As norovirus cases increase across the U.S., Moderna is conducting a phase 3 trial with 25,000 participants to test its experimental vaccine, CNBC reported.
The vaccine manufacturer is recruiting for the study across the U.S., Canada, U.K., Japan, the equatorial region, Australia and countries in South America. About 20,000 trial subjects will be ages 60 and up, and the other 5,000 will be between 18 and 59 years old.
On Sept. 30, Moderna said it had dosed the first participant in the trial evaluating the candidate, mRNA-1403.
The company expects results to be available in late 2025 or early 2026, according to CNBC.
Doran Fink, MD, PhD, Moderna's clinical therapeutic area head of gastrointestinal and bacterial pathogens, told the outlet there has been lots of interest in the trial. The heightened attention is likely because of the absence of an approved norovirus vaccine and the increased rates of the disease this virus season.
For January alone, the U.S. norovirus positivity rate, at 28%, is more than double than that of January 2024. Moreover, hospitals and emergency departments are already burdened as they operate at high capacity with increasing respiratory syncytial virus, flu and COVID-19 cases.
Similar to influenza, there are many types of norovirus, making it tricky to nail down a vaccine composition. Moderna's vaccine targets three genotypes that often result in infections, but not the new strain accounting for about 70% of outbreaks this season.