[en] Vaccination against COVID-19 constitutes a huge hope and a major challenge. For the first time in modern history, a global vaccination campaign has started worldwide in a short period of time and with products that were recently developed. Consequently, legitimate concerns regarding the safety and tolerability of COVID-19 vaccines arise.In line with international allergy societies, the Belgian Society for Allergy and Clinical Immunology (BelSACI) provides this statement to guide health care providers (general practitioners, specialists including allergists) and stakeholders.In this statement, we first review current evidence on allergic reactions to vaccines and the potential risk factors that have been identified.Second, we provide a risk stratification method that may be used as a worksheet during the vaccination campaign.Finally, we discuss the management of suspected or confirmed allergic reactions following vaccination.
Disciplines :
Dermatology
Author, co-author :
Tuyls, Sebastiaan; Sint Augustinus Ziekenhuis GZA, Antwerpen and UZ Leuven > Pulmonology Department
Van Der Brempt, Xavier; Clinique Saint-Luc, Bouge > Pulmonology Department and Allergopôle
Faber, Margaretha; Universitaire Ziekenhuizen Antwerpen and Universiteit Antwerpen > Allergology and Immunology Department, World Allergy Organization (WAO) Center of Excellence
GADISSEUR, Romy ; Centre Hospitalier Universitaire de Liège - CHU > Unilab > Laboratoire biochimie automatisée et analyses délocalisées
DEZFOULIAN, Bita ; Centre Hospitalier Universitaire de Liège - CHU > Autres Services Médicaux > Service de dermatologie
Schrijvers, Rik; KU Leuven > Department of Microbiology, Immunology and Transplantation, Allergy and Clinical Immunology Research Group
Froidure, Antoine; Cliniques Universitaires Saint-Luc ; Université Catholique de Louvain > Pulmonology Department, WAO Center of Excellence ; Institut de Recherche Expérimentale et Clinique
Language :
English
Title :
Allergic reactions to COVID-19 vaccines: statement of the Belgian Society for Allergy and Clinical Immunology (BelSACI)
Tyrrell CSB, Mytton OT, Gentry SV, et al. Managing intensive care admissions when there are not enough beds during the COVID-19 pandemic: a systematic review. Thorax. 2020; 76: 302–312. PubMed PMID: 33334908.
Kontis V, Bennett JE, Rashid T, et al. Magnitude, demographics and dynamics of the effect of the first wave of the COVID-19 pandemic on all-cause mortality in 21 industrialized countries. Nat Med. 2020; 26 (12): 1919–1928. PubMed PMID: 33057181.
Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med. 2020; 383 (25): 2451–2460. PubMed PMID: 32412710.
Piroth L, Cottenet J, Mariet AS, et al. Comparison of the characteristics, morbidity, and mortality of COVID-19 and seasonal influenza: a nationwide, population-based retrospective cohort study. Lancet Respir Med. 2020; 9: 251–259. PubMed PMID: 33341155.
Nurchis MC, Pascucci D, Sapienza M, et al. Impact of the burden of COVID-19 in Italy: results of disability-adjusted life years (DALYs) and productivity loss. Int J Environ Res Public Health. 2020; 17 (12): 4233. PubMed PMID: 32545827; PubMed Central PMCID: PMCPMC7345321.
Wiersinga WJ, Rhodes A, Cheng AC, et al. Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): a review. JAMA. 2020; 324 (8): 782–793. PubMed PMID: 32648899.
Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020; 383 (27): 2603–2615. PubMed PMID: 33301246; PubMed Central PMCID: PMCPMC7745181.
Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2020. PubMed PMID: 33378609; PubMed Central PMCID: PMCPMC7787219. DOI: 10.1056/NEJMoa2035389.
Voysey M, Clemens SAC, Madhi SA, et al. 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. PubMed PMID: 33306989; PubMed Central PMCID: PMCPMC7723445.
Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021; 397: 671–681. PubMed PMID: 33545094; PubMed Central PMCID: PMCPMC7852454.
Krause PR, Gruber MF. Emergency use authorization of COVID vaccines - safety and efficacy follow-up considerations. N Engl J Med. 2020; 383 (19): e107. PubMed PMID: 33064383.
