Vaccine News

With over 100 countries reporting chikungunya virus outbreaks this year, more international travelers may soon have access to an essential vaccine.

Valneva SE  today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of the only chikungunya vaccine (IXCHIQ®) currently approved in adults and adolescents aged 12 to 17 years.

The application also includes adding the two-year antibody persistence data to the product label, a key differentiator for IXCHIQ®.

This FDA application follows the submission of label extension applications to the European Medicines Agency and Health Canada two months ago. Both Canada and the EMA have already approved IXCHIQ.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release on November 26, 2024, “Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it’s imperative to ensure the vaccine is available to all age groups. This broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness which is currently spreading in areas that were previously unaffected."

"The long-term durability of the immune response from a single shot is also extremely important, especially for endemic countries where access to immunization can be difficult.”

As of November 22, 2024, the Pan American Health Organization reported over 412,089 chikungunya cases and 204 related deaths in the Americas this year. 

In the U.S., travel-related chikungunya cases have increased by about 16% in 2024.

The Lancet Infectious Diseases recently published an article showing that IXCHIQ was well tolerated in adolescents 28 days after a single injection, regardless of previous CHIKV infection.

In addition to the adolescent data, the U.S. and Canadian label extension applications included IXCHIQ®’s long-term antibody persistence data, which showed that the vaccine’s immune response was sustained by 97% of participants after 24 months and was equally durable in younger and older adults.

IXCHIQ® was launched in the U.S. at the beginning of March 2024, with launches in France and Canada underway.

In the U.S., IXCHIQ is available at travel clinics and pharmacies.

Valneva expects a marketing authorization in Brazil before the end of 2024 and expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) earlier this year to support broader access to the vaccine in Low and Middle-Income Countries, post-marketing trials and potential label extensions in children, adolescents and pregnant women.

CEPI will provide Valneva with up to $41.3 million of additional funding over the next five years, with support from the European Union’s Horizon Europe program.

Chikungunya is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes, which causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain is often debilitating and can persist for weeks to years.

A study published by MDPI on October 19, 2024, determined the incidence of post-chikungunya chronic rheumatism and its impact on quality of life and chronic fatigue in adults reached seven years.

The Texas Department of State Health Services (DSHS) announced today that the first locally acquired dengue virus case in Texas was reported in Cameron County, the southernmost county.

As of November 25, 2024, 106 travel-associated dengue cases, including one death, have been reported in Travis (Austin) (14), Dallas (13), and twenty other Texas counties. 

This is the highest annual case count that DSHS has reported since 2002.

Last year, Texas reported 79 travel-related dengue cases and one locally acquired case in Val Verde County.

Most dengue outbreaks in the U.S. have been linked to travelers visiting endemic areas, including Mexico. Located south of the Rio Grande River, Mexico has reported over 480,000 dengue cases and 262 related deaths in 2024.

From a prevention perspective, no dengue vaccines are currently unavailable in the U.S.

In Europe, dengue outbreaks are primarily associated with infections acquired in endemic countries. Local transmission remains rare, with only sporadic, small-scale outbreaks.

However, according to a Rapid Communication published by Eurosurveillance, Volume 29, Issue 47, on November 21, 2024, Italy's Marche Region experienced a locally-acquired dengue outbreak that peaked in early October 2024.

Fano, a small coastal city, reported autochthonous (local) cases beginning in August. By the end of October, 138 confirmed and 61 probable cases of DENV-2 had been notified. 

In total, the Italian National Public Health Authority has reported 213 locally acquired dengue cases in 2024.

Of note, the U.S. CDC's updated Global Dengue Level 1 - Practice Usual Precautions, Travel Health Advisory listed 26 countries, but not Italy.

From a prevention perspective, Takeda's second-generation QDENGA® tetravalent dengue vaccine was approved in Italy in 2023. Unfortunately, it is not offered in the United States in 2024.

The Florida Department of Health (FDH) published its Arbovirus Surveillance Update 46 on November 16, 2024, disclosing mosquito-borne disease cases, including chikungunya and dengue fever.

In Florida, 14 species of mosquitoes have been found to transmit diseases to humans. 

As of November 2024, Alachua, Bay, Broward, Holmes, Madison, Mantatee, Nassau, Orange, Palm Beach, Pasco, Pinellas, Sarasota, and Volusia counties are under a mosquito-borne illness advisory.

Additionally, Duval, Hillsborough,  Marion, Miami-Dade, Monroe, and Walton counties are currently under a mosquito-borne illness alert.

