Dengue

India to Offer Dengue Vaccinations in 2026

Donald Hackett — Mon, 28 Apr 2025 18:55:50 +0000

Reviewer:

With the world continuing to grapple for solutions to limited Dengue fever outbreaks, India may soon offer its population a proven vaccine.

In 2024, India reported over 230,000 dengue cases and 236 related fatalities.

According to reporting by The Times of India on April 28, 2025, the 'Make in India' initiative intends to offer Takeda's QDENGA® dengue vaccine in 2026.

This vaccine launch includes a collaboration with Hyderabad-based firm Biological E. Limited, which is expected to produce about 50 million QDENGA doses annually.

QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]) is an approved two-dose vaccine preventing dengue fever and/or Severe Dengue caused by any of Dengue's four serotypes.

On December 8, 2022, QDENGA became the first dengue vaccine approved in Europe for use regardless of previous exposure and without the need for pre-vaccination testing. Since then, the World Health Organization added QDENGA to its List of Prequalified Vaccines,

Currently, over 35 countries offer commercial access to the vaccine.

In the United States, Takeda announced on July 11, 2023, that the Company voluntarily withdrew the Biologics License Application for QDENGA following discussions with the U.S. Food and Drug Administration (FDA) on aspects of data collection that could not be addressed within the review cycle.

Furthermore, during the April 2025 U.S. Centers for Disease Control and Prevention (CDC) vaccine committee meeting, QDENGA was not on the agenda.

A previously FDA-approved Dengue vaccine (Dengvaxia) was withdrawn from the market in early 2024.

As of April 2025, the CDC has identified more cases of Dengue than expected among U.S. travelers returning from outbreak countries in the Americas. The CDC recently advised clinicians to consider Dengue in patients with fever who live in or have recently traveled to areas with a risk of Dengue.

The CDC reported on April 23, 2025, that 1,568 travel-related Dengue cases and one local case were reported in 31 jurisdictions this year. The U.S. territories of Puerto Rico and the U.S. Virgin Islands have become endemic for Dengue infections.

The CDC Travel Health Advisory, published on April 15, 2025, states that Dengue is a year-round risk in many parts of the world, and travelers to risk areas should take precautions to prevent mosquito bites.

Sub Title:

QDENGA dengue vaccine is available in various countries in 2025

Reference:

Dengue Cases and Deaths in the Country since 2019

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news18.com 2021

Dengue Infections Cause Cardiovascular Complications

Karen McClorey Hackett — Tue, 22 Apr 2025 08:59:41 +0000

Reviewer:

Robert Carlson, MD

When vacationers return with symptoms similar to a cold, most associate their illness with influenza. However, when visiting most countries in the Americas in 2025, one can also be exposed to the mosquito-transmitted dengue virus.

In the United States, dengue infections are often misdiagnosed. They can cause a range of symptoms, from a mild febrile illness to severe conditions such as dengue hemorrhagic fever and shock, which can result in cardiovascular collapse.

Recently, there have been more reports of atypical presentations following infection by any of the four dengue virus (DENV) serotypes, including cardiac manifestations such as electrocardiographic abnormalities, myocarditis, and pericarditis, which require further investigation.

This review, published on April 18, 2025, discusses our current understanding of the cardiovascular manifestations of dengue and their management, explores the proposed pathogenesis, and concludes with potential future research directions.

The global incidence of dengue has been increasing, partly due to higher travel volumes to areas where dengue is endemic and climate change, which has expanded the range of Aedes mosquito vectors, found at elevations below 2,500 feet.

Last year, more than 13 million dengue cases were reported, the highest year on record.

As of April 16, 2025, the U.S. CDC has reported 1,481 travel-related dengue cases in 30 jurisdictions this year. One locally acquired case in southeast Florida has been confirmed.

In 2024, 53 jurisdictions, led by Arizona, California, Florida, New Jersey, New York, and Puerto Rico, reported 9,391 dengue cases.

To reduce these dengue infections, the ideal DENV vaccine would elicit a balanced and highly protective immune response against all four serotypes of DENV.

Current tetravalent live-attenuated DENV vaccines have faced challenges due to the uneven replication of vaccine virus strains, which stimulate a strong immune response to one serotype and weak responses to the other three serotypes.

While forty countries have enabled access to a second-generation dengue vaccine by 2025, the United States government has not.

Which means it's best to avoid mosquito bites to prevent infection while vacationing in the Americas, including Miami Beach.

Sub Title:

Second generation dengue vaccines are available outside of the U.S.

References:

Cardiovascular Complications of Dengue Virus

Major acute cardiovascular events after dengue infection–A population-based observational study

Cardiovascular manifestations of the emerging dengue pandemic

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An Expert Opinion On Second-Generation Dengue Vaccine

Donald Hackett — Thu, 10 Apr 2025 16:17:55 +0000

Reviewer:

Robert Carlson, MD

In 2024, approximately 13 million dengue cases were reported, marking the highest year on record. Now classified as a grade 3 emergency, this mosquito-transmitted disease could cause additional outbreaks, endangering 4 billion people worldwide.

