Doctors have begun trials of the world’s first vaccine against the emetic norovirus, hoping the jab will bring huge health and economic benefits.
Norovirus causes illness and diarrhea and can spread rapidly between people in close contact, with outbreaks frequently occurring in hospitals, nursing homes, schools, and daycare centers.
Most people recover within two to three days, but the virus can be serious, especially for young people, the elderly, and people with weakened immune systems.
Dr Patrick Moore, a general practitioner and the country’s lead investigator on the UK trial, said there is currently no approved vaccine for norovirus in the world, and people who develop severe symptoms will be given an intravenous drip. He said that only.
Moore added that the burden of this bug is enormous, with approximately 685 million infections and 200,000 deaths worldwide each year. Around 4 million people are infected with norovirus each year in the UK, and it is thought that 12,000 people are admitted to hospital each year in the UK alone.
“In the UK, it is estimated that norovirus costs the NHS around £100m a year, which rises to around £300m when taking into account lost profits,” Moore said.
The Phase 3 clinical trial, called Nova 301, will run for two years and will enroll 25,000 adults, primarily those aged 60 and older, from countries including Japan, Canada and Australia.
A total of 27 NHS primary and secondary care sites across England, Scotland and Wales will take part in the trial, with approximately 2,500 participants expected to be recruited from late October. The team added that it also plans to use mobile units to make it easier for people to participate.
The UK arm of the study is part of a 10-year strategic partnership between Moderna and the UK, with collaboration between the National Institute for Health and Care Research (NIHR), the Department of Health and Social Care (DHSC) and the UK Health Security Agency. Involved. Government agency (UKHSA) and pharmaceutical company Moderna, which is producing the vaccine.
In the trial, half of the participants will be randomly assigned to receive the new vaccine, while the other half will receive a saline injection as a placebo.
Norovirus vaccines are based on mRNA technology, an approach used by companies such as Moderna and Pfizer/BioNTech to develop Covid jabs.
Such vaccines work by introducing single-stranded molecules (mRNA) into human cells. mRNA carries instructions that machinery within these cells can use to make proteins associated with the virus. These proteins turn on the body’s immune system and provide protection against future encounters with the virus itself.
In the case of the new jab, the mRNA carries instructions to create the protein coat of three different types of norovirus, triggering the formation of harmless virus-like particles that can trigger the production of antibodies.
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The research team said previous trials of the vaccine showed it elicited a strong immune response in humans, but the new trial will show whether the vaccine is effective against the virus itself. Please note that the aim is to investigate how long the protective effect, if effective, lasts.
“If it’s at least 65% (effective) or higher, we would consider it clinically meaningful,” Moderna’s Dr. Doran Fink said.
If the norovirus shot is successful, the company plans to submit a marketing application to regulators in 2026, with the review process expected to take up to a year. Further trials will also be conducted on teenagers and younger children.
Professor Saul Faust, from the University of Southampton and co-clinical director of the NIHR Vaccination Innovation Pathway, added that a successful vaccine could help care homes run as normal and people be able to visit their loved ones. Professor Moore said it could help prevent frailty. From becoming weak.
“You wouldn’t do these types of trials at this pace if it wasn’t for the people’s own benefit,” Faust said.
