Norovirus

US CDC - Foodborne Illness Acquired in the United States—Major Pathogens, 2019

With twelve norovirus outbreaks already confirmed in 2025, the cruise ship industry is on pace to set an unfortunate record without the availability of a preventive vaccine.

Last year, 18 norovirus outbreaks were confirmed on U.S.-based cruises.

According to a U.S. CDC Emerging Infectious Disease report (Volume 31, Number 4—April 2025), foodborne pathogens, led by norovirus, have impacted people's health for years.

On March 19, 2025, the CDC estimated the number of illnesses, hospitalizations, and deaths in the U.S. caused by seven major foodborne pathogens: Campylobacter spp., Clostridium perfringens, invasive Listeria monocytogenes, nontyphoidal Salmonella serotypes, atoxin-producing Escherichia c,oli and norovirus.

These pathogens caused about 9.9 million domestically acquired foodborne illnesses in 2019. Together with Toxoplasma gondii, these pathogens caused 53,300 hospitalizations and 931 deaths.

Each year, about 2,500 norovirus outbreaks occur in the U.S.

Specifically, the CDC writes, 'Norovirus caused most illnesses, about 5.5 million illnesses, and 22,400 hospitalizations, according to this analysis.'

'When considered with other information, such as major food sources of illnesses, population groups affected, and costs of making foods safer, the estimates can be used to prioritize food safety interventions.'

Regarding cruise ship norovirus outbreaks, a study published in January 2025 supports the CDC's conclusion.

A University of Surrey–led research team identified cruise ship dining areas as priorities for preventing disease outbreaks such as norovirus.

This study, published by Science of the Total Environment (Volume 962, January 25, 2025, 178286), measured CO2 concentrations, RH, and temperature levels on cruise ships while at sea.

Ventilation performance was assessed in nine spaces on a sailing cruise ship.

These researchers found that nightclubs and theaters are over-ventilated, while pubs and restaurants require increased ventilation.

The good news is that the probability of airborne infection in a speaking normal condition is low (<3 %).

This study's conclusion indicates that dining on cruise ship decks in the open air may be advisable to avoid a norovirus incident.

Visit this webpage to learn more about outbreaks of gastrointestinal illness on cruise ships in the CDC's Vessel Sanitation Program, including outbreak details and actions taken in response.

As of March 24, 2025, preventive vaccines targeting Human norovirus disease are in demand.

However, developing a broadly effective vaccine in 2025 remains challenging owing to the vast genetic and antigenic diversity of noroviruses, which have multiple co-circulating variants of different genotypes.

Several norovirus vaccine candidates and therapies are being conducted in clinical research this year.

Sub Title:

Norovirus vaccine development continues in March 2025

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Monitoring of indoor air quality at a large sailing cruise ship to assess ventilation performance and disease transmission risk

CDC - Outbreaks on Cruise Ships 2025

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Guillain-Barré Syndrome Risk Identified in Norovirus Vaccine Candidate

Karen McClorey Hackett — Mon, 17 Feb 2025 16:24:05 +0000

Reviewer:

Moderna Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Updates

With cruise ship voyages reporting additional norovirus outbreaks in 2025, vaccines that protect people against human norovirus disease are in demand.

Historically, developing a broadly effective norovirus vaccine has been challenging owing to the genetic and antigenic diversity of noroviruses.

Another concern has arisen due to Moderna Inc.'s recent announcement.

On February 14, 2025, Moderna stated the two-season Phase 3 clinical study evaluating the efficacy, safety, and immunogenicity of the Company's trivalent vaccine against norovirus (mRNA-1403) has been placed on U.S. FDA clinical hold following a single adverse event report of a case of Guillain-Barré syndrome (GBS). This case is currently under investigation.

Moderna's press release says the Company does not expect an impact on the mRNA-1403 study's efficacy readout timeline, as enrollment in the Northern Hemisphere has already been completed. The timing of the Phase 3 readout will depend on case accruals.

According to a report by Fierce Biotech, Moderna's president, Stephen Hoge, M.D., expanded on this announcement, pointing out that "GBS does happen."

Each year in the United States, 3,000 to 6,000 people develop GBS, some related to vaccination.

For example, since January 7, 2025, the U.S. FDA has required a GBS warning in the Prescribing Information for certain approved RSV vaccines during the 42 days following vaccination.

According to the U.S. CDC, GBS is a rare disorder where the body's immune system damages nerves. To study whether a new vaccine might cause GBS, the CDC compares the usual GBS rate to the observed GBS rate in vaccinated people.

While its cause is not fully understood, the syndrome often follows infection with a virus or bacteria. Most people fully recover from GBS, but some have permanent nerve damage, adds the CDC.

Other norovirus vaccine development efforts include HillVax. In November 2024, HillVax announced it was exploring the potential for continuing to develop its investigational virus-like particle-based bivalent norovirus vaccine candidate.

