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Efficacy of a rational algorithm to assess allergy risk in patients receiving the BNT162b2 vaccine
Institution:1. Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Milan, Italy;2. Vita-Salute San Raffaele University, Milan, Italy;3. Medical Affairs Department, IRCCS Ospedale San Raffaele, Milan, Italy;4. School of Hygiene and Public Health, Vita-Salute San Raffaele University, Milan, Italy;5. Anaesthesiology and Intensive Care Unit, IRCCS Ospedale San Raffaele, Milan, Italy;6. Haematology and Bone Marrow Transplantation Unit, IRCCS Ospedale San Raffaele, Milan, Italy
Abstract:Among 6146 hospital employees, 118 subjects with severe allergic background were identified through a screening questionnaire and stratified into 3 groups (Low-risk (LR), Intermediate (IR) and High-risk (HR) group), based on their allergic anamnesis.Data reports on hypersensitivity reactions (HypR) have been collected in both allergic and non-allergic subjects. Seventeen patients (14%) in the allergic population had a HypR after the first, the second or both doses. Skin manifestations were the most frequent ones. Allergic events were more frequent in HR (35%) than IR (10%; p = 0.005) or LR (0%; p = 0.074) subjects. No patient had anaphylaxis. All patients completed the vaccination schedule.13 HypR occurred in patients without severe allergic background (13/6028, 0,2%) including one (1/6148, 0.016% of total population) WAO grade-4 anaphylaxis.Our data suggest that BNT162b2 mRNA Covid-19 vaccine is relatively safe also in patients with severe allergic background; however, some precautions are required for high-risk patients.
Keywords:Anaphylaxis  COVID vaccine  Drug allergy  Mast cell disorders  Safety  Tryptase
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