Introduction: A mass vaccination campaign against SARS-CoV-2 was initiated in European countries on December 27, 2020. This study compared the antibody response in a sample of healthcare workers (HCWs) who, after the first dose of the BNT162b2 mRNA vaccine, were infected with SARS-CoV-2 (infection group) with the response in a control group of HCWs immunized with two doses (vaccine group).
Methods: This two-arm observational cohort study was carried out using routine health surveillance data obtained from HCWs at Bari Policlinico General Hospital (Italy).
Since the influenza season 2018/19, the Italian Ministry of Health recommended a dose of cell-based quadrivalent vaccine (Flucelvax Tetra) for HCWs (healthcare workers), because this vaccine seemed more efficacious in the prevention of AH3N2 virus. Due to the lack of pre-registration data, the safety profile of this new vaccine must be investigated in post-marketing surveillance. The aim of our study is to evaluate, through a post-marketing active surveillance program developed during the 2019/20 influenza season, any Adverse Events Following Immunization (AEFIs) that happened in the 7 days after immunization with Flucelvax Tetra.
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