As cases of the dreaded norovirus surge across Canada and the United States, there’s a glimmer of hope on the horizon: researchers are making strides toward developing a vaccine for the stomach virus.
The American pharmaceutical company Moderna is developing an mRNA-based vaccine candidate for norovirus, designated as mRNA-1403. This vaccine is designed to protect against multiple norovirus genotypes by instructing cells to produce virus-like particles that stimulate an immune response without causing infection, the company said in a September 2024 media release.
“Norovirus is a significant public health concern that affects millions of people worldwide each year, leading to severe symptoms and, in some cases, hospitalization,” said Stéphane Bancel, CEO of Moderna in the release.
“By advancing our investigational norovirus vaccine into a pivotal Phase 3 trial, we are one step closer to potentially providing a new tool to prevent infection from this highly contagious virus, which places a significant burden on health systems globally.”
Norovirus, commonly referred to as the stomach bug, also appears to be hitting Canadians harder this year, with cases rising above previous averages.
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Last month, preliminary data from the Public Health Agency of Canada (PHAC) showed that norovirus infections are being reported nationwide at rates higher than the five-year average from 2019 to 2023.
And an Ontario public health official recently confirmed that norovirus was detected in a group of 190 people at the University of Guelph who reported symptoms of gastroenteritis over the past week.
Norovirus is a very contagious virus that causes diarrhea and vomiting. Outbreaks occur more frequently during the fall and winter months and usually cause vomiting, diarrhea, stomach pain, body aches, headache and a fever. The symptoms can lead to dehydration, sometimes requiring hospitalization, especially in people with weakened immune systems, older adults and children.
Currently, there are no approved vaccines or antivirals to combat norovirus.
But Moderna hopes to change that with their vaccine.
The company’s vaccine is currently undergoing a Phase 3 clinical trial, known as the Nova 301 Trial, which aims to evaluate its safety, effectiveness and immune response in adults.
This trial plans to enroll approximately 25,000 participants globally, including individuals from the United States, Canada, Japan and the United Kingdom.
If the trial demonstrates that the vaccine is safe and effective, Moderna said it plans to submit a marketing application to U.S. health regulators in 2026, potentially leading to the first approved vaccine for norovirus.
Moderna isn’t the only pharmaceutical company trying to combat the stomach bug.
Vaxtart, a biotechnology company focused on developing oral vaccines, is also developing a norovirus vaccine, with their candidate currently in early-stage clinical trials.
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