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Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study.

ABSTRACT: INTRODUCTION:Hepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead to significant and lifelong morbidity. Hepatitis B vaccine (HepB) is recommended for anyone at increased risk for contracting HBV infection, including pregnant women. Limited data are available on the safety of HepB administration during pregnancy. OBJECTIVES:To assess the frequency of maternal HepB receipt among pregnant women and evaluate the potential association between maternal vaccination and pre-specified maternal and infant safety outcomes. METHODS:We examined a retrospective cohort of pregnancies in the Vaccine Safety Datalink (VSD) resulting in live birth outcomes from 2004 through 2015. Eligible pregnancies in women aged 12-55?years who were continuously enrolled from 6?months pre-pregnancy to 6?weeks postpartum in VSD integrated health systems were included. We compared pregnancies with HepB exposure to those with other vaccine exposures, and to those with no vaccine exposures. High-risk conditions for contracting HBV infection were identified up to one-year prior to or during the pregnancy using ICD-9 codes. Maternal and fetal adverse events were also evaluated according to maternal HepB exposure status. RESULTS:Among over 650,000 pregnancies in the study period, HepB was administered at a rate of 2.1 per 1000 pregnancies (n?=?1399), commonly within the first 5?weeks of pregnancy. Less than 3% of the HepB-exposed group had a high-risk ICD-9 code indicating need for HepB; this was similar to the rate among HepB unvaccinated groups. There were no significant associations between HepB exposure during pregnancy and gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, low birthweight or small for gestational age infants. CONCLUSIONS:Most women who received maternal HepB did not have high-risk indications for vaccination. No increased risk for the adverse events that were examined were observed among women who received maternal HepB or their offspring.

SUBMITTER: Groom HC

PROVIDER: S-EPMC6325631 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study.

Groom Holly C HC Irving Stephanie A SA Koppolu Padma P Smith Ning N Vazquez-Benitez Gabriela G Kharbanda Elyse O EO Daley Matthew F MF Donahue James G JG Getahun Darios D Jackson Lisa A LA Tse Kawai Alison A Klein Nicola P NP McCarthy Natalie L NL Nordin James D JD Sukumaran Lakshmi L Naleway Allison L AL

Vaccine 20180905 41

<h4>Introduction</h4>Hepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead to significant and lifelong morbidity. Hepatitis B vaccine (HepB) is recommended for anyone at increased risk for contracting HBV infection, including pregnant women. Limited data are available on the safety of HepB administration during pregnancy.<h4>Objectives</h4>To assess the frequency of maternal HepB receipt among pregnant women and evaluate the potential as ...[more]

PMID: 30194002

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Project description:IntroductionInfection with hepatitis A virus (HAV) during pregnancy, although uncommon, is associated with gestational complications and pre-term labor. Hepatitis A vaccine (HepA) is recommended for anyone at increased risk for contracting hepatitis A, including women at risk who are also pregnant. Limited data are available on the safety of maternal HepA vaccination.ObjectivesAssess the frequency of maternal HepA receipt and evaluate the potential association between maternal vaccination and pre-specified maternal and infant safety outcomes.MethodsA retrospective cohort of pregnancies in the Vaccine Safety Datalink (VSD) resulting in live births from 2004 through 2015 was included. Pregnancies with HepA exposure were compared to those with other vaccine exposures, and to those with no vaccine exposures. Risk factors for contracting hepatitis A were identified up to one-year prior to or during the pregnancy using ICD-9 codes. Maternal and fetal adverse events were evaluated according to maternal HepA exposure status. Adjusted odds ratio (OR) were used to describe the association.ResultsAmong 666,233 pregnancies in the study period, HepA was administered at a rate of 1.7 per 1000 (n = 1140), most commonly within the first six weeks of pregnancy. Less than 3% of those exposed to HepA during pregnancy had an ICD-confirmed risk factor. There were no significant associations between HepA exposure during pregnancy and gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, and low birthweight. There was a statistically significant association between HepA exposure during pregnancy and small-for-gestational age (SGA) infants (aOR 1.32, [95% CI 1.09, 1.60], p = 0.004).ConclusionsThe rate of maternal HepA vaccination was low and rarely due to documented risk factors for vaccination. HepA vaccination during pregnancy was not associated with an increased risk for a range of adverse events examined among pregnancies resulting in live births, but an identified association between maternal HepA and SGA infant outcomes, while likely due to unmeasured confounding, warrants further exploration.

