Doctors began to the world’s first vaccine against the vomiting bug norovirus in the hope that the sting will bring great health and economic benefits.
Norovirus causes illness and diarrhea and can spread very quickly between people who are in close contact, with outbreaks often occurring in hospitals, care homes, schools and nurseries.
While most people recover within two to three days, the virus can be serious, especially for very young people, the elderly or people with weakened immune systems.
Dr Patrick Moore, a GP and national lead investigator for the UK trial, said there were currently no approved vaccines for norovirus in the world, while people who became very ill were simply given intravenous fluids.
Moore added that the burden of the bug was huge, with about 685 million cases and 200,000 deaths worldwide each year. In the UK, there are thought to be around 4 million norovirus cases annually, with 12,000 hospitalizations per year in England alone.
“In the UK, norovirus is estimated to cost the NHS around £100 million a year [and] if you factor in lost earnings it’s around £300m,” said Moore.
Called Nova 301, the phase 3 clinical trial will run for two years, and will enroll 25,000 adults – focusing on those over 60 – from countries including Japan, Canada and Australia.
In total, 27 NHS primary and secondary care sites in England, Scotland and Wales will be involved in the trial, with around 2,500 participants to be recruited from the end of October. The team added that they will also use mobile units to make it easier for people to participate.
The British section of the study is part of the 10-year Moderna-UK Strategic Partnership and involves a collaboration between the National Institute for Health and Care Research (NIHR), the Department of Health and Social Care (DHSC), the UK Health Security Agency (UKHSA), and the pharmaceutical company Moderna, which produces the vaccine.
Within the trial, half of the participants will be randomly assigned to receive the new vaccine, and the other half will receive a saline shot as a placebo.
The norovirus vaccine is based on mRNA technology – an approach used by companies such as Moderna and Pfizer/BioNTech in developing their Covid jabs.
Such vaccines work by introducing a single-stranded molecule – mRNA – into human cells. The mRNA carries instructions that can be used by machinery within these cells to make proteins associated with the virus. These proteins then activate the body’s immune system, which provides protection against a future encounter with the virus itself.
In the case of the new jab, the mRNA carries instructions for making the protein coat of three different types of norovirus, which gives rise to the formation of harmless virus-like particles that can trigger the production of antibodies.
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While the team said earlier trials with the vaccine had shown it elicited a strong immune response in people, the new trial was designed to investigate whether the jab is effective against the virus itself and, if so, how long protection lasts.
“At least 65% [efficacy] or higher is what we would consider clinically significant,” said Moderna’s Dr. Doran Fink.
Should the norovirus sample be successful, the company expects to submit a marketing application to regulators in 2026, with the review process expected to take up to a year. Further trials would also be carried out in teenagers and younger children.
Prof Saul Faust, from the University of Southampton and co-clinical lead of the NIHR vaccination innovation pathway, added that a successful vaccine would help keep care homes running normally so people could visit their loved ones, while Moore said it would help those which is weakened to prevent. of getting weaker.
“We wouldn’t be doing this kind of trial at this kind of rate if it wasn’t going to benefit the individuals themselves,” Faust said.