Separately, Vaxart Inc.'s orally administered bivalent GI.1/GII.4 norovirus oral vaccine candidate is differentiated from others because it generates systemic and mucosal immunity delivered through the mouth and is stable at room temperature. On January 14, 2025, Vaxart stated it would proceed with a Phase 1, open-label, dose-ranging clinical trial, expected to initiate in the first half of 2025.

With about 20 million norovirus illnesses yearly in the United States, vaccine development activities targeting this disease will continue to be watched closely in 2025.

Sub Title:

Moderna mRNA-1403 is a trivalent norovirus vaccine candidate

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Cruise Ships and Norovirus Don't Mix

Karen McClorey Hackett — Sat, 28 Dec 2024 14:23:00 +0000

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Outbreaks on Cruise Ships in VSP's Jurisdiction

When vacationing on cruise ships in 2024, travelers encountered new environments and met other voyagers, which increased the risk of illness due to contaminated food, water, or, more commonly, through person-to-person contact.

To keep everyone informed about disease outbreaks at sea, the U.S. CDC's Vessel Sanitation Program updated its list of cruise ships reporting illnesses as of December 25, 2024.

The CDC data show that various acute gastroenteritis outbreaks occurred in 2024, most attributable to norovirus. The dominant symptoms reported were diarrhea, vomiting, and abdominal cramps.

For example, the CDC reported the Queen Mary 2 voyage on December 21, 2024, and the number of passengers who reported being ill during the journey out of a total number of passengers onboard was 294 of 2,565 (11.5%). Of the crew reported being sick, 54 of 1,233 (4.4%).

The causative agent of this situation was unknown but could have been norovirus. The CDC says it doesn't always know the cause of the outbreak at the beginning of an investigation.

Before you book a cruise, you can use the CDC's Advanced Cruise Ship Inspection Search solution to ensure your chosen cruise ship's sanitation score is 86 or higher. This CDC list reveals which cruise ships failed to meet the hygiene standards.

Cruise ships are not the only source for norovirus outbreaks.

During August - December 11, 2024, there were 495 norovirus outbreaks reported by NoroSTAT-participating states. During the same period last year, these states reported 363 norovirus outbreaks.

While vaccines against norovirus diseases are in high demand, developing a broadly effective vaccine remains difficult, owing to the diversity of noroviruses, which have multiple variants of different genotypes.

As of December 28, 2024, norovirus vaccines are unavailable, but various vaccine candidates are conducting research studies.

Moderna Inc., a leading pharmaceutical company, is developing an mRNA-1403 (trivalent) vaccine. The Nova 301 Phase 3 clinical trial is a randomized, observer-blind, placebo-controlled study expected to be completed in 2027.

Sub Title:

Norovirus vaccine candidate progresses in Nova 301 phase 3 clinical trial

References:

CDC Ship Score of 100 report

2024 norovirus season

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by K. Karin

Norovirus Outbreaks Return Without Approved Vaccines

Karen McClorey Hackett — Tue, 12 Dec 2023 15:56:54 +0000

Reviewer:

Hundreds of patients in hospital with norovirus ahead of winter

Recent data published in England and the United States show high levels of patients diagnosed with norovirus, the winter vomiting bug, as the end of 2023 approaches.

The timing of norovirus outbreaks can vary considerably from one season to the next, says the U.K. Health Security Agency.

According to the U.K.'s NHS, an average of 351 people were hospitalized with diarrhea and vomiting symptoms every day at the end of November compared to 126 in the same week in 2022.

There were also 13 children with the virus in hospital each day, compared to an average of just three for the same period in 2022.

The NHS national medical director, Professor Sir Stephen Powis, commented in a recent press release, "We all know somebody who has had some kind of nasty winter virus in the last few weeks, and today's data shows this is starting to trickle through to hospital admissions, with a much higher volume of norovirus cases compared to last year."

In the U.S., from August through November 13, 2023, there were 202 norovirus outbreaks reported by NoroSTAT-participating states.

California leads all states with 67 norovirus outbreaks reported this year.

During the same period last season, 134 norovirus outbreaks were reported by these states.

The most commonly detected norovirus genotype worldwide is genogroup II- genotype 4 (GII.4), which is the focus of leading vaccine candidates.

While the U.S. and U.K. have not approved a norovirus vaccine, late-stage candidates are advancing.

For example, HilleVax stated in a press release on September 20, 2023, that it intends to use the net proceeds from the recent $100 million offering to fund the clinical development of HIL-214.

".... we are adjusting our guidance to read out topline clinical data on all subjects in our NEST-IN1 phase 2/3 clinical trial to mid-2024," said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax.

HIL-214 is an investigational virus-like particle bivalent vaccine candidate for preventing moderate-to-severe acute gastroenteritis caused by norovirus in infants. The HIL-214 vaccine includes antigens from genotypes GI.1 and GII.4.

