Safety and use of tetanus-diphtheria-acellular pertussis-5 (Tdap5) vaccine during pregnancy: findings from 11 years of reporting to a pregnancy registry

References

• Centers for Disease Control and Prevention (CDC). Preventing tetanus, diphtheria, and pertussis among pregnant women and postpartum women and their infants. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008;57(RR–4):1–41.
   PubMedGoogle Scholar
• Gall SA, Myers J, Pichichero M. Maternal immunization with tetanus-diphtheria-pertussis vaccine: effect on maternal and neonatal serum antibody levels. Am J Obstet Gynecol. 2011;203(4):334.e1–5. doi:10.1016/j.ajog.2010.11.024.
   Google Scholar
• Leuridan E, Hens N, Peeters N, de Witte L, Van der Meeren O, Van Damme P. Effect of a prepregnancy pertussis booster dose on maternal antibody titers in young infants. Pediatr Infect Dis J. 2011;30(7):603–10. doi:10.1097/INF.0b013e3182093814.
   Web of Science ®Google Scholar
• Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged <12 months - Advisory Committee on Immunizations Practices (ACIP), 2011. MMWR. 2011;60(41):1424–26.
   PubMedGoogle Scholar
• Centers for Disease Control Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women – Advisory Committee on Immunization Practices (ACIP), 2012. MMWR. 2013;62(7):131–35.
   PubMed Web of Science ®Google Scholar
• American College of Obstetricians and Gynecologists. Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination. Committee opinion no. 438. Obstet Gynecol. 2009;114(2 Pt 1):398–400. doi:10.1097/AOG.0b013e3181b48f07.
   PubMedGoogle Scholar
• American College of Obstetricians and Gynecologists. Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination ACOG committee opinion no. 521. Obstet Gynecol. 2012;119(3):690–91. doi:10.1097/AOG.0b013e31824e1327.
   PubMedGoogle Scholar
• American College of Obstetricians and Gynecologists. Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination. Committee opinion no. 566. Obstet Gynecol. 2013;121(6):1411–14. doi:10.1097/01.AOG.0000431054.33593.e3.
   PubMedGoogle Scholar
• Medical Dictionary for Regulatory Activities (MedDRA). [accessed 2018 Aug 28]. http://www.meddra.org.
   Google Scholar
• US Food and Drug Administration (FDA). 21 code of federal regulation part 600.80 postmarketing reporting of adverse experiences. Fed Regist. 1997 [accessed 2018 Aug 28];62:52252–53. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=600.80.
   Google Scholar
• Brown LD, Cai TT, DasGupta A. Interval estimation for a binomial proportion. Stat Sci. 2001;16(2):101–33. doi:10.1214/ss/1009213286.
   Web of Science ®Google Scholar
• Center for Disease Control and Prevention (CDC). Data on selected pregnancy complications in the United States. [accessed 2019 Feb 18]. http://www.cdc.gov/reproductiveheatlh/maternalinfanthealth/pregnancy-complications.html.
   Google Scholar
• US Department of Health and Human Services, National Institute of Child Health and Human Development, National Institute of Health. Most common complications of pregnancy. [accessed 2019 Feb 18]. http://www.nichd.nih.gov/health/topics/pregnancy/conditioninfo/complications.
   Google Scholar
• Law A, McCoy M, Lynen R, Curkendall SM, Gatwood J, Juneau PL, Landsman-Blumberg P. The prevalence of complications and healthcare costs during pregnancy. J Med Econ. 2015;18(7):533–41. doi:10.3111/13696998.2015.1016229.
   PubMed Web of Science ®Google Scholar
• DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007–2010. Prev Chronic Dis. 2014;11:E104. doi:10.58888/pcd11.130415.
   PubMed Web of Science ®Google Scholar
• Chen Y, Quick WW, Yang W, Zhang Y, Baldwin A, Moran J, Moore V, Sahai N, Dall TM. Cost of gestational diabetes mellitus in the United States in 2007. Popul Health Manage. 2009;12(3):165–74. doi:10.1089/pop.2009.12303.
   PubMed Web of Science ®Google Scholar
• Griffin JB, Yu L, Watson D, Turner N, Walls T, Howe AS, Jiang Y, Pertussis P-H-H. Immunization in pregnancy safety (PIPS) study: a retrospective cohort study of safety outcomes in pregnant women vaccinated with Tdap vaccine. Vaccine. 2018;36(34):5173–79. doi:10.1016/j.vaccine.2018.07.011.
   PubMed Web of Science ®Google Scholar
• Layton JB, Butler AM, Li D, Boggess KA, Weber DJ, McGrath LJ, Prenatal B-DS. Tdap immunization and risk of maternal and newborn adverse events. Vaccine. 2017;35(33):4072–78. doi:10.1016/j.vaccine.2017.06.071.
