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. 2024 Apr 17;143(6):794–802. doi: 10.1097/AOG.0000000000005583

Obstetric Complications and Birth Outcomes After Antenatal Coronavirus Disease 2019 (COVID-19) Vaccination

Kimberly K Vesco 1,✉, Anna E Denoble 1, Heather S Lipkind 1, Elyse O Kharbanda 1, Malini B DeSilva 1, Matthew F Daley 1, Darios Getahun 1, Ousseny Zerbo 1, Allison L Naleway 1, Lisa Jackson 1, Joshua TB Williams 1, Thomas G Boyce 1, Candace C Fuller 1, Eric S Weintraub 1, Gabriela Vazquez-Benitez 1
PMCID: PMC11090513  PMID: 38626447

Messenger RNA coronavirus disease 2019 (COVID-19) vaccination during pregnancy was not associated with increased risk of preterm birth, small-for-gestational-age neonates, gestational diabetes, or hypertensive disorders of pregnancy.

Abstract

OBJECTIVE:

To evaluate the association between antenatal messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccination and risk of adverse pregnancy outcomes.

METHODS:

This was a retrospective cohort study of individuals with singleton pregnancies with live deliveries between June 1, 2021, and January 31, 2022, with data available from eight integrated health care systems in the Vaccine Safety Datalink. Vaccine exposure was defined as receipt of one or two mRNA COVID-19 vaccine doses (primary series) during pregnancy. Outcomes were preterm birth (PTB) before 37 weeks of gestation, small-for-gestational age (SGA) neonates, gestational diabetes mellitus (GDM), gestational hypertension, and preeclampsia–eclampsia–HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. Outcomes in individuals vaccinated were compared with those in propensity-matched individuals with unexposed pregnancies. Adjusted hazard ratios (aHRs) and 95% CIs were estimated for PTB and SGA using a time-dependent covariate Cox model, and adjusted relative risks (aRRs) were estimated for GDM, gestational hypertension, and preeclampsia–eclampsia–HELLP syndrome using Poisson regression with robust variance.

RESULTS:

Among 55,591 individuals eligible for inclusion, 23,517 (42.3%) received one or two mRNA COVID-19 vaccine doses during pregnancy. Receipt of mRNA COVID-19 vaccination varied by maternal age, race, Hispanic ethnicity, and history of COVID-19. Compared with no vaccination, mRNA COVID-19 vaccination was associated with a decreased risk of PTB (rate: 6.4 [vaccinated] vs 7.7 [unvaccinated] per 100, aHR 0.89; 95% CI, 0.83–0.94). Messenger RNA COVID-19 vaccination was not associated with SGA (8.3 vs 7.4 per 100; aHR 1.06, 95% CI, 0.99–1.13), GDM (11.9 vs 10.6 per 100; aRR 1.00, 95% CI, 0.90–1.10), gestational hypertension (10.8 vs 9.9 per 100; aRR 1.08, 95% CI, 0.96–1.22), or preeclampsia–eclampsia–HELLP syndrome (8.9 vs 8.4 per 100; aRR 1.10, 95% CI, 0.97–1.24).

CONCLUSION:

Receipt of an mRNA COVID-19 vaccine during pregnancy was not associated with an increased risk of adverse pregnancy outcomes; this information will be helpful for patients and clinicians when considering COVID-19 vaccination in pregnancy.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in pregnancy is associated with a higher overall risk of maternal mortality and serious morbidity,1 and severe or critical coronavirus disease 2019 (COVID-19) is associated with an increased risk of cesarean delivery, hypertensive disorders of pregnancy (HDP), and preterm birth (PTB).1–4 Although pregnant people were excluded from the initial COVID-19 vaccine clinical trials, multiple organizations have recommended COVID-19 vaccination during pregnancy.5 Subsequently, antenatal messenger RNA (mRNA) COVID-19 vaccination was found to reduce the risk of medically attended COVID-19 among pregnant people and COVID-19 hospitalizations in their infants during the first 6 months of life.6,7

Studies to date have not identified an increased risk of adverse pregnancy outcomes associated with antenatal COVID-19 vaccination.8–10 However, few prior studies have included first-trimester COVID-19 vaccine exposure or controlled for a history of COVID-19 before pregnancy. The goal of this study was to evaluate the association between antenatal receipt of mRNA COVID-19 vaccination and adverse pregnancy outcomes, including small-for-gestational-age (SGA) neonates, PTB, gestational diabetes mellitus (GDM), gestational hypertension, and preeclampsia–eclampsia–HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome in the Vaccine Safety Datalink (VSD).

