Zika Breaking News

Oct 31, 2023 • 4:42 am CDT

GSK Leads RSV Vaccine Marketing Competition

by Annette P.

According to Reuters, the new respiratory syncytial virus (RSV) vaccine's usage has surged since its launch in the summer of 2023.

According to IQVIA data seen by Reuters, as of October 30, 2023, GlaxoSmithKline Biologicals (GSK) AREXVY™ RSV vaccine accounts for about two-thirds of RSV immunizations delivered to adults aged 60 years in the United States.

GSK's market advantage could be related to its relationship with CVS Health, the dominant pharmacy chain in the U.S.

In Canada, which approved AREXVY on August 4, 2023, RSV vaccine awareness is leveraging a hockey superstar's endorsement.

"The Arexvy ad featuring Wayne Gretzky aims to dispel the misperception that RSV is only a concern for young children and encourages adults aged 60 and older, who are among those at greater risk, to speak to their healthcare provider about RSV prevention, including the Arexvy vaccine," a GSK spokesperson told Fierce Pharma Marketing yesterday.

In Europe, the European Commission authorized AREXVY in June 2023, followed by the U.K.'s Medicines and Healthcare products Regulatory Agency in July 2023.

On July 26, 2023, GSK estimated that nearly 80 million adults in the U.S. could receive an RSV shot for the first time.

On October 31, 2023, Pfizer Inc. reported U.S. revenues from its RSV vaccine ABRYSVO™, which contributed $375 million since May 2023.

RSV vaccine uptake is influenced by the impact on adults during each RSV season.

The World Health Organization Influenza Update N° 456, published in October 2023, reported early signs of RSV activity in parts of the European region.

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Oct 30, 2023 • 5:43 pm CDT

Cincinnati Company Abandons Vaccine Development Efforts

from Pixabay

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.

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Oct 30, 2023 • 4:20 pm CDT

Countermeasures Against Antimicrobial Resistance Include Flu Shots

by Jason Goh

The Journal of Antimicrobial Chemotherapy recently published a study that suggests that influenza vaccinations are associated with less unnecessary antibiotic use in people over 65.

On October 28, 2023, these researchers concluded that seasonal flu shots might be a countermeasure against antimicrobial resistance (AMR) because they can reduce unnecessary antimicrobial use for acute respiratory infection by mitigating the burden of such diseases.

In total, 244,642 people were enrolled in this study in Tokyo, Japan.

The average treatment effect of vaccination was:

−0.004 (95% CI −0.006 to −0.002) for the frequency of antibiotic prescription,

−0.005 (−0.007 to −0.004) for the frequency of healthcare facility consultation,

−0.001 (−0.002 to −0.001) for the risk of admission and

- 0.00 (0.00 to 0.00) for the risk of death.

Our results suggest that the seasonal influenza vaccine might have indirect benefits for not only preventing influenza-like illnesses but also as a countermeasure against AMR, wrote these researchers.

However, because we included only an older population, we cannot know whether a similar effect would be seen if children or young adults were the target population for the vaccine.

Globally, AMR is one of the leading causes of death.

The World Health Organization says that AMR happens when microorganisms, such as bacteria, fungi, viruses, and parasites, change when exposed to antimicrobial drugs, such as antibiotics, antifungals, antivirals, antimalarials, and anthelmintics.

On October 19, 2023, the WHO released 13 interventions to guide country prioritization when developing, implementing, and monitoring national action plans on AMR.

These interventions address the needs and barriers people and patients face when accessing health services through a people-centered approach to AMR.

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Oct 30, 2023 • 10:46 am CDT

Unlikely Triple-Epidemic in 2023 Says US CDC

US CDC respiratory disease forecast October 26, 2023

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.

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Oct 30, 2023 • 5:05 am CDT

Needle-Free Polio Immunization Study Launches

Tropis Needle-free System 2023

PharmaJet® recently announced the implementation of a study in Nigeria to evaluate the impact of intradermal vaccine administration of fractional inactivated poliovirus vaccine (fIPV) using their Tropis® ID Needle-free Injection System (NFIS).

Announced on October 24, 2023, the study, in collaboration with the National Primary Health Care Development Agency, Jhpiego, PATH, and the Sydani Group, is assessing coverage rates and potential cost reductions associated with using Tropis for fIPV delivery as compared to the current standard of intramuscular delivery of full dose IPV using needle and syringe.

