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The National Center for Immunization and Respiratory Diseases recently reported data indicating cases of norovirus are spiking in the United States.

Norovirus is a very contagious virus that causes vomiting and diarrhea.

As of March 15, 2023, the 3-week moving average is reaching a new peak since the norovirus outbreak began in August 2022.

Each of the four regions has displayed similar trends, with the Northeast registering the steepest uptick.

In the U.S., cases of norovirus occur most frequently during late fall, winter, and early spring. 

According to the U.S. Centers for Disease Control and Prevention (CDC), people can get norovirus illness many times in their life because there are many different types of noroviruses.

Infection with one type of norovirus may not protect you against other types.

The CDC says it is possible to develop immunity to specific types. But, it is not known exactly how long immunity lasts.

This may explain why so many people of all ages get infected during norovirus outbreaks. About 80% of children will experience a norovirus infection within one year of birth.

As of March 21, 2023, there are no approved norovirus vaccines in the U.S., Europe, or the U.K.

Vaccine Treats: 
Norovirus
Image: 
Image Caption: 
U.S. CDC Norovirus National Trends March 15, 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Boston
Vaccine: 
HIL-214 Norovirus Vaccine
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The peer review journal The Lancet Infectious Diseases published the results from a recent study examining prospective respiratory syncytial virus (RSV) surveillance data to assess the geotemporal prevalence of RSV A and B and functionally characterize the effect of the nirsevimab binding-site substitutions identified between 2015 and 2021.

Nirsevimab (Beyfortus®), an extended half-life monoclonal antibody (mAbs) to the RSV fusion protein, has been developed to protect infants for an entire RSV season. 

This AstraZeneca and Sanofi-funded observational analysis concluded on March 17, 2023, nirsevimab binding site was highly conserved, and escape variants were rare and have not increased over time.

The U.S. Food and Drug Administration (FDA) initially approved an injectable mAbs therapy for children in 1998.

Beyfortus has been granted various regulatory approvals.

As of March 21, 2023, neither the FDA nor the European Medicines Agency approved an RSV vaccine candidate for children or older adults.

However, various authorizations are expected in 2023.

Vaccine Treats: 
Respiratory Syncytial Virus (RSV)
Image: 
Image Caption: 
by R. Balouria
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
London
Vaccine: 
Beyfortus (Nirsevimab) RSV Antibody 2023
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Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Commission (EC) had approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged six months to 5 years old who are candidates for systemic therapy.

With this approval on March 21, 2023, Dupixent is the first and only targeted medicine indicated to treat these children in Europe and the U.S.

Dupixent is a fully human monoclonal antibody injection administered under the skin at different injection sites.

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before five years of age, which can often continue through adulthood.

“Watching an infant or young child grapple with the debilitating and wide-reaching impacts of severe atopic dermatitis is heartbreaking,” said Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research, in a press release.

“I’ve personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled. However, intervening with effective treatments during infancy and early childhood can help manage the challenging impact this disease has on children and their families during such formative years.”

Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Treatment options in this age group are primarily topical corticosteroids, which can be associated with safety risks and may impair growth when used long-term.

The approval is based on data from a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency primarily topical corticosteroids (TCS) or TCS alone (placebo) in 162 children aged six months to 5 years with moderate-to-severe atopic dermatitis.

At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population. However, in a subset of those with severe atopic dermatitis, patients randomized to Dupixent (n=63) experienced the following compared to placebo (n=62) at 16 weeks:

  • In addition, 46% of patients achieved 75% or greater improvement in overall disease severity compared to 7% treated with placebo, a co-primary endpoint.
  • 14% of patients achieved clear or almost clear skin compared to 2% treated with placebo, a co-primary endpoint.
  • 55% average reduction in overall disease severity from baseline compared to 10% with placebo.
  • 42% average reduction in itch from baseline compared to a 1% increase with placebo.

Dupixent also improved sleep quality, skin pain, and health-related quality of life compared to placebo in both the overall and severe populations. In addition, long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks.

The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. 

Dupixent is currently approved for one or more indications in more than 60 countries, including Europe, the U.S., and Japan. More than 600,000 patients are being treated with Dupixent globally.

Image: 
Image Caption: 
by Gerd Altmann
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Tarrytown
Polio outbreaks March 2023

Rockland County Offers Travelers Free Polio Boosters

Polio return to New York likely in 2023
March 20, 2023
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Sweden's Public Health Agency recently reported several severe influenza cases have occurred in Orebro County, located west of Stockholm. Complications can occur in connection with influenza infection, but this outbreak is unusual. 

