Updated guidance regarding the risk of allergic 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 B.K. 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. Bingemann, Carsten Bindslev-Jensen, Kim Blumenthal, Aideen ByrneJulia Cahill, Scott Cameron, Dianne Campbell, Ronna Campbell, Michael Cavender, Edmond S. Chan, Sharon Chinthrajah, Pasquale Comberiati, 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, Blanka Kaplan, Constance H. Katelaris, Harold Kim, John M. Kelso, David A. Khan, David Lang, Dennis Ledford, Michael Levin, Jay A. Lieberman, Richard Loh, Douglas P. Mack, Bruce Mazer, Ketan Mody, Gisele 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, Stephen Sample, Ajay Sheshadri, Javed Sheik, Sayantani B. Sindher, Jonathan M. Spergel, Cosby A. Stone, David Stukus, Mimi L.K. 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

Research output: Contribution to journalReview articlepeer-review

7 Scopus citations


This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination 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 recommendations. 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 United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against >15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination 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 premedication, split-dosing, or special precautions because of a comorbid allergic history.

Original languageEnglish
Pages (from-to)309-325
Number of pages17
JournalJournal of Allergy and Clinical Immunology
Issue number2
StatePublished - Aug 2023


  • COVID-19
  • SARS-CoV-2
  • allergic reactions
  • anaphylaxis
  • mRNA COVID-19 vaccine
  • polyethylene glycol
  • polysorbate 80
  • repeat allergic reactions
  • skin testing
  • vaccination


Dive into the research topics of 'Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach'. Together they form a unique fingerprint.

Cite this