Safety and effectiveness of acellular pertussis vaccination during pregnancy: a systematic review.
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ABSTRACT:
SUBMITTER: Vygen-Bonnet S
PROVIDER: S-EPMC7020352 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
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Safety and effectiveness of acellular pertussis vaccination during pregnancy: a systematic review.
Vygen-Bonnet Sabine S Hellenbrand Wiebke W Garbe Edeltraut E von Kries Rüdiger R Bogdan Christian C Heininger Ulrich U Röbl-Mathieu Marianne M Harder Thomas T
BMC infectious diseases 20200213 1
<h4>Background</h4>Infants < 3 months of age are at highest risk for developing severe complications after pertussis. The majority of pregnant women has low concentrations of pertussis-specific antibodies and thus newborns are insufficiently protected by maternally transferred antibodies. Acellular pertussis vaccination during pregnancy was recently implemented in various countries. Here, we assessed the evidence for safety and effectiveness of pertussis vaccination during pregnancy.<h4>Methods< ...[more]
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Project description:IntroductionThis observational retrospective matched cohort study evaluated the safety of a prenatal tetanus, diphtheria, acellular pertussis (Tdap) vaccination, Boostrix. We previously reported on the risk of maternal and neonatal outcomes; here we report on the risk of congenital anomalies in infants at birth through 6 months of age.MethodsThe study included pregnant Kaiser Permanente Southern California members. Women who received the Tdap vaccine on or after the 27th week of pregnancy between January 2018 and January 2019 were matched to women who were pregnant between January 2012 and December 2014 and were not vaccinated with Tdap during pregnancy. Unadjusted and adjusted relative risks (aRRs) with 95% confidence intervals were estimated by Poisson regression. Quantitative secular trend analyses, from 2011 to 2017, were conducted on congenital anomalies with a statistically significant aRR > 1.ResultsThe analysis consisted of 16,350 and 16,088 live-born infants in the Tdap-exposed and unexposed cohorts, respectively. Of the 14 congenital anomaly body systems evaluated, 8 (eye, ear/face/neck, respiratory, upper gastrointestinal, genital, renal, musculoskeletal, integument) had statistically significant elevated aRRs, with point estimates ranging from 1.17 to 2.02. The observed elevated aRRs were consistent with their respective secular increases over time.ConclusionCautious interpretation of these findings is warranted as these increases may have resulted from improved identification and diagnosis. Furthermore, the biological plausibility of an association between maternal vaccine exposure in the third trimester of pregnancy and birth defects is low. The overall study findings support the safety of maternal immunization with Boostrix during the third trimester of pregnancy.Trial registrationClinicalTrials.gov identifier, NCT03463577.
| S-EPMC9925651 | biostudies-literature
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.
| S-EPMC10496691 | biostudies-literature
Project description:Vaccination against pertussis has reduced the disease burden dramatically, but the most severe cases and almost all fatalities occur in infants too young to be vaccinated. Recent epidemiologic evidence suggests that targeted vaccination of mothers during pregnancy can reduce pertussis incidence in their infants. To evaluate the cost-effectiveness of antepartum maternal vaccination in the United States, we created an age-stratified transmission model, incorporating empirical data on US contact patterns and explicitly modeling parent-infant exposure. Antepartum maternal vaccination incurs costs of $114,000 (95% prediction interval: 82,000, 183,000) per quality-adjusted life-year, in comparison with the strategy of no adult vaccination, and is cost-effective in the United States according to World Health Organization criteria. By contrast, vaccinating a second parent is not cost-effective, and vaccination of either parent postpartum is strongly dominated by antepartum maternal vaccination. Nonetheless, postpartum vaccination of mothers who were not vaccinated antepartum improves upon the current recommendation of untargeted adult vaccination. Additionally, the temporary direct protection of the infant due to maternal antibody transfer has efficacy for infants comparable to that conferred to toddlers by the full primary vaccination series. Efficient protection against pertussis for infants begins before birth. We highly recommend antepartum vaccination for as many US mothers as possible.
| S-EPMC4908210 | biostudies-literature
Project description:BackgroundAcellular pertussis vaccine studies postulate that waning protection, particularly after the adolescent booster, is a major contributor to the increasing US pertussis incidence. However, these studies reported relative (ie, vs a population given prior doses of pertussis vaccine), not absolute (ie, vs a pertussis vaccine naïve population) efficacy following the adolescent booster. We aim to estimate the absolute protection offered by acellular pertussis vaccines.MethodsWe conducted a systematic review of acellular pertussis vaccine effectiveness (VE) publications. Studies had to comply with the US schedule, evaluate clinical outcomes, and report VE over discrete time points. VE after the 5-dose childhood series and after the adolescent sixth-dose booster were extracted separately and pooled. All relative VE estimates were transformed to absolute estimates. VE waning was estimated using meta-regression modeling.FindingsThree studies reported VE after the childhood series and four after the adolescent booster. All booster studies reported relative VE (vs acellular pertussis vaccine-primed population). We estimate initial childhood series absolute VE is 91% (95% CI: 87% to 95%) and declines at 9.6% annually. Initial relative VE after adolescent boosting is 70% (95% CI: 54% to 86%) and declines at 45.3% annually. Initial absolute VE after adolescent boosting is 85% (95% CI: 84% to 86%) and declines at 11.7% (95% CI: 11.1% to 12.3%) annually.InterpretationAcellular pertussis vaccine efficacy is initially high and wanes over time. Observational VE studies of boosting failed to recognize that they were measuring relative, not absolute, VE and the absolute VE in the boosted population is better than appreciated.
