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

Maarten M Immink; Jeanet M Kemmeren; Lisa Broeders; Mireille N Bekker; Hester E de Melker; Elisabeth A M Sanders; Nicoline A T van der Maas

doi:10.1016/j.vaccine.2022.12.061

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

Vaccine. 2023 Jan 27;41(5):1074-1080. doi: 10.1016/j.vaccine.2022.12.061. Epub 2023 Jan 4.

Authors

Maarten M Immink¹, Jeanet M Kemmeren², Lisa Broeders³, Mireille N Bekker⁴, Hester E de Melker², Elisabeth A M Sanders⁵, Nicoline A T van der Maas⁶

Affiliations

¹ Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands; Department of Obstetrics, Wilhelmina Children's Hospital, University Medical Center Utrecht, and Utrecht University, Utrecht, the Netherlands.
² Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands.
³ The Dutch Perinatal Registry, Perined, Utrecht, the Netherlands.
⁴ Department of Obstetrics, Wilhelmina Children's Hospital, University Medical Center Utrecht, and Utrecht University, Utrecht, the Netherlands.
⁵ Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands; Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, and Utrecht University, Utrecht, the Netherlands.
⁶ Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3720 MA Bilthoven, the Netherlands. Electronic address: nicoline.van.der.maas@rivm.nl.

PMID: 36604217
DOI: 10.1016/j.vaccine.2022.12.061

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: Second trimester maternal Tdap vaccination appears safe and well-tolerated. Comparison between second versus third trimester vaccination yielded no reactogenicity concerns.

Keywords: Maternal vaccination; Pertussis; Pregnancy; Reactogenicity; Safety.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Bacterial Vaccines
Diphtheria* / prevention & control
Diphtheria-Tetanus-acellular Pertussis Vaccines* / adverse effects
Female
Humans
Netherlands / epidemiology
Pregnancy
Pregnancy Trimester, Second
Tetanus* / prevention & control
Vaccination / adverse effects
Whooping Cough* / prevention & control

Substances

Diphtheria-Tetanus-acellular Pertussis Vaccines
Bacterial Vaccines