June 13, 2025

A real-life multicenter experience for the post-pandemic management of hypersensitivity reactions to Covid-19 vaccines

Alessandra Arcolaci, Lucia Guidolin, Elisa Olivieriet al. Vaccine Volume 61 2025,127337, https://doi.org/10.1016/j.vaccine.2025.127337.

Abstract

The management of patients with immediate hypersensitivity reactions (IHSR) to COVID-19 vaccines and their components, polyethylene glycol (PEG) 2000 and polisorbate 80 (PS80), has evolved since the beginning of the vaccination campaign. Despite the end of the pandemics, ensuring safe access to COVID-19 vaccination remains critical, especially for individuals with underlying health conditions.

In this retrospective study, we evaluated 333 patients who underwent a standardized allergy work-up, including skin testing (ST) with vaccine components, to assess their eligibility for COVID-19 vaccination. 155 patients had a history of IHSRs to PEG-containing drugs, and 178 reported a IHSR following a prior vaccine dose.

The majority (92 %) tested negative and were safely vaccinated. Among the 8 % tested positive, 66.7 % tolerated re-vaccination without any reactions. These findings highlight the overall safety of COVID-19 vaccination, even in patients considered at risk for allergic reactions, and challenge the necessity of routine ST for vaccine eligibility. Moreover, the observation that most reactions occurred after the first dose, and that patients with prior IHSRs were often safely re-vaccinated – frequently with the same vaccine — question the role of an IgE-mediated mechanism of the reactions and confirm the safety of vaccination. In conclusion, patients deemed at risk for COVID-19 vaccine-related IHSRs were safely vaccinated, supporting a more selective approach to allergy work-up and the importance of evidence-based risk assessment.

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