Therefore, access to innovative vaccines has become an essential public health priority in 2025.

Today, Taylor and Francis Online published a research article titled TAK-003: Development of a Tetravalent Dengue Vaccine. These independent researchers wrote on April 10, 2025, 'One tetravalent dengue vaccine based on a yellow fever backbone has been approved, but due to increased risk of severe disease in dengue-naïve recipients, its use is limited to individuals with prior dengue exposure.'

And that first-generation vaccine has been withdrawn from most markets, including the United States.

However, this article summarizes the clinical development of QDENGA® (TAK-003), a tetravalent dengue vaccine based on a live-attenuated DENV-2 backbone. They discuss vaccine development and preclinical and clinical work leading to a commercially available formulation.

This article's conclusion is inserted below:

Dengue presents a substantial burden on healthcare systems in endemic countries. With increasing urbanization and other factors such as increased global travel and changing weather patterns, DENV will likely spread into currently temperate regions over the coming decades, with potentially millions of dengue-naïve people becoming newly exposed to the virus.

Given the limited effectiveness of current control strategies, an effective dengue vaccine that can be universally administered regardless of previous exposure is a much-needed tool in the global armamentarium against dengue.

A multimodal approach to preventing dengue disease should incorporate routine vector control and public education to reduce mosquito exposure.

Emerging technologies, such as CRISPR, to reduce fertility and flight in Ae. aegypti, infection of mosquitoes with Wolbachia to reduce DENV infection of the mosquitoes, and reverse sterilization of mosquitoes might also be incorporated into multimodal approaches to disease reduction.

Ideally, a vaccine such as TAK-003 should be implemented into national childhood vaccination schedules in endemic regions to provide high immunity levels in young children at risk for DENV infection.

TAK-003 may also be useful in outbreak settings and as a travel vaccine.

Health economic assessments conducted by public health authorities can inform decisions about vaccine incorporation into a dengue prevention strategy.

Collecting real-world evidence will benefit the evaluation of vaccine performance across endemic populations following vaccine introduction. Ideally, within the next 5 years, routine vaccination against dengue in endemic areas and the successful introduction of other mosquito-control technologies can substantially reduce the global burden of dengue disease.

As of 2025, most dengue cases in the United States remain travel-related.

On April 9, 2025, the U.S. CDC reported 1,435 travel-related Dengue cases and one local case had been reported in 30 jurisdictions this year.

However, in 2024, Florida, Puerto Rico, and the U.S. Virgin Islands confirmed numerous locally acquired dengue cases.

While transmission of dengue virus serotypes (DENV-1, -2, -3, and 4) remains high in the Region of the Americas, DENV-3 has become the most common (84%) serotype identified in 2025.

To help identify dengue cases in the U.S., the CDC recently issued this Health Alert Network Health Update to provide additional information to healthcare providers, including updates to testing recommendations.

The CDC wrote on March 18, 2025, 'Healthcare providers, public health departments, and the public are urged to continue to take steps to prevent, detect, diagnose, and respond to dengue.'

By following this CDC advice, dengue outbreaks may be reduced in 2025.

Sub Title:

Qdenga dengue vaccine authorized in 40 countries in 2025

References:

TAK-003: development of a tetravalent dengue vaccine

Ongoing Risk of Dengue Virus Infections and Updated Testing Recommendations in the United States

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US CDC Dengue case map April 2, 2025

Brazil's Dengue Outbreak Moves South

Karen McClorey Hackett — Wed, 02 Apr 2025 10:40:27 +0000

Reviewer:

Robert Carlson, MD

For decades, the Federative Republic of Brazil has been one of the most affected countries by dengue outbreaks in the world, with an average of over three million confirmed cases most years.

Over the past 25 years, nearly 18 million Brazilians have been infected with this mosquito-transmitted virus.

However, Brazil was the unfortunate leader in the Region of the Americas last year, reporting over 9.6 million dengue cases and 5,441 related deaths in 2024. Many of those cases were confirmed in São Paulo.

According to a commentary published by The Lancet on March 22, 2025, this 'situation poses a concern about whether the epidemic will be recurrent or decline as more people get infected and develop lifelong immunity.'

There are four dengue viruses, which means people can be infected multiple times.

A study published in 2024 concluded that the co-circulation of multiple dengue virus genotypes is associated with increased cases, highlighting the importance of continuous surveillance.

There is a concern about whether the current range of dengue across the territory will be rescinded, maintained, or expanded. The latter appears to be the present situation, with particular concern for the South region.

These researchers created risk maps for potential outbreaks using Brazil's historic dengue incidence rate to answer this.

'First, we summarized the dengue incidence for each municipality over the past ten years. We aggregated the confirmed dengue cases from 2015 to 2024 and calculated the cases-to-population ratio, representing the historical incidence.

To create a more accurate version of this ratio, we applied a Bayesian model that considers the case counts from neighboring areas to estimate the actual number of cases within each municipality.

