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TicoVac Tick-Borne Encephalitis Vaccine

TicoVac Tick-Borne Encephalitis Vaccine Dosage, News, Side Effects, Usage

Pfizer's TicoVac™ (whole virus, inactivated) is an approved vaccine indicated for active immunization to prevent tick-borne encephalitis (TBE), marketed under the brand names FSME-Immun® (Encepur N) in Europe and TICOVAC™ in the United States It was developed using a master 'seed' virus similar to the TBE virus found in nature TicoVac's formulation has changed over time, including removing thimerosal and transitioning the production virus seed from mouse brain suspension to chick embryo fibroblast cells.

TicoVac vaccination induces neutralizing antibodies against the virus, as the sequence and structure of the virus subtype match those found in nature The virus is inactivated using formaldehyde; therefore, the vaccine cannot cause disease TicoVac protects people from known TBE virus subtypes in children (from one year of age) and adults, including the European, Siberian, and Far Eastern subtypes.

On August 13, 2021, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) had approved TICOVAC™ (tick-borne encephalitis vaccine) for active immunization to prevent TBE in individuals 1 year of age and older.1 TICOVAC™is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic areas. DrugBank Accession Number: DB16611

TicoVac Approvals

The TicoVac vaccine has been used for over 20 years in Europe. On September 7, 2021, the U.S. Food and Drug Administration (FDA) published updated information on STN: 125740 (Pfizer Ireland Pharmaceuticals) TBE Vaccine and the BLA Clinical Review Memorandum. The U.K., Europe, and Canada also published updated information on the TicoVac vaccine. In 2025, TicoVac will be available in the U.S. at certain pharmacies.

TicoVac Vaccine for Travel

International travelers are recommended to complete the primary TicoVac Immunization Series at least seven days before visiting areas with potential TBE exposure The risk for exposure to infected ticks is highest for persons in areas where TBE is endemic during the primary TBE virus transmission season of April–November Based on approximately 20–25 million U.S. citizen trips to countries with TBE risk each year, a mean of <1 diagnosed TBE case each year In Europe, a median of 36 traveler cases (range = 25–65 cases) were reported annually during 2014–2020.

U.S. CDC ACIP Presentations Regarding TicoVac Vaccine

In November 2023, the U.S. CDC published Morbidity and Mortality Weekly Report - Tick-Borne Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023 Susan Hills, MBBS, MTH Medical Epidemiologist Arboviral Diseases Branch Centers for Disease Control and Prevention, presented on February 23, 2022: Work Group activities since the last meeting and recommendations for consideration and vote The CDC voted in the affirmative On January 12, 2022, the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) reviewed the following presentations: TICK-BORNE ENCEPHALITIS VACCINE Katherine Poehling, MD, MPH; TICK-BORNE ENCEPHALITIS VACCINE Susan Hills, MBBS, MTH; Evidence to Recommendations; Laboratory workers: Evidence to Recommendations - 46 laboratory-acquired infections globally, all before 1995.

TicoVac Vaccine Indication

TicoVac is a vaccine that prevents TBE in individuals one year and older Tell your doctor if you or your child have ever been infected with or been vaccinated against Yellow fever, Japanese encephalitis, or Dengue viruses Antibodies might be in your blood that can react with the Tick-Borne Encephalitis (TBE) Virus used in tests to measure your antibody levels These tests could then give wrong results The effect of TicoVac 0.5 ml during pregnancy or while breastfeeding is unknown.

TicoVac Vaccines Dosage

Primary Vaccination: Three doses: For intramuscular use only; Dosage and Vaccination Schedule - 1 through 15 years of age: each dose 0.25 mL; 16 years of age and older: each dose 0.5 mL A booster dose (fourth dose) may be given at least three years after completion of the primary immunization.

TicoVac Vaccine Junior

TicoVac Junior is for individuals aged 1 to 15 who receive 0.25 mL. The first and second doses should be administered at intervals of 1 to 3 months.

TicoVac Vaccine Effectiveness

According to the U.S. CDC, no randomized controlled trials (RCTs) have been conducted to demonstrate the efficacy of the TBE vaccine in preventing clinical diseases Vaccine effectiveness (VE) studies for the TBE vaccine using a different schedule, with a previous vaccine formulation or with VE assessed in combination with another TBE vaccine or both, have been published; however, no studies assessing VE of the TBE vaccine alone in its current formulation and according to the U.S. licensed schedule exist A correlate of protection has not been formally established, and no standardized reference reagents are available.

TicoVac Side Vaccine Interactions

TicoVac drug interactions are listed at this link.

TicoVac Vaccine News

November 10, 2023 - The U.S. CDC published: Tick-Borne Encephalitis Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023.

July 9, 2022 - Scientific Results published findings of a study of the VE in Germany of the ENCEPUR (Bavarian Nordic) and FSME-IMMUN (Pfizer).

February 23, 2022—Katherine Poehling, MD, MPH, ACIP TBE Vaccine Work Group Chair, presented an update before a committee vote. The update reviewed considerations for using the TBE vaccine and proposed recommendations for laboratory workers and individuals who travel abroad.

September 29, 2021 - Katherine Poehling, M.D. The U.S. CDC's ACIP TBE Vaccine Work Group chair presented a review of TBE information, including its epidemiology, clinical presentation, diagnosis, treatment, and outcomes.

August 13, 2021—The U.S. Food and Drug Administration (FDA) approved TICOVAC for active immunization to prevent TBE in individuals one year and older.

December 1, 2014 - Pfizer acquires Baxter's vaccine portfolio, including Neis Vac-C and FSME-IMMUN/TicoVac.

January 30, 2003 - Study: Tolerability of modified tick-borne encephalitis vaccine FSME-IMMUN "NEW" in children: results of post-marketing surveillance. These results demonstrate that, in routine medical practice, the FSME-IMMUN "NEW" vaccine, administered at a dose of 1.2 micrograms of antigen per 0.25 milliliters, is safe for the first vaccination in children.

TicoVac Vaccine Clinical Trials

Pfizer's TBE vaccine has been involved in over 26 clinical studies over the past 20 years In clinical trials, the safety and immunogenicity of TICOVAC™ were assessed across two age groups (1-15 years of age and >16 years of age) In these studies, seropositivity rates were 99.5% in 1-15-year-olds and 98.7-100% in adults >15 years following three doses Clinical studies demonstrated that TICOVAC™ was generally well-tolerated, with no unexpected adverse events or vaccine-related serious adverse events observed The most common adverse reactions across both age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain.

Clinical Trial NCT00890422: Evaluation of Immunogenicity of Different Tick-Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine (immunization) - Last Update Posted on April 29, 2009

Clinical Trial NCT00894686: Tick-borne encephalitis (TBE) Seropersistence After the First Booster and Response to the Second Booster in Children, Adolescents, and Young Adults.

Clinical Trial NCT00161863: Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years - Completed study - January 2003.

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Manufacturer:

Pfizer

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Vaccine:

TicoVac Tick-Borne Encephalitis Vaccine

VIS:

PDF

Availability:

Europe, UK, USA, Canada

Generic:

FSME-Immun

Drug Class:

Vaccine

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Clinical Trial Phase II:

Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Wh

Clinical Trial Phase III:

Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Clinical Trial Phase IV:

TBE Seropersistence up to 10 Years After First Booster in Adults

Lab Test:

CDC

Condition:

Tick-borne encephalitis

Availability Link:

PfizerPro

Last Reviewed:

Friday, May 9, 2025 - 11:55

Brand:

TICOVAC

Accession Number:

DB16611

Status:

Approved

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FDA First In Class:

Yes

Kosher:

Yes

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mOJg231N

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United States of America

Zika Vaccines

Zika Virus Vaccine Candidates December 2025

Developing a safe and efficacious Zika vaccine and monoclonal antibody (mAb) is a global health priority, says the World Health Organization (WHO). However, as of December 2025, the U.S. Food and Drug Administration (FDA), Brazil, the European Medicines Agency (EMA), and the United Kingdom have not approved any Zika vaccine or mAb. A series of papers summarizes the key challenges and knowledge gaps that must be addressed to advance Zika vaccine research. As of 2025, a review identified 16 Zika vaccine candidates in Phase 1 or 2 trials, and three monoclonal antibodies (mAbs) were in Phase 1 trials. Zika vaccine clinical trials involving a DNA-based, modified vaccinia Ankara vector platform and purified inactivated vaccine candidates (January 2023, May 2023, October 2023) demonstrate that these vaccine candidates can induce Zika-neutralizing monoclonal antibodies.

Since 2016, approximately $350 million in research funding for a Zika vaccine has been mobilized (Chapman et al., 2020; U.K.'s Newton Fund, U.S. HHS). The U.S. National Institute of Allergy and Infectious Diseases (NIAID) is developing multiple vaccine candidates to prevent Zika infection.

France-based Valneva SE's VLA1601 is the most advanced Zika vaccine candidate. It is a second-generation, highly purified, inactivated, adjuvanted vaccine candidate adsorbed on aluminum hydroxide. On March 26, 2024, Valneva Austria GmbH announced the initiation of an additional two-dose, Phase 1 clinical trial (VLA1601-102), with initial results posted on November 4, 2025.

