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

被引：176

作者：

Greenhawt, Matthew ^{[1
]}

Abrams, Elissa M. ^{[2
]}

Shaker, Marcus ^{[3
]}

Chu, Derek K. ^{[4
,5
]}

Khan, David ^{[6
]}

Akin, Cem ^{[7
]}

Alqurashi, Waleed ^{[8
]}

Arkwright, Peter ^{[9
]}

Baldwin, James L. ^{[7
]}

Ben-Shoshan, Moshe ^{[10
]}

Bernstein, Jonathan ^{[11
]}

Bingemann, Theresa ^{[12
]}

Blumchen, Katharina ^{[13
]}

Byrne, Aideen ^{[14
]}

Bognanni, Antonio ^{[15
]}

Campbell, Dianne ^{[16
]}

Campbell, Ronna ^{[17
]}

Chagla, Zain ^{[18
]}

Chan, Edmond S. ^{[19
]}

Chan, Jeffrey ^{[20
]}

Comberiati, Pasquale ^{[21
,22
]}

Dribin, Timothy E. ^{[51
]}

Ellis, Anne K. ^{[23
]}

Fleischer, David M.

Fox, Adam ^{[24
]}

Frischmeyer-Guerrerio, Pamela A. ^{[25
]}

Gagnon, Remi ^{[26
]}

Grayson, Mitchell H. ^{[27
]}

Horner, Caroline C. ^{[28
]}

Hourihane, Jonathan ^{[29
]}

Katelaris, Constance H. ^{[30
]}

Kim, Harold ^{[31
,32
]}

Kelso, John M. ^{[33
]}

Lang, David ^{[34
,37
]}

Ledford, Dennis ^{[35
]}

Levin, Michael ^{[36
]}

Lieberman, Jay ^{[37
]}

Loh, Richard ^{[38
]}

Mack, Doug ^{[39
]}

MaZer, Bruce ^{[10
]}

Mosnaim, Giselle ^{[37
,40
]}

Munblit, Daniel ^{[41
,42
]}

Mustafa, S. ShahZad ^{[43
]}

Nanda, Anil ^{[44
]}

Oppenheimer, John ^{[45
]}

Perrett, Kirsten P. ^{[46
]}

Ramsey, Allison ^{[43
]}

Rank, Matthew ^{[47
,48
]}

Robertson, Kara ^{[49
]}

Sheikh, Javed ^{[50
]}

机构：

[1] Univ Colorado, Sch Med, Food Challenge & Res Unit, Sect Allergy & Clin Immunol,Childrens Hosp Colora, 13123 E 16th Ave, Aurora, CO 80045 USA

[2] Univ Manitoba, Sect Allergy & Immunol, Dept Pediat & Child Hlth, Winnipeg, MB, Canada

[3] Lebanon Dartmouth Geisel Sch Med, Sect Allergy & Immunol, Dartmouth Hitchcock Med Ctr, Hanover, NH USA

[4] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Dept Med, Hamilton, ON, Canada

[5] McMaster Univ, Res Inst St Joes Hamilton, Evidence Allergy Grp, Hamilton, ON, Canada

[6] Univ Texas Southwestern Med Ctr Dallas, Dept Med, Div Allergy & Immunol, Dallas, TX 75390 USA

[7] Univ Michigan Sch, Dept Internal Med, Div Allergy & Clin Immunol, Ann Arbor, MI USA

[8] Univ Ottawa, Dept Pediat & Emergency Med, Ottawa, ON, Canada

[9] Univ Manchester, Lydia Becker Inst Immunol & Inflammat, Manchester, Lancs, England

[10] McGill Univ, Montreal Childrens Hosp, Div Allergy Immunol & Dermatol, Dept Pediat,Hlth Ctr, Montreal, PQ, Canada

[11] Univ Cincinnati, Div Immunol, Dept Internal Med, Cincinnati, OH USA

[12] Univ Rochester, Sch Med & Dent, Div Allergy Immunol & Rheumatol, Rochester, NY USA

[13] Univ Hosp Frankfurt, Dept Paediat & Adolescent Med, Paediat Pneumol Allergol & Cyst Fibrosis, Frankfurt, Germany

[14] Childrens Hlth Ireland Crumlin, Crumlin, Ireland

[15] McMaster Univ, Evidence Allergy Grp, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada

[16] Childrens Hosp Westmead, Sydney, NSW, Australia

[17] Mayo Clin, Dept Emergency Med, Rochester, MI USA

[18] McMaster Univ, Dept Med, Div Infect Dis, Hamilton, ON, Canada

[19] Univ British Columbia, BC Childrens Hosp, Div Allergy & Immunol, Vancouver, BC, Canada