| S-EPMC6005504 | biostudies-literature
Project description:To assess pregnancy and birth outcomes in infants born to women who did or did not receive tetanus, diphtheria, acellular pertussis (Tdap) vaccine during pregnancy.Retrospective cohort. Pregnant women 12-45 years of age who received Tdap at Intermountain Healthcare facilities and their infants were identified and compared with mother-infant pairs without documented Tdap from May 2005 through August 2009. Primary measures included pregnancy outcomes and infant health outcomes at birth through 12 months.From 162,448 pregnancies we identified 138 women (0.08%) with documented Tdap administration during pregnancy (cases); 552 pregnant women without documented Tdap were randomly selected as controls. Of 138 immunized women, 63% received Tdap in the first trimester and 37% after. Tdap was given most commonly as wound prophylaxis. The incidence of spontaneous or elective abortion was no greater in Tdap cases than in controls. There were no significant differences in preterm delivery, gestational age, or birth weight between groups. One or more congenital anomaly was identified in 3.7% (95% CI 1.2%-8.5%) of case infants and 4.4% (95% CI 2.7%-6.5%) of control infants (P = .749). In infants born to women receiving Tdap during pregnancy, 3.6% (0.8%-10.2%) had International Classification of Diseases, Ninth Revision, Clinical Modification diagnoses consistent with complex chronic conditions within 12 months compared with 10.4% (95% CI 7.2%-14.4%) of infants of controls (P = .054).Documented Tdap administration during pregnancy was uncommon and occurred most often in the first trimester as prophylaxis following trauma. No increase in adverse outcomes was identified in infants born to women receiving Tdap compared with infants of controls.
| S-EPMC4102585 | biostudies-other
Project description:INTRODUCTION:It is recommended that all pregnant women in the U.S. receive tetanus, diphtheria, acellular pertussis (Tdap) immunization to prevent infant pertussis. This study's objective was to examine the clinical effectiveness of prenatal Tdap, and whether effectiveness varies by gestational age at immunization. METHODS:A nationwide cohort study of pregnant women with deliveries in 2010-2014 and their infants was performed. Commercial insurance claims data were analyzed in 2016-2017 to identify Tdap receipt by the pregnant women, and hospitalizations and outpatient visits for pertussis in their infants until the infants reached 18 months of age. Pertussis occurrence was compared between infants of mothers who received prenatal Tdap (overall and stratified by gestational age at administration) and infants of unvaccinated mothers. RESULTS:There were 675,167 mother-infant pairs in the cohort. Among infants whose mothers received prenatal Tdap, the rate of pertussis was 43% lower (hazard ratio=0.57, 95% CI=0.35, 0.92) than infants whose mothers did not receive prenatal or postpartum Tdap; this reduction was consistent across pertussis definitions (hazard ratio for inpatient-only pertussis=0.32, 95% CI=0.11, 0.91). Pertussis rates were also lower for infants whose mothers received Tdap during the third trimester. Infants whose mothers received Tdap at <27 weeks of gestation did not experience reductions in pertussis rates (hazard ratio for pertussis=1.10, 95% CI=0.54, 2.25). CONCLUSIONS:Infants of mothers who received prenatal Tdap experienced half the rate of pertussis as compared with infants of unimmunized mothers. These results do not provide evidence to support changing the currently recommended timing of Tdap administration in pregnancy.
| S-EPMC6054882 | biostudies-literature
Project description:BACKGROUND:Maternal pertussis vaccination has been introduced in several countries to prevent pertussis morbidity and mortality in infants too young to be vaccinated. Our review aimed to systematically collect and summarize the available evidence on the effectiveness of interventions used to improve pertussis vaccination uptake in pregnant women. METHODS:We conducted a systematic search of MEDLINE/PubMed, PMC and CINAHL. Before and after studies and those with a concurrent control group were considered for inclusion. Standardized effect sizes were described as the ratio of the odds to be vaccinated in the intervention group compared with the standard care group and absolute benefit increase (ABI) were calculated. RESULTS:Six studies were included in the review, of which three were randomized controlled trials (RCTs). Strategies to improve uptake were focused on healthcare providers, pregnant women, or enhancing vaccine access. Healthcare provider interventions included provider reminder, education, feedback and standing orders. Interventions directed at pregnant women focused solely on education. Observational studies showed: (1) the provision of maternal pertussis vaccination by midwives at the place of antenatal care has improved uptake of pertussis vaccine during pregnancy from 20% to 90%; (2) introduction of an automated reminder within the electronic medical record was associated with an improvement in the pertussis immunization rate from 48% to 97%; (3) an increase in prenatal pertussis vaccine uptake from 36% to 61% after strategies to increase provider awareness of recommendations were introduced. In contrast to these findings, interventions in all three RCTs (2 involved education of pregnant women, 1 had multi-component interventions) did not demonstrate improved vaccination uptake. CONCLUSIONS:Based on the existing research, we recommend incorporating midwife delivered maternal immunization programs at antenatal clinics, use of a provider reminder system to target unvaccinated pregnant women and include maternal pertussis immunization as part of standard antenatal care.
