Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine when administered during pregnancy as part of the maternal immunization program in Brazil: a single center, observational, retrospective, cohort study

Mauro Sancovski, Narcisa Mesaros, Yang Feng, M Angeles Ceregido, Dominique Luyts, Eliana De Barros, Mauro Sancovski, Narcisa Mesaros, Yang Feng, M Angeles Ceregido, Dominique Luyts, Eliana De Barros

Abstract

Reduced antigen diphtheria-tetanus-acellular pertussis (Tdap) vaccination is included in the maternal immunization program in Brazil since September 2014. We investigated associations between maternal Tdap vaccination and pregnancy-related adverse events (AEs) (gestational diabetes, pregnancy-related hypertension, and pregnancy hemorrhage) and neonatal AEs of interest (preterm birth and small for gestational age). This descriptive, observational, retrospective, single-center study in Brazil (NCT02757950) compared data from medical charts of 1203 pregnant women who received Tdap as part of the maternal immunization program and delivered between May 2015 and February 2017 (exposed cohort) and 1259 unvaccinated women who delivered between September 2012 and August 2014 (unexposed cohort). Index dates were defined as the time of vaccination (27-39 gestational weeks; exposed cohort) or 27 gestational weeks (unexposed cohort). Cumulative incidences were calculated as the number of women with each event between index and delivery dates divided by the total number of women with vaccination date available in the exposed cohort (N = 1199) or the total number of women in the unexposed cohort (N = 1259). Cumulative incidences per 1000 persons were 8.34 versus 17.47 for gestational diabetes, 9.17 versus 24.62 for pregnancy-related hypertension, 3.34 versus 15.09 for pregnancy hemorrhage, 53.38 versus 96.11 for preterm birth, and 57.55 versus 49.25 for small for gestational age in the exposed versus unexposed cohorts. No increased risk of pregnancy-related AEs or neonatal AEs of interest was found following maternal vaccination with Tdap. These results should be interpreted cautiously due to limitations inherent to retrospective observational studies.

Keywords: Pertussis; adverse event; maternal vaccination; neonate; pregnancy.

Figures

Figure 1.
Figure 1.
Focus on the patient.
Figure 2.
Figure 2.
Flow of participants. Notes: Exposed cohort, pregnant women who had received Tdap as part of the maternal immunization program in Brazil; unexposed Cohort, women pregnant before implementation of the maternal immunization program in Brazil who did not receive Tdap. N, number of participants.Note: Participant may have more than one elimination code assigned.aDue to missing information (i.e., no data reported but subject number allocated).

