tetano
Editor, Senior Moderator
BMJ Open
. 2025 Dec 23;15(12):e106494.
doi: 10.1136/bmjopen-2025-106494. Safety of COVID-19 vaccines among pregnant individuals in Quebec, Canada: a population-based retrospective cohort study from the Canadian Immunization Research Network
Marilou Kiely[SUP] 1 2 [/SUP], Ella Diendere[SUP] 3 [/SUP], Isaora Dialahy[SUP] 4 [/SUP], Gentiane Perrault-Sullivan[SUP] 3 [/SUP], Nicholas Brousseau[SUP] 2 3 [/SUP], Shu Qin Wei[SUP] 5 [/SUP], Denis Talbot[SUP] 6 2 [/SUP], Amélie Boutin[SUP] 2 7 [/SUP], Caroline Quach[SUP] 8 [/SUP], Sarah Jorgensen[SUP] 9 [/SUP], Isabelle Boucoiran[SUP] 10 11 [/SUP]
Affiliations
Objective: To estimate the association between maternal COVID-19 vaccination during pregnancy and adverse neonatal and maternal outcomes.
Design: Population-based retrospective cohort study using a hospitalisation database linked with other health administrative databases.
Setting: Province of Quebec, Canada, from 1 May 2021 to 30 June 2023.
Participants: All singleton pregnancies resulting in a live birth or stillbirth at ≥20 weeks of gestation, excluding those with a conception date <42 weeks before the end of the study period.
Primary outcome measures: We used robust Poisson regression models to estimate adjusted risk ratios (aRRs) for chorioamnionitis, postpartum haemorrhage, caesarean delivery, preterm birth, very preterm birth, small for gestational age (SGA), maternal and neonatal admission to intensive care unit (ICU, NICU) and severe neonatal morbidity. We used a Cox regression model with a time-varying exposure variable to estimate adjusted HRs (aHRs) for stillbirth. Propensity score weighting was used to adjust for potential confounding.
Results: Among 140 073 singleton pregnancies resulting in live birth or stillbirth, 61 282 individuals (43.8%) received at least one dose of messenger RNA COVID-19 vaccine during pregnancy. Vaccination during pregnancy was not associated with an increased risk of chorioamnionitis (aRR 0.99, 95% CI 0.95 to 1.04), postpartum haemorrhage (aRR 1.03, 95% CI 0.99 to 1.06), very preterm birth (aRR 1.04, 95% CI 0.89 to 1.21) and stillbirth (aHR 1.14, 95% CI 0.94 to 1.39). Vaccination during pregnancy was significantly associated with a reduced risk of caesarean delivery (aRR 0.94, 95% CI 0.92 to 0.96), maternal ICU admission (aRR 0.80, 95% CI 0.65 to 0.98), SGA (aRR 0.94, 95% CI 0.91 to 0.98), NICU admission (aRR 0.91, 95% CI 0.85 to 0.96), preterm birth (aRR 0.94, 95% CI 0.90 to 0.99) and severe neonatal morbidity (aRR 0.91, 95% CI 0.85 to 0.98).
Conclusions: Our findings suggest that COVID-19 vaccination during pregnancy was not associated with an increased risk of adverse outcomes. Ongoing surveillance of the safety of maternal COVID-19 vaccination is essential as doses continue to be recommended for this group.
Keywords: COVID-19; INFECTIOUS DISEASES; Immunization Programs; Pregnancy.
. 2025 Dec 23;15(12):e106494.
doi: 10.1136/bmjopen-2025-106494. Safety of COVID-19 vaccines among pregnant individuals in Quebec, Canada: a population-based retrospective cohort study from the Canadian Immunization Research Network
Marilou Kiely[SUP] 1 2 [/SUP], Ella Diendere[SUP] 3 [/SUP], Isaora Dialahy[SUP] 4 [/SUP], Gentiane Perrault-Sullivan[SUP] 3 [/SUP], Nicholas Brousseau[SUP] 2 3 [/SUP], Shu Qin Wei[SUP] 5 [/SUP], Denis Talbot[SUP] 6 2 [/SUP], Amélie Boutin[SUP] 2 7 [/SUP], Caroline Quach[SUP] 8 [/SUP], Sarah Jorgensen[SUP] 9 [/SUP], Isabelle Boucoiran[SUP] 10 11 [/SUP]
Affiliations
- PMID: 41436261
- PMCID: PMC12730766
- DOI: 10.1136/bmjopen-2025-106494
Objective: To estimate the association between maternal COVID-19 vaccination during pregnancy and adverse neonatal and maternal outcomes.
Design: Population-based retrospective cohort study using a hospitalisation database linked with other health administrative databases.
Setting: Province of Quebec, Canada, from 1 May 2021 to 30 June 2023.
Participants: All singleton pregnancies resulting in a live birth or stillbirth at ≥20 weeks of gestation, excluding those with a conception date <42 weeks before the end of the study period.
Primary outcome measures: We used robust Poisson regression models to estimate adjusted risk ratios (aRRs) for chorioamnionitis, postpartum haemorrhage, caesarean delivery, preterm birth, very preterm birth, small for gestational age (SGA), maternal and neonatal admission to intensive care unit (ICU, NICU) and severe neonatal morbidity. We used a Cox regression model with a time-varying exposure variable to estimate adjusted HRs (aHRs) for stillbirth. Propensity score weighting was used to adjust for potential confounding.
Results: Among 140 073 singleton pregnancies resulting in live birth or stillbirth, 61 282 individuals (43.8%) received at least one dose of messenger RNA COVID-19 vaccine during pregnancy. Vaccination during pregnancy was not associated with an increased risk of chorioamnionitis (aRR 0.99, 95% CI 0.95 to 1.04), postpartum haemorrhage (aRR 1.03, 95% CI 0.99 to 1.06), very preterm birth (aRR 1.04, 95% CI 0.89 to 1.21) and stillbirth (aHR 1.14, 95% CI 0.94 to 1.39). Vaccination during pregnancy was significantly associated with a reduced risk of caesarean delivery (aRR 0.94, 95% CI 0.92 to 0.96), maternal ICU admission (aRR 0.80, 95% CI 0.65 to 0.98), SGA (aRR 0.94, 95% CI 0.91 to 0.98), NICU admission (aRR 0.91, 95% CI 0.85 to 0.96), preterm birth (aRR 0.94, 95% CI 0.90 to 0.99) and severe neonatal morbidity (aRR 0.91, 95% CI 0.85 to 0.98).
Conclusions: Our findings suggest that COVID-19 vaccination during pregnancy was not associated with an increased risk of adverse outcomes. Ongoing surveillance of the safety of maternal COVID-19 vaccination is essential as doses continue to be recommended for this group.
Keywords: COVID-19; INFECTIOUS DISEASES; Immunization Programs; Pregnancy.