The spread of influenza A and B is estimated to continue throughout the country as of March 17, 2023.

During week #10, there was roughly the same number of cases of influenza A (385 cases) as influenza B (364 cases). 

So far, eleven newly admitted patients with laboratory-confirmed influenza have been reported in intensive care during week 10, of which six with influenza A and five with influenza B. 

The current investigation aims to assess whether there are more influenza B cases with serious complications than expected and whether there is any common contributing cause. Therefore, the Public Health Authority has asked other infection control units to investigate whether there are similar cases in other regions.

Of the 21 countries that reported sentinel primary care specimen influenza virus positivity above the 10% epidemic threshold, France, Hungary, Romania, and Slovenia reported activity above 40%.

So far, sequencing of clinical specimens from severe cases in Sweden has identified B/Victoria viruses belonging to subgroup V1A.3a.2, which is the dominant influenza type B virus circulating across Europe and the northern hemisphere 2022-23 and 2023-24 influenza vaccine strain (B/Austria/1359417/2021-like virus).

When traveling abroad, the U.S. Centers for Disease Control and Prevention suggests getting a second flu shot if visiting an area with influenza activity.

Various flu shots are available in the U.S. at health clinics and travel pharmacies.

Vaccine Treats: 
Influenza
Image: 
Image Caption: 
from Pixabay
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Stockholm
Vaccine: 
Flucelvax Quadrivalent Influenza Vaccine
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The Socialist Republic of Vietnam's Health Ministry today announced it has requested for visitors arriving from African countries with Marburg virus disease outbreaks to be monitored for three weeks while in-country.

The ministry also requested samples be taken in suspected cases while at local airports.

"This is a highly dangerous disease," the ministry noted, according to local media on March 20, 2023.

The request was made as the highly contagious disease killed nine people in Equatorial Guinea and could spread further into other African regions and Spain.

As of March 20, 2023, no approved Marburg vaccines or antivirals exist.

Vaccine Treats: 
Marburg Virus
Image: 
Image Caption: 
Vietnam airports March 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Hanoi
Vaccine: 
cAD3-Marburg Vaccine
Photo of Magic Johnson

NBA's Magic Raises RSV Awareness

GSK Sideline RSV national health education campaign launches
March 20, 2023
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Vaccitech plc today announced topline interim data from the HPV001 Phase 1b/2 clinical trial of VTP-200 heterologous prime-boost immunotherapy in women with low-grade cervical human papillomavirus (HPV) lesions.

It is estimated that approximately 291 million women worldwide are carriers of HPV DNA.

Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 placebo-controlled study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint. Immunogenicity results showed high responses, defined as an average greater than 1,000 spot-forming units per million peripheral blood mononuclear cells in an ELISPOT assay, especially to the E1, E2, and E6 antigens.

VTP-200 was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs.

"These interim data are a promising step in the right direction, and we look forward to seeing the final data in early 2024," said Bill Enright, CEO of Vaccitech, in a press release on March 20, 2023.

"Currently, people with persistent HPV infections have no treatment options until they develop high-grade lesions. Being told to return for a repeat cervical screening every 6 to 12 months without a treatment option can be frustrating and anxiety-provoking."

"VTP-200 is intended to treat HPV infections, potentially before the virus causes these high-grade lesions."

VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions.

Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma.

Over 95% of cervical cancers are caused by HPV infection.

The American Cancer Society predicts that in 2022, approximately 14,100 new cases of invasive cervical cancer were diagnosed in the U.S., with over 4,280 women dying from the disease.

In the U.S., various HPV vaccines are authorized for women and men and available at most clinics and clinical pharmacies in March 2023.

Vaccine Treats: 
Cervical Cancer
Image: 
Image Caption: 
by Engin Akyurt
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
England
Vaccine: 
Gardasil 9 HPV Vaccine

JNJ-1802 Dengue Antiviral

JNJ-1802 Dengue Antiviral 2023

Janssen Pharmaceutical Companies JNJ-1802 first-in-class dengue antiviral uses a novel mechanism of action to prevent the interaction between two viral proteins (NS3 and NS4B), thereby stopping the ability of the virus to replicate. JNJ-1802 was shown to be safe and well tolerated in a Phase 1 first-in-human clinical study and is progressing into Phase 2 clinical studies for the prevention and treatment of dengue.

