) that requires [11] that risks to clinical trial participants be minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk.
Moderna has acknowledged [7] the potential for PEG to produce “systemic side effects.” Despite FDA recommendations that clinical trial participants be pre-screened for pre-existing PEG antibodies, Moderna is not conducting such screening in the COVID vaccine clinical trials, setting the stage for potentially drastic and life-threatening responses among participants.
CHD Note: At the time of publication, we have not received a response from either the OHRP or Dr. Fauci. We will update our readers with any developments as they occur.
Read the full article at ChildrensHealthDefense.org [2].
Comment on this article at VaccineImpact.com [12].
© 2020 Children’s Health Defense, Inc.
This work is reproduced and distributed with the permission of Children’s Health Defense, Inc.
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