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Allergenic components of the mRNA-1273 vaccine for COVID-19: possible involvement of polyethylene glycol and IgG-mediated complement activation
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  • Ludger Klimek,
  • Natalija Novak,
  • Beatriz Cabanillas,
  • Marek Jutel,
  • Jean Bousquet,
  • Cezmi Akdis
Ludger Klimek
Zentrum für Rhinologie und Allergologie
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Natalija Novak
University of Bonn
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Beatriz Cabanillas
University of Bonn
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Marek Jutel
Wrocław Medical University
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Jean Bousquet
Université Versailles, St-Quentin-en-Yvelines
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Cezmi Akdis
University of Zurich
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Abstract

Following the emergency use authorization of the vaccine mRNA-1273 on 18th December 2020 in the US and the vaccine BNT162b2 one week earlier, two mRNA vaccines are in currently used for the prevention of coronavirus disease 2019 (COVID-19). Phase 3 pivotal trials on both vaccines excluded individuals with a history of allergy to vaccine components. Immediately after the initiation of vaccination in the United Kingdom, Canada, and in the US, anaphylactic reactions have been reported. While the culprit trigger requires investigation, initial reports suggested the excipient polyethylene glycol 2000 (PEG-2000), which is contained in both vaccines as PEG-micellar carrier system as the potential culprit. Surface PEG chains form a hydrate shell to increase stability and prevent opsonization. Allergic reactions to such PEG-ylated lipids are rarely IgE-mediated, but may result from complement activation-related pseudoallergy (CARPA) that has been described to similar liposomes. In addition, mRNA-1273 also contains tromethamine (trometamol), which has been reported to cause anaphylaxis to e.g. gadolinium-based or iodinated contrast media. Skin prick-, intradermal-, epicutaneous- tests, in vitro sIgE assessment, evaluation of sIgG/IgM, as well as basophil activation test are in use to demonstrate allergic reactions to various components of the vaccines.

Peer review status:ACCEPTED

30 Dec 2020Submitted to Allergy
30 Dec 2020Submission Checks Completed
30 Dec 2020Assigned to Editor
01 Jan 2021Reviewer(s) Assigned
13 Jan 2021Review(s) Completed, Editorial Evaluation Pending
14 Jan 2021Editorial Decision: Revise Minor
08 Feb 20211st Revision Received
08 Feb 2021Submission Checks Completed
08 Feb 2021Assigned to Editor
09 Feb 2021Reviewer(s) Assigned
19 Feb 2021Review(s) Completed, Editorial Evaluation Pending
20 Feb 2021Editorial Decision: Accept