Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response
Introduction Nipah virus is a high-consequence pathogen that causes sporadic outbreaks with high mortality, and there are currently no vaccines or therapeutics available for Nipah. Vaccine development against Nipah faces challenges due to its current epidemiology with limited outbreak sizes, which i...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Expert Review of Vaccines |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/14760584.2025.2476523 |
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| author | Sol Kim Hyolim Kang Laura Skrip Sushant Sahastrabuddhe Ausraful Islam Sung-Mok Jung Juan F. Vesga Akira Endo W. John Edmunds Kaja Abbas |
| author_facet | Sol Kim Hyolim Kang Laura Skrip Sushant Sahastrabuddhe Ausraful Islam Sung-Mok Jung Juan F. Vesga Akira Endo W. John Edmunds Kaja Abbas |
| author_sort | Sol Kim |
| collection | DOAJ |
| description | Introduction Nipah virus is a high-consequence pathogen that causes sporadic outbreaks with high mortality, and there are currently no vaccines or therapeutics available for Nipah. Vaccine development against Nipah faces challenges due to its current epidemiology with limited outbreak sizes, which impedes the feasibility of conducting vaccine efficacy trials focused on disease endpoints.Areas covered We review the progress of Nipah vaccine candidates in human clinical trials and highlight the challenges in evaluating the vaccine efficacy due to the sporadic nature of Nipah outbreaks, given the epidemic potential of Nipah virus and its implications for pandemic preparedness. We examine the alternative regulatory pathways, including the US FDA’s Animal Rule and EMA’s conditional marketing authorization, which permit vaccine approval based on surrogate markers rather than efficacy data from the large-scale Phase-3 efficacy trials. The need for standardized immune surrogate markers is emphasized, alongside calls for international collaboration to develop such endpoints and manage stockpile strategies.Expert opinion We recommend alignment among vaccine developers, regulators, and global health stakeholders to incentivize Nipah vaccine development and approval through alternative regulatory pathways, as well as ensuring epidemic preparedness via strategic vaccine stockpiling and response through targeted deployment strategies. |
| format | Article |
| id | doaj-art-83ea1e1c8ac04b088f95babd25a39857 |
| institution | DOAJ |
| issn | 1476-0584 1744-8395 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Expert Review of Vaccines |
| spelling | doaj-art-83ea1e1c8ac04b088f95babd25a398572025-08-20T03:12:27ZengTaylor & Francis GroupExpert Review of Vaccines1476-05841744-83952025-12-0124118319310.1080/14760584.2025.2476523Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and responseSol Kim0Hyolim Kang1Laura Skrip2Sushant Sahastrabuddhe3Ausraful Islam4Sung-Mok Jung5Juan F. Vesga6Akira Endo7W. John Edmunds8Kaja Abbas9Department of Infectious Disease Epidemiology and Dynamics, London School of Hygiene and Tropical Medicine, London, UKDepartment of Infectious Disease Epidemiology and Dynamics, London School of Hygiene and Tropical Medicine, London, UKDepartment of Infectious Disease Epidemiology and Dynamics, London School of Hygiene and Tropical Medicine, London, UKInstitute of Tropical Medicine, Nagasaki University, Nagasaki, JapanInfectious Diseases Division, icddr,b, Dhaka, BangladeshCarolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USAStatistics, Modelling & Economics Division, UK Health Security Agency, London, UKDepartment of Infectious Disease Epidemiology and Dynamics, London School of Hygiene and Tropical Medicine, London, UKDepartment of Infectious Disease Epidemiology and Dynamics, London School of Hygiene and Tropical Medicine, London, UKDepartment of Infectious Disease Epidemiology and Dynamics, London School of Hygiene and Tropical Medicine, London, UKIntroduction Nipah virus is a high-consequence pathogen that causes sporadic outbreaks with high mortality, and there are currently no vaccines or therapeutics available for Nipah. Vaccine development against Nipah faces challenges due to its current epidemiology with limited outbreak sizes, which impedes the feasibility of conducting vaccine efficacy trials focused on disease endpoints.Areas covered We review the progress of Nipah vaccine candidates in human clinical trials and highlight the challenges in evaluating the vaccine efficacy due to the sporadic nature of Nipah outbreaks, given the epidemic potential of Nipah virus and its implications for pandemic preparedness. We examine the alternative regulatory pathways, including the US FDA’s Animal Rule and EMA’s conditional marketing authorization, which permit vaccine approval based on surrogate markers rather than efficacy data from the large-scale Phase-3 efficacy trials. The need for standardized immune surrogate markers is emphasized, alongside calls for international collaboration to develop such endpoints and manage stockpile strategies.Expert opinion We recommend alignment among vaccine developers, regulators, and global health stakeholders to incentivize Nipah vaccine development and approval through alternative regulatory pathways, as well as ensuring epidemic preparedness via strategic vaccine stockpiling and response through targeted deployment strategies.https://www.tandfonline.com/doi/10.1080/14760584.2025.2476523Alternative regulatory pathwayNipah virusHenipavirus nipahensepandemic preparednessvaccine efficacy trialsvaccine licensure |
| spellingShingle | Sol Kim Hyolim Kang Laura Skrip Sushant Sahastrabuddhe Ausraful Islam Sung-Mok Jung Juan F. Vesga Akira Endo W. John Edmunds Kaja Abbas Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response Expert Review of Vaccines Alternative regulatory pathway Nipah virus Henipavirus nipahense pandemic preparedness vaccine efficacy trials vaccine licensure |
| title | Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response |
| title_full | Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response |
| title_fullStr | Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response |
| title_full_unstemmed | Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response |
| title_short | Progress and challenges in Nipah vaccine development and licensure for epidemic preparedness and response |
| title_sort | progress and challenges in nipah vaccine development and licensure for epidemic preparedness and response |
| topic | Alternative regulatory pathway Nipah virus Henipavirus nipahense pandemic preparedness vaccine efficacy trials vaccine licensure |
| url | https://www.tandfonline.com/doi/10.1080/14760584.2025.2476523 |
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