| アブストラクト | BACKGROUND: Although multiple post-licensure studies demonstrated that coronavirus disease-2019 (COVID-19) vaccines are safe for use during pregnancy, none of them have identified a signal of disproportionate reporting. AIM: To assess the disproportionality in reported adverse events among pregnant persons receiving COVID-19 vaccination compared with influenza vaccines in spontaneous reporting databases. METHODS: Individual case safety reports (ICSRs) with COVID-19 vaccines (Pfizer, AstraZeneca, Moderna and Johnson & Johnson) and influenza vaccines were retrieved from spontaneous reporting databases in the Vaccine Adverse Event Report System (VAERS) and the EudraVigilance (EV) system between 1 December 2020 and 31 October 2023. Both datasets were combined through a common data model. Pregnancy-associated ICSRs were identified using adaptations to the European Medicines Agency (EMA) algorithm based on age groups and key medical conditions. We compared the disproportionate reporting of High-Level Terms (HLT) after COVID-19 vaccines of interest (e.g. mRNA vaccine) with another COVID-19 viral vector-based/protein subunit and influenza vaccines during pregnancy. The proportional reporting ratio (PRR) with 95% confidence intervals (CIs) was calculated using a combined dataset. PRR met the predefined criteria (PRR >/= 2, lower 95% CI >/= 2 and N >/= 3), confirming a potential signal of disproportionate reporting (SDR). RESULTS: A total of 22,383 pregnancy-related ICSRs were included. Five associations met the PRR threshold: inborn errors of steroid synthesis 35.1 (95% CI 7.8-158.3); non-site-specific embolism and thrombosis 15.9 (95% CI 3.1-82.2); general signs and symptoms not elsewhere classified (NEC) 11.17 (95% CI 3.3-38.1); peripheral nervous system disorders congenital NEC 4.2 (95% CI 2.3-7.7); and vascular anomalies congenital NEC 3.7 (95% CI 2.4-5.6), all associated with viral vector-based/protein subunit. CONCLUSIONS: Despite this analysis, several statistical disproportionalities were identified during pregnancy; the case-by-case analysis shows that embolism and thrombosis require prioritized investigation through proper causal inference studies. |
|---|
| ジャーナル名 | Drug safety |
|---|
| Pubmed追加日 | 2025/6/11 |
|---|
| 投稿者 | Roque-Pereira, Leonardo; Sisay, Malede Mequanent; Ogar, Comfort K; Duran, Carlos E; van Puijenbroek, Eugene; Weibel, Daniel; Verhamme, Katia; Sturkenboom, Miriam |
|---|
| 組織名 | Department of Data Science and Biostatistics, Julius Center for Health Sciences;and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.;L.RoquePereira@umcutrecht.nl.;Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for;Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.;PharmacoTherapy, Epidemiology, Economics, University of Groningen, Groningen;Research Institute of Pharmacy, Groningen, the Netherlands.;Pharmacovigilance Centre Lareb, 's-Hertogenbosch, the Netherlands.;Department of Medical Informatics, Erasmus University Medical Center, Rotterdam,;the Netherlands. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40495022/ |
|---|