   PubMed Web of Science ®Google Scholar
• DeSilva M, Vazquez-Benitez G, Nordin JD, Lipkind HS, Klein NP, Cheetham TC, Naleway AL, Hambidge SJ, Lee GM, Jackson ML, et al. Maternal Tdap vaccination and risk of infant morbidity. Vaccine. 2017;35(29):3655–60. doi:10.1016/j.vaccine.2017.05.041.
   PubMed Web of Science ®Google Scholar
• Sukumaran L, McCarthy NL, Kharbanda EO, McNeil MM, Naleway AL, Klein NP, Jackson ML, Hambidge SJ, Lugg MM, Li R, et al. Association of Tdap vaccination with acute events and adverse birth outcomes among pregnant women with prior tetanus-containing immunizations. JAMA. 2015;314(15):1581–87. doi:10.1001/jama.2015.12790.
   PubMed Web of Science ®Google Scholar
• Sukumaran L, McCarthy NL, Kharbanda EO, Weintraub ES, Vazquez-Benitez G, McNeil MM, Li R, Klein NP, Hambidge SJ, Naleway AL, et al. Safety of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis and influenza vaccinations in pregnancy. Obstet Gynecol. 2015;126(5):1069–74. doi:10.1097/AOG.0000000000001066.
   PubMed Web of Science ®Google Scholar
• Donegan K, King B, Bryan P. Safety of pertussis vaccination in pregnant women in UK: observational study. BMJ. 2014;349:g4219. doi:10.1136/bmj.g4219.
   PubMed Web of Science ®Google Scholar
• Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway A, Omer SB, Hambidge SJ, Lee GM, Jackson ML, et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA. 2014;312(18):1897–904. doi:10.1001/jama.2014.14825.
   PubMed Web of Science ®Google Scholar
• Walls T, Graham P, Petousis-Harris H, Hill L, Austin N. Infant outcomes after exposure to Tdap vaccine in pregnancy: an observational study. BMJ Open. 2016;6(1):e009536. doi:10.1136/bmjopen-2015-009536.
   PubMed Web of Science ®Google Scholar
• Petousis-Harris H, Walls T, Watson D, Paynter J, Graham P, Turner N. Safety of Tdap vaccine in pregnant women: an observational study. BMJ Open. 2016;6(4):e010911. doi:10.1136/bmjopen-2015-010911.
   PubMed Web of Science ®Google Scholar
• Berenson AB, Hirth JM, Rahman M, Laz TH, Rupp RE, Sarpong KO. Maternal and infant outcomes among women vaccinated against pertussis during pregnancy. Hum Vaccin Immunother. 2016;12(8):1965–71. doi:10.1080/21645515.2016.1157241.
   PubMed Web of Science ®Google Scholar
• Morgan JL, Baggari SR, McIntire DD, Sheffield JS. Pregnancy outcomes after antepartum tetanus, diphtheria, and acellular pertussis vaccination. Obstet Gynecol. 2015;125(6):1433–38. doi:10.1097/AOG.0000000000000862.
   PubMed Web of Science ®Google Scholar
• Shakib JH, Korgenski K, Sheng X, Varner MW, Pavia AT, Byington CL. Tetanus, diphtheria, acellular pertussis vaccine during pregnancy: pregnancy and infant health outcomes. J Pediatr. 2013;163(5):1422–26. doi:10.1016/j.jpeds.2013.06.021.
   PubMed Web of Science ®Google Scholar
• Moro PL, Cragan J, Tepper N, Zheteyeva Y, Museru O, Lewis P, Broder K. Enhanced surveillance of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines in pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2011–2015. Vaccine. 2016;34(20):2349–53. doi:10.1016/j.vaccine.2016.03.049.
   PubMed Web of Science ®Google Scholar
• Zheteyeva YA, Moro PL, Tepper NK, Rasmussen SA, Barash FE, Revzina NV, Kissin D, Lewis PW, Yue X, Haber P, et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. Am J Obstet Gynecol. 2012;207(1):59.e1–7. doi:10.1016/j.ajog.2012.05.006.
   PubMed Web of Science ®Google Scholar
• American College of Obstetrics and Gynecology (ACOG). Practice bulletin no. 172: premature rupture of membranes. Obstet Gynecol. 2016;128(4):e165–e177. doi:10.1097/AOG.0000000000001712.
   PubMedGoogle Scholar
• Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Mathews TJ. Births: final data for 2015. National Vital Statistics Reports; 66( 1). Hyattsville, MD: National Centre for Health Statistics; 2017. [accessed 2019 Feb 18]. http://www.cdc.gov/nchs/data/nvsr/vnsr67/nvsr67_01.pdf.