For the short-term period, we assumed that the ratio reflects lifelong immunity and that it is unlikely for a dengue season to include serotypes that were not represented in our dataset. Then, the complement of the ratio was calculated to determine the outbreak risk.

'This means that areas (in the south and mountains) with low dengue incidence over the past ten years are likely to be more susceptible to dengue outbreaks,' wrote these researchers.

Mosquitoes that spread Dengue viruses usually live below 6,500 feet elevation; therefore, a person's chances of getting dengue in high altitudes are very low.

To notify international travelers, the U.S. Centers for Disease Control and Prevention (CDC) published a Health Update on March 18, 2025, highlighting the ongoing risk of dengue infections and updates to testing recommendations.

On March 20, 2025, the CDC reissued a Global Travel Health Notice regarding dengue outbreaks in the Americas, which highlighted Brazil.

While about 40 countries offer dengue prevention vaccines in 2025, the U.S. does not.

Sub Title:

Dengue is a vaccine preventable disease in April 2025

Reference:

On the verge: outbreak risk after two years of record-breaking dengue epidemics in Brazil

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The Lancet March 22, 2025

U.S. CDC Under-Discloses Dengue Outbreaks

Donald Hackett — Fri, 21 Mar 2025 14:51:36 +0000

Reviewer:

Robert Carlson, MD

With the World Health Organization (WHO) and over 100 countries reporting Dengue cases in 2025 and classifying Dengue outbreaks as a grade 3 global emergency, the new U.S. CDC Travel Health Advisory appears to be under-highlighting this global health issue.

On March 20, 2025, the CDC only identified 16 countries with higher-than-expected Dengue cases among U.S. travelers returning from those countries.

Previously, the CDC stated that the Dengue virus was endemic in the U.S. territories of Puerto Rico, American Samoa, and the U.S. Virgin Islands. In the continental U.S., Dengue is frequently detected in Florida's Miami-Dade County.

As of March 21, 2025, the WHO/PAHO data dashboard indicates over 1.2 million Dengue cases and 348 related fatalities have already been reported this year in the Region of the Americas, which includes the United States.

In 2024, more than 13 million Dengue cases were reported in the Americas, making it the highest year on record.

The CDC stated today that international 'travelers should practice prevention measures for all areas with a risk of dengue, an acute febrile illness.'

An estimated 40%–80% of DENV infections are asymptomatic.

However, symptoms in perinatally infected neonates typically present during the first week of life and include fever, hemorrhagic manifestations, hypotension, and thrombocytopenia.

A previous study found that 'compared to uninfected mothers, babies born to mothers with dengue are likely to have worse outcomes. Preterm birth and low birth weight are frequently observed in dengue-affected pregnancies, which can have serious effects on the health and development of the child.'

The CDC recommends that visitors to Dengue-risk areas prevent mosquito bites by using an EPA-registered insect repellent, wearing long-sleeved shirts and pants outdoors, and sleeping in rooms with window screens.

While many countries have authorized a second-generation Dengue vaccine (QDENGA) to reduce the number of mosquito-transmitted Dengue infections, this vaccine is unavailable in the U.S.

However, several Dengue vaccine candidates are conducting late-stage clinical trials, which could be authorized in the U.S. in the future.

Sub Title:

Dengue vaccine unavailable in the United States in 2025

References:

US CDC Global Dengue March 20, 2025

Review of Maternal and Perinatal Outcomes of Dengue in Pregnancy

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WHO Dengue Case Map March 2025

Unintentional Dengue Vaccination Produce Few Side Effects for Neonates

Karen McClorey Hackett — Wed, 19 Mar 2025 19:01:23 +0000

Reviewer:

Robert Carlson, MD

Millions of couples vacation in the Caribbean, where Dengue virus is endemic. While visiting these countries, some women have gotten vaccinated with the second-generation Dengue vaccine, which is not an authorized use.

TAK-003 (QDENGA) vaccination is authorized in about 40 countries in 2025 but is contraindicated during pregnancy and lactation.

Original Research published by Taylor and Francis Online on March 18, 2025, found no evidence of increased adverse pregnancy outcomes following unintentional TAK-003 vaccination occurring inside the exposure window compared with placebo.

This post-hoc analysis of phase 2 and 3 clinical studies evaluated pregnancy outcomes and neonatal adverse events (AEs) following unintentional vaccination when women could be pregnant within 44 days before the last menstrual period until the outcome of pregnancy.

Of the 557 reported pregnancies in these studies, 38 occurred inside the exposure window. Of these, 28 (TAK-003, n = 23; placebo, n = 5) resulted in live births, four resulted in elective terminations (TAK-003, n = 2; placebo, n = 2), five in spontaneous abortions (TAK-003, n = 3; placebo, n = 2) and one unknown outcome (placebo).

Of the spontaneous abortions, there was no significant difference between TAK-003 and placebo recipients or between those occurring within or outside the exposure window.

However, six mothers who received TAK-003 in the exposure window and two neonates experienced serious AEs, but none were considered TAK-003 related.

