Coronavirus Breaking News

During the initial months of 2023, millions of people were frustrated by the lack of herpes simplex virus (HSV) vaccine development news.

As of February 28, 2023, the U.S. Food and Drug Administration has not authorized any HSV vaccine.

While herpes-candidate vaccines have been conducting clinical research for years, recent messenger RNA (mRNA) technology announcements raised hopes in 2022

These mRNA herpes vaccines are being produced by industry leaders Moderna Inc. and BioNTech SE.

Moderna's herpes simplex virus (HSV) vaccine candidate (mRNA-1608) is an mRNA vaccine targeted against HSV-2 disease, focused on inducing a strong antibody response with neutralizing functionality combined with cell-mediated immunity.

However, mRNA-1608 has yet to launch a human-based phase 1 clinical study.

Based on BioNTech's mRNA platform, the BNT163 candidate vaccine encodes three HSV-2 glycoproteins to help prevent HSV cellular entry and spread and counteract the immunosuppressive properties of HSVs.

BNT163's phase 1 clinical study includes 108 participants and was recently updated on January 5, 2023, and has an Estimated Study Completion Date of June 2025.

Herpes is a sexually transmitted disease (STD), says the FDA. There are two types of HSV that can cause genital herpes: HSV-1 and HSV-2.

Most cases of recurrent genital herpes are caused by HSV-2, and 11.9% of persons aged 14–49 years are estimated to be infected in the U.S.

However, an increasing proportion of anogenital herpetic infections have been attributed to HSV-1, which is prominent among young women.

To increase transparency, the U.S. National Instuties of Health and its partners launched STI Watch, a portal containing updated information on vaccine development status. 

Other herpes vaccine news is posted at PrecisionVaccinations.com/Herpes.

Anixa Biosciences, Inc. today announced that the U.S. Patent and Trademark Office had issued a Notice of Allowance broadening the protection of Anixa's novel breast cancer vaccine technology. 

This technology was invented by the late Dr. Vincent Tuohy and developed at Cleveland Clinic, and Anixa is the exclusive worldwide licensee. 

Anixa's breast cancer vaccine candidate, currently in Phase 1 clinical trials, takes advantage of endogenously produced proteins that have a function at certain times in life but then become "retired" and disappear from the body. 

One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues but is present in most triple-negative breast cancers. 

Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. 

The vaccine candidate also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. 

Dr. Amit Kumar, Chairman and CEO of Anixa, commented in a press release on February 27, 2023, "This breast cancer vaccine has the potential to prevent Triple Negative Breast Cancer, the deadliest form of breast cancer, and perhaps other forms of breast cancer that express alpha-lactalbumin."

"In addition, with our partners at Cleveland Clinic, we .... plan to present data from the trial at the annual American Association for Cancer Research meeting in April (2023)."

One in eight women in the U.S. will be diagnosed with invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are Triple-Negative Breast Cancer.

The U.S. Centers for Disease Control and Prevention (CDC) recently concluded that reducing the number of persons traveling while infected with the SARS-CoV-2 virus could reduce associated transmission in airports, aircraft, and destination communities.

This CDC analysis published on February 24, 203, found post-arrival SARS-CoV-2 test results were 52% less likely to be positive when the predeparture COVID-19 testing requirement was in effect.

This finding was factual even when controlling for other factors, such as incidence in the flight’s country of origin and pool size.

Based on observed, real-world traveler data, these findings support the value of predeparture testing as a tool for reducing SARS-CoV-2 transmission associated with travel and were consistent with estimates from previous modeling studies.

The CDC continues to recommend testing before and after international travel.

Moderna, Inc. and Merck recently announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with high-risk melanoma following complete resection.

Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. 

The FDA granted Breakthrough Therapy Designation based on positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial.

"The FDA's Breakthrough Designation for mRNA-4157/V940 in combination with KEYTRUDA reflects the excitement that we have for the potential promise of individualized cancer treatments," said Stephen Hoge, M.D., Moderna's President, in a press release on February 22, 2023.

