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
| Autor: | Julie Wang, Jonathan A. Bernstein, Moshe Ben-Shoshan, Caroline C. Horner, John Oppenheimer, David B.K. Golden, Theresa Bingemann, Daniel Munblit, Derek K. Chu, David A. Khan, Katharina Blumchen, Elissa M. Abrams, Paul Turner, S. Shahzad Mustafa, John K. Witry, Jay A. Lieberman, Harold Kim, James L. Baldwin, Margitta Worm, David Fleischer, Remi Gagnon, Richard Loh, Waleed Alqurashi, Anne K. Ellis, David R. Stukus, James M. Tracy, Aideen Byrne, John M. Kelso, Jeffrey Chan, Mimi L.K. Tang, Adam T. Fox, Anna Whalen-Browne, Jonathan Hourihane, Anil Nanda, Zain Chagla, Peter D. Arkwright, Marcus Shaker, Jonathan M. Spergel, Edmond S. Chan, Constance H. Katelaris, Allison Ramsey, Timothy E. Dribin, David M. Lang, Doug Mack, Pamela A. Frischmeyer-Guerrerio, Bruce Mazer, Ronna L. Campbell, Pasquale Comberiati, Dennis K. Ledford, Dana Wallace, Mitchell H. Grayson, Dianne E. Campbell, Antonio Bognanni, Matthew A. Rank, Susan Waserman, Javed Sheikh, Timothy K. Vander Leek, Matthew Greenhawt, Cem Akin, Michael Levin, Kirsten P Perrett, Kara Robertson, Giselle Mosnaim |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Emergency Use Authorization
Allergy GRADE Grading of Recommendation Assessment Development and Evaluation Anaphylaxis/diagnosis Immunology and Allergy Medicine GRADE Approach Viral Shared decision making COVID-19 Coronavirus disease 2019 Polysorbate 80 Incidence (epidemiology) Vaccination BCC Brighton Collaboration criteria Adenovirus-vector vaccine Allergic reactions Allergy specialist Anaphylaxis COVID-19 GRADE mRNA vaccine Polyethylene glycol SARS-CoV-2 Skin testing COVID-19 Vaccines Consensus Humans RNA Viral PEG Polyethylene glycol Meta-analysis medicine.medical_specialty MEDLINE Special Article EUA Emergency use authorization Internal medicine Hypersensitivity CDC U.S. Centers for Disease Control and Prevention SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 business.industry VAERS Vaccine Adverse Event Reaction System medicine.disease IgE Immunoglobulin E Infectious disease (medical specialty) RNA business |
| Zdroj: | The Journal of Allergy and Clinical Immunology. in Practice Greenhawt, M, Abrams, E M, Shaker, M, Chu, D K, Kahn, D, Akin, C, Alqurashi, W, Arkwright, P, Baldwin, J L, Ben-shoshan, M, Bernstein, J, Bingeman, T, Blumchen, K, Byrne, A, Bognanni, A, Campbell, D, Campbell, R, Chagla, Z, Chan, E S, Chan, J, Comberiatti, P, Dribin, T E, Ellis, A K, Fleischer, D M, Fox, A, Frischmeyer-guerrerio, P A, Gagnon, R, Grayson, M H, Horner, C C, Hourihane, J, Katelaris, C H, Kim, H, Kelso, J M, Lang, D, Ledford, D, Levin, M, Lieberman, J, Loh, R, Mack, D, Mazer, B, Mosnaim, G, Munblit, D, Mustafa, S S, Nanda, A, Oppenheimer, J, Perrett, K P, Ramsey, A, Rank, M, Robertson, K, Shiek, J, Spergel, J M, Stukus, D, Tang, M L, Tracy, J M, Turner, P J, Whalen-browne, A, Wallace, D, Wang, J, Wasserman, S, Witty, J K, Worm, M, Vander Leek, T K & Golden, D B 2021, ' 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 ', The Journal of Allergy and Clinical Immunology: In Practice, vol. 9, no. 10, pp. 3546-3567 . https://doi.org/10.1016/j.jaip.2021.06.006 |
| DOI: | 10.1016/j.jaip.2021.06.006 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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