These researchers identified a significant concern... administering live-attenuated vaccines during pregnancy is the potential for vertical transmission and a replicating vaccine virus posing a risk to the fetus.

The limitations of this post-hoc analysis include the small sample size of unintentional pregnancies occurring within the exposure window. Therefore, the quality and level of information about the pregnancies differed and depended on the extent of availability and level of antenatal care sought.

Currently, 46 countries and territories in the Americas report dengue outbreaks. About 1.2 million Dengue infections have already been reported in 2025.

As of March 19, 2025, the QDENGA vaccine remains unavailable in the United States.

Takeda Pharmaceuticals International AG, the producer of QDENGA, funded this study.

Sub Title:

Dengue vaccine is contraindicated during pregnancy and lactation

Reference:

Pregnancy outcomes following unintentional exposure to TAK-003

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Do Dengue and Tennis Mix in Miami

Karen McClorey Hackett — Wed, 19 Mar 2025 08:40:01 +0000

Reviewer:

Robert Carlson, MD

With about 390,000 worldwide tennis fans attending the Miami Open 2025 tennis tournament, most Florida visitors are unaware of ongoing mosquito-transmitted health risks in late March.

The Miami Open 2025 is an international tennis event that welcomes fans from the Caribbean, Central and South America.

Throughout the Region of the Americas, including southeast Florida, Dengue outbreaks set records last year. In total, 49 countries and territories reported over 13 million cases in 2024.

In the continental United States, the U.S. Centers for Disease Control and Prevention (CDC) reported that locally acquired Dengue cases were confirmed in Florida (91), California (18), and Texas (1) last year.

Additionally, a record number of dengue cases (3,483) were identified among U.S. travelers in 2024, an 84% increase from 2023. The highest number of travel-associated cases was reported in Florida (1,016).

As of March 19, 2025, about 1.2 million Dengue cases and 348 related fatalities have been reported in the Americas this year.

To better inform everyone of this health risk, the CDC issued a Health Update regarding Dengue fever outbreaks on March 18, 2025. According to the CDC, these disease outbreaks are expected to continue throughout 2025, with increased dengue activity in endemic areas, such as Brazil, Cuba, and Puerto Rico.

According to the Florida Department of Health, Miami-Dade County led all counties in Local (91) and Travel (1,016) cases last year. So far in 2025, 44 cases of Dengue have been confirmed in Florida among people who have traveled internationally, including 23 people arriving from Cuba.

Additionally, Miami-Dade County reports its initial locally-acquired Dengue case of 2025.

To alert visitors to the greater Miami area, Florida's health department issued a mosquito-borne illness alert scheduled to remain in effect until December 31, 2025. Furthermore, Duval, Hillsborough, Manatee, and Pasco counties are also under mosquito-borne illness alerts.

Since Dengue vaccines remain unavailable in the U.S. in 2025, the CDC advises preventing mosquito bites during travel, particularly when visiting areas with frequent Dengue virus transmission.

Recently, DENV-4 has become the dominant subtype.

In addition, the CDC says travelers should prevent mosquito bites for a few weeks after returning home to avoid possibly spreading the virus to others if they are in an area where mosquitoes are active.

An additional disease prevention recommendation is posted on the Miami Open 2025 website.

'We urge everyone attending events at Hard Rock Stadium to adhere to the COVID-19 recommendations of the CDC, which include getting vaccinated and wearing masks in indoor spaces, regardless of vaccination status.'

The CDC and Florida both recommend wearing long-sleeved shirts when possible to reduce mosquito bite risks, which may also prevent sunburns while watching tennis matches!

Note: This news article was updated on March 20, 2025, to include local Dengue case in Miami-Dade County.

Sub Title:

Miami Dade County Florida under mosquito-borne illness alert until December 2025

Reference:

Miami-Dade County Alerts

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Italy's Mosquito Tracking System Sets New Standard

Karen McClorey Hackett — Tue, 18 Mar 2025 10:04:03 +0000

Reviewer:

Robert Carlson, MD

The spread of invasive mosquito species, such as the tiger mosquito, poses global health risks due to their potential to carry diseases such as chikungunya, dengue, malaria, and Zika.

An innovative use case in Italy connected the operational mosquito monitoring agency with OEMC tools and data to address the expanding health risk posed by climate change.

The Mosquito Alert System leverages continuous capillary point observations from the regional administration and different state-of-the-art machine-learning techniques to provide data-driven insights for mosquito population control.

This system provides two open-source model applications whose outputs support and integrate Emilia-Romagna region (RER) efforts to manage and control Ae. albopictus populations. Data on mosquito occurrence has been collected daily since 2017 (755 overlaps in 10 main cities).

The project includes spatial analysis and modeling training in open-source environments to support decision-making and enhance the region’s control strategies.

When using this system, public health agencies, regional environmental departments, and communities will benefit from improved identification of where mosquito eggs are at risk.

In the United States, this system could help identify dengue-carrying mosquitos in Miami, Florida, and San Juan, Puerto Rico, where dengue vaccines are unavailable in 2025.

