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

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Review › Forskning › peer review

12 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	Journal of Allergy and Clinical Immunology
Vol/bind	152
Udgave nummer	2
Sider (fra-til)	309-325
Antal sider	17
ISSN	0091-6749
DOI	https://doi.org/10.1016/j.jaci.2023.05.019
Status	Udgivet - 2023

Bibliografisk note

Funding Information:
Disclosure of potential conflict of interest: M. Greenhawt has received past research support to his institution from DBV Technologies, and the Agency for Healthcare Research and Quality; receives current research support from Novartis and Silota; is a consultant for Aquestive; is a member of physician/medical advisory boards for DBV Technologies, Nutricia, Novartis, Aquestive, Allergy Therapeutics, AstraZeneca, ALK-Abelló, and Prota; is an unpaid member of the scientific advisory council for the National Peanut Board and medical advisory board of the International Food Protein Induced Enterocolitis Syndrome Association; is a member of the Brighton Collaboration Criteria Vaccine Anaphylaxis 2.0 working group; is the senior associate editor for the Annals of Allergy, Asthma & Immunology; and is member of the Joint Task Force on Allergy Practice Parameters. He has received honorarium for lectures from ImSci, RMEI Medical Education, MedLearningGroup, and multiple state/local allergy societies. T. E. Dribin has received support from the National Institutes of Health, under Award Number 25 2KL2TR001426-05A1 and the National Center for Advancing Translational Sciences of the National Institutes 26 of Health, under Award Number 2UL1TR001425 - 05A1.

Publisher Copyright:
© 2023

Adgang til dokumentet

10.1016/j.jaci.2023.05.019

https://pmc.ncbi.nlm.nih.gov/articles/PMC10247143/pdf/main.pdfLicens: Andet

Citationsformater

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.; 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.

I: Journal of Allergy and Clinical Immunology, Bind 152, Nr. 2, 2023, s. 309-325.

Publikation: Bidrag til tidsskrift › Review › Forskning › 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, bind 152, nr. 2, s. 309-325. https://doi.org/10.1016/j.jaci.2023.05.019

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. I: Journal of Allergy and Clinical Immunology. 2023 ; Bind 152, Nr. 2. s. 309-325.

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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.",

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",

}

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

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

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 -