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The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands

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Abstract

Introduction

The annual reformulation of the seasonal influenza vaccine results in fluctuating frequencies and severity of adverse effects following immunization (AEFIs), which stresses the importance of pharmacovigilance. Also, sex-related factors are known to influence the development of AEFIs. This study aims to describe the difference in incidence and course (i.e., time-to-onset, time-to-recovery, and perceived burden) of AEFIs between males and females after seasonal influenza vaccination.

Methods

We assessed data from cohort event monitoring studies, which were performed over nine consecutive years (2013–2021), each covering several months during the seasonal influenza campaign in the Netherlands. Participants reported information about AEFIs over a 30-day period in three questionnaires. The effect of sex, age, body mass index, study year, and comorbidities on the incidence of any AEFI, local reactions, fever and the five most reported AEFIs was analyzed using logistic regression. The difference in time-to-onset, time-to-recovery, and perceived burden between males and females was analyzed by the Kruskal–Wallis test.

Results

The cohort included 7789 participants (53.0% females). Females had around 2.5-fold (p < 0.001) higher odds of developing any AEFI compared with males. Some study years and comorbidities were positively associated with AEFI incidence, whereas age was negatively associated. An AEFI had a significant shorter time-to-onset, a longer time-to-recovery, and a higher perceived burden in females compared to males.

Conclusion

Overall, the results confirm that females experience AEFIs more often than males. Additionally, this study shows that the course of AEFIs only partially differs between the sexes.

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Authors and Affiliations

  1. Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch, The Netherlands

    P. Slingerland, Florence P. A. M. van Hunsel, T. Lieber, L. van Balveren & J. W. Duijster

Authors
  1. P. Slingerland
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  2. Florence P. A. M. van Hunsel
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  3. T. Lieber
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  4. L. van Balveren
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  5. J. W. Duijster
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Corresponding author

Correspondence to Florence P. A. M. van Hunsel.

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Funding

No funding was received for this study.

Conflicts of interest/Competing interests

The authors declare no relevant conflicts of interest.

Data availability

All data relevant to the study are included in the article or uploaded as Supplementary Information. The datasets for this manuscript are not publicly available because of the data protection policy of the Pharmacovigilance Centre Lareb. Requests to access the datasets should be directed to the first author and will be granted on reasonable request.

Code availability

The SQL statements for the data used in this article are not publicly available because of the data protection policy of Lareb. Requests to access the datasets should be directed to the corresponding author and will be granted on reasonable request.

Author contributions

L.v.B. designed the original cohort event monitoring (CEM) studies and performed data collection and cleaning. P.S., J.D., and F.v.H. designed the study part covering analysis of the total cohort data. J.D. and T.L. performed data aggregation, and L.v.B. and P.S. performed data preparation and preanalysis data coding. P.S. performed statistical data analysis and original draft preparation. All authors contributed to the article and approved the submitted version.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Ethical approval and consent to participate

If a study in the Netherlands is subject to the Medical Research Involving Human Subjects Act (WMO), it must undergo a review by an accredited Medical Research Ethics Committee or the central committee on research involving human subjects (CCMO). This study was deemed not to fall under the WMO act. The observational study was conducted in compliance with the Methodological Standards for ENCePP Study Protocols and Dutch national laws and regulations. The Netherlands Pharmacovigilance Centre Lareb is registered at the Dutch Data Protection Authority (College Bescherming Persoonsgegevens) under registration numbers 1315581 and 1315591. On the study website, background information about the study and a statement regarding the protection of the privacy of the participants involved is mentioned. Participants are informed that their data will be used for the purpose of the research and publication of study results. Informed consent is given upon participant’s registration on the study website.

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Slingerland, P., van Hunsel, F.P.A.M., Lieber, T. et al. The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands. Drug Saf 46, 1323–1334 (2023). https://doi.org/10.1007/s40264-023-01356-7

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