METHODS

The VSD is a collaborative project between the Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office and several integrated health care organizations across the United States.11 To monitor the safety of vaccines in use in the United States, health care organizations that participate in the VSD use vaccination and health outcome data from electronic health records (EHRs). Pregnancies were identified using a dynamic pregnancy algorithm based on International Classification of Diseases, Tenth Revision (ICD-10) diagnosis codes, procedure codes, estimated dates of delivery, and last menstrual period dates from EHR data.12 Outcomes were identified using ICD-10 diagnosis codes associated with clinical, inpatient, and emergency department encounters and supplemented with delivery and birth records. This study was approved by the IRBs of all participating sites and the CDC with a waiver of informed consent and was conducted in accordance with federal law and CDC policy (see 45 C.F.R. part 46.114; 21 C.F.R. part 56.114).

The study population included pregnant people aged 16–49 years who enrolled in one of eight VSD sites (Kaiser Permanente: Washington, Northwest, Northern California, Southern California, and Colorado; Denver Health; HealthPartners; and Marshfield Clinic) from 8 weeks of gestation through the end of pregnancy and had a singleton live birth with an estimated date of delivery between June 1, 2021, and January 31, 2022. We selected this date range to help reduce potential truncation bias, ensuring that individuals with shorter pregnancies at the start of the study period and those with longer pregnancies at the end of the study period would be eligible and that pregnant individuals were eligible to receive a vaccine before 20 weeks of gestation.13,14 Eight weeks of gestation for enrollment was chosen to coincide with the typical onset of prenatal care, when detailed data for each pregnancy first appear in the EHR.

Three COVID-19 vaccines (Pfizer–BioNTech, Moderna, and Johnson & Johnson/Janssen) were available in the United States during the study period. This analysis focused on the mRNA COVID-19 vaccine primary series, the most commonly used vaccine series, and excluded persons who received other COVID-19 vaccines (ie, Johnson & Johnson/Janssen) during pregnancy. Some individuals received one or more doses of an mRNA COVID-19 vaccine before pregnancy; they were included to reduce healthy vaccinee bias and were categorized for this analysis based only on their pregnancy-related vaccine exposure. The VSD vaccine files include EHR data, as well as medical and pharmacy claims, and are supplemented through bidirectional communication with regional or state immunization information systems with standardized data-quality checks and deduplication of vaccines from multiple sources, as previously described.15,16 Booster doses were excluded due to the limited numbers of these exposures, which primarily occurred in late pregnancy given the study period. The period of vaccine exposure varied by outcome (described below), with the earliest vaccine exposures occurring December 15, 2020. We also examined outcomes in relation to the timing of first vaccine administration during pregnancy by trimester.

The primary birth outcomes were PTB before 37 weeks of gestation and SGA neonates. The primary maternal outcomes were GDM and HDP, with gestational hypertension analyzed separately from the combined outcome of preeclampsia–eclampsia–HELLP syndrome. Preterm birth was defined as birth before 37 weeks of gestation, and SGA was defined as birth weight less than the 10th percentile for gestational age compared with a U.S. reference population.17 Gestational diabetes mellitus diagnoses were identified using the ICD-10 code O24.4 and required at least one inpatient diagnosis or two outpatient diagnoses, a method that has been shown to be more effective in capturing GDM diagnoses when compared with laboratory data alone.18 Gestational hypertension and preeclampsia–eclampsia–HELLP syndrome were identified using ICD-10 codes (O13.x, O14.x, O15.x, and O16.x) and required one inpatient or emergency room-based diagnosis or two outpatient diagnoses occurring at or beyond 20 weeks of gestation, through 2 weeks postpartum. Chronic (pre-existing) hypertension was identified using ICD-10 codes. In addition, if HDP was documented before 20 weeks of gestation, it was reclassified as chronic hypertension. Pregnant individuals identified as having chronic hypertension were excluded from analyses of gestational hypertension but were included in analyses of preeclampsia–eclampsia–HELLP syndrome; hence, the reason for examining these outcomes separately.

