OBJECTIVE: This study aimed to improve the post-marketing surveillance on mRNA anti-SARS-CoV-2 vaccines, characterizing the adverse events (AEs) after the first dose of mRNA BNT162b vaccine. The associations between the AEs and individuals' characteristics were explored. PATIENTS AND METHODS: All adult healthcare workers at Niguarda Hospital (Milan, Italy) who were referred for the first dose of vaccine were offered to participate in a cross-sectional survey during the second-dose administration, between 18 January and 7 February 2021. All participants completed a questionnaire about age, gender, weight, height, medical history, concurrent therapies, employment status, previous diagnosis/testing for SARS-CoV-2 infection, and a list of 24 AEs (solicited AEs). The development of at least one solicited AEs was the main outcome. AEs were stratified by the presence of injection-site symptoms, systemic symptoms or both, and the differences between strata were assessed as a secondary outcome. Biometric data and reports of a previous diagnosis of SARS-CoV-2 infection were also explored, as predictors of the main outcome. RESULTS: 7,014 healthcare workers were included. An incidence of 3 per 10.000 persons for serious AEs following the first administration of the mRNA BNT162b vaccine was found. An association between the development of non-serious AEs with young age, female gender, low body mass index, and previous history of SARSCoV- 2 was described. CONCLUSIONS: This real-life study supported data on the safety profile of the BNT162b2 mRNA vaccine. Our findings on the associations between the development of non-serious AEs with some individual characteristics may help physicians and patients make educated and informed medical decisions towards anti-COVID-19 vaccination.

Ughi, N., Del Gaudio, F., Dicuonzo, A., Orso, M., Micheloni, G., Puoti, M., et al. (2021). Host factors and history of SARS-CoV-2 infection impact the reactogenicity of BNT162b2 mRNA vaccine: Results from a cross-sectional survey on 7,014 workers in healthcare. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 25(24), 7985-7996 [10.26355/eurrev_202112_27649].

Host factors and history of SARS-CoV-2 infection impact the reactogenicity of BNT162b2 mRNA vaccine: Results from a cross-sectional survey on 7,014 workers in healthcare

Puoti M.;Zoppini L.;
2021

Abstract

OBJECTIVE: This study aimed to improve the post-marketing surveillance on mRNA anti-SARS-CoV-2 vaccines, characterizing the adverse events (AEs) after the first dose of mRNA BNT162b vaccine. The associations between the AEs and individuals' characteristics were explored. PATIENTS AND METHODS: All adult healthcare workers at Niguarda Hospital (Milan, Italy) who were referred for the first dose of vaccine were offered to participate in a cross-sectional survey during the second-dose administration, between 18 January and 7 February 2021. All participants completed a questionnaire about age, gender, weight, height, medical history, concurrent therapies, employment status, previous diagnosis/testing for SARS-CoV-2 infection, and a list of 24 AEs (solicited AEs). The development of at least one solicited AEs was the main outcome. AEs were stratified by the presence of injection-site symptoms, systemic symptoms or both, and the differences between strata were assessed as a secondary outcome. Biometric data and reports of a previous diagnosis of SARS-CoV-2 infection were also explored, as predictors of the main outcome. RESULTS: 7,014 healthcare workers were included. An incidence of 3 per 10.000 persons for serious AEs following the first administration of the mRNA BNT162b vaccine was found. An association between the development of non-serious AEs with young age, female gender, low body mass index, and previous history of SARSCoV- 2 was described. CONCLUSIONS: This real-life study supported data on the safety profile of the BNT162b2 mRNA vaccine. Our findings on the associations between the development of non-serious AEs with some individual characteristics may help physicians and patients make educated and informed medical decisions towards anti-COVID-19 vaccination.
Articolo in rivista - Articolo scientifico
Adverse events; Anti-COVID-19 vaccination; Healthcare workers; mRNA anti-SARS-CoV-2 vaccines; Post-marketing surveillance;
English
7985
7996
12
Ughi, N., Del Gaudio, F., Dicuonzo, A., Orso, M., Micheloni, G., Puoti, M., et al. (2021). Host factors and history of SARS-CoV-2 infection impact the reactogenicity of BNT162b2 mRNA vaccine: Results from a cross-sectional survey on 7,014 workers in healthcare. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 25(24), 7985-7996 [10.26355/eurrev_202112_27649].
Ughi, N; Del Gaudio, F; Dicuonzo, A; Orso, M; Micheloni, G; Puoti, M; Pani, A; Scaglione, F; Zoppini, L; Rossetti, C; Epis, O; Bellavia, G; Giroldi, S; Moreno, M; Bosio, M
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/352614
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