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The safety of primary series COVID-19 vaccine exposure in pregnancy has been well-studied; however, no research to date has been conducted among United States (US) military service members, a unique population with specific vaccination requirements for active duty service and early COVID-19 vaccine access. This retrospective cohort study leveraged data from the Department of Defense Birth and Infant Health Research program to identify live births among active duty US military service members in calendar year 2021. Administrative military personnel data, immunization files, and medical encounter records were used to develop study variables and determine COVID-19 vaccine receipt in pregnancy. Cox and modified Poisson regression models estimated hazard (HR) and risk ratios (RR), respectively, with 95 % confidence intervals (CI) for vaccine receipt and selected neonatal outcomes; models were adjusted for baseline characteristics using inverse probability of treatment weighting and further adjusted for SARS-CoV-2 infection in pregnancy. There were 7184 singleton live births included for analysis, of which 2867 (39.9 %) were among service members exposed to their first COVID-19 vaccine dose in pregnancy and 4317 (60.1 %) among service members unexposed to any COVID-19 vaccine during or prior to pregnancy. Baseline differences between exposed and unexposed service members (e.g., age, race and ethnicity, marital status, occupation) were fully attenuated after applying weights. COVID-19 vaccine initiation in pregnancy was not associated with preterm birth (<37 weeks' gestation; adjusted HR: 1.02, 95 % CI: 0.83–1.26), small for gestational age (<10th percentile; adjusted HR: 1.01, 95 % CI: 0.78–1.30), low birthweight (<2500 g; adjusted HR: 1.01, 95 % CI: 0.80–1.28), or neonatal intensive care unit admission (adjusted RR: 0.90, 95 % CI: 0.75–1.07). Primary series COVID-19 vaccine exposure in pregnancy was common in this military cohort. Vaccine receipt was not associated with increased risk for any adverse outcome under study, substantiating findings from existing literature. •Nearly 40 % of pregnant military service members received a COVID-19 vaccine.•Vaccine exposure in pregnancy was not associated with adverse neonatal outcomes.•Propensity score weighting controlled for baseline differences by exposure status.•Adjustment sets included laboratory-confirmed SARS-CoV-2 infection in pregnancy.

The Department of Defense encourages service members ≤26 years of age to receive the human papillomavirus (HPV) vaccine. Although this vaccine is not recommended in pregnancy, inadvertent vaccination may occur. The objective of this study was to assess whether active duty US military women who received the quadrivalent HPV vaccine (4vHPV) during pregnancy were at increased risk for adverse maternal or infant outcomes. The study population included active duty US military women aged 17–28 years with at least one pregnancy between 2007 and 2014, and the infants resulting from those pregnancies. Pregnancies, live births, and outcomes were identified using medical codes in administrative medical records. Exposure to 4vHPV during pregnancy was ascertained from personnel immunization records. Multivariable regression models were used to calculate risk estimates and 95% confidence intervals for the maternal outcomes of spontaneous abortion, preeclampsia/eclampsia and preterm labor, and the infant outcomes of preterm birth, birth defects, growth problems in infancy or in utero, and infant sex. Overall, 90,600 pregnancies and 75,670 singleton infants were identified. Approximately 2% of pregnancies and infants were exposed to 4vHPV during pregnancy. After adjustments, no positive associations were detected between inadvertent exposure to 4vHPV during pregnancy and any adverse pregnancy or infant outcomes. Our findings add to an established body of literature demonstrating the safety of 4vHPV when inadvertently administered during pregnancy. Although 4vHPV is no longer administered in the US, its use continues overseas; therefore, safety studies remain important. Furthermore, such studies can provide reassurance to women inadvertently exposed to nonavalent HPV vaccine (9vHPV) in pregnancy, which protects against four of the same antigens as 4vHPV, since safety of 9vHPV has not yet been established in pregnant women.