Sub Title:

Norovirus vaccine candidates

References:

UKHSA National norovirus and rotavirus week 49 report

US CDC NoroSTAT Data Dec. 11, 2023

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US CDC norovirus outbreak map Oct, 31, 2023

Norovirus Upsets Spring Break for Cruisers

Karen McClorey Hackett — Thu, 09 Mar 2023 18:54:03 +0000

Reviewer:

U.S. CDC - Investigation Update on the Ruby Princess

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed more than 300 people became ill on a Galveston, Texas, based cruise ship last week.

On March 7, 2023, the CDC's Investigation Update regarding vomiting and diarrhea on the Princess Cruises' Ruby Princess voyage #RU305P determined:

passengers who reported being ill during the voyage: 284 of 2881 (9.9%),
crew reporting being ill: 34 of 1159 (2.9%).

According to Houston Public Media, Briana Latter, a spokesperson for Princess Cruises, wrote in an emailed statement that there were cases of "mild gastrointestinal illness" on board the ship.

She did not answer a question to determine whether passengers or crew members were hospitalized after disembarking – a detail not addressed in an online report released by the CDC.

"The cause likely is the common but contagious virus called norovirus," Latter added.

The Ruby Princess was disinfected before another set of passengers and crew members embarked on another cruise shortly after the infected group arrived on Galveston Island on March 5, 2023.

While the Ruby Princess remained at sea, the CDC said Princess Cruises increased cleaning and disinfection procedures, notified all guests about the outbreak, and collected stool samples from those infected so the samples could be sent to a CDC lab for testing.

Latter said Princess Cruises' sanitization program, developed in coordination with the CDC, includes disinfecting high-touch surfaces like railings, door handles, and elevator buttons; encouraging passengers to use their in-cabin restrooms along with washing their hands and using hand sanitizer; and isolating ill passengers in their cabins until they no longer are contagious.

"At the first sign of an increase in the numbers of passengers reporting to the medical center with gastrointestinal illness, we immediately initiated additional enhanced sanitization procedures to interrupt the person-to-person spread of this virus," Latter commented.

The CDC posts current norovirus outbreaks and alerts at this link.

Noroviruses are very contagious RNA viruses. They are the most common viral pathogens causing epidemic and endemic acute gastroenteritis.

Previously, the U.S. Food and Drug Administration (FDA) reported an unrelated food-based norovirus outbreak in late February 2023.

The FDA announced it was working with local officials and Canadian public health authorities on a norovirus outbreak linked to raw oysters from British Columbia, Canada.

While norovirus vaccines are in demand, the FDA and the European Medicines Agency have not approved a vaccine candidate as of March 9, 2023.

A leading candidate in development is HilleVax, Inc. HIL-214 virus-like particle-based bivalent vaccine, being tested to prevent moderate-to-severe acute gastroenteritis caused by norovirus.

HIL-214 has been studied in nine clinical trials and generated safety data from more than 4,500 subjects.

Sub Title:

HIL-214 virus like particle-based bivalent vaccine candidate is conducting research

References:

Houston Public Radio Mar 2023

FDA Advises Restaurants, Retailers and Consumers to Avoid Canadian Raw Oysters

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Norovirus Infections Increase 66% in England

Karen McClorey Hackett — Tue, 14 Feb 2023 17:28:28 +0000

Reviewer:

UK Health Security Agency norovirus data 2023

The most common infectious cause of vomiting and diarrhea has been surging in England in 2023.

The U.K. Health Security Agency (UKHSA) data released on February 9, 2023, shows a 66% increase in reports of confirmed norovirus cases, mostly in seniors.

These norovirus outbreaks have increased in hospitals, schools, and care home settings.

While high numbers of cases in this age group are expected at this time of year, these levels haven't been seen in over a decade, wrote the UKHSA.

During the 2022-2023 season to date, the majority (77%) of samples characterized were norovirus Genogroup 2 (GII), of which the most frequently identified strain was genotype GII.4 (39%).

In response to the increase in cases, UKHSA is reminding the public of the actions that they can take to reduce the spread of norovirus since vaccines are not approved in 2023.

When someone with norovirus vomits, the droplets contaminate the surrounding surfaces.

Dr. Lesley Larkin, Surveillance Lead, Gastrointestinal Infections and Food Safety (One Health) Division at UKHSA, stated in a press release, "Please stay at home if you are experiencing norovirus symptoms and do not return to work (particularly if you work with vulnerable people or food) or send sick children to school or nursery until 48 hours after symptoms have cleared."

"If you have a loved one in a care home or hospital, please avoid visiting until 48 hours after symptoms have cleared."

"Furthermore, regular hand washing is essential to help stop the spread of this bug."

"But remember, alcohol gels do not kill off norovirus, so soap and warm water are best."