Sub Title:

Infected mosquitoes can carry chikungunya, dengue, malaria, and Zika viruses in 2025

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Visiting San Juan Puerto Rico Includes Dengue Risk

Karen McClorey Hackett — Sat, 22 Feb 2025 18:40:37 +0000

Reviewer:

Robert Carlson, MD

The current dengue outbreak in Puerto Rico is the first since 2013, marking an unusually long gap between outbreaks. In 2025, residents and about 5 million visitors to this U.S. territory will continue to be at risk for this mosquito-transmitted disease.

According to the U.S. Centers for Disease Control and Prevention (CDC) MMWR (74(5);54–60) published on February 20, 2025, this dengue outbreak began atypically during the low transmission season and intensified into the high season. Case numbers peaked in October and remained elevated through December 2024.

This pattern raises concerns about the potential for high transmission continuing into the next dengue season, which coincides with the annual influx of vacationers from the United States.

During 2024, the highest dengue incidence was observed in younger age groups, particularly those aged 10–19. In contrast, most fatal cases have occurred among older adults.

Geographically, although the highest case counts were in the San Juan municipality, with over 2 million residents, the highest dengue incidence occurred in Rincón, Lares, and Maricao, all municipalities outside the metropolitan areas in central and western Puerto Rico.

The CDC wrote, 'Persons living in or traveling to Puerto Rico should use Environmental Protection Agency–approved repellents, wear protective clothing, and stay in places with door and window screens. In addition, healthcare providers should maintain a high suspicion of dengue among persons with fever and potential exposure to mosquitoes in Puerto Rico.

The ongoing dengue outbreak underscores the increasing risk of dengue throughout the Region of the Americas, as the region reported record-breaking case numbers in 2024, about 13 million.

The CDC says more effective dengue control and prevention tools, including safe and effective dengue vaccines for all age groups and scalable vector control methods, are urgently needed to protect at-risk populations in countries with endemic disease and travelers from areas without endemic dengue.

In June 2024, the CDC updated a Health Alert Network Health Advisory, notifying healthcare providers, public health authorities, and the public of an increased risk of local dengue infections in areas such as southeast Florida, a 2.5-hour flight from San Juan.

Last year, the Florida Health Department reported over 999 travel-associated and 91 locally acquired dengue cases throughout the state.

The CDC does not recommend protective vaccination, as no dengue vaccines were available in the U.S. in late February 2025.

However, new, innovative vaccines gaining U.S. FDA approval may fill this void.

Note: This news article was updated of Florida data clarification on February 24, 2025.

Sub Title:

San Juan leads Puerto Rico Dengue Outbreak in 2025

Reference:

US CDC MMWR - Feb. 2025

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Brazil's Dengue Vaccine Production to Reach 100 Million

Karen McClorey Hackett — Thu, 20 Feb 2025 14:59:43 +0000

Reviewer:

Robert Carlson, MD

The government of São Paulo, Brazil, through the State Department of Health, recently declared a state of public health emergency 'in view of dengue becoming epidemic.'

This agency says the 'cause of concern is the reappearance of the mosquito-transmitted dengue serotype 3 after seventeen years without circulation, as the Sao Pailo State population is not immune to this specific dengue strain.'

As of February 19, 2025, the emergency measure was adopted after the state of São Paulo reported 280 cases of dengue fever per 100,000 inhabitants in 2025, near the threshold for a state of emergency. State Secretary of Health Eleuses Paiva signed the state of emergency decree.

Data from the State Department of Health indicate more than 124,000 cases and 113 deaths throughout the state in 2025 alone, with 225 cities reporting more than 300 cases per 1,000 inhabitants, some of them in the northwest region.

Eleuses pointed out a series of measures to combat dengue fever in the state, including the vaccine developed by the Butantan Institute, which the National Health Surveillance Agency approves.

According to Secretary Paiva, the country will only be able to rid itself of the dengue epidemic that emerges yearly with large-scale vaccinations.

"We are providing the Butantan Institute with all the necessary infrastructure to ensure that we can produce the vaccine properly, as we are again experiencing a dengue epidemic. There is only one way to end dengue in our country, and that is to be able to put the vaccine in the arms of all Brazilians. In this sense, we have the full commitment of Butantan, the government, and the secretariat to focus on this," said Eleuses in a media release.

The director of the Butantan Institute, Esper Kallás, stated that the Institute made a Butantan-DV vaccine registration request on December 16, 2024. Butantan-DV is the only single-dose vaccine capable of neutralizing the four dengue serotypes.

"We ....intend to have the entire package sent back to Anvisa for consideration in the coming weeks," Kallás added.

"In 2025, we are working on the final stages of adjusting the processes and producing the initial batches, with the expectation of delivering 1 million doses, which would represent 1 million vaccinated people (in 2025)."

"In 2026, we would scale up and deliver another 60 million doses, and in 2027, another 40 million doses, to achieve the 100 million vaccination curve for the Brazilian population," explained Esper Kallás.

