First-ever trial of Norovirus vaccine to take place in the UK

Over the next two weeks, the new mRNA vaccine from Moderna will enter the final stages of testing with promising results indicating that it triggers a robust immune response.

Experts suggest that the vaccine could potentially prevent people from developing the vomiting and diarrhea bug, which is responsible for approximately 12,000 hospital admissions in the UK each year.

How does the norovirus vaccine function?

The vaccine utilizes mRNA technology to instruct the immune system to identify a “foreign” protein in viruses and initiate a defense mechanism. In this case, it targets three main strains of the norovirus.

You can reduce the risk of catching or spreading Norovirus by following a few simple steps:

🧼 Wash your hands
🍽️ Keep surfaces and utensils clean
❌ Stay home if you’re unwell

👉 Learn more: https://t.co/WTZTRrTVzj#Norovirus #WinterHealth #StayWellThisWinter #NHS #StomachBug pic.twitter.com/xeYmNmv9Em

— Manor Court Surgery (@ManorCourtSurg) October 18, 2024

Dr. Patrick Moore, the chief investigator of the study and National Institute for Health and Care Research (NIHR) director in the South West, mentioned that currently, there are “no approved vaccines for norovirus anywhere in the world,” and the only available treatment for severely ill patients in hospitals is intravenous fluids.

He further explained, “Norovirus, also known as the winter vomiting bug, is highly contagious.”

“It leads to vomiting and diarrhea, typically lasting for two to three days. It can affect individuals of all ages and usually peaks during the winter months in the UK…but norovirus can be present throughout the entire year.”

“About one in five cases of gastroenteritis are caused by norovirus – approximately four million cases annually in the UK and around 685 million cases globally.”

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Nearly 30 NHS hospitals in the UK to participate in the norovirus vaccine trial

A total of 27 NHS hospitals and centers in England, Scotland, and Wales are involved in the trial, with some operating mobile clinics that could visit care homes or other community locations.


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How the norovirus vaccine trial will be conducted

The goal is to recruit 2,500 participants in the UK for the trial by the end of December. Half of them will receive the vaccine while the other half will receive a placebo.

For approximately 25 months, all participants in the trial will be monitored, and experts hope to achieve an efficacy rate of 65% or higher for the vaccine.

Moderna’s analysis will also determine whether the vaccine should be administered seasonally like the flu vaccine or if it can provide lifelong immunity.

The company aims to submit marketing applications in 2026 to have the vaccine approved by health regulators.

Health and Social Care Secretary Wes Streeting stated, “Norovirus is extremely contagious and places significant strain on the NHS every winter, costing taxpayers around £100 million annually.

“The UK is at the forefront of developing a first-of-its-kind vaccine for this vomiting bug, starting with this groundbreaking vaccine trial conducted through the Government-funded National Institute for Health and Care Research.


Differentiating between a cold, the flu, and COVID-19


“This not only represents a significant vote of confidence in the UK’s life sciences sector, but a successful vaccine will help transition our healthcare system from treating sickness to preventing it – reducing the burden on the NHS and keeping people healthy during the colder months.”

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Who is eligible to participate in the trial?

The trial’s lead researchers mentioned that it will include adults of all ages, with a particular focus on encouraging individuals aged 60 and above to join as they are more susceptible to severe complications from norovirus.

If the vaccine proves effective in adults, the trial may be expanded to include children.

The study also involves the US, Canada, and Japan, with a potential extension to Australia. Overall, approximately 25,000 participants are expected to be recruited globally.

Dr. Melanie Ivarsson, chief development officer at Moderna, expressed, “We are excited to launch this trial in the UK – by advancing our investigational mRNA norovirus vaccine into a pivotal phase 3 trial, we are one step closer to potentially offering a new tool for preventing infection from this highly contagious virus, which poses a significant burden on healthcare systems worldwide.”

Dr. Moore highlighted that older adults and individuals with weakened immune systems are more susceptible to severe complications and death from norovirus, with around 80 deaths per year in the UK and approximately 200,000 deaths globally, including 50,000 children.

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Approximately two-thirds of outbreaks occur in care homes, but environments such as hospitals, nurseries, and schools are also at risk.

Occupations that can be heavily impacted include healthcare and care workers, childcare providers, military personnel, cruise ship staff, flight attendants, and food service workers.

This new trial is part of the Government’s 10-year strategic collaboration with Moderna, which involves the company establishing a new mRNA research, development, and manufacturing facility and investing in UK clinical trials.

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Professor Lucy Chappell, NIHR chief executive and chief scientific adviser to the Department of Health and Social Care, stated, “This innovative vaccine has the potential to make a difference in many lives – especially for our most vulnerable citizens – and reduce the burden of seasonal illnesses on the NHS.

“Leveraging the UK’s expertise in vaccine development, the DHSC through the NIHR and Moderna are conducting this large-scale trial expeditiously, so that individuals in the UK and worldwide can benefit sooner.”