Travel Vaccine Breaking News

A virus-like particle (VLP) based vaccine candidate in development to prevent moderate-to-severe acute gastroenteritis (AGE) in infants caused by norovirus infection is being discontinued.

This is unfortunate news since the health burden of norovirus falls disproportionately on young children and older adults.

HilleVax, Inc. today announced topline data results from NEST-IN1, a Phase 2b, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of the HIL-214 vaccine candidate in infants of approximately five months of age at the time of initial vaccination at sites in the United States and Latin America.

In the NEST-IN1 study, there were 51 primary endpoint events, with 25 in the vaccine arm (n=1,425) and 26 in the placebo arm (n=1,399), resulting in a vaccine efficacy of 5% (95% confidence interval; -64%, 45%). 

The study did not meet its primary efficacy endpoint against moderate or severe AGE events due to GI.1 or GII.4 norovirus genotypes. And no clinical benefit was observed across secondary endpoints. The company plans to discontinue further development of HIL-214 in infants.

HIL-214 did exhibit a safety and immunogenicity profile consistent with what was observed in the prespecified analysis of the first 200 subjects in NEST-IN1 and previously reported studies.

“We are disappointed that the NEST-IN1 study did not meet its primary efficacy endpoint,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax, in a press release on July 8, 2024.

“While HIL-214 previously showed clinical benefit in adults, NEST-IN1 was the first efficacy study conducted in infants for a norovirus vaccine candidate. We believe the efficacy in the infant setting may have been impacted by the appearance of multiple emerging GII.4 strains in this trial.”

The company stated it is exploring the potential for continued development of HIL-214 and HIL-216 in adults, HilleVax’s Phase 1 ready vaccine candidate.

Currently, there are no U.S. FDA-approved norovirus vaccines.

Globally, norovirus is estimated to result in approximately 700 million cases of AGE and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year.

The U.S. CDC publishes information about gastrointestinal illness outbreaks on cruise ships in the Vessel Sanitation Program during 2024, including details and actions taken in response.

Dengue poses a year-round risk in many parts of the world, with outbreaks occurring frequently. As of July 2024, the United States has reported travel-related and locally acquired cases of dengue fever. This indicates the U.S. is quietly joining the over 100 countries currently facing outbreaks.

As of July 5, 2024, the U.S. Centers for Disease Control and Prevention (CDC) has reported 2,391 dengue cases in 45 jurisdictions.

The unfortunate leader reporting mosquito-transmitted disease is the state of Florida.

Florida Health's latest weekly vector-borne illness report confirmed that ten locally acquired dengue cases were reported from four counties (Miami-Dade (6), Monroe (2), Pasco, and Tampa) in 2024.

In 2023, 186 humans were reported from five Florida counties to have locally contracted dengue.

Additionally, 244 travel-associated dengue cases were reported, mainly by visitors from Brazil and Cuba. In 2023, Florida Health reported 609 travel-associated dengue cases.

While most disease outbreaks of this nature have a variety of preventive vaccines and treatments available, dengue is an anomaly.

The CDC's Health Advisory, dated June 25, 2024, stated, 'No antiviral medications are approved to treat dengue. Treatment is supportive and requires careful volume management.'

"Maintain a high suspicion for dengue among patients with fever and recent travel (within 14 days before illness onset) to areas with frequent or continuous dengue transmission.'

'Healthcare providers should consider locally acquired dengue among patients with signs and symptoms highly compatible with dengue (e.g., fever, thrombocytopenia, leukopenia, aches, pains, rash) in areas with competent mosquito vectors.'

Also, in late June 2024, the CDC informed its vaccine committee that U.S. residents do not currently have access to a previously approved dengue vaccine.

Furthermore, the CDC did not clarify if the second-generation Qdenga® vaccine would be authorized in 2024.

The U.S. National Institutes of Health (NIH) recently announced a Phase 1 trial testing the safety of an experimental nasal vaccine may provide enhanced breadth of protection against emerging variants of the SARS-CoV-2 coronavirus is now enrolling healthy adults at three sites in the United States.

Announced on July 1, 2024, the NIH is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in pre-clinical studies by scientists from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases.

The investigational vaccine, MPV/S-2P, uses murine pneumonia virus (MPV) as a vector to deliver a version of the SARS-CoV-2 spike protein (S-2P) stabilized in its prefusion conformation. MPV has aan affinity for epithelial cells that line the respiratory tract and may be effective in delivering vaccines to the places where natural coronavirus infections begin.

NIAID Director Jeanne M. Marrazzo, M.D., M.P.H., commented in a press release, “While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease."

"With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission.”

This is the first NIAID clinical trial to be conducted as part of the U.S. Department of Health and Human Services Project NextGen. More information about the trial is available at clinicaltrials.gov using the identifier NCT06441968.

For the 2024-2025 season, the U.S. CDC has recommended updated COVID-19 vaccines.

Note - Link correction was completed on July 4, 2024.

