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Allergic Reactions to COVID-19 Vaccines: Statement of the Belgian Society for Allergy and Clinical Immunology (Belsaci)

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Allergic Reactions to COVID-19 Vaccines: Statement of the Belgian Society for Allergy and Clinical Immunology (Belsaci) Acta Clinica Belgica International Journal of Clinical and Laboratory Medicine ISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/yacb20 Allergic reactions to COVID-19 vaccines: statement of the Belgian Society for Allergy and Clinical Immunology (BelSACI) Sebastiaan Tuyls, Xavier Van Der Brempt, Margaretha Faber, Romy Gadisseur, Bita Dezfoulian, Rik Schrijvers & Antoine Froidureon behalf of the BelSACI To cite this article: Sebastiaan Tuyls, Xavier Van Der Brempt, Margaretha Faber, Romy Gadisseur, Bita Dezfoulian, Rik Schrijvers & Antoine Froidureon behalf of the BelSACI (2021): Allergic reactions to COVID-19 vaccines: statement of the Belgian Society for Allergy and Clinical Immunology (BelSACI), Acta Clinica Belgica, DOI: 10.1080/17843286.2021.1909447 To link to this article: https://doi.org/10.1080/17843286.2021.1909447 Published online: 01 Apr 2021. Submit your article to this journal Article views: 12 View related articles View Crossmark data Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=yacb20 ACTA CLINICA BELGICA https://doi.org/10.1080/17843286.2021.1909447 Allergic reactions to COVID-19 vaccines: statement of the Belgian Society for Allergy and Clinical Immunology (BelSACI) Sebastiaan Tuylsa*, Xavier Van Der Bremptb*, Margaretha Faber c, Romy Gadisseurd, Bita Dezfouliane, Rik Schrijversf and Antoine Froidure g,h on behalf of the BelSACI aPulmonology Department, Sint Augustinus Ziekenhuis GZA, Antwerpen and UZ Leuven, Leuven, Belgium; bPulmonology Department and Allergopôle, Clinique Saint-Luc, Bouge, Belgium; cAllergology and Immunology Department, World Allergy Organization (WAO) Center of Excellence, Universitaire Ziekenhuizen Antwerpen and Universiteit Antwerpen, Antwerpen, Belgium; dClinical Biology Department, CHU Liège and Université de Liège, Liège, Belgium; eDermatology Department, CHU Liège and Université de Liège, Liège, Belgium; fKU Leuven Department of Microbiology, Immunology and Transplantation, Allergy and Clinical Immunology Research Group, KU Leuven, Leuven, Belgium; gPulmonology Department, WAO Center of Excellence, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium; hInstitut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Bruxelles, Belgium ABSTRACT KEYWORDS Vaccination against COVID-19 constitutes a huge hope and a major challenge. For the first time COVID-19; vaccine; allergy; in modern history, a global vaccination campaign has started worldwide in a short period of anaphylaxis; adverse events 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 practi­ tioners, 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. Introduction coding mRNA for the Spike (S) protein of the corona­ The SARS-Cov-2-related disease 2019 (COVID-19) pan­ virus is injected, resulting in the production of demic currently affects most countries since S protein by the patient’s cells and subsequent immu­ March 2020 and results in an unprecedented burden nization. Of note, this technology has already been on health care systems [1] and death excess [2,3]. used in animal vaccines, but this is the first time in Overall mortality is substantially higher than that human vaccines. Two other vaccines are now available from other respiratory viruses like Influenza [4]. In (https://www.cbip.be), developed by AstraZeneca Belgium, the first and second waves peaked in April (AZT1222 vaccine) [9] and the Gamaleya Institute for and November 2020, respectively, with, for both Epidemiology and Microbiology (Gam-COVID-Vac, aka waves, close to 6,000 hospitalized patients including Sputnik V vaccine). These two are based on the recom­ almost 1,500 patients in intensive care units (ICU), binant adenovirus (rAd) technology, which consists in often requiring mechanical ventilation (www.scien the injection of coding DNA (cDNA) for the coronavirus sano.be). Beside the human losses, this pandemic has S protein, a non-replicative chimpanzee-originating already resulted in a very high cost from a socio- adenovirus being used as the vector [10]. This relatively economic perspective [5]. recent technique also results in the generation of spe­ To date, there is no effective treatment to cure cific antibodies toward the S protein. All four vaccines COVID-19, and current therapeutic measures only aim have been evaluated