Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study
<b>Background:</b> Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to asse...
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MDPI AG
2024-09-01
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| Online Access: | https://www.mdpi.com/2076-393X/12/9/1059 |
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| author | Nicoletta Luxi Francesco Ciccimarra Chiara Bellitto Monika Raethke Florence van Hunsel Thomas Lieber Erik Mulder Luca L’Abbate Francisco Batel Marques Fabiana Furci Andreea Farcas Janneke Giele-Eshuis Kathryn Morton Simona Sonderlichová Nicolas H. Thurin Felipe Villalobos Fabio Riefolo Miriam C. Sturkenboom Gianluca Trifirò |
| author_facet | Nicoletta Luxi Francesco Ciccimarra Chiara Bellitto Monika Raethke Florence van Hunsel Thomas Lieber Erik Mulder Luca L’Abbate Francisco Batel Marques Fabiana Furci Andreea Farcas Janneke Giele-Eshuis Kathryn Morton Simona Sonderlichová Nicolas H. Thurin Felipe Villalobos Fabio Riefolo Miriam C. Sturkenboom Gianluca Trifirò |
| author_sort | Nicoletta Luxi |
| collection | DOAJ |
| description | <b>Background:</b> Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs. those without a history of allergy. <b>Methods:</b> From February 2021 to February 2023, a web-based prospective study gathered vaccinee-reported outcomes using electronic questionnaires across eleven European countries. Baseline and up to six follow-up questionnaires captured data on vaccinee demographics, as well as both solicited and unsolicited adverse reactions. <b>Results:</b> Overall, 3476 vaccinees with a history of allergy were matched with 13,872 vaccinees from the general population at the first vaccination cycle and were included in the analysis. A total of 825 vaccinees with a history of allergy who had received a booster dose, matched to 3297 vaccinees from the general population, were included in the analysis. Higher rates of ADRs occurred after the first vaccination cycle compared to after the booster dose (64–91% vs. 56–79%). However, most reported ADRs were solicited and not serious, and no case of anaphylaxis was reported. Women and vaccinees with a history of allergy reported ADRs more frequently than men and the matched controls, respectively. Compared to other COVID-19 vaccines, a higher proportion of vaccinees experiencing at least one ADR following their first vaccination cycle was observed with Comirnaty and Vaxzevria. Statistically significant differences were observed among the study cohorts for median TTO after the second dose, and for median TTR following the first vaccination cycle and booster dose (<i>p</i> < 0.001). <b>Conclusions:</b> Typically, any drug or vaccine use carries a risk of severe allergic reactions, yet the benefits of vaccination generally outweigh these potential risks, as shown with the COVID-19 vaccines. |
| format | Article |
| id | doaj-art-32268c14cfcb43ab9d7ed72fffc2eb4a |
| institution | OA Journals |
| issn | 2076-393X |
| language | English |
| publishDate | 2024-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj-art-32268c14cfcb43ab9d7ed72fffc2eb4a2025-08-20T01:55:57ZengMDPI AGVaccines2076-393X2024-09-01129105910.3390/vaccines12091059Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance StudyNicoletta Luxi0Francesco Ciccimarra1Chiara Bellitto2Monika Raethke3Florence van Hunsel4Thomas Lieber5Erik Mulder6Luca L’Abbate7Francisco Batel Marques8Fabiana Furci9Andreea Farcas10Janneke Giele-Eshuis11Kathryn Morton12Simona Sonderlichová13Nicolas H. Thurin14Felipe Villalobos15Fabio Riefolo16Miriam C. Sturkenboom17Gianluca Trifirò18Department of Medicine, University of Verona, 37134 Verona, ItalyDepartment of Diagnostics and Public Health, University of Verona, 37134 Verona, ItalyDepartment of Diagnostics and Public Health, University of Verona, 37134 Verona, ItalyNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH ’s-Hertogenbosch, The NetherlandsNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH ’s-Hertogenbosch, The NetherlandsNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH ’s-Hertogenbosch, The NetherlandsNetherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH ’s-Hertogenbosch, The