Partners are also evaluating the acceptability and feasibility of using needle-free from the healthcare worker and caregiver perspective.

The study will run through January 2024, with children at 22 urban and rural health facilities receiving fIPV with Tropis. Evidence from the study is intended to inform policy regarding intradermal delivery of polio vaccine in routine immunization settings.

Paul LaBarre, Vice President of Global Business Development, PharmaJet, commented in a press release, “This (effort) builds on our experience in Pakistan where Tropis has been demonstrated to increase coverage rates. Including additional campaigns in Somalia, we have provided more than 10 million syringes for polio immunization programs."

"On this World Polio Day 2023, we restate our commitment to the Global Polio Eradication Initiative.”

As of October 30, 2023, the U.S. CDC confirms over thirty countries have reported polio outbreaks in the past year.

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Oct 29, 2023 • 1:32 pm CDT

820 Million Novel Polio Vaccinations Completed

GPEI polio case map 2023

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.

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Oct 28, 2023 • 12:13 pm CDT

New Tuberculosis Vaccines are Coming

From Pixabay

Tuberculosis (TB) is not only the world's biggest infectious killer, but it also destroys families and livelihoods. Besides the fear of dying from the disease, in many communities, a diagnosis can sentence someone to social isolation, wrote Linda Geddes in an article published by Gavi, the Vaccine Alliance, on October 24, 2023.

While the Bacillus Calmette–Guérin (BCG) vaccine provides significant protection against TB disease in infants and young children, new vaccines that block infection and prevent TB disease are urgently needed.

More than 100 years have passed since the first administration of the BCG vaccine; hopes are building that a vaccine that could protect all age groups against all types of TB may finally be in reach.

Fortunately, several TB vaccine candidates are now in late-stage clinical trials, raising hopes that an affordable and effective vaccine may soon be within reach.

Today's BCG vaccines are based on different attenuated strains of M. bovis.

These BCG vaccines are recommended for newborns in countries with a high burden of TB.

TB vaccines are among the most widely used, reaching more than 80% of infants in countries where the BCG vaccine is included in routine childhood immunisation programs.

In the United States, vaccinations with the TICE® BCG version are limited and generally offered to children in areas experiencing community spreading of TB.

The U.S. CDC reported in March 2023 that TB cases increased by 5% in 2022, with 8,300 confirmed cases. In addition, about 13 million people live with latent TB infection in the U.S.

Recent data indicates TB rates are accelerating by double digits in certain Texas areas (Dallas, Hidalgo County, Houston, San Antonio) in 2023.

Gedde's full, unedited article is posted at this link.

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Oct 28, 2023 • 11:03 am CDT

RSV Season Begins to Spike

US CDC Weekly Emergency Department Visits by Age Group and Respiratory Illness October 21, 2023

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.

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Oct 27, 2023 • 4:21 pm CDT

Pneumonia Deaths Surpass Influenza and COVID-19

CDC pneumonia, influenza, and COVID-19 weekly summary October 27, 2023

The U.S. National Center for Health Statistics (NCHS) Mortality Surveillance reported on October 27, 2023, that most respiratory disease deaths last week were related to pneumonia, not COVID-19 or influenza.

During week #42, the NCHS reported 1,379 pneumonia deaths, compared with 637 COVID-19 and 20 influenza.

While these diseases have U.S. FDA-approved vaccines available in 2023, preventing pneumonia deaths is more complicated, as viruses, bacteria, and fungi can all cause pneumonia.

According to the U.S. CDC, pneumonia is an infection of the lungs that can cause mild to severe illness in people of all ages.

Globally, pneumonia claimed the lives of 2.5 million people, including 672,000 children, in 2019 alone.

Vaccines can help prevent most pneumonia cases caused by pneumococcus bacteria, SARS-CoV-2, or influenza viruses.

These immunizations include

COVID-19
Haemophilus influenzae type b
Influenza
Measles
Pertussis
Pneumococcal
Respiratory syncytial virus
Varicella

According to the CDC, these immunizations are safe and may be coadministered. But side effects can occur which are usually mild and go away on their own within a few days.

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

Note: The NCHS data presented on October 27, 2023, are preliminary and may change as more data are received and processed.

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Oct 27, 2023 • 1:26 pm CDT

Phase 3 Study of Influenza and COVID-19 Combination Vaccine Launches

from Pixabay

Moderna, Inc. recently announced that the first participant has been dosed in a Phase 3 study of the Company's combination vaccine candidate against influenza and COVID-19 (mRNA-1083) in the U.S.

