Vaccine News

Tonix Pharmaceuticals Holding Corp. today announced that the National Institute of Allergy and Infectious Diseases (NIAID) will conduct a Phase 1 clinical trial with TNX-1800 (recombinant horsepox virus, live vaccine), expected to start in the second half of 2024.

The Phase 1 study involving TNX-1800 assesses safety and immunogenicity in approximately 60 healthy adult volunteers.

Tonix is developing a novel vaccine platform that, primarily by eliciting a T-cell immune response, will provide durable protection against severe disease and prevent forward transmission.

A related horsebox-based vaccine, TNX-8011, protected animals against challenge with monkeypox virus delivered directly into the lungs.

TNX-801 is also the vector on which TNX-1800 is based and has been shown to be >1,000-fold more attenuated than modern vaccinia virus vaccine (VACV) strains in immunocompromised mice.

Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, commented in a press release on November 2, 2023, "TNX-1800 will be the first vaccine candidate using our live virus recombinant pox virus (RPV) platform technology to enter clinical trials."

"We hope to expand the portfolio of RPV-based vaccines to address several other known respiratory threats, including smallpox, mpox and tuberculosis."

"We are committed to supporting NIAID in assembling a variety of vaccine platform options to ensure the availability of effective vaccines in the face of known and emerging threats."

"We look forward to participating in the Project NextGen initiative."

Project NextGen is an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines and therapeutics.

As of November 2023, mpox vaccines are U.S. FDA-approved and available in certain cities.

According to a study published in Sexually Transmitted Diseases, most study participants receiving mpox vaccination in Washington, DC, reported decreasing sexual behaviors associated with mpox virus transmission.

Overall, between 46%–61% of study participants reported a decrease in sexual behaviors associated with mpox.

In DC, over 41,000 mpox vaccinations have been administered since the global outbreak began in May 2022.

Published on October 26, 2023, the study was led by U.S. Centers for Disease Control and Prevention researchers and involved 711 adults seeking mpox vaccination from August to October 2022.

The median participant age was 32 years; 52% were White, 20.5% were Black, 14.6% were Hispanic, 7.9% were Asian, 2.0% were multiracial, and 0.3% were American Indian/Alaska Native.

And 9% had HIV.

Most of the study participants were men who had sex with men (61%), 27% were women, and 3.8% were men who had sex with only women.

According to D.C. Health, there have been 543 cumulative mpox cases, 24 hospitalizations, and 0 related fatalities since May 2022.

Mpox is a sexually transmitted disease that is often prevented with a U.S. FDA-approved vaccine.

Bavarian Nordic's JYNNEOS® (MVA-BN®, IMVAMUNE®) mpox-smallpox vaccine was offered in the U.S. during this study.

A study published by The Lancet Infectious Disease on October 11, 2023, attempted to answer questions regarding the durability and strength of protection following infection and JYNNEOS vaccination.

This analysis reported that people vaccinated with JYNNEOS frequently developed low or medium mpox-neutralizing antibodies compared to infected individuals.

As of October 31, 2023, the JYNNEOS vaccine remains available in key cities in the U.S.

YS Biopharma Co., Ltd. today announced the completion of enrollment in its Phase 3 clinical trial of the PIKA rabies vaccine. The clinical trial will include 4,500 subjects and assess the vaccine's safety, immunogenicity, and lot-to-lot consistency.

Previous Phase 1 and Phase 2 clinical trials of the PIKA Rabies Vaccine have demonstrated its safety and strong immunogenicity, with the PIKA Rabies Vaccine eliciting a detectable immune response in as quick as seven days.

Given these results, the PIKA Rabies Vaccine has the potential to achieve best-in-class accelerated protection and meet the World Health Organization (WHO) goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens.

The PIKA Rabies Vaccine utilizes YS Biopharma's proprietary PIKA adjuvant technology and is designed to produce a more robust immune response in a shorter time span than existing rabies vaccines.

As of October 31, 2023, there are several approved rabies vaccines available.

In a press release, Dr. Zenaida Mojares, Chief Medical Officer of YS Biopharma, commented, "We remain dedicated to leveraging our advanced PIKA adjuvant technology to enhance global health and well-being, and are thrilled to explore the near-term and long-term possibilities it offers."

According to the WHO, rabies has an almost 100% fatality rate upon emergence of clinical symptoms. Each year, it claims the lives of approximately 59,000 individuals in more than 150 countries.

Although rabies is typically lethal without treatment, the administration of post-exposure prophylaxis can effectively prevent fatalities when initiated following possible exposure.

According to the U.S. CDC, human rabies cases are rare in the United States, with only one to three reported annually.

Rabies virus is transmitted through direct contact with saliva or brain/nervous system tissue from an infected animal.

In the U.S., people usually get rabies from the bite of a rabid bat, not dogs.

Rabies vaccination is just one of several travel vaccines recommended when visiting at-risk countries, such as Haiti.

Blue Water Biotech, Inc. today issued the following shareholder letter from its CEO, Dr. Neil Campbell.

As of October 30, 2023, Blue Water's vaccine development initiatives highlighted separate indications, such as chlamydia, influenza, malaria, and mpox.

The CEO's letter is excerpted below:

As we close out October, the first month of my tenure, I want to take this opportunity to personally communicate with you while providing an update on the direction of Blue Water Biotech.

As part of the shift in business strategy and to enhance shareholder value, the Company will focus on building a foundation of therapeutic, diagnostic, and service products in oncology that will bolster and enrich clinicians' medical practices.