•Assessed safety of a boosting vs. priming pandemic H1N1 vaccine dose in pregnancy.•Restricted study population to vaccine-compliant U.S. military women.•Detected no increased risks for spontaneous abortion or birth defects. One recent study suggested an association between receipt of pandemic H1N1 (pH1N1)-containing vaccines in consecutive influenza seasons and spontaneous abortion, but corroborating scientific evidence is limited. In the present study, we leveraged a population of vaccine-compliant pregnant military women to examine history of pH1N1-containing influenza vaccination and adverse pregnancy outcomes. Because seasonal influenza vaccination is compulsory for military service, safety concerns regarding repeat vaccination are particularly relevant in this population. Pregnancies and live births from Department of Defense Birth and Infant Health Research program data were linked with military personnel immunization records to identify women vaccinated with a pH1N1-containing vaccine in pregnancy prior to 21 6/7 weeks’ gestation, October 2009–April 2015. Cox and modified Poisson regression models estimated associations between vaccination with pH1N1- versus non–pH1N1-containing influenza vaccine in the season prior to the index pregnancy, and spontaneous abortion and birth defects, respectively. Cox models were calculated for two periods of follow-up: through (1) 21 6/7 weeks’ gestation and (2) 28 days postvaccination. Of 26,264 pregnancies, 21,736 (82.8%) were among women who received a dose of pH1N1-containing vaccine in the prior influenza season and 4,528 (17.2%) were among women who received non–pH1N1-containing vaccine in the prior influenza season. Among 23,121 infants, 19,365 (83.8%) and 3,756 (16.2%) had mothers exposed and unexposed to pH1N1-containing vaccine in the prior influenza season, respectively. The adjusted hazard ratio (aHR) for spontaneous abortion approximated 1.0 across the complete follow-up period (95% confidence interval [CI]: 0.89–1.13) and was slightly elevated when censored at 28 days postvaccination, though the CI was imprecise (aHR: 1.19; 95% CI: 0.97–1.46). No associations with birth defects were observed. This work lends additional safety evidence and support for vaccination against pH1N1 in pregnancy, regardless of the vaccine received in the prior influenza season.

ObjectiveTo evaluate the potential for adverse health outcomes among infants born to US Coast Guard (USCG) responders to the Deepwater Horizon (DWH) oil spill disaster.MethodsDepartment of Defense Birth and Infant Health Research programme data identified a cohort of singleton infants born 2010–2011 to USCG personnel in the DWH Oil Spill Coast Guard Cohort study. Infants were included if their military parent (‘sponsor’) responded to the oil spill during a selected reproductive exposure window (ie, 3 months preconception for male sponsors and periconception through pregnancy for female sponsors), or if their sponsor was a non-responder. χ2 tests and multivariable log-binomial regression were used to compare the demographic and health characteristics of infants born to spill responders and non-responders.ResultsOverall, 1974 infants with a male sponsor (n=182 responder, n=1792 non-responder) and 628 infants with a female sponsor (n=35 responder, n=593 non-responder) in the DWH Oil Spill Coast Guard Cohort were identified. Health outcomes were similar among the offspring of male responders and non-responders. The frequency of any poor live birth outcome (ie, low birth weight, preterm birth or birth defect) was higher among infants born to female responders (17.1%, n=6) than non-responders (8.9%, n=53); the maternal age-adjusted association was suggestively elevated (risk ratio 1.93, 95% CI 0.89 to 4.16).ConclusionInfant health outcomes were comparable between the offspring of male USCG oil spill responders and non-responders. Findings were limited by the small number of infants identified, particularly among female responders, and should be interpreted with caution.

•This study is the first to assess the safety of Tdap vaccination among pregnant U.S. military women.•Tdap vaccine exposure was examined in the first trimester and between 27 and 36 weeks’ gestation.•No increased risks for adverse maternal, fetal, or infant outcomes were detected. The tetanus, diphtheria, and acellular pertussis (Tdap) vaccine was approved for U.S. adults in 2005 and recommended for administration in every pregnancy in 2012, with optimal timing between 27 and 36 weeks’ gestation. In the military, however, a current Tdap vaccination status is compulsory for service, and active duty women may be inadvertently exposed in early pregnancy. Safety data in this population are limited. To assess safety of inadvertent (0–13 weeks’ gestation) and recommended (27–36 weeks’ gestation) exposure to the Tdap vaccine in pregnancy. Pregnancies and live births from Department of Defense Birth and Infant Health Research program data were linked with military personnel immunization records to determine pregnancy Tdap vaccine exposure among active duty women, 2006–2014. Multivariable Cox and generalized linear regression models estimated associations between Tdap vaccine exposure and adverse pregnancy or infant outcomes. Of 145,883 pregnancies, 1272 were exposed to the Tdap vaccine in the first trimester and 9438 between 27 and 36 weeks’ gestation. Neither inadvertent nor recommended vaccine exposure were associated with spontaneous abortion, preeclampsia, or preterm labor. Among 117,724 live born infants, 984 were exposed to the Tdap vaccine in the first trimester and 9352 between 27 and 36 weeks’ gestation. First trimester exposure was not associated with birth defects, growth problems in utero, growth problems in infancy, preterm birth, or low birth weight. Tdap vaccine exposure between 27 and 36 weeks’ gestation was not associated with any adverse infant outcome. Among a population of active duty women in the U.S. military who received the Tdap vaccine during pregnancy, we detected no increased risks for adverse maternal, fetal, or infant outcomes. Our findings corroborate existing literature on the safety of exposure to the Tdap vaccine in pregnancy.

