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, Elissa M. Abrams, Marcus Shaker, Derek K. Chu, David Kahn, Cem Akin, Waleed Alqurashi, Peter Arkwright, James L. Baldwin, Moshe Ben-shoshan, Jonathan Bernstein, Theresa Bingeman, Katerina Blumchen, Aideen Byrne, Antonio Bognanni, Dianne Campbell, Ronna Campbell, Zain Chagla, Edmond S. Chan, Jeffrey ChanPasquale Comberiatti, Timothy E. Dribin, Anne K. Ellis, David M. Fleischer, Adam Fox, Pamela A. Frischmeyer-guerrerio, Remi Gagnon, Mitchell H. Grayson, Caroline C. Horner, Johnathan Hourihane, Constance H. Katelaris, Harold Kim, John M. Kelso, David Lang, Dennis Ledford, Michael Levin, Jay Lieberman, Richard Loh, Doug Mack, Bruce Mazer, Gissele Mosnaim, Daniel Munblit, S Shahzad Mustafa, Anil Nanda, John Oppenheimer, Kirsten P. Perrett, Allison Ramsey, Matt Rank, Kara Robertson, Javed Shiek, Jonathan M. Spergel, David Stukus, Mimi Lk. Tang, James M. Tracy, Paul J. Turner, Anna Whalen-browne, Dana Wallace, Julie Wang, Susan Wasserman, John K. Witty, Margitta Worm, Timothy K. Vander Leek, David Bk. Golden

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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.

Original languageEnglish
Pages (from-to)3546-3567
Number of pages22
JournalThe Journal of Allergy and Clinical Immunology: In Practice
Volume9
Issue number10
Early online date18 Jun 2021
DOIs
Publication statusPublished - Oct 2021

Keywords

  • Adenovirus-vector vaccine
  • Allergic reactions
  • Allergy
  • Allergy specialist
  • Anaphylaxis
  • COVID-19
  • GRADE
  • Polyethylene glycol
  • Polysorbate 80
  • SARS-CoV-2
  • Shared decision making
  • Skin testing
  • Vaccination
  • mRNA vaccine
  • Humans
  • Anaphylaxis/diagnosis
  • Consensus
  • COVID-19 Vaccines
  • RNA, Viral
  • GRADE Approach

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