Austin

Pharmacy Information Systems Saved the Vaccine Industry

Donald Hackett — Mon, 26 May 2025 16:35:38 +0000

During the recent pandemic, hundreds of millions relied on overlooked technology platforms to access updated vaccination records and make informed decisions.

Over the past decade, Immunization Information Systems (IISs) have become essential public health tools across every state. These systems support clinical decision-making in clinics and pharmacies, helping to reduce both under- and over-vaccination.

According to a research article published by Expert Review of Vaccines on May 20, 2025, 36% of IISs operate nationally, 47.7% meet the U.S. CDC definition, and 17% are interoperable with personal health records.

And 11.7% provide direct access to vaccination data for vaccinees or their guardians.

Other key features include automated reminder systems for recipients and providers (12.1%), near real-time or real-time data entry (11%), the inclusion of demographic and socioeconomic data (16.7%), and the capacity to document vaccine refusal or hesitancy (10.2%).

These researchers say, 'IIS improves population-level surveillance of vaccine-preventable diseases. Persistent data standardization, interoperability, and cost-effectiveness evaluation limitations must be addressed.'

'Strengthening these aspects is crucial to fully harness the potential of IISs in various healthcare settings, where enhanced vaccination tracking and targeting are most urgently needed.'

In many ways, IISs are similar to SureScripts, which was founded in 2001 by CEO Kein Hutcheson and Kurt Proctor.

Today, this innovative platform enables doctors and pharmacists to exchange e-prescribing information seamlessly. About 27.2 billion network transactions have been processed.

Another platform has been the backbone of IIS for several decades.

STC Health has collaborated with the CDC to set the national standards for state immunization registries since 1993. Over the years, STC's national immunization data exchange network has 50,000 + pharmacies to all IIS and managed 1 billion immunization events during the pandemic.

In the second half of 2025, these systems will continue providing access to international travelers' clinical data, helping AI applications determine which travel vaccine is needed for their next destination.

For example, new vaccines such as Valneva SE's IXCHIQ® chikungunya vaccine are now recommended when visiting outbreak areas in the Indian Ocean and South America.

As the former U.S. Secretary General Dr. C. Everett Koop once said, with better health information, providers and patients can effectively collaborate to 'take charge of your health.'

Sub Title:

SureScripts, STC Health and Immunization Information Systems empower effective pharmacy clinical decisions

Reference:

Immunization information systems’ implementation and characteristics across the world: a systematic review of the literature

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by Gerd Altmann

Rabies Vaccine Airdrop Flights Launch in Texas in 2025

Karen McClorey Hackett — Fri, 03 Jan 2025 21:12:35 +0000

Reviewer:

Robert Carlson, MD

The Texas Department of State Health Services (DSHS) today announced the launching of the annual Oral Rabies Vaccination Program (ORVP) bait drop for animals on January 7, 2024.

The OVRP program for 2025 includes additional bait distribution areas in far West Texas, parts of El Paso County, and other counties bordering New Mexico. The geographic expansion is in response to a new Arizona fox rabies virus variant that has moved east and been confirmed in Sierra County, New Mexico.

ORVP is in its 31st year and has proven an effective defense against the spread of domestic dog/coyote rabies and the Texas gray fox variants.

Two rabies epizootics (large disease outbreaks in animals) involving coyotes and gray foxes began in 1988. The outbreaks involved the Texas fox rabies virus variant in gray fox populations in west/west-central Texas and the domestic dog-coyote rabies virus variant in coyote populations in south Texas.

No human rabies cases attributable to these variants have been identified since ORVP began.

"Texas has eliminated two canid rabies variants by using the Oral Rabies Vaccination Program," commented Kathy Parker, DSHS ORVP Director, in a press release on January 3, 2024.

"By moving the program to include far now West Texas, DSHS strives to protect the people and animals in that area."

Throughout the U.S., bites from bats, not dogs, cause most rabies infections in people.

During 2024, there were rabies-related fatalities reported by a resident of northern Kentucky and one in Merced County, California.

The oral rabies vaccines, enclosed in small, plastic packets that resemble fast-food ketchup packages, are dipped in fish oil and coated with fish-meal crumbles to attract targeted wildlife. They do not pose a threat to pets or other non-canine wildlife.

Before the rabies vaccination program began, Texas had experienced human deaths due to canine rabies, and many people had to receive postexposure rabies treatment following infection.

The first ORVP bait drop was held in 1995 in South Texas. In 1994, before the first airdrop, Texas had 122 animal cases of the domestic dog/coyote rabies variant.

The first vaccine airdrop targeting the fox variant was conducted in 1996 in West and Central Texas. There were 244 animal cases from this variant in 1995, but that dropped to zero cases by May 2009. A case of fox variant rabies was identified in a cow in 2013.

Still, no additional gray fox variant cases have been identified in Texas following expanded bait distribution in the following three years.

The annual project costs approximately $2.3 million and is funded by the State of Texas and the USDA Animal and Plant Health Inspection Service/Wildlife Services.

Rabies is a viral infection that causes brain and spinal cord inflammation. Globally, rabies is a vaccine-preventable viral disease found in more than 150 countries and territories, according to the World Health Organization.

