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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.
Greenhawt, Matthew; Abrams, Elissa M; Shaker, Marcus; Chu, Derek K; Khan, David; Akin, Cem; Alqurashi, Waleed; Arkwright, Peter; Baldwin, James L; Ben-Shoshan, Moshe; Bernstein, Jonathan; Bingemann, Theresa; Blumchen, Katharina; Byrne, Aideen; Bognanni, Antonio; Campbell, Dianne; Campbell, Ronna; Chagla, Zain; Chan, Edmond S; Chan, Jeffrey; Comberiati, Pasquale; Dribin, Timothy E; Ellis, Anne K; Fleischer, David M; Fox, Adam; Frischmeyer-Guerrerio, Pamela A; Gagnon, Remi; Grayson, Mitchell H; Horner, Caroline C; Hourihane, Jonathan; Katelaris, Constance H; Kim, Harold; Kelso, John M; Lang, David; Ledford, Dennis; Levin, Michael; Lieberman, Jay; Loh, Richard; Mack, Doug; Mazer, Bruce; Mosnaim, Giselle; Munblit, Daniel; Mustafa, S Shahzad; Nanda, Anil; Oppenheimer, John; Perrett, Kirsten P; Ramsey, Allison; Rank, Matthew; Robertson, Kara; Sheikh, Javed.
  • Greenhawt M; 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.
  • Abrams EM; Department of Pediatrics and Child Health, Section of Allergy and Immunology, The University of Manitoba, Winnipeg, Man, Canada.
  • Shaker M; Dartmouth-Hitchcock Medical Center, Section of Allergy and Immunology, Lebanon; Dartmouth Geisel School of Medicine, Hanover, NH.
  • Chu DK; 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.
  • Khan D; Division of Allergy and Immunology, Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.
  • Akin C; Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan School, Ann Arbor, Mich.
  • Alqurashi W; Department of Pediatrics and Emergency Medicine, University of Ottawa, Ottawa, Ont, Canada.
  • Arkwright P; Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.
  • Baldwin JL; Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan School, Ann Arbor, Mich.
  • Ben-Shoshan M; Division of Allergy, Immunology, and Dermatology, Department of Pediatrics, McGill University Health Center-Montreal Children's Hospital, Montreal, Quebec, Canada.
  • Bernstein J; Division of Immunology, Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio.
  • Bingemann T; Division of Allergy, Immunology, and Rheumatology, University of Rochester School of Medicine and Dentistry, Rochester, NY.
  • Blumchen K; Department of Paediatric and Adolescent Medicine, Paediatric Pneumology, Allergology, and Cystic Fibrosis, University Hospital Frankfurt, Frankfurt am Main, Germany.
  • Byrne A; Children's Health Ireland at Crumlin, Crumlin, Ireland.
  • Bognanni A; Department of Health Research Methods, Evidence and Impact, Evidence in Allergy Group, McMaster University, Hamilton, Ont, Canada.
  • Campbell D; The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
  • Campbell R; Department of Emergency Medicine, Mayo Clinic, Rochester, Minn.
  • Chagla Z; Division of Infectious Diseases, Department of Medicine, McMaster University, Hamilton, Ont, Canada.
  • Chan ES; BC Children's Hospital, Division of Allergy and Immunology, The University of British Columbia, Vancouver, BC, Canada.
  • Chan J; Department of Emergency Medicine, Southlake Regional Medical Center, Newmarket, Ont, Canada.
  • Comberiati P; 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.
  • Dribin TE; Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
  • Ellis AK; Division of Allergy and Immunology, Department of Medicine, Queen's University, Kingston, Ont, Canada.
  • Fleischer DM; Section of Allergy and Clinical Immunology, Food Challenge and Research Unit, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo.
  • Fox A; Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.
  • Frischmeyer-Guerrerio PA; Laboratory of Allergic Diseases, Food Allergy Research Section, National Institutes of Allergy and Infectious Diseases, the National Institutes of Health, Bethesda, Md.
  • Gagnon R; Clinique Spécialisée en Allergie de la Capitale, Quebec, Quebec, Canada.
  • Grayson MH; Division of Allergy and Immunology, Department of Clinical Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.
  • Horner CC; Division of Allergy and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, Mo.
  • Hourihane J; Department of Paediatrics, Royal College of Surgeons, Dublin, Ireland.
  • Katelaris CH; Campbelltown Hospital, Western Sydney University, New South Wales, Australia.
  • Kim H; Western University, Londo, McMaster University, Hamilton, Ont, Canada.
  • Kelso JM; Division of Allergy, Asthma, and Immunology, Scripps Clinic, San Diego, Calif.
  • Lang D; Department of Allergy and Clinical Immunology, Respiratory Institute, Cleveland Clinic, Cleveland, Ohio.
  • Ledford D; Division of Allergy and Immunology, Department of Medicine, University of South Florida Morsani College of Medicine, Tampa, Fla.
  • Levin M; Division of Paediatric Allergology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
  • Lieberman J; Division of Allergy and Immunology, The University of Tennessee, Memphis, Tenn.
  • Loh R; Immunology Department, Perth Children's Hospital, Perth, Western Australia, Australia.
  • Mack D; McMaster University Hamilton, Halton Pediatric Allergy, Burlington, Ont, Canada.
  • Mazer B; Division of Allergy, Immunology, and Dermatology, Department of Pediatrics, McGill University Health Center-Montreal Children's Hospital, Montreal, Quebec, Canada.
  • Mosnaim G; Division of Pulmonary, Allergy, and Critical Care, Department of Medicine, NorthShore University Health System, Evanston, Ill.
  • Munblit D; Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia, Inflammation, Repair, Development Section, National Heart and Lung Institute, Faculty of Medicine, Imperial College London,
  • Mustafa SS; Rochester Regional Health, University of Rochester School of Medicine and Dentistry, Rochester, NY.
  • Nanda A; Asthma and Allergy Center, Lewisville and Flower Mound, Texas, Division of Allergy and Immunology, University of Texas Southwestern Medical Center, Dallas, Texas.
  • Oppenheimer J; UMDMJ Rutgers University School of Medicine, New Brunswick, NJ.
  • Perrett KP; Murdoch Children's Research Institute, Department of Paediatrics, University of Melbourne, Royal Children's Hospital, Parkville, Victoria, Australia.
  • Ramsey A; Rochester Regional Health, University of Rochester School of Medicine and Dentistry, Rochester, NY.
  • Rank M; Division of Allergy, Asthma, and Clinical Immunology, Mayo Clinic, Scottsdale, Division of Pulmonology, Phoenix Children's Hospital, Phoenix, Ariz.
  • Robertson K; Division of Clinical Immunology and Allergy, St. Joseph's Health Care, the Schulich School of Medicine and Dentistry, Western University, London, Ont, Canada.
  • Sheikh J; Kaiser Permanente Los Angeles Medical Center, Los Angeles, Calif.
J Allergy Clin Immunol Pract ; 9(10): 3546-3567, 2021 10.
Article in English | MEDLINE | ID: covidwho-1275424
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Anaphylaxis Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews / Systematic review/Meta Analysis Topics: Vaccines Limits: Humans Language: English Journal: J Allergy Clin Immunol Pract Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Anaphylaxis Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews / Systematic review/Meta Analysis Topics: Vaccines Limits: Humans Language: English Journal: J Allergy Clin Immunol Pract Year: 2021 Document Type: Article