Allergies and COVID-19 vaccines: An ENDA/EAACI Position paper.
COVID-19 vaccine
allergy test
anaphylaxis
mRNA vaccines
risk assessment
Journal
Allergy
ISSN: 1398-9995
Titre abrégé: Allergy
Pays: Denmark
ID NLM: 7804028
Informations de publication
Date de publication:
08 2022
08 2022
Historique:
revised:
17
12
2021
received:
13
09
2021
accepted:
03
01
2022
pubmed:
4
2
2022
medline:
10
8
2022
entrez:
3
2
2022
Statut:
ppublish
Résumé
Anaphylaxis, which is rare, has been reported after COVID-19 vaccination, but its management is not standardized. Members of the European Network for Drug Allergy and the European Academy of Allergy and Clinical Immunology interested in drug allergy participated in an online questionnaire on pre-vaccination screening and management of allergic reactions to COVID-19 vaccines, and literature was analysed. No death due to anaphylaxis to COVID-19 vaccines has been confirmed in scientific literature. Potential allergens, polyethylene glycol (PEG), polysorbate and tromethamine are excipients. The authors propose allergy evaluation of persons with the following histories: 1-anaphylaxis to injectable drug or vaccine containing PEG or derivatives; 2-anaphylaxis to oral/topical PEG containing products; 3-recurrent anaphylaxis of unknown cause; 4-suspected or confirmed allergy to any mRNA vaccine; and 5-confirmed allergy to PEG or derivatives. We recommend a prick-to-prick skin test with the left-over solution in the suspected vaccine vial to avoid waste. Prick test panel should include PEG 4000 or 3500, PEG 2000 and polysorbate 80. The value of in vitro test is arguable. These recommendations will lead to a better knowledge of the management and mechanisms involved in anaphylaxis to COVID-19 vaccines and enable more people with history of allergy to be vaccinated.
Sections du résumé
BACKGROUND
Anaphylaxis, which is rare, has been reported after COVID-19 vaccination, but its management is not standardized.
METHOD
Members of the European Network for Drug Allergy and the European Academy of Allergy and Clinical Immunology interested in drug allergy participated in an online questionnaire on pre-vaccination screening and management of allergic reactions to COVID-19 vaccines, and literature was analysed.
RESULTS
No death due to anaphylaxis to COVID-19 vaccines has been confirmed in scientific literature. Potential allergens, polyethylene glycol (PEG), polysorbate and tromethamine are excipients. The authors propose allergy evaluation of persons with the following histories: 1-anaphylaxis to injectable drug or vaccine containing PEG or derivatives; 2-anaphylaxis to oral/topical PEG containing products; 3-recurrent anaphylaxis of unknown cause; 4-suspected or confirmed allergy to any mRNA vaccine; and 5-confirmed allergy to PEG or derivatives. We recommend a prick-to-prick skin test with the left-over solution in the suspected vaccine vial to avoid waste. Prick test panel should include PEG 4000 or 3500, PEG 2000 and polysorbate 80. The value of in vitro test is arguable.
CONCLUSIONS
These recommendations will lead to a better knowledge of the management and mechanisms involved in anaphylaxis to COVID-19 vaccines and enable more people with history of allergy to be vaccinated.
Substances chimiques
COVID-19 Vaccines
0
Vaccines
0
Vaccines, Synthetic
0
mRNA Vaccines
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2292-2312Informations de copyright
© 2022 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.
Références
Castells MC, Phillips EJ. Maintaining safety with SARS-CoV-2 vaccines. N Engl J Med. 2021;384(7):643-649.
Worm M, Bauer A, Wedi B, et al. Practical recommendations for the allergological risk assessment of the COVID-19 vaccination - a harmonized statement of allergy centers in Germany. Allergol Select. 2021;26(5):72-76.
https://www.forbes.com/sites/jvchamary/2020/11/29/coronavirus-vaccines-difference/
Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-416. doi:10.1056/NEJMoa2035389
Logunov DY, Dolzhikova IV, Zubkova OV, et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4. Erratum in: Lancet. 2021 Jan 9;397(10269):98.