Various rabies vaccines for people are available in 2025. In the U.S., Bavarian Nordic's RabAvert® vaccine is offered to people.

Sub Title:

West Texas Included in Oral Rabies Vaccination Program for Animals

References:

Texas DSHS’s Oral Rabies Vaccination Program expands bait distribution area

Texas ORVP project is at the national forefront of rabies control in terrestrial wildlife reservoirs

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Google Maps - Jan. 3, 2025

Herpes Vaccine Availability Is Aspirational in 2025

Karen McClorey Hackett — Wed, 25 Dec 2024 16:45:24 +0000

Reviewer:

Robert Carlson, MD

With about 20% of young adults infected with one of the herpes simplex viruses (HSV) in 2024, the World Health Organization (WHO) recently raised awareness of the related costs and vaccine candidate landscape.

On December 11, 2024, the WHO revealed that the Global Health Sector Strategy on HIV, viral hepatitis, and sexually transmitted infections for 2022-2030 highlighted the cost of genital herpes infections. The WHO reaffirmed that it is also working to advance research and develop new prevention tools, such as vaccines.

Dr. Meg Doherty, Director of Global HIV, Hepatitis, and Sexually Transmitted Infections Programs for the WHO, commented on December 11, 2024, "Better herpes prevention and treatment options are urgently needed to reduce transmission....."

WHO estimates that over 200 million people aged 15 to 49 suffered at least one such symptomatic episode in 2020. In addition to sores, genital herpes can, on occasion, lead to serious complications, including neonatal herpes.

Economic losses due to genital herpes infection can be significant when considering the lifelong nature of the disease. Furthermore, quality-of-life losses have been found to outweigh treatment spending and productivity reductions.

A study published in July 2024 showed that both genital HSV-2 ($31.2 billion) and HSV-1 ($4 billion) infection-related healthcare expenditures and productivity loss were estimated in 2016.

According to the U.S. CDC, HSV-1 often causes oral herpes, resulting in cold sores or fever blisters on or around the mouth. Most people with oral herpes get it during childhood or young adulthood from non-sexual contact with saliva.

Unfortunately, genital herpes has become common in the U.S. CDC estimates show there are over 500,000 new genital herpes infections annually.

Most of the time, herpes infections cause no or few symptoms. However, for some people, they lead to painful genital sores and blisters that can recur throughout life, causing significant discomfort and often requiring multiple healthcare visits.

Currently, there is no cure for herpes, although some OTC treatments can relieve symptoms.

Developing preventive and therapeutic HSV vaccines has been challenging for decades.

In 2024, the WHO published its preferred product characteristics for Alpha (α) herpesvirus vaccines and updated its pipeline review.

As of December 25, 2024, herpes vaccine candidates are based on DNA, Messenger RNA (mRNA), protein subunits, killed virus, and attenuated live virus vaccine technologies.

For example, Moderna Inc.' sInc.' vaccine candidate mRNA-1608 is an mRNA vaccine targeting HSV-2. A Phase 1/2, Randomized, Observer-Blind, Controlled, Dose-Ranging Study of mRNA-1608 indicates an estimated completion date of April 11, 2025.

Dr. Sami Gottlieb, Medical Officer within WHO's Sexual and Reproductive Health and Research, commented in a media release that "expanding research and investment in developing new herpes vaccines and therapies and their equitable use could play a critical role in improving the quality of life for people around the world."

As of" December 2024, the U.S. Food and Drug Administration, Brazil, Canada, China, Europe, India, Japan, and the U.K. had not authorized preventive or therapeutic herpes HSV-1 or HSV-2 vaccines. The WHO, the U.S. National Instuties of Health, and global partners launched STI Watch, a portal containing updated information on vaccine development status.

Sub Title:

Herpes vaccines could save $35 billion a year

References:

Estimated economic burden of genital herpes and HIV

20% of adults worldwide has a genital herpes infection - WHO

Estimated global and regional economic burden of genital herpes simplex virus infection among 15–49 year-olds

WHO - Global health sector strategies 2022-2030

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Spending on GH treatment, wage losses due to GH, HIV cases attributable to HSV-2, related ART spending, and QALY losses due to GH in 90 LMICs, by WHO region

Texas' Updated Respiratory Disease Dashboard Offers Real-Time Vaccination Insights

Donald Hackett — Mon, 09 Dec 2024 16:41:34 +0000

Reviewer:

Robert Carlson, MD

The Texas Department of State Health Services (DSHS) today announced that it has updated its Interactive Respiratory Disease Dashboard to include updated hospitalization reporting and more visual features.

DSHS's dashboard, launched in January 2024, also includes information on emergency department visits, fatalities from influenza, and other respiratory viruses and is accessible through the Texas Health Data website.

Texans and healthcare professionals can use the information to gain real-time, actionable insights, which is essential at this time of year. Last week, Texas influenza-like illness activity increased to 'moderate,' with some neighboring states, including Louisiana, reporting 'high' levels.

In addition to the dashboard, DSHS publishes a weekly Texas Respiratory Virus Surveillance Report with laboratory results, outpatient influenza-like illness surveillance, regional and county-level data, and more.

