BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy
Millions of people have died because of the COVID-19 pandemic. The vaccination campaign helped tackle the pandemic and saved millions of lives. In a retrospective pharmacovigilance study, we explored the safety of the BNT162b2 (Comirnaty) vaccine among healthcare workers (HCWs) in a large Italian te...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-02-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/11/2/477 |
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| author | Flavia Beccia Luca Regazzi Eleonora Marziali Viria Beccia Domenico Pascucci Nadia Mores Giuseppe Vetrugno Patrizia Laurenti |
| author_facet | Flavia Beccia Luca Regazzi Eleonora Marziali Viria Beccia Domenico Pascucci Nadia Mores Giuseppe Vetrugno Patrizia Laurenti |
| author_sort | Flavia Beccia |
| collection | DOAJ |
| description | Millions of people have died because of the COVID-19 pandemic. The vaccination campaign helped tackle the pandemic and saved millions of lives. In a retrospective pharmacovigilance study, we explored the safety of the BNT162b2 (Comirnaty) vaccine among healthcare workers (HCWs) in a large Italian teaching hospital, and 2428 Adverse Events Reports (AERs) filed by HCWs after the administration of the first dose of vaccine were collected and analyzed, reporting the results quantitively and comparing them to the vaccine Summary of Product Characteristics (SPC). Spearman’s correlation coefficients were computed to investigate the correlation among reported adverse effects, and recurrent clusters of symptoms were investigated through the Principal Component Analysis (PCA) and k-means Cluster Analysis. The BNT162b2 vaccine’s safety profile was favorable, with predominant reports of early onset, mild, non-serious and short-term resolved symptoms. We observed higher than the expected frequency for various non-serious undesirable effects, especially among those listed and classified as less common in the SPC. Furthermore, we identified three clusters of adverse effects that were frequently reported together, defined by the presence/absence of fatigue, malaise, localized pain, chills, pyrexia, insomnia, nausea and injection site pain. Post-marketing pharmacovigilance activities, together with targeted public health interventions, can be valuable tools to promote vaccination and improve the control of the spread of the pandemic, especially in sensitive settings and populations such as hospitals and healthcare professionals. |
| first_indexed | 2024-03-11T08:02:06Z |
| format | Article |
| id | doaj.art-b18897e6c266436faf33d2bac59d8c93 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-11T08:02:06Z |
| publishDate | 2023-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-b18897e6c266436faf33d2bac59d8c932023-11-16T23:44:58ZengMDPI AGVaccines2076-393X2023-02-0111247710.3390/vaccines11020477BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in ItalyFlavia Beccia0Luca Regazzi1Eleonora Marziali2Viria Beccia3Domenico Pascucci4Nadia Mores5Giuseppe Vetrugno6Patrizia Laurenti7Section of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, 00168 Rome, ItalySection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, 00168 Rome, ItalySection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, 00168 Rome, ItalyMedical Oncology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, 00168 Rome, ItalySection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, 00168 Rome, ItalyDepartment of Pharmacology, Faculty of Medicine, Università Cattolica del Sacro Cuore, 00168 Rome, ItalyRisk Management Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, ItalySection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, 00168 Rome, ItalyMillions of people have died because of the COVID-19 pandemic. The vaccination campaign helped tackle the pandemic and saved millions of lives. In a retrospective pharmacovigilance study, we explored the safety of the BNT162b2 (Comirnaty) vaccine among healthcare workers (HCWs) in a large Italian teaching hospital, and 2428 Adverse Events Reports (AERs) filed by HCWs after the administration of the first dose of vaccine were collected and analyzed, reporting the results quantitively and comparing them to the vaccine Summary of Product Characteristics (SPC). Spearman’s correlation coefficients were computed to investigate the correlation among reported adverse effects, and recurrent clusters of symptoms were investigated through the Principal Component Analysis (PCA) and k-means Cluster Analysis. The BNT162b2 vaccine’s safety profile was favorable, with predominant reports of early onset, mild, non-serious and short-term resolved symptoms. We observed higher than the expected frequency for various non-serious undesirable effects, especially among those listed and classified as less common in the SPC. Furthermore, we identified three clusters of adverse effects that were frequently reported together, defined by the presence/absence of fatigue, malaise, localized pain, chills, pyrexia, insomnia, nausea and injection site pain. Post-marketing pharmacovigilance activities, together with targeted public health interventions, can be valuable tools to promote vaccination and improve the control of the spread of the pandemic, especially in sensitive settings and populations such as hospitals and healthcare professionals.https://www.mdpi.com/2076-393X/11/2/477COVID-19ComirnatyBNT162b2pharmacovigilancepandemicsafety |
| spellingShingle | Flavia Beccia Luca Regazzi Eleonora Marziali Viria Beccia Domenico Pascucci Nadia Mores Giuseppe Vetrugno Patrizia Laurenti BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy Vaccines COVID-19 Comirnaty BNT162b2 pharmacovigilance pandemic safety |
| title | BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy |
| title_full | BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy |
| title_fullStr | BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy |
| title_full_unstemmed | BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy |
| title_short | BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy |
| title_sort | bnt162b2 covid 19 vaccine safety among healthcare workers of a tertiary hospital in italy |
| topic | COVID-19 Comirnaty BNT162b2 pharmacovigilance pandemic safety |
| url | https://www.mdpi.com/2076-393X/11/2/477 |
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