   Google Scholar
• Ventura SJ, Curtin SC, Abma JC, Henshaw SK. Estimated pregnancy rates and rates of pregnancy outcomes for the United States, 1990-2008. National Vital Stat Rep. 2012;60(7):1–21.
   PubMedGoogle Scholar
• Stulberg DB, Cain LR, Dahlquist I, Lauderdale DS. Ectopic pregnancy rates in the Medicaid population. Am J Obstet Gynecol. 2013;208(4):274.e7. doi:10.1016/j.ajog.2012.12.038.
   PubMed Web of Science ®Google Scholar
• Trabert B, Holt VL, Yu O, Van den Eeden SK, Scholes D. Population-based ectopic pregnancy trends, 1993–2007. Am J Prev Med. 2011;40(5):556–60. doi:10.1016/j.amepre.2010.12.026.
   PubMed Web of Science ®Google Scholar
• Van den Eeden SK, Shan J, Bruce C, Glasser M. Ectopic pregnancy rate and treatment utilization in a large managed care organization. Obstet Gynecol. 2005;105:1052–57. doi:10.1097/01.AOG.0000158860.26939.2d.
   PubMed Web of Science ®Google Scholar
• Yuen CYS, Tarrant M. Determinants of uptake of influenza vaccination among pregnant women – a systematic review. Vaccine. 2014;32(36):4602–13. doi:10.1016/j.vaccine.2014.06.067.
   PubMed Web of Science ®Google Scholar
• Legge A, Dodds L, MacDonald NE, Scott J, McNeil S. Rates and determinants of seasonal influenza vaccination in pregnancy and association with neonatal outcomes. CMAJ. 2014;186(4):E157–64. doi:10.1503/cmaj.130499.
   PubMed Web of Science ®Google Scholar
• Korver AM, Smith RJ, Van Camp G, Schleiss MR, Bitner-Glindzicz MAK, Lustig LR, Usami S-I, Boudewyns AN. Congenital hearing loss. Nat Rev Dis Primers. 2017;3(1):16094. doi:10.1038/nrdp.2016.94.
   PubMed Web of Science ®Google Scholar
• Murphy-Kaulbeck L, Dodds L, Joseph KS, Van den Hof M. Single umbilical artery risk factors and pregnancy outcomes. Obstet Gynecol. 2010;116(4):843–50. doi:10.1097/AOG.0b013e3181f0bc08.
   PubMed Web of Science ®Google Scholar
• American Heart Association. Patent Foramen Ovale (PFO). [accessed 2019 Feb 18]. http://www.heart.org/en/health-topics/congenital-heart-defects/about-congenital-heart-defects/patent-foramen-ovale.
   Google Scholar
• Parker SE, MMai CT, Canfield MA, Rickard R, Wang Y, Meyer RE, Anderson P, Mason CA, Collins JS, Kirby RS, et al. Updated national birth prevalence estimates for selected birth defects in the United States, 2004–2006. Birth Defects Res Part A. 2010;88(12):1008–16. doi:10.1002/bdra.20735.
   PubMed Web of Science ®Google Scholar
• Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39(12):1890–900. doi:10.1016/S0735-1097(02)01886-7.
   PubMed Web of Science ®Google Scholar
• Franch RH, Gay BB Jr. Congenital stenosis of the pulmonary artery branches: a classification, with postmortem findings in two cases. Am J Med. 1963;35(4):512–29. doi:10.1016/0002-9343(63)90149-9.
   PubMed Web of Science ®Google Scholar
• Stanford Children’s Health. Factors contributing to congenital birth defects [accessed 2019 Feb 23]. http://www.stanfordchildrens.org/en/topic/default?id=factors-contributing-to-congenital-heart-disease-90-P01788.
   Google Scholar
• Ul Haq F, Jalil F, Hashmi S, Jumani MI, Imdad A, Jabeen M, Hashmi JT, Irfan FB, Imran M, Atiq M. Risk factors predisposing to congenital heart defects. Ann Pediatr Cardiol. 2011;4(2):117–21. doi:10.4103/0974-2069.84641.
   PubMedGoogle Scholar
• Abqari S, Gupta A, Shahab T, Rabbani MU, Ali SM, Firdaus U. Profile and risk factors for congenital heart defects: a study in a tertiary care hospital. Ann Pediatr Cardiol. 2011;9(3):216–21. doi:10.4103/0974-2069.189119.
   Google Scholar
• Weber JCP. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. Adv Inflam Res. 1984;6:1–7.
   Google Scholar
• Centers for Disease Control and Prevention (CDC). Summary of notifiable diseases, 2012. MMWR. 2014;61(53):1–121.
   PubMedGoogle Scholar