Most people will fully recover within 2 to 3 days, and it is essential to drink plenty of fluids to prevent dehydration, especially for the very young, elderly, or those with weakened immune systems, which are more at risk.

As of February 14, 2023, the UKHSA, the U.S. Food and Drug Administration, and the European Medicines Agency have not approved a norovirus vaccine.

However, two vaccines are making progress.

Vaxart, Inc. announced on February 14, 2023, that it had dosed the first subject in a study of its oral tablet bivalent vaccine candidate. Vaxart expects to report topline data from the Phase 2 study in mid-2023.

And HillVax LLC's HIL-214 bivalent vaccine candidate is in development to prevent moderate-to-severe illness caused by norovirus infection.

UKHSA's national norovirus surveillance team monitors national surveillance data from multiple systems in England to ensure early detection of any unusual norovirus activity.

Sub Title:

Norovirus vaccine candidates are conducting clinical studies

References:

UK National norovirus and rotavirus surveillance reports: 2022 to 2023

Norovirus vaccine candidates 2023

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Certain Canadian Oysters Contaminated with Vibrio

Karen McClorey Hackett — Wed, 06 Apr 2022 15:17:33 +0000

Reviewer:

FDA Advises Restaurants and Retailers Not to Serve or Sell Potentially Contaminated Raw Oysters from Canada (April 2022)

The U.S. Food and Drug Administration (FDA) recently announced a Public Health Alert advising consumers and retailers to avoid potentially contaminated raw oysters from British Columbia, Canada.

On April 4, 2022, the FDA confirmed that the agency is working with federal, state, and local officials and Canadian public health authorities regarding potential norovirus outbreaks.

The FDA has confirmed that potentially contaminated raw oysters harvested in the south and central parts of Baynes Sound, British Columbia, Canada, were distributed to restaurants and retailers in California, Colorado, Florida, Hawaii, Illinois, Massachusetts, Minnesota, New Jersey, Nevada, New York, Oregon, Texas, and Washington states.

Furthermore, it is possible that additional states received these oysters through further distribution within the U.S. Retailers should not serve the raw oysters harvested from those locations.

And people should not eat any raw oysters from the locations listed above and should throw them in the garbage.

The U.S. CDC says raw oysters contaminated with Vibrio can be life-threatening, even fatal when eaten by someone with liver disease, diabetes, or a weakened immune system.

Vibrio bacteria naturally inhabit coastal waters where oysters live. Because oysters feed by filtering water, bacteria can concentrate in their tissues.

According to the FDA, food contaminated with norovirus may look, smell, and taste normal. However, anyone who consumes raw shellfish is at risk of contracting norovirus.

The seriousness of any case depends on many factors, including how much bacteria is ingested and the person's underlying health conditions.

Oysters can cause illness if eaten raw, particularly for those with compromised immune systems.

A person usually develops symptoms 12 to 48 hours after being exposed to norovirus. However, most people with norovirus illness get better within 1 to 3 days.

The most common symptoms of norovirus are diarrhea, vomiting, nausea, and stomach pain.

Other symptoms include fever, headache, and body ache.

If you have norovirus illness, you can feel extremely ill and vomit or have diarrhea many times a day.

This can lead to dehydration, especially in young children, older adults, and people with other illnesses.

Call your healthcare provider if you think you or someone you are caring for is severely dehydrated, says the FDA.

Furthermore, it is also essential to be aware that noroviruses are relatively resistant to heat. They can survive temperatures as high as 145°F.

Therefore, the U.S. CDC says that quick steaming processes often used to cook shellfish may not heat foods enough to kill noroviruses.

To protect yourself and others from norovirus:

Wash your hands thoroughly with soap and water often.
Carefully wash fruits and vegetables before preparing and eating them.
Cook oysters and other shellfish thoroughly before eating them.
Do not prepare food or care for others when you are sick and for at least two days after symptoms stop.
Clean and disinfect contaminated surfaces.
Wash contaminated laundry thoroughly.

Moreover, here are a few FDA facts about oysters:

MYTH: Alcohol kills harmful bacteria.

Fact: Alcohol may impair a person's reasonable judgment, but it doesn't destroy harmful bacteria.

MYTH: Just a few oysters can't hurt you.

Fact: Roberta Hammond, Ph.D., the Food and Waterborne Disease Coordinator for Florida, cites a case where a fatality caused by Vibrio vulnificus occurred after eating only three oysters.

To read about other Raw Oyster Myths, please visit this FDA webpage.

Vax-Before-Travel publishes fact-checked, research-based news.

Updated on April 7, 2022, for accuracy.

Sub Title:

Contaminated oysters may look, smell, and taste normal

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New Ways to Prevent Rotavirus

Don Hackett — Wed, 14 Oct 2020 13:05:12 +0000

Reviewer:

Biomedical Sciences Researchers Find New Way to Prevent and Cure Rotavirus, Other Viral Infections

A combination of substances secreted by the immune system can prevent rotavirus infection, as well as potentially treat other viral infections that target epithelial cells, according to researchers in the Institute for Biomedical Sciences at Georgia State University (GSU).