[20] Southlake Reg Med Ctr, Dept Emergency Med, Newmarket, ON, Canada

[21] Univ Pisa, Sect Pediat, Dept Clin & Expt Med, Pisa, Italy

[22] IM Sechenov First Moscow State Med Univ, Dept Clin Immunol & Allergol, Moscow, Russia

[23] Queens Univ, Dept Med, Div Allergy & Immunol, Kingston, ON, Canada

[24] Guys & St Thomas NHS Fdn Trust, London, England

[25] NIAID, NIH, Food Allergy Res Sect, Lab Allerg Dis, 9000 Rockville Pike, Bethesda, MD 20892 USA

[26] Allergie Capitale, Quebec City, PQ, Canada

[27] Ohio State Univ, Coll Med, Natl Childrens Hosp, Div Allergy & Immunol,Dept Clin Pediat, Columbus, OH 43210 USA

[28] Washington Univ, Sch Med, Dept Pediat, Div Allergy & Pulm Med, St Louis, MO 63110 USA

[29] Royal Coll Surg, Dept Paediat, Dublin, Ireland

[30] Univ Western Sydney, Campbelltown Hosp, Sydney, NSW, Australia

[31] Western Univ, London, ON, Canada

[32] McMaster Univ, Hamilton, ON, Canada

[33] Scripps Clin, Div Allergy Asthma & Immunol, San Diego, CA USA

[34] Cleveland Clin, Resp Inst, Dept Allergy & Clin Immunol, Cleveland, OH 44106 USA

[35] Univ South Florida Morsani, Coll Med, Dept Med, Div Allergy & Immunol, Tampa, FL 33620 USA

[36] Univ Cape Town, Fac Hlth Sci, Div Paediat Allergol, Cape Town, South Africa

[37] Univ Tennessee, Div Allergy & Immunol, Memphis, TN USA

[38] Perth Childrens Hosp, Immunol Dept, Perth, Australia

[39] McMaster Univ Hamilton, Halton Pediat Allergy, Burlington, ON, Canada

[40] NorthShore Univ Hlth Syst, Dept Med, Divis Pulm Allergy & Crit Care, Evanston, IL USA

[41] Sechenov Univ, Sechenov First Moscow State Med Univ, Inst Childs Hlth, Dept Paediat & Paediat Infect Dis, Moscow, Russia

[42] Imperial Coll London, Fac Med, Natl Heart & Lung Inst, Repair Dev Sect, London, England

[43] Univ Rochester, Sch Med & Dent, Rochester Reg Hlth, Rochester, NY USA

[44] Univ Texas Southwestern Med Ctr Dallas, Div Allergy & Immunol, Asthma & Allergy Ctr Lewisville & Flower Mound, Dallas, TX 75390 USA

[45] UMDMJ Rutgers Univ, Sch Med, New Brunswick, NJ USA

[46] Univ Melbourne, Murdoch Childrens Res Inst, Royal Childrens Hosp, Dept Paediat, Victoria, Parkville, Vic, Australia

[47] Mayo Clin, Div Allergy Asthma & Clin Immunol, Scottsdale, AZ USA

[48] Phoenix Childrens Hosp, Div Pulmonol, Phoenix, AZ USA

[49] Western Univ, Schulich Sch Med & Dent, Divis Clin Immunol & Allergy, St Josephs Hlth Care, London, ON, Canada

[50] Kaiser Permanente Los Angeles Med Ctr, Los Angeles, CA USA

来源：

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE | 2021年 / 9卷 / 10期

基金：

美国国家卫生研究院;

关键词：

SARS-CoV-2; COVID-19; Vaccination; Adenovirus-vector vaccine; mRNA vaccine; Anaphylaxis; Allergic reactions; Polyethylene glycol; Polysorbate; 80; Skin testing; Shared decision making; GRADE; Allergy; Allergy specialist; PRACTICE PARAMETER UPDATE; COVID-19; VACCINE; HYPERSENSITIVITY REACTIONS; MACROGOL HYPERSENSITIVITY; POLYETHYLENE-GLYCOLS; STRANDED-RNA; ANAPHYLAXIS; SAFETY; POLYSORBATE-80; BNT162B2;

D O I：

10.1016/j.jaip.2021.06.006

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

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. (C) 2021 American Academy of Allergy, Asthma & Immunology

引用

页码：3546 / 3567

页数：22

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