As the excerpts from the Moderna prospectus illustrate, Moderna scientists are fully aware of PEG-related safety concerns. In the prospectus, Moderna admits that “unacceptable health risks or adverse side effects” could make it difficult to recruit or retain clinical trial participants and also that an “unfavorable benefit risk ratio could inhibit market acceptance” if their product proceeds to market.

Addressing the efficacy side of the equation, a mid-2019 study by authors who “are or have been employees of Moderna, Inc. and receive salary and stock options from Moderna, Inc.” further admitted that anti-PEG antibodies “present significant challenges to the clinical efficacy of PEGylated therapeutics and will require strategies to overcome [their] effects.”

In light of the recent acknowledgement of anaphylactic reactions to Pfizers’ PEG-containing COVID-19 vaccine, CHD continues to have grave safety and efficacy concerns about the use of PEG in vaccines due to the high percentage of the population having preexisting antibodies to PEG. While it’s unlikely that everyone with pre-existing PEG antibodies will have a severe reaction to a vaccine containing PEG, it is dangerous to assume that none will.

While vaccine manufacturers and federal agencies providing oversight on COVID vaccine development are quick to point out that the clinical trials did not identify safety concerns with the vaccine, they fail to mention the fact that the trial participants were excluded from the study if they had a history of severe allergic reactions and those in the trial were never screened for PEG antibodies.

Multiple previous studies regarding the prevalence of anti-PEG antibodies in the population have stated that pre-screening should be done prior to any administration of a PEG-containing medication. Screening  is likely to be even more important in the case of a vaccine intended for parenteral administration to as many people as possible that contains a substance to which the majority of the population unknowingly has antibodies.

Not characterizing trial participants’ adverse reactions in relation to anti-PEG antibody presence and levels eliminates insights into these interactions is a missed opportunity to prevent harmful adverse events.

Now we are left in a situation where life-threatening adverse events are occurring after widespread use of the vaccine has begun. A finger needs to be pointed squarely at the vaccine manufacturers and regulatory agencies who buried their heads in the sand to legitimate safety concerns in their rush to approve a COVID vaccine. Unfortunately, the public is now left to bear the burden of exposing these lapses in safety.