Challenges, Advances, and Future Directions in Nipah Virus Vaccine Development.

Nipah virus (NiV) is a highly pathogenic zoonotic pathogen. Since its discovery in 1998, recurrent epidemics have occurred in South and Southeast Asia, with a case fatality rate ranging from 40% to 100%. The outbreak in West Bengal, India in early 2026 has once again highlighted its severe threat to public health. To date, no licensed human vaccines or specific therapeutics against NiV are available worldwide. This review systematically summarizes the breakthroughs in antigen design for NiV vaccines, with a focus on conformational stabilization of prefusion F (pre-F) protein, chimeric G/F antigens, and multivalent nanoparticle strategies. In addition, we comparatively analyze the clinical progress of mainstream vaccine platforms, including viral vectors, mRNA and subunit vaccines. Given the sporadic nature and high mortality of NiV infection, the conventional licensing pathway relying on large-scale phase III clinical trials faces substantial practical obstacles. Accordingly, this article discusses adaptive adjustments in regulatory science. We propose several strategies to accelerate the clinical translation and emergency stockpiling of NiV vaccine candidates, including establishing unified correlates of protection thresholds, coordinating multinational regulatory resources, and optimizing the implementation of Animal Rule.