We collected self-reported race and Hispanic ethnicity from EHR data and categorized individuals as Hispanic; non-Hispanic White, Black, or Asian; or other race or unknown. We also calculated the following: maternal age at delivery; the Kessner Adequacy of Prenatal Care Utilization Index,19 which is based on the timing of the initiation of prenatal care and the number of prenatal care encounters; and the neighborhood poverty level measured as the percentage of households in an individual’s Census tract whose income is below 100% of the federal poverty level, which came from the American Community Survey 5-year summary for 2020.20 We identified comorbidities associated with an increased risk for our planned outcomes; they included cardiovascular disease and pre-existing hypertension, liver and pulmonary disease (including COVID-19), epilepsy, systemic lupus erythematosus and immunosuppressive conditions, cancer, obesity, and tobacco and other substance use. The presence of comorbidities was defined as having one or more inpatient or two or more outpatient diagnoses for the period 3 years before pregnancy (and from March 2020 for COVID-19) through 22 weeks of gestation before the ascertainment of the outcomes (detailed diagnosis code list presented in Appendix 1, available online at http://links.lww.com/AOG/D645). The presence of maternal obesity (defined as body mass index [BMI, calculated as weight in kilograms divided by height in meters squared] of 30 or higher) in the 6 months before pregnancy or in the first trimester if preconception data were not available was identified using ICD-10 codes and BMI data. A history of tobacco use from 6 months before any time during pregnancy was identified from EHR data, supplemented by nicotine dependence diagnosis codes, and classified as a binary variable.

Given the specific inclusion and exclusion criteria for each outcome, the sample size for each analysis varied. We examined the characteristics for each analytic cohort using the mean and standard deviation for continuous variables, and the frequency and percent for categorical variables. We estimated standardized mean differences (SMDs) to assess the potential for confounding for each covariate based on the difference between exposed and unexposed groups in each analytic cohort.21 We used an SMD in absolute values less than 0.20 to identify negligible differences between groups. Our analytic approach varied for each outcome, as described below, to account for the expected timing of the onset of the outcome in pregnancy. To address potential confounding, we constructed seven propensity scores for mRNA COVID-19 vaccination during pregnancy, one for each outcome-specific analytic cohort (PTB and SGA, GDM, gestational hypertension, preeclampsia–eclampsia–HELLP syndrome) as well as for each trimester-specific analysis for PTB and SGA. Covariates included in the propensity scores were age at delivery, calendar week of last menstrual period, race and Hispanic ethnicity, VSD site, Adequacy of Prenatal Care Utilization Index, neighborhood poverty level, and comorbidities. Logistic regression was used to estimate the propensity score, and all covariates were entered as main effects. Maternal age and calendar week of last menstrual period were modeled using a smoothing parameter approach. Stabilized inverse probability weights were computed and used as weights in the regression models. We further evaluated whether covariates were balanced after applying the stabilized inverse probability weights for each analytic cohort and evaluated whether the distribution of the score overlapped between vaccinated and unvaccinated individuals.

For PTB and SGA, we included individuals who received an mRNA COVID-19 vaccine at any time from pregnancy onset (last menstrual period) through one day before delivery. For SGA analyses, individuals with missing information on birth weight were excluded. We compared all individuals who received at least one COVID-19 vaccine dose during pregnancy to all those who were unexposed during pregnancy using a time-dependent exposure Cox model and compared individuals who received an mRNA COVID-19 vaccine in the first, second, or third trimester with those who were not exposed to the vaccine during pregnancy. Receipt of a vaccine in each trimester was not exclusive of vaccination in another trimester. For example, an individual vaccinated in the first and second trimesters would be included in both groups. A time dependent Cox model adjusts for the potential bias introduced because individuals who are vaccinated later in pregnancy have less time available to have PTB.