•This is the first observational cohort study to assess JE vaccination in pregnancy.•JE vaccination in pregnancy was not associated with select reproductive outcomes.•Results are similar to animal models; risk from inactivated vaccines is unlikely.•These findings are reassuring for pregnant travelers to JE endemic regions. Japanese encephalitis (JE) vaccine is an inactivated vaccine that has shown no risks in pregnancy in animal models, but epidemiologic studies are lacking. U.S. military service members located in JE endemic regions are required to be vaccinated; understanding the potential adverse events (AEs), including AEs that may occur in pregnancy, is needed. Here, we assessed pregnancy and infant health outcomes in association with JE vaccination in pregnancy. The study population consisted of 192,570 pregnancies to active duty women (2003–2014), captured in the Department of Defense Birth and Infant Health Research program. JE vaccine in pregnancy, vaccine count, formulation, trimester, and whether first career dose coincided with pregnancy were compared with unexposed pregnancies to assess risk of pregnancy and infant health outcomes. Adjusted risk estimates and 95% confidence intervals (CIs) were calculated by multivariable models. Of the 192,570 identifed pregnancies, 513 were exposed to the JE vaccine; 474 exposures occurred in the first trimester. For all outcomes, elevated risk estimates ranging from 1.53 to 1.70, were observed with receipt of >1 JE vaccine in pregnancy, though 95% CIs were wide and encompassed the null. First dose of JE vaccination in pregnancy was associated with a 1.87 (95% CI: 1.12–3.13) times increased risk of low birthweight (LBW) when excluding pregnancies exposed to other non-routinely recommended vaccinations in pregnancy. All other associations were null in both main and subset analyses. The overall results of these analyses provide reassuring findings for the safety of JE vaccination in pregnancy. Higher counts of JE vaccine received in pregnancy yielded large yet non-statistically significant risk estimates for all outcomes, though likely driven by lack of pregnancy awareness. An association was observed with LBW in subset analyses, but it was limited to women receiving their first JE vaccine and not observed in the larger main analyses.

•Clinicians recommend women receive Tdap vaccine at 27–36weeks of pregnancy for every pregnancy.•Among military mothers Tdap vaccination in pregnancy increased from 0.2% in 2006 to 32.3% in 2013.•Tdap vaccination at 27–36weeks of pregnancy was protective against infant acute respiratory infection.•Protection was also seen among mothers with prior vaccination, supporting repeat vaccination.•Of the 15 infants with pertussis, only 1 mother received Tdap vaccine in pregnancy (1st trimester). To protect infants from pertussis infection, the Advisory Committee on Immunization Practices (ACIP) recommends women receive the tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine between 27 and 36weeks of pregnancy. Here, we assessed the association between timing of maternal Tdap vaccination during pregnancy and acute respiratory infection (ARI) in infants <2months of age. This retrospective cohort study included 99,434 infants born to active duty military women in the Department of Defense Birth and Infant Health Registry from 2006 through 2013. Multivariable log-binomial regression was used to calculate relative risks (RRs) and 95% confidence intervals (CIs) for the association between maternal Tdap vaccination during pregnancy and infant ARI at <2months of age. Infants of mothers who received Tdap vaccination during pregnancy vs those who did not were 9% less likely to be diagnosed with an ARI at <2months of age (RR, 0.91; 95% CI, 0.84–0.99), and the risk was 17% lower if vaccination was received between 27 and 36weeks of pregnancy (RR, 0.83; 95% CI, 0.74–0.93). Similar results were observed when comparing mothers who received Tdap vaccination prior to pregnancy in addition to Tdap vaccination between 27 and 36weeks of pregnancy versus mothers who only received vaccination prior to pregnancy (RR, 0.85; 95% CI, 0.74–0.98). Maternal Tdap vaccination between 27 and 36weeks of pregnancy was consistently protective against infant ARI in the first 2months of life vs no vaccination during pregnancy, regardless of Tdap vaccination prior to pregnancy. Our findings strongly support current ACIP guidelines recommending Tdap vaccination in late pregnancy for every pregnancy.