As of February 2025, the single-dose, tetravalent, live-attenuated Butantan-DV Dengue Vaccine is conducting phase 3 clinical trials. The vaccine results from a partnership between Butantan, the U.S. National Institutes of Health, and the American Type Culture Archive. Development of the tetravalent dengue vaccine began at Butantan Institute in 2010.

In addition to Brazil's needs, dengue vaccines are needed throughout the Region of the Americas, which set all-time case and fatality records in 2024.

For example, Florida's southeast coast has reported locally-acquired dengue cases in the United States for the past few years.

On January 20, 2025, the World Health Organization classified dengue as a grade 3 emergency, with an estimated 4 billion people at risk globally.

When visiting a dengue outbreak area in 2025, the U.S. CDC suggests discussing disease prevention options with a travel vaccine expert. As of February 20, 2025, no dengue vaccines are offered in the U.S.

Sub Title:

Sao Paulo Brazil declares public health emergency in 2025

Reference:

São Paulo government declares state of emergency for dengue fever

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by Peggy Lachmann-Anke

Will Dengue Passive Immunization Become Available in the USA

Donald Hackett — Wed, 12 Feb 2025 20:12:10 +0000

Reviewer:

Robert Carlson, MD

As travelers in the United States prepare for another year of record-setting Dengue fever outbreaks, a human monoclonal antibody (mAb) candidate from a Bethesda, MD-based company may soon obtain U.S. FDA approval.

As of February 12, 2025, the National Institutes of Health and AbViro LLC phase IIa clinical trial is exposing healthy volunteers in Maryland and Vermont to a weakened strain of the Dengue virus. The study will compare three AV-1 dose levels in adults challenged with DENV-3, the most infectious Dengue virus strain.

This study launched in early January 2025 and is expected to be completed this Fall.

If successful, the AV1 vaccine candidate could become the first dengue fever treatment approved by the FDA. Previously, the Dengvaxia® vaccine was approved but has since been withdrawn from the U.S. market.

Furthermore, the market-leading second-generation vaccine, Qdenga, is not approved in the U.S.

Currently, no approved Dengue vaccines or mAb are available in the U.S.

National Institute of Allergy and Infectious Diseases director Jeanne Marrazzo commented in a media release, "When caring for a patient who is critically ill with Dengue, healthcare providers have few options other than providing supportive care. We must find safe and effective therapeutics to provide much-needed relief to people suffering from Dengue."

While vaccines are designed to stimulate the body's immune system for many years, therapeutic mAbs provide rapid protection following injection.

Another mAb is being developed in India in a phase 3 study.

Dengushield, developed by Serum Institute of India Pvt. Ltd., is a highly potent inhibitor of all four types of dengue viruses. In a phase 1 study announced in February 2024, this mAb was found safe and well tolerated. It showed a dose-proportionate increase in pharmacokinetic exposure.

To alert international travelers to their Dengue risk, the CDC has issued Travel Health Advisories in 2025. Previously, the WHO classified Dengue as a grade 3 emergency, with an estimated 4 billion people at risk globally.

Within the U.S., Miami, Florida, and San Juan, Puerto Rico, are leaders in reporting locally acquired dengue cases.

Without an approved preventive vaccine or a mAb, the CDC suggests avoiding mosquito bites as the best defense against contracting Dengue in 2025.

Sub Title:

AV1 is a dengue human monoclonal antibody candidate

Reference:

A Study to Evaluate the Safety and Efficacy of AV-1 Against Dengue Virus 3 (DENV-3) Infection

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US CDC Feb. 2025

DENV-3 Risk in the Americas Increases

Donald Hackett — Sat, 08 Feb 2025 21:40:30 +0000

Reviewer:

Robert Carlson, MD

Following the unexpected dengue virus surge in 2024, the Pan American Health Organization / World Health Organization (PAHO/WHO) issued an Epidemiological Alert today focusing on the risk of dengue outbreaks this year.

These health agencies stated on February 7, 2025, that the magnitude of dengue outbreaks is usually associated with the introduction or increase in circulation of one of dengue's four serotypes other than the one that previously predominated in an affected region.

Given the risk of an increase in the circulation of DENV-3 in the southern hemisphere of the Region of the Americas in 2025, the PAHO/WHO) urges Member States to prepare for a possible increase in cases.

As of February 8, 2025, the PAHO reported 292,400 dengue cases and 56 related fatalities in 23 countries.

In 2024, 50 countries and territories reported 13,027,747 cases, 8,186 of which were fatal (the case fatality rate was 0.063%).

In the United States, 53 jurisdictions reported 9,391 dengue cases in 2024.

A significant number of these cases were DENV-3.

In 1994, the DENV-3 serotype was reintroduced to the Americas after a 16-year absence.

Initially, DENV-3 spread throughout the Central American Isthmus and Mexico subregion and reached Puerto Rico, other Caribbean islands, and South America.

In 2000, DENV-3 was detected in Rio de Janeiro, Brazil, causing a large-scale outbreak that lasted three years. DENV-3 was linked to fatal cases.

