The next generation of maternal vaccines: scientific advances, regulatory readiness, and strategic planning in Europe.
10 affiliations
- 1Centre for Neonatal and Paediatric Infection and Vaccine Institute, City St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK.
- 2NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
- 3Centre for the Evaluation of Vaccination, University of Antwerp, Drie Eikenstraat 663, 2650, Edegem, Antwerp, Belgium.
- 4Vaccine Confidence Project, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
- 5Vaccine Institute, City St George's, University of London, Cranmer Terrace, London, SW17 0RE, UK.
- 6Fetal Medicine Unit, Department of Obstetrics and Gynaecology, St George's University Hospitals NHS Foundation Trust, London, UK.
- 7Vaccine & Infectious Disease Institute (Vaxinfectio), Centre for the Evaluation of Vaccination (CEV), Faculty of Medicine and Health Sciences, Campus Drie Eiken, Vaccinopolis D.Z.141, Drie Eikenstraat 663, 2650, Antwerp, Belgium.
- 8Makerere University Johns Hopkins University Research Collaboration, Kampala, Uganda.
- 9Pathogen Immunology Group, UKHSA, Porton Down, UK.
- 10Faculty of Medicine and Institute for Life Sciences, University of Southampton and NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Abstract
With the recent approval of maternal RSV vaccines and late-phase trials underway for a GBS vaccine, Europe is entering a new era of maternal immunisation. Yet scientific progress is outpacing pregnancy-specific evidence and preparedness for equitable implementation. Pregnant women are often excluded from early vaccine trials, while national recommendations, surveillance and delivery vary across Europe, even after regulatory authorisation. Without coordinated planning, new maternal vaccines risk reproducing the delays and inequities seen with influenza, pertussis and COVID-19 vaccination. In this Review, we examine scientific advances in the next generation of maternal vaccines, including mRNA, protein conjugate, nanoparticle and combination approaches, and candidates against emerging and other priority pathogens. We discuss barriers to including pregnant women in trials, assess regulatory and pharmacovigilance readiness, and identify health-system and vaccine-confidence risks to equitable rollout. We offer strategic recommendations for Europe's maternal immunisation roadmap, from research investment to policy integration, provider education, and equity-centred planning. Realising this potential will require integrated action across research, regulation, implementation, and communication. This is the final paper in the Series on the future of maternal vaccination in Europe and synthesises its findings into a framework for Europe and beyond.
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BibTeX
@article{heath2026next,
title = {{The next generation of maternal vaccines: scientific advances, regulatory readiness, and strategic planning in Europe.}},
author = {Paul T Heath and Eva P Galiza and Pamela Jump Salcedo and Emilie Karafillakis and Asma Khalil and Kirsten Maertens and Kirsty Le Doare and Christine E Jones},
journal = {The Lancet regional health. Europe},
year = {2026},
month = oct,
doi = {10.1016/j.lanepe.2026.101899},
url = {https://europepmc.org/article/MED/42927194},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - The next generation of maternal vaccines: scientific advances, regulatory readiness, and strategic planning in Europe.
AU - Paul T Heath
AU - Eva P Galiza
AU - Pamela Jump Salcedo
AU - Emilie Karafillakis
AU - Asma Khalil
AU - Kirsten Maertens
AU - Kirsty Le Doare
AU - Christine E Jones
PY - 2026
DA - 2026/10/15
JO - The Lancet regional health. Europe
DO - 10.1016/j.lanepe.2026.101899
UR - https://europepmc.org/article/MED/42927194
AB - With the recent approval of maternal RSV vaccines and late-phase trials underway for a GBS vaccine, Europe is entering a new era of maternal immunisation. Yet scientific progress is outpacing pregnancy-specific evidence and preparedness for equitable implementation. Pregnant women are often excluded from early vaccine trials, while national recommendations, surveillance and delivery vary across Europe, even after regulatory authorisation. Without coordinated planning, new maternal vaccines risk reproducing the delays and inequities seen with influenza, pertussis and COVID-19 vaccination. In this Review, we examine scientific advances in the next generation of maternal vaccines, including mRNA, protein conjugate, nanoparticle and combination approaches, and candidates against emerging and other priority pathogens. We discuss barriers to including pregnant women in trials, assess regulatory and pharmacovigilance readiness, and identify health-system and vaccine-confidence risks to equitable rollout. We offer strategic recommendations for Europe's maternal immunisation roadmap, from research investment to policy integration, provider education, and equity-centred planning. Realising this potential will require integrated action across research, regulation, implementation, and communication. This is the final paper in the Series on the future of maternal vaccination in Europe and synthesises its findings into a framework for Europe and beyond.
SN - 2666-7762
ER -