Anaphylaxis to Pfizer/BioNTech mRNA COVID-19 Vaccine in a Patient With Clinically Confirmed PEG Allergy

Abstract

Although allergic responses to the mRNA COVID-19 vaccines are rare, recent reports have suggested that a small number of individuals with allergy to polyethylene glycol (PEG), a component of the mRNA lipid nanoshell, may be at increased risk of anaphylaxis following vaccination. In this report, we describe a case of a patient who received an mRNA COVID-19 vaccine, experienced anaphylaxis, and was subsequently confirmed to have anti-PEG allergy by skin prick testing. The patient had previously noticed urticaria after handling PEG powder for their occupation and had a history of severe allergic response to multiple other allergens. Importantly, as many as 70% of people possess detectable levels of anti-PEG antibodies, indicating that the detection of such antibodies does not imply high risk for an anaphylactic response to vaccination. However, in people with pre-existing anti-PEG antibodies, the administration of PEGylated liposomes may induce higher levels of antibodies, which may cause accelerated clearance of other PEGylated therapeutics a patient may be receiving. It is important to improve awareness of PEG allergy among patients and clinicians.

A systemic review and recommendation for an autopsy approach to death followed the COVID 19 vaccination

“…Anaphylaxis is more frequently reported with the mRNA vaccine ( Table 1 ). In three of the mRNA vaccination studies, hypersensitive and/or allergy source of Pfizer vaccine is linked to the presence of PEG [12] , [13] , [14] . Perivascular lymphocytic infiltration with or without mentioning eosinophils were found in biopsy of allergy skin reaction [15] , [16] , [17] , [18] .…”

mRNA vaccines in the prevention and treatment of diseases

“…These are suspected to be the consequence of the production of pro‐inflammatory cytokines such as IL‐1β and IL‐6 141–143 . Second, an increasing number of studies has verified the immunogenicity of PEG; therefore, repeated administration of PEG can induce allergic reactions 143,144 . In addition, the hypersensitivity reactions observed after mRNA‐1273 and BNT162b2 administration are likely to be attributed to the formation of anti‐PEG antibodies after the first vaccination 145,146 .…”

“…[141][142][143] Second, an increasing number of studies has verified the immunogenicity of PEG; therefore, repeated administration of PEG can induce allergic reactions. 143,144 In addition, the hypersensitivity reactions observed after mRNA-1273 and BNT162b2 administration are likely to be attributed to the formation of anti-PEG antibodies after the first vaccination. 145,146 Fortunately, it has been reported that alternative lipids can be involved to prevent aggregate formation.…”

Nanostructures for the Prevention, Diagnosis, and Treatment of SARS-CoV-2: A Review

“…Also allergic symptoms have been reported in a small proportion of people vaccinated against PEGylated substances used in the architecture of NLPs. 156 Although approaches such as the use of precisely designed adenoviruses as nanocarriers as in the Oxford/Astra Zeneca vaccine or the self-assembled protein segments within nanoparticles as in the Novavax vaccine allow thermostable systems that can be used at room temperature, these approaches have not yet been as successful as mRNA vaccines. For these reasons, it is essential to pursue studies on nanotechnology-enabled vaccines and to design nanocarriers, adjuvants, and active agents with advanced multifunctional properties including stimuli-responsivity, high biocompatibility, thermostability, and controllable biodegradation.…”