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Valneva SE announced today that it continues co-developing VLA15, a Phase 3 vaccine candidate, the only Lyme disease program in late-stage clinical development.
VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia, representing the most common serotypes found in the United States and Europe.
On August 12, 2025, Valneva confirmed its development partner, Pfizer Inc., is currently executing the randomized, placebo-controlled Phase 3 field efficacy study. The participants will be monitored for the occurrence of Lyme disease cases until the end of the 2025 Lyme disease season in the U.S. (end of October), with topline data expected as soon as all Lyme disease cases are confirmed.
In a press release, Valneva wrote that Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.
Lyme disease is the most common tickborne disease in the United States and Europe.
Lyme disease remains an expanding health risk in the U.S. It is a bacterial illness transmitted to humans through the bite of infected ticks. These ticks become infected by feeding on animals that carry the bacteria in their blood.
Over 89,000 cases of Lyme disease were reported to the U.S. CDC by state health departments and the District of Columbia in 2023. Recent estimates using other methods suggest that approximately 476,000 people may be diagnosed and treated for Lyme disease each year in the U.S.
The incidence of Lyme disease in Europe is highest in the Scandinavian and Baltic states in northern Europe and Austria, the Czech Republic, Germany, and Slovenia in central Europe.
The Florida Department of Health (FDH) today reported that additional locally-acquired and travel-related Dengue fever cases have been confirmed in various counties in 2025.
As of August 9, 2025, FDH confirmed ten locally acquired dengue cases (DEN-3, DENV-4) were reported in Miami-Dade (2) and Brevard (8) counties in 2025.
While several cities are located in Brevard County, Melbourne has the largest population at risk for this mosquito-transmitted disease, with over 87,000 residents.
To alert residents, DOH-Brevard has issued a Mosquito-Borne Illness Alert that is scheduled to be in effect through September 12, 2025.
Additionally, there have been 141 travel-related Dengue cases in Florida, most related to travelers from Cuba.
The FDH says Dengue infections can present as a flu-like illness with severe muscle aches and joint pain, fever, and sometimes a rash, and may appear within 15 days after being bitten by an infected mosquito.
Furthermore, Dengue fever is not contagious.
Currently, Dengue vaccines are unavailable in the continental U.S. However, Puerto Rico is testing a first-generation vaccine on children.
The NYC Health Department confirmed today it is investigating a community cluster of Legionnaires' disease in Central Harlem, New York City, New York.
As of August 11, there are 90 confirmed cases, three related fatalities, and 17 people are currently hospitalized with Legionnaires' disease in NYC.
The Health Department says the risk to most people in these ZIP codes (10027, 10030, 10035, 10037, and 10039) is low.
This community outbreak is not related to a building's hot or cold water supply. Residents in these ZIP codes can continue to drink water, bathe, shower, cook, and use their air conditioner.
The Health Department has sampled and tested water from cooling towers in the investigation zone. Any cooling towers with initial positive results for Legionella bacteria have completed the treatment required by the Health Department. We are continuing to monitor and let buildings know if additional treatment is needed.
A building plumbing system is separate from a cooling tower system.
If you live or work in the area and have flu-like symptoms, see a health care provider right away or visit NYC Health + Hospitals or call 311 or 844-NYC-4NYC (844-692-4692).
Legionnaires' disease is not spread from person to person. You cannot get Legionnaires' disease from someone who is sick. Symptoms include cough, fever, chills, muscle aches, and shortness of breath. Infected people usually develop symptoms 2 to 10 days after exposure, though it can be as long as two weeks.
As of August 12, 2025, there are no vaccines available to prevent this disease.
There is a global resurgence of chikungunya that started with increasing outbreaks in the Indian Ocean islands in March 2025, which has continued into mid-August.
According to the World Health Organization (WHO), these outbreaks mirror trends seen 20 years ago when a major outbreak began in the Indian Ocean before spreading globally and affecting nearly half a million people.
Recent estimates suggest that 5.6 billion people live in areas suitable for the spread of diseases carried by the Aedes mosquito, including chikungunya.
In the Region of the Americas, over 209,000 cases and three related fatalities have already been confirmed in 2025.
In the United States, Florida has reported four travel-related cases of chikungunya confirmed this year. The countries of origin were Bolivia, Brazil, Indonesia, and Sri Lanka.
Eleven instances of chikungunya were confirmed in Florida in 2024
To clarify how this mosquito-borne disease is transmitted during international travel, the WHO published a new Q&A on August 8, 2025, with information for the public on the disease, how it spreads, its symptoms, treatment, prevention, and more.
Additionally, the WHO and the U.S. CDC recommend that those traveling to an area reporting chikungunya cases speak with a travel vaccine expert regarding prevention options.
The Centre for Health Protection (CHP) of the Department of Health recently confirmed a total of five Chikungunya Fever (CF) cases have been recorded in Hong Kong in 2025, all of which were travel-related.
Additionally, as of August 10, 2025, one probable (local) case of this disease has been identified.
The CHP says that given the occurrence of multiple imported cases in Hong Kong, there is a risk of secondary local transmission via mosquitoes.
The CHP issued a letter reminding doctors to arrange testing for patients presenting symptoms consistent with CF, regardless of their travel history. Testing should also be considered for patients showing any symptoms of CF who have a travel history to affected areas, based on clinical judgment. The CHP's Public Health Laboratory Services Branch is providing free testing to ensure rapid diagnosis.
According to the U.S. CDC's Level 2 - Practice Enhanced Precautions, Travel Health Advisory issued on August 1, 2025, there is a substantial Chikungunya outbreak in Guangdong Province, China.
Most local and travel cases have been reported in Foshan City, which is located north of Hong Kong.
The CDC writes, 'You can protect yourself by preventing mosquito bites, which includes using insect repellent; wearing long-sleeved shirts and pants; and staying in places with air conditioning or that have screens on the windows and doors.'
Additionally, vaccination is recommended for travelers who are visiting an area with a chikungunya outbreak. Two chikungunya vaccines are approved for use in the United States and are available at travel vaccine retailers.
At present, there is no locally registered Chikungunya vaccine available in Hong Kong.
Since the beginning of 2025, and as of August 6, 2025, six countries in Europe have reported human cases of West Nile virus infection: Bulgaria, France, Greece, Hungary, Italy, and Romania.
Italy's health ministry says Most infected people show no symptoms. Of those who do, about 20% have mild symptoms: fever, headache, nausea, vomiting, swollen lymph nodes, and skin rashes.
However, as of August 10, 2025, Italy has reported 13 related fatalities in 2025, with new cases reported in Caserta and Lazio.
Currently, there are no vaccines authorized to protect people from this mosquito-transmitted virus.
The producer of the Yellow Fever vaccine, Sanofi, recently advised the United Kingdom's National Travel Health Network and Centre (NaTHNaC) that the yellow fever vaccine Stamaril® (17D-YFV, 17D-213) is expected to be available for ordering in the UK by August 15, 2025.
Since August 1, 2025, the UK has had limited access to Stamaril.
The NaTHNaC says this YF vaccine's availability is subject to change, and this should be taken into account when advising the traveller. Where a provider is unable to provide the YF vaccine during this vaccine shortage, the provider is expected to proactively research alternative supplies in their locality and direct international travellers accordingly.
If attempts to source the YF vaccine are unsuccessful, health professionals can contact the NaTHNaC advice line to discuss with an advisor.
Regardless of vaccine access in the UK, various countries, such as Brazil and Colombia, require proof of YF vaccination upon arrival in 2025.
As of August 10, 2025, the travel vaccination centers in the United States have access to the YF-VAX vaccine, which Sanofi also produces.
