Dataset Information

Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013.

ABSTRACT: INTRODUCTION:Since October 2012, the combined tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine (Tdap) has been recommended in the United States during every pregnancy. METHODS:In this observational study from the Vaccine Safety Datalink, we describe receipt of Tdap during pregnancy among insured women with live births across seven health systems. Using a retrospective matched cohort, we evaluated risks for selected medically attended adverse events in pregnant women, occurring within 42 days of vaccination. Using a generalized estimating equation, we calculated adjusted incident rate ratios (AIRR). RESULTS:Our vaccine coverage cohort included 438,487 live births between January 1, 2007 and November 15, 2013. Across the coverage cohort, 14% received Tdap during pregnancy. By 2013, Tdap was administered during pregnancy in 41.7% of live births, primarily in the 3rd trimester. Our vaccine safety cohort included 53,885 vaccinated and 109,253 matched unvaccinated pregnant women. There was no increased risk for a composite outcome of medically attended acute adverse events within 3 days of vaccination. Similarly, across the safety cohort, over a 42 day window, incident neurologic events, thrombotic events, and new onset proteinuria did not differ by maternal receipt of Tdap. Among women receiving Tdap at 20 weeks gestation or later, as compared to their matched controls, there was no increased risk for gestational diabetes or cardiac events while venous thromboembolic events and thrombocytopenia were diagnosed within 42 days of vaccination at slightly decreased rates. CONCLUSION:Tdap coverage during pregnancy increased from 2007 through 2013, but was still below 50%. No acute maternal safety signals were detected in this large cohort.

SUBMITTER: Kharbanda EO

PROVIDER: S-EPMC6506839 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013.

Kharbanda Elyse Olshen EO Vazquez-Benitez Gabriela G Lipkind Heather S HS Klein Nicola P NP Cheetham T Craig TC Naleway Allison L AL Lee Grace M GM Hambidge Simon S Jackson Michael L ML Omer Saad B SB McCarthy Natalie N Nordin James D JD

Vaccine 20160104 7

<h4>Introduction</h4>Since October 2012, the combined tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine (Tdap) has been recommended in the United States during every pregnancy.<h4>Methods</h4>In this observational study from the Vaccine Safety Datalink, we describe receipt of Tdap during pregnancy among insured women with live births across seven health systems. Using a retrospective matched cohort, we evaluated risks for selected medically attended adverse events in pregnan ...[more]

PMID: 26765288

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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: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.

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:Vaccination of pregnant women with influenza vaccine and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) can decrease the risk for influenza and pertussis among pregnant women and their infants. The Advisory Committee on Immunization Practices (ACIP) recommends that all women who are or might be pregnant during the influenza season receive influenza vaccine, which can be administered at any time during pregnancy (1). ACIP also recommends that women receive Tdap during each pregnancy, preferably during the early part of gestational weeks 27-36 (2,3). Despite these recommendations, vaccination coverage among pregnant women has been found to be suboptimal with racial/ethnic disparities persisting (4-6). To assess influenza and Tdap vaccination coverage among women pregnant during the 2019-20 influenza season, CDC analyzed data from an Internet panel survey conducted during April 2020. Among 1,841 survey respondents who were pregnant anytime during October 2019-January 2020, 61.2% reported receiving influenza vaccine before or during their pregnancy, an increase of 7.5 percentage points compared with the rate during the 2018-19 season. Among 463 respondents who had a live birth by their survey date, 56.6% reported receiving Tdap during pregnancy, similar to the 2018-19 season (4). Vaccination coverage was highest among women who reported receiving a provider offer or referral for vaccination (influenza = 75.2%; Tdap = 72.7%). Compared with the 2018-19 season, increases in influenza vaccination coverage were observed during the 2019-20 season for non-Hispanic Black (Black) women (14.7 percentage points, to 52.7%), Hispanic women (9.9 percentage points, to 67.2%), and women of other non-Hispanic (other) races (7.9 percentage points, to 69.6%), and did not change for non-Hispanic White (White) women (60.6%). As in the 2018-19 season, Hispanic and Black women had the lowest Tdap vaccination coverage (35.8% and 38.8%, respectively), compared with White women (65.5%) and women of other races (54.0%); in addition, a decrease in Tdap vaccination coverage was observed among Hispanic women in 2019-20 compared with the previous season. Racial/ethnic disparities in influenza vaccination coverage decreased but persisted, even among women who received a provider offer or referral for vaccination. Consistent provider offers or referrals, in combination with conversations culturally and linguistically tailored for patients of all races/ethnicities, could increase vaccination coverage among pregnant women in all racial/ethnic groups and reduce disparities in coverage.

Dataset Information

Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013.

Publications

Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013.

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