The substances identified in this pre-clinical GSU study which was published on October 2, 2020, officially known as cytokines, are interleukin 18 (IL-18) and interleukin 22 (IL-22). IL-18 and IL-22 are produced when the body detects a protein in the whip-like appendage of bacteria.

The study, which investigated how these cytokines inhibit rotavirus infection, found when mice were treated with both IL-18 and IL-22, the cytokines promoted each other’s expression, but also impeded rotavirus by independent, distinct mechanisms that involved activating receptors in intestinal epithelial cells.

According to the GSU researchers, the actions resulted in rapid and complete expulsion of rotavirus, even in hosts with severely compromised immune systems.

Furthermore, this combo therapy was also found to be effective for norovirus, a contagious virus that causes vomiting and diarrhea.

“Our study reports a novel means of eradicating a viral infection, particularly viruses that infect epithelial cells,” said Dr. Andrew Gewirtz, senior author of the study and a professor in the Institute for Biomedical Sciences at GSU, in a press release. “The results suggest that a cocktail that combines IL-18 and IL-22 could be a means of treating viral infections that target short-lived epithelial cells with high turnover rates.”

The study is funded by grants from the US National Institutes of Health.

Rotavirus is an enteric infection that can cause severe morbidity and contributes to childhood mortality in resource-poor countries where the existing vaccine is of moderate efficacy, states the US Centers for Disease Control and Prevention (CDC).

Most children who get the vaccine will be protected from severe rotavirus disease. About 7 out of 10 children will be protected from rotavirus disease of any severity.

Each year, rotavirus vaccination prevents an estimated 40,000 to 50,000 hospitalizations among US infants and young children.

Two rotavirus vaccines are currently licensed for infants in the USA:

RotaTeq is given in 3 doses at ages 2 months, 4 months, and 6 months,
Rotarix is given in 2 doses at ages 2 months and 4 months.

The first dose of either vaccine should be given before a child is 15 weeks of age. Children should receive all doses of rotavirus vaccine before they turn 8 months old.

Both vaccines are given by putting drops in the child’s mouth, says the CDC.

PrecisionVaccinations publishes research-based vaccine news.

Sub Title:

Georgia State University research identifies a combination therapy for norovirus prevention

References:

IL-22–induced cell extrusion and IL-18–induced cell death prevent and cure rotavirus infection

CDC: otavirus vaccine is the best way to protect your child against rotavirus disease

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Norovirus Suspected Stowaway on Cruise Ship

Danielle Reiter RN — Mon, 25 Nov 2019 14:52:41 +0000

Reviewer:

CDC: Burden of Norovirus Illness in the U.S.

Passengers aboard the Norwegian Cruise Line’s Norwegian Joy docked at the Port of Los Angeles on November 24, 2019, were evaluated by paramedics as they disembarked, with 4 individuals sent to a local hospital for further medical treatment, reported various Tweets.

According to Los Angeles Times reporting, Fire Department spokesman Brian Humphrey said there were no details about the passengers’ illness. And, Humphrey said ‘none of their symptoms were life-threatening.’

The Norwegian cruise line issued a statement about the incident, saying ‘the safety, security, and well-being of our guests and crew is our number one priority.’

‘During Norwegian Joy’s Panama Canal sailing, a few passengers experienced a stomach-related illness. To mitigate any impact of this rare occurrence, we implemented stringent sanitation procedures,’ reported Fox News.

Built in 2017, the Norwegian Joy cruise ship has a passenger capacity of 3,805. The Norwegian Joy cruises year-round from the west coast to Alaska, the Mexican Riviera, and Panama Canal from Miami and Los Angeles, says the company’s website.

The US Centers for Disease Control and Prevention (CDC) Vessel Sanitation Program (VSP) requires a report when 2 percent or more of the passengers or crew have a gastrointestinal illness.

People often associate cruise ships with Acute Gastrointestinal illnesses.

About 20 percent of Acute Gastroenteritis, which causes diarrhea and vomiting, is caused by Norovirus, according to the CDC.

Norovirus is very contagious and can affect anyone, and it is the most common cause of diarrhea and vomiting in the United States and globally. You can get norovirus from an infected person, from contaminated food or water, or by touching contaminated surfaces.

The virus causes your stomach, intestines, or both to get inflamed, leading to stomach pain, nausea, diarrhea, and throwing up.

But, cruise ship illnesses are not that frequent.

From 2008 to 2014, 74 million passengers sailed on cruise ships in the CDC Vessel Sanitation Program’s jurisdiction.

And, only 129,678 passengers met the program’s case definition for Acute Gastrointestinal illness, and only 10 percent were part of a norovirus outbreak.

