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Cited by 60Bacterial Infections and VaccinesDiphtheria, Corynebacterium, and TetanusVaccine Coverage and Hesitancy

Prenatal Tdap immunization and risk of maternal and newborn adverse events.

Open access
Layton, J. Bradley, Butler, Anne M., Li, Dongmei, Boggess, Kim A., Weber, David J., McGrath, Leah J., Becker-Dreps, Sylvia·2017·Vaccine
DOI 10.1016/j.vaccine.2017.06.071PMC PMC5546155
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Abstract

Many countries recommend combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis immunization (Tdap) during pregnancy to stimulate transplacental transmission of pertussis antibodies to newborns. The immune system can be altered during pregnancy, potentially resulting in differing immunization risks in pregnant women. The safety of widespread Tdap immunization during pregnancy needs to be established. Our objective was to assess whether prenatal Tdap immunization was associated with adverse birth outcomes, and to evaluate the effect of timing of Tdap administration on these outcomes. We identified pregnancies at delivery in a large insurance claims database (2010-2014). Tdap immunization was categorized as optimal prenatal (27+weeks), early prenatal (<27weeks), postpartum (≤7days post-delivery), or none. Medical claims were searched to identify maternal adverse immunization reactions (e.g. anaphylaxis, fever, Guillian-Barre syndrome [GBS]), adverse birth outcomes (e.g. preeclampsia/eclampsia, premature rupture or membranes, chorioamnionitis) and newborn outcomes (e.g. respiratory distress, pulmonary hypertension, neonatal jaundice). Women with optimal or early prenatal Tdap were compared to those not immunized in pregnancy, using propensity score-weighted log-binomial regression and Cox proportional hazards models to estimate risk ratios (RR) and hazard ratios (HR). We identified 1,079,034 deliveries and 677,075 linked newborns; 11.5% were immunized optimally and 2.3% immunized early. There were 1 case of post-immunization anaphylaxis, and 12 cases of maternal encephalopathy (all post- delivery); there were no cases of GBS. Optimally-timed immunization was associated with small increased relative risks of: chorioamnionitis [RR=1.11, (95% CI: 1.07-1.15), overall risk=2.8%], and postpartum hemorrhage [RR=1.23 (95% DI: 1.18-1.28), overall risk=2.4%]; however, these relative increases corresponded to low absolute risk increases. Tdap was not associated with increased risk of any adverse newborn outcome. Overall, prenatal Tdap immunization was not associated with newborn adverse events, but potential associations with chorioamnionitis consistent with one previous study and postpartum hemorrhage require further investigation.

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  • Pertussis vaccine has been shown to be safe in pregnancy in numerous well-designed cohort studies.

    “Similarly pertussis vaccine has been shown to be safe in pregnancy in numerous well designed cohort studies (Sukumaran et al., 2015; DeSilva et al., 2016, 2017; Layton et al., 2017).”

    From Vaccine Safety: Myths and Misinformation (2020) · cites this paper as Layton et al., 2017

    The Introduction describes prenatal Tdap as generally accepted as safe, and the Results report no increased risk for the newborn outcomes studied. But the Discussion reports associations with chorioamnionitis and postpartum hemorrhage that require further investigation. The cited cohort therefore supports a qualified safety claim, not an unqualified statement that the vaccine has been shown safe in pregnancy. (LLM, conf=0.87)

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  1. [9]4.12 Pertussis. The Australian Immunisation Handbook 10th Edition: Australian Government Department of Health; 2016.

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Authors
Layton, J. B., Butler, A. M., Li, D., Boggess, K. A., Weber, D. J., McGrath, L. J., & Becker-Dreps, S.
Affiliations
  • University of North Carolina at Chapel Hill (US)
  • Washington University in St. Louis (US)
Corresponding author
Layton, J. Bradley
ORCID
Venue
Vaccine
Publisher
Elsevier BV
Published
2017-07
Volume
35
Issue
33
Pages
4072-4078
ISSN
0264-410X (ISSN-L)
DOI
10.1016/j.vaccine.2017.06.071
PMC
PMC5546155
OpenAlex
W2731631449
Cited by
60
References
39
Citations by year
2026: 2 · 2025: 4 · 2024: 2 · 2023: 5 · 2022: 2 · 2021: 15 · 2020: 10 · 2019: 8 · 2018: 7 · 2017: 3 · 2012: 1
FWCI
6.19
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Vaccine (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
  • UNC Libraries
Funders
  • US National Institute of Allergy and Infectious Disease (5R21AI115205)
  • Department of Epidemiology (UL1TR001111)
  • UNC Gillings School of Global Public Health (2015213)
  • Cecil G. Sheps Center for Health Services Research
  • UNC
  • Doris Duke Charitable Foundation
Topics
  • Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Endocrinology › Diphtheria, Corynebacterium, and Tetanus
  • Social Sciences › Health › Vaccine Coverage and Hesitancy
Keywords
pregnancy, vaccine safety, chorioamnionitis, postpartum hemorrhage, adverse birth outcomes, anaphylaxis, pertussis, transplacental antibody transfer, health insurance claims, Guillain-Barré syndrome, preeclampsia
MeSH terms
Adult, Female, Humans, Infant, Newborn, Pregnancy, Pregnancy Outcome, Prenatal Care, Cohort Studies, Risk Assessment, Diphtheria-Tetanus-acellular Pertussis Vaccines, Young Adult, Drug-Related Side Effects and Adverse Reactions

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