The next generation of maternal vaccines: scientific advances, regulatory readiness, and strategic planning in Europe

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.