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.