In Costa Rica, in 2022, this serotype represented 0.18% of the total serotyped samples, a percentage that increased to 25% during 2023. During 2024, DENV-3 was the predominant serotype in the country, with 56% of the total serotyped samples.

In Florida, most of last year's locally acquired and travel-related dengue cases were serotyped as DENV-3 and 4.

As of the end of 2024, the Texas Department of State Health Services reported (143) imported dengue cases led by Travis (18) and Dallas (19), one local case in Cameron County, but did not disclose the virus types.

The PAHO/WHO wrote, 'The reappearance of a serotype that did not circulate in the last decade, such as DENV-3, combined with the increase in the susceptible population, not only increases the probability of severe cases of dengue but could also cause epidemics that overload health services, exceeding their capacity to respond.'

Furthermore, the Region should be aware of co-infections with other arbovirus cases, such as chikungunya and Zika, to prevent severe cases and deaths associated with these three diseases.

As of February 8, 2025, an enhanced, second-generation dengue vaccine was authorized in 40 countries and available in 27, but not in the U.S. And a third-generation vaccine focused on all four dengue viruses is conducting late-stage research in Brazil.

However, other travel vaccines, such as chikungunya, polio, and measles, are available at clinics and pharmacies.

Sub Title:

Second Generation dengue vaccine available in 27 countries in 2025

Reference:

Epidemiological Alert - Risk of dengue outbreaks due to increased circulation of DENV-3 in the Americas Region

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Sunday, February 9, 2025 - 07:00

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PAHO Feb. 8, 2025

Over 8,100 People Died from Dengue in the Americas

Karen McClorey Hackett — Wed, 22 Jan 2025 14:53:25 +0000

Dengue fever disease has afflicted humanity for centuries and possibly longer. To increase awareness, the World Health Organization (WHO) has classified dengue outbreaks as a grade 3 emergency.

In 2024, this mosquito-transmitted virus set new, unfortunate records in over 100 countries worldwide, with an estimated 4 billion people at risk.

For example, the Pan American Health Organization (PAHO) reported over 13 million dengue cases and 8,151 related fatalities in the Region of the Americas last year.

This PAHO data surpasses 2023 when 4,617,108 dengue cases were confirmed in over 40 countries.

And in 53 United States jurisdictions, 9,391 dengue cases were confirmed as of December 31, 2024.

Furthermore, without ample supply and access to dengue vaccines, the outbreak in the Americas started on a similar trend in 2025.

As of January 22, 2025, 136,567 dengue cases and nine related fatalities had been reported in the Americas this year.

To curtail this trend, the WHO recently published its Global Strategic Preparedness, Readiness, and Response Plan (SPRP), which is excerpted below:

In the past 20 years, the global prevalence and impact of chikungunya, dengue, and other arboviruses, such as Zika, have been a significant threat to public health, particularly in tropical areas where the diseases are endemic.

As these diseases thrive primarily in urban settings and easily and quickly cross borders, the fight against dengue and other arboviruses demands a concerted, strategic, and informed response, which this SPRP aims to achieve.

Our multifaceted approach emphasizes integrated surveillance, laboratory diagnosis, vector control, community engagement, clinical management, and research and development. By tackling these diseases from multiple angles, we aim to reduce the disease burden, save lives, and minimize the socioeconomic impact of dengue and other Aedes-borne arboviruses.

The SPRP also includes measures for safe programming to ensure our interventions are secure and do not exacerbate the risk for those already vulnerable to severe disease from dengue and other arboviruses or those involved in responding to the crisis.

Dengue prevention and control are shared responsibilities, and everyone has a role to play, from maintaining clean environments to supporting vector control initiatives and seeking timely medical care.

Regarding vaccines, the SPRP commits to supporting research and innovation to fill knowledge gaps, improving diagnostic and treatment options, and developing novel prevention strategies, including vaccines. Safe and effective dengue vaccine development has been pursued over several decades.

The first dengue vaccine (Dengvaxia®) was licensed in 2015 in several disease-endemic countries. However, it was not widely introduced in in-country programs because it requires pre-vaccination testing.

A second-generation dengue vaccine (Qdenga®) has been widely licensed based on phase 3 results showing a high level of vaccine efficacy both in previously uninfected and infected individuals.

Recognizing some remaining data gaps in seronegative individuals, WHO has issued a conditional recommendation for use in routine immunization programs for geographic locations with high transmission intensity and where dengue poses a significant public health problem, targeting children aged 6–16 years.

As of January 22, 2025, neither dengue vaccine is offered in the United States.

Another dengue vaccine (Butantan-DV) is currently in phase 3 clinical development and should be submitted for licensure soon.

The U.S. Food and Drug Administration and European Medicines Agency recently licensed a first-generation chikungunya vaccine. The WHO is assessing the vaccine recommendations and will eventually develop a position on using chikungunya vaccines.

'Together, we can turn the tide against this disease, protect vulnerable populations, and pave the way for a healthier future,' concluded Dr. Tedros Adhanom Ghebreyesus, Director-General, WHO.