The development of preventive vaccines for norovirus is currently underway; however, there is not a norovirus vaccine available today.

Though there are more than 30 known genotypes of human norovirus, nearly 60 percent of outbreaks are caused by GII.4 genotype strains.

This is why in February 2015, the Bill and Melinda Gates Foundation, CDC Foundation, and the CDC brought together norovirus experts from around the world to discuss how to make the norovirus vaccine a reality.

Various important questions remain regarding how humans develop immunity to norovirus, how long immunity lasts, and whether immunity to one norovirus strain protects against infection from other strains.

The human norovirus vaccine candidate TAK-214. which is in Phase 2b clinical trial, uses virus-like particle antigens, which are proteins that precisely mimic the outer surface of norovirus. This vaccine includes antigens from genotypes GI.1 and GII.4, to represent both of the genogroups that cause the majority of human illness.

There are also relevant questions as to how a norovirus vaccine would be used to prevent the most disease and protect those at highest risk for severe illness, says the CDC.

Recent norovirus vaccine news

Norovirus Oral Vaccine Candidate Launches Phase 1b Study
A study has revealed insights on how norovirus outbreaks were caused by a specific genogroup II type 4 (GII.4) in hospitals, long-term care facilities, and outpatient facilities.
Takeda clarifies TAK-214 norovirus vaccine strategy.

The CDC estimates that norovirus causes approximately 19 to 21 million illnesses in the United States each year, resulting in 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mostly among young children and older adults.

According to the CDC, norovirus can be found in vomit or feces before the onset of symptoms and can remain in feces for weeks after symptoms cease. Any laundry contaminated with vomit or feces should be immediately washed and disinfected to prevent the spread of norovirus.

The CDC emphasizes proper hand hygiene, especially after using the bathroom or changing diapers, and always before eating, preparing or handling food. Alcohol-based hand sanitizers can be used in addition to hand-washing but sanitizers are not as effective as soap and water and should not be used independently for removing norovirus particles.

In a previous Johns Hopkins University-led study, researchers estimated the global economic impact of norovirus disease at $60 billion.

Norovirus news published by Vax-Before-Travel

Sub Title:

Vaxart completed Phase 1 clinical trials with its monovalent oral tablet vaccine based on the GI.1 norovirus strain,

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Sick Norwegian Cruise Line passengers checked by paramedics in L.A.

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Oral Bivalent Norovirus Vaccine Meets Phase 1b Study Endpoints

Don Hackett — Thu, 26 Sep 2019 13:12:29 +0000

Reviewer:

Vaxart’s Tableted Oral Bivalent Norovirus Vaccine Meets Primary and Secondary Endpoints in Phase 1b Study

A California based biotechnology company announced positive topline results from the Phase 1b study with its oral tableted bivalent norovirus vaccine in healthy adults.

This study’s results, published on September 25, 2019, met all primary endpoints for safety and demonstrated robust immunogenicity, with 78 - 93 percent of subjects responding by eliciting IgA antibody-secreting cells (ASC), a key marker for mucosal immunity and a potential correlate of protection for norovirus disease

The oral norovirus GI.1 and GII.4 vaccines were well tolerated, with no treatment-related serious adverse events reported.

Vaxart’s bivalent vaccine demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain for the bivalent cohort of the study, and 86% and 90%, respectively, for the two monovalent cohorts of the study.

There was no interference observed in the bivalent arm of the study.

“These (study) results are in line with the robust immune response profile seen in previous studies with our noro-GI.1 tablet vaccine, while the immunogenicity of our new noro-GII.4 tablet vaccine trended even higher with an IgA ASC response rate of 90% or greater,” said Wouter Latour, M.D., chief executive officer of Vaxart, Inc.

“We are now forging ahead with the Phase 2 dose confirmation study planned for 2020.”

The Phase 1b norovirus bivalent vaccine trial enrolled a total of 80 subjects.

After enrollment of an open-label sentinel GII.4 group of 5 subjects, the remaining 75 subjects were randomized in a blinded manner to one of 4 treatment groups: 15 subjects in each monovalent group received an oral 5x1010 I.U. dose of either the norovirus GII.4 or GI.1 vaccine, 30 subjects in the bivalent group received a 5x1010 I.U. dose of both the norovirus GII.4 and GI.1 vaccine administered concurrently, and 15 subjects received placebo tablets.

The trial was designed to evaluate safety, immunogenicity, and interference of Vaxart’s oral bivalent norovirus vaccine by comparing the bivalent vaccine group to the two monovalent vaccine groups, as well as the placebo group.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that norovirus causes approximately 19 to 21 million illnesses in the United States each year, resulting in 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mostly among young children and older adults.

“Norovirus is a very contagious disease which can be especially harmful to children under age 5, as well as to older adults,” said William Schaffner, M.D., medical director of the National Foundation for Infectious Diseases and Professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine.

