Vaccine News

HDT Bio Corp. today announced that it has partnered with the Biomedical Advanced Research and Development Authority (BARDA), under Project NextGen's Enabler's program. 

Through this BARDA partnership, HDT Bio has received a $749,000 contract, supporting proof-of-concept studies for on-demand manufacturing and release processes that use HDT Bio's LION™ formulation for RNA vaccine production.

These studies will provide proof-of-concept data on the LION platform in support of on-demand manufacturing and release processes that enable rapid production of 1000 repRNA vaccine doses in seven days.

LION is a proprietary nanoemulsion tailored for RNA-based vaccines and therapeutics production designed to enable facile formulation and faster manufacturing compared to the characteristics of standard lipid nanoparticles used in existing vaccine products. 

"We look forward to contributing to the broader access to treatment and prevention strategies of future infectious diseases," commented Steven Reed, Ph.D., Co-founder and Chief Executive Officer of HDT Bio, in a press release on January 23, 204.

With an initial investment of $5 billion, Project NextGen intends to accelerate and streamline the development of the next generation of vaccines and treatments through public-private collaborations.

The Project NextGen Enabler's program aims to advance next-generation vaccine and therapeutics technologies, including the development of innovative cGMP manufacturing of vaccines that decrease costs, speed production, increase efficacy, and improve access.

Previous BARDA - Project NextGen awards include, but are not limited to, $8.5 million to CastleVax for a vector-based intranasal vaccine candidate, $10 million to Gritstone Bio for a self-amplifying mRNA vaccine candidate, and $9.27 million to Vaxart's evaluation of its oral pill XBB COVID-19 vaccine candidate.

Project NextGen is separated from the Disease X initiative.

Since the approval of Respiratory Syncytial Virus (RSV) vaccines and an enhanced monoclonal antibody in 2023, the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have received reports of RSV vaccines being administered in error to young children and pregnant women.

A Clinician Outreach and Communication Activity COCA Now email issued today says the number of reports received by the Vaccine Adverse Event Reporting System (VAERS) as of January 17, 2024, suggests that these types of errors are uncommon in young children less than two years of age (25 reports) and pregnant women (128 reports).

The CDC stated this is a relatively small amount of errors compared to the estimated one million infants protected from RSV either through infant receipt of Beyfortus™ (nirsevimab) or by pregnant women being vaccinated.

According to the CDC, most of these administration error reports described no adverse event. When an adverse event was concurrently reported to VAERS, most reports were classified as nonserious.

The CDC, FDA, and other federal agencies said they continue to monitor the safety of RSV vaccines and reports of vaccine administration errors and will share information with the public as it becomes available.

On January 22, 2024, the CDC published Recommendations for Healthcare Providers who Have Administered Incorrect RSV Vaccine Products to Their Patients.

As the world awaits the approval of a Human Immunodeficiency Virus (HIV) vaccine, a novel candidate based on Gorilla adenoviral vector (GRAd-HIV) technology was recently funded by The Bill & Melinda Gates Foundation.

Over the past few decades, various HIV vaccine candidates have not succeeded in human clinical trials.

Announced on January 22, 2024, ReiThera Srl, the Ragon Institute of Mass General, MIT, Harvard, and IAVI confirmed a collaboration to develop a novel HIV vaccine candidate that will be composed of ReiThera’s GRAd vector and HIV T-cell epitopes.

ReiThera’s vaccine platform uses a novel proprietary GRAd vector belonging to species C adenoviruses that are considered among the most potent vaccine carriers for the induction of CD8 T-cell responses to the encoded antigens and having a low seroprevalence in humans.

Prior findings by the Ragon Institute have shown that mutation of residues at important network positions disproportionately impaired viral replication and occurred with high frequency in epitopes presented by protective human leukocyte antigen (HLA) class I alleles.

Moreover, CD8+ T-cell targeting of highly networked epitopes distinguished individuals who naturally control HIV, even in the absence of protective HLA alleles.

“We are thrilled to have the opportunity to collaborate with ReiThera and IAVI, with the support of the Bill & Melinda Gates Foundation, to advance the GRAd-HIV highly networked T-cell vaccine candidate towards clinical evaluation,” said Gaurav Gaiha, Ragon faculty member, in a press release.

“We are particularly pleased that this takes place with partners in sub-Saharan Africa, given the immense need for new solutions to curtail the ongoing HIV epidemic.”

Key partners in this program include researchers at the Africa Health Research Institute, the National Institute for Communicable Diseases in South Africa, Mutala Trust, and Charles River Medical Group in Zimbabwe.

IAVI is the sponsor and will execute a phase I clinical trial.

Last year, the World Health Organization (WHO) confirmed the first known case of Western Equine Encephalitis (WEE) in more than two decades in Argentina.

Since then, and until January 9, 2024, 21 human cases in Argentina have been confirmed by the WHO/PAHO.

To alert international travelers to this WEE health risk, the U.S. CDC issued a Level 1 - Practice Usual Precautions, Travel Health Notice on January 12, 2024.

