Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach - 03/08/23

Doi : 10.1016/j.jaci.2023.05.019

Matthew Greenhawt, MD, MBA, MSC ^a,^⁎ , Timothy E. Dribin, MD ^b,^c, Elissa M. Abrams, MD, MPH ^d, Marcus Shaker, MD, MSc ^e,^f, Derek K. Chu, MD, PhD ^g,^h,^i,^j, David B.K. Golden, MDCM ^k, Cem Akin, MD ^l, Akterini Anagnostou, MD, PhD ^m,ⁿ, Faisal ALMuhizi, MD ^o, Waleed Alqurashi, MD ^p, Peter Arkwright, MD, PhD ^q, James L. Baldwin, MD ^l, Aleena Banerji, MD ^r, Philippe Bégin, MD ^s, Moshe Ben-Shoshan, MD, MSc ^t, Jonathan Bernstein, MD ^u, Theresa A. Bingemann, MD ^v, Carsten Bindslev-Jensen, MD, PhD, DMSci ^w, Kim Blumenthal, MD, MPH ^r, Aideen Byrne, FRCPCH, PhD ^x, Julia Cahill, BScPhm, ACPR, MPH ^y, Scott Cameron, MD ^z, Dianne Campbell, MD, PhD ^aa, Ronna Campbell, MD, PhD ^bb, Michael Cavender, DO ^cc, Edmond S. Chan, MD ^dd, Sharon Chinthrajah, MD ^ee,^ff,^gg, Pasquale Comberiati, MD ^hh, Jacqueline J. Eastman, MD ^ii,^jj, Anne K. Ellis, MD, MSc, FRCPC ^kk, David M. Fleischer, MD ^a, Adam Fox, MD, FRCPCH ^ll, Pamela A. Frischmeyer-Guerrerio, MD, PhD ^mm, Remi Gagnon, MD, MSc ⁿⁿ, Lene H. Garvey, MD, PhD ^oo,^pp, Mitchell H. Grayson, MD ^qq, Ghislaine Annie Clarisse Isabwe, MD ^t, Nicholas Hartog, MD ^ii,^jj, David Hendron, DO ^rr, Caroline C. Horner, MD, MSCI ^ss, Johnathan O'B Hourihane, MD ^tt, Edward Iglesia, MD, MPH ^uu, Manstein Kan, MD, FRCPC ^vv, Blanka Kaplan, MD ^ww, Constance H. Katelaris, AO, MBBS, PhD, FRACP ^xx, Harold Kim, MD ^g,^yy, John M. Kelso, MD ^zz, David A. Khan, MD ^aaa, David Lang, MD ^bbb, Dennis Ledford, MD ^ccc, Michael Levin, MD, PhD ^ddd, Jay A. Lieberman, MD ^eee, Richard Loh, MD ^fff, Douglas P. Mack, MD, MSc ^ggg,^hhh, Bruce Mazer, MD ^t, Ketan Mody, MD ⁱⁱⁱ, Gisele Mosnaim, MD, MS ^jjj, Daniel Munblit, MD, PhD ^kkk, S. Shahzad Mustafa, MD ^lll, Anil Nanda, MD ^aaa,^mmm, Richard Nathan, DO ⁿⁿⁿ, John Oppenheimer, MD ^ooo, Iris M. Otani, MD ^ppp, Miguel Park, MD ^qqq, Ruby Pawankar, MD ^rrr, Kirsten P. Perrett, MBBS, FRACP, PhD ^jjj,^sss,^ttt, Jonny Peter, MD, PhD ^uuu, Elizabeth J. Phillips, MD ^uu,^vvv, Matthieu Picard, MD, FRCPC ^www, Mitchell Pitlick, MD ^qqq, Allison Ramsey, MD ^lll, Trine Holm Rasmussen, MD ^w, Melinda M. Rathkopf, MD ^xxx, Hari Reddy, MD ^yyy,^zzz, Kara Robertson, MD, FRCPC ^aaaa,^bbbb, Pablo Rodriguez del Rio, MD, PhD ^cccc, Stephen Sample, MD ^dddd, Ajay Sheshadri, MD, MSCI ^eeee, Javed Sheik, MD ^ffff, Sayantani B. Sindher, MD ^ee,^ff,^gg, Jonathan M. Spergel, MD, PhD ^gggg,^hhhh, Cosby A. Stone, MD ^uu, David Stukus, MD ^qq, Mimi L.K. Tang, MBBS, PhD ^iiii,^jjjj,^ttt, James M. Tracy, DO ^kkkk,^llll, Paul J. Turner, BM, BCh, FRACP, PhD ^mmmm,ⁿⁿⁿⁿ, Timothy K. Vander Leek, MD ^oooo, Dana V. Wallace, MD ^pppp, Julie Wang, MD ^qqqq,^rrrr, Susan Wasserman, MSc, MD ^ssss, David Weldon, MD ^tttt, Anna R. Wolfson, MD ^r, Margitta Worm, MD ^uuuu, Mona-Rita Yacoub, MD ^vvvv
^a Section of Allergy and Clinical Immunology, Children’s Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo
^b Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
^c Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio
^u Division of Immunology, Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio
^d Department of Pediatrics and Child Health, Section of Allergy and Immunology, The University of Manitoba, Winnipeg, Canada
^e Dartmouth-Hitchcock Medical Center, Section of Allergy and Immunology, Lebanon, NH
^f Dartmouth Geisel School of Medicine, Hanover, NH
^g Faculty of Medicine, and the Department of McMaster University, Hamilton, Canada
^h Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada
^ggg Department of Pediatrics, McMaster University, Hamilton, Canada
^ssss Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University, Hamilton, Canada
ⁱ The Research Institute of St. Joe’s Hamilton, Hamilton, Canada
^j Evidence in Allergy Group, McMaster University Medical Centre, Hamilton, Canada
^k Division of Allergy and Clinical Immunology, Johns Hopkins University School of Medicine, Baltimore, Bethesda
^l Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan School, Ann Arbor, Mich
^m Section of Immunology, Allergy, and Retrovirology, Department of Pediatrics, Baylor College of Medicine, Houston, Tex
ⁿ Section of Immunology, Allergy and Retrovirology, Department of Pediatrics, Texas Children’s Hospital, Houston, Tex
^eeee Department of Pulmonary Medicine, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, Tex
^o Division of Allergy and Clinical Immunology, Department of Internal Medicine, Security Forces Hospital Program, Riyadh, Arabia
^p Department of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, Canada
^q Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, United Kingdom
^r Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Mass
^s Centre Hospital Universitaire Sainte-Justine, Montreal, Canada
^t Division of Allergy, Immunology, and Dermatology, Department of Pediatrics, McGill University Health Center–Montreal Children’s Hospital, Montreal, Canada
^www Hôspital Maisonneuve-Rosemont, Université de Montréal, Montreal, Canada
^v Division of Allergy, Immunology, and Rheumatology, University of Rochester School of Medicine and Dentistry, Rochester, NY
^lll Rochester Regional Health, University of Rochester School of Medicine and Dentistry, Rochester, NY
^w Department of Dermatology and Allergy Center, Odense Research Centre for Anaphylaxis, Odense, Denmark
^x Department of Paediatrics, School of Medicine, Trinity College Dublin, Dublin, Ireland
^tt Department of Paediatrics, Royal College of Surgeons, Dublin, Ireland
^y University of Alberta, Faculty of Medicine, Calgary, Canada
^z Allergy Victoria, Victoria, British Columbia, Canada
^aa The Children’s Hospital at Westmead, Sydney, Australia
^xx Campbelltown Hospital, Western Sydney University, Sydney, Australia
^bb Department of Emergency Medicine, Mayo Clinic, Rochester
^qqq Division of Allergic Diseases, Mayo Clinic, Rochester