"These great tools help us show you what is happening regarding respiratory illnesses in your community with data and easy-to-follow visuals," said DSHS Chief State Epidemiologist Varun Shetty, MD, MBA, MS, in a media release on December 9, 2024.

"Our goal is to empower you with the information you need to stay safe this season."

The respiratory virus season traditionally runs from October to May, and DSHS recommends that Texans get immunized to protect themselves and their families from severe illness, hospitalization, and even death.

From an availability perspective, over 92 million flu shots have been distributed in the U.S., targeting the 2024-2025 flu season. These vaccines are generally available at health clinics and community pharmacies throughout Texas.

"With this new DSHS information, pharmacists on main-street can easily communicate the latest respiratory trends to their patients,' said Jeanne Waggener, Bachelor of Science in Pharmacy from the University of Texas at Austin and an Honorary Doctor of Pharmacy degree from the Oklahoma State Board of Pharmacy.

"These last weeks of December are the peak time for viruses to spread, especially with family and work celebrations bringing people together. It's essential everyone speaks with their pharmacist about medications and vaccine options," added Waggener.

Additionally, the U.S. CDC encourages international travelers to speak with a travel vaccine expert about vaccination options at least one month before traveling abroad for the winter holidays.

Sub Title:

Texas Respiratory Illness Interactive Dashboard

References:

Texas Respiratory Illness Interactive Dashboard

Texas Health officials update features and content on respiratory illness dashboard

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Texas Respiratory Illness Interactive Dashboard 2024

Texas Joins California, Florida, Others Reporting Local Dengue Cases

Karen McClorey Hackett — Tue, 26 Nov 2024 22:19:43 +0000

Reviewer:

Robert Carlson, MD

According to local health officials, the global dengue virus outbreak in 2024 has reached another U.S. state.

On November 25, 2024, the Texas Department of State Health Services (DSHS) reported the first locally acquired case of dengue virus in a Cameron County resident located in south Texas. As of today, there have been 106 travel-associated dengue cases, including one death reported in Texas.

Since 2013, 625 travel-related dengue cases have been reported, and 40 cases have been acquired in Cameron, Hidalgo, Starr, Val Verde, Webb, and Willacy counties.

This unfortunate activity may continue through 2024 as disease-carrying mosquitoes remain active in much of Texas into December.

"It is important for health care providers to consider a diagnosis of dengue virus and test for it if their patient has symptoms consistent with the disease," said DSHS Commissioner Jennifer Shuford, MD, MPH, in a press release.

While this DSHS news is unsettling, Texas ranks well behind other U.S. states and territories.

In California, the San Bernardino County Public Health Department recently reported a locally-acquired dengue case in San Bernardino. The Los Angeles County Department of Public Health has reported 12 locally acquired dengue cases in the San Gabriel Valley. And in San Diego, Escondido, and Visa reported local dengue cases in 2024.

As of November 23, 2024, the Florida Health Department reported over 803 travel-associated and 66 locally acquired dengue cases this year.

Throughout New York, including New York City, 301 dengue cases have been confirmed in 2024.

Furthermore, Puerto Rico's Department of Health confirmed dengue is endemic in the greater San Juan area, with 4,467 cases reported this year.

Dengue is a viral disease caused by any of the four related viruses: dengue virus 1, 2, 3, and 4, says the U.S. CDC. A person can be infected with dengue multiple times in their life.

Symptoms of dengue usually begin within 2 weeks of being bitten by an infected mosquito and typically last 2–7 days. Most people recover after about a week, but no specific medicine treats dengue.

From a prevention perspective, dengue vaccines are currently unavailable in the U.S.

Sub Title:

Dengue Vaccines are unavailable in the U.S.

References:

Texas public health officials announce first locally acquired case of dengue virus in 2024

US CDC Dengue 2024

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US CDC Dengue Map November 2024

Texas Leads This Year's West Nile Virus Outbreak

Karen McClorey Hackett — Mon, 02 Sep 2024 08:19:45 +0000

Reviewer:

Robert Carlson, MD

Recent media coverage has highlighted the rarely discussed mosquito-borne disease that is leading causes about 1 out of 150 infected people to develop a serious, sometimes fatal, illness.

Since the U.S. Centers for Disease Control and Prevention (CDC) first detected West Nile virus (WNV) in the United States in 1999, the annual number of reported cases has varied widely. WNV detections usually occur during the summer and extend into the fall season, especially in the southern states.

So far this year, about 464 West Nile cases have been reported in 33 states across the continental United States. In 2023, the CDC confirmed 2,566 WNV cases.

As of the end of August 2024, the state of Texas is the unfortunate leader this year, followed by Nebraska, Nevada, and California in the current ranking.

The Texas Department of State Health Services weekly report issued on August 29, 2024, confirmed 39 WNV cases and two related deaths this year. In 2023, Texas reported 90 cases and six deaths.

Most WNV cases in Texas have been reported near Dallas (19) and Houston (27).

The CDC says WNV cannot be transmitted from humans to humans with the disease. The dominant mode of transmission, by far, is through mosquito bites. Humans are also believed to be “dead-end hosts,” meaning that a mosquito that bites an infected human will not transmit the virus to another human.

However, there have been documented cases of transmission through blood transfusion, organ transplantation, and, rarely, from mother to baby during pregnancy and breastfeeding.