Voysey M, Clemens SAC, Madhi SA, et al. Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98.
Livingston EH, Malani PN, Creech CB. The Johnson & Johnson vaccine for COVID-19. JAMA. 2021;325(15):1575.
Sadoff J, Le Gars M, Shukarev G, et al. Interim results of a phase 1-2a trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. 2021;384(23):2187-2201.
Magnusson SE, Altenburg AF, Bengtsson KL, et al. Matrix-M™ adjuvant enhances immunogenicity of both protein- and modified vaccinia virus Ankara-based influenza vaccines in mice. Immunol Res. 2018;66(2):224-233.
Zhang Y, Zeng G, Pan H, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21(2):181-192.
- Ng WH, Liu X, Mahalingam S. Development of vaccines for SARS-CoV-2. F1000Research. 2020;9:991.
Stone CA Jr, Rukasin CRF, Beachkofsky TM, Phillips EJ. Immune-mediated adverse reactions to vaccines. Br J ClinPharmacol. 2019;85(12):2694-2706.
Kelso JM, Greenhawt MJ, Li JT, et al. Adverse reactions to vaccines practice parameter 2012 update. J Allergy Clin Immunol. 2012;130(1):25-43.
Su JR, Moro PL, Ng CS, Lewis PW, Said MA, Cano MV. Anaphylaxis after vaccination reported to the vaccine adverse event reporting system, 1990-2016. Journal of Allergy and Clinical Immunology. 2019;143(4):1465-1473.
COVID-19 Response Team; Food and Drug Administration. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine - United States. December 14-23, 2020. MMWR Morb Mortal Wkly Rep. 2021;70(2):46-51.
Shimabukuro T, Nair N. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine. JAMA. 2021;325(8):780-781.
- Greenhawt M, Abrams EM, Shaker M, et al. 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. J Allergy Clin Immunol Pract. 2021; published online. June 18. https://doi.org/10.1016/j.jaip.2021.06.006
Bruusgaard-Mouritsen MA, Johansen JD, Garvey LH. Clinical manifestations and impact on daily life of allergy to polyethylene glycol (PEG) in ten patients. Clin Exp Allergy. 2021;51(3):463-470.
Garvey LH, Nasser S. Anaphylaxis to the first COVID-19 vaccine: is polyethylene glycol (PEG) the culprit? Br J Anaesth. 2021;126(3):e106-e108.
Cabanillas B, Akdis C, Novak N. Allergic reactions to the first COVID-19 vaccine: a potential role of Polyethylene glycol? Allergy. 2021;76(6):1617-1618.
Klimek L, Novak N, Cabanillas B, Jutel M, Bousquet J, Akdis CA. Allergenic components of the mRNA-1273 vaccine for COVID-19: possible involvement of polyethylene glycol and IgG-mediated complement activation. Allergy. 2021;76(11):3307-3313. doi:10.1111/all.14794
https://www.cdc.gov/mmwr/volumes/70/wr/mm7004e1.htm#:~:text=Early%20safety%20monitoring%20of%20Moderna,allergic%20reactions%2C%20based%20on%20U.S
https://ansm.sante.fr/dossiers-thematiques/covid-19-suivi-hebdomadaire-des-cas-deffets-indesirables-des-vaccins
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-0
- Rüggeberg JU, Gold MS, Bayas JM, et al. Brighton Collaboration Anaphylaxis Working Group. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675-5684.
Sokolowska M, Eiwegger T, Ollert M, et al. EAACI statement on the diagnosis, management and prevention of severe allergic reactions to COVID-19 vaccines. Allergy. 2021;76(6):1629-1639.
