Safety of COVID-19 Vaccination During Pregnancy and Lactation: A VigiBase Analysis.

Autor:	Kang D; Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea., Choi A; School of Pharmacy, Sungkyunkwan University, Suwon, Korea., Park S; School of Pharmacy, Sungkyunkwan University, Suwon, Korea., Choe SA; Department of Preventive Medicine, Korea University College of Medicine, Seoul, Korea., Shin JY; Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.; School of Pharmacy, Sungkyunkwan University, Suwon, Korea.; Department of Clinical Research Design & Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Korea. shin.jy@skku.edu.
Jazyk:	angličtina
Zdroj:	Journal of Korean medical science [J Korean Med Sci] 2024 Jan 08; Vol. 39 (1), pp. e3. Date of Electronic Publication: 2024 Jan 08.
DOI:	10.3346/jkms.2024.39.e3
Abstrakt:	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. Competing Interests: Dr. Shin received grants from the Ministry of Food and Drug Safety, the National Research Foundation of Korea, and pharmaceutical companies, including Pfizer, Celltrion, and SK Bioscience. No other relationships or activities have influenced the submitted work. (© 2024 The Korean Academy of Medical Sciences.)
Databáze:	MEDLINE
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