Skip to main content
2024 ISPE Annual Meeting Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back

Pregnancy and lactation

Session: Poster Session B

(248) Cohort event monitoring of COVID-19 vaccine safety using patient-reported outcomes in pregnant women.

Tuesday, August 27, 2024
8:00 AM – 6:00 PM CEST
Location: Convention Hall II

    Presenting Author(s)

  • Emeline Maisonneuve, MD (she/her/hers)

    PhD student
    Institute of Primary Health Care (BIHAM)
    Bern, Switzerland

    • Co-Author(s)

  • FC

    Francesco Ciccimarra

    Department of Diagnostics and Public Health, University of Verona
    Verona, Italy

  • NL

    Nicoletta Luxi

    Department of Medicine, University of Verona
    Verona, Italy

  • CB

    Chiara Bellitto, MS (she/her/hers)

    Post-graduate student
    Department of Diagnostics and Public Health, University of Verona, Verona, Italy
    Verona, Italy

  • MR

    Monika Raethke

    Netherlands Pharmacovigilance Centre Lareb
    ’s Hertogenbosch, Netherlands

  • Florence P.A.M van Hunsel, PharmD, PhD

    Lead Safety Innovation
    Netherlands Pharmacovigilance Centre Lareb
    'S-Hertogenbosch, Netherlands

  • TL

    Thomas Lieber

    Netherlands Pharmacovigilance Centre Lareb
    ’s Hertogenbosch, Netherlands

  • EM

    Erik Mulder

    Netherlands Pharmacovigilance Centre Lareb, Netherlands

  • FR

    Fabio Riefolo, PhD

    Medical Writer
    Teamit Institute, Partnership, Barcelona Health Hub, Barcelona, Spain.
    Barcelona, Spain

  • FV

    Felipe Villalobos, MD, PhD

    Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
    Barcelona, Spain

  • Nicolas H. Thurin, PharmD, PhD

    Special consultant
    Bordeaux PharmacoEpi, INSERM CIC-P 1401, Université de Bordeaux
    Bordeaux, France

  • FB

    Francisco Batel Marques

    Laboratory of Social Pharmacy and Public Health, School of Pharmacy, University of Coimbra
    Coimbra, Portugal

  • KM

    Kathryn Morton

    Drug Safety Research Unit
    Southampton, United Kingdom

  • FO

    Fergal O'Shaughnessy

    Rotunda Hospital
    Dublin, Ireland

  • SS

    Simona Sonderlichová

    Faculty of Medicine, SLOVACRIN, Pavol Jozef Šafárik University in Košice
    Košice, Slovakia

  • AF

    Andreea Farcas

    Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Romania

  • SS

    Satu J. Siiskonen

    Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands, Netherlands

  • DB

    David Baud

    Materno-Fetal and Obstetrics Research Unit, Department Woman-Mother-Child, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland, Switzerland

  • JG

    Janneke Giele-Eshuis

    Department of Data Science and Biostatistics, University Medical Centre Utrecht
    Utrecht, Netherlands

  • Miriam C.J.M. Sturkenboom, PhD

    Professor
    Department of Data Science & Biostatistics, Julius Global Health, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands
    Utrecht, Netherlands

  • Gianluca Trifirò, MD, FISPE

    Full Professor of Pharmacology
    Università di Verona
    Verona, Italy

  • AP

    Alice Panchaud

    Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Service of Pharmacy, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland, Switzerland

Background: COVID-19 vaccination is still only accepted by half of pregnant women in Europe. Further scientific evidence on the safety of the COVID-19 vaccine could help overcome vaccine hesitancy in this population.

Objectives: To describe and compare the incidence of local and systemic solicited adverse drug reactions (ADRs) following the booster dose of different COVID-19 vaccines in pregnant women versus the general female population.

Methods:

Design: Web-based prospective observational cohort event monitoring study.
Setting: In eight European countries between February 2021 and November 2022, pregnant women, and women from the general population, who received a booster dose of COVID-19 vaccine, were included in the study if they registered within 48 hours after vaccination and completed at least the baseline questionnaire and one follow-up questionnaire.
Exposure: mRNA COVID-19 vaccine of different brands used for booster dose.
Main outcome measures: The proportion of solicited ADRs following the booster dose by vaccine brand was computed across participating countries in pregnant and non-pregnant women.
Statistical analysis: Descriptive analysis of medical characteristics of pregnant vaccinees, and a random sample (1:4 ratio) of age- and vaccine brand-matched vaccinees from the general female population. Comparison of the proportion of solicited local and systemic ADRs in pregnant and non-pregnant vaccinees, following a booster dose of mRNA COVID-19 vaccine, and stratified by vaccine brand.

Results: Overall, 359 pregnant women were matched with 1,432 women from the general population. Medical history by organ system was comparable between both groups, except for mental health conditions which were higher in the non-pregnant cohort and overweight/obesity which was higher in the pregnant cohort.
The non-pregnant women reported occurrence of at least one solicited ADR more frequently (72.3%) than the pregnant women (56.4%). Regarding local ADRs, non-pregnant women reported significantly more pain (48.0% vs 38.8%), and more swelling (19.6% vs 10.1%). As for systemic ADRs, non-pregnant women reported all symptoms more frequently (e.g. arthralgia, chills, fatigue, headache, malaise, myalgia, and pyrexia) than pregnant women, except nausea, which was similar between both groups. Moreover, solicited ADRs were more frequent after Spikevax (Moderna) than after Comirnaty (Pfizer/BioNtech) booster vaccines for pregnant (69% vs 50.8%) as well as for non-pregnant women (77.4% vs 69.8%).

Conclusions: This prospective study on COVID-19 vaccine safety monitoring showed that non-pregnant vaccinated women from the general population reported solicited ADRs more frequently than pregnant vaccinated women.