ZPIV is a Zika virus vaccine candidate with a purified, formalin-inactivated Zika virus. In June 2023, a study found that ZPIV was well tolerated in flavivirus-naïve and previously vaccinated adults; the immunogenicity of ZPIV in bats varied significantly by flavivirus vaccination status. Immune bias towards the flavivirus antigen of initial exposure and the timing of vaccination may have impacted responses. In this Phase 1 clinical trial, a third ZPIV dose significantly reduced, but did not eliminate, the immunogenicity discrepancy.

TAK-426 (PIZV) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate. It is being tested to provide safety and immunogenicity data for further clinical development.

Brazil-based Butantan Institute is developing a vaccine against the Zika virus. Animal tests are expected to begin in the second half of 2024.

iosBio OraPro-Zika is an orally administered Zika virus vaccine candidate based on a non-replicating human adenovirus type 5 (AdHu5) (E1/E3 deleted) expressing Zika transgenes.

GEO-ZM02 is constructed using a modified vaccinia Ankara vector platform. Preclinical studies demonstrated that a single dose of GEO-ZM02 provided 100% protection against the lethal Zika virus. This Zika vaccine is based on the virus's NS1 protein, which is not associated with the antibody-dependent enhancement of infection.

Ad26.ZIKV.001 is a replication-incompetent human adenovirus serotype 26 (ad26) vector vaccine candidate. In a clinical trial, researchers found that two doses of Ad26 were effective. ZIKV. 001 were safe, causing mild to moderate reactogenicity and inducing persistent neutralizing antibody responses. The single dose had lower peak antibody levels but was durable for a year.

GeneOne Life Science and Inovio Pharmaceuticals' phase 1, open-label clinical trial of the DNA vaccine GLS-5700 elicited anti-ZIKV immune responses.

VRC5283 is a Zika virus DNA vaccine candidate composed of a single closed-circular DNA plasmid encoded with wild-type precursor transmembrane M and envelope proteins from the H/PF/2013 strain of ZIKV. It is being tested in a phase 2 clinical study.

The University of Adelaide was awarded $1.35 million in funding to develop a novel DNA vaccine, pVAX-tpaNS1, for the treatment of the Zika virus. Dry-coating of pVAX-tpaNS1 on the HD-MAP device resulted in no loss of vaccine stability at 40°C storage over 28 days.

rZIKV/D4Δ30-713 is a live attenuated chimeric Zika candidate vaccine expressing the premembrane (prM) and envelope (E) genes of a contemporary ZIKV strain within a dengue DEN4Δ30 background. It completed a phase 1 clinical trial. The researchers wrote: Our results suggest rZIKV/DEN4Δ30 is over-attenuated and thus will not be further developed as a candidate ZIKV vaccine.

ZikaEnv:aghFc is a plant-based recombinant vaccine that transiently expresses the ZIKV envelope protein. At a low dose (1–5 μg), it induces humoral and cellular immunity.

Duke-NUS researchers used live-attenuated vaccine (ZIKV-LAV) strains of the Zika virus, which are weakened and have limited ability to infect healthy cells.

ZIKV E DIII-specific antibody ZK2B10, isolated from a ZIKV convalescent individual, is being developed by Uvax Bio.

Research suggests that the novel, auto-adjuvanted, virus-like particle technology EDIII-QβVLP vaccine is a promising candidate for preventing ZIKV infection, with potential applications in combating this and other emerging flaviviruses.

Zika Infection in Infants

On July 3, 2025, The Lancet published: A decade later, what have we learned from the Zika epidemic in children with intrauterine exposure? The Zika virus in pregnancy carries severe teratogenic potential to the fetus, ranging from congenital Zika syndrome to milder neurodevelopmental sequelae. Congenital Zika syndrome is associated with a spectrum of alterations that can affect cognitive, language, and motor development. The first human cases were detected in 1952. Since 2013, 31 countries and territories have reported cases of congenital microcephaly and other central nervous system malformations associated with Zika virus infection.

Zika and Dengue Co-Infections

A significant safety concern for vaccine development against ZIKV is the antibody-dependent enhancement of infection between ZIKV and the Dengue virus. Preexisting immunity to ZIKV has been recognized as a factor that can aggravate subsequent Dengue infection in animal models and humans. As of November 2025, Dengue vaccines are offered in various countries, but not in the United States.

Zika Outbreaks

Zika outbreaks have been confirmed in numerous countries in 2025.

5 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Thursday, December 11, 2025 - 11:10

Description:

Zika vaccine candidates are conducting clinical trials in 2025.

Condition:

Zika

BBV87 Chikungunya Vaccine

BBV87 Chikungunya Vaccine Description

Bharat Biotech International Ltd's (BBIL) Chikungunya vaccine candidate (BBV87) is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype. Based on the ECSA strain, BBIL developed a pure, inactivated CHIKV immunogenic formulation. BBV87 vaccine completed standard pre-clinical studies, and the adjuvanted vaccine elicited an optimum immune response in phase 1 clinical trials in India.

On August 24, 2023, the International Vaccine Institute (IVI) announced the first participant received BBV87 in a Phase II/III clinical trial in Costa Rica, marking the start of a multi-country study funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the Department of Biotechnology, India. In addition to the trial at Clinica San Agustin in Costa Rica, trials are expected to begin in Panama and Colombia by September 2021 and in Thailand and Guatemala soon after.

On June 15, 2023, MDPI published: An Overview of Indian Biomedical Research on the Chikungunya Virus with Particular Reference to Its Vaccine. This review gives an overview of the outbreak history and CHIKV-related research in India to favor novel; high-quality research works that promote effective treatment and preventive strategies, including vaccine development, against CHIKV infection.

Inactivated virion technology has a safety profile that potentially makes this vaccine accessible to special populations, such as immunocompromised and pregnant women, that some other technologies cannot reach.

The first report on CHIKV was from Tanzania, an eastern African country, in 1952. The first CHIKV outbreak in India was recorded in the city of Kolkata in 1963. Chikungunya is an emerging arthritogenic arboviral illness caused by the chikungunya virus (CHIKV), a member of the genus Alphavirus in the Togaviridae family. The pathologic mechanism of this virus leads to acute infection of several weeks, which can persist for months with an incubation period of 2–12 days. The hallmark characteristics of CHIKV infection are saddle-back fever, polyarthralgia (mainly in small joints – ankles, toes, wrists, and phalanges), and a petechial or maculopapular rash (mainly on the face, limbs, and trunk). CHIKV affects all age groups with dengue-like symptoms characterized by nausea, fever, chills/rigors, headache, polyarthralgia, myalgia, photophobia, and skin rash.

Bharat Biotech creates innovative vaccines and bio-therapeutics trusted by physicians around the world. USFDA, KFDA, and WHO approve BBIL's manufacturing facilities.

BBV87 Chikungunya Vaccine Indication

Chikungunya virus was first identified in Tanzania in 1952, with sporadic disease outbreaks reported across Africa and Asia. In 2004, the disease began to spread quickly, causing large-scale outbreaks worldwide. Since the re-emergence of the virus, the total number of cases has been estimated at over 3.4 million in 43 countries. Outbreaks during the last decade worldwide have prompted the National Institute of Allergy and Infectious Diseases (NIAID) to add CHIKV to the category C priority pathogen biodefense list.

BBV87 Chikungunya Vaccine Dosage

A 2-dose live-inactivated vaccine (BBV87) against Chikungunya is being tested.

BBV87 Chikungunya Vaccine News

June 3, 2020 - The Coalition for Epidemic Preparedness Innovations (CEPI) announced a new partnering agreement to advance the development of a Chikungunya vaccine. The CEPI will provide the consortium up to US $14.1 million for vaccine manufacturing and clinical development of a 2-dose live-inactivated vaccine (BBV87) against Chikungunya. The European Union's Horizon 2020 program supports the funding through an existing framework partnership agreement with CEPI. The consortium was also supported with a grant of up to US $2.0 million from the Indian Government's Ind-CEPI initiative to fund the set-up of GMP manufacturing facilities for the vaccine in India and subsequent manufacture of clinical trial materials.

June 2, 2020 - Oslo, Norway; Seoul, South Korea; Telangana, India—CEPI, in collaboration with Ind-CEPI, has announced a new partnering agreement with a consortium comprising Bharat Biotech (BBIL) and the International Vaccine Institute (IVI) to advance the development of a Chikungunya vaccine.

BBV87 Chikungunya Vaccine Clinical Trial

The BBV87 vaccine candidate completed pre-clinical studies, and an optimum immune response was elicited by the adjuvanted vaccine in phase 1 clinical trials in India.

A Phase II/III Adaptive Seamless Design, Randomized, Controlled Trial To Evaluate Safety And Immunogenicity of 2 Dose-Regimen of BBV87 Chikungunya Vaccine In Healthy Subjects Aged 12 to 65 Years in Latin America and Asia.

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Manufacturer:

Bharat Biotech

Reviewer:

Robert Carlson, MD

Vaccine:

BBV87 Chikungunya Vaccine

Availability:

N/A - conducting clinical research

Generic:

BBV87

Drug Class:

Vaccine

Clinical Trial Phase II:

Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia (IVICHIK001)

Condition:

Chikungunya

Last Reviewed:

Sunday, November 12, 2023 - 07:50

Status:

Candidate

Manufacturer Country ID:

FDA First In Class:

Yes

GEO-ZM02 Zika Vaccine

GEO-ZM02 Zika Vaccine Candidate

The GeoVax Labs GEO-CM02 Zika virus vaccine candidate is based on a novel GV-MVA-VLP platform that integrates recombinant Modified Vaccinia Ankara (MVA) vector technology with advanced antigen design and state-of-the-art manufacturing technologies. GEO-ZM02 is designed to function through the induction of T-cell responses rather than antibodies to eliminate the risk of Antibody-Dependent Enhancement (ADE), a serious side effect observed in flavivirus infections when an individual does not have a fully protective immune response from vaccination or a previous infection which causes a more serious disease if infected.

