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
File(s)1-s2.0-S2213219821006711-main.pdf (2.44 MB)
Accepted version
Author(s)
Type
Journal Article
Abstract
Concerns for anaphylaxis may hamper SARS-CoV-2 immunization efforts. We convened a multi-disciplinary group of international experts in anaphylaxis comprised 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 WHO global coronavirus database, and the grey 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 GRADE approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases/million (n=41,000,000 vaccinations, 95%CI 4.02-15.59; 26 studies, moderate certainty), the prevalence of PEG allergy is 103 cases/million (95%CI 88-120; 2 studies, very low certainty), and the sensitivity for PEG skin testing is poor though 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.
Date Issued
2021-10
Date Acceptance
2021-06-11
Citation
Journal of Allergy and Clinical Immunology: In Practice, 2021, 9 (10), pp.3546-3567
ISSN
2213-2198
Publisher
Elsevier
Start Page
3546
End Page
3567
Journal / Book Title
Journal of Allergy and Clinical Immunology: In Practice
Volume
9
Issue
10
Copyright Statement
© 2021 American Academy of Allergy, Asthma & Immunology. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Licence http://creativecommons.org/licenses/by-nc-nd/4.0/
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/34153517
PII: S2213-2198(21)00671-1
Subjects
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
Anaphylaxis
COVID-19
COVID-19 Vaccines
Consensus
GRADE Approach
Humans
RNA, Viral
SARS-CoV-2
Humans
Anaphylaxis
RNA, Viral
Consensus
GRADE Approach
COVID-19
SARS-CoV-2
COVID-19 Vaccines
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2021-06-18