Norovirus is recognized as the leading cause of acute gastroenteritis in the United States. It is a common intestinal infection that typically lasts three to five days and is marked by diarrhea, vomiting, abdominal cramps, nausea, and sometimes fever, says the CDC.

Norovirus symptoms can be more severe in high-risk patients (older adults and young children) and may lead to serious complications, including death. Norovirus causes frequent, debilitating and widespread outbreaks in the military, food industry, travel industry, child care facilities, elderly homes, and healthcare facilities.

In a recent study by Johns Hopkins University and the CDC, researchers estimated the global economic impact of norovirus disease at $60 billion, $34 billion of which occurred in high-income countries, including the United States, Europe, and Japan.

Vaxart, Inc. is a clinical-stage biotechnology company focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform.

Norovirus news published by Precision Vaccinations

Sub Title:

Vaxart oral norovirus GI.1 and GII.4 vaccine was reported well tolerated

References:

Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines (VXA-NVV-103)

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Norovirus Vaccine Strategy Clarified

Don Hackett — Tue, 25 Jun 2019 17:44:22 +0000

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Sera Antibody Repertoire Analyses Reveal Mechanisms of Broad and Pandemic Strain Neutralizing Responses after Human Norovirus

Researchers have discovered an antibody that broadly inhibits multiple strains of pandemic norovirus, a major step forward in the development of an effective vaccine for the dreaded stomach virus.

This is good news since there is no commercially available norovirus vaccine.

The most important discovery of this study is ‘a human antibody that can bind to a highly conserved region of the virus common among different strains of norovirus, potentially neutralizing all GII.4 strains of norovirus that exist in nature.’

This is important news since human noroviruses are the leading cause of acute gastroenteritis, according to the Centers for Disease Control and Prevention (CDC).

The study was led by the University of North Carolina at Chapel Hill Gillings School of Global Public Health and colleagues at the University of Texas at Austin and the National Institutes of Health Vaccine Research Center.

It describes for the first time the structure of the binding interaction between the norovirus and a human antibody that may work against many strains of the pandemic ‘stomach bug.’

Though there are more than 30 known genotypes of human norovirus, nearly 60 percent of outbreaks are caused by GII.4 genotype strains, the authors wrote.

A human antibody that can target these highly conserved areas will provide broad protection for a prolonged period of time. With this knowledge, vaccine developers will have a better understanding of how, and how often, to reformulate the vaccine over time.

“We’ve established an understanding of the virus and how it changes, how the body’s immune response targets it and how we can use that information to make a better vaccine, said the researchers in a press release.

“In order to design an effective vaccine for norovirus, scientists needed to identify a neutralizing antibody that could work against many strains of the virus, as well as strains that will circulate in the future.”

The paper’s authors partnered with Takeda Vaccines, which is in Phase 2b clinical trial with a human norovirus vaccine candidate, TAK-214.

The TAK-214 vaccine candidate uses virus-like particle antigens, which are proteins that precisely mimic the outer surface of norovirus. This vaccine includes antigens from genotypes GI.1 and GII.4, to represent both of the genogroups that cause the majority of human illness.

Recent norovirus news:

Norovirus is an inflammation of the stomach and intestines. It accounts for nearly one in five cases of diarrhea and vomiting, and is responsible for an estimated 200,000 deaths per year, mostly in infants, children and the elderly, says the CDC.

Norovirus illness is not related to the flu, which is caused by the influenza virus.

Authors who collaborated on this research are George Georgiou, Jonathon McDaniel, and Scott Kerr, from the University of Texas at Austin’s Department of Chemical Engineering, Department of Molecular Biosciences and Institute for Cell and Molecular Biology; Jan Vinje, and Veronica Costantini, from the Centers for Disease Control and Prevention; and Peter Kwong, Anita Changela, and Raffaello Verardi, from the Vaccine Research Center at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases.

No conflicts of interest were disclosed.

Sub Title:

Takeda norovirus vaccine candidate TAK-214 uses virus-like particle antigens

References:

Scientists discover a powerful antibody that inhibits multiple strains of norovirus

CDC: Norovirus

Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

Norovirus Bivalent-Vaccine Efficacy Study

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health, vaccines, vaccinations, norovirus, diarrhea, stomach bug, Takeda, norovirus vaccine

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Tetravalent Norovirus Vaccine Study Launched in China

Don Hackett — Wed, 05 Jun 2019 17:58:36 +0000

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China approves norovirus vaccine for clinical trial

China’s National Medical Products Administration (NMPA) has approved a clinical trial for the world's first tetravalent vaccine candidate against norovirus on May 30, 2019.

This vaccine’s developer is the Institut Pasteur of Shanghai (IPS), which is under the Chinese Academy of Sciences.

The vaccine candidate, after four years of development, can theoretically prevent 80 to 90 percent of norovirus infections," said Huang Zhong, who leads the project at IPS, and reported by Xinhuanet.

