Safe Administration of SARS-CoV-2 Vaccine After Desensitization to a Biologic Containing Polysorbate 80 in a Patient With Polyethylene Glycol–Induced Severe Anaphylaxis and Sensitization to Polysorbate 80

Nin-Valencia, A; Fiandor, A; Lluch, M; Quirce, S; Caballero, T; Revuelto, R Heredia; González-Muñoz, M; Caballero, ML; Cabañas, R

doi:10.18176/jiaci.0830

Cited by 5 publications

(5 citation statements)

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“…Immunization by cosmetic products via the skin of mice was shown recently by Ibrahim et al [52] . It is also important to mention that Abs against PEG and polysorbate-80 (PS-80), which is a branched PEG derivative, can mutually cross-react [38] , [53] , [54] , and PS-80 is also widespread as an ingredient in drugs, vaccines, vitamins, food products, and beverages [51] , [55] . Thus, the anti-PEG ELISA does not necessarily distinguish between anti-PEG and anti-polysorbate Abs.…”

Section: Discussionmentioning

confidence: 99%

Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions to PEG-containing Covid-19 vaccines: Evidence for immunogenicity of PEG

Kozma

Mészáros

Berenyi

et al. 2023

Vaccine

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Section: Discussionmentioning

confidence: 99%

Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions to PEG-containing Covid-19 vaccines: Evidence for immunogenicity of PEG

Kozma

Mészáros

Berenyi

et al. 2023

Vaccine

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“…The low, near baseline Ab levels in most samples is most easily rationalized by low level immunization via the skin or per os by daily exposure to PEG, an excipient in many oral, topical, and parenteral pharmaceutical products, hygiene and cosmetic items, and processed food and beverages. 35 It is also important to mention that Abs against PEG and polysorbate 80 (PS-80), which is a branched PEG derivative, can mutually cross-react, [36][37][38] and PS-80 is also widespread as an ingredient in drugs, vaccines, vitamins, food and drinks. 35,39 Thus, the anti-PEG ELISA does not necessarily distinguishes between these Abs.…”

Section: Resultsmentioning

confidence: 99%

Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions and immunogenicity of PEG-containing Covid-19 vaccines

Kozma

Mészáros

Berenyi

et al. 2022

Preprint

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The polyethylene-glycol (PEG)-containing Covid-19 vaccines can cause hypersensitivity reactions (HSRs), or rarely, life-threatening anaphylaxis. A causal role of anti-PEG antibodies (Abs) has been proposed, but not yet proven in humans. The 191 blood donors in this study included 10 women and 5 men who displayed HSRs to Comirnaty or Spikevax Covid-19 vaccines with 3 anaphylaxis. 118 donors had pre-vaccination anti-PEG IgG/IgM values as measured by ELISA, of which >98% were over background regardless of age, indicating the presence of these Abs in almost everyone. Their values varied over 2-3 orders of magnitude and displayed strong left-skewed distribution with 3-4% of subjects having >15-30-fold higher values than the respective median. First, or booster injections with both vaccines led to significant rises of anti-PEG IgG/IgM with >10-fold rises in about ~10% of Comirnaty, and all Spikevax recipients, measured at different times after the injections. The anti-PEG Ab levels measured within 4-months after the HSRs were significantly higher than those in nonreactors. Serial testing of plasma (n=361 tests) showed the SARS-CoV-2 neutralization IgG to vary over a broad range, with a trend for biphasic dose dependence on anti-PEG Abs. The highest prevalence of anti-PEG Ab positivity in human blood reported to date represents new information which can most easily be rationalized by daily exposure to common PEG-containing medications and/or household items. The significantly higher, HSR-non-coincidental blood level of anti-PEG Abs in hypersensitivity reactor vs. non-reactors, taken together with relevant clinical and experimental data in the literature, suggest that anti-PEG Ab supercarrier people might be at increased risk for HSRs to PEG-containing vaccines, which themselves can induce these Abs via bystander immunogenicity. Our data also raise the possibility that anti-PEG Abs might also contribute to the reduction of these vaccines' virus neutralization efficacy. Thus, screening for anti-PEG Ab supercarriers may identify people at risk for HSRs or reduced vaccine effectiveness.

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“…A possible alternative option to vaccine desensitization could be to desensitize patients directly with excipients suspected of being the relevant allergen in hypersensitivity reactions to SARS-CoV-2 vaccines (in particular, PEG and Polysorbate 80). To date, the scientific literature reports that this option has only been explored in only two single cases: a patient with certified PEG allergy underwent a PEG desensitization protocol followed by an already scheduled colonoscopy (PEG is used in preparation for the colonoscopy) and anti-SARS-CoV-2 vaccination with BNT162b2 [ 28 ]; in another case, a patient with anaphylaxis after preparation for PEG colonoscopy, found to be sensitized to both PEG and polysorbate 80 and scheduled to start anti-Tumor Necrosis Factor (TNF) alpha drug therapy for Crohn's disease, was successfully desensitized with infliximab (an anti-TNF alpha drug with polysorbate 80 as excipient) and subsequently vaccinated against SARS-CoV-2, without hypersensitivity reactions, with Ad26.COV2.S vaccine containing polysorbate 80 as excipient [ 29 ]. We did not consider it appropriate to desensitize with PEG or Polysorbate 80, as the role of these excipients in determining hypersensitivity reactions to anti-SARS-CoV-2 vaccines is still not fully understood [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

Desensitization Protocols for Anti-SARS-CoV-2 Vaccines in Patients with High Risk of Allergic Reactions

et al. 2023

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Vaccines for SAR-CoV-2 are the most effective preventive treatment able to reduce the risk of contracting the infection and experiencing worse outcomes whenever the infection is contracted. Despite their rarity, hypersensitivity reactions to the anti-SARS-CoV-2 vaccine have been described and could become the reason not to complete the vaccination. Desensitization protocols for other vaccines have been described and validated, while the use of this approach for anti-SARS-CoV-2 vaccines is still anecdotal. We herein describe our experience with 30 patients with previous allergic reactions to anti-SARS-CoV-2 vaccines or to any of their excipients, proving that they are effective and safe; only two patients experienced hypersensitivity reaction symptoms during the desensitization procedure. Moreover, in this article, we propose desensitization protocols for the most common anti-SARS-CoV-2 vaccines.

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Safe Administration of SARS-CoV-2 Vaccine After Desensitization to a Biologic Containing Polysorbate 80 in a Patient With Polyethylene Glycol–Induced Severe Anaphylaxis and Sensitization to Polysorbate 80

Cited by 5 publications

References 0 publications

Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions to PEG-containing Covid-19 vaccines: Evidence for immunogenicity of PEG

Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions to PEG-containing Covid-19 vaccines: Evidence for immunogenicity of PEG

Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions and immunogenicity of PEG-containing Covid-19 vaccines

Desensitization Protocols for Anti-SARS-CoV-2 Vaccines in Patients with High Risk of Allergic Reactions

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