Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy)
IntroductionAmong adverse events following immunization (AEFIs), allergic reactions elicit the most concern, as they are often unpredictable and can be life-threatening. Their estimates range from one in 1,000,000 to one in 50,000 vaccine doses. This report describes allergic events following immuni...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-02-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1074246/full |
| _version_ | 1797894357368438784 |
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| author | Pasquale Stefanizzi Davide Ferorelli Francesco Livio Scazzi Antonio Di Lorenzo Andrea Martinelli Chiara Trinchera Lorenza Moscara Enrico Miniello Danilo Di Bona Silvio Tafuri |
| author_facet | Pasquale Stefanizzi Davide Ferorelli Francesco Livio Scazzi Antonio Di Lorenzo Andrea Martinelli Chiara Trinchera Lorenza Moscara Enrico Miniello Danilo Di Bona Silvio Tafuri |
| author_sort | Pasquale Stefanizzi |
| collection | DOAJ |
| description | IntroductionAmong adverse events following immunization (AEFIs), allergic reactions elicit the most concern, as they are often unpredictable and can be life-threatening. Their estimates range from one in 1,000,000 to one in 50,000 vaccine doses. This report describes allergic events following immunization reported from 2020 to 2021 in Puglia, a region in the South-East of Italy with around 4 million inhabitants. Its main objective is to describe the allergic safety profile of currently employed vaccines.Materials and methodsThis is a retrospective observational study. The study period spanned from January 2020 to December 2021, and the whole Apulian population was included in the study. Information regarding AEFIs reported in Puglia during the study period was gathered from the Italian Drug Authority’s pharmacovigilance database (National Pharmacovigilance Network, RNF). The overall number of vaccine doses administered was extrapolated by the Apulian online immunization database (GIAVA). Reporting rates were calculated as AEFIs reported during a certain time span/number of vaccine doses administered during the same period.Results10,834,913 vaccine doses were administered during the study period and 95 reports of allergic AEFIs were submitted to the RNF (reporting rate 0.88/100,000 doses). 27.4% of the reported events (26/95) were classified as serious (reporting rate 0.24/100,000 doses). 68 out of 95 (71.6%) adverse events were at least partially resolved by the time of reporting and none of them resulted in the subject’s death.ConclusionsAllergic reactions following vaccination were rare events, thus confirming the favourable risks/benefits ratio for currently marketed vaccines. |
| first_indexed | 2024-04-10T07:07:40Z |
| format | Article |
| id | doaj.art-c84d67d3b5d943818c69caa321c8fbcc |
| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-04-10T07:07:40Z |
| publishDate | 2023-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj.art-c84d67d3b5d943818c69caa321c8fbcc2023-02-27T05:41:35ZengFrontiers Media S.A.Frontiers in Immunology1664-32242023-02-011410.3389/fimmu.2023.10742461074246Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy)Pasquale Stefanizzi0Davide Ferorelli1Francesco Livio Scazzi2Antonio Di Lorenzo3Andrea Martinelli4Chiara Trinchera5Lorenza Moscara6Enrico Miniello7Danilo Di Bona8Silvio Tafuri9Bari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyBari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyBari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyBari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyBari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyBari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyBari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyBari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyBari Policlinico General Hospital, Department of Emergency and Organ Transplantation, Bari, ItalyBari Policlinico General Hospital, Interdisciplinary Department of Medicine, Bari, ItalyIntroductionAmong adverse events following immunization (AEFIs), allergic reactions elicit the most concern, as they are often unpredictable and can be life-threatening. Their estimates range from one in 1,000,000 to one in 50,000 vaccine doses. This report describes allergic events following immunization reported from 2020 to 2021 in Puglia, a region in the South-East of Italy with around 4 million inhabitants. Its main objective is to describe the allergic safety profile of currently employed vaccines.Materials and methodsThis is a retrospective observational study. The study period spanned from January 2020 to December 2021, and the whole Apulian population was included in the study. Information regarding AEFIs reported in Puglia during the study period was gathered from the Italian Drug Authority’s pharmacovigilance database (National Pharmacovigilance Network, RNF). The overall number of vaccine doses administered was extrapolated by the Apulian online immunization database (GIAVA). Reporting rates were calculated as AEFIs reported during a certain time span/number of vaccine doses administered during the same period.Results10,834,913 vaccine doses were administered during the study period and 95 reports of allergic AEFIs were submitted to the RNF (reporting rate 0.88/100,000 doses). 27.4% of the reported events (26/95) were classified as serious (reporting rate 0.24/100,000 doses). 68 out of 95 (71.6%) adverse events were at least partially resolved by the time of reporting and none of them resulted in the subject’s death.ConclusionsAllergic reactions following vaccination were rare events, thus confirming the favourable risks/benefits ratio for currently marketed vaccines.https://www.frontiersin.org/articles/10.3389/fimmu.2023.1074246/fullvaccinationallergic eventsanaphylaxisAEFIssurveillancereporting rate |
| spellingShingle | Pasquale Stefanizzi Davide Ferorelli Francesco Livio Scazzi Antonio Di Lorenzo Andrea Martinelli Chiara Trinchera Lorenza Moscara Enrico Miniello Danilo Di Bona Silvio Tafuri Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy) Frontiers in Immunology vaccination allergic events anaphylaxis AEFIs surveillance reporting rate |
| title | Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy) |
| title_full | Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy) |
| title_fullStr | Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy) |
| title_full_unstemmed | Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy) |
| title_short | Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy) |
| title_sort | allergic adverse events following immunization data from post marketing surveillance in apulia region south of italy |
| topic | vaccination allergic events anaphylaxis AEFIs surveillance reporting rate |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1074246/full |
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