Sub Title:

Dengue vaccine candidate Butantan-DV is in phase 3 study in 2025

References:

Global strategic preparedness, readiness and response plan for dengue and other Aedes-borne arboviruses

US CDC - Dengue Travel Alert

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Cochrane Review 2024

New Zealand Visitors Increasing in 2025

Karen McClorey Hackett — Sat, 04 Jan 2025 15:06:30 +0000

Reviewer:

Robert Carlson, MD

New Zealand's tourism industry is well-positioned to set international visitor records in 2025. Over the last few weeks, various government agencies have updated Vista requirements and safety advisories and clarified vaccination recommendations for visitors to the 'Most Beautiful Country.'

New Zealand is an island nation in the Pacific Ocean southwest of Australia. It has two main islands, the North and South Islands, and over 700 smaller islands that offer world-class tourism opportunities.

New Zealand's tourism upswing began in 2024. For example, 240,200 overseas visitors arrived last October, far surpassing the previous year's totals.

About 46% of these visitors were from Australia, 9% were from the United States, and 5% were from the United Kingdom.

To encourage future visitors, the U.S. Department of State announced, on January 3, 2025, an updated travel advisory for visiting New Zealand.

The State Department's lowest-level advisory advises exercising normal precautions in New Zealand and enrolling in the Smart Traveler Enrollment Program to receive alerts and make locating you in an emergency easier.

While in New Zealand, the U.S. Consulate General in Auckland offers various support services.

Seperately, the UK Health Security Agency confirmed on January 2, 2025, If you are planning to visit a remote area in New Zealand, check with the local tourist authorities for advice.

The New Zealand government recently announced reforms to the Accredited Employer Work Visa program. The changes will be implemented throughout 2025, beginning in January.

From a health perspective, the U.S. CDC says there are no Health Travel Advisories currently in effect when visiting New Zealand. Check the vaccines and medicines list and see a healthcare provider at least a month before your trip to get the necessary medications.

Most mosquito-borne disease cases in New Zealand are acquired overseas. Dengue fever was the most commonly reported disease as the global outbreak reached the entire Pacific Region in 2024.

Dengue vaccines have become available, and new vaccine candidates are nearing approval in 2025.

Sub Title:

New Zealand most beautiful country offers healthy and safe vacation options in 2025

References:

Travel Advisory January 3, 2025New Zealand - Level 1: Exercise Normal Precautions

UK Health Security Agency

NZ International travel: October 2024

NZ Visa program 2025

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by Claudio Bianchi

Will the U.S. FDA Approve Brazil's Dengue Vaccine

Donald Hackett — Tue, 17 Dec 2024 16:35:14 +0000

Reviewer:

Robert Carlson, MD

With over 12.7 million dengue virus cases and 7,828 related fatalities in 2024, countries throughout the Region of the Americas are seeking access to innovative vaccines.

The United States is one of those countries needing a dengue vaccine.

To potentially meet demand next year, the Butantan Institute today announced that it submitted the last batch of documents required for the registration of its dengue vaccine candidate (Butantan-DV) to Brazil's National Health Surveillance Agency (Anvisa).

With this, the Institute completed the submission of information. This phased evaluation tends to speed up the registration release process.

Butantan-DV, if approved, will be the world's first single-dose vaccine against dengue.

"The fact that the Butantan Institute can contribute with the world's first single-dose vaccine against dengue shows that it is worth investing in research conducted in Brazil and in the internal development of immunobiologicals. We will wait and respect all Anvisa procedures. But we are confident in the results that will come," commented Esper Kallás, director of the Butantan Institute, in a press release on December 16, 2024.

This announcement does not mean Butantan-DV will be available to Brazilians immediately after registration approval. If Anvisa's registration opinion is positive, the Institute must request price approval from the Chamber of Drug Market Regulation, which sets the price of new drugs in Brazil.

After this assessment, the National Commission for the Incorporation of Technologies into the Unified Health System will study the possibility of incorporating the vaccine into the local system.

From an efficacy perspective, Butantan-DV is very protective.

The vaccine's clinical studies were completed in June 2024, when the last participant completed five years of follow-up. Recently, results from phase 3 of the clinical trial, published in The Lancet Infectious Diseases, showed 89% protection against severe dengue and prolonged efficacy and safety for up to five years.

In the U.S., dengue vaccine access has been disrupted in 2024.

The one approved dengue vaccine has been withdrawn from the market, and Takeda withdrew its application to the U.S. FDA to approve its dengue vaccine.

As of December 17, 2024, people living in areas reporting locally acquired dengue, such as Miami, Los Angeles, and San Juan, Puerto Rico, do not have access to preventive vaccines.

Furthermore, the CDC's updated Dengue Global Travel Health Advisory does not include a disease prevention option for travelers to 23 countries.

Many international travelers hope governments will approve next-generation dengue vaccines and candidates in 2025, potentially increasing access.

Sub Title:

Butantan-DV is a single-dose effective safe dengue vaccine

Reference:

Butantan asks Anvisa to register its dengue vaccine, the world's first single-dose vaccine

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US CDC Dengue Global Alert - December 16, 2024