Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study
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 safet...
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doaj-a198d15698fe4cecab0d6ede33100b652021-05-31T23:12:16ZengMDPI AGVaccines2076-393X2021-05-01945645610.3390/vaccines9050456Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational StudyPasquale Stefanizzi0Sara De Nitto1Giuseppe Spinelli2Sabrina Lattanzio3Paolo Stella4Domenica Ancona5Maria Dell'Aera6Margherita Padovano7Savino Soldano8Silvio Tafuri9Francesco Paolo Bianchi10Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70124 Bari, ItalyDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70124 Bari, ItalyDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70124 Bari, ItalyDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70124 Bari, ItalyRegional Center for Pharmacovigilance, 52100 Puglia, ItalyRegional Center for Pharmacovigilance, 52100 Puglia, ItalyDepartment of Pharmacy, Bari Policlinico General Hospital, 70124 Bari, ItalyDepartment of Pharmacy, Bari Policlinico General Hospital, 70124 Bari, ItalyHealth Hospital Management, Bari Policlinico General Hospital, 70124 Bari, ItalyDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70124 Bari, ItalyDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70124 Bari, ItalySince 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. The study was carried out in a sample of HCWs of Policlinico General University-Hospital (Apulia, South Italy). AEFIs were classified as ‘serious’ or ‘not serious’ according to the WHO (World Health Organization) guidelines; the WHO causality assessment algorithm was applied to classify serious AEFIs. A total of 741 HCWs were enrolled, and 430 AEFIs (reporting rate: 58.0 (95%CI: 54.4–61.6) × 100 enrolled) were recorded. Of these, 429 of 430 (99.8%; reporting rate: 57.8 (95%CI: 54.2–61.5) × 100 enrolled) were classified as not serious and one (0.2%; reporting rate: 0.13 (0.03–0.75) × 100 enrolled) was classified as serious. Local reactions were the adverse reaction reported most frequently (88%); regarding the serious AEFI, causality assessment excluded the causal link with the administration of the vaccine. All the AEFIs resolved without sequelae. Flucelvax Tetra showed a profile of high safety. Due to their characteristics of greater sensitivity than passive surveillance, active surveillance programs can be useful in defining the safety profiles of a given vaccine/drug in certain population subgroups.https://www.mdpi.com/2076-393X/9/5/456post-marketing active surveillancevaccinationinfluenzacausality assessmentadverse reactions |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Pasquale Stefanizzi Sara De Nitto Giuseppe Spinelli Sabrina Lattanzio Paolo Stella Domenica Ancona Maria Dell'Aera Margherita Padovano Savino Soldano Silvio Tafuri Francesco Paolo Bianchi |
spellingShingle |
Pasquale Stefanizzi Sara De Nitto Giuseppe Spinelli Sabrina Lattanzio Paolo Stella Domenica Ancona Maria Dell'Aera Margherita Padovano Savino Soldano Silvio Tafuri Francesco Paolo Bianchi Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study Vaccines post-marketing active surveillance vaccination influenza causality assessment adverse reactions |
author_facet |
Pasquale Stefanizzi Sara De Nitto Giuseppe Spinelli Sabrina Lattanzio Paolo Stella Domenica Ancona Maria Dell'Aera Margherita Padovano Savino Soldano Silvio Tafuri Francesco Paolo Bianchi |
author_sort |
Pasquale Stefanizzi |
title |
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study |
title_short |
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study |
title_full |
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study |
title_fullStr |
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study |
title_full_unstemmed |
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study |
title_sort |
post-marketing active surveillance of adverse reactions following influenza cell-based quadrivalent vaccine: an italian prospective observational study |
publisher |
MDPI AG |
series |
Vaccines |
issn |
2076-393X |
publishDate |
2021-05-01 |
description |
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. The study was carried out in a sample of HCWs of Policlinico General University-Hospital (Apulia, South Italy). AEFIs were classified as ‘serious’ or ‘not serious’ according to the WHO (World Health Organization) guidelines; the WHO causality assessment algorithm was applied to classify serious AEFIs. A total of 741 HCWs were enrolled, and 430 AEFIs (reporting rate: 58.0 (95%CI: 54.4–61.6) × 100 enrolled) were recorded. Of these, 429 of 430 (99.8%; reporting rate: 57.8 (95%CI: 54.2–61.5) × 100 enrolled) were classified as not serious and one (0.2%; reporting rate: 0.13 (0.03–0.75) × 100 enrolled) was classified as serious. Local reactions were the adverse reaction reported most frequently (88%); regarding the serious AEFI, causality assessment excluded the causal link with the administration of the vaccine. All the AEFIs resolved without sequelae. Flucelvax Tetra showed a profile of high safety. Due to their characteristics of greater sensitivity than passive surveillance, active surveillance programs can be useful in defining the safety profiles of a given vaccine/drug in certain population subgroups. |
topic |
post-marketing active surveillance vaccination influenza causality assessment adverse reactions |
url |
https://www.mdpi.com/2076-393X/9/5/456 |
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