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 ApproachCitation formats

  • External authors:
  • Matthew Greenhawt
  • Elissa M. Abrams
  • Marcus Shaker
  • Derek K. Chu
  • David Kahn
  • Cem Akin
  • Waleed Alqurashi
  • James L. Baldwin
  • Moshe Ben-shoshan
  • Jonathan Bernstein
  • Theresa Bingeman
  • Katerina Blumchen
  • Aideen Byrne
  • Antonio Bognanni
  • Dianne Campbell
  • Ronna Campbell
  • Zain Chagla
  • Edmond S. Chan
  • Jeffrey Chan
  • Pasquale Comberiatti
  • Timothy E. Dribin
  • Anne K. Ellis
  • David M. Fleischer
  • Adam Fox
  • Pamela A. Frischmeyer-guerrerio
  • Remi Gagnon
  • Mitchell H. Grayson
  • Caroline C. Horner
  • Johnathan Hourihane
  • Constance H. Katelaris
  • Harold Kim
  • John M. Kelso
  • David Lang
  • Dennis Ledford
  • Michael Levin
  • Jay Lieberman
  • Richard Loh
  • Doug Mack
  • Bruce Mazer
  • Gissele Mosnaim
  • Daniel Munblit
  • S Shahzad Mustafa
  • Anil Nanda
  • John Oppenheimer
  • Kirsten P. Perrett
  • Allison Ramsey
  • Matt Rank
  • Kara Robertson
  • Javed Shiek
  • Jonathan M. Spergel
  • David Stukus
  • Mimi Lk. Tang
  • James M. Tracy
  • Paul J. Turner
  • Anna Whalen-browne
  • Dana Wallace
  • Julie Wang
  • Susan Wasserman
  • John K. Witty
  • Margitta Worm
  • Timothy K. Vander Leek
  • David Bk. Golden

Standard

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. / Greenhawt, Matthew; Abrams, Elissa M.; Shaker, Marcus; Chu, Derek K.; Kahn, David; Akin, Cem; Alqurashi, Waleed; Arkwright, Peter; Baldwin, James L.; Ben-shoshan, Moshe; Bernstein, Jonathan; Bingeman, Theresa; Blumchen, Katerina; Byrne, Aideen; Bognanni, Antonio; Campbell, Dianne; Campbell, Ronna; Chagla, Zain; Chan, Edmond S.; Chan, Jeffrey; Comberiatti, Pasquale; Dribin, Timothy E.; Ellis, Anne K.; Fleischer, David M.; Fox, Adam; Frischmeyer-guerrerio, Pamela A.; Gagnon, Remi; Grayson, Mitchell H.; Horner, Caroline C.; Hourihane, Johnathan; Katelaris, Constance H.; Kim, Harold; Kelso, John M.; Lang, David; Ledford, Dennis; Levin, Michael; Lieberman, Jay; Loh, Richard; Mack, Doug; Mazer, Bruce; Mosnaim, Gissele; Munblit, Daniel; Mustafa, S Shahzad; Nanda, Anil; Oppenheimer, John; Perrett, Kirsten P.; Ramsey, Allison; Rank, Matt; Robertson, Kara; Shiek, Javed; Spergel, Jonathan M.; Stukus, David; Tang, Mimi Lk.; Tracy, James M.; Turner, Paul J.; Whalen-browne, Anna; Wallace, Dana; Wang, Julie; Wasserman, Susan; Witty, John K.; Worm, Margitta; Vander Leek, Timothy K.; Golden, David Bk.

In: The Journal of Allergy and Clinical Immunology: In Practice, 18.06.2021.

Research output: Contribution to journalArticlepeer-review

Harvard

Greenhawt, M, Abrams, EM, Shaker, M, Chu, DK, Kahn, D, Akin, C, Alqurashi, W, Arkwright, P, Baldwin, JL, Ben-shoshan, M, Bernstein, J, Bingeman, T, Blumchen, K, Byrne, A, Bognanni, A, Campbell, D, Campbell, R, Chagla, Z, Chan, ES, Chan, J, Comberiatti, P, Dribin, TE, Ellis, AK, Fleischer, DM, Fox, A, Frischmeyer-guerrerio, PA, Gagnon, R, Grayson, MH, Horner, CC, Hourihane, J, Katelaris, CH, Kim, H, Kelso, JM, Lang, D, Ledford, D, Levin, M, Lieberman, J, Loh, R, Mack, D, Mazer, B, Mosnaim, G, Munblit, D, Mustafa, SS, Nanda, A, Oppenheimer, J, Perrett, KP, Ramsey, A, Rank, M, Robertson, K, Shiek, J, Spergel, JM, Stukus, D, Tang, ML, Tracy, JM, Turner, PJ, Whalen-browne, A, Wallace, D, Wang, J, Wasserman, S, Witty, JK, Worm, M, Vander Leek, TK & Golden, DB 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. https://doi.org/10.1016/j.jaip.2021.06.006

APA

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., ... 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. https://doi.org/10.1016/j.jaip.2021.06.006