Voices of Alzheimer's, a national advocacy organization led by people living with Alzheimer's disease, today announced it celebrates the U.S. Food and Drug Administration's (FDA) decision to grant traditional approval of donanemab (Kisunla) for treating early Alzheimer's disease.

Following last year's first-ever traditional approval of a drug to slow the progression of Alzheimer's, today's decision builds on that progress by providing patients, care partners, and providers with another alternative to care during the early stages of the disease.

While Kisunla is not a cure, new treatment options still bring tremendous hope to affected families and offer priceless additional time for people in the early stages of Alzheimer's disease.

Jim Taylor, President & CEO of Voices of Alzheimer's and husband to Geri, who was diagnosed with Alzheimer's in 2012, said in a press release on July 2, 2024, "Today is a day for celebration in the Alzheimer's community. When doctors diagnosed my wife Geri with Alzheimer's, there was not a single approved treatment to slow the progression of the disease."

"Now, a decade later, we have two traditionally approved disease-modifying treatments and further advancements in the pipeline."

Taylor continued, "I am also encouraged by the evidence supporting stopping treatment with Kisunla when amyloid plaques are removed."

"People living with Alzheimer's and their care partners already face significant costs and burdens in their day-to-day lives. The possibility of stopping treatment could translate to lower costs and a reduced treatment burden."

In light of this news, Voices of Alzheimer's reiterates our call for the Centers for Medicare and Medicaid Services to remove coverage with evidence development requirements for the entire class of monoclonal antibody treatments for Alzheimer's.

The total cost of Kisunla will vary by patient based on when they complete treatment, says Eli Lilly.

Lilly Support Services for Kisunla is a free support program committed to helping patients navigate treatment with Kisunla. The program includes coverage determination assistance, care coordination, nurse navigator support, customized support, and resources. For more information, visit www.Kisunla.Lilly.com or call 1-800-LillyRx (1-800-545-5979).

Alzheimer's disease preventive vaccine candidates continue to be researched in clinical trials.

In the past two years, H5 influenza virus subtypes have caused severe disease in birds and mammals in the United States. Because of various media reports, there is concern about the risk of these viruses spreading to humans, which could generate another pandemic.

On June 27, 2024, the U.S. Centers for Disease Control and Prevention (CDC) confirmed that the risk to people is very low. However, the U.S. government continues its multi-year effort to prepare for this risk.

Moderna, Inc. today announced a project award of $176 million to accelerate the development of mRNA-based pandemic influenza vaccines. The award program is within the U.S. Department of Health and Human Services (HHS).

The project award will support the late-stage development of an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against the H5 influenza virus.

This new HHS agreement also includes additional options to prepare and accelerate responses to future public health threats.

"mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on July 2, 2024.

In July 2023, Moderna initiated a Phase 1/2 study to generate safety and immunogenicity data for the investigational pandemic influenza vaccine (mRNA-1018) in healthy adults. The study includes vaccine candidates against H5 and H7 avian influenza viruses.

Results from the study are expected in 2024 and will inform Phase 3 development plans.

Currently, there are U.S. FDA-approved pandemic vaccines (Audenz) and various development initiatives underway, funded by the U.S. government. 

Furthermore, the CDC has confirmed annual flu shots may not be effective against these influenza subtypes. 

When the U.S. Centers for Disease Control and Prevention (CDC) published a Health Advisory (CDCHAN-00511) on June 25, 2024, it indicated that dengue fever posed a health risk in southeast Florida, New York, and Puerto Rico.

However, according to new CDC data, Massachusetts has reported 50 dengue cases this year.

While the CDC did not disclose whether these dengue cases were locally acquired, it can be assumed that they are travel-related since the mosquitoes that spread dengue are not found that far north in the United States.

However, countries in the Region of the Americas have reported a record-breaking number of dengue cases, exceeding the highest number ever recorded in a single year. 

From a local guidance perspective, the Massachusetts Health Department (MDH) says there is no vaccine (Dengvaxia is no longer available in the U.S.); the best way to protect yourself is to not get bitten by mosquitoes.

MDH's website states if you have recently traveled to a region where mosquito-borne diseases are common and have any related symptoms, you should call your healthcare provider immediately and explain your travel history and symptoms.

Moderna, Inc. today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union (EU) for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect older adults.

Following the CHMP's positive opinion, the European Commission will decide on the authorization of mRESVIA.

In the EU, RSV is estimated to cause approximately 160,000 hospital admissions in adults each year.

"The positive opinion from the EMA CHMP for mRESVIA highlights the innovation and adaptability of our mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on June 28, 2024. "mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration...."

In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA, which uses the same lipid nanoparticles as the Moderna COVID-19 vaccines.

As of June 30, 2024, the FDA has approved three vaccines and one monoclonal antibody (Beyfortus) to prevent RSV in people.

As of May 22, 2024, the CDC's RSVVaxView reported that the overall RSV vaccination rate among pregnant women was about 17.8%, and an estimated 24.4% of adults 60 years and older reported receiving an RSV vaccine.