• 786 travel-associated dengue cases were reported, mainly by Brazil, Cuba, and Puerto Rico visitors.
• 90 Oropouche cases were reported in individuals with a travel history to an endemic area such as Cuba. Miami-Dade led the Florida counties with 53 cases.
• 66 cases of locally acquired dengue were reported from six counties, led by Miami-Dade with 40.
• 63 cases of malaria were reported in individuals with a travel history to a malaria-endemic area, such as Africa (Nigeria).
• 9 chikungunya cases with an onset in 2024 have been reported in individuals with a travel history to Brazil (5) and India (4).

The U.S. Centers for Disease Control and Prevention, Canada Health, and the United Kingdom have not issued vaccination requirements for visitors to Florida in 2024.

In Florida, the newly approved chikungunya vaccine (IXCHIQ®) is available at many pharmacies, but dengue and malaria vaccines are currently unavailable in the U.S.

A research letter recently published by The NEJM assessed the serostatus of asylum seekers in New York City.

On November 20, 2024, the researchers disclosed that about 27% of the participants in a study were seronegative for measles. This data indicates these people did not have protective antibodies against this highly contagious disease.

As of late November 2024, the U.S. CDC reported eight imported and six locally-acquired measles cases have been reported in New York City this year.

Nationwide, the CDC reported 277 measles cases in 32 jurisdictions as of November 7, 2024. Measles outbreaks have been declared in sixteen areas this year.

If one person has measles, up to 90% of people around them will also get it if they are unvaccinated or otherwise not immune.

'Anyone who has received two doses of a measles vaccine is considered immune for life and unlikely to get measles,' wrote NYC Health.

Since measles is a vaccine-preventable disease, most pharmacies in New York offer measles vaccination services. Call 311 for information on where you or your child can get vaccinated.

While the CDC has not issued a Travel Health Advisory focused on New York City, the U.K. says travelers to the U.S. should be up to date with routine vaccinations, including the measles, mumps, and rubella vaccine.

Dyadic International, Inc. announced today that it has been awarded a $3 million grant from the Gates Foundation for the cell line development of monoclonal antibodies (mAbs) targeting respiratory syncytial virus (RSV) and malaria utilizing the company's proprietary C1 protein production platform to provide globally accessible treatment options for underserved populations.

Mark Emalfarb, Founder and CEO of Dyadic, stated in a press release on November 21, 2024, "We believe C1's increased efficiency and cost-effectiveness can expand access to therapeutics and vaccines for populations impacted by health disparities."

The versatile C1-cell protein production platform is based on an industrially proven microorganism (C1) designed to accelerate development, reduce production costs, and improve the scalability and performance of biologic vaccines and therapeutics for both human and animal health markets.

Currently, the C1 platform is being utilized in collaborations with leading pharmaceutical, biotech, academic, and government organizations to develop innovative vaccines and treatments.

If these research efforts succeed, Dyadic plans to commercialize these and other antibodies through licensure, expanding access to affordable treatment options for patients worldwide and reducing the global burden of infectious diseases.

As of late November, U.S. FDA-approved RSV mAbs (Beyfortus™) are in full supply and are offered to newborn infants in the U.S.

In November 2024, a sample of municipal sewage collected in Warsaw, Poland, revealed the presence of wild poliovirus type 2.

Initial analysis suggests it is linked to the cVDPV2 emergence originating in Zamfara, northern Nigeria. This year, it has been detected internationally, including recently in Barcelona, Spain. 

Poland's health ministry wrote on November 18, 2024, 'This disclosure does not indicate disease among humans, but according to WHO guidelines, suggests the need to take preventive measures.'

In connection with this incident, the State Sanitary Inspectorate took several actions, including updating poliomyelitis vaccine stock levels. In 2023, the vaccination rate of children aged 3 in Poland was 86%.

The last poliovirus detections in Poland were recorded in 1982 and 1984.

'However, due to cases of this vaccine-preventable disease in Asia and Africa, continuous surveillance is being carried out in Warsaw for flaccid paralysis cases, and municipal sewage is being tested for poliomyelitis viruses,' added the ministry.

According to the Global Polio Eradication Initiative, similar poliovirus detections have recently occurred in various countries. For example, Pakistan reported additional wild poliovirus type 1 cases, increasing the total cases to 50 in 2024.

When the U.S. CDC updated its Level 2—Practice Enhanced Precautions, Travel Health Advisory, in August 2024, Poland was not among the 37 countries that had reported poliovirus issues. 

The CDC says that before traveling to any of the listed destinations, adults who have previously completed the entire routine polio vaccine series may receive a single lifetime booster dose of the polio vaccine. Regardless of age, anyone who has not been vaccinated can get the disease. 

Polio vaccines are offered at health clinics and pharmacies in the U.S.