This Zika vaccine candidate is based on the NS1 protein of Zika, which is not associated with ADE of infection. Moreover, an NS1-based vaccine has the potential advantage of blocking the transmission of Zika from humans to its mosquito vectors.

The GeoVax MVA platform is a large virus capable of carrying several vaccine antigens express proteins that assemble into VLP immunogens within (in vivo) the vaccine recipient. Vaccines produced on this platform are safe, highly immunogenic, suitable for repeated use, stable at refrigerator temperatures, lyophilized, and amenable to rapid and affordable scale-up for epidemic response and routine vaccination.

The U.S. Patent and Trademark Office issued a Notice of Allowance for Patent Application No. 17/000,768 titled, "Method for Generating a ZIKV Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein." The claims to be granted in the patent cover GeoVax's MVA vector comprising a nucleic acid sequence encoding a ZIKV nonstructural (NS1) protein, of which GEO-ZM02 is designed.

GeoVax Labs, Inc. is a clinical-stage biotechnology company located in Atlanta, GA, developing human vaccines and immunotherapies against infectious diseases and cancer using novel proprietary platforms. The company's lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax's lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations.

GEO-ZM02 Indication

A pathogen endemic in parts of the world, Zika virus (ZIKV), is linked to an increase in microcephaly in infants and neurodegenerative disease, Guillain-Barre syndrome, in adults. Zika is a member of the Flaviviridae family, which includes other significant pathogens affecting patients worldwide, such as dengue fever, yellow fever, Japanese encephalitis, tick-borne encephalitis, and West Nile viruses.

GEO-ZM02 News 2023

January 25, 2023 - "Our novel Zika vaccine candidate, GEO-ZM02, is constructed using our modified vaccinia Ankara (MVA) vector platform. Preclinical studies demonstrated a single dose of GEO-ZM02 provided 100% protection against a lethal dose of Zika virus," stated GeoVax CEO David Dodd in a press release. "Addressing many of the world's most threatening infectious diseases is part of our vision and corporate priorities for MVA's applications, including an MVA-based next-generation COVID-19 vaccine currently in Phase 2 clinical trials."

April 12, 2022 – GeoVax Labs, Inc. announced that on April 21, 2022, its Chief Scientific Officer, Mark J. Newman, Ph.D., will participate in an expert panel discussion on the topic of Pan-Corona and Universal Vaccines during the World Vaccine Congress in Washington, DC.

March 18, 2020 - GeoVax's Chief Scientific Officer, Farshad Guirakhoo, Ph.D., stated, "We are pleased with our three vaccine candidates' rapid progress with design, construction, and in vitro characterizations. From here, we will narrow it down to one vaccine candidate based on the safety, immunogenicity and protective efficacy of our PreMaster Seed Viruses observed in upcoming animal studies. The final candidate will proceed directly to manufacturing and initial human clinical testing for safety and immunogenicity."

GEO-ZM02 Clinical Trial

Completed preclinical evaluation.

0 min read

Manufacturer:

GeoVax

Reviewer:

Robert Carlson, MD

Vaccine:

GEO-ZM02 Zika Vaccine

VIS:

PDF

Availability:

N/A

Generic:

GEO-ZM02

Drug Class:

Vaccine

Condition:

Zika

Last Reviewed:

Wednesday, January 25, 2023 - 16:20

Status:

Candidate

Manufacturer Country ID:

FDA First In Class:

Yes

Vax-Before-Travel Vaccines

Vax-Before-Travel Vaccines December 2025

Over the past few decades, viruses transmitted by mosquitoes have spread rapidly worldwide, resulting in significant disease outbreaks in previously unexposed populations. Recent research indicates that millions are not adequately immunized against diseases before visiting endemic countries. The World Health Organization (WHO) states that one infectious person on an airplane can transform a local disease outbreak into a global pandemic. The WHO publishes selected trends in vaccine-preventable diseases and an extensive list of recommended vaccinations.

However, several travel vaccines are available to prevent diseases. As of 2025, the U.S. Centers for Disease Control and Prevention (CDC) stated that getting vaccinated against infectious diseases is one of the most effective ways to protect your health while traveling abroad. The CDC's Yellow Book: Health Information for International Travel, Edition 2026, recommends administering most travel vaccines at least one month before departure to ensure maximum protection. The CDC lists various vaccine recommendations.

Vaccine appointments are available commercially at certified clinics and travel pharmacies in the U.S. Additionally, pre- and post-travel virus testing services are offered at this link. Additionally, the European Center for Disease Prevention and Control (ECDC) Vaccine Scheduler enables comparisons of vaccination schedules between two European countries, by disease across all countries, or within a selected group of countries.

Travel Vaccine Advisories

The U.S. CDC, the U.K. Travel Health Pro, the Pan American Health Organization (PAHO), and the ECDC publish Travel Health Advisories and Assessments, including guidance for cruise ships, enabling international travelers to confirm vaccine recommendations by country. The U.S. Department of State publishes Travel Advisories, and U.S. embassies issue local travel health security notices. Seperately, Travel vaccine certificates and passport information have also been updated.

Anthrax Vaccines

CYFENDUS ™ (AV7909, BioThrax®), a two-dose anthrax vaccine for Post-Exposure Prophylaxis, was approved on July 20, 2023.

Avian Influenza Vaccines

Audenz™ is a monovalent, adjuvanted, cell-based, inactivated subunit vaccine approved by the U.S. FDA. Various pandemic influenza vaccines have also been approved in Europe and the U.K.

Chikungunya Vaccines

As of 2025, chikungunya is a vaccine-preventable disease. The U.S. FDA-approved chikungunya vaccines include IXCHIQ® and VIMKUNYA®.

Cholera Vaccine

Cholera vaccine availability improved in the U.S. in late 2024 and is expected to be readily available in 2025. WHO-prequalified oral cholera vaccines, including Dukoral®, Shanchol™, and Euvichol®, are available for international travelers. Administration instructions differ for children aged 2–5 years versus people aged 6 years and older. Follow the package insert instructions for additional recommendations.

Vaxchora is an oral cholera vaccine for active immunization against the disease caused by Vibrio cholerae serogroup O1.

DUKORAL ® is available in Europe, the U.K., and various other countries.

Dengue Vaccines

As of 2025, various countries have approved QDENGA®, a tetravalent dengue vaccine, and in December 2025, Brazil approved the single-dose Butantan-DV dengue vaccine. Several dengue vaccine candidates are conducting late-stage studies in 2025. The the first-generation Dengvaxia vaccine remains available in Puerto Rico.

Diphtheria Vaccines

The U.S. CDC advises that travelers 2 months and older traveling to outbreak areas should receive an age-appropriate dose of a diphtheria toxoid-containing vaccine if they are not fully vaccinated or have not received a booster dose within the past 5 years before departure. In 2024, 11 vaccines will be available to help protect against diphtheria.

Ebola Vaccines

Ebola outbreaks in Africa began in 1976 and continued in 2024. Zaire Ebolavirus vaccines are only available in limited supply outside Africa.

Ervebo (Ebola Zaire Vaccine, Live) is a recombinant, replication-competent vaccine for Ebola Zaire.

Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) are Ebola vaccine therapies.

Ebanga™ (mAb114, Ansuvimab-zykl) is a human monoclonal antibody approved for the treatment of Zaire ebolavirus infections.

Sudan Ebolavirus vaccines are being developed in clinical trials.

Influenza Vaccines

Flu shots are recommended for international travel in areas where the influenza virus is prevalent.

Japanese Encephalitis Vaccines

JENVAC is a single-dose inactivated Japanese Encephalitis Vaccine. This Vero cell-derived vaccine is prepared from the virus's Indian strain (Kolar- 821564XYs).

Ixiaro is an inactivated, adsorbed vaccine derived from Vero cell culture that targets the Japanese encephalitis virus. It is prepared by propagating the JEV strain SA14-14-2 in Vero cells. For children aged 2 months to 17 years, the primary series consists of two intramuscular doses administered 28 days apart (doses may be given at 7-day intervals in travelers aged 18 years or older). The last dose of IXIARO should be administered at least 1 week before travel.

Lassa Fever Vaccine

Lassa fever is an acute viral hemorrhagic fever without an approved vaccine in 2025.

Lyme Disease Vaccines

Lyme disease vaccine candidates are conducting late-stage clinical studies. Valneva's VLA15 is a multivalent recombinant protein vaccine candidate.

Malaria Vaccines

Malaria outbreaks continue in 2025, and vaccines are available in Africa but not in the U.S. Monoclonal antibodies (mAb) could prevent malaria.

Mosquirix (RTS,S/AS01e) is a recombinant vaccine that triggers the immune system to defend against the first stages of infections when the Plasmodium falciparum malaria parasite enters the human host's bloodstream through a mosquito bite.

R21/Matrix-M™ Malaria vaccine is produced by the Serum Institute of India and developed by scientists at the University of Oxford in England.

Marburg Disease Vaccines

Marburg vaccine candidates are conducting clinical trials, and various Marburg disease outbreaks have been reported in 2025.