References

    1. Sealey KL, Belcher T, Preston A.. Bordetella pertussis epidemiology and evolution in the light of pertussis resurgence. Infect Genet Evol. 2016;40:136–43. doi:10.1016/j.meegid.2016.02.032.
    1. Winter K, Harriman K, Zipprich J, Schechter R, Talarico J, Watt J, Chavez G. California pertussis epidemic, 2010. J Pediatr. 2012;161(6):1091–96. doi:10.1016/j.jpeds.2012.05.041.
    1. WHO SAGE pertussis working group Background paper; SAGE 2014. April [accessed 2018 April16]. .
    1. Burns DL, Meade BD, Messionnier NE. Pertussis resurgence: perspectives from the Working Group Meeting on pertussis on the causes, possible paths forward, and gaps in our knowledge. J Infect Dis. 2014;209(Suppl 1):S32–S325. doi:10.1093/infdis/jit491.
    1. Centers for Disease Control and Prevention (CDC) Pertussis epidemic–washington, 2012. MMWR Morb Mortal Wkly Rep. 2012;61(28):517–22.
    1. Public Health England (PHE) Guidelines for the public health management of pertussis in England. Published May 2018 v2.0. Gateway number: 2018043 [accessed 2019 January22]. .
    1. Guimaraes LM, Carneiro EL, Carvalho-Costa FA. Increasing incidence of pertussis in Brazil: a retrospective study using surveillance data. BMC Infect Dis. 2015;15:442. doi:10.1186/s12879-015-1222-3.
    1. Tan T, Dalby T, Forsyth K, Halperin SA, Heininger U, Hozbor D, Plotkin S, Ulloa-Gutierrez R, Wirsing von Konig CH. Pertussis Across the Globe: recent Epidemiologic Trends From 2000 to 2013. Pediatr Infect Dis J. 2015;34(9):e222–32. doi:10.1097/INF.0000000000000795.
    1. de Barros ENC, Nunes AA, de Abreu A, Furtado BE, Tanaka E, Cintra O, Cintra MA, Coelho EB.. Epidemiological profile and burden of pertussis in Brazil from 2010 to 2015 - Systematic and data review. Presented at the 36th Congreso Interamericano de Infectología Pediátrica/17th Congreso Latinoamericano de Infectología Pediátrica, 2017. November 8–11; Cancun, México [accessed 2018 June13]. .
    1. Ministry of Health Informe técnico para implantação da vacina adsorvida difteria, tétano e coqueluche (Pertussis Acelular) Tipo adulto – dTpa. Brasília, Setembro 2014. [accessed 2018 April16]. .
    1. Healy CM. Vaccines in pregnant women and research initiatives. Clin Obstet Gynecol. 2012;55(2):474–86. doi:10.1097/GRF.0b013e31824f3acb.
    1. Keller-Stanislawski B, Englund JA, Kang G, Mangtani P, Neuzil K, Nohynek H, Pless R, Lambach P, Zuber P. Safety of immunization during pregnancy: a review of the evidence of selected inactivated and live attenuated vaccines. Vaccine. 2014;32(52):7057–64. doi:10.1016/j.vaccine.2014.09.052.
    1. Amirthalingam G, Andrews N, Campbell H, Ribeiro S, Kara E, Donegan K, Fry NK, Miller E, Ramsay M. Effectiveness of maternal pertussis vaccination in England: an observational study. Lancet. 2014;384(9953):1521–28. doi:10.1016/s0140-6736(14)60686-3.
    1. Malek A, Sager R, Kuhn P, Nicolaides KH, Schneider H. Evolution of maternofetal transport of immunoglobulins during human pregnancy. Am J Reprod Immunol. 1996;36:248–55.
    1. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646.
    1. Eberhardt CS, Blanchard-Rohner G, Lemaitre B, Boukrid M, Combescure C, Othenin-Girard V, Chilin A, Petre J, de Tejada BM, Siegrist CA. Maternal immunization earlier in pregnancy maximizes antibody transfer and expected infant seropositivity against pertussis. Clin Infect Dis. 2016;62(7):829–36. doi:10.1093/cid/ciw027.
    1. Public Health England (PHE) Vaccination against pertussis (Whooping cough) for pregnant women - 2016. Information for healthcare professionals. PHE publications gateway number: 2016111. Document Version No. v.4. [accessed 2019 January22]. .
    1. Centers for Disease Control and Prevention (CDC) Get the whooping cough vaccine while you are pregnant. 2017. July 24 [accessed 2019 January22]. .
    1. Ministry of Health. Orientações sobre Vacinação Calendário Nacional de Vacinação 2018. [accessed February262019]. .
    1. Santoz Z, Renoiner E, Pereira M, Oliveira D, Millington M, Matos Z, Nishioka S, Rosa F. The vaccination strategy of pertussis in Brazil. Abstract 107. 11th International Symposium on Bordetella; 2016. April 5–8; Buenos Aires, Argentina.
