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. 2022 Jul 30;40(32):4503-4512.
doi: 10.1016/j.vaccine.2022.06.009. Epub 2022 Jun 16.

Safety of tetanus, diphtheria, acellular pertussis (Tdap) vaccination during pregnancy

Hung Fu Tseng  1 , Lina S Sy  2 , Bradley K Ackerson  3 , Gina S Lee  4 , Yi Luo  4 , Ana Florea  4 , Tracy Becerra-Culqui  4 , Sara Y Tartof  4 , Yun Tian  4 , Christine Taylor  4 , Laura Campora  5 , Maria Angeles Ceregido  5 , Anastasia Kuznetsova  5 , Jean-Etienne Poirrier  5 , Dominique Rosillon  5 , Laura Valdes  5 , Brigitte Cheuvart  5 , Narcisa Mesaros  5 , Nadia Meyer  5 , Adrienne Guignard  5 , Lei Qian  4
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Free article

Safety of tetanus, diphtheria, acellular pertussis (Tdap) vaccination during pregnancy

Hung Fu Tseng et al. Vaccine. .
Free article

Abstract

The objective of this study was to evaluate the safety of prenatal tetanus, diphtheria, acellular pertussis (Tdap) vaccination. This cohort study was conducted among pregnant members at Kaiser Permanente Southern California (KPSC). The exposed cohort consisted of women who received Tdap vaccine on or after the 27th week of pregnancy between January 2018 and January 2019. The unexposed cohort consisted of matched women who were pregnant between January 2012 and December 2014 and were not vaccinated with any Tdap vaccine throughout their pregnancy. Maternal and infant characteristics and pre-specified endpoints were collected through automated data and review of the electronic health records. Unadjusted and adjusted relative risks (aRRs) with confidence intervals (CIs) were estimated by Poisson regression. Non-inferiority testing (i.e., to rule out a two-fold increase) was conducted for primary endpoints with adjustment for multiplicity. Superiority testing was conducted without multiplicity adjustment for secondary endpoints. The analysis consisted of 16,606 pairs of Tdap recipients and unexposed pregnant women. For the primary endpoints, the aRR for preeclampsia/eclampsia was 1.38 (98.75% CI:1.21-1.58) and the aRR for intrauterine infection was 1.28 (98.75% CI:1.12-1.47). These increases were consistent with the background increasing trend of these diagnoses among all pregnant women at KPSC since 2011, and the upper limit of the 98.75% CI of both aRRs did not exceed the pre-specified threshold of 2. No increased risks of small for gestational age (aRR = 1.04, 98.75% CI:0.94-1.16) or preterm delivery (aRR = 0.71, 98.75% CI:0.64-0.78) were observed. No evidence of increased risks for secondary endpoints, including poor fetal growth, preterm pre-labor rupture of membranes, stillbirth/fetal death, placental abruption, transfusion during delivery hospitalization, and neonatal death, was observed. Prenatal Tdap vaccination after the 27th week of pregnancy was not associated with increased risks of pre-specified maternal and infant outcomes, supporting the safety of Tdap vaccination during pregnancy.

Keywords: Maternal immunization; Observational study; Pregnancy; Tdap vaccine; Vaccine safety.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Hung Fu Tseng reports financial support was provided by GSK Vaccines. Hung Fu Tseng reports a relationship with Moderna Therapeutics Inc that includes: funding grants. HFT, GSL, and YT received research funding from GSK group of companies and Moderna for other studies outside of the submitted work. LSS received research funding from GSK group of companies, Novavax, Seqirus, Dynavax, and Moderna for other studies outside of the submitted work. BKA received research funding from GSK group of companies, Novavax, Seqirus, Dynavax, Moderna, Pfizer, and Genentech for other studies outside of the submitted work. YL received research funding from GSK group of companies, Seqirus, Moderna, and Pfizer for other studies outside of the submitted work. AF received research funding from GSK group of companies, Moderna, Pfizer, and Gilead for other studies outside of the submitted work. TBC received research funding from GSK group of companies for other studies outside of the submitted work. SYT received research funding from Pfizer for other studies outside of the submitted work. CT received research funding from GSK and Novavax for other studies outside of the submitted work. LC, MAC, AK, LV, BC, NMeyer and AG are employees of the GSK group of companies. LC, MAC, AK, LV, BC, NMeyer and AG hold shares in the GSK group of companies. JEP, DR and NMesaros were employees of the GSK group of companies and held shares at the time of this study. The authors have no non-financial competing interest to declare. LQ received research funding from GSK group of companies, Moderna, and Dynavax for other studies outside of the submitted work.].

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