Reactogenicity and safety of second trimester maternal tetanus, diphtheria and acellular pertussis vaccination in the Netherlands

• Published in: Vaccine Vol. 41; no. 5; pp. 1074 - 1080
• Main Authors: Immink, Maarten M., Kemmeren, Jeanet M., Broeders, Lisa, Bekker, Mireille N., de Melker, Hester E., Sanders, Elisabeth A.M., van der Maas, Nicoline A.T.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 27.01.2023; Elsevier Limited
• Subjects: Age; Analgesics; Bacterial Vaccines; Common cold; Diphtheria; Diphtheria - prevention & control; Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects; Erythema; Female; Fever; Gestational age; Headache; Headaches; Humans; Maternal vaccination; Mothers; Muscles; Muscular fatigue; Netherlands - epidemiology; Pain; Pertussis; Population; Pregnancy; Pregnancy Trimester, Second; Prenatal care; Questionnaires; Reactogenicity; Safety; Stiffness; Tetanus; Tetanus - prevention & control; Vaccination - adverse effects; Vaccines; Whooping cough; Whooping Cough - prevention & control; Womens health; Netherlands; Pregnancy; Pertussis; Safety; Reactogenicity; Maternal vaccination
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2022.12.061

•Maternal Tdap vaccination between 20 and 24 weeks of gestation is well-tolerated.•67.5 % of pregnant women experienced ≥ 1 local reaction and 63.6 % ≥1 systemic AE.•0.6 % of pregnant women reported mild-to-moderate fever (≥38.0˚C) post-vaccination.•Tdap vaccination between 20 and 24 vs 30-33w GA shows no increased reactogenicity.•Maternal Tdap vaccination yields no increased risks adverse pregnancy outcomes. Maternal tetanus-diphtheria-and-acellular-pertussis (Tdap) vaccination is offered to all pregnant women during their second trimester in the Netherlands since December 2019. We assessed second trimester Tdap vaccination reactogenicity and compared with third trimester data from a similar study. For safety assessment, adverse pregnancy outcomes were compared with national data from 2018, before Tdap vaccine-introduction. Pregnant women were included between August 2019-December 2021 and received Tdap vaccination between 20 and 24w gestational age (GA). Participants completed a questionnaire on solicited local reactions and systemic adverse events (AEs) within one week after vaccination. Results were compared with historical data on reactogenicity from women vaccinated between 30 and 33w GA (n = 58). Regarding safety-related outcomes, each participant was matched to four unvaccinated pregnant women from the Dutch Perinatal Registry, based on living area, parity and age. Among 723 participants who completed the questionnaire, 488 (67.5 %) experienced ≥ 1 local reaction with pain at the injection site as most reported reaction (62.3 %), and 460 (63.6 %) experienced ≥ 1 systemic AE with stiffness in muscles/joints (38.9 %), fatigue (28.9 %), headache (14.5 %) and common cold-like symptoms (11.0 %) most frequently reported. 4 women (0.6 %) reported fever (≥38.0˚C). Symptoms were considered mild and transient within days. No difference in AEs were found between vaccination at 20-24w versus 30-33w GA. 723 participants were matched to 2,424 unvaccinated pregnant women with no increased rates of premature labor, small-for-gestational-age, or other adverse pregnancy outcomes. Second trimester maternal Tdap vaccination appears safe and well-tolerated. Comparison between second versus third trimester vaccination yielded no reactogenicity concerns.