Developed by Moderna using mRNA technology, the jab aims to combat three major strains of the highly contagious virus.
The trial will involve 2,500 participants across 27 NHS hospitals and centres in England, Scotland and Wales.
Health Secretary Wes Streeting hailed the study as a “huge vote of confidence” in the UK’s life sciences sector, emphasising its potential to reduce pressure on the NHS.
Developed by Moderna using mRNA technology, the jab aims to combat three major strains of the highly contagious virus
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Norovirus currently has no approved vaccine worldwide.
The only treatment available for severe cases is intravenous fluids.
Doctor Patrick Moore, the study’s chief investigator, noted that norovirus causes about one in five cases of gastroenteritis, affecting four million people yearly in the UK and 685 million globally.
If successful, the vaccine could mark a significant shift towards preventative healthcare in the fight against this widespread illness.
The new mRNA vaccine targets the immune system, instructing it to recognise and attack a specific protein on norovirus strains. Early results indicate a strong immune response.
Half of the trial participants will receive the vaccine, while the others will get a placebo. The study will follow subjects for about 25 months.
Researchers aim for at least 65 per cent efficacy. If achieved, Moderna plans to seek regulatory approval by 2026.
Until then, the vaccine’s potential as a seasonal jab or lifelong protection is under investigation.
Adults of all ages can join the trial, with a focus on those over 60, who are more vulnerable to severe norovirus effects.
Doctor Melanie Ivarsson from Moderna expressed enthusiasm about the trial’s UK launch, highlighting the vaccine’s potential to prevent infections from this burdensome virus.
She said: “We are delighted to bring this trial to the UK – by advancing our investigational mRNA 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.”
The study is part of a 10-year partnership between the UK government and Moderna, involving the construction of a new mRNA facility and investment in UK clinical trials.
Professor Lucy Chappell, NIHR chief executive, emphasised the vaccine’s potential to improve lives and reduce seasonal illness burdens on the NHS.
She said: “This novel vaccine could make a difference to the lives of many – especially our most vulnerable citizens – and reduce the burden of seasonal illness on the NHS.
“Leveraging the UK’s expertise in vaccine development, the DHSC through the NIHR and Moderna are delivering this large-scale trial at pace, so that people across the UK and the world can benefit sooner.”
Norovirus, commonly known as the winter vomiting bug, is a highly infectious virus that causes gastroenteritis. It affects people of all ages, typically peaking during winter months in the UK.
The virus leads to symptoms of vomiting and diarrhoea, usually lasting two to three days.
The virus is particularly problematic in care homes, hospitals, nurseries, and schools due to its high transmissibility.
It results in around 12,000 hospital admissions and 80 deaths in the UK every year, placing significant strain on the NHS.
Norovirus leads to around 12,000 hospital admissions in the UK every year, placing significant strain on the NHS.
PA
The economic impact is also substantial, with norovirus costing UK taxpayers approximately £100 million annually.
Older adults and immunocompromised patients are at higher risk of severe complications and death from norovirus.
The only treatment available for serious cases in hospital is intravenous fluids.
The trial’s success could pave the way for further studies involving children. Researchers are optimistic about extending the vaccine’s reach to younger populations if it proves effective in adults.
Alongside the UK, the US, Canada, and Japan are participating in the study, with potential expansion to Australia. Globally, around 25,000 people are expected to be recruited.
The trial’s extensive follow-up period of 25 months aims to provide comprehensive data on the vaccine’s long-term efficacy and safety.
If successful, this vaccine could significantly reduce the burden on healthcare systems worldwide, potentially preventing millions of infections annually.
Health and Social Care Secretary Wes Streeting said: “Norovirus is highly infectious and puts the NHS under huge strain every winter, costing taxpayers around £100 million a year.
“The UK is leading the way to develop a world-first vaccine for this vomiting bug, starting with this innovative vaccine trial delivered through the Government-funded National Institute for Health and Care Research.
“Not only is this a huge vote of confidence in the UK’s life sciences sector, but a successful vaccine will help shift our health system away from sickness and towards prevention – reducing pressure on the NHS and keeping people well during the colder months.”