Moderna Halts Norovirus Vaccine Trial Enrollment After Phase 3 Setback
By Dr. Zubair Khalid, DVM, MS, PhD ·
Moderna has abandoned plans to enroll a new cohort in a phase 3 trial of its experimental norovirus vaccine. The company will now meet with regulators to determine next steps for the program. The decision follows a missed endpoint in the late-stage study.
The vaccine candidate is based on Moderna’s messenger RNA platform. Norovirus is a highly contagious virus that causes acute gastroenteritis, leading to vomiting and diarrhea. No vaccine is currently approved for norovirus prevention anywhere in the world.
A successful vaccine would address a major unmet need in public health. Norovirus outbreaks are common in schools, nursing homes, cruise ships, and military settings. The virus causes roughly 200,000 deaths annually worldwide, mostly in young children and older adults. Several biotech and pharmaceutical companies have attempted to develop a norovirus vaccine, but none has reached the market.
Moderna’s setback adds to the challenges facing mRNA vaccine development beyond COVID-19. The company has been expanding its pipeline into infectious diseases, including respiratory syncytial virus (RSV), influenza, and latent viruses. A norovirus vaccine would have been a significant addition to that portfolio.
The company has not disclosed whether it will redesign the trial or abandon the program entirely. Regulatory discussions will shape the future of the candidate.
Source: Original report