J Korean Med Sci.  2023 Oct;38(41):e314. 10.3346/jkms.2023.38.e314.

Effectiveness and Safety of COVID-19 Vaccination During Preconceptional and Preclinical Pregnancy Period: A National Population Study

• Gwak E
• Kim T
• Shin JY
• Choi NK
• Han S
• Lee JY
• Choe YJ
• Choe SA

• KMID: 2547173
• DOI: http://doi.org/10.3346/jkms.2023.38.e314

Abstract

Background
We aimed to assess the risk of maternal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and early abortive outcomes after the association between coronavirus disease 2019 (COVID-19) vaccination during the preconceptional period and preclinical pregnancy, which are likely to be inadvertent vaccination.
Methods
We used data from the Korea Disease Control and Prevention Agency-COVID19-National Health Insurance Service cohort from December 2020 to December 2021. The vaccinated pregnant women were matched to unvaccinated pregnant controls at a 1:4 ratio. The risks of SARS-CoV-2 infection and intensive care unit (ICU) admission within 14 days of infection were analyzed to assess its effectiveness. For safety measures, the adjusted relative risks (aRRs) of early abortive outcomes for the first COVID-19 vaccination during the preconceptional and preclinical periods were calculated considering covariates. We compared the risk of early abortion between mRNA and viral vector vaccines.
Results
The overall COVID-19 vaccination rates during the preconceptional period and preclinical pregnancy were 3.1% (6,662/215,211) and 2.6% (5,702/215,211), respectively. The cumulative incidence of ICU admission within 14 days of SARS-CoV-2 infection was 6/100,000 in the unvaccinated group, whereas there were no ICU admissions in the vaccinated groups. The risks of early abortive outcomes were not significantly different between the preconceptional vaccination group and the unvaccinated group (aRR, 1.04; 95% confidence interval [CI],0.99–1.10) or between preclinical pregnancy vaccination and their matched controls (1.02; 95% CI, 0.96–1.08). mRNA and viral vector vaccines have shown similar risks for early abortive outcomes and miscarriages.
Conclusion
Our findings have provided compelling evidence regarding the effectiveness and safety of COVID-19 vaccination prior to and during early pregnancy. Further research is required to extend the safety and efficacy profiles of COVID-19 vaccines to pregnant women and their babies.

Keyword

SARS-CoV-2; COVID-19; Vaccination; Safety; Pregnancy

Figure

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  Fig. 1 Concept of coronavirus disease 2019 vaccination during preconceptional and preclinical pregnancy periods and the first T1US as a landmark. The time of T1US was used as a landmark where the observation of the outcome of interest starts.T1US = first-trimester obstetric ultrasonography, LMP = last menstrual period.

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