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The misery of the common stomach flu may be coming to an end. Pharmaceutical company Moderna has launched a large-scale Phase III trial that will test a vaccine against norovirus, a frequent and sometimes dangerous source of food poisoning.
Modern New Test 301 they hope to put it in full force this year, after the first dose given to a volunteer last September. About 25,000 volunteers over the age of 18 are expected to enroll in the randomized, double-blind, placebo-controlled trial, which will ultimately take two years to complete. People around the world could participate in the research, including much of the United States
Norovirus is the leading cause of foodborne illness in America, counting about 20 million cases every year. Most cases of norovirus are short-lived – if very uncomfortable – with symptoms such as diarrhea, vomiting, and flu-like illnesses lasting up to three days. For many, it is a miserable but manageable ordeal. However, a significant number of people seek medical care, leading to more than two million doctor visits and nearly half a million emergency room trips each year. In rare cases, the infection can become severe enough to result in hospitalization or even death. About 100,000 Americans are hospitalized from norovirus, while 900 die from it each year. It is a peer bigger problem in parts of the world with weaker health and sanitation programs.
“Norovirus is a significant public health concern that affects millions of people around the world every year, leading to severe symptoms and, in some cases, hospitalization,” said Stéphane Bancel, CEO of Moderna, in a declaration last fall. “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 with this highly contagious virus, which places a significant burden on healthcare systems in the world”.
Although norovirus has long been a thorn in humanity’s side, the urgency for a vaccine is now certainly high. After a brief hiatus throughout the initial pandemic era, norovirus has returned to the U.S. During the last half of 2024, approximately 500 norovirus outbreaks have been reported, a substantial increase compared to the year previous And this winter’s norovirus season is on track to be the worst experienced in over a decade.
Scientists have he struggled to develop a successful norovirus vaccine. Historically, we have not been able to grow the virus in the laboratory or in small animals, which hinders our study. The virus is also naturally resistant to our defenses. There are several disease-causing types of norovirus circulating at any given time, and being recently infected with one strain does not necessarily protect you from others. Our natural immunity to a specific strain also tends to wane over time, perhaps it will only last a few months for some.
But more recently, scientists have been able to create effective laboratory models to study norovirus, and have developed some promising strategies for vaccination. Moderna’s vaccine candidate, for example, tries to create immunity by training the body to target virus-like particles (VLPs) that closely resemble norovirus but contain no actual virus. The candidate uses the same basic mRNA technology implemented in Moderna’s covid-19 vaccines to do this. mRNA vaccines prompt the body’s cells to produce a target protein that is then recognized by the immune system as a possible threat (in this case, norovirus VLPs).
The company’s candidate is codenamed mRNA-1403, and it is designed to induce immunity to at least three common types of norovirus, which will hopefully ensure widespread protection. While norovirus is a terrible experience for everyone, it is more likely to cause serious illness in vulnerable populations, such as people with weakened immune systems and the elderly. So most of the test volunteers (20,000) will be over 60 years old. norovirus vaccines for children still, though.
There are more than 250 study sites for the Nova 301 test worldwide, with more than 100 located in the United States alone. Participants are required to be in good general health (this may include having well-controlled chronic health conditions), and not to have had a recent history of gastrointestinal disease, among other criteria. The main part of the trial is expected to last two years, with the final results expected by May 2027. Those interested in potentially participating can take a survey created by Moderna. here.
