Vaccine News

Dyadic International, Inc. today announced successful top-line results for the Phase 1 clinical trial of its recombinant protein RBD vaccine candidate, DYAI-100.

This marks the first-in-human use of a recombinant protein vaccine expressed by Dyadic's C1-cell expression platform.

"We are excited to share the top-line results from what we believe marks the first-in-human clinical trial for a vaccine antigen produced using a filamentous fungal cell line, such as our C1 platform," said Mark Emalfarb, CEO of Dyadic, in a press release on November 29, 2023.

"While vaccines and antibodies produced from our C1-cell protein production platform have previously demonstrated safety and efficacy in animal studies, this trial represents the initial evaluation of a C1-cell produced protein in humans and is a key milestone for the Company."

"Notably, no Serious Adverse Events were reported, and the clinical study successfully met its primary endpoint demonstrating that a C1-produced antigen was both safe and well-tolerated in both the low and high dose groups."

DYAI-100, also known as the C1-SARS-CoV-2 RBD vaccine, is a novel receptor-binding domain (RBD) recombinant protein booster vaccine candidate, highly expressed in Dyadic's proprietary C1-cell protein production platform for the prevention of COVID-19.

The C1-SARS-CoV-2 RBD vaccine candidate consists of the SARS-CoV-2 RBD adjuvanted with Alhydrogel 85® 2%.

Dyadic's gene expression and protein production platforms are based on the highly productive and scalable fungus  Thermothelomyces heterothallica (formerly Myceliophthora thermophila). 

Previously, the U.S. FDA conducted a digital workshop, "Next-Gen Vaccines without the right platform limit pandemic effectiveness," posted on YouTube.

China is confronting a wave of respiratory illnesses that have sparked conversations on social media, drawing attention to the pneumonia wave in the fourth week of November 2023, announced GlobalData.

On November 30, 2023, Shreyasee Majumder, Social Media Analyst at GlobalData, commented in a press release, "Influencers express varied opinions and concerns about the surge of respiratory illnesses in China.

Some influencers expressed concerns over overwhelmed hospitals, particularly those treating children, undiagnosed cases, and lack of data transparency.

Social media influencers also draw comparisons to recent pandemics, stressing the need for transparent information, global cooperation, and proactive public health strategies to address the evolving pneumonia challenge."

GlobalData's Social Media Analytics Platform captures a few influencer opinions, such as Annie Sparrow, Associate Professor Global Health Icahn School Medicine, who posted on X:

"It's concerning that @WHO's presser doesn't mention confirmed mycoplasma outbreak in South Korea. Mycoplasma is treatable, but there is no vaccine, and there are some indications that the pneumonia may be antimicrobial resistant."

CSL and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) approved ARCT-154, a self-amplifying Messenger RNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. 

The MHLW's approval was based on positive clinical data from several ARCT-154 studies, including an ongoing 16,000-subject efficacy study performed in Vietnam as well as a Phase 3 COVID-19 booster trial, which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparator.  

Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year.

"Today's approval marks a historic and exciting milestone as the first sa-mRNA vaccine in the world to be registered, and supports CSL's promise to protect global public health," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL, in a press release on November 27, 2023.

"We are committed to working with health authorities worldwide to ensure this important vaccine technology will be available to people at risk for COVID-19." 

mRNA vaccine technology protects against infectious diseases by instructing cells in the body to make a specific protein, stimulating the immune response, and leaving a blueprint to recognize and fight future infection, wrote the company. 

However, sa-mRNA makes copies of the mRNA which generates the production of more protein compared to an equivalent amount of mRNA in a vaccine. The technology can potentially create more potent cellular immune responses and increase the duration of protection while using considerably lower doses of mRNA. 

"Self-amplifying mRNA technology has the potential to be an enduring vaccine option," commented Nobel laureate Dr. Drew Weissman. "I look forward to seeing this next-generation mRNA technology protect many from COVID-19 and possibly other harmful infectious diseases."

CSL includes three businesses: CSL Behring, CSL Seqirus, and CSL Vifor. It provides lifesaving products to patients in more than 100 countries and employs 32,000 people.

The U.K. Health Security Agency (UKHSA) announced today that it has detected a confirmed human case of influenza A(H1N2)v, known as swine flu.

Influenza A(H1) viruses are enzootic in swine populations in most regions of the world. There have been a total of 50 human cases of influenza A(H1N2)v reported globally since 2005.

In August 2023, the U.S. confirmed a human infection with a novel influenza A(H1N2) variant virus in Michigan. 

This is the first Influenza A(H1N2)v detection of this flu strain in a human in the U.K. 

The individual concerned experienced a mild illness and has fully recovered.

The individual was tested by their G.P. after experiencing respiratory symptoms. Influenza A(H1N2)v virus was detected by UKHSA using polymerase chain reaction testing and characterized using genome sequencing. 