Measles Vaccines

Measles outbreaks continue in 2025, including in U.S. cities such as those in Texas. Various measles vaccines are available at pharmacies.

Meningococcal Disease Vaccines

The U.S. CDC lists various Meningococcal Disease vaccines, such as Bexsero® (MenB-4C).

MERS Vaccine

As of 2025, no approved MERS-CoV vaccine exists, but cases continue to be reported in the Middle East. The VTP-500 vaccine candidate completed Phase I clinical trials in the United Kingdom and Saudi Arabia. The University of Oxford conducted a Phase Ib trial in the U.K. to assess the vaccination of older adults.

Norovirus Vaccine

As of 2025, the U.S. FDA has not approved a norovirus vaccine candidate; however, Moderna's vaccine is currently in Phase 3 clinical trials. The Nova 301 Phase 3 study, evaluating the efficacy, safety, and immunogenicity of mRNA-1403 in adults, is expected to be completed in 2027.

Mpox Vaccines

The JYNNEOS smallpox-mpox vaccine is commercially available in the U.S., Africa, and numerous other countries.

Nipah Virus Vaccines

Nipah virus vaccine candidates are continuing in Phase 1 clinical trials in 2023. Since 1999, Nipah outbreaks have occurred in Asia, including Bangladesh and India.

Oropouche Virus Vaccine

As of July 17, 2025, no vaccine is available to prevent Oropouche, and no medicines are available to treat infections. In 2025, commercial testing services will become available in the United States.

Plague Vaccine

The WHO-Plague Vaccines in Preclinical Development and Clinical Trials was published in 2023. The primary outcomes assessed were efficacy, safety, and immunogenicity using the Cochrane Collaboration's tool. The study concluded that a single-dose F1-based mRNA-LNP vaccine is effective in protecting against the lethal plague bacterium.

Polio Vaccines

Polio vaccination, including booster shots, is recommended when visiting polio-endemic countries. Infants and children should complete as much of the recommended, age-appropriate polio vaccine series as possible before departure.

IPOL is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). Sanofi Pasteur's single-antigen IPOL vaccine is a highly purified, inactivated poliovirus vaccine with enhanced potency.

Sabin Inactivated Poliovirus Vaccine is a liquid trivalent vaccine produced from Sabin poliovirus type 1, 2, and 3 strains grown on Vero cells.

nOPV2 polio vaccine is derived from the live, infectious virus, but it has been 'triple-locked using genetic engineering to prevent it from becoming harmful. nOPV2 is genetically more stable than existing OPVs.

Rabies Vaccines

Various rabies vaccines and candidates seek to reduce rabies mortality in 2025. The number of recommended pre-exposure prophylaxis doses was decreased in 2021 from 3 to 2, administered with an interval of at least 7 days.

Rocky Mountain Spotted Fever

RMSF is endemic in multiple border states in northern Mexico, including Baja California, Sonora, Chihuahua, Coahuila, and Nuevo León. As of December 2023, no approved vaccine for RMSFine exists. However, the CDC says early treatment with doxycycline saves lives.

Rotavirus Vaccines

Since 2019, the WHO has prequalified four rotavirus vaccines. GSK's Rotarix is a live, attenuated rotavirus vaccine that exposes your child to a small dose of the virus, which causes the body to develop immunity to the disease.

Tickborne Encephalitis Vaccine

TicoVac vaccine is marketed by Pfizer Inc. under the brand names FSME-Immun® in Europe and TICOVAC™ in the U.S. It was developed using a master 'seed' virus similar to the Tickborne encephalitis virus found in nature. The TBE vaccine is approved for individuals aged 1 year and older. It is recommended for use among people traveling to or moving to a TBE-endemic area who will have extensive tick exposure, based on their planned outdoor activities and itinerary.

Tuberculosis Vaccine

The U.S. CDC recommends the BCG vaccine to help prevent tuberculosis and to provide nonspecific protective effects, such as against bladder cancer. Various versions of the BCG vaccine are available globally in 2025.

Typhoid Vaccine

Typhoid vaccines are available in 2023 and are recommended for people traveling to places where typhoid fever is common, such as South Asia (India). Capsules should be swallowed whole and taken ≥2 hours after eating or drinking and 1 hour before subsequent eating or drinking. All four capsules should be taken at least 1 week before potential exposure. A booster dose of Ty21a should be taken every 5 years, if indicated.

Vivotif oral vaccine (capsules) is indicated for the immunization of adults and children over six years of age against the disease caused by Salmonella Typhi. It contains live bacteria called Salmonella typhi strain Ty21a, which does not cause typhoid fever. Bavarian Nordic A/S owns Vivotif Oral and is available in the U.S.

Typbar TCV is a vaccine containing the polysaccharide of Salmonella typhi Ty2 conjugated to Tetanus Toxoid.

Typhim VI is a sterile solution prepared from the purified polysaccharide capsule of Salmonella typhi (Ty 2 strain).

Urinary Track Infection Vaccine and Treatments

Uromune™, an inactivated oral spray vaccine for Urinary Tract Infection (UTI), was approved in various countries in 2025.

Pivya™ antibacterial tablet is approved for female adults with uncomplicated UTIs in Europe.

Yellow Fever Vaccines

The WHO publishes yellow fever vaccination requirements for entry into certain countries. Outbreaks have been confirmed in 2025. The yellow fever vaccine is contraindicated in infants <6 months of age and should be administered to children 6–8 months of age after careful consideration of risk at destination and the ability of caregivers to prevent mosquito bites.

YF-VAX® vaccine is licensed in the U.S. and takes about 10 days to achieve maximum immunity.

Stamaril® is distributed in over 70 countries in 2024, but not in the U.S.

Zika Virus Vaccines

While Zika virus outbreaks continue primarily in India and the Region of the Americas in 2025, no approved Zika vaccine is currently available.

Note: This content is aggregated from various news sources and vaccine research organizations and has been fact-checked by healthcare professionals, including Dr. Robert Carlson.

10 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Saturday, December 13, 2025 - 20:25

Description:

Yellow fever, Zika, polio, malaria, measles, Lyme, cholera, chikungunya, and dengue disease vaccinations in 2025.

Jenvac Japanese Encephalitis Vaccine

JENVAC® Vaccine

JENVAC® is a single-dose inactivated Japanese Encephalitis (JE) Vaccine. This Vero cell-derived vaccine is prepared from an Indian strain (Kolar- 821564XY) of the JE virus. JENVAC has been developed in collaboration with India's National Institute of Virology. It is a safe and highly effective vaccine that protects against all known strains of Japanese Encephalitis.

JENVAC® is a safe and highly effective vaccine that protects against all the known strains of JE. World Health Organization showed that 6,383 cases of JE were reported in India between 2018 and 2022.

Bharat Biotech is a pioneering biotechnology company based in India known for its world-class R&D and manufacturing capabilities.

JENVAC Indication

Japanese Encephalitis is the most common cause of viral Encephalitis in Asia. JE is a mosquito-borne flavivirus and belongs to the same genus as dengue, yellow fever, and West Nile viruses. JE is transmitted to humans through bites from infected mosquitoes of the Culex species. Most JE infections are mild (fever and headache) or without apparent symptoms, but approximately 1 in 250 infections result in severe clinical illness. Severe disease is characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, paralysis, and ultimately death.

JE's case-fatality rate can be as high as 30% among those with disease symptoms. Of those who survive, 20%–30% suffer permanent intellectual, behavioral, or neurological sequelae such as paralysis, recurrent seizures, or the inability to speak. There is no antiviral treatment for patients with JE. Treatment is supportive to relieve symptoms and stabilize the patient.

JENVAC Dosage

Data from a 2-dose study shows that a single dose of JENVAC is sufficient to elicit the immune response as the subjects who received a single dose were 98.67% sero-protected, and the 4-fold sero-conversion was at 93.14% for the ≥1 year to ≤50 years age group. JENVAC vaccine is administered intramuscularly into the deltoid region of the upper arm for adults and the anterolateral regarea of the thigh for children. As per the Recommended immunization schedule (2018-19), the JE vaccine should be administered at 12 months and 13 months. Infants younger than two months should not be administered JE the vaccine; People who have had a life-threatening allergic reaction to the JE vaccine or any ingredient in the vaccine.

JENVAC Adverse Events

The most common adverse events noted were pain, swelling, or redness where the shot was given, headache and muscle aches (mostly in adults), and low fever (mainly in children). Serious side effects from the JE vaccine are very infrequent.

JENVAC Vaccine News

February 2024 - India's government will vaccinate over 25 lakh children in four districts, including Indore, Bhopal, Narmadapuram, and Sagar, beginning February 27, 2024.

August 1, 2022 - Japanese Encephalitis has claimed four more lives in Assam, India, taking the death toll to 52.

0 min read

Manufacturer:

Bharat Biotech

Reviewer:

Robert Carlson, MD

Vaccine:

Jenvac Japanese Encephalitis Vaccine

VIS:

PDF

Availability:

Not licensed for use in the US

Generic:

JE Vaccine

Drug Class:

Vaccine

Find Price:

Discounts

Clinical Trial Phase II:

A Phase II/III, Randomized, Single Blinded, Active Controlled Study to Evaluate the Immunogenicity and Safety of inactivated Jap

Condition:

Japanese Encephalitis

Last Reviewed:

Saturday, February 24, 2024 - 05:50

Brand:

JENVAC

Status:

Approved

Manufacturer Country ID:

Kosher:

Yes

Halal:

Yes

Countries:

India

Rate Vaccine:

EH65UOFx

Chikungunya Vaccines

Chikungunya Vaccines December 2025

Chikungunya vaccines have been commercially available since 2023 and are approved in various countries, including the United States, as of December 2025. Like many vaccines, Chikungunya virus (CHIKV) vaccine technologies, such as live-attenuated virus vaccines, inactivated viral vaccines, recombinant viral vaccines, chimeric alphavirus candidates, DNA vaccines, and virus-like particles, focus on optimizing the balance between efficacy, immunogenicity, and safety, according to the World Health Organization (WHO).

