| アブストラクト | BACKGROUND: There is limited evidence on the safety of coronavirus disease 2019 (COVID-19) vaccination during pregnancy and lactation. Thus, we aimed to evaluate the association between COVID-19 vaccination during pregnancy and lactation and reporting risk of adverse pregnancy or lactation outcomes. METHODS: Using VigiBase, we performed a disproportionality analysis with case/non case design. Cases were defined based on the Standardized MedDRA Queries (SMQs) of "pregnancy and neonatal topics" and non-cases were defined as all other adverse events. We included all reports with COVID-19 vaccines as the suspected cause. Using the full database as the comparators, reporting odds ratios (RORs) with 95% confidence intervals (CIs) were estimated by logistic regression while adjusting for maternal age. Infants' age and sex were additionally adjusted in analyzing the risk of COVID-19 vaccination during lactation. RESULTS: We identified 10,266 and 6,474 reports with the SMQ of "pregnancy and neonatal topics" associated with COVID-19 vaccines during pregnancy and lactation, respectively. No significant RORs of adverse pregnancy outcomes associated with COVID-19 vaccines during pregnancy were observed; however, "functional lactation disorders" showed significant disproportionality during lactation with adjusted ROR of 1.48 (95% CI, 1.21-1.79). Further analysis that analyzed "functional lactation disorders" at a preferred term level, showed higher ROR in mastitis (2.76 [95% CI, 1.45-5.27]). CONCLUSION: Overall, we did not observe a positive association between COVID-19 vaccination during pregnancy and risk of reporting adverse pregnancy outcomes. However, we found a significant disproportionate reporting association between COVID-19 vaccination during lactation and "functional lactation disorders", specifically mastitis. Continuous surveillance is warranted to confirm the safety of COVID-19 vaccine during pregnancy and lactation. |
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| ジャーナル名 | Journal of Korean medical science |
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| 投稿日 | 2024/1/9 |
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| 投稿者 | Kang, Dayeon; Choi, Ahhyung; Park, Suneun; Choe, Seung-Ah; Shin, Ju-Young |
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| 組織名 | Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon,;Korea.;School of Pharmacy, Sungkyunkwan University, Suwon, Korea.;Department of Preventive Medicine, Korea University College of Medicine, Seoul,;Department of Clinical Research Design & Evaluation, Samsung Advanced Institute;for Health Sciences & Technology, Sungkyunkwan University, Seoul, Korea.;shin.jy@skku.edu. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38193325/ |
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