August 03, 2020

Expressing Concerns to Moderna’s Principal Investigators

Letter by Harold R Gielow, LtCol USMC (Ret)

Recently, Harold R Gielow, LtCol USMC (Ret) sent an email to the principal investigators in Moderna’s mRNA 1273 phase 3 trial outlining his concerns. He has yet to receive a reply.

“The article “Analysis of Pre-existing IgG and IgM Antibodies against Polyethylene Glycol (PEG) in the General Population” notes that approximately 72% of the US population has preexisting anti-PEG antibodies. The reference further states, “…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.”

As Moderna’s mRNA1273 candidate vaccine uses a pegylated LNP (lipid nanoparticle) vector , what procedures are included in the trial to mitigate this risk?”

Our country is spending billions to fast track and produce a vaccine that over 70% of the population has preexisting antibodies to – to the vaccine! This makes no sense. Additionally, the trial procedures I have read include no steps to mitigate this risk, either to the trial participants or the general public.

BioNTech/Pfizer’s vaccine variants also use a pegylated lipid nanoparticle vector.

… many with PEG hypersensitivity go undiagnosed, thus presenting an unreasonable hazard to administering these vaccines to a population, the vast majority of which is proven by science to have anti-PEG antibodies.

I have a severe anaphylactic response to polyethylene glycol. It was diagnosed by Johns Hopkins. I have had multiple ambulance rides and emergency room visits due to inadvertent ingestion/injection with medications containing polyethylene glycol. It is classified by FDA as biologically inert/inactive. It is anything but that. The incidences of hypersensitivity reactions to PEG are, understandably, increasing, although many with PEG hypersensitivity go undiagnosed, thus presenting an unreasonable hazard to administering these vaccines to a population, the vast majority of which is proven by science to have anti-PEG antibodies. The cited study used blood samples from 1990-1999. The study showed a steady and dramatic increase in anti-PEG antibodies over time.

PEG is ubiquitous in our environment. It is nearly impossible to avoid, more so as our government classifies it as biologically inactive.

I have communicated my concern to my congressman, my senator, FDA, NIH, the White House, a cousin in biomedical research, multiple scientific writers, and countless others. Perhaps with your background and profile, you can get attention on this issue. I frankly believe not mitigating this risk in a worldwide pandemic situation is gross negligence, Moderna’s scientists having contributed to scientific studies pointing out these issues with polyethylene glycol.”