Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach

Matthew Greenhawt; Timothy E. Dribin; Elissa M. Abrams; Marcus Shaker; Derek K. Chu; David B.K. Golden; Cem Akin; Akterini Anagnostou; Faisal ALMuhizi; Waleed Alqurashi; Peter Arkwright; James L. Baldwin; Aleena Banerji; Philippe Bégin; Moshe Ben-Shoshan; Jonathan Bernstein; Theresa A. Bingemann; Carsten Bindslev-Jensen; Kim Blumenthal; Aideen Byrne; Julia Cahill; Scott Cameron; Dianne Campbell; Ronna Campbell; Michael Cavender; Edmond S. Chan; Sharon Chinthrajah; Pasquale Comberiati; Jacqueline J. Eastman; Anne K. Ellis; David M. Fleischer; Adam Fox; Pamela A. Frischmeyer-Guerrerio; Remi Gagnon; Lene H. Garvey; Mitchell H. Grayson; Ghislaine Annie Clarisse Isabwe; Nicholas Hartog; David Hendron; Caroline C. Horner; Johnathan O.B. Hourihane; Edward Iglesia; Manstein Kan; Blanka Kaplan; Constance H. Katelaris; Harold Kim; John M. Kelso; David A. Khan; David Lang; Dennis Ledford; Michael Levin; Jay A. Lieberman; Richard Loh; Douglas P. Mack; Bruce Mazer; Ketan Mody; Gisele Mosnaim; Daniel Munblit; S. Shahzad Mustafa; Anil Nanda; Richard Nathan; John Oppenheimer; Iris M. Otani; Miguel Park; Ruby Pawankar; Kirsten P. Perrett; Jonny Peter; Elizabeth J. Phillips; Matthieu Picard; Mitchell Pitlick; Allison Ramsey; Trine Holm Rasmussen; Melinda M. Rathkopf; Hari Reddy; Kara Robertson; Pablo Rodriguez del Rio; Stephen Sample; Ajay Sheshadri; Javed Sheik; Sayantani B. Sindher; Jonathan M. Spergel; Cosby A. Stone; David Stukus; Mimi L.K. Tang; James M. Tracy; Paul J. Turner; Timothy K. Vander Leek; Dana V. Wallace; Julie Wang; Susan Wasserman; David Weldon; Anna R. Wolfson; Margitta Worm; Mona Rita Yacoub

doi:10.1016/j.jaci.2023.05.019

Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach

Matthew Greenhawt, Timothy E. Dribin, Elissa M. Abrams, Marcus Shaker, Derek K. Chu, David B.K. Golden, Cem Akin, Akterini Anagnostou, Faisal ALMuhizi, Waleed Alqurashi, Peter Arkwright, James L. Baldwin, Aleena Banerji, Philippe Bégin, Moshe Ben-Shoshan, Jonathan Bernstein, Theresa A. Bingemann, Carsten Bindslev-Jensen, Kim Blumenthal, Aideen ByrneJulia Cahill, Scott Cameron, Dianne Campbell, Ronna Campbell, Michael Cavender, Edmond S. Chan, Sharon Chinthrajah, Pasquale Comberiati, Jacqueline J. Eastman, Anne K. Ellis, David M. Fleischer, Adam Fox, Pamela A. Frischmeyer-Guerrerio, Remi Gagnon, Lene H. Garvey, Mitchell H. Grayson, Ghislaine Annie Clarisse Isabwe, Nicholas Hartog, David Hendron, Caroline C. Horner, Johnathan O.B. Hourihane, Edward Iglesia, Manstein Kan, Blanka Kaplan, Constance H. Katelaris, Harold Kim, John M. Kelso, David A. Khan, David Lang, Dennis Ledford, Michael Levin, Jay A. Lieberman, Richard Loh, Douglas P. Mack, Bruce Mazer, Ketan Mody, Gisele Mosnaim, Daniel Munblit, S. Shahzad Mustafa, Anil Nanda, Richard Nathan, John Oppenheimer, Iris M. Otani, Miguel Park, Ruby Pawankar, Kirsten P. Perrett, Jonny Peter, Elizabeth J. Phillips, Matthieu Picard, Mitchell Pitlick, Allison Ramsey, Trine Holm Rasmussen, Melinda M. Rathkopf, Hari Reddy, Kara Robertson, Pablo Rodriguez del Rio, Stephen Sample, Ajay Sheshadri, Javed Sheik, Sayantani B. Sindher, Jonathan M. Spergel, Cosby A. Stone, David Stukus, Mimi L.K. Tang, James M. Tracy, Paul J. Turner, Timothy K. Vander Leek, Dana V. Wallace, Julie Wang, Susan Wasserman, David Weldon, Anna R. Wolfson, Margitta Worm, Mona Rita Yacoub

Allergic Diseases

Research output: Contribution to journal › Review article › peer-review

Abstract

This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against >15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history.

