North Carolina

First Chikungunya Vaccine Approved for Adolescents

Karen McClorey Hackett — Sat, 22 Mar 2025 15:40:02 +0000

Reviewer:

For about 200 years, health organizations like the World Health Organization (WHO) have confirmed Chikungunya virus transmissions. In 2024, outbreaks reached an unfortunate level in the Region of the Americas.

Last year, 425,138 Chikungunya virus (CHIKV) cases and 236 associated fatalities were reported by the Pan American Health Organization. This year has started with over 55,000 cases as of early March.

The vast majority of the infections were in unvaccinated people.

To address this shortcoming, the U.S. Food and Drug Administration recently approved a novel Chikungunya vaccine produced by Bavarian Nordic A/S, which became commercially available on March 18, 2025.

This announcement means before international travelers plan their next trip to CHIKV-endemic areas such as Argentina and Brazil, the VIMKUNYA™ vaccine is available for adolescents and adults to help prevent the contraction of this mosquito-transmitted disease and the potential for long-term illness.

Peter Costa, Bavarian Nordic's Medical Director of North America, informed Vax-Before-Travel News on March 21, 2025, "that "With approved use for those 12 years of age and older, VIMKUNYA™ addresses an important unmet public health need by expanding the eligibility for vaccination against Chikungunya."

"As the first virus-like particle (VLP) single-dose, pre-filled syringe vaccine, VIMKUNYA™ provides a crucial new tool to help protect at-risk individuals traveling to regions where the CHIKV is spreading."

"Chikungunya virus remains a significant global health concern. We're confident in the ability of VIMKUNYA™ to address this previously unmet medical need in adolescents as well as offer prevention for "adults."

According to Bavarian Nordic, access to VIMKUNYA™ depends on location and individual circumstances.

In some areas, a prescription may be required, so travelers should check with their healthcare provider or a travel health clinic to determine availability and whether they need a prescription. Patients may also ask their employer about coverage as a travel health expense if receiving VIMKUNYA™ for work-related travel.

Those visiting or living in areas where Chikungunya is present or with risk factors for severe disease should consult a healthcare professional to assess their need for vaccination.

"The age indication is significant as children tend to be less diligent in using insect repellants," Duellyn Pandis, DNP, MS, APRN, FNP-C, informed Vax-Before-Travel News.

"Also important is this vaccine can be used in immune-compromised individuals as it is not a live vaccine," added Pandis, President & CEO of Passport Health of Tampa Bay.

Vimkunya vaccination triggers the production of neutralizing antibodies at 22 days and up to 183 days post-vaccination. Studies have shown that VLP vaccines are highly immunogenic, have a proven safety record, and typically elicit high titer-neutralizing antibodies needed to protect against CHIKV.

As of March 2025, the U.S. Centers for Disease Control and Prevention (CDC) lists countries and territories with evidence of CHIKV transmission. From 2006 to 2023, about 4,500 travel-related CHIKV cases were reported in the U.S. in areas such as California, Florida, Massachusetts, Puerto Rico, and Texas.

Additionally, the CDC Level 2 Advisory was reissued this year regarding the expanding Chikungunya outbreak in La Réunion island, an overseas department and region of France.

Since the beginning of 2025, 8,600 locally acquired cases have been reported in this vacation destination, which is located about 500 miles east of Madagascar.

The CDC recommends speaking to your healthcare provider about vaccination options if traveling to an area at risk for Chikungunya.

Note: This news article was updated with a travel vaccine expert insight on March 24, 2025.

Sub Title:

VIMKUNYA is the first virus-like particle single-dose chikungunya vaccine

Reference:

Bavarian Nordic Announces Commercial Launch of Chikungunya Vaccine in the U.S.

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Sunday, March 23, 2025 - 05:30

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US CDC March 2025

Newest Chikungunya Vaccine Candidate's Benefits Are Measurable

Karen McClorey Hackett — Thu, 19 Dec 2024 20:28:32 +0000

Reviewer:

Robert Carlson, MD

As 2024 comes to a close, chikungunya virus (CHIKV) outbreaks have become prevalent in many tropical regions, particularly in Africa, South America, and Southeast Asia.

For the first time, the World Health Organization confirmed mosquito-transmitted CHIKV outbreaks have been identified in 115 countries, many located in the Region of the Americas.

As of December 19, 2024, the Pan American Health Organization reported over 421,000 CHIKV cases and 211 related fatalities in the Americas this year.

