The Risk of Allergic Reaction to SARS-CoV-2 Vaccines and Recommended Evaluation and Management: A Systematic Review, Meta-Analysis, GRADE Assessment, and International Consensus Approach

Matthew Greenhawt, Section of Allergy and Clinical Immunology, Food Challenge and Research Unit, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo.
Elissa M. Abrams, Department of Pediatrics and Child Health, Section of Allergy and Immunology, The University of Manitoba, Winnipeg, Man, Canada.
Marcus Shaker, Dartmouth-Hitchcock Medical Center, Section of Allergy and Immunology, Lebanon; Dartmouth Geisel School of Medicine, Hanover, NH.
Derek K. Chu, Department of Medicine, McMaster University Department of Health Research Methods, Evidence and Impact, McMaster University; The Research Institute of St. Joe's Hamilton; Evidence in Allergy Group, McMaster University, Hamilton, Ont, Canada.
David Khan, Division of Allergy and Immunology, Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.
Cem Akin, Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan School, Ann Arbor, Mich.
Waleed Alqurashi, Department of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, Ont, Canada.
Peter Arkwright, Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.
James L. Baldwin, Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan School, Ann Arbor, Mich.
Moshe Ben-Shoshan, Division of Allergy, Immunology, and Dermatology, Department of Pediatrics, McGill University Health Center-Montreal Children's Hospital, Montreal, Quebec, Canada.
Jonathan Bernstein, Division of Immunology, Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio.
Theresa Bingemann, Division of Allergy, Immunology, and Rheumatology, University of Rochester School of Medicine and Dentistry, Rochester, NY.
Katharina Blumchen, Department of Paediatric and Adolescent Medicine, Paediatric Pneumology, Allergology, and Cystic Fibrosis, University Hospital Frankfurt, Frankfurt am Main, Germany.
Aideen Byrne, Children's Health Ireland at Crumlin, Crumlin, Ireland.
Antonio Bognanni, Department of Health Research Methods, Evidence and Impact, Evidence in Allergy Group, McMaster University, Hamilton, Ont, Canada.
Dianne Campbell, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
Ronna Campbell, Department of Emergency Medicine, Mayo Clinic, Rochester, Minn.
Zain Chagla, Division of Infectious Diseases, Department of Medicine, McMaster University, Hamilton, Ont, Canada.
Edmond S. Chan, BC Children's Hospital, Division of Allergy and Immunology, The University of British Columbia, Vancouver, BC, Canada.
Jeffrey Chan, Department of Emergency Medicine, Southlake Regional Medical Center, Newmarket, Ont, Canada.
Pasquale Comberiati, Department of Clinical and Experimental Medicine, Section of Pediatrics, University of Pisa, Pisa, Italy, Department of Clinical Immunology and Allergology, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.
Timothy E. Dribin, Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Anne K. Ellis, Division of Allergy and Immunology, Department of Medicine, Queen's University, Kingston, Ont, Canada.
David M. Fleischer, Section of Allergy and Clinical Immunology, Food Challenge and Research Unit, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo.
Adam Fox, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.
Pamela A. Frischmeyer-Guerrerio, Laboratory of Allergic Diseases, Food Allergy Research Section, National Institutes of Allergy and Infectious Diseases, the National Institutes of Health, Bethesda, Md.
Remi Gagnon, Clinique Spécialisée en Allergie de la Capitale, Quebec, Quebec, Canada.
Mitchell H. Grayson, Division of Allergy and Immunology, Department of Clinical Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.
Caroline C. Horner, Division of Allergy and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, Mo.
Jonathan Hourihane, Department of Paediatrics, Royal College of Surgeons, Dublin, Ireland.
Constance H. Katelaris, Campbelltown Hospital, Western Sydney University, New South Wales, Australia.
Harold Kim, Western University, Londo, McMaster University, Hamilton, Ont, Canada.

Department

Allergy and Immunology

Document Type

Article

Publication Title

The journal of allergy and clinical immunology. In practice

Abstract

Concerns 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.

DOI

10.1016/j.jaip.2021.06.006

Publication Date

6-22-2021

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