Safety of Tetanus, Diphtheria, Acellular Pertussis (Tdap) Vaccination During Pregnancy

37 Pages Posted: 30 Nov 2021

See all articles by Hung Fu Tseng

Hung Fu Tseng

Kaiser Permanente Southern California

Lina S. Sy

Kaiser Permanente Southern California

Bradley K. Ackerson

Kaiser Permanente Southern California

Gina S. Lee

Kaiser Permanente Southern California; Kaiser Permanente Southern California

Yi Luo

Kaiser Permanente Southern California

Ana Florea

Kaiser Permanente Southern California

Tracy Becerra-Culqui

Kaiser Permanente Southern California

Sara Y. Tartof

Kaiser Permanente Southern California - Department of Research & Evaluation

Yun Tian

Kaiser Permanente Southern California

Christine Taylor

Kaiser Permanente Southern California

Laura Campora

Slaoui Center for Vaccines Research, GSK

Maria Angeles Ceregido

GSK

Anastasia Kuznetsova

GSK

Jean-Etienne Poirrier

GSK; GSK

Dominique Rosillon

GSK

Laura Valdes

GSK

Brigitte Cheuvart

GSK

Narcisa Mesaros

GSK

Nadia Meyer

GSK

Adrienne Guignard

GSK; GSK

Lei Qian

Kaiser Permanente Southern California; Kaiser Permanente Southern California

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.

Note:
Funding Information: This research was funded by GlaxoSmithKline Biologicals S.A.

Declaration of Interests: All Kaiser Permanente authors received research funding from the GSK group of companies for conduct of the study. 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.

Ethics Approval Statement: This study was approved by the KPSC Institutional Review Board. No informed consent was required as the Tdap vaccine was a licensed and recommended vaccine for eligible members’ routine clinical care.

Keywords: vaccine safety, Tdap vaccine, maternal immunization, pregnancy, observational study

Suggested Citation

Tseng, Hung Fu and Sy, Lina S. and Ackerson, Bradley K. and Lee, Gina S. and Luo, Yi and Florea, Ana and Becerra-Culqui, Tracy and Tartof, Sara Y. and Tian, Yun and Taylor, Christine and Campora, Laura and Ceregido, Maria Angeles and Kuznetsova, Anastasia and Poirrier, Jean-Etienne and Rosillon, Dominique and Valdes, Laura and Cheuvart, Brigitte and Mesaros, Narcisa and Meyer, Nadia and Guignard, Adrienne and Qian, Lei, Safety of Tetanus, Diphtheria, Acellular Pertussis (Tdap) Vaccination During Pregnancy. JVAC-D-21-03018, Available at SSRN: https://ssrn.com/abstract=3974848

Hung Fu Tseng (Contact Author)

Kaiser Permanente Southern California ( email )

Mission Viejo, CA
United States

Lina S. Sy

Kaiser Permanente Southern California ( email )

CA
United States

Bradley K. Ackerson

Kaiser Permanente Southern California ( email )

Mission Viejo, CA
United States

Gina S. Lee

Kaiser Permanente Southern California ( email )

United States

Kaiser Permanente Southern California ( email )

United States

Yi Luo

Kaiser Permanente Southern California ( email )

United States

Ana Florea

Kaiser Permanente Southern California ( email )

Mission Viejo, CA
United States

Tracy Becerra-Culqui

Kaiser Permanente Southern California ( email )

United States

Sara Y. Tartof

Kaiser Permanente Southern California - Department of Research & Evaluation ( email )

Pasadena, CA
United States

Yun Tian

Kaiser Permanente Southern California ( email )

United States

Christine Taylor

Kaiser Permanente Southern California ( email )

United States

Laura Campora

Slaoui Center for Vaccines Research, GSK ( email )

Rockville
United States

Maria Angeles Ceregido

GSK ( email )

United Kingdom

Anastasia Kuznetsova

GSK ( email )

United Kingdom

Jean-Etienne Poirrier

GSK ( email )

United Kingdom

GSK ( email )

United Kingdom

Dominique Rosillon

GSK ( email )

United Kingdom

Laura Valdes

GSK ( email )

United Kingdom

Brigitte Cheuvart

GSK ( email )

United Kingdom

Narcisa Mesaros

GSK ( email )

United Kingdom

Nadia Meyer

GSK ( email )

United Kingdom

Adrienne Guignard

GSK ( email )

United Kingdom

GSK ( email )

United Kingdom

Lei Qian

Kaiser Permanente Southern California ( email )

United States

Kaiser Permanente Southern California ( email )

United States

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