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Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies

INTRODUCTION: This 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 in...

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Autores principales: Florea, Ana, Sy, Lina S., Ackerson, Bradley K., Qian, Lei, Luo, Yi, Becerra-Culqui, Tracy, Lee, Gina S., Tian, Yun, Zheng, Chengyi, Bathala, Radha, Tartof, Sara Y., Campora, Laura, Ceregido, Maria Angeles, Kuznetsova, Anastasia, Poirrier, Jean-Etienne, Rosillon, Dominique, Valdes, Laura, Cheuvart, Brigitte, Mesaros, Narcisa, Meyer, Nadia, Guignard, Adrienne, Tseng, Hung-Fu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9925651/
https://www.ncbi.nlm.nih.gov/pubmed/36520325
http://dx.doi.org/10.1007/s40121-022-00731-8
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author Florea, Ana
Sy, Lina S.
Ackerson, Bradley K.
Qian, Lei
Luo, Yi
Becerra-Culqui, Tracy
Lee, Gina S.
Tian, Yun
Zheng, Chengyi
Bathala, Radha
Tartof, Sara Y.
Campora, Laura
Ceregido, Maria Angeles
Kuznetsova, Anastasia
Poirrier, Jean-Etienne
Rosillon, Dominique
Valdes, Laura
Cheuvart, Brigitte
Mesaros, Narcisa
Meyer, Nadia
Guignard, Adrienne
Tseng, Hung-Fu
author_facet Florea, Ana
Sy, Lina S.
Ackerson, Bradley K.
Qian, Lei
Luo, Yi
Becerra-Culqui, Tracy
Lee, Gina S.
Tian, Yun
Zheng, Chengyi
Bathala, Radha
Tartof, Sara Y.
Campora, Laura
Ceregido, Maria Angeles
Kuznetsova, Anastasia
Poirrier, Jean-Etienne
Rosillon, Dominique
Valdes, Laura
Cheuvart, Brigitte
Mesaros, Narcisa
Meyer, Nadia
Guignard, Adrienne
Tseng, Hung-Fu
author_sort Florea, Ana
collection PubMed
description INTRODUCTION: This 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. METHODS: The 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. RESULTS: The 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. CONCLUSION: Cautious 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 REGISTRATION: ClinicalTrials.gov identifier, NCT03463577. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-022-00731-8.
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spelling pubmed-99256512023-02-15 Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies Florea, Ana Sy, Lina S. Ackerson, Bradley K. Qian, Lei Luo, Yi Becerra-Culqui, Tracy Lee, Gina S. Tian, Yun Zheng, Chengyi Bathala, Radha Tartof, Sara Y. Campora, Laura Ceregido, Maria Angeles Kuznetsova, Anastasia Poirrier, Jean-Etienne Rosillon, Dominique Valdes, Laura Cheuvart, Brigitte Mesaros, Narcisa Meyer, Nadia Guignard, Adrienne Tseng, Hung-Fu Infect Dis Ther Original Research INTRODUCTION: This 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. METHODS: The 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. RESULTS: The 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. CONCLUSION: Cautious 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 REGISTRATION: ClinicalTrials.gov identifier, NCT03463577. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-022-00731-8. Springer Healthcare 2022-12-15 2023-02 /pmc/articles/PMC9925651/ /pubmed/36520325 http://dx.doi.org/10.1007/s40121-022-00731-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Florea, Ana
Sy, Lina S.
Ackerson, Bradley K.
Qian, Lei
Luo, Yi
Becerra-Culqui, Tracy
Lee, Gina S.
Tian, Yun
Zheng, Chengyi
Bathala, Radha
Tartof, Sara Y.
Campora, Laura
Ceregido, Maria Angeles
Kuznetsova, Anastasia
Poirrier, Jean-Etienne
Rosillon, Dominique
Valdes, Laura
Cheuvart, Brigitte
Mesaros, Narcisa
Meyer, Nadia
Guignard, Adrienne
Tseng, Hung-Fu
Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies
title Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies
title_full Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies
title_fullStr Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies
title_full_unstemmed Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies
title_short Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies
title_sort investigating tetanus, diphtheria, acellular pertussis vaccination during pregnancy and risk of congenital anomalies
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9925651/
https://www.ncbi.nlm.nih.gov/pubmed/36520325
http://dx.doi.org/10.1007/s40121-022-00731-8
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