Vancouver

Author

Greenhawt, Matthew ; Abrams, Elissa M. ; Shaker, Marcus ; Chu, Derek K. ; Kahn, David ; Akin, Cem ; Alqurashi, Waleed ; Arkwright, Peter ; Baldwin, James L. ; Ben-shoshan, Moshe ; Bernstein, Jonathan ; Bingeman, Theresa ; Blumchen, Katerina ; Byrne, Aideen ; Bognanni, Antonio ; Campbell, Dianne ; Campbell, Ronna ; Chagla, Zain ; Chan, Edmond S. ; Chan, Jeffrey ; Comberiatti, Pasquale ; Dribin, Timothy E. ; Ellis, Anne K. ; Fleischer, David M. ; Fox, Adam ; Frischmeyer-guerrerio, Pamela A. ; Gagnon, Remi ; Grayson, Mitchell H. ; Horner, Caroline C. ; Hourihane, Johnathan ; Katelaris, Constance H. ; Kim, Harold ; Kelso, John M. ; Lang, David ; Ledford, Dennis ; Levin, Michael ; Lieberman, Jay ; Loh, Richard ; Mack, Doug ; Mazer, Bruce ; Mosnaim, Gissele ; Munblit, Daniel ; Mustafa, S Shahzad ; Nanda, Anil ; Oppenheimer, John ; Perrett, Kirsten P. ; Ramsey, Allison ; Rank, Matt ; Robertson, Kara ; Shiek, Javed ; Spergel, Jonathan M. ; Stukus, David ; Tang, Mimi Lk. ; Tracy, James M. ; Turner, Paul J. ; Whalen-browne, Anna ; Wallace, Dana ; Wang, Julie ; Wasserman, Susan ; Witty, John K. ; Worm, Margitta ; Vander Leek, Timothy K. ; Golden, David Bk. / 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. In: The Journal of Allergy and Clinical Immunology: In Practice. 2021.

Bibtex

@article{301f2a3680ee4766a2932924bd049ef7,
title = "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",
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.",
author = "Matthew Greenhawt and Abrams, {Elissa M.} and Marcus Shaker and Chu, {Derek K.} and David Kahn and Cem Akin and Waleed Alqurashi and Peter Arkwright and Baldwin, {James L.} and Moshe Ben-shoshan and Jonathan Bernstein and Theresa Bingeman and Katerina Blumchen and Aideen Byrne and Antonio Bognanni and Dianne Campbell and Ronna Campbell and Zain Chagla and Chan, {Edmond S.} and Jeffrey Chan and Pasquale Comberiatti and Dribin, {Timothy E.} and Ellis, {Anne K.} and Fleischer, {David M.} and Adam Fox and Frischmeyer-guerrerio, {Pamela A.} and Remi Gagnon and Grayson, {Mitchell H.} and Horner, {Caroline C.} and Johnathan Hourihane and Katelaris, {Constance H.} and Harold Kim and Kelso, {John M.} and David Lang and Dennis Ledford and Michael Levin and Jay Lieberman and Richard Loh and Doug Mack and Bruce Mazer and Gissele Mosnaim and Daniel Munblit and Mustafa, {S Shahzad} and Anil Nanda and John Oppenheimer and Perrett, {Kirsten P.} and Allison Ramsey and Matt Rank and Kara Robertson and Javed Shiek and Spergel, {Jonathan M.} and David Stukus and Tang, {Mimi Lk.} and Tracy, {James M.} and Turner, {Paul J.} and Anna Whalen-browne and Dana Wallace and Julie Wang and Susan Wasserman and Witty, {John K.} and Margitta Worm and {Vander Leek}, {Timothy K.} and Golden, {David Bk.}",
year = "2021",
month = jun,
day = "18",
doi = "10.1016/j.jaip.2021.06.006",
language = "English",
journal = "The journal of allergy and clinical immunology. In practice",
issn = "2213-2201",
publisher = "Elsevier BV",

}

RIS

TY - JOUR

T1 - 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

AU - Greenhawt, Matthew

AU - Abrams, Elissa M.

AU - Shaker, Marcus

AU - Chu, Derek K.

AU - Kahn, David

AU - Akin, Cem

AU - Alqurashi, Waleed

AU - Arkwright, Peter

AU - Baldwin, James L.

AU - Ben-shoshan, Moshe

AU - Bernstein, Jonathan

AU - Bingeman, Theresa

AU - Blumchen, Katerina

AU - Byrne, Aideen

AU - Bognanni, Antonio

AU - Campbell, Dianne

AU - Campbell, Ronna

AU - Chagla, Zain

AU - Chan, Edmond S.

AU - Chan, Jeffrey

AU - Comberiatti, Pasquale

AU - Dribin, Timothy E.

AU - Ellis, Anne K.

AU - Fleischer, David M.

AU - Fox, Adam

AU - Frischmeyer-guerrerio, Pamela A.

AU - Gagnon, Remi

AU - Grayson, Mitchell H.

AU - Horner, Caroline C.

AU - Hourihane, Johnathan

AU - Katelaris, Constance H.

AU - Kim, Harold

AU - Kelso, John M.

AU - Lang, David

AU - Ledford, Dennis

AU - Levin, Michael

AU - Lieberman, Jay

AU - Loh, Richard

AU - Mack, Doug

AU - Mazer, Bruce

AU - Mosnaim, Gissele

AU - Munblit, Daniel

AU - Mustafa, S Shahzad

AU - Nanda, Anil

AU - Oppenheimer, John

AU - Perrett, Kirsten P.

AU - Ramsey, Allison

AU - Rank, Matt

AU - Robertson, Kara

AU - Shiek, Javed

AU - Spergel, Jonathan M.

AU - Stukus, David

AU - Tang, Mimi Lk.

AU - Tracy, James M.

AU - Turner, Paul J.

AU - Whalen-browne, Anna

AU - Wallace, Dana

AU - Wang, Julie

AU - Wasserman, Susan

AU - Witty, John K.

AU - Worm, Margitta

AU - Vander Leek, Timothy K.

AU - Golden, David Bk.

PY - 2021/6/18

Y1 - 2021/6/18

N2 - 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.

AB - 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.

U2 - 10.1016/j.jaip.2021.06.006

DO - 10.1016/j.jaip.2021.06.006

M3 - Article

JO - The journal of allergy and clinical immunology. In practice

JF - The journal of allergy and clinical immunology. In practice

SN - 2213-2201

ER -