‘The norovirus has long eluded the world's vaccine development, as traditional strategies of inactivation and attenuation fail on the virus that cannot be cultured in vitro on a large scale.

"This was further complicated by the virus' many genotypes, regional variations and its propensity to mutate,’ according to Huang.

This clinical trial is expected to last for 5 years before the vaccine can apply for new drug registration, which will benefit norovirus prevention in both China and abroad, said Tang Hong, a researcher with the IPS.

This norovirus vaccine candidate was jointly developed by the IPS and Anhui Zhifei Longcom Biopharmaceutical Co. Ltd.

Data from the US Centers for Disease Control and Prevention (CDC) suggest that noroviruses are the leading cause of acute gastroenteritis across all age groups seeking medical care in emergency departments, outpatient clinics, and community health centers.

Recent reviews of the literature on outpatient and hospital-based studies in developing and developed countries report that norovirus gastroenteritis account for 10–15 percent of severe cases in children less than 5 years of age.

Each year, noroviruses cause 19–21 million illnesses and results in 56,000–71,000 hospitalizations and 570–800 deaths.

Noroviruses are single-stranded RNA viruses of the family Caliciviridae and thus undergo genetic drift due to an error-prone RNA polymerase, as well as the ability to undergo recombination, says the CDC.

Polyvalent vaccines including multiple norovirus genotypes and/or other viruses acquired by the enteric route have been developed. One vaccine candidate has reached phase II clinical trials and several others are in pre-clinical stages of development.

Recent norovirus vaccine news:

Sub Title:

Norovirus vaccines could prevent 50% of acute gastroenteritis

References:

Norovirus vaccines: Correlates of protection, challenges and limitations

nfectivity of GII.4 human norovirus does not differ between T-B-NK+ severe combined immunodeficiency (SCID) and non-SCID

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health, vaccines, vaccinations, norovirus, china,

Section:

Clinical Trials

Featured:

Norovirus Oral Vaccine Candidate Launches Phase 1b Study

Don Hackett — Tue, 19 Mar 2019 13:57:54 +0000

Reviewer:

John Paul Sanchez, PharmD

Vaxart Announces Initiation of Bivalent Norovirus Vaccine Phase 1b Clinical Trial

A clinical-stage biotechnology company announced the initiation of a Phase 1b oral recombinant, bivalent norovirus vaccine clinical trial.

This is important news since there is currently no vaccine to protect people against norovirus.

Norovirus is considered one of the most infectious foodborne pathogens given its low infectious dose and resistance to nearly every common sanitization process used in food production.

Contamination of cruise ships is particularly well described in recent press articles.

The bivalent norovirus vaccine study consists of two parts, an open-label lead-in phase during which 6 subjects will be dosed with norovirus GII.4 vaccine, and a double-blind, placebo-controlled phase during which a total of 80 subjects dosed with either placebo, norovirus GI.1 vaccine, norovirus GII.4 vaccine or both norovirus vaccines.

Vaxart Inc. said it expects to receive topline data from the Phase 1b clinical study in the second half of 2019.

In addition, Vaxart reported it remains on track to initiate the Phase 2 monovalent norovirus challenge study in the second quarter of 2019, with results expected in the second half of 2019.

Wouter Latour, M.D., chief executive officer of Vaxart, said in a press release, “Norovirus infection disproportionately affects the elderly and the very young, and we believe an oral vaccine would be the optimal approach to prevent the significant morbidity and even mortality in these age groups.”

Norovirus is recognized as the leading cause of acute gastroenteritis in the United States. It is a common intestinal infection that typically lasts 3 to 5 days and is marked by diarrhea, vomiting, abdominal cramps, nausea and sometimes fever.

Symptoms can be more severe in older adults and young children and may lead to serious complications including death. Norovirus causes frequent and widespread outbreaks in the military, food industry, travel industry, child care facilities, elderly homes, and healthcare facilities.

In a 2016 study by Johns Hopkins University and the CDC, researchers estimated the global economic impact of norovirus disease at $60 billion, $34 billion of which occurred in high-income countries, including the United States, Europe, and Japan.

Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform.

For more information, please visit Vaxart.

Sub Title:

Vaxart’s oral bivalent tablet norovirus GII.4 vaccine candidate progresses in clinical studies

References:

Vaxart Announces Publication of the Phase 1 Results of its Oral Norovirus Tablet Vaccine in Journal of Clinical Investigation

Norovirus

The High Cost of Norovirus Worldwide

Burden of Norovirus Illness in the U.S.

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health, vaccines, vaccinations, norvirus, stomach flu, cruise ships, throw up, diarrhea, vomit

Section:

Clinical Trials

Featured:

Cruising with Norovirus in 2019

Don Hackett — Fri, 01 Feb 2019 21:11:51 +0000

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