From a prevention perspective, Harris County Public Health’s Mosquito Control and Vector Control Division (MVCD) conducted an aerial spray operation in August 2024 to reduce the number of mosquitos.

“Harris County is experiencing an increase of WNV infection in mosquitoes and infections in humans. This situation has prompted the need to supplement the ongoing countywide Ultra Low Volume ground treatment with aerial treatment in the designated areas to protect the health of our community members better,” said Dr. Maximea Vigilant, MVCD Director, in a press release on August 9, 2024.

In Europe, WNV cases have been reported this year by Austria, Bulgaria, Croatia, France, Germany, Greece, Hungary, Italy, Romania, Spain, Albania, Serbia, and Kosovo.

Furthermore, while several veterinary vaccines have been licensed, WNV human vaccines have not progressed beyond phase 2 clinical trials.

In phase 2 trials, the ChimeriVax-WN02 live attenuated recombinant yellow fever vaccine strain expressing the premembrane and envelope genes had a good safety profile and immunogenicity after a single dose.

Several factors have hindered WNV vaccine candidates, deploying various technologies, such as live attenuated chimeric, DNA, recombinant subunit, and inactivated whole-virus vaccines, from progressing into phase 3 clinical development.

These challenges include implementing vaccine efficacy studies.

In April 2024, the CDC conducted a meeting with the primary purpose of informing the public of the 'next steps' toward the deployment of a human WNV vaccine.

Sub Title:

West Nile Virus vaccines for people are unavailable in 2024

References:

Texas DSHS WNV cases August 2024

US CDC WNV data as of August 27, 2024

Human West Nile Virus Vaccine Meeting and Request for Information

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Texas DSHS West Nile Virus Map September 2024

Texas Doubles Dengue Detections in One Month

Donald Hackett — Fri, 16 Aug 2024 19:14:50 +0000

Reviewer:

Robert Carlson, MD

While much of the United States has been spared from the dengue fever virus outbreak that is currently affecting the Region of the Americas, there has been a concerning increase in the number of cases in Texas.

According to the Texas Department of Health Services (DHSH), the number of imported dengue cases rose from ten on July 9, 2024, to twenty-seven in fifteen counties, led by Collin (5) and Travis (4) on August 13, 2024. There have not been any locally-transmitted dengue cases in Texas this year.

Today, the Harris County Health Department expressed concerns that the DHSH's data may be underreporting dengue cases this year. They informed Precision Vaccination News that clinics in the greater Houston, Texas, area rarely test patients for any of the four dengue virus types.

Harris County staff said that under-diagnosis is highly probable since dengue's symptoms are similar to those of influenza. It can take up to two weeks to develop, and the illness generally lasts less than a week.

Furthermore, based on disease reporting by Texas's southern neighbor, the increasing case trend in Mexico may continue throughout 2024 as the disease-carrying mosquitoes progress northward due to climate changes.

The Pan American Helath Organization's latest report indicates Mexico has confirmed over 164,000 dengue cases this year. In 2023, Mexico reported about 277,000 dengue cases.

Overall, 43 countries and territories in the Region reported more than 11.285,516 dengue cases and about 6,265 related deaths in 2024.

To alert travelers visiting thirteen countries in the Americas, including Mexico, the U.S. CDC reissued a Level 1 Travel Health Advisory in 2024. The advisory states that visiting these countries may increase one's risk of dengue.

From a prevention perspective, two dengue vaccines have been used globally, but neither vaccine is generally available in the U.S.

To meet increasing consumer demand, the second-generation QDENGA® vaccine from Takeda GmbH is now available in 22 countries without requiring pre-admission virus testing.

Additional outbreak news is posted at DengueNews.com.

Sub Title:

Dengue vaccine access is limited in Texas

Reference:

TDHSH dengue report - Aug. 13, 2024

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US CDC dengue travel alert map 2024

Funding for Phase Four Vaccine Studies Needed

Donald Hackett — Mon, 15 Jul 2024 18:21:08 +0000

Reviewer:

Robert Carlson, MD

While many people have recently learned about the clinical trial research process, most are unaware these studies are conducted according to a plan containing an essential fourth type of study: phase four.

These late-stage studies, often called post-marketing research, are conducted after the U.S. FDA has approved a vaccine or medication.

Clinical research leaders wrote a comprehensive Perspective, suggesting an innovative method for increasing the number of phase four studies.

The New England Journal of Medicine published the article VOL on July 6, 2024. 391 NO. 2—Funding Postauthorization Vaccine-Safety Science, which wrote, 'the United States benefits from a robust federal immunization program that has been successful in controlling and eliminating many diseases.

However, the widespread vaccine hesitancy observed during the recent pandemic suggests that the public is no longer satisfied with the traditional safety goal of simply detecting and quantifying the associated risks after a vaccine has been authorized.

The authors continued that post-authorization studies are needed to fully characterize the safety profile of a new vaccine since prelicensure clinical trials have limited sample sizes, follow-up durations, and population heterogeneity.

Post-authorization vaccine safety research requires adequate and timely funding directly linked to introducing new vaccines.

However, the U.S. CDC's vaccine safety monitoring budget has remained stagnant at about $20 million per year.

