Vaccine News

While the global flu season has not been very severe, recent data indicates the southern United States is experiencing a sudden spike in influenza cases.

According to the U.S. Centers for Disease Control and Prevention (CDC), during week #45, 3.5% of patient visits reported were due to respiratory illness that included fever plus a cough or sore throat. 

As of November 17, 2023, the regions with the highest percentage of respiratory specimens testing positive for influenza were Regions 8 (7.4%), 4 (7.0%), 6 (6.5%) and 9 (5.3%).

For regional and state-level data and age group distribution, please visit FluView Interactive. 

From a severity perspective, the National Center for Health Statistics Mortality Surveillance confirmed that during week #44, 21 people died from influenza. 

Previously, influenza deaths were reported during weeks #43 (32) and #42 (43).

Furthermore, one influenza-associated pediatric death occurring during the 2023-2024 season has been reported to the CDC.

The CDC continues recommending most people over six months of age get an annual flu vaccine.

From an availability perspective, over 147 million flu vaccine doses have been distributed in the U.S. Various flu shots are available at clinics and pharmacies in the U.S.

PharmaJet® today announced the start of the first human clinical trial for a Venezuelan Equine Encephalitis (VEE) vaccine delivered with PharmaJet Precision Delivery Systems.

The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose, vaccination schedule, and delivery system most suitable for use in subsequent broader clinical evaluations of the VEE DNA vaccine candidate.

VEEV is a mosquito-borne alphavirus that has caused sporadic outbreaks and epidemics in North Central and South America. Aerosolized VEEV is highly infectious with greater mortality rates than natural infection and is listed as a potential biothreat agent with no approved human vaccine or therapeutic.

Disease outbreaks frequently involve equines– horses, donkeys, mules, zebras – and humans.

DNA vaccination has proven particularly effective at eliciting protective immune responses against the alphavirus challenge.

As previously reported, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and PharmaJet found, in a non-human primate challenge study, that a prime and single boost by either the intramuscular (Stratis) or intradermal route (Tropis) resulted in humoral and cellular immune responses that provided significant protection against VEEV disease and viremia.

These results paved the way for advancing the candidate vaccine into human trials and approval to proceed was recently granted by the Institutional Review Board (IRB), the Army's Office of Human Research Oversight, and the FDA.

President and CEO of PharmaJet, Chris Cappello, said in a press release, "The PharmaJet Precision Delivery Systems are optimized for field use and have also shown immunogenicity levels higher than with needle-syringe."

"We look forward to the clinical results from the human trial of this promising DNA vaccine candidate with our commercially available needle-free precision delivery systems."

The VEE DNA vaccine candidate is being evaluated as part of a multi-year agreement between PharmaJet and the Joint Science and Technology Office of the U.S. Defense Threat Reduction Agency.

The study, in collaboration with USAMRIID, aims to advance further the clinical assessment of the vaccine with the PharmaJet Precision Delivery Systems: Tropis Intradermal and Stratis Intramuscular.

PharmaJet Systems effectively delivers nucleic acid-based vaccines compatible with military operations and the warfighter environment, in addition to being preferred by end-users compared to other delivery technologies.

Longhorn Vaccines and Diagnostics today presented new data from an animal study of LHNVD-301, the company's lead tuberculosis (TB) vaccine candidate.

The data presented at The Union World Conference on Lung Health 2023 on November 15, 2023, showed that a mycobacterium tuberculosis (MTB) vaccine could generate broader protection against pathogens susceptible to antimicrobial resistance (AMR).

LHNVD-301 is an unconjugated, peptide-based vaccine that combines a MTB heat shock protein epitope and a peptidoglycan (PGN) epitope.

PGN is a cell wall component of bacteria that plays a vital role in infections.

The combination of heat shock protein and PGN generates broad reactive antibodies.

It represents a novel approach that combats AMR while targeting tuberculosis by combining multiple epitopes specific to MTB and common to gram-positive bacteria into a peptide vaccine.

Longhorn CEO Gerald W. Fischer, MD, commented in a press release, "We are developing LHNVD-301 to address MTB as a global threat and combat AMR."

"Unconjugated peptides targeting epitopes of multiple pathogens enable a cost-effective, easily scalable approach for vaccine development, which is crucial for covering those most at risk for TB."

While TB is an ancient disease, outbreaks caused an estimated 10.6 million infections and 1.3 million deaths in 192 countries and areas in 2022.

As of November 2023, 16 TB vaccines are available globally, and various BCG vaccine candidates are under development.

Nouscom recently announced the completion of its Series C equity financing, raising $72 million that will be used to continue advancing and expanding Nouscom's wholly-owned clinical pipeline to achieve multiple clinical value catalysts.

As of November 13, 2023, the funding proceeds will support the following initiatives:

Readout from Nouscom's ongoing randomized Phase 2 clinical trial for NOUS-209, an off-the-shelf vaccine targeting 209 shared neoantigens, in combination with pembrolizumab for the treatment of Mismatch Repair/Microsatellite Instable Metastatic Colorectal Cancer.

Final readout from the ongoing Phase 1b study and advancement of NOUS-209 monotherapy in Lynch Syndrome carriers investigating the potential to intercept, prevent, or delay cancer before it occurs. LS carriers have a genetic predisposition to and, consequently, a higher risk of developing certain cancers. Promising initial results from this study were reported on October 31, 2023.

Completion of a Phase 1b study evaluating NOUS-PEV, a personalized cancer immunotherapy, in combination with a checkpoint inhibitor in patients with advanced melanoma and entry into randomized Phase 2 trials in indications with high unmet medical needs.

Nouscom has also exclusively out-licensed VAC-85135, an off-the-shelf immunotherapy developed under a multi-project agreement, which is currently under evaluation in a Phase 1 clinical trial for the treatment of Myeloproliferative Neoplasms sponsored by Janssen Research & Development and Bristol Myers Squibb.