Original language	English (US)
Pages (from-to)	309-325
Number of pages	17
Journal	Journal of Allergy and Clinical Immunology
Volume	152
Issue number	2
DOIs	https://doi.org/10.1016/j.jaci.2023.05.019
State	Published - Aug 2023

Keywords

COVID-19
SARS-CoV-2
allergic reactions
anaphylaxis
mRNA COVID-19 vaccine
polyethylene glycol
polysorbate 80
repeat allergic reactions
skin testing
vaccination

ASJC Scopus subject areas

Immunology and Allergy
Immunology

Access to Document

10.1016/j.jaci.2023.05.019

Cite this

Greenhawt, M., Dribin, T. E., Abrams, E. M., Shaker, M., Chu, D. K., Golden, D. B. K., Akin, C., Anagnostou, A., ALMuhizi, F., Alqurashi, W., Arkwright, P., Baldwin, J. L., Banerji, A., Bégin, P., Ben-Shoshan, M., Bernstein, J., Bingemann, T. A., Bindslev-Jensen, C., Blumenthal, K., ... Yacoub, M. R. (2023). Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach. Journal of Allergy and Clinical Immunology, 152(2), 309-325. https://doi.org/10.1016/j.jaci.2023.05.019

Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach. / Greenhawt, Matthew; Dribin, Timothy E.; Abrams, Elissa M. et al.
In: Journal of Allergy and Clinical Immunology, Vol. 152, No. 2, 08.2023, p. 309-325.

Research output: Contribution to journal › Review article › peer-review

Greenhawt, M, Dribin, TE, Abrams, EM, Shaker, M, Chu, DK, Golden, DBK, Akin, C, Anagnostou, A, ALMuhizi, F, Alqurashi, W, Arkwright, P, Baldwin, JL, Banerji, A, Bégin, P, Ben-Shoshan, M, Bernstein, J, Bingemann, TA, Bindslev-Jensen, C, Blumenthal, K, Byrne, A, Cahill, J, Cameron, S, Campbell, D, Campbell, R, Cavender, M, Chan, ES, Chinthrajah, S, Comberiati, P, Eastman, JJ, Ellis, AK, Fleischer, DM, Fox, A, Frischmeyer-Guerrerio, PA, Gagnon, R, Garvey, LH, Grayson, MH, Isabwe, GAC, Hartog, N, Hendron, D, Horner, CC, Hourihane, JOB, Iglesia, E, Kan, M, Kaplan, B, Katelaris, CH, Kim, H, Kelso, JM, Khan, DA, Lang, D, Ledford, D, Levin, M, Lieberman, JA, Loh, R, Mack, DP, Mazer, B, Mody, K, Mosnaim, G, Munblit, D, Mustafa, SS, Nanda, A, Nathan, R, Oppenheimer, J, Otani, IM, Park, M, Pawankar, R, Perrett, KP, Peter, J, Phillips, EJ, Picard, M, Pitlick, M, Ramsey, A, Rasmussen, TH, Rathkopf, MM, Reddy, H, Robertson, K, Rodriguez del Rio, P, Sample, S, Sheshadri, A, Sheik, J, Sindher, SB, Spergel, JM, Stone, CA, Stukus, D, Tang, MLK, Tracy, JM, Turner, PJ, Vander Leek, TK, Wallace, DV, Wang, J, Wasserman, S, Weldon, D, Wolfson, AR, Worm, M & Yacoub, MR 2023, 'Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach', Journal of Allergy and Clinical Immunology, vol. 152, no. 2, pp. 309-325. https://doi.org/10.1016/j.jaci.2023.05.019

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title = "Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach",

abstract = "This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against >15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history.",

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note = "Publisher Copyright: {\textcopyright} 2023",

year = "2023",

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doi = "10.1016/j.jaci.2023.05.019",

language = "English (US)",

volume = "152",

pages = "309--325",

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T1 - Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management

T2 - A GRADE assessment and international consensus approach

AU - Greenhawt, Matthew

AU - Dribin, Timothy E.

AU - Abrams, Elissa M.

AU - Shaker, Marcus

AU - Chu, Derek K.

AU - Golden, David B.K.

AU - Akin, Cem

AU - Anagnostou, Akterini

AU - ALMuhizi, Faisal

AU - Alqurashi, Waleed

AU - Arkwright, Peter

AU - Baldwin, James L.