^cc Carilion Clinic, Verona, Va
^dd Division of Allergy and Immunology, BC Children’s Hospital, The University of British Columbia, Vancouver, Canada
^ee Division of Pulmonary, Allergy and Critical Care, Department of Medicine, Stanford University School of Medicine, Palo Alto, Calif
^ff Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, Calif
^gg Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Palo Alto, Calif
^hh Department of Clinical and Experimental Medicine, Section of Pediatrics, University of Pisa, Pisa, Italy
ⁱⁱ Corewell Health Allergy and Immunology, Grand Rapids, Mich
^jj Michigan State University College of Human Medicine, Grand Rapids, Mich
^kk Division of Allergy and Immunology, Department of Medicine, Queen’s University, Kingston, Canada
^ll Guys’s and St Tomas’s Hospital National Health Service Foundation Trust, London, Mass
^mmmm Imperial College Healthcare National Health Service Trust, London, Mass
ⁿⁿⁿⁿ Royal Brompton and Harefield National Health Service Foundation Trust, London, Mass
^kkk Inflammation, Repair and Development Section, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, Mass
^mm Laboratory of Allergic Diseases, Food Allergy Research Section, National Institutes of Allergy and Infectious Diseases, the National Institutes of Health, Bethesda, Md
ⁿⁿ Clinique Spécialisée en Allergie de la Capitale, Québec, Canada
^oo Allergy Clinic, Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark
^pp Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
^qq Division of Allergy and Immunology, Department of Pediatrics, Nationwide Children’s Hospital, The Ohio State University College of Medicine, Columbus, Ohio
^rr Access Health Care Physicians LLC, New Port Richey, Fla
^ss Division of Allergy and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, Mo
^uu Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn
^vvv Center for Drug Safety and Immunology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn
^vv Fraser Allergy, Langley, Canada
^ww Division of Allergy and Immunology, Northwell Health, New York, NY
^qqqq Division of Pediatric Allergy and Immunology, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY
^rrrr Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY
^yy Division of Clinical Immunology and Allergy, Department of Medicine, Western University, St Joseph’s Health Care, London (Canada), Mass
^bbbb Schulich School of Medicine and Dentistry, Western University, St Joseph’s Health Care, London (Canada), Mass
^aaaa Division of Clinical Immunology and Allergy, St Joseph’s Health Care, London (Canada), Mass
^zz Division of Allergy, Asthma, and Immunology, Scripps Clinic, San Diego, Calif
^aaa Division of Allergy and Immunology, Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Tex
^bbb Department of Allergy and Clinical Immunology, Respiratory Institute, Cleveland Clinic, Cleveland, Ohio
^ccc Division of Allergy and Immunology, Department of Medicine, University of South Florida Morsani College of Medicine, Tampa, Fla
^ddd Division of Paediatric Allergology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
^eee Division of Allergy and Immunology, The University of Tennessee, Memphis, Tenn
^fff Immunology Department, Perth Children’s Hospital, Perth, Australia
^hhh Halton Pediatric Allergy, Burlington, Canada
ⁱⁱⁱ Elite Sports Medicine Institute Ltd, Westmont, Ill
^jjj Division of Pulmonary, Allergy and Critical Care, Department of Medicine, NorthShore University Health System, Evanston, Ill
^mmm Asthma and Allergy Center, Lewisville and Flower Mound, Dallas, Tex
ⁿⁿⁿ Idaho Falls Infectious Diseases, Idaho Falls, Idaho
^ooo University of Medicine and Dentistry of New Jersey, Rutgers University School of Medicine, New Brunswick, NJ
^ppp Division of Pulmonary, Critical Care, Allergy, and Sleep Medicine, University of California San Francisco, San Francisco, Calif
^rrr Department of Pediatrics, Nippon Medical School, Tokyo, Japan
^sss Population Allergy Group and the Centre for Food and Allergy Research, Murdoch Children’s Research Institute, University of Melbourne, University of Melbourne, Royal Children’s Hospital, Parkville, Australia
ⁱⁱⁱⁱ Department of Allergy Immunology, Murdoch Children’s Research Institute, Melbourne, Parkville, Australia
^ttt Department of Paediatrics, University of Melbourne, Parkville, Australia
^jjjj Department of Allergy and Immunology, Royal Children’s Hospital, Parkville, Australia
^uuu Division of Allergy and Clinical Immunology, Department of Medicine, University of Cape Town and the Allergy and Immunology Unit, University of Cape Town Lung Institute, Cape Town
^xxx Allergy and Asthma Associates of Allen, Allen, Tex
^yyy Allergy, Asthma and Immunology Center of Alaska, Anchorage, Alaska
^zzz Department of Pediatrics, University of Washington School of Medicine, Seattle, Wash
^cccc Allergy Department, University Hospital Niño Jesus, Madrid, Spain
^dddd Memorial Hospital and Health Care Center, Jasper, Ind
^ffff Kaiser Permanente Los Angeles Medical Center, Los Angeles, Calif
^gggg Division of Allergy and Immunology, Children’s Hospital of Philadelphia, Philadelphia, Pa
^hhhh Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania, Philadelphia, Pa
^kkkk Allergy, Asthma, and Immunology Associates PC, Omaha, Neb
^llll Department of Pediatrics, University of Nebraska School of Medicine, Omaha, Neb
^oooo Pediatric Allergy and Immunology, Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Canada
^pppp Nova Southeastern University College of Allopathic Medicine, Fort Lauderdale, Fla
^tttt Baylor Scott and White Clinic, College Station, Tex
^uuuu Division of Allergology and Immunology, Department of Dermatology, Venereology and Allergology, Charité–Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
^vvvv Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Hospital, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, Segrate, Milan, Italy