ObjectiveTo characterize hospitals where military-insured newborns received care and test the association of regional perinatal risk with neonatal intensive care unit (NICU) capacity.Study designWe identified birth hospitals for live newborns October 2015–December 2018 (n = 296,568) and assigned newborns to health service areas (HSAs). Perinatal risk factors and the number of neonatal special care beds and neonatologists were calculated at HSA levels. Cross-sectional correlation analyses assessed perinatal risk factors and capacity across HSAs.Results27.0% (n = 10) of military birth hospitals had special care beds (intermediate and intensive) compared with 44.3% of civilian hospitals (n = 1224; p < 0.05). The number of special care beds and neonatologists per newborn varied more than twofold across regions and were only weakly associated with the proportion of higher risk newborns (R2 < 0.05).ConclusionsThe lack of meaningful association of regional perinatal risk with NICU capacity poses challenges for effective specialized care among military-associated newborns.

The National Smallpox Vaccine in Pregnancy Registry (NSVIPR) actively follows women inadvertently vaccinated with smallpox vaccine during or shortly before pregnancy to evaluate their reproductive health outcomes. Approximately 65% of NSVIPR participants also inadvertently received Anthrax Vaccine Adsorbed (AVA) while pregnant, providing a ready opportunity to evaluate pregnancy and infant health outcomes among these women. AVA-exposed pregnancies were ascertained using NSVIPR and electronic healthcare data. Rates of pregnancy loss and infant health outcomes, including major birth defects, were compared between AVA-exposed and AVA-unexposed pregnancies. Analyses included AVA-exposed and AVA-unexposed pregnant women who also received smallpox vaccine 28 days prior to or during pregnancy. Rates of adverse outcomes among the AVA-exposed group were similar to or lower than expected when compared with published reference rates and the AVA-unexposed population. The findings provide reassurance of the safety of AVA when inadvertently received by a relatively young and healthy population during pregnancy.

Abstract Background Yellow fever (YF) is a rare viral disease that can be prevented through receipt of a live attenuated vaccine. In the US military, service members must receive the YF vaccine before assignment to endemic areas, putting active duty service women at heightened risk for inadvertent exposure during preconception or pregnancy. Few studies have investigated the safety of YF vaccination in pregnancy to date, and none in a military population. Methods Department of Defense Birth and Infant Health Research program data were used to identify pregnancies and infants among active duty US military women, 2003–2014. Multivariable regression models estimated associations with YF vaccine exposure during preconception/pregnancy and adverse outcomes (e.g. spontaneous abortion, birth defects). Sensitivity analyses were performed that excluded pregnancies exposed to other live vaccines. For analyses of birth defects only, a secondary sensitivity analysis was performed that excluded infants diagnosed with chromosomal anomalies. Results Of the 196 802 pregnancies and 160 706 singleton infants identified, 1347 (0.7%) and 1132 (0.7%), respectively, were exposed to the YF vaccine. No increased risks for adverse pregnancy or infant outcomes were observed in the main analysis. In sensitivity analyses that excluded pregnancies exposed to other live vaccines, preconception YF vaccine exposure was associated with birth defects [adjusted risk ratio (aRR) = 1.71, 95% confidence interval (CI) = 1.08–2.73]; this association was attenuated when further excluding infants with chromosomal anomalies (aRR = 1.59, 95% CI = 0.97–2.62). Conclusions Overall, YF vaccine exposure did not appear to be associated with most adverse outcomes among this population of pregnant military women. A tenuous association between preconception YF vaccine exposure and birth defects was observed in sensitivity analyses, which may warrant further investigation.