.... the Company has established early-stage preclinical and clinical programs in various vaccine technologies. These vaccine programs were targeting a wide number of diseases and conditions that would have consumed an enormous amount of Company resources.

Considering the evolving market dynamics and post-pandemic challenges, we conducted a strategic and tactical assessment, which led us to conclude that the optimal path for the Company lies in de-prioritizing the vaccine programs to focus our efforts on expanding our oncology offerings.

In summary, our business strategy shift aims to enhance shareholder value by establishing a strong foothold in both therapeutic and diagnostic aspects of oncology. 

The Company's SEC Report of unscheduled material events or corporate events on October 30, 2023, is linked here.

The U.S. Centers for Disease Control and Prevention (CDC) recently reported that fall 2023 respiratory hospitalization 'triple-demic' may not actually occur this year.

On October 26, 2023, the CDC stated it continues to anticipate that the upcoming fall and winter respiratory disease season will likely result in a similar number of hospitalizations as last season.

The CDC wrote .....We continue to have low-to-moderate confidence in this assessment due to uncertainties anticipating the timing and levels of peak disease activity. As of October 20, 2023, respiratory virus activity in the U.S. is low nationally.

Although COVID-19 activity continues to decline in many areas of the United States and globally, it remains the cause of most new respiratory virus hospitalizations and deaths.

Additionally, sustained increases in RSV activity in the southern U.S. indicate the start of the 2023-2024 RSV season, with the mid-Atlantic and Northeastern regions also experiencing elevated activity.

RSV activity remains in line with normal seasonal patterns before the emergence of the SARS-CoV-2 coronavirus.

Furthermore, influenza activity remains low in most areas of the country, but small increases were reported in some places.

According to recent influenza outbreak modeling by the Scenario Modeling Hub, influenza hospitalizations will likely fall within the range observed from 2010 – 2020.

The World Health Organization's (WHO) recent report indicates the CDC's revised forecast is on-target. On October 16, 2023, the WHO published Influenza Update N° 456, showing that influenza and RSV detections remained low globally.

According to the CDC, vaccination remains the best way to protect yourself and your loved ones against serious disease outcomes. As of October 30, 2023, various flu shots and other vaccines are generally available at health clinics and pharmacies in the U.S.

To mark World Polio Day on October 24, 2023, supporters from over 30 countries joined the Make Polio History campaign to tell governments that eradication is possible and urgently needed. 

According to the U.S. Centers for Disease Control and Prevention (CDC), there are thirty-one countries reporting polio cases in 2023.

The CDC says polio is a crippling and potentially deadly disease that affects the nervous system. Some people have only minor symptoms, such as fever, tiredness, nausea, headache, nasal congestion, sore throat, cough, stiffness in the neck and back, and pain in the arms and legs.

In rare cases, polio infection causes permanent loss of muscle function (paralysis). Polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain.

Countries are deploying an innovative, novel oral polio vaccine type 2 (nOPV2) to better address the evolving risk of type 2 circulating vaccine-derived poliovirus (cVDPV2).

The vaccine is a modified version of the type 2 monovalent OPV vaccine, which clinical trials have shown provides comparable protection against poliovirus while being more genetically stable and less likely to be associated with the emergence of cVDPV2 in low immunity settings.

Thus, nOPV2 can be a significant tool for more sustainably stopping polio outbreaks.

As of October 29, 2023, approximately 820 million doses of nOPV2 had been administered across 35 countries. An additional 16 countries have met the requirements for using nOPV2 in the event of a polio outbreak.

However, the nOPV2 is not authorized by the U.S. Food and Drug Administration.

Since 2000, the only polio vaccine used in the U.S. is the inactivated polio vaccine (IPV), which protects against severe disease, including paralysis. IPVs are generally available at clinics and pharmacies in the U.S.

While the World Health Organization (WHO) Influenza Update N° 456 says respiratory syncytial virus (RSV) activity was generally low or decreasing globally, new data indicates the United States is seeing measurable increases.

The U.S. Centers for Disease Control and Prevention (CDC) RSV detection graphs showed increases throughout the U.S. as of October 27, 2023.

The National Respiratory and Enteric Virus Surveillance System (NREVSS) reports that the weekly percentage of RSV polymerase chain reaction (PCR) test positivity was 10.9% as of October 21, 2023.

During the 2022–2023 RSV season, positive test results peaked in November.

From an age perspective, the Weekly Emergency Department Visits chart clearly indicates that the most affected by this RSV season have been children under one-year-old.

In 2022, the JAMA Network conducted an Original Investigation that found 96 (95% CI, 92-99) RSV deaths among children younger than one year. And a study published by the Journal of Infectious Diseases determined that RSV-related deaths in infants <1 year peaked at about one month.

Furthermore, a meta-analysis of eleven studies published in October 2023 found that the meta-estimate of RSV-positive tests among pregnant women was  3.4%  (95% CI: 1.9; 54).

According to the CDC, RSV has geographic trends in the U.S.

Florida's RSV season is longer than the rest of the country and has distinct regional patterns.

The Florida Department of Health reported as of week #42, October 21, 2023, RSV activity was increasing in hospital admissions and emergency room rates, with current outbreaks in Martin (1), Pinellas (2), and Volusia (1). 

Fortunately, for the first time, there are approved RSV vaccines and passive immunizations available in the U.S. this season.