Karafillakis E, Larson HJ, consortium A. The benefit of the doubt or doubts over benefits? A systematic literature review of perceived risks of vaccines in European populations. Vaccine. 2017; 35 (37): 4840–4850. PubMed PMID: 28760616.
Caubet JC, Ponvert C. Vaccine allergy. Immunol Allergy Clin North Am. 2014; 34 (3): 597–613, ix. PubMed PMID: 25017679.
Peng B, Wei M, Zhu FC, et al. The vaccines-associated Arthus reaction. Hum Vaccin Immunother. 2019; 15 (11): 2769–2777. PubMed PMID: 30945978; PubMed Central PMCID: PMCPMC6930064.
McNeil MM, DeStefano F. Vaccine-associated hypersensitivity. J Allergy Clin Immunol. 2018; 141 (2): 463–472. PubMed PMID: 29413255; PubMed Central PMCID: PMCPMC6602527.
Castells M. Diagnosis and management of anaphylaxis in precision medicine. J Allergy Clin Immunol. 2017; 140 (2): 321–333. PubMed PMID: 28780940.
Su JR, Moro PL, Ng CS, et al. Anaphylaxis after vaccination reported to the vaccine adverse event reporting system, 1990-2016. J Allergy Clin Immunol. 2019; 143 (4): 1465–1473. PubMed PMID: 30654049; PubMed Central PMCID: PMCPMC6580415.
Shimabukuro TT, Cole M, Su JR. Reports of anaphylaxis after receipt of mRNA COVID-19 vaccines in the US-December 14, 2020-January 18, 2021. JAMA. 2021; 325: 1101. PubMed PMID: 33576785.
Ruggeberg JU, Gold MS, Bayas JM, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007; 25 (31): 5675–5684. PubMed PMID: 17448577.
Motosue MS, Bellolio MF, Van Houten HK, et al. Risk factors for severe anaphylaxis in the United States. Ann Allergy Asthma Immunol. 2017; 119 (4): 356–61e2. PubMed PMID: 28958375.
Clark S, Wei W, Rudders SA, et al. Risk factors for severe anaphylaxis in patients receiving anaphylaxis treatment in US emergency departments and hospitals. J Allergy Clin Immunol. 2014; 134 (5): 1125–1130. PubMed PMID: 24985399.
Castells MC, Phillips EJ. Maintaining safety with SARS-CoV-2 vaccines. N Engl J Med. 2020; 384: 643–649. PubMed PMID: 33378605; PubMed Central PMCID: PMCPMC7787218.
Kozma GT, Meszaros T, Vashegyi I, et al. Pseudo-anaphylaxis to polyethylene glycol (PEG)-coated liposomes: roles of anti-PEG IgM and complement activation in a porcine model of human infusion reactions. ACS Nano. 2019; 13 (8): 9315–9324. PubMed PMID: 31348638.
Klimek L, Jutel M, Akdis CA, et al. ARIA-EAACI statement on severe allergic reactions to COVID-19 vaccines - an EAACI-ARIA position paper. Allergy. 2020. PubMed PMID: 33378789. DOI: 10.1111/all.14726.
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. PubMed PMID: 33452689. DOI: 10.1111/all.14739.
Rama TA, Moreira A, Castells M. mRNA COVID-19 vaccine is well tolerated in patients with cutaneous and systemic mastocytosis with mast cell activation symptoms and anaphylaxis. J Allergy Clin Immunol. 2021; 147: 877–878. PubMed PMID: 33485650; PubMed Central PMCID: PMCPMC7816615.
Garvey LH, Nasser S. Anaphylaxis to the first COVID-19 vaccine: is polyethylene glycol (PEG) the culprit? Br J Anaesth. 2020. PubMed PMID: 33386124; PubMed Central PMCID: PMCPMC7834677. DOI: 10.1016/j.bja.2020.12.020
Wenande E, Garvey LH. Immediate-type hypersensitivity to polyethylene glycols: a review. Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology. 2016; 46 (7): 907–922. PubMed PMID: 27196817.
Dhami S, Panesar SS, Roberts G, et al. Management of anaphylaxis: a systematic review. Allergy. 2014; 69 (2): 168–175. PubMed PMID: 24251536.