    1. Dabrera G, Amirthalingam G, Andrews N, Campbell H, Ribeiro S, Kara E, Fry NK, Ramsay M. A case-control study to estimate the effectiveness of maternal pertussis vaccination in protecting newborn infants in England and Wales, 2012-2013. Clin Infect Dis. 2015;60(3):333–37. doi:10.1093/cid/ciu821.
    1. Abu Raya B, Edwards KM, Scheifele DW, Halperin SA. Pertussis and influenza immunisation during pregnancy: a landscape review. Lancet Infect Dis. 2017;17(7):e209–e22. doi:10.1016/s1473-3099(17)30190-1.
    1. Leuridan E. Pertussis vaccination in pregnancy: state of the art. Vaccine. 2017;35(35 Pt A):4453–56. doi:10.1016/j.vaccine.2017.03.061.
    1. Gkentzi D, Katsakiori P, Marangos M, Hsia Y, Amirthalingam G, Heath PT, Ladhani S. Maternal vaccination against pertussis: a systematic review of the recent literature. Arch Dis Child Fetal Neonatal Ed. 2017;102(5):F456–F63. doi:10.1136/archdischild-2016-312341.
    1. Vizzotti C, Neyro S, Katz N, Juarez MV, Perez Carrega ME, Aquino A, Kaski Fullone F. Maternal immunization in Argentina: A storyline from the prospective of a middle income country. Vaccine. 2015;33(47):6413–19. doi:10.1016/j.vaccine.2015.07.109.
    1. 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):1422-6e1-4. doi:10.1016/j.jpeds.2013.06.021.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. McMillan M, Clarke M, Parrella A, Fell DB, Amirthalingam G, Marshall HS. Safety of tetanus, diphtheria, and pertussis vaccination during pregnancy: a systematic review. Obstet Gynecol. 2017;129(3):560–73. doi:10.1097/aog.0000000000001888.
    1. Augustynowicz E, Lutynska A, Piotrowska A, Paradowska- Stankiewicz I. The safety and effectiveness of vaccination against influenza and pertussis in pregnant women. Przegl Epidemiol. 2017;71:55–67.
    1. Furuta M, Sin J, Ng ESW, Wang K. Efficacy and safety of pertussis vaccination for pregnant women – a systematic review of randomised controlled trials and observational studies. BMC Pregnancy Childbirth. 2017;17:390. doi:10.1186/s12884-017-1559-2.
    1. 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.
    1. Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway AL, Lee GM, Hambidge S, Jackson ML, Omer SB, et al. Maternal Tdap vaccination: coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013. Vaccine. 2016;34(7):968–73. doi:10.1016/j.vaccine.2015.12.046.
    1. Layton JB, Butler AM, Li D, Boggess KA, Weber DJ, McGrath LJ, Becker-Dreps S. Prenatal Tdap immunization and risk of maternal and newborn adverse events. Vaccine. 2017;35(33):4072–78. doi:10.1016/j.vaccine.2017.06.071.
    1. 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.
    1. Wanlapakorn N, Maertens K, Chaithongwongwatthana S, Srimuan D, Suratannon N, Vongpunsawad S, Mai Phuong Tran T, Hens N, Van Damme P, Locht C, et al. Assessing the reactogenicity of Tdap vaccine administered during pregnancy and antibodies to Bordetella pertussis antigens in maternal and cord sera of Thai women. Vaccine. 2018;36(11):1453–59. doi:10.1016/j.vaccine.2018.01.059.
    1. DeSilva M, Vazquez-Benitez G, Nordin JD, Lipkind HS, Romitti PA, DeStefano F, Kharbanda EO. Tdap vaccination during pregnancy and microcephaly and other structural birth defects in offspring. Jama. 2016;316(17):1823–25. doi:10.1001/jama.2016.14432.
    1. World Health Organization Microcephaly - Brazil. Disease outbreak news. 2015. December 15 [accessed 2018 December12]. .
    1. DeSilva M, Munoz FM, McMillan M, Kawai AT, Marshall H, Macartney KK, Joshi J, Oneko M, Rose AE, Dolk H, et al. Congenital anomalies: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2016;34(49):6015–26. doi:10.1016/j.vaccine.2016.03.047.
    1. Munoz FM, Sheffield JS, Beigi RH, Read JS, Swamy GK, Jevaji I, Rasmussen SA, Edwards KM, Fortner KB, Patel SM, et al. Research on vaccines during pregnancy: protocol design and assessment of safety. Vaccine. 2013;31(40):4274–79. doi:10.1016/j.vaccine.2013.07.042.

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