Noroviruses (NoVs), known as Norwalk-like viruses, are a group of highly variable single-stranded positive-sense RNA viruses and members of the family Caliciviridae. Noroviruses are one of the most highly infectious viruses known and are transmitted from human to human (fecal-oral) and via food/water sources. In the community, NoVs most commonly cause a self-limiting mild disease of short duration with gastrointestinal symptoms, usually resolving after 1 to 3 days. However, in infants, elderly and immunocompromised persons dehydration can occur requiring medical attention and/or hospital admission for the administration of IV fluids.
Globally, norovirus is associated with approximately one-fifth of all diarrhea cases (Lopman BA et al 2016, with a similar prevalence in both children and adults. Norovirus is the 2nd most common cause of diarrheal death in children <5 yrs (after rotavirus) and the most common cause in children >5 yrs with similar patterns across WHO regions. Recent Global Burden of Disease (GBD, 2021) data has estimated norovirus was responsible for 124,000 deaths (25,800-224,000, all ages) with 29,600 (9,650-55,000) occurring in children < 5 yrs (Hmwe Hmwe K et al 2025). Like many enteric pathogens, norovirus disproportionally affects children in developing world countries (LMICs) which account for 82% of the burden and 97% of global mortality (Barstch SM et al 2016) whereas in developed countries, the elderly and vulnerable are more affected.
Sporadic Norovirus outbreaks are a well-known issue in confined environments such as long-term care facilities, hospitals, military installations, day-care centres and commercial cruise ship liners. In these cases, the virus can cause severe disruption and economic loss. One study estimates the societal economic burden at $60.3 bn (95% UI: $44.4–83.4 billion) (Barstch SM et al 2016) mostly due to lost productivity.
Norovirus is a highly variable virus due to antigenic drift of the major capsid protein gene (VP1). Therefore, new pandemic GII strains, which generally occur every 2-4 years, allow the virus to escape pre-existing immunity and often increase the overall infection burden. A good example is the recent emergence of GII.17 (over GII.4) as the predominant US strain (Barclay L et al 2025). Such changes heighten the need for continued surveillance and new interventions beyond supportive care because improved sanitation and hygiene are not sufficient to control norovirus.
Because of the success of the rotavirus vaccine in reducing diarrheal disease burden, it is hoped a new norovirus vaccine can have a similar impact, now that the virus has taken a prominent role. Furthermore, recent progress with human challenge models have been important for norovirus vaccine “proof of concept”. The WHO Health Organisation has reiterated the global need for a norovirus vaccine by the publication of a Vaccine Value Profile in 2023 (Armah G et al 2023). The most advanced Western norovirus program is mRNA-based and operated by ModernaTX (mRNA-1403/05) now at Phase 3 testing. Both HilleVax (HIL-214/216, acquired from Takeda/Ligocyte) and Vaxart (oral adenovirus), are in clinical stages of testing but have encountered various setbacks. Merck & Co (V330) are a new entrant to the field. Chinese developers (e.g. National Vaccine and Serum Institute, NVSI) are also pressing ahead with late-stage clinical studies with more focus on younger age groups.
For summer 2025, VacZine Analytics has published a new MarketVIEW product focused on the global demand and potential value of a new norovirus vaccine. The study comprises a comprehensive Executive presentation + MS Excel-based model(s), which forecasts the potential of Norovirus vaccines across 113 major Western and emerging markets and GAVI to 2039*. The forecast model contains value ($ m) and volume (mio doses) predictions along with launch timeframe, TPP, pricing and penetration estimates for all major market segments. The study includes a thorough review of global epidemiology, economic burden, impact studies and competitive R&D vaccine landscape. Brand new model scenarios explore segment prioritization (post-COVID-19), vaccine duration of immunity and various new adjustments. This product is ideally suited to those organisations requiring an extended, up-to-date global forecast for this complex vaccine opportunity.
THIS PRODUCT IS AN EXECUTIVE PRESENTATION (>300 slides, .pdf) + scenario forecast MODEL(s)
Photo Credit: Peter Hansen on Unsplash *some countries are rolled up
References used:
- Armah G et al. (2023). Vaccine value profile for norovirus. Vaccine, 41, S134-S152
- Barclay L et al. Increasing Predominance of Norovirus GII.17 over GII.4, United States, 2022–2025. Emerg Inf Dis. Vol 31 No 7, July 2025
- Bartsch SM et al. Global economic burden of norovirus gastroenteritis. PLoS One 2016; 11: e0151219
- Kyu, Hmwe Hmwe et al. Global, regional, and national age-sex-specific burden of diarrhoeal diseases, their risk factors, and aetiologies, 1990–2021, for 204 countries and territories: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Infect Diseases, Vol 25. Issue 5, 519-536
- Lopman BA et al. The vast and varied global burden of norovirus: prospects for prevention and control. PLOS medicine 2016 13(4): e1001999. doi10.1371/journal.pmed
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