J Korean Med Sci.  2024 Jan;39(1):e3. 10.3346/jkms.2024.39.e3.

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

• Kang D
• Choi A
• Park S
• Choe SA
• Shin JY

• KMID: 2550793
• DOI: http://doi.org/10.3346/jkms.2024.39.e3

Abstract

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.

Keyword

COVID-19 Vaccine; Pregnancy; Adverse Pregnancy Outcomes; VigiBase

Figure

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  Fig. 1 Flowchart of reports with COVID-19 vaccines during pregnancy and lactation.SMQ = Standardized Medical Dictionary for Regulatory Activities Query, COVID-19 = coronavirus disease 2019.

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  Fig. 2 Disproportionality analysis on the SMQs of “Pregnancy and neonatal topics” associated with COVID-19 vaccines during pregnancy and lactation.SMQ = Standardized Medical Dictionary for Regulatory Activities Query, NCOVID = number of reports with COVID-19 vaccine as suspected drug, ROR = reporting odds ratio, CI = confidence interval, COVID-19 = coronavirus disease 2019.aFor pregnancy analysis, maternal age was adjusted and for lactation analysis, maternal age, infant age, and infant sex were adjusted.

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  Fig. 3 Disproportionality analysis for reporting “Functional lactation disorders” associated with COVID-19 vaccines during lactation at a PT level.PT = preferred term, NCOVID = number of reports with COVID-19 vaccine as suspected drug, aROR = adjusted reporting odds ratio, CI = confidence interval, COVID-19 = coronavirus disease 2019.

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