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논문 기본 정보

자료유형
학술저널
저자정보
Kang Dayeon (Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.) Choi Ahhyung (School of Pharmacy, Sungkyunkwan University, Suwon, Korea.) Park Suneun (School of Pharmacy, Sungkyunkwan University, Suwon, Korea.) Choe Seung-Ah (Department of Preventive Medicine, Korea University College of Medicine, Seoul, Korea.) Shin Ju-Young (Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.School of Pharmacy, Sungkyunkwan University, Suwon, Korea.Department of Clinical Research Design)
저널정보
대한의학회 Journal of Korean Medical Science Journal of Korean Medical Science Vol.39 No.1
발행연도
2024.1
수록면
1 - 11 (11page)
DOI
10.3346/jkms.2024.39.e3

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초록· 키워드

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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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