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

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 ris...

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Autores principales: Citu, Ioana Mihaela, Citu, Cosmin, Gorun, Florin, Sas, Ioan, Bratosin, Felix, Motoc, Andrei, Burlea, Bogdan, Rosca, Ovidiu, Malita, Daniel, Gorun, Oana Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8955378/
https://www.ncbi.nlm.nih.gov/pubmed/35330023
http://dx.doi.org/10.3390/jcm11061698
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author Citu, Ioana Mihaela
Citu, Cosmin
Gorun, Florin
Sas, Ioan
Bratosin, Felix
Motoc, Andrei
Burlea, Bogdan
Rosca, Ovidiu
Malita, Daniel
Gorun, Oana Maria
author_facet Citu, Ioana Mihaela
Citu, Cosmin
Gorun, Florin
Sas, Ioan
Bratosin, Felix
Motoc, Andrei
Burlea, Bogdan
Rosca, Ovidiu
Malita, Daniel
Gorun, Oana Maria
author_sort Citu, Ioana Mihaela
collection PubMed
description 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.
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spelling pubmed-89553782022-03-26 The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination Citu, Ioana Mihaela Citu, Cosmin Gorun, Florin Sas, Ioan Bratosin, Felix Motoc, Andrei Burlea, Bogdan Rosca, Ovidiu Malita, Daniel Gorun, Oana Maria J Clin Med Article 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. MDPI 2022-03-18 /pmc/articles/PMC8955378/ /pubmed/35330023 http://dx.doi.org/10.3390/jcm11061698 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Citu, Ioana Mihaela
Citu, Cosmin
Gorun, Florin
Sas, Ioan
Bratosin, Felix
Motoc, Andrei
Burlea, Bogdan
Rosca, Ovidiu
Malita, Daniel
Gorun, Oana Maria
The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination
title The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination
title_full The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination
title_fullStr The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination
title_full_unstemmed The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination
title_short The Risk of Spontaneous Abortion Does Not Increase Following First Trimester mRNA COVID-19 Vaccination
title_sort risk of spontaneous abortion does not increase following first trimester mrna covid-19 vaccination
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8955378/
https://www.ncbi.nlm.nih.gov/pubmed/35330023
http://dx.doi.org/10.3390/jcm11061698
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