tetano
Editor, Senior Moderator
Vaccines (Basel)
. 2021 May 4;9(5):456.
doi: 10.3390/vaccines9050456.
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study
Pasquale Stefanizzi[SUP] 1 [/SUP], Sara De Nitto[SUP] 1 [/SUP], Giuseppe Spinelli[SUP] 1 [/SUP], Sabrina Lattanzio[SUP] 1 [/SUP], Paolo Stella[SUP] 2 [/SUP], Domenica Ancona[SUP] 2 [/SUP], Maria Dell'Aera[SUP] 3 [/SUP], Margherita Padovano[SUP] 3 [/SUP], Savino Soldano[SUP] 4 [/SUP], Silvio Tafuri[SUP] 1 [/SUP], Francesco Paolo Bianchi[SUP] 1 [/SUP]
Affiliations
Abstract
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.
Keywords: adverse reactions; causality assessment; influenza; post-marketing active surveillance; vaccination.
. 2021 May 4;9(5):456.
doi: 10.3390/vaccines9050456.
Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study
Pasquale Stefanizzi[SUP] 1 [/SUP], Sara De Nitto[SUP] 1 [/SUP], Giuseppe Spinelli[SUP] 1 [/SUP], Sabrina Lattanzio[SUP] 1 [/SUP], Paolo Stella[SUP] 2 [/SUP], Domenica Ancona[SUP] 2 [/SUP], Maria Dell'Aera[SUP] 3 [/SUP], Margherita Padovano[SUP] 3 [/SUP], Savino Soldano[SUP] 4 [/SUP], Silvio Tafuri[SUP] 1 [/SUP], Francesco Paolo Bianchi[SUP] 1 [/SUP]
Affiliations
- PMID: 34064483
- DOI: 10.3390/vaccines9050456
Abstract
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.
Keywords: adverse reactions; causality assessment; influenza; post-marketing active surveillance; vaccination.