Banerji A, Wickner PG, Saff R, et al. mRNA vaccines to prevent COVID-19 disease and reported allergic reactions: current evidence and suggested approach. J Allergy Clin Immunol Pract. 2020;S2213-2198(20):31411-31412.
Turner PJ, Ansotegui IJ, Campbell DE, et al. COVID-19 vaccine-associated anaphylaxis: a statement of the world allergy organization anaphylaxis committee. World Allergy Organ J. 2021;14(2):100517.
Wenande E, Garvey LH. Immediate-type hypersensitivity to polyethylene glycols: a review. ClinExp Allergy. 2016;46(7):907-922.
Amsler E, Al-Raddadi R, Frances C. Allergic contact dermatitis caused by PEG-22/dodecyl glycol copolymer in a skin-repairing cream. Contact Dermatitis. 2017;77(1):54-55.
Antolin-Amerigo D, Sánchez-González MJ, Barbarroja-Escudero J, Rodríguez-Rodríguez M, Álvarez-Perea A, Alvarez-Mon M. Allergicreaction to polyethyleneglycol in a painter. Occup Med OxfEngl. 2015;65:502-504.
Corazza M, Virgili A, Ricci M, Bianchi A, Borghi A. Contact sensitization to emulsifying agents: an underrated issue? Dermat Contact Atopic Occup Drug. 2016;27:276-281.
Özkaya E, Kılıç S. Polyethylene glycol as marker for nitrofurazone allergy: 20 years of experience from Turkey. ContactDermatitis. 2018;78(3):211-215.
Pizzimenti S, Heffler E, Gentilcore E, et al. Macrogol hypersensitivity reactions during cleansing preparation for colon endoscopy. J Allergy Clin Immunol Pract. 2014;2:353-354.
Armstrong JK, Hempel G, Koling S, et al. Antibody against poly(ethylene glycol) adversely affects PEG-asparaginase therapy in acute lymphoblastic leukemia patients. Cancer. 2007;110:103-111.
Rau RE, Dreyer Z, Choi MR, et al. Outcome of pediatric patients with acute lymphoblastic leukemia/lymphoblastic lymphoma with hypersensitivity to pegaspargase treated with PEGylated Erwinia asparaginase, pegcrisantaspase: A report from the Children’s Oncology Group. Pediatr Blood Cancer. 2018;65(3):10.1002.
Borderé A, Stockman A, Boone B, et al. A case of anaphylaxis caused by macrogol 3350 after injection of a corticosteroid. Contact Dermatitis. 2012;67:376-378.
Co-Minh HB, Demoly P, Guillot B, Raison-Peyron N. Anaphylactic shock after oral intake and contact urticaria due to polyethylene glycols. Allergy. 2007;62:92-93.
Valois A, Waton J, Avenel-Audran M, et al. Dermatology and Allergy group (GAD) of the French Society of Dermatology. Contact sensitization to modern dressings: a multicentre study on 354 patients with chronic leg ulcers. Contact Dermatitis. 2015;72(2):90-96.
Barbaud A, Collet E, Le Coz CJ, Meaume S, Gillois P. Contact allergy in chronic leg ulcers: results of a multicentre study carried out in 423 patients and proposal for an updated series of patch tests. Contact Dermatitis. 2009;60(5):279-287.
Palacios Castaño MI, Venturini Díaz M, LoberaLabairu T, González Mahave I, Del Pozo Gil MD, BlascoSarramián A. Anaphylaxis due to the excipient polysorbate 80. J Investig Allergol Clin Immunol. 2016;26:394-396.
Badiu I, Geuna M, Heffler E, Rolla G. Hypersensitivity reaction to human papillomavirus vaccine due to polysorbate 80. BMJ Case Rep. 2012;2012:bcr0220125797
Kozma GT, Shimizu T, Ishida T, Szebeni J. Anti-PEG antibodies: Properties, formation, testing and role in adverse immune reactions to PEGylated nano-biopharmaceuticals. Adv Drug Deliv Rev. 2020;154-155:163-175.
