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Pregnancy and lactation

Session: Poster Session B

(279) Maternal outcomes in women receiving COVID-19 vaccination during pregnancy compared with influenza vaccines in spontaneous reporting databases

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

    Presenting Author(s)

  • Leonardo Roque-Pereira, PharmD, MSc

    PhD Candidate
    Department Datascience & Biostatistics, Global Health, University Medical Center Utrecht, United Kingdom

    • Co-Author(s)

  • Malede Sisay, MSc

    PhD candidate
    University Medical Center Utrecht, Utrecht, the Netherlands, Netherlands

  • CD

    Carlos E. Durán, MD, PhD

    Assistant Professor
    Department of Data Science and Biostatistics, University Medical Center Utrecht
    Utrecht, Netherlands

  • DW

    Daniel Weibel

    Vaccine monitoring Collaboration for Europe VAC4EU, 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

Background: Pregnant people were not included in the pivotal COVID-19 vaccine trials but many pregnant people were vaccinated.

Objectives: Identify potential disproportionality in reported adverse events in pregnant people receiving COVID-19 vaccination compared to adverse events reported with influenza vaccines in spontaneous reporting databases from US and Europe.

Methods: We used quantitative signal detection algorithms (SDA) on data from the Vaccine Adverse Event Reporting System (VAERS) and Eudravigilance system. Methods included Proportional reporting ratio (PRR), time to onset, reporting odds ratio (ROR), Multi-Item Gamma Poisson Shrinker (MGPS), Bayesian Confidence Propagation Neural Network (BCPN) and Regression-Adjusted Gamma Poisson Shrinker (RGPS). Individual case reports (ICSRs) included ICSR related to COVID-19 vaccines (i.e., Pfizer, Astrazeneca, Moderna, and JnJ) and influenza vaccines received between December 1, 2020, to October 31. We identified the pregnancy related ICSRs through the MedDRA dictionary codes.

Results: A total of 937,180 of ICSRs associated with COVD-19 and Influenza vaccines in VAERS were retrieved. Of them, 13,722 were abortion & stillbirth cases and 636 of cases were maternal complications. The PRR of abortion and stillbirth was 1.98 (IC95% 1.63-2.41) whereas the PRR of maternal complications is 1.88 (IC95% 1.27-2.79).

Conclusions: Initial crude PRR analysis showed minor disproportionality on abortion and still birth and maternal complications for COVID-19 vaccines.