Chikungunya Vaccine Approved and Available

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) issued recommendations for the CHIKV vaccine in April 2025, which were adopted by the HHS Secretary on May 13, 2025. As of May 21, 2025, these recommendations are the official guidelines of the CDC.

In the United Kingdom, IXCHIQ® and Vimkunya® vaccines have been reviewed by the Joint Committee on Vaccination and Immunization as of August 7, 2025, and guidance will be drafted for the UK Health Security Agency's green book,' Immunization against infectious disease. Health professionals offering these vaccines must ensure they are adequately informed on their use.

The IXCHIQ chikungunya vaccine from Valneva SE was approved in the U.S. in 2023 and in Canada, Europe, the United Kingdom, and Brazil. On August 22, 2025, it was removed from the U.S. market.

VIMKUNYA® is a virus-like particle vaccine produced by Bavarian Nordic A/S. It was approved in the U.S. and Europe in 2025. It became commercially available at travel clinics and pharmacies in March 2025.

Chikungunya Vaccine Candidates 2025

The WHO states that several advanced chikungunya vaccine candidates are either undergoing or have already completed regulatory review.

Bharat Biotech International Ltd.'s Chikungunya vaccine candidate, BBV87, is an inactivated whole-virion vaccine based on a strain derived from an East, Central, and South African genotype.

Moderna's mRNA-1944 vaccine candidate encodes a fully human IgG antibody, initially isolated from the B cells of a patient with a prior history of dengue. A study published in March 2025 concluded that the results from both mouse and rhesus macaque models indicate that the vaccine could be a candidate for clinical use against CHIKV.

CD8+ T cell CHIKV Adaptive Vaccine candidate. Including the ligandome into the vaccine construct will require the selection of eight to twelve peptides from the CHIKV peptide set (ligandome), all of which meet several specific criteria. In efficacy studies, the following will then need to be completed.

The Access to Advanced Health Institute received an $18 million award from the National Institutes of Health to develop a temperature-stable, single-dose vaccine candidate for the chikungunya virus. The vaccine uses an innovative RNA platform technology.

A CHIKV vaccine candidate based on baculovirus displaying the chikungunya E1-E2 envelope confers protection against clinical challenges in mice. C57BL/6 mice were immunized with non-adjuvanted recombinant baculovirus-induced IgG antibodies against E2, with a predominant IgG2c subtype, neutralizing antibodies, and a specific IFN-γ CD8+ T-cell response. A second dose significantly boosted the antibody response.

CHIKV mRNA vaccines study - the results from both mouse and rhesus macaque models indicate that the vaccine could be a candidate for clinical use against CHIKV. Based on the favorable protective effects described in March 2025, 'we consider both mCV-1 and mCV-2 to be potential candidate vaccines for further evaluation in subsequent phase I studies.'

Chikungunya Infections in Infants

This study describes the epidemiological characteristics, clinical presentation, and evolution of unvaccinated patients with CHIKV admitted to the Pediatric Emergency Department in Asunción, Paraguay, during the 2023 epidemic. Results showed a predominance of febrile infants with altered PAT who presented septic shock within the first 24 hours of hospital admission, 15% of patients with seizures, and 2.5% who died.

Chikungunya Virus Mutations

A study published in May 2025 stated the ongoing large outbreak in Sri Lanka is due to the Indian Ocean lineage and the E1:K211E/E2:V264A sublineage of the Chikungunya virus, which has acquired specific, previously uncharacterized mutations. The impact of these mutations on vaccine effectiveness has not been disclosed.

Chikungunya Outbreaks

As of 2025, millions of people live in areas where Chikungunya is endemic. Chikungunya outbreak news is posted at this link.

4 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Saturday, December 13, 2025 - 11:25

Description:

Chikungunya preventive vaccines have been approved in the United States for 2025

Condition:

Chikungunya

Dengue Vaccines

Dengue Vaccines September 2025

According to the World Health Organization (WHO), in 2025, Dengue is a vaccine-preventable disease, with approved vaccines available. As of September 2025, the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Pan American Health Organization (PAHO), the European Medicines Agency (EMA), Australia's Technical Advisory Group on Immunisation, and Brazil's National Health Surveillance Agency (ANVISA) recommend dengue vaccination for specific individuals living in or visiting dengue-risk areas, such as Puerto Rico and Brazil. The UK Health Security Agency published updated dengue vaccination guidance in the 'Green Book' (Chapter 15a) in October 2024.

Dengvaxia® is a live attenuated tetravalent chimeric vaccine approved by the U.S. FDA and various countries. Dengvaxia is no longer offered in the U.S., except for children in Puerto Rico, where Dengue fever has become endemic.

QDENGA® dengue vaccine is approved or authorized in various countries and does not require pre-admission testing. As of July 2025, the U.S. FDA has not approved this vaccine.

Dengue Vaccine Candidates

As of September 2025, clinical trials for the dengue vaccine candidate are recruiting new participants. A review, published in 2025, highlights the challenges in developing a third-generation dengue vaccine. A study published in April 2025 found that the antibody avidity index is essential for characterizing protective DENV immune responses.

Merck's MOBILIZE-1 Phase 3 clinical trial is being initiated for V181, a live attenuated quadrivalent dengue vaccine candidate. As of June 12, 2025, the study will evaluate a single dose of V181 for the prevention of dengue disease caused by any of the four serotypes of the dengue virus, regardless of previous exposure.

Panacea Biotech, in collaboration with the Indian Council of Medical Research (ICMR), is developing the DengiAll dengue vaccine. The tetravalent dengue vaccine strain (TV003/TV005), initially created by the U.S. National Institutes of Health, has shown promising results in preclinical and clinical trials worldwide. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results. With 3 years of follow-up, the single-dose tetravalent dengue vaccine, TV005, was well tolerated and immunogenic for all four serotypes in young children to adults, including individuals with no previous dengue exposure. Panacea Biotec has worked extensively on these strains to create a full-fledged vaccine formulation and holds a process patent. In August 2024, ICMR and Panacea announced the launch of a Phase 3 clinical trial in India.

Butantan Institute's Butantan-DV tetravalent dengue vaccine candidate demonstrated 67-79% efficacy in preventing the disease in Brazil, according to a Phase 3 clinical study, which is ongoing through 2024. On December 16, 2024, the Company submitted the proposal to Anvisa for approval. The institute can produce 100 million doses if approved over the next three years. On February 1, 2024, an Original Article concluded that a clinical study found a single dose of Butantan-DV prevented symptomatic DENV-1 and DENV-2, regardless of dengue serostatus at baseline, through 2 years of follow-up. Butantan-DV is derived from a technology licensed from the U.S. National Institutes of Health (NIH) in 2009. Under the collaboration agreement announced in December 2018, Merck and Instituto Butantan are sharing clinical study data.

Serum Institute of India's tetravalent dengue vaccine live candidate, Dengusiil, is conducting phase 2 clinical research in 2024. A previous Phase 1 study concluded that a single dose of Dengusiil was safe and well-tolerated in adults, and highly immunogenic, with trivalent or tetravalent seroconversion and seropositivity in most participants (69%).

National Institute of Allergy and Infectious Diseases - TetraVax-DV T005 (rDEN3Δ30/31-7164) is a live attenuated tetravalent vaccine. A Phase 2 clinical trial revealed that, with three years of follow-up, a single dose of TV005 was well-tolerated and immunogenic for all four serotypes in young children and adults, including individuals with no prior dengue exposure. Results of a phase 2 study of TV005 in Bangladesh, published in 2024, reported the waning of antibody titers in children aged 1–4 years who were seronegative at the time of vaccination. Only 22–28% of children in this age group remained seropositive for DENV-1, DENV-3, and DENV-4 after three years of follow-up, compared with 69% seropositivity for DENV-2.

TetraVax-DV-TV003 (V180) is a live-attenuated, recombinant, tetravalent investigational dengue vaccine, currently undergoing a Phase 3 clinical trial in Brazil. Dr. Stephen Whitehead's laboratory developed the vaccine. Merck recently completed a phase 1 study (V180-001).

The DV1-DV4 vaccine candidate is transitioning into a human clinical study. This new vaccine construct, which comprises Nature's gene-chip peptides bound to a quantum cluster gold nanoparticle delivery system, demonstrated an excellent safety profile in a repeat-dose Good Laboratory Practice (GLP)- grade toxicology study using a standard industry model.

Àvida Biotech's novel oral vaccine candidate for Dengue does not require cold transport or storage and has completed proof of concept in a mouse model. Additionally, the University of Buffalo's Center for Integrated Global Biomedical Sciences will provide expertise in preclinical drug development.

K.M. Biologics' KD-382 vaccine is a live-attenuated tetravalent dengue candidate in Phase 1 clinical trials. A single dose is expected to be effective against all four serotypes. Additionally, this live attenuated virus vaccine is expected to induce neutralizing antibodies and cellular immunity, similar to that caused by natural infection.

