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. 2022 Mar 18;11(6):1698.
doi: 10.3390/jcm11061698.

The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination

Ioana Mihaela Citu  1 , Cosmin Citu  2 , Florin Gorun  2 , Ioan Sas  2 , Felix Bratosin  3 , Andrei Motoc  4 , Bogdan Burlea  5 , Ovidiu Rosca  3 , Daniel Malita  6 , Oana Maria Gorun  5
Affiliations

The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination

Ioana Mihaela Citu et al. J Clin Med. .

Abstract

Clinical trials for COVID-19 vaccines initially excluded pregnant women due to safety concerns, and when the vaccines were authorized for emergency use, they were not recommended for this population. However, observational studies discovered that pregnant women infected with COVID-19 have higher risks of negative pregnancy and delivery outcomes compared to non-pregnant women, raising the question of the risks-benefits of administering COVID-19 vaccines to pregnant women. By mid-2021, there was general consensus on the relative safety of COVID-19 vaccination during pregnancy; therefore, it is critical to investigate the safety issues related to these vaccines, considering the increasing acceptance among pregnant women. To address these concerns, we developed a research project to study the short-term effects and outcomes of COVID-19 vaccination during the first trimester of pregnancy. Our research followed an observational retrospective design for 12 months from the beginning of the vaccination campaign, and included 124 cases of spontaneous abortions and 927 ongoing pregnancies. The odds of spontaneous abortion were non-significant for both versions of the mRNA vaccine (Pfizer BNT162b2 AOR = 1.04, CI = 0.91-1.12; Moderna mRNA-1273 AOR = 1.02, CI = 0.89-1.08). Overall, our data indicated that the risk of spontaneous abortion after mRNA COVID-19 immunization during the first trimester of pregnancy is commensurate with the predicted risk in non-vaccinated pregnant women. These findings contribute to the growing body of information regarding the safety of mRNA COVID-19 vaccination during pregnancy.

Keywords: COVID-19; SARS-CoV-2; first trimester; pregnancy vaccination.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Baseline Characteristics Comparison between Women who Suffered a Spontaneous Abortion and Women Who Carried a Pregnancy until Delivery, Stratified by COVID-19 Type.
Figure 2
Figure 2
Probability of spontaneous abortion by the effect of independent risk factors.
See this image and copyright information in PMC

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