Safety Evaluation of Tetanus, Diphtheria, and Acellular Pertussis Vaccine (Tdap) During Pregnancy Among Vietnamese Women.

Background: In Vietnam, the Ministry of Health recently approved the use of Tdap vaccines-Boostrix (2022) and Adacel (2024)-for administration during pregnancy, aiming to provide passive antibody transfer to protect newborns against pertussis and tetanus from birth. However, uptake remains low, largely because Tdap is not included in the National Expanded Program on Immunization, vaccine hesitancy persists among obstetricians, and local safety data in pregnancy are limited. Methods: We conducted a prospective cohort study from September 2023 to September 2024 involving 485 pregnant women between 27 and 36 weeks of gestation at two major hospitals in Ho Chi Minh City: University Medical Center and Gia Dinh People's Hospital. Participants received either Tdap or monovalent tetanus toxoid vaccine (TT) as a comparator. Results: Among women in the Tdap group, 49.8% reported at least one adverse event following immunization (AEFI). Local reactions were the most frequent, primarily injection-site pain (43.8%). Fatigue (12.8%) was the most common systemic reaction, followed by headache (3.9%). Grade 3 AEFIs occurred in 5% of the Tdap group and included extensive local reactions (erythema or swelling > 3 cm), high-grade fever (≥40 °C), and severe fatigue interfering with daily activities or requiring hospitalization. Women receiving Tdap had 1.52-fold higher injection-site pain compared with those receiving TT (95% CI: 0.060-0.782). Importantly, co-administration of Tdap with inactivated quadrivalent influenza vaccine (IIV4) did not increase the risk of AEFIs. Furthermore, no evidence was found that Tdap vaccination adversely affected the course of pre-existing maternal comorbidities, which remained stable throughout pregnancy. Conclusions: This first large-scale Vietnamese cohort provides reassuring evidence on the safety of Tdap vaccination during pregnancy. These findings support broader implementation of maternal Tdap immunization, including concomitant administration with IIV4, to protect both mothers and infants.