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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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Autores principales: Stefanizzi, Pasquale, De Nitto, Sara, Spinelli, Giuseppe, Lattanzio, Sabrina, Stella, Paolo, Ancona, Domenica, Dell’Aera, Maria, Padovano, Margherita, Soldano, Savino, Tafuri, Silvio, Bianchi, Francesco Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147936/
https://www.ncbi.nlm.nih.gov/pubmed/34064483
http://dx.doi.org/10.3390/vaccines9050456
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author Stefanizzi, Pasquale
De Nitto, Sara
Spinelli, Giuseppe
Lattanzio, Sabrina
Stella, Paolo
Ancona, Domenica
Dell’Aera, Maria
Padovano, Margherita
Soldano, Savino
Tafuri, Silvio
Bianchi, Francesco Paolo
author_facet Stefanizzi, Pasquale
De Nitto, Sara
Spinelli, Giuseppe
Lattanzio, Sabrina
Stella, Paolo
Ancona, Domenica
Dell’Aera, Maria
Padovano, Margherita
Soldano, Savino
Tafuri, Silvio
Bianchi, Francesco Paolo
author_sort Stefanizzi, Pasquale
collection PubMed
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.
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spelling pubmed-81479362021-05-26 Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study Stefanizzi, Pasquale De Nitto, Sara Spinelli, Giuseppe Lattanzio, Sabrina Stella, Paolo Ancona, Domenica Dell’Aera, Maria Padovano, Margherita Soldano, Savino Tafuri, Silvio Bianchi, Francesco Paolo Vaccines (Basel) Article 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. MDPI 2021-05-04 /pmc/articles/PMC8147936/ /pubmed/34064483 http://dx.doi.org/10.3390/vaccines9050456 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Stefanizzi, Pasquale
De Nitto, Sara
Spinelli, Giuseppe
Lattanzio, Sabrina
Stella, Paolo
Ancona, Domenica
Dell’Aera, Maria
Padovano, Margherita
Soldano, Savino
Tafuri, Silvio
Bianchi, Francesco Paolo
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study
title 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_short 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147936/
https://www.ncbi.nlm.nih.gov/pubmed/34064483
http://dx.doi.org/10.3390/vaccines9050456
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