For GDM, the exposure window was limited to vaccinations that occurred between the last menstrual period and 22 weeks of gestation to predate the timing of universal GDM screening and diagnosis, which typically occurs at 24–28 weeks of gestation. A propensity score was constructed for receiving COVID-19 vaccine during this timeframe. We compared individuals who received at least one COVID-19 vaccine dose during pregnancy with unexposed persons and evaluated the association between COVID-19 vaccine and GDM using a Poisson model with robust variance.

For gestational hypertension and preeclampsia–eclampsia–HELLP syndrome, analyses were limited to comparing individuals who received a COVID-19 vaccine before 20 weeks of gestation compared with women unexposed during the entire pregnancy. We limited vaccine exposures for the HDP outcomes to those that occurred before 20 weeks of gestation to ensure that vaccination happened before diagnosis, which must occur at or after 20 weeks of gestation.22 Propensity scores were constructed for receiving the COVID-19 vaccine from last menstrual period to 20 weeks of gestation for gestational hypertension and preeclampsia–eclampsia–HELLP syndrome. We evaluated the associations among COVID-19 vaccine and these outcomes using a Poisson model with robust variance.

RESULTS

We identified 69,419 pregnancies that ended in live birth. After excluding persons with incomplete enrollment (9,925) or receipt of nonprimary series mRNA COVID-19 vaccines during pregnancy (3,903), our largest analytic cohort included 55,591 pregnancies; of these, 23,517 (42.3%) individuals received one or two primary series mRNA COVID-19 vaccine doses during pregnancy. Given the specific exclusions and gestational age requirements applied to the other outcomes, the analytic sample sizes for each maternal outcome were smaller than for birth outcomes, and the percentage of pregnancies exposed to COVID-19 vaccine varied (SGA: n=51,478, 42.7% exposed to COVID-19 vaccine; GDM: n=41,774, 24.5% exposed; gestational hypertension: n=39,201, 21.8% exposed; and preeclampsia–eclampsia–HELLP syndrome: n=41,054, 21.9% exposed) (Fig. 1).

Fig. 1. Flowchart of Vaccine Safety Datalink pregnancies eligible for outcome-specific analyses. EDD, estimated date of delivery; COVID-19, coronavirus disease 2019.

Fig. 1.

Vesco. COVID-19 Vaccination and Pregnancy Outcomes. Obstet Gynecol 2024.

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Differences in characteristics between those who did and did not receive a primary series mRNA COVID-19 vaccine during pregnancy are shown for the largest analytic cohort (PTB outcome, n=55,591, Table 1). Compared with persons who did not receive a COVID-19 vaccine during pregnancy, those who received a vaccine were older (mean age 31.7 years ±SD 4.8 vs 29.6 ± 5.3, SMD 0.45) and were more likely to be non-Hispanic Asian (24.7% vs 12.3%, SMD 0.33) but less likely to be Hispanic (31.7% vs 41.4%, SMD −0.23) or non-Hispanic Black (4.7% vs 10.4%, SMD −0.23). The neighborhood poverty level was lower among those who were vaccinated (SMD −0.26). The groups did not differ in the adequacy of prenatal care or pre-existing comorbidities.

Table 1.

Characteristics of People With Pregnancies Ending in Live Births With Estimated Due Dates of June 1, 2021–January 31, 2022 Who Did and Did Not Receive a First Series mRNA Coronavirus Disease 2019 (COVID-19) Vaccine During Pregnancy, From Eight U.S. Health Care Organizations in the Vaccine Safety Datalink

graphic file with name ong-143-794-g002.jpg

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After applying the stabilized inverse probability weights to baseline characteristics, no differences were observed between those who received an mRNA COVID-19 vaccine and those that did not (Fig. 2 for the overall cohort and Appendices 2–4 for the GDM, gestational hypertension, and preeclampsia cohorts, respectively; Appendices 2–4 are available online at http://links.lww.com/AOG/D645). Distribution of the propensity score overlapped between vaccinated and unvaccinated individuals (Appendix 5, available online at http://links.lww.com/AOG/D645). Characteristics identified by the SMD were similar for all the analytic cohorts, propensity scores were generated by trimester because calendar week at pregnancy onset varied in the association with receipt of mRNA COVID-19 vaccine.