Although these resources have been used efficiently, this inadequate level of funding has adversely affected the speed and completeness of the science.

The unedited, complete Perspective is posted at this NEJM link.

These authors did not disclose industry conflicts of interest and were from the Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore; Emory University, Atlanta; the University of Pennsylvania, Philadelphia; and the Brighton Collaboration, Task Force for Global Health, Decatur, GA.

Sub Title:

Following authorization vaccine clinical research efforts continues

References:

NEJM - Funding Postauthorization Vaccine-Safety Science

US FDA Clinical Trial Basics

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by Pete Linforth

Second-Gen Passive Immunization Significantly Protects Infants from RSV

Karen McClorey Hackett — Thu, 11 Jul 2024 21:32:10 +0000

Reviewer:

Robert Carlson, MD

The New England Journal of Medicine recently published the results of a randomized controlled clinical trial that reaffirms the estimated effectiveness of Beyfortus™ (nirsevimab), a second-generation monoclonal antibody that reduces the risk of hospitalization for respiratory syncytial virus (RSV)- associated bronchiolitis in infants by 83%.

This finding is significant since RSV is the leading cause of bronchiolitis, resulting in about three million hospitalizations each year worldwide.

This study, funded by the National Agency for AIDS Research–Emerging Infectious Disease and others, included 1035 infants, of whom 690 were case patients (median age, 3.1 months; interquartile range, 1.8 to 5.3) and 345 were matched control patients (median age, 3.4 months; interquartile range, 1.6 to 5.6).

The effectiveness of a single-dose nirsevimab therapy against RSV-associated bronchiolitis resulting in critical care was 69.6% (95% CI, 42.9 to 83.8) (27 of 193 case-patients [14.0%] vs. 47 of 146 matched control patients [32.2%]).

And against RSV-associated bronchiolitis resulting in ventilatory support was 67.2% (95% CI, 38.6 to 82.5) (27 of 189 case-patients [14.3%] vs. 46 of 151 matched control patients [30.5%]).

The European Commission granted Beyfortus worldwide approval on November 4, 2022, followed by approvals from the U.K., Canada, and the U.S. FDA.

In the United States, among females with an infant <8 months, 41.3% reported that their infant received nirsevimab as of May 2024. For the 2024-2025 RSV season, Beyfortus's supply is expected to meet demand.

Sub Title:

Beyfortus a recombinant human immunoglobulin G1 kappa long-acting mAbs that binds to the prefusion conformation of the RSV F protein

References:

Nirsevimab and Hospitalization for RSV Bronchiolitis

Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis (ENVIE)

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Age Groups:

Infant

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Vaccination Can Reduce Gonorrhea Cases

Karen McClorey Hackett — Wed, 10 Jul 2024 10:26:11 +0000

Reviewer:

Robert Carlson, MD

The Journal of Infection recently published insights on how vaccination can reduce the incidence of gonorrhea, a common sexually transmitted disease. Gonorrhea is one of the fastest-growing diagnoses by percent change (16.8%).

This new study's findings indicate that MenB vaccines may offer moderate protection against gonococcal infections.

Published on July 8, 2024, this systematic review and meta-analysis assessed the effectiveness of 4CMenB and MenB-OMV vaccines for meningococcal vaccination against gonococcal infections across 12 studies conducted in countries including the United States, New Zealand, Canada, Cuba, Australia, and Norway.

Modeling studies have suggested that even a partially effective vaccine could reduce the population prevalence of gonococcal infections by 35–60% within ten years and decrease incidence by up to 25% over 70 years.

These findings emphasize the potential value of incorporating meningococcal vaccination into strategies to control gonococcal infections, particularly in regions with high incidence rates and limited treatment options due to antibiotic resistance.

However, further research is needed to ascertain the factors associated with vaccine protection and to provide more substantial evidence for cost-effectiveness analysis. This will inform vaccination strategies for the more effective management of gonococcal infections.

Furthermore, other countries besides the United Kingdom should consider 4CMenB vaccination programs for those at high risk of gonococcal infection.

In the U.S., GSK's Bexsero® (MenB-4C) vaccine was U.S. FDA-approved for intramuscular injection in 2015 for 10- through 25-year-olds to prevent meningococcal group B disease caused by Neisseria meningitidis bacteria. As of 2024, people between the ages of 16 and 23 can receive the Bexsero vaccine based on 'shared clinical decision-making.'

This literature search was conducted in PubMed, Embase, Cochrane Library, CINAHL, Google Scholar, clinical trial registries, and major health and immunization conferences.

A meta-analysis was performed with the DerSimonian-Laird random-effects model to estimate the pooled VE.

All study authors receive no personal payments from the industry. The authors declare the following financial interests/personal relationships that may be considered potential competing interests: Helen Marshall is an investigator on vaccine trials sponsored by iILiAD Biotechnologies, Pfizer, and Sanofi. Helen Marshall’s institution receives funding for investigator-led studies from industry, including GSK, Pfizer, and Sanofi Pasteur.