AU - Banerji, Aleena

AU - Bégin, Philippe

AU - Ben-Shoshan, Moshe

AU - Bernstein, Jonathan

AU - Bingemann, Theresa A.

AU - Bindslev-Jensen, Carsten

AU - Blumenthal, Kim

AU - Byrne, Aideen

AU - Cahill, Julia

AU - Cameron, Scott

AU - Campbell, Dianne

AU - Campbell, Ronna

AU - Cavender, Michael

AU - Chan, Edmond S.

AU - Chinthrajah, Sharon

AU - Comberiati, Pasquale

AU - Eastman, Jacqueline J.

AU - Ellis, Anne K.

AU - Fleischer, David M.

AU - Fox, Adam

AU - Frischmeyer-Guerrerio, Pamela A.

AU - Gagnon, Remi

AU - Garvey, Lene H.

AU - Grayson, Mitchell H.

AU - Isabwe, Ghislaine Annie Clarisse

AU - Hartog, Nicholas

AU - Hendron, David

AU - Horner, Caroline C.

AU - Hourihane, Johnathan O.B.

AU - Iglesia, Edward

AU - Kan, Manstein

AU - Kaplan, Blanka

AU - Katelaris, Constance H.

AU - Kim, Harold

AU - Kelso, John M.

AU - Khan, David A.

AU - Lang, David

AU - Ledford, Dennis

AU - Levin, Michael

AU - Lieberman, Jay A.

AU - Loh, Richard

AU - Mack, Douglas P.

AU - Mazer, Bruce

AU - Mody, Ketan

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AU - Munblit, Daniel

AU - Mustafa, S. Shahzad

AU - Nanda, Anil

AU - Nathan, Richard

AU - Oppenheimer, John

AU - Otani, Iris M.

AU - Park, Miguel

AU - Pawankar, Ruby

AU - Perrett, Kirsten P.

AU - Peter, Jonny

AU - Phillips, Elizabeth J.

AU - Picard, Matthieu

AU - Pitlick, Mitchell

AU - Ramsey, Allison

AU - Rasmussen, Trine Holm

AU - Rathkopf, Melinda M.

AU - Reddy, Hari

AU - Robertson, Kara

AU - Rodriguez del Rio, Pablo

AU - Sample, Stephen

AU - Sheshadri, Ajay

AU - Sheik, Javed

AU - Sindher, Sayantani B.

AU - Spergel, Jonathan M.

AU - Stone, Cosby A.

AU - Stukus, David

AU - Tang, Mimi L.K.

AU - Tracy, James M.

AU - Turner, Paul J.

AU - Vander Leek, Timothy K.

AU - Wallace, Dana V.

AU - Wang, Julie

AU - Wasserman, Susan

AU - Weldon, David

AU - Wolfson, Anna R.

AU - Worm, Margitta

AU - Yacoub, Mona Rita

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N2 - This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against >15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history.

AB - This guidance updates 2021 GRADE (Grading of Recommendations Assessment, Development and Evaluation) recommendations regarding immediate allergic reactions following coronavirus disease 2019 (COVID-19) vaccines and addresses revaccinating individuals with first-dose allergic reactions and allergy testing to determine revaccination outcomes. Recent meta-analyses assessed the incidence of severe allergic reactions to initial COVID-19 vaccination, risk of mRNA-COVID-19 revaccination after an initial reaction, and diagnostic accuracy of COVID-19 vaccine and vaccine excipient testing in predicting reactions. GRADE methods informed rating the certainty of evidence and strength of recommendations. A modified Delphi panel consisting of experts in allergy, anaphylaxis, vaccinology, infectious diseases, emergency medicine, and primary care from Australia, Canada, Europe, Japan, South Africa, the United Kingdom, and the United States formed the recommendations. We recommend vaccination for persons without COVID-19 vaccine excipient allergy and revaccination after a prior immediate allergic reaction. We suggest against >15-minute postvaccination observation. We recommend against mRNA vaccine or excipient skin testing to predict outcomes. We suggest revaccination of persons with an immediate allergic reaction to the mRNA vaccine or excipients be performed by a person with vaccine allergy expertise in a properly equipped setting. We suggest against premedication, split-dosing, or special precautions because of a comorbid allergic history.

KW - COVID-19

KW - SARS-CoV-2

KW - allergic reactions

KW - anaphylaxis

KW - mRNA COVID-19 vaccine

KW - polyethylene glycol

KW - polysorbate 80

KW - repeat allergic reactions

KW - skin testing

KW - vaccination

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JO - Journal of Allergy and Clinical Immunology

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Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management: A GRADE assessment and international consensus approach

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