Emergex PepGNP-Dengue DengueTcP™, Its Novel T Cell-Priming Immune Set-Point Candidate, uses 100% synthetic vaccines to 'prime' naive CD8+ T-Cells to generate virus-specific CTL (CD8+ Cytotoxic T Lymphocyte cells) to kill infected cells before productive viral infection, thus preventing viral replication and disease in the vaccinated person. naNO-DENGUE: A Phase-I study of a nanoparticle-based peptide vaccine against Dengue virus.

CodaVax-DENV is a next-generation, tetravalent, live-attenuated dengue vaccine candidate under development by Codagenix Inc. The Company's vaccine design platform has enabled the precise and rational attenuation of contemporary serotypes of all four dengue virus strains through selective codon deoptimization. With this approach, Codagenix can rationally balance all four virus serotypes to produce a safe and highly immunogenic vaccine. On October 24, 2023, Codagenic announced that the U.S. Department of Defense awarded the Company $5.88 million to advance the development of its CodaVax-DENV program. The funding supports good manufacturing practices of drug substances and tetravalent drug products for a Phase 1 study and a first-in-human Phase 1 safety and immunogenicity trial. This award complements a $4.4 million Department of Defense (DoD) award granted in 2022.

Indian Immunologicals Limited (IIL) anticipates launching its dengue fever vaccine commercially by 2026. IIL's Managing Director, K. Anand Kumar, stated on August 20, 2024, that the vaccine's early-stage trials involving approximately 90 individuals aged 18-50 did not demonstrate any adverse effects. The U.S. National Institute of Health provided IIL with the dengue virus required to develop the vaccine. ILI is a subsidiary of the National Dairy Development Board.

Dengue Monoclonal Antibody Therapy

Dengushield (VIS513) is a humanized monoclonal antibody (mAb), not a vaccine, that delivers passive immunization and is evaluated in phase 2 clinical trials to treat Dengue. VIS513 is a highly potent inhibitor of all four types of dengue viruses, both in vitro and in preclinical animal models. VIS513 was licensed to the Serum Institute of India Pvt. Ltd (SIIPL) for development and commercialization may cost 5,000 to 10,000 rupees per dose. SIIPL funded a Phase 1 study announced in February 2024, and the VIS513 mAb was found to be safe and well-tolerated, with a dose-proportionate increase in pharmacokinetic exposure. A phase 3 study is ongoing.

AbViro LLC (Janssen, LP) AV-1 dengue mAb candidate (JNJ-64281802) is conducting a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Safety and Efficacy of Three Dose Levels in Healthy Adults Challenged With a Controlled Human Infection Strain of DENV-3. Before or after AV-1 dosing, each volunteer will receive an attenuated (weakened) dengue virus injection. If AV-1 shows promising results in this clinical trial, researchers may pursue further clinical evaluations of its safety and efficacy against the dengue virus. In earlier studies using this challenge virus, most volunteers developed a rash, and some had other mild dengue symptoms, such as joint and muscle pain or headache. None of the volunteers developed dengue fever or severe Dengue.

Dengue Outbreaks 2025

Visit Vax-Before-Travel for the latest travel alerts regarding dengue outbreaks in June 2025.

8 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Friday, September 5, 2025 - 13:40

Description:

Dengue vaccines are approved by various countries in September 2025.

Condition:

Dengue

TetraVax-DV (V180) Dengue Vaccine

TetraVax-DV (V180) Dengue Vaccine Clinical Trials, Dosage, News, Side Effects, Usage

Merck & Co., Instituto Butantan, and Medigen Vaccine Biologics (MVB), co-developed TetraVax-DV, V180, Butantan-DV, and TV003) adjuvanted, tetravalent subunit dengue vaccine candidate comprised truncated forms of envelope proteins (DEN-80E), derived from strains of all four dengue virus serotypes (DEN-1 strain 258848, DEN-2 strain PR159 S1, DEN-3 strain CH53489, and DEN-4 strain H241). The DEN-80E subunits are expressed from plasmids in the Drosophila S2 cell expression system and are formulated with either ISCOMATRIX (saponin, cholesterol, and phospholipid adjuvant; CSL) or Alhydrogel (aluminum hydroxide gel adjuvant; Brenntag Nordic).

In 2024, according to a phase 3 clinical study conducted in Brazil, the V180 vaccine candidate was found to be 79.6% effective in preventing dengue. During this period, no serious dengue cases were reported in the participants. The positive result is the result of more than ten years of work with international partners. In the phase 2 clinical trial, the results were published in an article in The Lancet Infectious Diseases. According to the clinical study report, no vaccine-related SAEs were observed in 54 subjects aged 20-70. The immunogenicity data demonstrates that the vaccinated group produced higher neutralizing antibody titers (GMTs of PRNT50, and had a higher seropositivity rate against types of Dengue virus than the controlled group. Moreover, the vaccinated group remained expressing neutralizing responses on day 180 and day 365 after vaccination, this result reveals that MVC's dengue vaccine shows immunogenicity not only within 20-50-year-old subjects but also in the elder group aged 51-70 years old.

Development of the tetravalent dengue vaccine began at Butantan Institute in 2010 with FAPESP's support (Grant number: 08/50029-7), using a formulation created by researchers affiliated with the US National Institutes of Health (NIH). Clinical trials in Brazil began in 2013, with the support of the Butantan Foundation and BNDES, Brazil's national development bank, under the aegis of the project "Development of a tetravalent dengue vaccine," led by Neuza Frazatti Gallina, winner of the 2023 Péter Murányi Prize.

On December 16, 2022, Merck announced, 'We are highly encouraged by the tremendous progress scientists and clinicians at the Instituto Butantan have made in developing their single-dose dengue vaccine candidate.' In February 2024, infectious disease specialist Esper Kallás informed Agência FAPESP, "In June (2024), we'll complete the five-year follow-up period. Once the data has been consolidated, we'll know how long the vaccine-induced protection will last."

Instituto Butantan, in São Paulo state, Brazil, is the largest producer of vaccines and serums in Latin America and the main producer of immunological products in Brazil. MVC is a biopharmaceutical company focusing on developing and mass-producing vaccines and biologics. It is located at No. 68, Shengyi 3rd Rd., Zhubei City, Hsinchu County 302, Taiwan (R.O.C.).

TetraVax-DV (V180) Vaccine Dosage

V180 is administered as an intramuscular injection. A single dose schedule was evaluated in the phase 3 study. The two-dose schedule could still be improved to reduce the risk of non-compliance. However, it is believed that V180 would achieve significant commercial potential as part of a heterologous prime-boost strategy.

TetraVax-DV (V180) Dengue Vaccine News

February 1, 2024 - The NEJM published an Original Article - Live, Attenuated, Tetravalent Butantan–Dengue Vaccine in Children and Adults.

April 8, 2023 - The phase II study for the dengue vaccine in Taiwan finished the bridging and proof-of-concept study assessed ethnic differences and evaluated the immunogenicity of the elderly population.

December 16, 2022 - Butantan confirmed its dengue vaccine is 79.6% effective in phase 3 study results.

April 13, 2022 - A new strain of dengue was detected in Brazil in a man from Aparecida de Goiânia by researchers from the Oswaldo Cruz Foundation and the Central Public Health Laboratory of Goiás. The serotype two genotype, also known as the cosmopolitan genotype, is the most widespread dengue virus lineage globally, but it had never been found in Brazil.

March 24, 2020 - The Lancet published a study: Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomized placebo-controlled phase 2 trial. Butantan-DV and TV003 were safe and induced robust, balanced neutralizing antibody responses against the four DENV serotypes. The efficacy evaluation of the Butantan-DV vaccine is ongoing.

February 15, 2018 - Global Drug Analysis: V180 - More Compact Dosing Schedule Could Make It a More Attractive Alternative to Dengvaxia.

V180 Dengue Vaccine Clinical Trials

ClinicalTrials NCT02406729: Over a 3-year enrollment period, 16,235 participants received either Butantan-DV (10,259 participants) or placebo (5976 participants). The overall 2-year vaccine efficacy was 79.6% (95% confidence interval [CI], 70.0 to 86.3) — 73.6% (95% CI, 57.6 to 83.7) among participants with no evidence of previous dengue exposure and 89.2% (95% CI, 77.6 to 95.6) among those with a history of exposure.

Clinical Trial NCT02450838: Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005).

Clinical Trial NCT01477580: Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001) (Completed, No results posted).

0 min read

Manufacturer:

Instituto Butantan

Reviewer:

Robert Carlson, MD

Vaccine:

TetraVax-DV (V180) Dengue Vaccine

Availability:

TBD

Generic:

V180

Drug Class:

vaccine

Clinical Trial Phase I:

Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)

Clinical Trial Phase II:

Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine

Clinical Trial Phase III:

Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine

Condition:

Dengue

Last Reviewed:

Tuesday, March 26, 2024 - 10:20

Brand:

TetraVax-DV

Status:

Candidate

Manufacturer Country ID:

Brazil

FDA First In Class:

Yes

Side Effects:

NEJM study

QDENGA Dengue Vaccine

QDENGA® (TAK-003) Dengue Vaccine Clinical Trials, Dosage, Indication, Side Effects

Takeda GmbH's QDENGA® (TAK-003) (Dengue Tetravalent Vaccine [Live, Attenuated]) is an approved two-dose vaccine preventing dengue fever and/or Severe Dengue caused by any of the four serotypes of the dengue virus. QDENGA is based on dengue serotype 2, which provides the genetic backbone for all four dengue virus serotypes. The active substance of QDENGA (ATC code: J07BX04) contains live attenuated dengue viruses, which replicate locally and elicit humoral and cellular immune responses against dengue serotypes.