Sub Title:

Bexsero Meningitis B vaccine availability for young adults based on shared clinical decision-making

References:

Vaccine effectiveness and impact of meningococcal vaccines against gonococcal infections: A systematic review and meta-analysis

STD Diagnoses Rose 4.8 Percent from 2020 to 2023

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by Marcela

Parkinson's Prevention May Include Tetanus Vaccination

Karen McClorey Hackett — Sun, 23 Jun 2024 23:09:28 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

While no approved vaccines target Parkenson's disease (PD), several clinical pathways are being investigated with innovative technologies in 2024.

Different monoclonal antibodies have been investigated as passive immunization, and novel active immunization modalities targeting PD are being studied.

Recently, the findings of a non-peer-reviewed study reveal a significant reduction in PD occurrence following anti-tetanus vaccination, with a time-dependent association between the elapsed time since vaccination and the rate and progression of PD.

A large-scale observational study in Leumit Health Services in Israel selected 1,446 patients who received a PD diagnosis between the ages of 45 and 75,

This study found that 1.6% of those with PD had received the tetanus vaccine before their diagnosis, compared with 3.2% of those without. And no study participant developed PD within two years of being immunized.

This study's findings suggest that vaccination against tetanus neurotoxin (active or passive), possibly combined with treatments aimed at eradicating C. tetani from body reservoirs, could offer promising avenues to prevent PD occurrence and slow disease progression.

Most tetanus vaccinations performed in LHS in the cohort were with DT IMOVAX from Sanofi-Pasteur, with an adult dose of 0.5ml.

These researchers wrote on May 21, 2024, that these results are supported by evidence that antimicrobial treatments significantly alter disease severity, suggesting the actual involvement of Clostridium Tetani in PD pathology.

Additionally, these researchers wrote that further research should explore factors affecting C. tetani proliferation and colonization potential, particularly regarding medication, diet, food supplements, hygiene products, and lifestyle habits.

It strongly supports a large-scale prospective randomized controlled trial to test and validate the protective effect of anti-tetanus vaccination on PD progression in early and advanced stages of PD and in subjects at risk.

This study was funded internally by Leumit Health Services.

Seperately, Vaxxinity, Inc. announced in June and March 2024 positive clinical data from its randomized, double-blind, placebo-controlled Phase 1 clinical trial for its new therapy UB-312.

UB-312 is the first active immunotherapy candidate to show a reduction of pathological alpha-synuclein (aSyn) in PD patients' cerebrospinal fluid (CSF). UB-312 targets aggregated forms of aSyn, the toxic species that underlies PD and other synucleinopathies.

After a single priming regimen, those treated with UB-312 in the 300/100/100µg dosing group showed a 20% decrease from baseline in aggregated aSyn in the CSF compared to a 3% increase in the placebo group (p<0.05).

Further, a post hoc analysis showed that patients with detectable UB-312-induced antibodies in the CSF exhibited improvement in activities of daily living. These data also suggest a correlation between a reduction in aggregated aSyn in the brain and a change in MDS-UPDRS II (R=0.52, p=0.001).

The Michael J. Fox Foundation funded a two-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients and conduct exploratory research to assess target engagement.

These immunization strategies and other therapies may soon alter PD progression.

Sub Title:

UB-312 targets toxic forms of aggregated α-synuclein in the brain to fight Parkinson’s disease

References:

Anti-tetanus vaccination is associated with reduced occurrence and slower progression of Parkinson’s disease

UB-312 Phase 1 study

Parkinson’s Active Immunotherapy Medicine Phase 1 Study Positive Results

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MJFF June 2024

Innovative UTI Medication Needed for Children

Karen McClorey Hackett — Tue, 11 Jun 2024 21:12:33 +0000

Reviewer:

Robert Carlson, MD

A new analysis of emergency department (ED) visits for pediatric urinary tract infections (UTIs sheds light on antibiotic prescribing practices, as reported today in the journal Pediatrics.

Published on June 11, 2024, the Research Brief assessed changes in antibiotic prescribing at ED visits for pediatric UTIs from 2011 to 2020 using nationally representative data from the National Hospital Ambulatory Medical Care Survey. A total of 1,083 UTI visits by non-pregnant patients ages 18 and younger were included in the analysis.

Over the study period, trimethoprim-sulfamethoxazole prescriptions declined from 20.6% to 9.9% of visits, while the use of cephalosporins increased from 15.2% to 32.6% of visits, and the use of third-generation cephalosporins (e3GC) remained unchanged.

"Although e3GC use had increased previously, their prescription rate did not significantly change, perhaps reflecting appropriate use in areas with higher resistance," the authors wrote.

"Given their association with the development of resistance, ongoing monitoring and quality improvement will be important."

According to the U.S. CDC, UTIs are common infections in children caused by bacteria, often from the skin or rectum, entering the urethra and infecting the urinary tract. In high-income countries, UTIs affect up to 2.8% of children annually, with recurrence rates ranging from 8% to 30%.

Specifically, recurrent urinary tract infections (rUTIs) pose a significant health concern, particularly among young women. It is estimated that 11.3% of females develop at least one episode of UTI within the first 16 years of life.

A separate announcement today indicates that the next-generation RECCE® 327 intravenous and topical therapy is successfully advancing in phase 2 research. RECCE 327 is being developed to treat severe and potentially life-thretions caused by Gram-positive and Gram-negative bacteria.

