Final Testing Phase of New Norovirus mRNA Vaccine Begins
The new jab is manufactured by Moderna and utilizes the same technology as the COVID-19 vaccines.
A new mRNA vaccine targeting norovirus, the vomiting bug, is currently undergoing trials in the UK. Health Secretary Wes Streeting expressed hope that it could alleviate the strain on the NHS.
It is suggested that this innovative vaccine may prevent individuals from contracting the vomiting and diarrhea bug, which causes approximately 80 deaths annually in the UK and is associated with around 12,000 hospital admissions per year according to NHS data.
The mRNA technology functions by instructing the immune system to identify a “foreign” protein on viruses and initiate a defensive response, in this case, targeting three main strains of norovirus.
Dr. Patrick Moore, the lead investigator of the study and National Institute for Health and Care Research (NIHR) director in the southwest, noted that without a vaccine, intravenous fluids are the only available treatment for individuals severely affected by norovirus.
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He highlighted that norovirus typically reaches its peak during winter and is highly contagious.
“About one in five cases of gastroenteritis are caused by norovirus—approximately four million cases yearly in the UK and roughly 685 million globally,” he mentioned.
2,500 Participants
About 27 NHS hospitals and facilities across England, Scotland, and Wales are participating in the trial, some running mobile clinics that can visit care homes or other community locations.
The goal is to enroll 2,500 participants before the end of December, with half receiving the vaccine and the other half a placebo.
All participants will be monitored for around 25 months, with Moderna anticipating an efficacy rate of 65 percent or higher for the vaccine.
Moderna will also assess whether the vaccine should be administered seasonally similar to the flu shot or if it could provide lifelong immunity.
The company aims to submit marketing applications in 2026 for regulatory approval of the vaccine.
Streeting stated, “Norovirus is highly contagious and strains the NHS significantly every winter, costing taxpayers around £100 million annually.
“The UK is at the forefront of developing a pioneering vaccine for this illness, starting with this innovative vaccine trial organized through the Government-funded National Institute for Health and Care Research.
“This is not only a significant vote of confidence in the UK’s life sciences sector but a successful vaccine could help alleviate pressure on the NHS by shifting our focus towards prevention, keeping people healthy during colder months,” he added.
The researchers leading the trial mentioned that it will encompass adults of all ages, with a focus on encouraging individuals aged 60 and above to participate as they are more vulnerable to norovirus.
Children Might Participate
If the vaccine demonstrates effectiveness in adults, the trial may expand to include children.
The United States, Canada, and Japan are also involved in the study, with the possibility of extending to Australia. The global recruitment target is around 25,000 individuals.
The vaccine is engineered to combat three strains of the virus responsible for over two-thirds (67 percent) of norovirus cases in 2023-24.
Melanie Ivarsson, chief development officer at Moderna, remarked, “We are excited 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 poses a significant burden on health systems worldwide.”
Moore mentioned that globally the illness accounts for around 200,000 deaths yearly, of which 50,000 are children.
About two-thirds of outbreaks occur in care homes, while settings such as hospitals, nurseries, and schools are also considered hotspots.
10-Year Moderna Partnership
The new trial is part of the government’s 10-year strategic partnership with Moderna, which includes the establishment of a new mRNA research, development, and manufacturing facility in Oxfordshire and investments in UK clinical trials.
Professor Lucy Chappell, NIHR chief executive and chief scientific adviser to the Department of Health and Social Care, remarked, “This innovative vaccine could make a significant impact on numerous lives—especially the most vulnerable among us—and alleviate the seasonal illness burden on the NHS.
“Leveraging the UK’s expertise in vaccine development, the DHSC, through the NIHR and Moderna, is swiftly conducting this large-scale trial so that people in the UK and globally can benefit sooner,” Chappell added.
Moderna was established in 2010. It partnered with Merck in 2015 to develop cancer treatments. In January 2016, the Bill and Melinda Gates Foundation pledged at least $20 million in grant funding to the company.
In December 2018, Moderna went public through the largest initial public offering by a biotechnology company, raising $621 million by selling 27 million shares at $23 per share.
From 2020 to 2021, Moderna received $955 million from Operation Warp Speed to expedite the development of its COVID-19 vaccine candidate, with a total commitment of $4.9 billion to produce 300 million vaccine doses.
