🦠 Norovirus Vaccine Tracker Dashboard
Updated July 2026. Tracking norovirus vaccine development to prevent acute gastroenteritis. Norovirus causes an estimated 685 million cases and 200,000 deaths annually worldwide, plus about $60 billion in global healthcare and productivity costs — yet no licensed vaccine is available. 2025–2026 major developments: Moderna's mRNA-1403 is now the most advanced candidate — the Phase 3 Nova 301 trial (25,000 participants) began September 30, 2024. FDA placed the trial on a temporary clinical hold in February 2025 following a case of Guillain-Barré syndrome; after the hold was lifted, the trial's Southern Hemisphere portion struggled to accrue sufficient cases. In November 2025, Moderna announced the trial would enroll a second Northern Hemisphere season (2025–2026) for additional case accrual; readout timing remains dependent on cases accrued. Setback for competition: Takeda's VLP norovirus vaccine — spun out into HilleVax in 2021 — failed a Phase 2 trial in 2024. Vaxart's oral tablet norovirus vaccine reported positive Phase 1 data on its second-generation constructs in June 2025 and is preparing to advance to Phase 2, with a Phase 3 possible in 2026 pending funding. This tracker monitors all norovirus vaccine candidates targeting GI and GII genogroups. Norovirus prevention resources.
Norovirus Vaccines by Development Phase
685M
Annual Cases Globally
🔬 Phase 3 Clinical Trials
Technology
Bivalent VLP (GI.1/GII.4)
Phase 3 Efficacy
Target: >50% prevention
Details: TAK-214 is a bivalent intramuscular vaccine containing virus-like particles (VLPs) from GI.1 and GII.4 norovirus strains, which cause ~90% of norovirus outbreaks. Phase 2b trial (NCT03897933) in 4,712 healthy adults showed 66% efficacy against moderate-to-severe acute gastroenteritis caused by vaccine-matched strains and 52% efficacy against all norovirus gastroenteritis. The ongoing Phase 3 NOVA trial is enrolling ~25,000 participants globally. Vaccine targets high-risk populations including healthcare workers, food handlers, military personnel, and travelers.
Current Status: Phase 3 enrollment ongoing. If successful, could be first licensed norovirus vaccine, potentially available by 2025-2026. Takeda has invested over $200 million in norovirus vaccine development since acquiring LigoCyte in 2011.
🧬 Phase 2 Clinical Trials
Technology
Bivalent VLP
Phase 2 Results
Strong immunogenicity
Description: VLA1554 demonstrated strong immunogenicity with high seroconversion rates (>95%) against both GI.1 and GII.4 strains in Phase 2 trials. Well-tolerated with mostly mild-to-moderate adverse events. Valneva is exploring pediatric populations and different dosing regimens.
Technology
mRNA (LNP delivery)
Target
Multiple norovirus strains
Description: Moderna's mRNA platform leveraging COVID-19 vaccine technology for norovirus prevention. mRNA-1403 encodes norovirus capsid proteins from multiple genotypes. Early-phase data showed robust antibody responses. Moderna announced Phase 2 initiation in 2023, exploring efficacy in controlled human infection models.
🧪 Phase 1 Clinical Trials
Technology
Intranasal VLP delivery
Advantage
Mucosal IgA response
Description: Intranasal delivery targets mucosal immunity at primary infection site. Early Phase 1 safety trials assessing tolerability and IgA responses. May provide superior protection against GI infection compared to IM vaccines.
Technology
P particle subunit
Coverage
Multiple GI/GII strains
Description: P particle vaccines contain the protruding (P) domain of norovirus capsid protein, which binds host receptors. Smaller and more stable than full VLPs. Early trials assess safety and immunogenicity across diverse norovirus genotypes.
Technology
Replication-deficient adenovirus
Target
Strong T cell responses
Description: Adenovirus vector expressing norovirus capsid proteins. Aims to induce both humoral and cellular immunity. Phase 1 safety and immunogenicity studies ongoing.
🔬 Preclinical Development
Description: Self-amplifying RNA (saRNA) and circular RNA platforms promise enhanced immunogenicity with lower doses. Preclinical studies in animal models show robust antibody and T cell responses. Could enable pan-norovirus coverage with single vaccine.
Description: Ferritin-based and other nanoparticle scaffolds displaying norovirus antigens. Improved stability and immunogenicity compared to traditional VLPs. Animal studies demonstrate cross-reactive antibodies against diverse norovirus strains.
Description: Oral norovirus vaccines targeting intestinal immunity. Enteric-coated formulations protect VLPs from gastric acid. Preclinical studies show strong mucosal IgA responses in GI tract.
Description: Combining broadly neutralizing monoclonal antibodies with VLP vaccines for immediate and long-term protection. Targets immunocompromised populations and outbreak response. Animal models show synergistic protective effects.
Description: DNA vaccines with electroporation or adjuvants to enhance immunogenicity. Stable, easy to manufacture, and capable of inducing cellular immunity. Preclinical data in non-human primates show protective antibody titers.
Description: Using plant-based expression systems (tobacco plants) for rapid, scalable VLP production. Cost-effective manufacturing for global deployment. Preclinical immunogenicity studies demonstrate comparable responses to insect cell-derived VLPs.