Recent data indicate JNJ-1802 is effective against all four dengue serotypes in mouse models and provides strong protection against two tested serotypes (DENV-1 and -2) in non-human primates. These findings build on research published in the journal Nature in 2021 that first identified the novel mechanism of action from the same chemical series as JNJ-1802.

Janssen Pharmaceutical Companies focuses on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology,  Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

New Jersey-based Johnson & Johnson’s work against dengue is one part of a larger, more than 15-year legacy working to address the burden of Neglected Tropical Diseases, a group of about 20 communicable diseases that affect more than 1.7 billion people in 149 countries around the world. Additionally, the Company launched the Satellite Center for Global Health Discovery at Duke-NUS Medical School in Singapore in June 2022, which is focused on accelerating early-stage discovery research to address the growing challenge of flaviviruses, including dengue. 

JNJ-1802 Indication

JNJ-1802 is indicated to protect people against four dengue serotypes. Current research supports the further clinical development of JNJ-1802 for both the prevention and treatment of dengue. Dengue reinfection is possible due to the presence of four dengue serotypes.

JNJ-1802 News 2023

March 15, 2023 - Janssen Announces Novel Dengue Antiviral Demonstrates Efficacy in Preclinical Data Published in Nature.

October 6, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced the publication of preclinical data in the journal Nature showing that an early-stage compound with a novel mechanism of action could potentially treat all serotypes of dengue fever and provide a period of protection against acquiring the dengue virus.

JNJ-1802 Clinical Trials

Phase 2 clinical trial - Last Update Posted: February 16, 2023.

Phase 2 ClinicalTrials.gov Identifier: NCT04906980 - Last Update Posted: March 15, 2023.

The Phase 1 double-blind, randomized, placebo-controlled study was conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of the novel dengue antiviral compound, which is being developed to prevent dengue. Results from the study show that Janssen’s breakthrough compound administered orally in single or multiple doses, was safe and well-tolerated, with no serious adverse events reported. The preclinical results also demonstrated promising safety data and excellent efficacy at preventing dengue virus infection in mouse and non-human primate models by blocking the interaction between two viral proteins (NS3 and NS4B) that are needed in the replication process of the dengue virus.

0 min read
Manufacturer: 
Janssen
Reviewer: 
Robert Carlson, MD
Vaccine: 
JNJ-1802 Dengue Antiviral
Availability: 
N/A
Generic: 
JNJ-1802
Drug Class: 
Antiviral
Clinical Trial Phase I: 
Phase 1 study
Clinical Trial Phase II: 
A Study of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants
Condition: 
Dengue
Last Reviewed: 
Monday, March 20, 2023 - 05:05
Status: 
Candidate
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
0 min read

The Florida Health Department recently reported there had been 39 travel-associated dengue cases as of March 11, 2023. And in 2022, 903 travel-associated dengue cases were confirmed, primarily focusing on south Florida.

Since Miami, Florida is a significant destination for many southern hemisphere travelers, updated research is helping identify where these dengue-infected visitors originate.

In 2022, of the total of cases reported in the Pan American Health Region (PAHO) was 1,370,072.

The highest number of severe dengue cases reported by the PAHO was in Brazil, with 1,450 cases (31.5%), Colombia with 1,371 cases (29.8%), Honduras 436 cases (9.5%), Mexico with 410 cases (8.9%), and the Dominican Republic 279 with cases (6.1%).

With the increased access to dengue prevention vaccines such as Qdenga® in Brazil, an unanswered question is whether Miami should require proof of vaccination before visiting.

While the recent pandemic generated much debate about vaccination requirements, over 30 PAHO countries continue requiring yellow fever vaccination verification before visiting in March 2023.

With Miami International Airport's (MIA) record-breaking growth carrying into 2023, the airport is expecting its busiest spring break travel season.

Passenger totals at MIA in January and February 2023 were all-time highs for those months, with February bringing in a total of 4.1 million passengers. 

According to aviation analytics provider Cirium, MIA is the fastest-growing U.S. airport in airline seats compared to pre-pandemic levels.

Overall, the U.S. TSA recently reported a slight increase in air passenger screening at airports in the U.S. as compared with 2019 activity.

Vaccine Treats: 
Dengue
Image: 
Image Caption: 
Miami International Airport March 2023
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Miami
Vaccine: 
QDENGA (TAK-003) Dengue Vaccine