The Polysorbate containing AstraZeneca COVID‐19 vaccine is tolerated by polyethylene glycol (PEG) allergic patients

Abstract

Suspected anaphylaxis to the COVID-19 vaccines in the UK is reported at a rate of about 11-17 per million doses for the Pfizer/ BioNTech and AstraZeneca vaccines respectively [MHRA yellow card data, 23 June 2021]. This will underestimate the true size of the problem as cases are not reported and 43% of these data relate to second doses. However, after investigation, true allergy is rarely found and many are not IgE mediated 1 and are often labelled immunogenic reactions. Recent studies have shown successful revaccination in patients who had suspected allergic reactions to their first dose. 2,3 Polysorbate 80 (PS80) is the potentially allergenic excipient in the AstraZeneca and Janssen/Johnson and Johnson COVID-19 vaccines. PS80 is used as an excipient in many drugs (including some vaccines, e.g., some influenza vaccines) and as a food additive and is thus widely tolerated. 4 There have been cases of clinical reactivity

Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management

“…An excipient structurally similar to PEG due to shared moieties (=CH 2 CH 2 and =CH 2 CH 2 OH) is PS80, also known as Tween 80 or E 433, and it is present in more recently marketed viral vector and recombinant protein COVID-19 vaccines. Clinical cross-reactivity between PEG and PS80 has rarely been documented [48,60,61], but has not occurred in COVID-19 vaccine setting experience, even in case of in vitro skin test cross-reactivity [62]. Of note, in vivo and in vitro evidence of PS80 allergy is limited and isolated sensitization through PS80 seems uncommon, even rarer than through PEG [63].…”

Milk allergy over‐diagnosis

“…In one recent series, 3 of 10 patients with PEG allergy had a positive skin prick test to polysorbate-80. 8 Reassuringly, Sellaturay et al 9 undertook a genome-wide association study and meta-analysis of other similar studies to identify whether there were specific single nucleotide polymorphisms associated with the combined phenotype of asthma/eczema, different to those linked with asthma or eczema alone. They identified two polymorphisms in a novel locus, OCA2, which has not previously been linked with asthma or eczema.…”

“…In one recent series, 3 of 10 patients with PEG allergy had a positive skin prick test to polysorbate‐80 8 . Reassuringly, Sellaturay et al 9 report that in their relatively large cohort of eight patients with previous PEG anaphylaxis and positive PEG skin tets, all patients tolerated the Astra‐Zeneca COVID‐19 vaccine without reaction. This means that for people who have PEG allergy and therefore cannot receive the Pfizer or Moderna COVID‐19 vaccines, there is still a safe route to COVID‐19 vaccination.…”

“…PEG allergy is rare, with perhaps the largest series reporting ten patients described in this journal a year ago 8 . In this issue, Sellaturay et al 9 address the question of whether patients with PEG allergy, for whom the Pfizer vaccine is contraindicated, can safely receive the Astra‐Zeneca vaccine. The theoretical basis for addressing this potential cross‐reactivity is that the Astra‐Zeneca COVID‐19 vaccine contains the excipient polysorbate‐80, chemically related to PEG.…”

Successful Desensitization to mRNA COVID-19 Vaccine in a Case Series of Patients With a History of Anaphylaxis to the First Vaccine Dose

“…Other strategies aiming to improve vaccination safety have been reported in the literature. The notion that PEG allergic patients can safely receive a non-PEG COVID-19 vaccine such as AstraZeneca has been described in the literature ( 25 ), even for patient with positive skin testing for polysorbate 80 ( 26 ). Further, a single dose omalizumab was been used as a pre-treatment option for two patients having presented an anaphylactoid reaction following their first mRNA COVID-19 vaccine dose ( 27 ).…”