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

In: Journal of Allergy and Clinical Immunology, Vol. 152, No. 2, 2023, p. 309-325.

Research output: Contribution to journalReviewResearchpeer-review

Harvard

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

APA

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

Vancouver

Greenhawt M, Dribin TE, Abrams EM, Shaker M, Chu DK, Golden DBK et al. 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. 2023;152(2):309-325. https://doi.org/10.1016/j.jaci.2023.05.019

Author

Greenhawt, Matthew ; Dribin, Timothy E. ; Abrams, Elissa M. ; Shaker, Marcus ; Chu, Derek K. ; Golden, David B.K. ; Akin, Cem ; Anagnostou, Akterini ; ALMuhizi, Faisal ; Alqurashi, Waleed ; Arkwright, Peter ; Baldwin, James L. ; Banerji, Aleena ; Bégin, Philippe ; Ben-Shoshan, Moshe ; Bernstein, Jonathan ; Bingemann, Theresa A. ; Bindslev-Jensen, Carsten ; Blumenthal, Kim ; Byrne, Aideen ; Cahill, Julia ; Cameron, Scott ; Campbell, Dianne ; Campbell, Ronna ; Cavender, Michael ; Chan, Edmond S. ; Chinthrajah, Sharon ; Comberiati, Pasquale ; Eastman, Jacqueline J. ; Ellis, Anne K. ; Fleischer, David M. ; Fox, Adam ; Frischmeyer-Guerrerio, Pamela A. ; Gagnon, Remi ; Garvey, Lene H. ; Grayson, Mitchell H. ; Isabwe, Ghislaine Annie Clarisse ; Hartog, Nicholas ; Hendron, David ; Horner, Caroline C. ; Hourihane, Johnathan O.B. ; Iglesia, Edward ; Kan, Manstein ; Kaplan, Blanka ; Katelaris, Constance H. ; Kim, Harold ; Kelso, John M. ; Khan, David A. ; Lang, David ; Ledford, Dennis ; Levin, Michael ; Lieberman, Jay A. ; Loh, Richard ; Mack, Douglas P. ; Mazer, Bruce ; Mody, Ketan ; Mosnaim, Gisele ; Munblit, Daniel ; Mustafa, S. Shahzad ; Nanda, Anil ; Nathan, Richard ; Oppenheimer, John ; Otani, Iris M. ; Park, Miguel ; Pawankar, Ruby ; Perrett, Kirsten P. ; Peter, Jonny ; Phillips, Elizabeth J. ; Picard, Matthieu ; Pitlick, Mitchell ; Ramsey, Allison ; Rasmussen, Trine Holm ; Rathkopf, Melinda M. ; Reddy, Hari ; Robertson, Kara ; Rodriguez del Rio, Pablo ; Sample, Stephen ; Sheshadri, Ajay ; Sheik, Javed ; Sindher, Sayantani B. ; Spergel, Jonathan M. ; Stone, Cosby A. ; Stukus, David ; Tang, Mimi L.K. ; Tracy, James M. ; Turner, Paul J. ; Vander Leek, Timothy K. ; Wallace, Dana V. ; Wang, Julie ; Wasserman, Susan ; Weldon, David ; Wolfson, Anna R. ; Worm, Margitta ; Yacoub, Mona Rita. / Updated guidance regarding the risk of allergic reactions to COVID-19 vaccines and recommended evaluation and management : A GRADE assessment and international consensus approach. In: Journal of Allergy and Clinical Immunology. 2023 ; Vol. 152, No. 2. pp. 309-325.

Bibtex

@article{a1e927e83ae140c69fe1cfdbc8c79650,
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.",
keywords = "allergic reactions, anaphylaxis, COVID-19, mRNA COVID-19 vaccine, polyethylene glycol, polysorbate 80, repeat allergic reactions, SARS-CoV-2, skin testing, vaccination",
author = "Matthew Greenhawt and Dribin, {Timothy E.} and Abrams, {Elissa M.} and Marcus Shaker and Chu, {Derek K.} and Golden, {David B.K.} and Cem Akin and Akterini Anagnostou and Faisal ALMuhizi and Waleed Alqurashi and Peter Arkwright and Baldwin, {James L.} and Aleena Banerji and Philippe B{\'e}gin and Moshe Ben-Shoshan and Jonathan Bernstein and Bingemann, {Theresa A.} and Carsten Bindslev-Jensen and Kim Blumenthal and Aideen Byrne and Julia Cahill and Scott Cameron and Dianne Campbell and Ronna Campbell and Michael Cavender and Chan, {Edmond S.} and Sharon Chinthrajah and Pasquale Comberiati and Eastman, {Jacqueline J.} and Ellis, {Anne K.} and Fleischer, {David M.} and Adam Fox and Frischmeyer-Guerrerio, {Pamela A.} and Remi Gagnon and Garvey, {Lene H.} and Grayson, {Mitchell H.} and Isabwe, {Ghislaine Annie Clarisse} and Nicholas Hartog and David Hendron and Horner, {Caroline C.} and Hourihane, {Johnathan O.B.} and Edward Iglesia and Manstein Kan and Blanka Kaplan and Katelaris, {Constance H.} and Harold Kim and Kelso, {John M.} and Khan, {David A.} and David Lang and Dennis Ledford and Michael Levin and Lieberman, {Jay A.} and Richard Loh and Mack, {Douglas P.} and Bruce Mazer and Ketan Mody and Gisele Mosnaim and Daniel Munblit and Mustafa, {S. Shahzad} and Anil Nanda and Richard Nathan and John Oppenheimer and Otani, {Iris M.} and Miguel Park and Ruby Pawankar and Perrett, {Kirsten P.} and Jonny Peter and Phillips, {Elizabeth J.} and Matthieu Picard and Mitchell Pitlick and Allison Ramsey and Rasmussen, {Trine Holm} and Rathkopf, {Melinda M.} and Hari Reddy and Kara Robertson and {Rodriguez del Rio}, Pablo and Stephen Sample and Ajay Sheshadri and Javed Sheik and Sindher, {Sayantani B.} and Spergel, {Jonathan M.} and Stone, {Cosby A.} and David Stukus and Tang, {Mimi L.K.} and Tracy, {James M.} and Turner, {Paul J.} and {Vander Leek}, {Timothy K.} and Wallace, {Dana V.} and Julie Wang and Susan Wasserman and David Weldon and Wolfson, {Anna R.} and Margitta Worm and Yacoub, {Mona Rita}",
note = "Publisher Copyright: {\textcopyright} 2023",
year = "2023",
doi = "10.1016/j.jaci.2023.05.019",
language = "English",
volume = "152",
pages = "309--325",
journal = "Journal of Allergy and Clinical Immunology",
issn = "0091-6749",
publisher = "Mosby Inc.",
number = "2",

}

RIS

TY - JOUR

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

AU - Mosnaim, Gisele

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

N1 - Publisher Copyright: © 2023

PY - 2023

Y1 - 2023

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 - allergic reactions

KW - anaphylaxis

KW - COVID-19

KW - mRNA COVID-19 vaccine

KW - polyethylene glycol

KW - polysorbate 80

KW - repeat allergic reactions

KW - SARS-CoV-2

KW - skin testing

KW - vaccination

UR - http://www.scopus.com/inward/record.url?scp=85165645010&partnerID=8YFLogxK

U2 - 10.1016/j.jaci.2023.05.019

DO - 10.1016/j.jaci.2023.05.019

M3 - Review

C2 - 37295474

AN - SCOPUS:85165645010

VL - 152

SP - 309

EP - 325

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

SN - 0091-6749

IS - 2

ER -

ID: 370744425