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A biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases announced today that its clinical trial of Gedeptin® for patients with recurrent head and neck cancers is now actively enrolling patients at three major research centers in the U.S.

GeoVax Labs, Inc.'s phase 1/2 trial (NCT03754933) is evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options.

A recent phase 1 dose-ranging study evaluating the safety of a single cycle of Gedeptin therapy found the therapy well-tolerated, with evidence of a reduction in tumor size in patients with solid tumors.

David Dodd, GeoVax President and CEO, commented in a press release on February 7, 2023, "The support of the U.S. FDA and collaborations with Stanford, Emory, and Jefferson enable us to evaluate Gedeptin rapidly in 10 patients, with the potential to expand the trial to 25 patients subsequently."

"A successful outcome may lead to labeling discussions with the FDA and initiation of further Gedeptin investigations, including in combination with immune checkpoint inhibitors, for additional cancerous and non-cancerous tumor indications."

Most patients are diagnosed with locally advanced disease and treated with surgery, chemotherapy, and radiotherapy. About 50% of these patients will experience a recurrence of the disease.

The GeoVax study is partially funded by the FDA under its Orphan Products Clinical Trials Grants Program. 

The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of the mouth, salivary gland, and other oral cavities.

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National Cancer Inst. 2023.
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Mammals Infected With Highly Pathogenic Avian Influenza (HAPI) Virus

Mammals Infected With Highly Pathogenic Avian Influenza (HAPI) Virus

According to the U.S. Centers for Disease Control and Prevention (CDC) and the Department of Agriculture (USDA), mammalian infections with the highly pathogenic avian influenza (HAPI) virus will be a global concern in 2025. On January 6, 2025, the CDC stated that H5 bird flu is widespread in wild birds worldwide, causing outbreaks in wild birds, mammals, poultry, and dairy cows. Several recent human cases have been reported in U.S. dairy and poultry workers.

In addition, the World Health Organization (WHO) Technical report states that HAPI viruses (bird flu) are evolving, and various mammals are at risk. Furthermore, the U.K. Health Security Agency (UKHSA), World Organisation for Animal Health, the European CDC's Communicable Disease Threats Report, and the Pan American Health Organization (PAHO) have confirmed bears, cats, dogs, dolphins, ferrets, foxes, minks, penguins, sea lions, sea sealselephant seals, skunks, and other mammals had been infected with HAPI viruses.

On November 18, 2023, the CDC Emerging Infectious Diseases Volume 29, Number 12—December 2023, described the pathology of natural infection with highly pathogenic avian influenza A(H5N1) virus of Eurasian lineage Goose/Guangdong clade 2.3.4.4b in 50 red foxes (Vulpes vulpes), six striped skunks (Mephitis mephitis), four raccoons (Procyon lotor), two bobcats (Lynx rufus), 2 Virginia opossums (Didelphis virginiana), one coyote (Canis latrans), one fisher (Pekania pennanti), and 1 gray fox (Urocyon cinereoargenteus). This research confirmed that the genotype analysis indicates that the HAPI cases represent spillover infections from wild birds.

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Avian influenza H5N1 viruses have infected bears, cats, condors, dogs, dolphins, foxes, otters, raccoons, seals, sea lions, skunks.
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The Kaiser Family Foundation (KFF) Covid Vaccine Monitor announced today found 38% of people say their households were affected by this winter’s triple threat of respiratory viruses, with someone getting sick with influenza, COVID-19, or respiratory syncytial virus (RSV).

And 46% of the survey respondents say the news of these three viruses spreading has made them more likely to wear masks or take other precautions to avoid getting sick.

At the same time, 69% of the U.S. public says they are “not too” or “not at all” worried about getting seriously ill from COVID-19, though 31% still say they are worried.

That’s more than people say about the seasonal flu (26%) or RSV (25%).

The flu affected the largest share of households over the past month or so (27%).

With smaller shares saying someone in their homes got sick with COVID-19 (15%) or RSV (10%).

While various flu and COVID-18 vaccines are available in the U.S., RSV vaccine candidates have yet to be approved by the U.S. Food and Drug Administration in 2023.

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2023 KAISER FAMILY FOUNDATION
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Infant vaccination
Pertussis Incidence Decreases Following Maternal Vaccination
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On February 5, 2023, @Senasa_Peru tweeted that three dead sea lions and one dolphin had tested positive for the highly pathogenic avian influenza (HAPI) H5N1 virus. 

By November 30, 2022, HAPI had been reported in Ecuador and Peru related to about 14,000 pelican fatalities.

These reports indicate the ongoing HAPI outbreak has impacted numerous mammals throughout North and South America over the past year.

The USDA's Animal and Plant Health Inspection Service listing in 2023 includes about 110 H5N1 detections in skunks, bears, raccoons, and foxes confirmed in 2022.

USDA stated the Eurasian H5N1 strain initially appeared in North America in January 2022 and has affected 47 states, leading to the loss of over 58.2 million birds as of February 4, 2023.

As of February 2023, global surveillance data does not suggest widespread mammalian adaptation of the HAPI virus (low to moderate confidence), says the U.S. Centers for Disease Control and Prevention (CDC).