Takeda's clinical development program for QDENGA consists of Phase 3, Phase 2, and Phase 1 studies. Data in children and adolescents showed that QDENGA induced immune responses against all four dengue serotypes in seropositive and seronegative participants. In addition, QDENGA was generally safe and well-tolerated. In a Phase 2 study published on October 17, 2024, TAK-003 elicited durable T cell responses against all four DENV serotypes, regardless of baseline serostatus, in individuals aged 4–16 years residing in dengue-endemic countries. Furthermore, TAK-003-elicited CD4+ and CD8+ T cells were multifunctional and persisted for up to 3 years post-vaccination.

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. Europe's Committee for Medicinal Products for Human Use adopted a positive opinion on October 13, 2022, recommending that Takeda GmbH be granted marketing authorization for QDENGA EMEA/H/C/005155. In 2023, Brazil was the first country to integrate QDENGA into its public health system. The World Health Organization (WHO) added QDENGA® (TAK-003) to its List of Prequalified Vaccines, effective May 9, 2024. On May 3, 2024, the WHO published a paper on dengue vaccines, including final guidance on the use of QDENGA in public vaccination programs based on the SAGE recommendation. The WHO-SAGE recommends that TAK-003 be considered for public programs in high-transmission areas for individuals aged 6-16.

On November 3, 2025, Takeda announced data, including an exploratory analysis of a booster dose, confirming the favorable benefit-risk profile of QDENGA and that the two-dose regimen provides sustained protection against Dengue over 7 years. As of November 2025, QDENGA is authorized in the United Kingdom and a total of 41 countries.

Derek Wallace, President, Global Vaccine Business Unit, Takeda Pharmaceuticals, informed Vax-Before-Travel on November 6, 2025, "Dengue is spreading to areas once considered low-risk, with year-round peak seasons in many regions. These long-term data show that QDENGA's two-dose schedule provides sustained protection without a booster, simplifying vaccination efforts and improving our ability to combat Dengue globally."

Osaka-based Takeda Pharmaceutical Company Limited (TSE: 4502, NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people, and the planet in approximately 80 countries and regions. For more information about QDENGA (TAK-003), visit www.TakedaVaccines.com. QDENGA - Trademark Details: 2019-06-04.

QDENGA (TAK-003) Vaccine Availability 2025

The WHO recommends that countries consider introducing TAK-003 into their routine immunization programs in areas with high Dengue transmission intensity, where it poses a significant public health problem. Since 2022, QDENGA has been authorized in 41 countries, and 18.6 million doses have been distributed in 11 endemic countries including Indonesia (approved Aug 2022, available April 2023), Brazil (approved Mar 2023, available June 2023, Thailand (approved May 2023, available Aug 2023), Argentina (approved Apr 2023, available Oct 2023), Malaysia (approved Feb 2024, available June 2024), Colombia (approved Sept 2023, available July 2024), Germany (approved Dec 2022, available Feb 2023), Finland (approved Dec 2022, available Feb 2023), Sweden (approved Dec 2022, available Feb 2023), Norway (approved Dec 2022, available Feb 2023), Denmark (approved Dec 2022, available Mar 2023), The Netherlands (approved Dec 2022, available Mar 2023), Luxembourg (approved Dec 2022, available March 2023), Czech Republic (approved Dec 2022, available April 2023), Austria (approved Dec 2022, available April 2023), Belgium (approved Dec 2022, available April 2023), Ireland (approved Dec 2022, available April 2023), Portugal (approved Dec 2022, available May 2023), Spain (approved Dec 2022, available May 2023), U.K. (approved Jan 2023, available 2024), Slovakia (approved Dec 2022, available Aug 2023), Italy (approved Dec 2022, available Oct 2023), Poland (approved Dec 2022, available Dec 2023), Israel (approved May 2024, available July 2024), Switzerland (approved Aug. 2024), Malasyia, Thailand, and Vietnam. As of 2025, availability in the Philippines and India was [ending.

Qdenga (TAK-003) Vaccine Efficacy

A Takeda-funded study, based in Thailand, concluded on June 17, 2025, that the pragmatic introduction of TAK-003 into the immunization program would prevent 44% of cases and 53% of hospitalizations, resulting in $ 1.346 billion in savings over 20 years.

On October 17, 2024, the journal NPJ Vaccines published results from a study that concluded that TAK-003 was well tolerated and elicited durable T cell responses against all four dengue virus (DENV) serotypes, irrespective of baseline serostatus, in children and adolescents aged 4–16 years living in dengue-endemic countries. TAK-003-elicited CD4+ and CD8+ T cells were multifunctional and persisted for up to 3 years post-vaccination.

An exploratory analysis published on September 11, 2024 (December 2, 2024) demonstrated a vaccine efficacy (VE) of 82.1% for the onset of protection with TAK-003 in the safety population, measured over the three months between the first and second doses. The journal Vaccine published a Short Communication on September 7, 2024, reporting that QDENGA's vaccine efficacy (VE) against disease was 82.1% up to 3 months after the first dose. On October 2, 2023, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) confirmed that QDENGA demonstrated efficacy against all four serotypes of the virus in baseline seropositive children (4-16 years old) in endemic countries, as well as against serotypes 1 and 2 in baseline seronegative children. The SAGE recommended that the Vaccine be considered for introduction to children aged 6 to 16 years in settings with high dengue disease burden and high transmission intensity. Long-term efficacy results announced on June 9, 2022, supplemented previously published TIDES clinical study data, demonstrating QDENGA met its primary endpoint of overall VE against VCD, with 80.2% efficacy at 12-month follow-up, as well as all secondary endpoints for which there were a sufficient number of dengue cases at 18-month follow-up, including 90.4% VE against hospitalized Dengue. On May 20, 2021, an audio review of the Three-Year Efficacy of Takeda's Tetravalent Dengue Vaccine Candidate was published.

Qdenga (TAK-003) Time to Onset of Vaccine Efficacy

A study published in Vaccine on September 7, 2024, in the DEN-301 clinical trial estimated the Vaccine's efficacy onset to be approximately 2 weeks. Results from a study published in the Journal of Infectious Diseases on March 18, 2025, found that TAK-003 had a modest impact on asymptomatic dengue infections in the first months post-vaccination, particularly among baseline seropositive participants.

QDENGA and U.S. FDA

Takeda announced on July 11, 2023, that the Company voluntarily withdrew the U.S. Biologics License Application (BLA) for TAK-003 following discussions with the U.S. Food and Drug Administration (FDA) regarding data-collection aspects that could not be addressed within the current BLA review cycle. The plan for TAK-003 in the U.S. will be further evaluated, given the need for travelers and those living in dengue-endemic areas, such as Puerto Rico, Mexico, and Florida. On November 22, 2022, Takeda announced that the FDA had accepted and granted priority review of the Biologics License Application (BLA) for QDENGA to prevent dengue disease caused by any dengue virus serotype in individuals aged four years through 60 years.

QDENGA and U.S. CDC

During the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) meeting on October 26, 2023, Dr. Gabriela Paz-Bailey (CDC/NCEZID) led a QDENGA update. Wilbur Chen, MD, presented Updates on Dengue Vaccines. On June 22, 2023, I reviewed the following presentations: ACIP Dengue Vaccines Work Group introduction, Wilbur Chen, MD, MSc; Economic analysis and health impacts of routine vaccination with TAK-003 dengue vaccine in San Juan, Puerto Rico; Summary of two economic models for dengue vaccine TAK-003 use in Puerto Rico; Partial Evidence to Recommendations Framework for Dengue Vaccine TAK-003, presented by Joshua Wong, MD. On February 23, 2023, the ACIP met to discuss the following presentations: Introduction, Dr. W Chen; Takeda dengue vaccine (TAK-003) safety and efficacy, Dr. Shibidas Biswal; Workgroup considerations, Dr. Gabriela Paz-Bailey. Previously, Laura Adams, DVM, MPH, DACVPM, led the U.S. CDC's Dengue Epidemiology vaccine overview on October 20, 2022, during the CDC/ACIP Dengue Vaccine Workgroup presentation.

QDENGA (TAK-003) Indication

Dengue is now detected in 129 countries and set a record for cases in 2024. As more travelers return to the U.S. with dengue virus infections, the risk of local mosquito-borne transmission increases. In European Union Member States, QDENGA is indicated for the prevention of dengue disease in individuals aged 4 years and above. It prevents Dengue, which is caused by the four Dengue serotypes. On May 15, 2024, the WHO confirmed that Qdenga is approved for use in children aged 6–16 in settings with a high dengue burden and transmission intensity. The WHO says TAK-003 does not prevent all cases of Dengue.

