Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature
BackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess d...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-01-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1078736/full |
| _version_ | 1828051396924014592 |
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| author | Janneke W. Duijster Thomas Lieber Silvia Pacelli Silvia Pacelli Leontine Van Balveren Loes S. Ruijs Monika Raethke Agnes Kant Florence Van Hunsel |
| author_facet | Janneke W. Duijster Thomas Lieber Silvia Pacelli Silvia Pacelli Leontine Van Balveren Loes S. Ruijs Monika Raethke Agnes Kant Florence Van Hunsel |
| author_sort | Janneke W. Duijster |
| collection | DOAJ |
| description | BackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess differences in the incidence and course of reported AEFIs after COVID-19 vaccination between males and females in the Netherlands and provides a summary of sex-disaggregated outcomes in published literature.MethodsPatient reported outcomes of AEFIs over a six month period following the first vaccination with BioNTech-Pfizer, AstraZeneca, Moderna or the Johnson&Johnson vaccine were collected in a Cohort Event Monitoring study. Logistic regression was used to assess differences in incidence of ‘any AEFI’, local reactions and the top ten most reported AEFIs between the sexes. Effects of age, vaccine brand, comorbidities, prior COVID-19 infection and the use of antipyretic drugs were analyzed as well. Also, time-to-onset, time-to-recovery and perceived burden of AEFIs was compared between the sexes. Third, a literature review was done to retrieve sex-disaggregated outcomes of COVID-19 vaccination.ResultsThe cohort included 27,540 vaccinees (38.5% males). Females showed around two-fold higher odds of having any AEFI as compared to males with most pronounced differences after the first dose and for nausea and injection site inflammation. Age was inversely associated with AEFI incidence, whereas a prior COVID-19 infection, the use of antipyretic drugs and several comorbidities were positively associated. The perceived burden of AEFIs and time-to-recovery were slightly higher in females.DiscussionThe results of this large cohort study correspond to existing evidence and contribute to the knowledge gain necessary to disentangle the magnitude of the effect sex in response to vaccination. Whilst females have a significant higher probability of experiencing an AEFI than males, we observed that the course and burden is only to a minor extent different between the sexes. |
| first_indexed | 2024-04-10T19:37:07Z |
| format | Article |
| id | doaj.art-e6838dc9bde3458db2fe2e02932acff8 |
| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-04-10T19:37:07Z |
| publishDate | 2023-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Immunology |
| spelling | doaj.art-e6838dc9bde3458db2fe2e02932acff82023-01-30T04:53:57ZengFrontiers Media S.A.Frontiers in Immunology1664-32242023-01-011410.3389/fimmu.2023.10787361078736Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literatureJanneke W. Duijster0Thomas Lieber1Silvia Pacelli2Silvia Pacelli3Leontine Van Balveren4Loes S. Ruijs5Monika Raethke6Agnes Kant7Florence Van Hunsel8Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsNetherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsNetherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsSchool of Pharmacy, Biotechnology, and Sport Sciences, University of Bologna, Bologna, ItalyNetherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsNetherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsNetherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsNetherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsNetherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsBackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess differences in the incidence and course of reported AEFIs after COVID-19 vaccination between males and females in the Netherlands and provides a summary of sex-disaggregated outcomes in published literature.MethodsPatient reported outcomes of AEFIs over a six month period following the first vaccination with BioNTech-Pfizer, AstraZeneca, Moderna or the Johnson&Johnson vaccine were collected in a Cohort Event Monitoring study. Logistic regression was used to assess differences in incidence of ‘any AEFI’, local reactions and the top ten most reported AEFIs between the sexes. Effects of age, vaccine brand, comorbidities, prior COVID-19 infection and the use of antipyretic drugs were analyzed as well. Also, time-to-onset, time-to-recovery and perceived burden of AEFIs was compared between the sexes. Third, a literature review was done to retrieve sex-disaggregated outcomes of COVID-19 vaccination.ResultsThe cohort included 27,540 vaccinees (38.5% males). Females showed around two-fold higher odds of having any AEFI as compared to males with most pronounced differences after the first dose and for nausea and injection site inflammation. Age was inversely associated with AEFI incidence, whereas a prior COVID-19 infection, the use of antipyretic drugs and several comorbidities were positively associated. The perceived burden of AEFIs and time-to-recovery were slightly higher in females.DiscussionThe results of this large cohort study correspond to existing evidence and contribute to the knowledge gain necessary to disentangle the magnitude of the effect sex in response to vaccination. Whilst females have a significant higher probability of experiencing an AEFI than males, we observed that the course and burden is only to a minor extent different between the sexes.https://www.frontiersin.org/articles/10.3389/fimmu.2023.1078736/fullCOVID-19 vaccinesexadverse event after vaccinationpatient reported outcomepharmacovigilancelongitudinal cohort design |
| spellingShingle | Janneke W. Duijster Thomas Lieber Silvia Pacelli Silvia Pacelli Leontine Van Balveren Loes S. Ruijs Monika Raethke Agnes Kant Florence Van Hunsel Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature Frontiers in Immunology COVID-19 vaccine sex adverse event after vaccination patient reported outcome pharmacovigilance longitudinal cohort design |
| title | Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature |
| title_full | Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature |
| title_fullStr | Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature |
| title_full_unstemmed | Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature |
| title_short | Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature |
| title_sort | sex disaggregated outcomes of adverse events after covid 19 vaccination a dutch cohort study and review of the literature |
| topic | COVID-19 vaccine sex adverse event after vaccination patient reported outcome pharmacovigilance longitudinal cohort design |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2023.1078736/full |
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