Australia-based Recce Pharmaceuticals Limited reports it has completed the dosing of its latest cohort in its Phase I/II UTI/Urosepsis clinical trial, evaluating RECCE® 327 at fast infusion rates.

An Independent Safety Committee will review and evaluate the data, with preliminary results expected in mid-2024.

Data from this trial is expected to pave the way for a Phase II UTI/Urosepsis efficacy trial, potentially establishing R327 as a frontline treatment.

According to the Company, administering antibiotics through rapid intravenous infusions has proven to be a safe and effective method that significantly impacts patient treatment, reduces wait times, and alleviates nursing workloads worldwide.

Recce's Chief Executive Officer James Graham commented in a press release on June 11, 2024, "We have reached a new milestone in this trial by administering a 4,000mg dose over a fast 20-minute infusion to all subjects, the highest dosage achieved so far in this clinical trial."

"This is a significant step forward in bringing us closer to establishing R327 as a leading treatment for those suffering from UTI/Urosepsis."

The U.S. FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation, labeling it for Fast Track Designation.

From a prevention perspective, a restricted-access oral spray rUTI vaccine (Uromune™ MV140) is available in other countries in 2024, but not in the U.S.

Sub Title:

RECCE 327 fast dosing UTI medication advances in Phase 2 clinical research

References:

Emergency Department Antibiotic Prescribing for Pediatric Urinary Tract Infections

Cohort Dosing Complete Ph I/II UTI/Urosepsis Clinical Trial

Management of Pediatric Urinary Tract Infections

Image:

Age Groups:

Adolescent

Google News Keywords:

UTI, vaccinations

Featured:

Fact checked:

Wednesday, June 12, 2024 - 05:30

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by Thao Tang Van

$30 Million Brings Clinical Trials to Main Street

Donald Hackett — Tue, 11 Jun 2024 09:32:14 +0000

Reviewer:

Robert Carlson, MD

A Special Communication recently published by the JAMA Network stated that optimal healthcare delivery, both now and in the future, requires a continuous loop of knowledge generation, dissemination, and uptake on how best to provide care.

This perspective integrates determining what interventions work and how best to ensure they are provided to those who need them.

Most providers know that a randomized clinical trial (RCT) is the most rigorous instrument for determining what works in health care.

However, significant issues with the clinical trials enterprise and the lack of integration with healthcare delivery compromise medicine’s ability to best serve society.

Currently, healthcare delivery is a house divided, to the detriment of both and the detriment of society.

Repairing the division requires ethical and regulatory oversight changes, study design, data infrastructure, and incentive structures for stakeholders in both enterprises.

On June 3, 2024, these researchers wrote that solutions exist for Main Street providers to participate but have not been prioritized.

To address the opportunity, the National Institutes of Health (NIH) announced on June 6, 2024, that it is investing approximately $30 million between 2024 and 2025 to pilot a national primary care research network that integrates clinical research with community-based primary care.

The new initiative, Communities Advancing Research Equity for Health—or CARE for Health—seeks to improve access to RCT research to inform medical care, particularly for those in communities historically underrepresented in clinical research or underserved in health care.

NIH Director Monica M. Bertagnolli, M.D., laid out her vision for CARE for Health in a Science Editorial:

“Despite tremendous scientific progress, the health of important segments of the U.S. population is getting worse, not better,” said Dr. Bertagnolli.

“Health is dependent upon many factors. We recognize that environmental and societal factors are very important and that each community is unique.:

"Because of this, we must adapt our research to be more inclusive and more responsive to the needs of communities currently underserved in health research."

"Our vision for CARE for Health is to help primary care providers and their patients contribute to knowledge generation and to deliver evidence back to them to achieve better care.”

Participating clinical sites, such as pharmacies, can choose research studies based on health issues affecting and prioritizing their communities. Patients can contribute their data to research to generate results that are clinically meaningful to them.

Are you interested in receiving NIH program updates? Sign up for the NIH Common Fund’s CARE for Health email listserv to receive periodic updates on program planning and activities.

Sub Title:

Integrating Clinical Trials With the Practice of Medicine

References:

The Integration of Clinical Trials With the Practice of Medicine Repairing a House Divided

$30 million pilot to test feasibility of a national primary care research network

Image:

Google News Keywords:

health, vaccines, vaccinations

Featured:

Fact checked:

Tuesday, June 11, 2024 - 06:15

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US NIH June 2024

200 Long COVID Symptoms Could Last Years

Karen McClorey Hackett — Wed, 05 Jun 2024 20:18:22 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Since the COVID-19 pandemic began in late 2019, many people who contracted the SARS-CoV-2 coronavirus have been experiencing symptoms for extended periods, sometimes lasting for months or even years.

According to the Centers for Disease Control and Prevention, about 17% of Americans have experienced Long COVID.

Today, the National Academies of Sciences, Engineering, and Medicine released a new report to clarify which symptoms are associated with a Long COVID diagnosis.

This report highlights over 200 symptoms associated with Long COVID and states that a positive COVID-19 test is not required to diagnose the condition.

The new report published on June 5, 2024, says that some health effects of Long COVID, including chronic fatigue and post-exertional malaise, cognitive impairment (sometimes referred to as “brain fog”), and autonomic dysfunction, can impair an individual’s ability to work or attend school for six months to two years or more after COVID-19 infection.

