Work

Risk of perinatal death and preterm birth among an observational cohort of women vaccinated against SARS-CoV-2 in pregnancy: CDC COVID-19 vaccine pregnancy registry

Year: 2026

Type: article

Abstract: BACKGROUND: COVID-19 vaccine clinical trials excluded pregnant women; additional data on safety of COVID-19 vaccines in pregnancy can strengthen clinical recommendations. OBJECTIVE: To assess risk of perinatal death (stillbirth and neonatal death), and preterm birth among women receiving COVID-19 vaccines just prior to or during pregnancy. METHODS: The Centers for Disease Control and Prevention's COVID-19 Vaccine Pregnancy Registry (C19VPR) is an observational cohort of women receiving ≥1 COVID-19 vaccine between December 15, 2020, and June 21, 2021, up to 30 days before their last menstrual period or during pregnancy. Data were collected through interviewer-administered phone surveys. We matched C19VPR pregnancies to 2019 US National Vital Statistics System (NVSS) data based on race, ethnicity, and age group. We estimated week-specific and cumulative risk of perinatal death and preterm birth using a fetuses-at-risk approach among singleton pregnancies ending ≥6 weeks' gestation. For C19VPR participants, pregnancies entered the risk pool at gestational age of vaccination. We compared C19VPR estimates to NVSS using Cox regression to calculate hazard ratios and 95% confidence intervals adjusted for race, ethnicity, age, and pre-pregnancy body mass index. Among C19VPR pregnancies, we used Cox regression to assess difference in risk by vaccine manufacturer. RESULTS: Cumulative risk of perinatal death among C19VPR pregnancies and NVSS were 4.8 and 8.1 per 1000 births, respectively. Cumulative risk of preterm births among C19VPR pregnancies and NVSS were 6.6% and 12.1%, respectively. Adjusted hazard ratios (aHR) suggested lower cumulative risk of perinatal death and preterm birth among C19VPR pregnancies (vaccinated) compared with 2019 NVSS (pre-pandemic estimate) (aHR 0.62 95%CI 0.46, 0.83; aHR 0.55 95%CI 0.51, 0.58, respectively). Within the C19VPR cohort, risks of perinatal death and preterm birth did not differ by vaccine manufacturer. CONCLUSION: We found no evidence of increased risk of perinatal death or preterm birth after COVID-19 vaccination in pregnancy.

Source: Vaccine

DOI: 10.1016/j.vaccine.2026.128461