5. Will FDA and NIAID now require mRNA vaccine manufacturers to conduct assessments of the immunogenicity of the pegylated lipid nanoparticles used in their COVID-19 vaccines, and will they also consider pre-screening of all mRNA vaccine recipients for the presence and titers of anti-PEG antibodies? 

The fact that our federal agencies, responsible for assuring the public that the products they receive are safe and effective, have dropped the ball in their rush to develop COVID-19 vaccines is truly tragic. An important opportunity was missed.

According to Zhang, “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. Re-exposure to PEG-containing drugs may greatly increase the chance for adverse effects due to B cell memory of anti-PEG abs.”

Due to the use of PEG in thousands of consumer products, including e-cigarettes and medications, it’s reasonable to assume that a growing number of people will develop anti-PEG antibodies.

If high-titer anti-PEG abs are present in the blood, even people without known allergies may have severe hypersensitive reactions when receiving PEG containing therapeutics for the first time, studies show.

We urge federal agencies that such screening be recommended prior to administration of any vaccines that use PEG in their manufacturing process. Ideally, since anyone could unknowingly have anti-PEG antibodies, everyone should be screened before getting the Pfizer of Moderna vaccines. But at the very least, we recommend that anyone who has had an undiagnosed allergic reaction consult with their physicians and request testing for anti-PEG antibodies before taking any COVID vaccine.