Vaccine News

The U.S. Centers for Disease Control and Prevention (CDC) says the Plague was first introduced into the United States in 1900. The plague bacterium (Yersinia pestis) is transmitted by fleas and cycles naturally among wild rodents. 

Over the decades, the Plague spread from urban rats to rural rodent species and became entrenched in many areas of the western U.S.

Almost all of the cases reported in the last 20 years have occurred among people living in small towns and villages or agricultural areas rather than in larger towns and cities, says the CDC.

As of 2024, the CDC estimates that seven human cases of Plague occur in the U.S. each year.

Recent plague cases include the Pueblo Department of Public Health and Environment confirming a human case of Plague in a Pueblo County resident on July 9, 2024.

And in February 2024, health officials in Oregon reported a case of bubonic Plague in a resident who they said likely contracted it from a pet cat.

Globally, the most human plague cases since the 1990s have occurred in Africa.

From a prevention perspective, plague vaccines are no longer available in the U.S. However, plague vaccine candidates are in development but are not expected to be commercially available in the immediate future.

In March 2023, the first mRNA-based, lipid nanoparticle vaccine was found effective against lethal bacteria in mice.

Tiba Biotech LLC today announced its new partnership with the Biomedical Advanced Research and Development Authority (BARDA) through the initiation of an EZ-BAA contract to develop groundbreaking therapeutics against influenza.

The U.S. $749,999 BARDA contract supports early-stage therapeutic platform development for the Flexible and Strategic Therapeutics program.

This BARDA initiative aims to advance cutting-edge therapeutic platform technologies, such as RNA-mediated interference, which could be rapidly deployed in response to emerging viral threats. The therapeutic will target the highly conserved viral nucleoprotein and will be delivered via Tiba’s RNABLTM platform.

Tiba Biotech’s initial focus will be developing a prototype RNAi-based therapeutic for H1N1 influenza (swine flu), a type of influenza A virus.

Every year, there are rare, sporadic human infections with influenza viruses that usually circulate in pigs and not people, says the U.S. CDC.

On June 28, 2024, the CDC reported the second and third U.S. human infections in 2024.

This initiative is a natural extension of Tiba’s ongoing work combating influenza pandemic threats, most notably in the form of a novel multi-antigen mRNA-based H7N9 flu vaccine funded under a Phase II SBIR award from the National Institutes of Health and ongoing collaborations with the Collaborative Influenza Vaccine Innovation Centers.

Tiba was also recently accepted into BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation—JLABS and BARDA. The initiative aims to harness innovation to combat future known and unknown health threats.

Texas public health officials announced today that they are urging Texans to protect against mosquito bites after confirming ten travel-associated dengue cases for 2024.

As of July 11, 2024, all of the dengue cases reported in Texas this year were acquired while traveling internationally.

However, a small number of dengue cases have been acquired from mosquito bites in southern Texas in recent years. Mosquitoes that carry the dengue virus are found in both Mexico and Texas.

The Texas Department of State Health Services (DSHS) confirmed the new dengue cases were reported in Collin, Dallas, Fort Bend, McMullen, Montgomery, and Travis counties.

In 2023, there were 79 cases of dengue in Texas, including one locally acquired case in Val Verde County.

To the south of Texas, Mexico has reported about 1,000 dengue cases in 2024. In 2023, Mexico reported over 277,000 dengue cases.

“Unfortunately, many mosquitoes in Texas can spread diseases, such as West Nile and dengue. These diseases are often mild, but some people will develop severe illness,” said DSHS Commissioner Jennifer Shuford, MD, MPH, in a press release.

According to DSHS, about 25% of dengue infections become symptomatic.

Most people recover completely within two weeks. However, about one in 20 symptomatic people develop a severe infection called Dengue Hemorrhagic Fever that can be fatal if untreated.

From a prevention perspective, two dengue vaccines are used in various countries but not in the U.S. as of July 11, 2024.

Biotechnology company Apriori Bio recently announced it was awarded $1.1 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance its biology-informed artificial intelligence platform Octavia™, aimed at protecting humanity against rapidly evolving viruses by designing variant-resilient vaccines.

The new seed funding from CEPI will focus on pandemic influenza strain H3N2, which has previously affected pigs, birds, and humans.

The Octavia platform works by characterizing large libraries of viral variants on their ability to bind to cells in the human body and evade the immune response. Then, using machine learning, Octavia generates maps to identify the mutations that have the greatest ‘escape potential’ and could, therefore, pose the greatest threat.

Octavia builds and trains its algorithms using computational insights and experimental biological data. This includes studying viral evolutionary trees to identify the point at which viral variability is most likely to occur and exploring how mutations could affect each other.

These insights can guide the design and updating of new vaccines and existing vaccines so that they can protect against worrisome variants for years to come.

Lovisa Afzelius, Ph.D., MBA, Co-founder and CEO of Apriori, said in a press release on July 7, 2024, “We are honored to be recognized by a global leader in pandemic preparedness who shares our commitment to better protecting humanity from rapidly evolving viruses."

CEPI’s 2022-2026 plan, known as CEPI 2.0, will help the world make the scientific progress needed to respond to the next Disease X threat with a new vaccine in just 100 days. This goal is known as the 100 Days Mission. 

The World Health Organization (WHO) Disease Outbreak News confirmed the mpox outbreak in South Africa has expanded. 

The sudden appearance of unlinked mpox cases in South Africa without a history of international travel, the high HIV prevalence among confirmed cases, and the high case-fatality ratio suggest that community transmission of the mpox virus is underway

As of July 9, 2024, 20 confirmed mpox cases, with three related fatalities in Gauteng, Western Cape, and KwaZulu-Natalhave provinces, have been reported since May 2024.

These mpox cases are South Africa's first since 2022, when five cases were reported, none fatal.

The WHO stated, 'Discussions are underway regarding options for vaccine procurement.'

Currently, two mpox vaccines are being deployed in other African countries.

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.