J Clin Med. 2022 Mar; 11(6): 1698.
Published online 2022 Mar 18. doi: 10.3390/jcm11061698
The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination
Ioana Mihaela Citu,1Cosmin Citu,2,*Florin Gorun,2Ioan Sas,2Felix Bratosin,3Andrei Motoc,4Bogdan Burlea,5Ovidiu Rosca,3Daniel Malita,6 and Oana Maria Gorun5
Yoav Yinon, Academic Editor
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.
During the study period, we identified a total of 3094 pregnancies with a first trimester presentation in the outpatient clinic, of which 927 had received at least one dose of mRNA vaccine. There were 124 (13.4%) cases of spontaneous abortions among those who received the COVID-19 vaccine, and 271 (12.5%) spontaneous abortions identified in pregnant women who were not vaccinated against SARS-CoV-2 infection (p-value = 0.506) (Table 1). The average age of women who decided to vaccinate against SARS-CoV-2 during their first trimester of pregnancy was significantly lower than those who refused (29.5 years vs. 31.6 years, p-value < 0.001). However, in the first group, there were significantly more infections with SARS-CoV-2 before pregnancy (15.9% vs. 8.9%, p-value < 0.001).
This study determined that the risk of spontaneous abortion after mRNA COVID-19 immunization during the first trimester of pregnancy is similar to the 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.