To address this serious disease, Bavarian Nordic A/S recently announced that the European Medicines Agency had validated its marketing authorization application for CHIKV VLP, the Company's vaccine candidate for immunization to prevent disease caused by CHIKV infection in individuals 12 years of age and older.

This application supports the vaccine's potential approval by the European Commission in the first half of 2025.

Previously, Bavarian Nordic completed the submission of a Biologics License Application to the U.S. FDA in June 2024, and it is also expecting approval in 2025.

To clarify the benefits of this adjuvanted VLP-based vaccine candidate, Vax-Before-Travel spoke with Peter Costa, the Medical Director for Bavarian Nordic in North America. Costa highlighted three benefits, which are as follows:

"The age range for our vaccine candidate addresses an unmet need for 12-17-year-olds. Our clinical data did include 12+, so that's part of the reason for the accelerated review by the U.S. FDA."

"Regarding our vaccine's onset of protection, which is an essential consideration for international travelers visiting at-risk destinations. Many travelers wait very close to their departure date to seek advice, so our vaccine's onset of protection is an important attribute."

"The data presented – about 50% of individuals saw an immune response as early as one week after vaccination."

"Then, by day 15, if you look at our 12-64 population, you will see a response rate of 97%. The primary endpoint was day 22; that's where we saw 98% of the 12-64-year-olds. But even on day 15, we saw 97%."

"Two weeks after vaccination, that's a very rapid onset of protection and a measurable benefit for last-minute travelers."

"Additionally, this vaccine will be delivered to providers in pre-filled syringes. This ease of use and potential reduction in administration errors is important for the travel clinic, pharmacy, and the customer," added Costa.

As of December 19, 2024, one FDA-approved live attenuated chikungunya vaccine is available at travel clinics and pharmacies in the U.S. and various countries. Valneva SE's IXCHIQ® monovalent, single-dose, live-attenuated chikungunya vaccine.

Valneva and the Serum Institute of India recently announced an exclusive license agreement that will enable the supply of IXCHIQ in Asia in 2025.

Sub Title:

Chikungunya outbreaks continue in 2024

References:

Bavarian Nordic Receives EMA Filing Acceptance and Validation of the MAA for its Chikungunya Vaccine

Infectomics of Chikungunya Virus: Roles Played by Host Factors

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Friday, December 20, 2024 - 07:15

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by Gerd Altmann

Uncomplicated UTI CRISPR-Cas3 Treatment Shows Positive Results

Karen McClorey Hackett — Mon, 12 Aug 2024 13:24:35 +0000

Reviewer:

Robert Carlson, MD

As millions of women and men continue battling the impact of urinary tract infections (UTI), innovative, advanced technology therapies are progressing through clinical trials.

A recent Phase 2 trial evaluating LBP-EC01, a CRISPR-Cas3 genetically engineered bacteriophage therapy designed to treat patients with uncomplicated urinary tract infections (uUTIs) caused by antimicrobial-resistant (AMR) and multi-drug-resistant (MDR) Escherichia coli (E. coli), reported positive news.

CRISPR–Cas technologies have enabled programmable gene editing.

This study's primary and secondary objectives were met in the open-label randomized Part 1 of the clinical trial to treat uUTIs caused by antibiotic-resistant E. coli.

Locus Biosciences's CFO Joseph Nixon previously stated, 'Like all of our products, LBP-EC01 is very selective for the target pathogen, preserving the many species of beneficial bacteria in the patient's microbiome.'

On August 12, 2024, Locus Biosciences, which is developing a new class of precision-engineered bacteriophage treatments for a diverse set of bacterial diseases, announced the first public report of data from the randomized, uncontrolled, open-label Part 1 of its two-part, U.S. government-funded Phase 2 ELIMINATE trial.

Published by The Lancet Infectious Diseases, 39 UTI patients were randomly assigned between August 2022 and August 2023. After the protocol was updated, 31 participants were allocated into three groups with different dosing regimens.

"A regimen consisting of two days of intraurethral LBP-EC01 and three days of concurrent intravenous LBP-EC01 (1 × 1×1010 PFU) and oral TMP–SMX twice a day was well tolerated, with consistent pharmacokinetic profiles in urine and blood."

LBP-EC01 and TMP–SMX dosing resulted in a rapid and durable reduction of E. coli, eliminating clinical symptoms in evaluable patients.

These researchers concluded that 'LBP-EC01 holds promise in providing an alternative therapy for uUTIs, with further testing of the group A dosing regimen planned in the controlled, double-blind, second part of ELIMINATE.'

Juvenal E. Martinez, M.D., an investigator in the trial, said in a press release, "As the first Phase 2 engineered bacteriophage trial, ELIMINATE is breaking new ground in the quest to address increasingly prevalent serious MDR infections."