The source of their infection has not yet been ascertained and remains under investigation. Close contacts of the case are being followed up by UKHSA and partner organizations.

Any contacts will be offered testing as necessary and advised on any necessary further care if they have symptoms or test positive.

The case was detected as part of routine national flu surveillance undertaken by UKHSA and the Royal College of General Practitioners.

Chief Veterinary Officer Christine Middlemiss commented in a press release on November 27, 2023, "We know that some diseases of animals can be transferred to humans – which is why high standards of animal health, welfare, and biosecurity are so important."

"In this case, we are providing specialist veterinary and scientific knowledge to support the UKHSA investigation. Pig keepers must also report any suspicion of swine flu in their herds to their local vet immediately."

As of 2023, the U.S. FDA and the U.K have not approved a swine flu vaccine.

Recent research published in the Journal of Alzheimer's Disease shows following a pilot study for the treatment of pre-dementia and early Alzheimer's using a precision medicine protocol, ReCode.

ReCode uses precision medicine to personalize treatment for every patient based on test results and includes the BrainHQ training app, which is continually personalized for each user.

Results published on November 7, 2023, showed widespread improvement in cognitive performance under the globally recognized Montreal Cognitive Assessment measures.

Alzheimer's disease (AD) study participants also saw physical brain improvements in the brain imaging results that showed a trend toward renormalization to results typically seen in healthy older adults.

However, incorporating precision medicine approaches into everyday evaluation and care and future clinical trials would require fundamental changes in AD trial design, IRB considerations, funding considerations, laboratory evaluation, personalized treatment plans, treatment teams, and, ultimately, reimbursement guidelines.

Nonetheless, these researchers wrote that precision medicine approaches to AD, based on a novel model of AD pathophysiology, offer promise that has not been realized to date with traditional approaches.

In summary, the rationale for utilizing precision medicine protocols for treating patients with cognitive decline, or risk for decline, is based on the underlying mechanisms driving AD-related signaling and on promising initial results, supporting more extensive studies.

The implications for clinical practice, pharmaceutical candidate evaluation, and the societal burden of dementia are profound.

As of November 27, 2023, various AD vaccine candidates are conducting clinical studies.

According to the UK Health Security Agency's weekly influenza report, the 2023-2024 flu season vaccination rates vary across age groups.

As of November 23, 2023, the provisional proportion of people in England who have received the 2023 to 2024 influenza vaccine in targeted groups is as follows:

• 75.4% in all aged 65 years and over, and is higher compared to the equivalent week in the 2022 to 2023 season
• 36.8% in those aged under 65 years in a clinical risk group, and is lower compared to the equivalent week in the 2022 to 2023 season
• 37.9% in all aged two years, and is comparable to the equivalent week in the 2022 to 2023 season
• 28.2% in all pregnant women is comparable to the equivalent week in the 2022 to 2023 season.

For week #47, multiple indicators show that flu activity has remained stable and within baseline levels in England this week.

Influenza positivity remained stable at 1.8% in week #46 compared to 1.8% in the previous week.

Hospital admissions, including intensive care unit and high dependency unit admissions, remained within baseline levels this week.

Children under five years continue to have the highest hospital admissions, but this has decreased this week to a rate of 0.92 per 100,000 population.

Global flu season news as of November 27, 2023, is posted at Precision Vax.

In response to the ongoing Highly Pathogenic Avian Influenza (HPAI) outbreak in the western United States, ten vaccinated juvenile California condors will be released in the San Simeon mountains from November 28 to December 12, 2023.

The Condors were vaccinated with a killed, inactivated product conditionally licensed by the Center for Veterinary Biologics in 2016. The U.S. Fish and Wildlife Service has tested HAPI vaccine candidates on vultures in North Carolina for months.

This 'bird-flu' vaccine is designed to protect birds, not humans.

The U.S. government has already approved a bird flu vaccine for people and continues to invest in newer avian influenza vaccine candidates. 

On November 23, 2023, John Fitzrandolph reported for The San Luis Obispo Tribune that 21 condors died from HAPI infections in Arizona earlier in 2023. Currently, the total population of condors is estimated at 347 birds in the wild spread across California, Arizona, and Baja, Mexico.

The California Condor Recovery Program is an international multi-entity effort to recover the endangered California condor.was last updated in November 2023.

The program aims to take steps toward recovery by establishing two geographically distinct, self-sustaining populations, each with 150 birds in the wild and at least 15 breeding pairs, with a third population of condors retained in captivity.

California condors, members of the vulture family Cathartidae, are one of the largest flying birds in North America, with a wingspan of nearly 10 feet. 

In the wild, California condors may live up to 60 years. They mate for life and are attentive parents.

Avian influenza (Bird Flu) is a disease caused by influenza type A viruses that occur naturally among birds. The U.S. Centers for Disease Control and Prevention reported in June 2023, confirming the overall risk to human health associated with the ongoing HAPI outbreak in wild birds and poultry remains low.