It can be difficult to assess these health effects clinically or to determine their severity and impact on a person’s ability to function.

They also may not be captured in the Social Security Administration’s Listing of Impairments, which is used as an initial screening step in determining disability.

A more significant number of or more severe Long COVID symptoms are correlated with decreased quality of life, physical functioning, and ability to work or perform in school.

“Diagnosing, measuring, and treating Long COVID is complicated. This disease, which has existed in humans for less than five years, can present differently from person to person and can either resolve within weeks or persist for months or years,” said Paul Volberding, professor emeritus in the Department of Medicine at the University of California, San Francisco, and chair of the committee that wrote the report.

“Our report seeks to offer a clear summary of what research has found so far about diagnosing Long COVID, and what the disease can mean for an individual’s ability to function in their daily lives," said Volberding in a press release.

The report estimates that people whose infection was sufficiently severe to necessitate hospitalization are 2 to 3 times more likely to experience Long COVID than those who were not hospitalized.

Among individuals who were hospitalized, those requiring life support in an intensive care unit may be twice as likely to experience Long COVID.

However, people with mild disease can also develop Long COVID, and given the much higher number of people with mild versus severe disease, they make up the majority of people with Long COVID.

As of June 2024, no curative treatment or vaccine for Long COVID exists.

Management of the condition is based on current knowledge about treating its symptoms and health effects. As with other complex chronic health conditions, medical treatment for Long COVID is focused on managing symptoms and optimizing quality of life and function.

Recovery from Long COVID varies among individuals, and the data on recovery trajectories are rapidly evolving.

Based on recent U.S. CDC discussions, upgraded COVID-19 vaccines may alleviate some Long COVID infections in 2024-2025.

Undertaken by the Committee on the Long-Term Health Effects Stemming from COVID-19 and Implications for the Social Security Administration, the study was sponsored by the U.S. Social Security Administration.

Sub Title:

Long COVID diagnosis challenges healthcare providers

References:

National Academies of Sciences, Engineering, and Medicine

CDC Long COVID Household Pulse Survey

Long COVID Definitions and Models of Care

Image:

Google News Keywords:

vaccinations

Featured:

Fact checked:

Monday, June 10, 2024 - 21:45

Image Caption:

from Pixabay

Facebook's Fact Checkers Failed to Flag Gray Vaccine Information

Donald Hackett — Mon, 03 Jun 2024 19:29:39 +0000

Reviewer:

Robert Carlson, MD

A recently published study by Science shows that unflagged, factual, but misleading Facebook posts reduced the intent to receive a vaccine 46 times more than false posts flagged by fact-checkers as misinformation.

The Massachusetts Institute of Technology and the University of Pennsylvania researchers introduced a method combining crowdsourcing, machine learning, and large-scale observational data for estimating the causal effect of social media on societal outcomes. They surveyed thousands about the influence of headlines from vaccine-related news stories on their intent to vaccinate.

Announced on May 31, 2024, they found that the impact of flagrant vaccine misinformation on Facebook was significantly attenuated once third-party fact-checkers flagged and debunked such posts as false.

However, ambiguous misinformation remained unflagged as this 'gray' area eluded fact-checkers..... factually accurate but deceptive content.

This unflagged content cast doubts on vaccine safety or efficacy and was more consequential for driving vaccine hesitancy than flagged misinformation.

They found that flagged misinformation causally lowers vaccination intentions, conditional on exposure.

Specifically, given the comparatively low exposure rates, this content had much less of a role in driving overall vaccine hesitancy compared with vaccine-skeptical content, much of it from mainstream outlets that were not flagged by fact-checkers.

These researchers concluded that the only content dimension that consistently predicted a headline's impact on vaccination intentions was the extent to which the headline suggested that the vaccine was harmful to the people.

This review suggests that while limiting the spread of misinformation has significant public health benefits, it is also critically important to consider gray-area content that is factually accurate but misleading.

Companies like Facebook assert that First Amendment free speech rights must protect unflagged content.

Furthermore, X, formerly known as Twitter, has deployed an innovative solution to fact-checker effectiveness.

A Research Letter published in JAMA on April 24, 2024, led by John W. Ayers, Ph.D., from the Qualcomm Institute within UC San Diego, finds that X''s Community Notes helped counter false vaccine information with accurate, credible responses.

"Since the World Health Organization declared vaccine misinformation a risk, there have been surprisingly few achievements to celebrate," said Ayers in a press release.

"X Community Notes have emerged as an innovative solution, pushing back with accurate and credible health information."

Traditionally, the most trusted vaccine information came from healthcare providers.

Regarding the most trusted healthcare providers, doctors and pharmacists are at the top of the list. During the recent pandemic, these main-street professionals played a crucial role in scaling up vaccinations throughout the U.S.

Sub Title:

Community Notes successfully confronts vaccine misinformation

Reference:

Quantifying the impact of misinformation and vaccine-skeptical content on Facebook

Image:

Google News Keywords:

health, vaccines, vaccinations

Featured:

Fact checked:

Tuesday, June 4, 2024 - 06:45

Image Caption:

Impact of flagged misinformation versus unflagged content 2024