in phase III randomized trials, at dampening disease severity and mortality, with with efficacy rates ranging from 70% to more than sometimes conflicting results from different clinical 95% and a favourable safety profile, paving the way trials [6]. Fortunately, vaccines have been developed for their use in large populations across the globe. and are currently available: the first two vaccines hav­ Thus, the development of vaccines against COVID- ing shown efficiency are mRNA-based vaccines, devel­ 19 represents both a huge hope and a major challenge: oped by Pfizer-BioNTech and Moderna [7,8]. In brief, this is the first time in history that a worldwide CONTACT Antoine Froidure [email protected] Pulmonology Department, Cliniques Universitaires Saint-Luc and WAO Center of Excellence, Université Catholique de Louvain, Avenue Hippocrate 10, Bruxelles 1200, Belgium *These authors contributed equally to this work. © Belgian Society of Internal Medicine and Royal Belgian Society of Laboratory Medicine (2021) 2 S. TUYLS ET AL. vaccination campaign is undertaken in such a short administered, and only eight fatal events between period and in pandemic circumstances. This, along 1990 and 2016 [17]. with the relatively short period of time from develop­ In the two main studies that evaluated the effect of ment to availability of vaccines against COVID-19, has RNA vaccines against COVID-19 [7,8], the same number raised concerns regarding possible adverse events, of possible allergic reactions was observed in the trea­ especially allergic reactions [11]. Although precautions ted groups and the placebo groups: the events related are needed, unjustified mistrust toward vaccines [12] to hypersensitivity concerned 0.63% and 1.5% of the could slowdown the vaccination campaign, which patients who received Pfizer-BioNTech and Moderna would preclude to reach a sufficient vaccination cover­ vaccines, respectively, compared to 0.51% and 1.1% of age, and result in many unjustified resources to advice the patients in placebo groups in the same studies. from health care providers. Therefore, in line with the Additionally, the Food and Drug Administration (FDA) European Academy of Allergy and Clinical Immunology identified a weak signal suggesting more cases of (EAACI) and the Center for Disease Control (CDC), the hypersensitivity reactions in the vaccine group, but Belgian Society for Allergy and Clinical Immunology none of these reactions were severe or required the (BelSACI) wishes to provide the necessary indications administration of adrenaline. Note that patients with to caregivers and patients regarding the risk of allergic documented allergies to one of the vaccine compo­ reaction in case of administration of the vaccine nents were excluded from the studies. In addition, against COVID-19. patients with severe reactions associated with any vac­ cine were excluded from the Pfizer-BioNTech vaccine, those with a history of urticaria or anaphylaxis from the Current evidence on vaccine-related Moderna vaccine and those with a history of anaphy­ hypersensitivity laxis or angioedema from the AstraZeneca vaccine. The Vaccine-associated hypersensitivity reactions are rate of adverse allergic reactions was very low in both uncommon. Most adverse reactions to vaccines are phase III studies evaluating the efficacy of rAd vaccines, mild, including local swelling, pain, and localized with only one reported case of anaphylaxis for 12,021 rash. Those reactions are usually not reproducible patients having received the AZT1222 vaccine [9] and when the subject is re-exposed to the vaccine [13]. zero cases of anaphylaxis in the study on Sputnik III. Of note, local nodules are described in up to 20% of As the vaccination program for COVID-10 is under­ the patients receiving vaccines with an aluminium- way globally, real-life immunization data suggest that based adjuvant. Immunoglobulin (Ig)G-mediated anaphylaxis to these vaccines is rare. Recently, the delayed hypersensitivity (Arthus reaction) is rare Center for Disease Control (CDC) (https://www.cdc. and provokes a large and severe local reaction, gov) published two more detailed reports (Morbidity occurring within 72 hours, in sensitized individuals and Mortality Weekly Report, MMWR) on the docu­ [14]. Immediate hypersensitivity reactions are rare mented anaphylaxis cases at that time. For the Pfizer- to very rare but are important to identify, given BioNTech vaccine (MMWR 15 January 2021; 70:46–51 the large number of people vaccinated every year. https://www.cdc.gov/mmwr/volumes/70/wr/
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