Fig. 2. Standardized mean difference (SMD) plot for the full cohort before and after inverse probability weighting. PNC, prenatal care; CVD, cardiovascular disease; COVID-19, coronavirus disease 2019; Prop Score, propensity score.

Fig. 2.

Vesco. COVID-19 Vaccination and Pregnancy Outcomes. Obstet Gynecol 2024.

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Among those who received an mRNA COVID-19 vaccine, compared with those who did not, there was a lower likelihood of PTB (adjusted hazard ratio [aHR] 0.89, 95% CI, 0.83–0.94). Compared with no vaccine, receipt of an mRNA COVID-19 vaccine was not associated with the risk of SGA (aHR 1.06, 95% CI, 0.99–1.13). Neither PTB nor SGA were associated with COVID-19 vaccine when examining vaccine exposure by trimester of pregnancy (first, second, or third) (Table 2).

Table 2.

Adverse Pregnancy Outcomes and Adjusted Relative Risks and Hazard Ratios After mRNA Coronavirus Disease 2019 (COVID-19) Vaccination in Pregnancy at Eight U.S. Health Care Organizations in the Vaccine Safety Datalink

graphic file with name ong-143-794-g004.jpg

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In the subset of pregnancies during which the individual received an mRNA COVID-19 vaccine before 22 weeks of gestation, compared with those without evidence of vaccination during pregnancy, there was no difference in the risk of GDM (adjusted relative risk [aRR] 1.00, 95% CI, 0.90–1.10). The results did not differ when considering the trimester of vaccine exposure.

Among those who received an mRNA COVID-19 vaccine before 20 weeks of gestation, there was no difference in rates of gestational hypertension (aRR 1.08, 95% CI, 0.96–1.22) or preeclampsia–eclampsia–HELLP syndrome (aRR 1.10, 95% CI, 0.97–1.24). Again, the results did not differ when considering the trimester of vaccine exposure.

DISCUSSION

We found that receipt of one or more doses of a primary series mRNA COVID-19 vaccine during pregnancy, compared with no receipt, was associated with a decreased risk of PTB and was not associated with an increased risk of SGA, GDM, gestational hypertension, or preeclampsia–eclampsia–HELLP syndrome. In a prior analysis conducted with a subset of the current cohort, there was no association between receipt of an mRNA COVID-19 vaccine, and PTB or SGA.23 This study expanded on prior results23 through use of a larger sample size, analysis of obstetric complications and birth outcomes, and the inclusion of first-trimester mRNA COVID-19 vaccine exposures. Results from this study provide additional evidence regarding the safety of mRNA COVID-19 vaccine administration during pregnancy.

Prior studies have found that pregnant persons who have received one or more doses of a COVID-19 vaccine have increased protection from medically-attended COVID-19 and are at lower risk for severe maternal morbidity and mortality compared with those who were not vaccinated.6,24 The international INTERCOVID-2022 prospective cohort study of 4,618 pregnant people found that the effectiveness against severe complications of COVID-19 (severe maternal morbidity and referral to higher dependency care, intensive care unit admission, or death) was 74% (95% CI, 48–87) following a complete (two-dose) regimen and was further improved to 91% (95% CI, 65–98) after receipt of a booster.24 In that cohort, there was a reduced risk of PTB before 37 weeks of gestation (relative risk [RR] 0.81, 95% CI, 0.68–0.96) among vaccinated persons, compared with unvaccinated persons, and there was no increased risk of gestational hypertension (RR 1.22, 95% CI, 0.90–1.64) or preeclampsia–eclampsia–HELLP syndrome (RR 1.02, 95% CI, 0.73–1.42). These findings regarding PTB, gestational hypertension, and preeclampsia–eclampsia–HELLP syndrome are similar to those of our analysis.