"mRNA-4157/V940 in combination with KEYTRUDA provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents a new frontier in treating melanoma and other cancers."

"We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities."

mRNA-4157/V940 is a novel investigational mRNA-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the patient's tumor. Upon administration into the body, the algorithmically derived and mRNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

The FDA's Breakthrough Therapy Designation is granted to expedite the development and review of drugs that are intended to treat a serious condition, and when preliminary clinical evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint.

This news is essential since the rates of melanoma have been rising over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.

In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths.

In Mozambique, an outbreak of cholera has been growing exponentially since December 2022. The World Health Organization (WHO) recently reported heavy rainfall in the first weeks of February 2023 threatens to further worsen the situation with geographic spread to new districts.

The WHO confirmed on February 23, 2023, the first case of cholera in the current outbreak was reported from the Lago district in Niassa province in mid-September 2022.

And as of February 19, 2023, a cumulative total of 5,237 suspected cholera cases and 37 deaths (Case Fatality Ratio (CFR) 0.7%) have been reported in 29 districts from six out of 11 provinces in the country.

The WHO considers the risk of further disease spread as very high at the national and regional levels. 

For example, the neighboring African country of Malawi is facing the deadliest cholera outbreak in its history.

A request for approximately 700,000 doses of Oral Cholera Vaccine was approved by the International Coordinating Group on Vaccine Provision, and a vaccination campaign in affected districts in Gaza, Niassa, Sofala, and Zambezia provinces is in preparation and will start in late February 2023.

Additionally, the U.S. CDC recommends people visiting Mozambique should be vaccinated against measles and polio in 2023.

These travel vaccines are generally available at certified travel; clinics and pharmacies in the U.S.

The U.S. Influenza Hospitalization Surveillance Network (FluSurv-NET) recently reported as of February 18, 2023, this flu season's weekly hospitalization rate was abnormal.

This week's cumulative hospitalization rate is the second-highest rate observed in week #7 during previous seasons, going back to 2010-2011, followed by the 2017-2018 season.

However, this in-season cumulative hospitalization rate is still lower than end-of-season hospitalization rates for five flu seasons going back to 2010-2011.

When examining rates among 2,485 hospitalized adults with information on underlying medical conditions, 96.7% had at least one reported underlying medical condition.

The most commonly reported were hypertension, cardiovascular disease, metabolic disorder, and obesity. 

Among 1,019 hospitalized children with information on underlying medical conditions, 65.6% had at least one reported underlying medical condition.

The most commonly reported condition was asthma, followed by neurologic disease and obesity.

Additionally, the CDC confirmed there has been 115 influenza-associated pediatric fatalities (about 30% were vaccinated) during the 2022-2023 flu season.

And a recent CDC analysis published on February 22, 2023, and in a related MMWR on February 24, 2023, stated 2022-2023 influenza vaccine preliminary effectiveness was about 68% protective of pediatric patients.

And it protected about 43% of adults against influenza-related hospitalization. 

Updated flu season news is posted at PrecisionVaccinations.

A new study conducted in Las Vegas suggests that when testing for the SARS-CoV-2 coronavirus, the results may actually overestimate the virus's local health risks.

The findings from an Original Investigation suggest the continual influx of tourists in vacation destinations may distort clinical testing relevance.

While wastewater surveillance is a valuable complement to clinical tools and can provide time-sensitive data for decision-makers and policymakers, this study represents a novel approach to quantifying the confounding effects of mobile populations on wastewater surveillance data.

Furthermore, the detection of SARS-CoV-2 RNA in wastewater does not indicate infectivity, so while a significant viral load may be contributed by visitors (>60% in this study), this does not necessarily prove that visitors are a significant contributor to local COVID-19 transmission. 

Researchers from the University of Nevada collaborated with the Southern Nevada Water Authority on the study published by the JAMA Network Open on February 23, 2023.

Note: This study's conclusions may apply to other tourist destinations such as Paris, Miami, New York, London. and Tokyo.