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The Effect of Maternal Pertussis Vaccination on Neonatal Health Outcomes in the Dutch Pregnancy Drug Register

Petra J Woestenberg¹, Veronique Y F Maas¹, Maud de Feijter¹

¹Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, the Netherlands.

Birth Defects Research

|April 2, 2026

Insights

Maternal pertussis vaccination during pregnancy is safe for newborns. The study found no increased risk of adverse neonatal health outcomes, including hospitalization, confirming its safety for infant health.

Area of Science:

Obstetrics and Gynecology
Neonatal Health
Vaccinology

Background:

High infant pertussis morbidity and mortality necessitates evaluating maternal vaccination safety.
International attention is focused on pertussis vaccination during pregnancy.
This study assessed the safety of maternal pertussis vaccination concerning neonatal health in the Netherlands.

Purpose of the Study:

To evaluate the safety of maternal pertussis vaccination.
To assess the impact of pertussis vaccination during pregnancy on neonatal health outcomes.
To compare neonatal health outcomes between second and third trimester vaccinations.

Main Methods:

Utilized data from the Dutch Pregnancy Drug Register cohort.
Included participants with singleton live births ≥24 weeks gestation.
Employed log-binomial regression analysis with confounder correction to assess risks.

Main Results:

Maternal pertussis vaccination showed no increased risk for small/large for gestational age, low birth weight, or neonatal health problems.
A reduced risk of infant hospitalization due to infection (RR: 0.68, 95% CI: 0.47-0.99) was observed.
No increased risk was found for neonatal death, low Apgar score, or NICU admission; no difference between trimesters.

Conclusions:

Maternal pertussis vaccination is confirmed as safe regarding neonatal health outcomes.
The study supports the safety of vaccinating pregnant individuals against pertussis.
No adverse neonatal effects were linked to maternal pertussis immunization.

Read full analysis

Abstract

Background:

The currently high pertussis-related morbidity and mortality among infants has led to increased international attention for pertussis vaccination during pregnancy. We studied the safety of maternal pertussis vaccination in the Netherlands with respect to neonatal health.

Methods:

Data from the cohort the Dutch Pregnancy Drug Register were used. Pregnant participants self-reported their pertussis vaccination and the health outcomes of their offspring. Participants with a singleton live birth ≥ 24 weeks gestation were included. Using log-binomial regression analysis and correction for confounders, we studied the risk of maternal pertussis vaccination on various neonatal health outcomes. Moreover, we compared differences in health outcomes between second and third trimester vaccinations.

Results:

The study population included 10,280 participants (74.8% vaccinated against pertussis during pregnancy and 25.3% not). The adjusted risk ratio (RR) was: 1.01 (95% confidence interval [CI]: 0.82-1.23) for small for gestational age; 0.90 (95% CI: 0.73-1.11) for large for gestational age; 0.86 (95% CI: 0.59-1.25) for low birth weight; 1.06 (95% CI: 0.90-1.25) for neonatal health problems, and 0.68 (95% CI: 0.47-0.99) for infant hospitalization due to (suspicion of) infection. Also for the secondary outcomes neonatal death, low Apgar score, and neonatal intensive care unit admission, no increased risk after maternal pertussis vaccination was observed. There was no difference in neonatal health outcomes between second and third trimester pertussis vaccinations.

Conclusions:

The maternal pertussis vaccination did not increase the risk of several adverse neonatal health outcomes, confirming the safety of pertussis vaccination during pregnancy with respect to neonatal health outcomes.

Keywords:

Boostrix Tdap immunization infant health pregnancy safety whooping cough

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