As of October 24, 2023, the Phase 3 study is expected to enroll approximately 8,000 adults and will evaluate the immunogenicity, safety, and reactogenicity of mRNA‐1083 as compared with active control, co‐administered licensed influenza and SAR‐CoV‐2 vaccines in two independent age‐group sub‐study cohorts.

The mRNA-1083 candidate selected to advance to Phase 3 achieved hemagglutination inhibition antibody titers similar to or greater than those of both licensed quadrivalent influenza vaccines and SARS-CoV-2 neutralizing antibody titers similar to those of the Spikevax bivalent booster in the Phase 1/2 study.

mRNA‐1083 has the potential to efficiently reduce the overall burden of acute viral respiratory diseases by providing simultaneous protection against influenza and SARS‐CoV‐2 viruses in a single injection.

mRNA‐1083 offers greater convenience and has the potential to lead to increased compliance with vaccine recommendations.

This approach could benefit public health by synergistically increasing coverage rates against influenza and SARS‐CoV‐2 viruses.

The Company continues to target a potential initial regulatory approval for the combination vaccine in 2025.

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Oct 27, 2023 • 1:10 pm CDT

Vaccine Candidate Shows Robust Immune Response Against the Aβ40 Peptide in Early-Stage Alzheimer's Patients

by Ben Kerckx

Araclon Biotech recently announced encouraging final results from its Phase 2 clinical trial of ABvac40, an active vaccine against the Aβ40 peptide, for treating patients with early-stage Alzheimer's disease (AD).

The results show that ABvac40 had a favorable safety profile, elicited a robust immune response against Aβ40, and demonstrated some potential cognitive benefits in early-stage AD patients.

The vaccine candidate met the primary endpoints and showed differences between the vaccine- and placebo-treated groups in some secondary exploratory endpoints.

ABvac40 is uniquely designed to target the C-terminal end of the Aβ40 peptide.

Thus, it is believed to prevent harmful reactions and avoid immune triggers responsible for meningoencephalitis, a complication observed in earlier AD vaccines.

Emerging research suggests that Αβ40 plays a role in cerebral amyloid angiopathy, a highly prevalent condition among the growing number of AD patients.

Notably, although the clinical trial was not powered for finding efficacy on neuropsychological scales, the ABvac40-treated group exhibited as much as a 38% reduction in disease progression, as reflected by the Mini-Mental State Examination score, suggesting ABvac40's potential efficacy in addressing the cognitive decline associated with AD.

Other neuropsychological tests, such as the Repeatable Battery for the Assessment of Neuropsychological Status and the Trial Making Test, showed favorable results on ABvac40 compared to the placebo group.

Global or functional scales did not show differences between the ABvac40 and placebo groups. In addition, volumetric magnetic resonance imaging showed a lesser increase in whole-brain atrophy in the ABvac40 group compared to the placebo group.

"We are pleased to report final positive results from the Phase 2 study of ABvac40, including a robust immune response with some significant reduction in disease progression, all with a favorable safety profile," said Jose Terencio, Ph.D., Araclon chief executive officer and vice president of Grifols Innovation and New Technologies, in a press release on October 25, 2023.

"Previous vaccines in development for AD faced setbacks due to harmful meningoencephalitis side effects."

"The results reported for ABvac40 to date validate its clinical potential, positioning it as a promising therapeutic candidate for early AD treatment. We look forward to evaluating the next steps for this program."

As of October 27, 2023, the U.S. FDA has not approved a vaccine targeting AD.

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Oct 26, 2023 • 11:25 am CDT

Influenza and mRNA COVID-19 Vaccine Combo Posts Positive Topline Data

from Pixabay

Pfizer Inc. and BioNTech SE today announced positive topline results from a Phase 1/2 clinical study evaluating the safety, tolerability, and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults.

The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.

The topline results of the ongoing trial demonstrated that the combination formulations evaluated had a safety profile consistent with the safety profile of the companies' COVID-19 vaccine.

In the Phase 1/2 clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit.

A pivotal Phase 3 trial evaluating these lead formulations is expected to be initiated in the coming months.

"Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases. Co-infections and consecutive respiratory infection during this period can further increase the risk of severe illness," said Prof. Ugur Sahin, MD, CEO and Co-founder of BioNTech, in a press release on October 26, 2023.