Stone CA, Liu Y, Relling MV, et al. Immediate hypersensitivity to polyethylene glycols and polysorbates: more common than we have recognized. J Allergy Clin Immunol Pract. 2019;7:1533-1540.e8.
Povsic TJ, Lawrence MG, Lincoff AM, et al. Pre-existing anti-PEG antibodies are associated with severe immediate allergic reactions to pegnivacogin, a PEGylated aptamer. J Allergy Clin Immunol. 2016;138:1712-1715.
Zhou Z-H, Stone CA, Jakubovic B, et al. Anti-PEG IgE in anaphylaxis associated with polyethylene glycol. J Allergy Clin Immunol Pract. 2021;9(4):1731-1733.
Calogiuri G, Foti C, Bilo MB, Garvey LH. macrogols: misleading cause of drug hypersensitivity diagnosis. Clin Immunol Endocr Metabol Drugs. 2017;4:9-13.
Kounis NG, Koniari I, de Gregorio C, et al. Allergic reactions to current available COVID-19 vaccinations: pathophysiology, causality, and therapeutic considerations. Vaccines (Basel). 2021;9(3):221.
Gabizon A, Szebeni J. Complement activation: a potential threat on the safety of poly(ethylene glycol)-coated nanomedicines. ACS Nano. 2020;14:7682-7688.
Schwartzberg LS, Navari RM. Safety of polysorbate 80 in the oncology setting. Adv Ther. 2018;35:754-767.
Weiszhár Z, Czúcz J, Révész C, Rosivall L, Szebeni J, Rozsnyay Z. Complement activation by polyethoxylated pharmaceutical surfactants: Cremophor-EL, Tween-80 and Tween-20. Eur J Pharm Sci. 2012;45:492-498.
Perino E, Freymond N, Devouassoux G, Nicolas JF, Berard F. Xolair-induced recurrent anaphylaxis through sensitization to the excipient polysorbate. Ann Allergy Asthma Immunol. 2018;120(6):664-666.
Limaye S, Steele RH, Quin J, Cleland B. An allergic reaction to erythropoietin secondary to polysorbate hypersensitivity. J Allergy Clin Immunol. 2002;110:530.
Castells MC, Tennant NM, Sloane DE, et al. Hypersensitivity reactions to chemotherapy: outcomes and safety of rapid desensitization in 413 cases. J Allergy Clin Immunol. 2008;122:574-580.
Russo PA, Banovic T, Wiese MD, Whyte AF, Smith WB. Systemic allergy to EDTA in local anesthetic and radiocontrast media. J Allergy Clin Immunol Pract. 2014;2(2):225-229.e1.
Scala E, Giani M, Pirrotta L, et al. Selective severe anaphylactic reaction due to ketorolac tromethamine without nonsteroidal anti-inflammatory drug intolerance. J Allergy Clin Immunol. 2001;107(3):557.
Novembre E, Calogero C, Mori F, et al. Biphasic anaphylactic reaction to Ketorolac tromethamine. Int J ImmunopatholPharmacol. 2006;19(2):449-450.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/978187/Greenbook_chapter_14a_v7_12Feb2021.pdf
Muraro A, Halken S, Arshad SH, et al. EAACI food allergy and anaphylaxis guidelines group. EAACI food allergy and anaphylaxis guidelines. Primary prevention of food allergy. Allergy. 2014;69(5):590-601.
Dreskin SC, Halsey NA, Kelso JM, et al. International Consensus (ICON): allergic reactions to vaccines. World Allergy Organ J. 2016;9(1):32.
Rojas-Pérez-Ezquerra P, Crespo Quirós J, Tornero Molina P, Ochoa B, de Ocáriz ML, Zubeldia Ortuño JM. Safety of new MRNA Vaccines Against COVID-19 in Severe Allergic Patients. J Investig Allergol Clin Immunol. 2021;31(2):180-181.