^∗Corresponding author: Matthew Greenhawt, MD, MBA, MSc, Section of Allergy and Immunology, Children’s Hospital Colorado, University of Colorado School of Medicine, 13123 E. 16th Ave, Aurora, CO 80045.Section of Allergy and ImmunologyChildren’s Hospital ColoradoUniversity of Colorado School of Medicine13123 E. 16th AveAuroraCO80045

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Abstract

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.

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Key words : SARS-CoV-2, COVID-19, vaccination, mRNA COVID-19 vaccine, anaphylaxis, allergic reactions, repeat allergic reactions, polyethylene glycol, polysorbate 80, skin testing

Abbreviations used : BCC, COVID-19, CrI, GRADE, ISRR, NIAID, OR, PEG, PS, SARS-CoV-2

Mappa

Special Circumstances

Are patients with allergic comorbidities more likely to have mRNA COVID-19 vaccine reactions?

How should patients with a history of an allergic reaction to a mRNA-COVID-19 vaccine or vaccine excipient be managed in resource-limited settings where allergy consultation is not available?

How should concerns about the bivalent mRNA COVID-19 vaccine or initial reactions occurring on booster doses be managed?

Limitations

Conclusion

Disclosure Statement

The content is solely the responsibility of the 27 authors and does not necessarily represent the official views of the National Institutes of Health, Public Health Agency of Canada.