Updated Guidance Regarding The Risk ofAllergic Reactions to COVID-19 Vaccines and Recommended Evaluation and Management: A GRADE Assessment, and International Consensus Approach

Matthew Greenhawt, Timothy E. Dribin, Elissa M. Abrams, Marcus Shaker, Derek K. Chu, David Bk. Golden, Cem Akin, Akterini Anagnostou, Faisal Almuhizi, Waleed Alqurashi, Peter Arkwright, James L. Baldwin, Aleena Banerji, Philippe Bégin, Moshe Ben-Shoshan, Jonathan Bernstein, Theresa A. Bingeman, Carsten Bindslev-Jensen, Kim Blumenthal, Aideen ByrneJulia Cahil, Scott Cameron, Dianne Campbell, Ronna Campbell, Michael Cavender, Edmond S. Chan, Sharon Chinthrajah, Pasquale Comberiatti, Jacqueline J. Eastman, Anne K. Ellis, David M. Fleischer, Adam Fox, Pamela A. Frischmeyer-Guerrerio, Remi Gagnon, Lene H. Garvey, Mitchell H. Grayson, Ghislaine Annie Clarisse isabwe, Nicholas Hartog, David Hendron, Caroline C. Horner, Johnathan O'b hourihane, Edward Iglesia, Manstein Kan, Blanca Kaplan, Constance H. Katelaris, Harold Kim, John M. Kelso, David A. Kahn, David Lang, Dennis Ledford, Michael Levin, Jay A. Lieberman, Richard Loh, Douglas P. Mack, Bruce Mazer, Ketan Mody, Gissele Mosnaim, Daniel Munblit, S. Shahzad Mustafa, Anil Nanda, Richard Nathan, John Oppenheimer, Iris M. Otani, Miguel Park, Ruby Pawankar, Kirsten P. Perrett, Jonny Peter, Elizabeth J. Phillips, Matthieu Picard, Mitchell Pitlick, Allison Ramsey, Trine Holm Rasmussen, Melinda M. Rathkopf, Hari Reddy, Kara Robertson, Pablo Rodriguez del rio, Steven Sample, Ajay Sheshradi, Javed Shiek, Sayantani B. Sindher, Jonathan M. Spergel, Cosby A. Stone, David Stukus, Mimi Lk. Tang, James M. Tracy, Paul J. Turner, Timothy K. Vander leek, Dana V. Wallace, Julie Wang, Susan Wasserman, David Weldon, Anna R. Wolfson, Margitta Worm, Mona-rita Yacoub

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Abstract

This guidance updates 2021 GRADE recomendations regarding immediate allergic reactions following COVID-19 vaccines and addresses re-vaccinating individuals with 1 st dose allergic reactions and allergy testing to determine re-vaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 re-vaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommenations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the UK, and the US formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy, and re-vaccination after a prior immediate allergic reaction. We suggest against >15-minute post-vaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest re-vaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise, in a properly equipped setting. We suggest against pre-medication, split-dosing, or special precautions because of a comorbid allergic history.

Original languageEnglish
JournalJournal of Allergy and Clinical Immunology
Early online date7 Jun 2023
DOIs
Publication statusE-pub ahead of print - 7 Jun 2023

Keywords

  • SARS-CoV-2
  • COVID-19
  • vaccination
  • adenovirus vector vaccine
  • mRNA COVID-19 vaccine
  • anaphylaxis
  • allergic reactions
  • repeat allergic reactions
  • polyethylene glycol
  • polysorbate 80
  • skin testing
  • shared decision-making
  • GRADE
  • allergy
  • allergy specialist

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