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Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France

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Abstract

Introduction

In 2021, the massive Covid-19 vaccination campaign in France was accompanied by an intensified pharmacovigilance monitoring of their potential adverse drug reactions. The importance of this reporting might have led to an important selective reporting and overloading of Pharmacovigilance Centres, delaying the recording of some reports in the national pharmacovigilance database. In this context, we aimed to evaluate the impact of the Covid-19 vaccination campaign in France and related reports on spontaneous reporting of adverse drug reactions that were not related to the Covid-19 vaccine.

Methods

We performed time-series analyses considering the monthly number of adverse drug reactions reported between January 1, 2018 and April 30, 2022 using the French Pharmacovigilance database. The impact of the Covid-19 vaccination campaign on the monthly reporting not Covid-19 vaccine related was estimated using interrupted time-series. January 2021, marking the start of the campaign, was the intervention date in the models. Analyses were run globally first considering all adverse drug reaction reports, and second according to notifier type and to case seriousness.

Results

We included 170,294 reports registered in the French Pharmacovigilance database between January 1, 2018 and April 30, 2022 that were not Covid-19 vaccine-related. Among these, 77,067 (45.3%) were serious and 146,683 (86.1%) had been reported by health care professionals. The campaign start was associated with a nearly 35.0% decrease in average monthly reporting that was not Covid-19 vaccine-related, with a significant level decrease in the monthly number of reports of −658.0 (p < 10−3) immediately after the vaccination campaign start and a subsequent slope decrease of −50.0 (p < 10−3). This decrease was mainly due to a significant level and slope decrease (level: −739.2 p < 10−3; slope: −39 [p < 10−2]) for health care professional reports. A similar level decrease was found for the monthly number of both serious and non-serious reports (−402.3, p < 10−3; and −311.9, p = 10−2, respectively). According to the ATC 1 level, the decrease in the monthly number of reports showed similar patterns for all drugs. However, a potential increase in the number of serious reports suspecting antineoplastic and immunomodulating drugs (ATC L) or drugs targeting blood was observed (ATC B).

Conclusion

Our study showed a significant impact of the Covid-19 campaign vaccination in the reporting of adverse drug reactions that were not Covid-19 vaccine-related, of roughly 35%. This leads to a loss of information regarding the monitoring of drug safety that could have impacted the system capacity to detect safety signals for drugs other than Covid-19 vaccines.

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Acknowledgements

The authors would like to thank all members of the French Network of Pharmacovigilance Centres and the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) for the availability and the accuracy of the data.

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Authors and Affiliations

  1. INSERM, BPH, U1219 Team AHead, University of Bordeaux, 33000, Bordeaux, France

    Sibylle de Germay, Allison Singier, Francesco Salvo & Antoine Pariente

  2. Department of Medical Pharmacology, CHU of Bordeaux, 33000, Bordeaux, France

    Sibylle de Germay, Francesco Salvo & Antoine Pariente

Authors
  1. Sibylle de Germay
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  2. Allison Singier
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  3. Francesco Salvo
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  4. Antoine Pariente
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on behalf of the French Pharmacovigilance Network

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Correspondence to Sibylle de Germay.

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Funding

This research received no funding.

Conflict of interest

The authors declare no conflict of interest.

Ethics approval

In accordance with French regulations, formal approval by an investigational review board is not required for this type of study.

Consent to participate

As all data recorded in the French Pharmacovigilance database are anonymous, informed consent is waived.

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Not required.

Availability of data and material

The approval to access the anonymised data maintained by the French Network of Pharmacovigilance requires the data to be treated as confidential with protected and secure access. For this reason, the data cannot be shared publicly.

Code availability

The code will be made available upon reasonable request.

Author contributions

All authors contributed to the study conception and design. Validation of the data and analysis were performed by SG and AS. SG drafted the manuscript which was commented and reviewed by all authors. All authors read and approved the final manuscript.

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de Germay, S., Singier, A., Salvo, F. et al. Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France. Drug Saf 46, 1381–1389 (2023). https://doi.org/10.1007/s40264-023-01359-4

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