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 β yet no licensed vaccine is available. 2025β2026 major developments: Moderna's mRNA-1403 is now the most advanced candidate β 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-BarrΓ© 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 (2025β2026) for additional case accrual; readout timing remains dependent on cases accrued. Setback for competition: Takeda's VLP norovirus vaccine β spun out into HilleVax in 2021 β 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.
π View all Norovirus vaccine trials on ClinicalTrials.gov β
π CDC Norovirus Information β
π° Latest Norovirus Vaccine News (Google News) β