Barbaud A, Weinborn M, Garvey LH, et al. Intradermal tests with drugs: an approach to standardization. Front Med (Lausanne). 2020;15(7):156.
Garvey LH, Ebo DG, Mertes PM, et al. An EAACI position paper on the investigation of perioperative immediate hypersensitivity reactions. Allergy. 2019;74(10):1872-1884.
Marcelino J, Farinha S, Silva R, Didenko I, Proença M, Tomás E. Non-irritant concentrations for skin testing with SARS-CoV-2 mRNA Vaccine. J Allergy Clin Immunol Pract. 2021;9(6):2476-2477.
Lukawska J, Mandaliya D, Chan AWE, et al. Anaphylaxis to trometamol excipient in gadolinium-based contrast agents for clinical imaging. J Allergy Clin Immunol Pract. 2019;7(3):1086-1087.
Bruusgaard-Mouritsen MA, Jensen BM, Poulsen LK, Johansen JD, Garvey LH. Optimizing investigation of suspected allergy 1 to polyethylene glycols. J Allergy Clin Immunol. 2021;S0091-6749(21):00825-833.
Johnston MS, Galan A, Watsky KL, Little AJ. Delayed localized hypersensitivity reactions to the moderna COVID-19 vaccine: a case series. JAMA Dermatol. 2021;157(6):716-720.
McMahon DE, Amerson E, Rosenbach M, et al. Cutaneous reactions reported after Moderna and Pfizer COVID-19 vaccination: a registry-based study of 414 cases. J Am Acad Dermatol. 2021;85(1):46-55.
Català A, Muñoz-Santos C, Galván-Casas C, et al. Cutaneous reactions after SARS-CoV-2 vaccination: a cross-sectional Spanish nationwide study of 405 cases*. Br J Dermatol. 2022;186(1):142-152. doi: 10.1111/bjd.20639
Munavalli GG, Knutsen-Larson S, Lupo MP, Geronemus RG. Oral angiotensin-converting enzyme inhibitors for treatment of delayed inflammatory reaction to dermal hyaluronic acid fillers following COVID-19 vaccination-a model for inhibition of angiotensin II-induced cutaneous inflammation. JAAD Case Rep. 2021;10:63-68.
Bonadonna P, Brockow K, Niedoszytko M, et al. COVID-19 vaccination in mastocytosis: recommendations of the European Competence Network on Mastocytosis (ECNM) and American Initiative in Mast Cell Diseases (AIM). J Allergy Clin Immunol Pract. 2021;9(6):2139-2144.
Bommarito L, Mietta S, Nebiolo F, Geuna M, Rolla G. Macrogol hypersensitivity in multiple drug allergy. Ann Allergy Asthma Immunol. 2011;107:542-543.
Jover Cerdá V, Rodríguez Pacheco R, Doménech Witek J, Marco de la Calle FM, de la Sen Fernández ML. de la Sen Fernández ML. Immediate hypersensitivity to polyethylene glycols in unrelated products: when standardization in the nomenclature of the components of drugs, cosmetics, and food becomes necessary. Allergy Asthma. Clin Immunol. 2019;19(15):9.
Troelnikov A, Perkins G, Yuson C, et al. Basophil reactivity to BNT162b2 is mediated by PEGylated lipid nanoparticles in patients with PEG allergy. J Allergy Clin Immunol. 2021;148(1):91.
Labella M, Céspedes JA, Doña I, et al. The value of the basophil activation test in the evaluation of patients reporting allergic reactions to the BNT162b2 mRNA COVID-19 vaccine. Allergy. 2022;77(7):2067-2079. doi:10.1111/all.15148
Wenande EC, Skov PS, Mosbech H, Poulsen LK, Garvey LH. Inhibition of polyethylene glycol-induced histamine release by monomeric ethylene and diethylene glycol: a case of probable polyethylene glycol allergy. J Allergy Clin Immunol. 2013;131(5):1425-1427.