• Matthew Greenhawt, Elissa M Abrams, Marcus Shaker, Derek K Chu, David Khan, Cem Akin, Waleed Alqurashi, Peter Arkwright, James L Baldwin, Moshe Ben-Shoshan, Jonathan Bernstein, Theresa Bingemann, Katharina Blumchen, Aideen Byrne, Antonio Bognanni, Dianne Campbell, Ronna Campbell, Zain Chagla, Edmond S Chan, Jeffrey Chan, Pasquale Comberiati, Timothy E Dribin, Anne K Ellis, David M Fleischer, Adam Fox, Pamela A Frischmeyer-Guerrerio, Remi Gagnon, Mitchell H Grayson, Caroline C Horner, Jonathan Hourihane, Constance H Katelaris, Harold Kim, John M Kelso, David Lang, Dennis Ledford, Michael Levin, Jay Lieberman, Richard Loh, Doug Mack, Bruce Mazer, Giselle Mosnaim, Daniel Munblit, S Shahzad Mustafa, Anil Nanda, John Oppenheimer, Kirsten P Perrett, Allison Ramsey, Matthew Rank, Kara Robertson, Javed Shiek, Jonathan M Spergel, David Stukus, TangMimi L KMLKMurdoch Children's Research Institute, University of Melbourne, Royal Children's Hospital, Department of Allergy and Immunology, Royal Children's Hospital, Parkville, Victoria, Australia., James M Tracy, Paul J Turner, Anna Whalen-Browne, Dana Wallace, Julie Wang, Susan Waserman, John K Witry, Margitta Worm, Timothy K Vander Leek, and GoldenDavid B KDBKDivision of Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, Md..
• Section of Allergy and Clinical Immunology, Food Challenge and Research Unit, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo. Electronic address: Matthew.Greenhawt@childrenscolorado.org.
• J Allergy Clin Immunol Pract. 2021 Jun 18.

AbstractConcerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of international experts in anaphylaxis composed of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the World Health Organizstion (WHO) global coronavirus database, and the gray literature (inception, March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases per million (n = 41,000,000 vaccinations; 95% confidence interval [95% CI] 4.02-15.59; 26 studies, moderate certainty), the incidence of 0.15 cases per million patient-years (95% CI 0.11-0.2), and the sensitivity for PEG skin testing is poor, although specificity is high (15 studies, very low certainty). We recommend vaccination over either no vaccination or performing SARS-CoV-2 vaccine/excipient screening allergy testing for individuals without history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient, and a shared decision-making paradigm in consultation with an allergy specialist for individuals with a history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient. We recommend further research to clarify SARS-CoV-2 vaccine/vaccine excipient testing utility in individuals potentially allergic to SARS-CoV2 vaccines or their excipients.Copyright © 2021 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

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