A first-of-its-kind study testing an mRNA vaccine for norovirus, the highly contagious winter vomiting bug, is launching in the UK and around the world.

Norovirus, which causes vomiting and diarrhoea, is usually the result of a viral or bacterial infection and typically peaks in the colder months.

There’s no vaccine or specific treatment for norovirus, and while most people get better within a few days, it can make young people, older adults, and those with weakened immune systems very sick.

The new late-stage clinical trial will identify how well the vaccine protects against moderate to severe illness and will recruit about 25,000 adults in the UK, US, Canada, Japan, Australia, and South American countries, according to the UK’s National Institute for Health and Care Research (NIHR).

Most participants will be aged 60 or older, while 5,000 will be aged 18 to 59.

US patients have already begun receiving the vaccine. In the UK, about 2,500 people will be recruited between late October 2024 and early 2025, NIHR said.

“Outbreaks of norovirus have huge consequences, both on our health systems and our economy,” Dr Patrick Moore, co-director of clinical trial network Wessex Research Hubs and head of the UK study, said in a statement.

“This innovative trial is crucial in helping us advance healthcare”.

Impact of ‘highly contagious’ norovirus

Worldwide, there are about 685 million cases of norovirus per year, and it causes an estimated 200,000 deaths per year, mostly in low-income countries.

Between healthcare costs and productivity losses, norovirus costs the world $60 billion (€53.8 billion) annually.

In the UK, norovirus is estimated to cost the National Health Service (NHS) more than £100 million (€120 million) per year.

UK health secretary Wes Streeting said “a successful vaccine will help shift our health system away from sickness and towards prevention,” helping to relieve pressure on the health system.

This is a phase three trial, which is typically the final step before a drugmaker asks regulatory agencies to approve their vaccine or medicine for the public if the results are positive. The study is expected to last about two years.

Moderna, which made one of the mRNA-based COVID-19 vaccines, created the norovirus vaccine candidate.

Melanie Ivarsson, Moderna’s chief development officer, said the new trial means “we are one step closer to potentially providing a new tool to prevent infection from this highly contagious virus”.

ADVERTISEMENT

The UK arm of the study is part of a 10-year partnership between the government and Moderna to invest in mRNA research and shore up the country’s vaccine manufacturing capabilities.