However, seven human infections in 2022 were related to the HAPI.

Should a HAPI crossover outbreak occur in people, the CDC says one approved bird flu vaccine is available in the U.S., but with distribution controlled by the government.

The Audenz™ monovalent, adjuvanted, cell-based inactivated influenza (H5N1) subunit vaccine was approved in 2020 to protect individuals six months of age and older in the event of bird flu pandemics.

Other bird flu vaccine candidates and monoclonal antibody treatments were funded in 2022 and are in development.

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Human papillomavirus (HPV) is a fundamental cause of various cancers, anogenital warts, and recurrent respiratory papillomatosis that vaccination can prevent.

Beginning in 2019, U.S. guidelines recommended shared clinical decision-making (SCDM) for HPV vaccination among adults aged 27–45.

Researchers recently conducted a narrative review of existing literature on HPV vaccination in this mid-adult population.

The Open Forum Infectious Diseases published this analysis on January 11, 2023, concluding the available evidence demonstrates that HPV vaccination in mid-adults is safe, efficacious, and likely to benefit both HPV-naïve mid-adults and those with previous infections.

These researchers found universal mid-adult HPV vaccination in the U.S. could avert 20,934–37,856 cancer cases over 100 years, costing $141,000–$1,471,000 per quality-adjusted life-year gained.

The wide variation in these estimates reflects uncertainties in sexual behavior, HPV natural history, and naturally acquired immunity.

'Greater awareness among clinicians and mid-adult patients and broad implementation of SCDM may accelerate progress toward eliminating HPV-associated cancers and other diseases,' wrote these researchers.

HPV vaccines are generally available at clinics and pharmacies in the U.S. during 2023.

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Qurient Co. Ltd. and TB Alliance recently announced that they have entered into a license agreement to develop and commercialize telacebec (Q203), a first-in-class orally available cytochrome bc1 inhibitor for treating tuberculosis (TB) and other non-tuberculosis mycobacterium infections.

The potent efficacy of telacebec against drug-sensitive and drug-resistant TB has been demonstrated in preclinical and clinical studies.

Telacebec was successfully tested in Phase 2a early bactericidal activity study for TB, and the results were published in the New England Journal of Medicine (March 2020).

Telacebec has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA.

Mel Spigelman, MD, President and CEO of TB Alliance, stated in a press release on February 3, 2023, "TB Alliance is excited to partner with Qurient to bring about the next generation of TB cures."

"New drugs like telacebec are urgently needed in the fight against TB as well as certain NTM infections – compounds with potentially impactful novel mechanisms of action can have a significant benefit in combating the TB pandemic. "

"If we expect to regain ground lost to COVID-19, we need to use every tool we have to give patients the best possible treatment and save lives."

"We look forward to advancing this new compound as part of combination regimens that could yield a short, simple, safe, and highly effective cure for all forms of TB."

Vaccines to prevent TB, such as the BCG vaccine, have been available for about 100 years and are generally available in most countries in 2023.

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Vaccines for coronaviruses, influenza viruses, and other respiratory viruses
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The state of Florida's Week#4 Arbovirus Surveillance report disclosed no new locally-acquired dengue cases had been confirmed in 2023.

However, there were 68 cases of locally acquired dengue last year.

And Florida confirmed on January 28, 2023, international travelers continue returning to Florida infected with dengue.

So far, in 2023, 14 travel-associated dengue fever cases have been reported.

Last year, 871 travel-associated dengue cases were reported in Florida.

Since most of these dengue cases have been found in south Florida, the Florida Department of Health in Miami-Dade County issued a mosquito-borne illness advisory during the summer of 2022.

The U.S. Centers for Disease Control and Prevention says dengue is a vaccine-preventable disease. However, dengue vaccination in the U.S. with Dengvaxia requires pre-administration testing and counseling.

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The Columbus City Health Department tweeted today that the current measles outbreak in central Ohio reached 42 days or two incubation periods since the last rash onset in a confirmed case.

This milestone fits the U.S. CDC's definition of the end of an outbreak; however, 'we still have test results pending for suspected cases.'

Measles outbreaks are declared when the number of cases reported in an area is higher than the expected number of cases.

Around 90% of people who are not protected will become infected following exposure to the measles virus. 

As of February 3, 2023, the City of Columbus, Ohio, reported 85 measles cases since the initial cases were reportedpotentially connectedthese most unvaccinated children had been hospitalized.

Throughout the U.S., the CDC has reported two measles cases in 2 jurisdictions in 2023.

One of these new measles cases was reported in Kentucky, with a potential connection to the Ohio outbreak.

In response, the Jefferson County Public Schools, located near Lousiville, Kentucky, began conducting measles vaccination clinics at schools for about 10,000 under-vaccinated students.

The CDC reported on January 13, 2023, nationally, the 2-dose MMR coverage was 93.5% during the 2020–2021 school year.

Measles vaccines are generally available at clinics and pharmacies in the U.S.

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Columbus Dept Health Feb. 4, 2023
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