Introduction
In December 2021, the vaccination campaigns against the COVID-19 pandemic were initiated on an international level. Soon after authorization, reports on severe allergic reactions and anaphylaxis in the context of SARS-CoV-2 vaccination raised the alertness particularly in patients with a history of previous severe allergic reactions, atopic diseases and other allergic manifestations [1]. Until now four SARS-CoV-2 vaccines have been licensed in Germany: the mRNA vaccines Comirnaty® (BioNTech Manufacturing GmbH) and Spikevax® (MODERNA BIOTECH SPAIN, S.L.) and the vector vaccines Vaxzevria® (AstraZeneca AB) and COVID-19 vaccine Janssen® (Johnson & Johnson).
Vaccine related side effects may be caused by the excipients of the mRNA and vector vaccines, polyethylene glycol (PEG)/ polysorbate 80 (PS80) [2, 3]. Based on previous experience systemic allergic reactions to vaccines are very rare and range between 1-5 cases per 1 one million applications [4]. Regarding the Pfizer/ BioNTech BNT162B2 (Comirnaty®) SARS-CoV-2 Vaccine, by January 2021 4.7 cases of allergic reactions occurred per 1 one million applications in the US [5].
Herewith we established a multicenter protocol for individuals with suspected SARS-CoV-2 vaccination hypersensitivity within German Comprehensive Allergy Centers (CAC) (Berlin, Giessen, Göttingen, Hannover, Leipzig, Marburg, Dresden, Munich, Aachen, Oldenburg) and other large allergy centers in Germany (Augsburg, Bochum, Kiel, Köln, Freiburg, Hamburg, Leverkusen, Wiesbaden) in order to identify IgE-mediated hypersensitivity against SARS-CoV-2 vaccines as well as their excipients and to evaluate the frequency and characteristics of patients with respective hypersensitivities.