WEE is a rare, mosquito-borne viral disease that affects equines and humans. Most human cases are associated with epidemics in birds or horses.

The CDC says travelers to these regions of Argentina should avoid mosquito bites, which can transmit the Eastern Equine Encephalitis Virus (EEEV).

EEEV transmission is most common in and around freshwater hardwood swamps in the Atlantic and Gulf Coast states and the Great Lakes region in the U.S.

Only about 4-5% of human EEEV infections result in EEE.

In the United States, an average of 11 human cases of EEE are reported annually, according to the CDC. There were 7 EEEV neuroinvasive disease cases in 2023, reported by four states.

From 2012-2021, most cases of EEE have been reported from Massachusetts, Michigan, Florida, Georgia, and North Carolina.

As of 2024, the CDC says no vaccine prevents EEE virus infection.

However, the U.S. Army Medical Research Institute of Infectious Diseases developed a human vaccine for EEE in the mid-1980s, but it has never been approved for public use.

The U.S. government recently invested in a vaccine against western, eastern, and Venezuelan equine encephalitis viruses. 

MVA-BN® WEV has completed Phase 1 clinical development demonstrating potential for broad, and long-term protection, with a Phase 2 study planned for 2024.

The Costa Rica Ministry of Health today announced it confirmed a measles case near the capital city of San Jose.

This new measles patient was detected on January 11, 2024. In 2023, one measles patient was also confirmed.

Given this new measles case, the Costa Rica health authorities conducted all follow-up efforts to address the situation. Currently, this person is in good health.

An active community search for cases in San Josecito de San Rafael de Heredia was conducted on January 18, 2024. As a result of the search, no additional measles cases were found, as most of the people approached had completed vaccination schedules. A total of 408 houses were visited.

After the WHO Region of the Americas was declared measles-free in September 2016, a steady increase in imported measles cases from other WHO Regions and between countries within the Region of the Americas was observed.

For example, several states in the eastern United States have reported measles cases in early 2024.

Last year, the Pan American Health Organization / World Health Organization (PAHO/WHO) urged Member States to continue activities to increase and maintain adequate vaccination coverage against measles, rubella, and mumps (MMR).

Globally, the WHO has reported significant measles outbreaks throughout 2023.

In addition to measles, Costa Rica confronted an expansion of Dengue and Zika cases in 2023.

As the 2024 winter season begins to blanket the United States in snow, the Centers for Disease Control and Prevention today published updated insights regarding influenza vaccinations.

As of January 19, 2024, the CDC reported the percentage of the overall population who received one of the nine approved influenza vaccines was 47.5% (95% confidence interval).

From an age segmentation, the CDC reported the following:

• 46.1-48.8 for children,
• 46.7% (45.8-47.6) for adults 18+,
• 73.0% (70.8-75.2) among adults age 65+.

From an availability perspective, the CDC previously reported that over 155 million flu vaccines (egg, cell, and nasal-based) had been distributed during the 2023-2024 season, which are generally available at most pharmacies in the U.S.

Additionally, the CDC's FluView Updates for Week #2, ending January 13, 2024, stated that after several weeks of increases in key flu indicators through the end of 2023, two weeks of decreasing or stable trends nationally have been noted.

However, seasonal influenza activity remains elevated in most parts of the country.

Furthermore, the CDC is monitoring for a second period of increased influenza activity that often occurs after the winter holidays.

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced it is awarding $1.7 million to Syntiron to develop a maternal vaccine that targets Escherichia coli and Klebsiella pneumoniae.

Syntiron's Alloy-EK vaccine leverages iron receptor proteins (IRPs) as vaccine targets. IRPs are highly genetically conserved, which means they are less likely to change since they perform essential functions.

This makes these proteins reliable vaccine targets.

Syntiron developed the Alloy Platform to manufacture and formulate IRP vaccines safely that maintain robust immunity and cover a broad range of bacterial strains.

Neonatal sepsis is a life-threatening response to bloodstream infections that occur in newborns fewer than 28 days old. Due to their immature immune systems, newborns are particularly susceptible to infections.

Since neonatal sepsis progresses rapidly, the risk of death from neonatal sepsis increases by 7.6% every hour a treatment is delayed.

The BARNARDS study estimated that 2.5 million neonates or infants die in the first month of life of sepsis annually, with the most significant burden in low- and middle-income countries. 

"The bacteria targeted by this vaccine are a tremendous burden on public health for babies, children, and adults worldwide," said Lisa Herron-Olson, Ph.D., Managing Director of Syntiron, in a press release on January 18, 2024.

"Pregnant women are at particularly high risk of infection by these same bacteria that can cause neonatal sepsis in newborn babies."

"Preventing these infections by vaccination offers substantial potential health benefits to mothers and babies while reducing the spread of antimicrobial resistance."

Syntiron's innovation with the Alloy Platform leveraged molecular, bioinformatic, and immunological principles to engineer simpler proteins enriched in linear, immunodominant, and highly conserved peptides derived from IRPs.

Founded in 2004, Syntiron is a biotechnology company based in Saint Paul, MN, and has several vaccines in development that target bacterial infections.=