| S-EPMC6438510 | biostudies-literature
Project description:BackgroundPregnant women and their babies face significant risks from three vaccine-preventable diseases: COVID-19, influenza and pertussis. However, despite these vaccines' proven safety and effectiveness, uptake during pregnancy remains low.MethodsWe conducted a systematic review (PROSPERO CRD42023399488; January 2012-December 2022 following PRISMA guidelines) of interventions to increase COVID-19/influenza/pertussis vaccination in pregnancy. We searched nine databases, including grey literature. Two independent investigators extracted data; discrepancies were resolved by consensus. Meta-analyses were conducted using random-effects models to estimate pooled effect sizes. Heterogeneity was assessed using the I2 statistics.ResultsFrom 2681 articles, we identified 39 relevant studies (n = 168 262 participants) across nine countries. Fifteen studies (39%) were randomized controlled trials (RCTs); the remainder were observational cohort, quality-improvement or cross-sectional studies. The quality of 18% (7/39) was strong. Pooled results of interventions to increase influenza vaccine uptake (18 effect estimates from 12 RCTs) showed the interventions were effective but had a small effect (risk ratio = 1.07, 95% CI 1.03, 1.13). However, pooled results of interventions to increase pertussis vaccine uptake (10 effect estimates from six RCTs) showed no clear benefit (risk ratio = 0.98, 95% CI 0.94, 1.03). There were no relevant RCTs for COVID-19. Interventions addressed the 'three Ps': patient-, provider- and policy-level strategies. At the patient level, clear recommendations from healthcare professionals backed by text reminders/written information were strongly associated with increased vaccine uptake, especially tailored face-to-face interventions, which addressed women's concerns, dispelled myths and highlighted benefits. Provider-level interventions included educating healthcare professionals about vaccines' safety and effectiveness and reminders to offer vaccinations routinely. Policy-level interventions included financial incentives, mandatory vaccination data fields in electronic health records and ensuring easy availability of vaccinations.ConclusionsInterventions had a small effect on increasing influenza vaccination. Training healthcare providers to promote vaccinations during pregnancy is crucial and could be enhanced by utilizing mobile health technologies.
| S-EPMC10755181 | biostudies-literature
Project description:BackgroundTo reduce the risk of pertussis-related morbidity and mortality in early life, an increasing number of countries recommend maternal pertussis vaccination. However, there is limited knowledge about half-lives of vaccine-induced pertussis-specific maternal antibodies, especially in preterm infants, and factors potentially influencing them.MethodsWe compared 2 different approaches to provide estimates of the half-lives of pertussis-specific maternal antibodies in infants and explored potential effects on the half-life in 2 studies. In the first approach, we estimated the half-lives per child and used these estimates as responses in linear models. In the second approach, we used linear mixed effect models on a log2 transformed scale of the longitudinal data to use the inverse of the time parameter as an estimate for the half-lives.ResultsBoth approaches provided similar results. The identified covariates partly explain differences in half-life estimates. The strongest evidence we observed was a difference between term and preterm infants, with the preterm infants showing a longer half-life. Among others, a longer interval between vaccination and delivery increases the half-life.ConclusionsSeveral variables influence the decay speed of maternal antibodies. Both approaches have advantages and disadvantages, while the choice is secondary when assessing the half-life of pertussis-specific antibodies.Clinical trials registrationNCT02408926 and NCT02511327.
| S-EPMC10681861 | biostudies-literature
Project description:The COVID-19 pandemic has posed significant risks to pregnant women and those recently pregnant, leading to heightened mortality and morbidity rates. Vaccination has emerged as a pivotal strategy in reducing COVID-19-related deaths and illnesses worldwide. However, the initial exclusion of pregnant individuals from most clinical trials raised concerns about vaccine safety in this population, contributing to vaccine hesitancy. This review aims to consolidate the existing literature to assess the safety and efficacy of COVID-19 vaccination in pregnant populations and neonatal outcomes. Diverse studies were included evaluating various aspects of safety for women and their newborns, encompassing mild to severe symptoms across different vaccines. The findings indicate the overall safety and efficacy of COVID-19 vaccination, with minimal adverse outcomes observed, including mild side effects like pain and fever. Although most studies reported the absence of severe adverse outcomes, isolated case reports have raised concerns about potential associations between maternal COVID-19 vaccination and conditions such as fetal supraventricular tachycardia and immune-mediated diseases. Our review underscores the importance of ongoing surveillance and monitoring to ensure vaccine safety in pregnant women. Overall, COVID-19 vaccination during pregnancy remains a safe and effective strategy, emphasizing the need for continued research and vigilance to safeguard maternal and fetal health.
| S-EPMC11354065 | biostudies-literature