"Combination vaccines have the potential to become a mainstay of routine vaccination against respiratory diseases, especially for the vaccination of populations with a higher risk of severe illness."

Immunogenicity results induced by lead formulations in the companies' phase 1/2 trial showed point estimates for Geometric Mean Titer (GMT) ratios consistent with the criteria applied to regulatory-approved vaccines against the respective influenza and SARS-CoV-2 strains.

Point estimates for GMT ratios for all matched influenza vaccine strains with lead formulations were >1 relative to a licensed Quadrivalent Influenza Vaccine given concomitantly with the Pfizer-BioNTech COVID-19 vaccine.

Pfizer and BioNTech previously announced that their mRNA-based combination vaccine candidate for influenza and COVID-19 received Fast Track Designation from the U.S. Food and Drug Administration.

For the 2023-2024 flu season in the U.S., 136.94 million influenza vaccine doses had been distributed as of October 14, 2023.

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Oct 26, 2023 • 10:02 am CDT

Mpox Vaccine Receives Recommendation for Routine Use in Adults at Risk

by Consulta Fit

Bavarian Nordic A/S today announced the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the routine use of JYNNEOS® (MVA-BN®), the Company’s U.S. FDA-approved mpox / smallpox vaccine.

Specifically, the ACIP voted to recommend that individuals 18 years and older with certain risk factors receive the two-dose JYNNEOS regimen, a live, nonreplicating vaccine.

Previously, the ACIP had recommended JYNNEOS for individuals at risk during a mpox outbreak.

This represents the second national recommendation for Bavarian Nordic’s mpox vaccine in adult risk groups following a similar endorsement by the Standing Committee for Vaccination in Germany in 2022.

More recently, the European AIDS Clinical Society also recommended using the vaccine for adults infected with HIV or on pre-exposure prophylaxis treatment, which may support additional national recommendations for future vaccine use.

“Since the outbreak of mpox last year (May 2022), Bavarian Nordic has supplied millions of doses of our vaccine to more than 70 countries worldwide,” said Paul Chaplin, President and CEO of Bavarian Nordic, in a press release on October 25, 2023.

The CDC estimates that 2 million U.S. individuals are eligible for a vaccination against mpox under this recommendation.

To date, approximately 23% of this group has received the recommended two doses of JYNNEOS, leaving a significant number of people vulnerable to infection with mpox.

The ACIP reported in October 2023 JYNNEOS Vaccine Effectiveness against mpox ranges from 36% to 75% for 1-dose vaccination and 66% to 89% for 2-dose vaccination.

Pending approval of the updated recommendations, Bavarian Nordic is targeting a commercial launch of JYNNEOS in the U.S. in the first half of 2024.

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Oct 26, 2023 • 9:43 am CDT

Convalescent Plasma Reduced COVID-19 Mortality by 10%

by Jorge Gonzalez

In a study published in The New England Journal of Medicine, clinicians and researchers show that passive immunization by administering plasma taken from convalescent donors after infection with the SARS-CoV-2 coronavirus to patients suffering from acute respiratory distress syndrome requiring artificial mechanical ventilation significantly reduced mortality by 10%.

The effect on reducing mortality was more specifically observed in patients who received convalescent plasma during the first 48 hours after being put on artificial respiratory assistance.

The randomized phase 2 clinical trial involved 17 intensive care units in Belgian hospitals. It included a total of 475 patients from October 2020 to March 2022.

Thanks to the collaboration of the Belgian Red Cross and the laboratories of the KULeuven, UAntwerpen, and ULiège, the intensive care units of the study's partner hospitals were able to use convalescent plasma with high neutralizing antibody titres of 1/320 for 82.3% of patients and 1/160 for the remaining 17.7%.

"For the first time, we have demonstrated the therapeutic value of convalescent plasma in improving these patients' very poor vital prognosis. The reduction in mortality, of the order of 10%, is particularly noticeable in patients who were given convalescent plasma rapidly after the start of artificial respiratory ventilation", explains Dr. Benoît Misset, head of the intensive care unit at the CHU of Liège and Assistant Professor at the Faculty of Medicine at the University of Liège, who is responsible for and first author of this study.

"This study documents and confirms the value of convalescent plasma for passive immunization, but also against possible pathogenic variants and possibly in the event of future pandemics," wrote these researchers on October 25, 2023.

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