"This encouraging initial data supports the possible utility of bacteriophages and the potential of LBP-EC01 as a therapeutic option to address drug-resistant bacterial infections, such as UTIs, which have a high recurrence rate due to MDR pathogens."

This clinical trial is supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

In January 2024, BARDA provided the company with $23.9 million in research funding. BARDA previously committed up to $93 million to Locus for a $152 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. FDA for LBP-EC01.

Additional UTI therapies and vaccine development information is posted by Precision Vaccinations.

Sub Title:

LBP-EC01 is a CRISPR-Cas3 genetically engineered bacteriophage therapy designed to treat patients with uncomplicated urinary tract infections caused by antimicrobial-resistant and multi-drug-resistant Escherichia coli

Reference:

Safety, pharmacokinetics, and pharmacodynamics of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage cocktail

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Tuesday, August 13, 2024 - 06:00

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by Dean Moriarty

North Carolina Confirms 495 Hepatitis A Cases

Don Hackett — Sun, 01 Aug 2021 17:42:44 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The North Carolina Department of Health and Human Services (NCDHHS) recently announced the state had surpassed 1,000 reported cases of hepatitis A associated with a national outbreak that began in April 2017.

In addition, NCDHHS confirmed 63% of patients had required hospitalization, and 16 people have died from hepatitis A.

Since January 2021, 495 outbreak-associated cases of hepatitis A were reported by NCDHHS, indicating a marked increase in virus transmission.

Of the 2021 cases, 13% are also infected with hepatitis B and 48% with hepatitis C.

During the outbreak, Kentucky (5,132) and Florida (5,089) have reported the most hepatitis A cases in the USA.

Because hepatitis A causes inflammation of the liver, people with other forms of viral hepatitis or anyone with underlying liver disease are at risk of more serious illness if infected.

Since the outbreak began in 2017, the U.S. CDC’s Division of Viral Hepatitis has received about 41,855 reports of hepatitis A and 382 related deaths as of July 23, 2021.

The hepatitis A vaccine is the best way to prevent HAV infection. One dose of single-antigen hepatitis A vaccine has been shown to control outbreaks of hepatitis A.

And, prevaccination serologic testing is not required to administer a hepatitis A vaccine. Vaccinations should not be postponed if vaccination history cannot be obtained or records are unavailable.

People at risk for acquiring HAV infection or developing serious complications from HAV infection during the current hepatitis A outbreaks should be prioritized to receive the hepatitis A vaccine as soon as possible to do so safely, says the CDC.

The risk for person-to-person transmission of HAV continues during the COVID-19 pandemic, says the CDC.

"The best way to protect yourself against hepatitis A is through vaccination," said Dr. Erica Wilson, vaccine-preventable disease medical director in NCDHHS’ Division of Public Health, in a press statement issued on July 27, 2021.

"As always, good hand-washing is key, especially after using the bathroom, changing diapers, and before preparing or eating food. Using harm reduction strategies and syringe service programs is also key in reducing the risk for people who use drugs."

An updated list of U.S. FDA Approved hepatitis vaccines and vaccine candidates is published on this webpage.

Hepatitis A is usually transmitted through food or water that has been contaminated with small, undetectable amounts of feces from a contagious person. Individuals who use drugs, are experiencing homelessness, or men who have sex with men are at the highest risk for infection during the current outbreak.

Symptoms of hepatitis A include fever, fatigue, nausea, loss of appetite, and stomach pain. Jaundice (yellowing of the skin and/or eyes), dark-colored urine, and clay-colored bowel movements may also occur.

These symptoms appear 15-50 days (average 28 days) following infection with the virus.

However, young children can be infected without apparent symptoms.

The NCDHHS advises anyone with symptoms of hepatitis A to contact their health care provider or their local health department to be tested and linked to care assistance.

In addition, anyone exhibiting these symptoms should refrain from preparing food for others. Patients can transmit the virus to others in the two weeks before and one week after jaundice appears.

People with severe underlying medical conditions, such as hepatitis A, may be at higher risk for severe illness from COVID-19. Additional co-administration information is available on this CDC webpage.

PrecisionVaccinations publishes fact-checked research-based news.

Sub Title:

Hepatitis outbreaks can be reduced with one dose of single-antigen hepatitis A vaccine

References:

CDC: Widespread outbreaks of hepatitis A across the United States

North Carolina Hepatitis A Outbreak Surpasses 1,000 Cases

Hepatitis Vaccines

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