Dr. Marina Udier, Chief Executive Officer of Nouscom, commented in a press release, ".... This financing will allow us to further accelerate development across our wholly-owned clinical portfolio reporting multiple clinical trial readouts, including from our ongoing randomized Phase 2 clinical trial with NOUS-209."

"These Phase 2 data, if positive, have the potential to position Nouscom's neoantigen-based cancer vaccines amongst the most thrilling developments in the field."

According to a Review Article published by the journal Frontiers in Immunology in February 2023, Neoantigen vaccines are based on epitopes of antigenic parts of mutant proteins expressed in cancer cells. These highly immunogenic antigens may trigger the immune system to combat cancer cells. 

Precedence Statistics today announced the global virology market size reached $2.6 billion in 2022 and is projected to reach $4.26 billion by 2032, expanding at a CAGR of 5.10%.

The U.S. virology market reached $690 million in 2022 and is projected to expand at a CAGR of 5.20%, reaching around $1.14 billion by 2032.

The virology market encompasses the study, diagnosis, treatment, and prevention of viral infections. It includes research, pharmaceuticals, diagnostic tests, and vaccines related to viruses like HIV, influenza, and hepatitis, which is a significant driver for the growth of the virology market.

The rapid mutation rates of many viruses pose hurdles for drug and vaccine development, necessitating ongoing research and adaptability. 

The quest for effective vaccines to prevent viral diseases has also driven growth in this market. Government investments and public health initiatives have played a pivotal role in shaping the industry landscape.

The continuous evolution of vaccine technology, including mRNA and vector-based platforms, has broadened the scope of virology research.

Furthermore, the need for vaccine booster shots to combat emerging virus variants ensures a sustained demand for virology products.

Furthermore, the resumption of global travel contributes to the rapid spread of viruses, emphasizing the importance of virology in understanding, preventing, and managing infectious diseases worldwide.

Despite decades of efforts to control malaria outbreaks, there were over 24 million cases in 2021. The African Region continues to shoulder the heaviest malaria burden, comprising 95% of patients globally, reports to the World Health Organization (WHO).

Unfortunately, children are particularly vulnerable during malaria outbreaks, as nearly half a million African children die from malaria every year.

In October 2023, the WHO recommended the programmatic use of malaria vaccines to prevent P. falciparum malaria in children living in endemic areas.

According to Gavi, the Vaccine Alliance, the approved malaria vaccines are delivering positive results.

On November 7, 2023, Gavi confirmed in a news article that the Mosquirix™ (RTS,S/AS01) malaria vaccine reduced mortality from all causes by 13% in children in the age group eligible for vaccination.

In addition to the significant reduction in all-cause mortality, the vaccine was also responsible for a 22% reduction in hospitalization for severe clinical malaria in children eligible for the vaccine.

"This means.....more children are going to be saved from death in Africa," commented John Bawa, PATH Malaria Vaccine Implementation Lead for West Africa.

As of November 2023, the Mosquirix vaccine is available in African countries, including Malawi, Kenya, and Ghana. Eighteen countries across different African regions are set to receive millions of doses over the next few years.

The Mosquirix vaccine was created in 1987 as part of a collaboration between GlaxoSmithKline and the Walter Reed Army Institute of Research that began in 1984.

Alzamend Neuro, Inc. today announced that it has submitted an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for the initiation of AL001-PTSD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001, for treatment of patients with post-traumatic stress disorder (PTSD).

After receipt of a "study may proceed" communication from the FDA, Alzamend plans to initiate a Phase IIA study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in PTSD patients.

Alzamend anticipates that the new drug application ("NDA") development program for PTSD may, for safety, qualify for a 505(b)(2) NDA pathway to FDA approval, which can be available to new formulations of an approved drug.

"There are only two drugs approved by the FDA and currently available in generic form for PTSD patients," said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on November 13, 2023.

"Being able to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring (TDM) could positively impact the 9 million Americans afflicted with PTSD."

"We look forward to providing more details regarding the study's timeline and market opportunity in the near future."

Although lithium products do not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. In particular, treatment with low doses (300–600 mg/day) of lithium carbonate has been reported to provide effective treatment in the reduction of inappropriate anger, irritability, anxiety, and insomnia in those patients.

The clinical observation of mood swings beyond the normal range, but milder than those associated with BD, reportedly suggested the presence of a sub-threshold mood disorder in these PTSD patients.

It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD may be provided by pharmacological induction of mild transient amnesia.

Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option for BD but is underutilized, perhaps because of the need for TDM, that is, routine monitoring of lithium drug levels in blood to help assure safety and effectiveness.

Lithium was the first drug that required TDM by regulatory authorities in product labeling because the effective and safe range of therapeutic drug blood concentrations is narrow and well-defined for treating BD when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness.

AL001 is a novel lithium-delivery system that has the potential to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.

Results from Alzamend's recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer's patients and healthy subjects identified a maximum tolerated dose ("MTD") that an independent safety review committee vetted.

This MTD is designed to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts.

This MTD was assessed to be unlikely to require TDM.

PTSD is a mental and behavioral disorder that can develop because of exposure to a traumatic event, such as sexual assault, warfare, traffic collisions, child abuse, domestic violence, or other threats to a person's life.

According to the NIH, about 3.6%, or roughly 9 million, adults in the U.S. have PTSD in a given year, and 9% of people develop it at some point in their life.

Children may also experience very stressful events that affect their thoughts and feelings.

In much of the world, rates for a given year are between 0.5% and 1% of the population.

As of November 13, 2023, the FDA has not approved an Alzheimer's disease-related vaccine candidate.

NOte: On Dec. 11, 2023, the headline was updated.