NetherlandsDepartment of Diagnostics and Public Health, University of Verona, 37134 Verona, ItalyLaboratory of Social Pharmacy and Public Health, School of Pharmacy, University of Coimbra, 3000-548 Coimbra, PortugalProvincial Healthcare Unit, Section of Allergy, 89900 Vibo Valentia, ItalyPharmacovigilance Research Center, Iuliu Hatieganu University of Medicine and Pharmacy, 400347 Cluj-Napoca, RomaniaDepartment of Data Science and Biostatistics, Julius Global Health, University Medical Centre Utrecht, 3584 Utrecht, The NetherlandsDrug Safety Research Unit, Southampton SO31 1AA, UKFaculty of Medicine, SLOVACRIN, Pavol Jozef Šafárik University in Košice, 040 01 Košice, SlovakiaUniversity of Bordeaux, INSERM CIC-P 1401, Bordeaux PharmacoEpi, 146 rue Léo Saignat, 33076 Bordeaux, FranceFundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), 08007 Barcelona, SpainTeamit Institute, Partnerships, Barcelona Health Hub, 08025 Barcelona, SpainDepartment of Data Science and Biostatistics, Julius Global Health, University Medical Centre Utrecht, 3584 Utrecht, The NetherlandsDepartment of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy<b>Background:</b> Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs. those without a history of allergy. <b>Methods:</b> From February 2021 to February 2023, a web-based prospective study gathered vaccinee-reported outcomes using electronic questionnaires across eleven European countries. Baseline and up to six follow-up questionnaires captured data on vaccinee demographics, as well as both solicited and unsolicited adverse reactions. <b>Results:</b> Overall, 3476 vaccinees with a history of allergy were matched with 13,872 vaccinees from the general population at the first vaccination cycle and were included in the analysis. A total of 825 vaccinees with a history of allergy who had received a booster dose, matched to 3297 vaccinees from the general population, were included in the analysis. Higher rates of ADRs occurred after the first vaccination cycle compared to after the booster dose (64–91% vs. 56–79%). However, most reported ADRs were solicited and not serious, and no case of anaphylaxis was reported. Women and vaccinees with a history of allergy reported ADRs more frequently than men and the matched controls, respectively. Compared to other COVID-19 vaccines, a higher proportion of vaccinees experiencing at least one ADR following their first vaccination cycle was observed with Comirnaty and Vaxzevria. Statistically significant differences were observed among the study cohorts for median TTO after the second dose, and for median TTR following the first vaccination cycle and booster dose (<i>p</i> < 0.001). <b>Conclusions:</b> Typically, any drug or vaccine use carries a risk of severe allergic reactions, yet the benefits of vaccination generally outweigh these potential risks, as shown with the COVID-19 vaccines.https://www.mdpi.com/2076-393X/12/9/1059COVID-19 vaccinesadverse reactionsallergy historysafety profileanaphylaxis |
| spellingShingle | Nicoletta Luxi Francesco Ciccimarra Chiara Bellitto Monika Raethke Florence van Hunsel Thomas Lieber Erik Mulder Luca L’Abbate Francisco Batel Marques Fabiana Furci Andreea Farcas Janneke Giele-Eshuis Kathryn Morton Simona Sonderlichová Nicolas H. Thurin Felipe Villalobos Fabio Riefolo Miriam C. Sturkenboom Gianluca Trifirò Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study Vaccines COVID-19 vaccines adverse reactions allergy history safety profile anaphylaxis |
| title | Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study |
| title_full | Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study |
| title_fullStr | Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study |
| title_full_unstemmed | Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study |
| title_short | Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study |
| title_sort | safety of covid 19 vaccines among people with history of allergy a european active surveillance study |
| topic | COVID-19 vaccines adverse reactions allergy history safety profile anaphylaxis |
| url | https://www.mdpi.com/2076-393X/12/9/1059 |
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