Project description:ObjectiveTo evaluate whether the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccinations in pregnancy are associated with increased risk of stillbirth.MethodsWe performed a case-control study in the Vaccine Safety Datalink that was matched 1:4 on site, month, and year of last menstrual period, comparing the odds of vaccination in pregnancies that ended in stillbirth (defined as fetal loss at or after 20 weeks of gestation) compared with those that ended in live birth from January 1, 2012, to September 30, 2015. We included patients with singleton pregnancies that ended in stillbirth or live birth who had at least one prenatal care visit, pregnancy dating information, and continuous health plan enrollment for the duration of pregnancy. Medical records for all stillbirths were reviewed. We were statistically powered to detect an odds ratio (OR) of 1.37 when evaluating the association between influenza or Tdap vaccination and stillbirth. We also examined stillbirth rates in pregnant patients aged 14-49 years in the Vaccine Safety Datalink between 2007 and 2015.ResultsIn our matched analysis of 795 confirmed stillbirths in the case group and 3,180 live births in the control group, there was no significant association between influenza vaccination during pregnancy and stillbirth (343/795 [43.1%] stillbirths in the case group vs 1,407/3,180 [44.3%] live births in the control group, OR 0.94, adjusted OR 0.95, 95% CI 0.79-1.14, P=.54) and no significant association between Tdap vaccination during pregnancy and stillbirth (184/795 [23.1%] stillbirths in the case group vs 746/3,180 [23.5%] live births in the control group, OR 0.97, aOR 0.96, 95% CI 0.76-1.28, P=.91). From 2007 to 2015, the stillbirth rate in the Vaccine Safety Datalink was 5.2 per 1,000 live births and stillbirths.ConclusionNo association was found between vaccination during pregnancy and the odds of stillbirth. These findings support the safety of ACIP recommendations for vaccination during pregnancy.

Project description:ObjectiveIn 2012, recommendations for universal tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination during pregnancy were released. Our objective was to determine if Tdap, influenza, and pneumococcal vaccine uptake during pregnancy changed after the release of the guidelines, and identify factors associated with receiving the Tdap and influenza vaccine after 2012.MethodsWe conducted a retrospective cohort study on pregnant individuals who initiated prenatal care before 20 weeks' gestation between 11/2011-11/2012 ("pre-guideline") and 12/2012-12/2015 ("post-guideline"). Vaccine uptake dates were abstracted from medical records. The pre and post-guideline cohorts were compared to determine if Tdap vaccine uptake and timing improved after the new Tdap guidelines. We additionally examined influenza and pneumococcal vaccine uptake before and after guidelines. Factors associated with receipt of the Tdap and influenza vaccine during pregnancy in the post-guideline cohort were evaluated using multivariable logistic regression models.ResultsOf 2,294 eligible individuals, 1,610 (70.2%) received care in the post-guideline cohort. Among the pre-guideline cohort, 47.4% received Tdap, whereas Tdap uptake increased to 86.1% after the guidelines (p<0.001). Similarly, receiving the Tdap vaccine between the recommended time of 27-36 weeks gestational age improved from 52.5% to 91.8% after the guidelines (p<0.001). Vaccine frequency for influenza improved significantly from 61.2% to 72.0% (p<0.001), while frequency for pneumococcus were low and unchanged. An increased number of prenatal visits was associated with receiving the Tdap and influenza vaccines during pregnancy (respective, aOR 1.09 95% CI 1.05-1.13; aOR 1.50 95% CI 1.17-1.94). Non-Hispanic Black individuals were less likely to receive both the Tdap and influenza vaccines during pregnancy compared to non-Hispanic White individuals (respective, aOR 0.51 95% CI 0.33-0.80; aOR 0.68 95% CI 0.48-0.97).ConclusionsReceipt and timing of Tdap vaccine improved after implementation of the 2012 ACIP guidelines. Receipt of influenza vaccine uptake also improved during the study period, while uptake of the pneumococcal vaccine remained low. Significant racial disparities exist in receipt of Tdap and influenza vaccine during pregnancy.

Project description:ObjectiveWe conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases.MethodsElectronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty.ResultsOf 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case-control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty.ConclusionsEvidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base.

Dataset Information

Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study.

Publications

Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study.

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