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Tdap is an inactivated vaccine which, given the available data, has shown no vaccine-related adverse effects on pregnancy or on the health of the fetus/newborn child 1-4

BOOSTRIX is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older

  • Safety data from a prospective observational study and passive surveillance, where pregnant women were exposed to Tdap vaccination in the 2nd and 3rd trimester, have shown no vaccine-related adverse effects on pregnancy or on the health of the fetus/newborn child 2-4
  • Based on the observational data available to date, administering the vaccine during pregnancy does not appear to be associated with an increased risk of pregnancy complications like low birth weight or preterm delivery 1 2 5 6

Safety data on Maternal Immunization with the Tdap vaccine 5 7 8

USA: Tdap vaccines safety cohort included 53,885 vaccinated pregnant women 5

No increased risks for any pre-specified maternal safety outcomes within 42 days of vaccination 5

NZ: 793 pregnant women followed up for solicited and unsolicited outcomes (27.9% received concomitant flu vaccination) 7

Vaccination in NZ pregnant women was well tolerated with no SAE likely to be caused by the vaccine 7

Argentina: 1,258,723 doses of Tdap vaccine have been administered to pregnant women since strategy started 8

Tdap vaccination demonstrated a suitable safety profile. No serious adverse effects or fatalities have been reported 8

Tdap: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine.

References:

  1. Munoz FM. Pertussis vaccine in pregnant women: safety and uptake. Vaccine Develop Ther. 2016;6:1-8. [accessed February 2018]; Available at: https://www.dovepress.com/pertussis-vaccin-in-in-pregnant-women-safety-and-uptake-peer-reviewed-fulltext-article-VDT#
  2. Donegan K, et al. Safety of pertussis vaccination in pregnant women in UK: observational study. BMJ. 2014;11;349:4219.
  3. Moro PL, et al. 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;34:2349-2353.
  4. Sukumaran L, et al. Association of Tdap vaccination with acute events and adverse birth outcomes among pregnancy women with prior tetanus-containing immunizations. JAMA. 2015;314(15):1582-1587.
  5. Kharbanda EO, et al. Maternal Tdap vaccination: coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013. Vaccine. 2016:34(7):968-973.
  6. Furuta M, et al. Efficacy and safety of pertussis vaccination for pregnant woman – a systematic review of randomized controlled trails and observational studies. https://www.ncbi.nlm.nik.gov/pubmed/29166874; BMC Pregnancy Childbirth. 2017;17(1):390. Doi:10.1186/s12884-017-1559-2.
  7. Petousis-Harris H, et al. Safety of Tdap vaccine in pregnant women: an observational study. BMJ Open. 2016;6:e010911.
  8. Vizzotti C, et al. Maternal Immunization in Argentina: a storyline from the prospective of a middle income country. Vaccine. 2015;33(47):6413-6419.