We found that the risk of GDM did not differ significantly between vaccinated and unvaccinated individuals. Recent studies of nonpregnant adults have reported hyperglycemia in individuals with diabetes and possible accelerated-onset of de novo diabetes after COVID-19 vaccination.25–27 However, a recent retrospective study suggests that SARS-CoV-2 infection may increase the risk of diabetes, whereas COVID-19 vaccination may exert a protective effect.28 The mechanism or timeframe for exposure that may lead to an increased or reduced risk for diabetes related to COVID-19 vaccination outside of pregnancy is unclear. Regardless, our analysis does not suggest an increased risk of gestational diabetes after COVID-19 vaccination.

The strengths of this analysis include a large cohort with individuals of racial, ethnic, and geographic diversity and a well-established infrastructure for identifying vaccine administration and health outcomes.

Although we applied statistical methods to account for differences among those who accept vaccination and those who do not, a limitation of our analysis is possible residual confounding. Furthermore, we were unable to account for all cases of COVID-19 within the cohort because many were not medically attended and, therefore, not documented in the EHR. To reduce healthy vaccinee bias, we did not exclude individuals who received a COVID-19 vaccine before pregnancy. In addition, although we applied statistical methods to limit immortal time bias, it may have contributed to the “protective” association observed between COVID-19 vaccination and PTB. We considered examining whether the association between vaccine exposure and pregnancy outcomes varied by receipt of one compared with two vaccine doses during pregnancy; however, the comparison groups become complicated because pregnancies were not mutually exclusive between models and the statistical models were unstable. For analyses of pregnancy complications where vaccine exposures were limited to the first and second trimesters, our study may have insufficient power to detect associations. An additional limitation is the difficulty with ascertaining the actual timing of onset of GDM, gestational hypertension, and preeclampsia–eclampsia–HELLP syndrome using diagnosis codes. These conditions, as well as SGA (which is determined based on gestational age and weight at birth), may be ongoing for days to weeks before clinical detection, vaccine exposure, or documentation of a diagnosis code in the medical record. This study cohort included pregnant people with live births and insurance coverage from the first trimester through the end of pregnancy. This may limit generalizability, particularly to individuals with intermittent or no medical insurance, and those who did not receive prenatal care or who had a non–live-birth pregnancy outcome.

In conclusion, in this large retrospective cohort study, the receipt of an mRNA COVID-19 vaccination during pregnancy was not associated with increased adverse maternal or birth outcomes. These findings may provide additional reassurance to obstetric clinicians and patients considering mRNA COVID-19 vaccination in pregnancy.

Footnotes

Supported by the Centers for Disease Control and Prevention (CDC, Contract 200-2012-53526). The author group included a member of the CDC's Vaccine Safety Datalink team. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC. Mentioning a product or company name is for identification purposes only and does not constitute an endorsement by the CDC.

Financial Disclosure Kimberly K. Vesco's travel to the American Diabetes Association Meeting to present the research was covered by grant funds from the CDC. She received an Independent Grant for Learning and Change (Grant # 42360015), funded by Pfizer, Inc., and paid to her institution, to develop a novel menopause curriculum for medical residents. Darios Getahun's institution received funding from Hologic, Inc. and Johnson & Johnson. Candace C. Fuller is employed at Harvard Pilgrim Health Care institute, a non-profit organization that conducts work for government and private organizations, including pharmaceutical companies. Gabriela Vazquez-Benitez has received research funding from Sanofi Pasteur and AbbVie for unrelated work. Thomas Boyce has received grants from Pfizer, Moderna, and GlaxoSmithKline for unrelated research. The other authors did not report any potential conflicts of interest.

Presented at the 83rd Annual American Diabetes Association Scientific Sessions, June 23–26, 2023, San Diego, California.

The authors thank Jingyi Zhu, PhD, HealthPartners Institute, and Brad Crane, MS, Kaiser Permanente Center for Health Research, for their assistance with data management.

Each author has confirmed compliance with the journal's requirements for authorship.

Peer reviews and author correspondence are available at http://links.lww.com/AOG/D646.

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