QDENGA (TAK-003) Dosage

Under the approved dosing regimen, QDENGA should be administered subcutaneously in a two-dose schedule (0 and 3 months) at a dose of 0.5 mL. The WHO SAGE recommends administering QDENGA in a 2-dose schedule with a 3-month interval between doses. QDENGA should be administered preferably in the upper arm in the deltoid region. QDENGA must not be injected intravascularly, intradermally, or intramuscularly. In Europe, the EMA approved after reconstitution, one dose (0.5 mL) contains Dengue virus serotype 1 (live, attenuated)*: ≥ 3.3 log10 PFU/dose Dengue virus serotype 2 (live, attenuated): ≥ 2.7 log10 PFU/dose Dengue virus serotype 3 (live, attenuated): ≥ 4.0 log10 PFU/dose Dengue virus serotype 4 (live, attenuated): ≥ 4.5 log10 PFU/dose.

On September 2, 2024, Vaccine published an analysis that concluded that one dose of TAK-003 was as effective as two doses.

QDENGA (TAK-003) Coadministraion

Co-administration with a hepatitis A vaccine has been studied without increased side effects or impaired antibody response. When co-administered with the yellow fever vaccine, a lower level of neutralizing antibodies against DENV1 was seen, the clinical significance of which is unclear.

QDENGA Co-Administration With HPV9 Vaccine

According to a recent phase 3 clinical study published in the journal Vaccines (Volume 62, August 30, 2025, 127558), dengue-endemic countries, such as the Kingdom of Thailand, have already initiated national Human Papillomavirus (HPV) school-based vaccination programs. Researchers wrote on July 30, 2025, 'Due to the overlapping age range targeted by many vaccines, including 9vHPV (Merck GARDASIL 9®) and TAK-003 (Takeda's QDENGA®), integration of Dengue vaccination into existing vaccination programs could be a beneficial approach to increase vaccine coverage and reduce operational costs.'

QDENGA (TAK-003) Side Effects

A Phase 4 study published by ScienceDirect (Volume 42, Issue 26) on October 4, 2024, identified anaphylaxis as a safety signal for TAK-003 vaccines in adolescents. Most cases of anaphylaxis occurred 15 minutes after vaccination. In response, Brazil's Ministry of Health published recommendations to intensify efforts to ensure safe vaccination, including training for healthcare professionals and post-vaccination observation.

The ongoing Phase 3 study of TAK-003 demonstrated that rates of serious adverse events were 2.9% in the TAK-003 group and 3.5% in the placebo group during the continuing long-term follow-up (i.e., the second half of the three years following vaccination). Still, none of the cases were related to the study drug. The European Medicines Agency states that there is no clear evidence of an increased risk of severe dengue disease in individuals who have been previously infected with the disease.

QDENGA (TAK-003) Adverse Reactions

The most frequently reported adverse reactions post TAK-003 vaccination in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%), and fever (11%). Very common (≥1/10 of subjects): upper respiratory tract infection, decreased appetite, irritability, headache, drowsiness, myalgia, injection site pain, injection site erythema, malaise, asthenia, and fever.

In February 2025, a study reported that Vaccine-related reactions were frequently reported, predominantly after the first dose in dengue-naïve participants.

QDENGA (TAK-003) Contraindications

Contraindications include hypersensitivity to the active substances or excipients listed, as well as a history of hypersensitivity to QDENGA. Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g., 20 mg/day or 2 mg/kg body weight/day of prednisone for two weeks or more) within four weeks before vaccination. Individuals with symptomatic HIV infection or asymptomatic HIV infection, with impaired immune function, and pregnant and breastfeeding women.

QDENGA (TAK-003) Vaccination of Pregnant Women

A post-hoc analysis published on March 18, 2025, found no evidence of increased adverse pregnancy outcomes following unintentional TAK-003 vaccination within the exposure window, compared with placebo.

QDENGA Format

Qdenga is available as a powder and as an injection solution.

QDENGA (TAK-003) Vaccination Breakthrough Case

The immune response to dengue infection is complex and multifaceted, and the infection can progress to severe disease with limited clinical signs. This study, published in October 2024, examined a case involving a child who developed dengue symptoms after receiving the Qdenga vaccination. Despite initial negative diagnostic results, molecular analysis confirmed DENV4 infection.

QDENGA (TAK-003) Price

Takeda indicated in a March 16, 2023, presentation that the price of QDENGA in Indonesia would be USD 40 per dose, USD 26 ex-factory. For the travel market segment, vaccine pricing will be similar to that of other innovative travel vaccines in their respective countries. For example, the retail price in Germany would be USD 115 per dose. In Brazil, reports indicate QDENGA's price is about $171.

Qdenga (TAK-003) Vaccine Revenues

QDENGA Q4 FY2024 (April 2024-March 2025) Revenue was JPY 35.6B (+259%), QDENGA's FY2024 H1 Revenue was JPY 19.9B (+863% growth); FY2024 Q1 Revenue was JPY 9.5B (+1,099% growth).

QDENGA Vaccine Production

Biological E. Limited is committed to manufacturing up to 50 million QDENGA vaccine doses annually, accelerating Takeda's ability to deliver 100 million doses annually by 2030.

QDENGA Vaccine News

November 3, 2025 - "QDENGA is the most comprehensively studied dengue vaccine, with more than 60,000 participants globally in the clinical program, and these long-term data highlight the durability of its safety and efficacy profile, across diverse populations worldwide," said Derek Wallace, M.D., president of the Global Vaccine Business Unit at Takeda.

August 25, 2025 - A study reported: We find some evidence of a risk of vaccine-induced disease enhancement in seronegative vaccine recipients for dengue serotypes 3 and 4, especially for children under 6 years of age. Because of this, the benefits of vaccination in lower-transmission settings are less specific, and more data on the long-term efficacy of Qdenga against serotypes 3 and 4 are needed.

June 9, 2025 - Thailand's Public Health Minister Somsak Thepsuthin unveiled a new national strategy during the 2025 ASEAN Dengue Day event, which includes deploying QDENGA vaccinations in 2025.

February 18, 2025 - The Philippine Medical Association requested access to new-generation dengue vaccines.

September 7, 2024: The journal Vaccine published a Short communication titled "Early onset of protection of the TAK-003 dengue vaccine: Data from the DEN-301 clinical trial." The Estimated time to the onset of Qdenga vaccine efficacy was approximately two weeks.

May 10, 2024 - The World Health Organization prequalified Takeda's QDENGA vaccine. "The prequalification of TAK-003 is an important step in the expansion of global access to dengue vaccines, as it is now eligible for procurement by UN agencies, including UNICEF and PAHO," said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification.

May 9, 2024 - Takeda announced financial results for fiscal year 2023 (period ended March 31, 2024).

October 3, 2023 – Takeda announced that the WHO Strategic Advisory Group of Experts on Immunization issued recommendations for the use of QDENGA.

July 11, 2023 - "Our clinical program was designed to account for the complex global nature of dengue, and data from our 4.5-year trial has built confidence in TAK-003's ability to help provide long-term protection against dengue, with a positive benefit and risk profile regardless of baseline serostatus," said Gary Dubin, M.D., president of Takeda's Vaccines Business Unit.

June 22, 2023 - The U.S. CDC's Advisory Committee on Immunization Practices reviewed various dengue vaccine presentations.

May 23, 2023 - Filomeno Fortes, Director of Portugal's Institute of Hygiene and Tropical Medicine, confirmed the authorization of the Qdenga vaccine.

May 11, 2023 - Takeda announced its collaboration with Brazil's National Health Surveillance Agency. In March 2023, QDENGA received the first approval in Latin America.

March 13, 2023 - José Manuel Caamaño, president of Takeda in Brazil, stated in a press release, "We are proud to make our vaccine available to the Brazilian government and health care providers with the hope that it may become an important tool to help combat dengue as part of an integrated dengue management program along with vector control."

February 6, 2023 - Takeda UK Ltd. announced that the U.K.'s Medicines and Healthcare products Regulatory Agency had granted marketing authorization for Qdenga.

October 20, 2022: The U.S. CDC vaccine committee presented Dengue Epidemiology: Globally and in the U.S., including ACIP dengue vaccine recommendations.

October 14, 2022 - The EMA's human medicines committee recommended granting marketing authorization for the QDENGA Dengue Tetravalent Vaccine (Live, Attenuated) to prevent dengue virus serotypes 1, 2, 3, and 4 in individuals aged four years and above.

August 22, 2022: Gary Dubin, president of Takeda's Vaccine Business Unit, announced, "We're proud to introduce QDENGA as a new dengue prevention tool to the people of Indonesia. We will continue to work with additional regulatory agencies to make QDENGA available globally."

March 17, 2020 - The Lancet published the 'Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17.

November 6, 2019: Takeda's Dengue Vaccine Candidate Demonstrates Protection in Children Aged Four to 16, Regardless of Previous Dengue Exposure.

November 5, 2019 – Takeda Pharmaceutical Company announced plans for a new manufacturing plant in Singen, Germany, for TAK-003.

January 29, 2019 - Takeda announced that TAK-003, which is in a pivotal Phase 3 trial, met the primary efficacy endpoint.

September 7, 2016 - Takeda Initiated the Global Phase 3 Clinical Trial (TIDES) of the Dengue Vaccine Candidate (TAK-003).

QDENGA TAK-003 Clinical Trials

The approval of QDENGA is based on results from 19 Phase 1, 2, and 3 trials involving more than 28,000 children and adults, including 4.5 years of follow-up data from the global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. The study was designed in collaboration with the World Health Organization (WHO) for a second-generation dengue vaccine. A study published in the journal Vaccine on August 22, 2023, reported an efficacy of approximately 80.2% (95% CI, 73.3–85.3) against any serotype in the primary analysis. QDENGA's effectiveness declined over time, with 62% (95% CI, 56.6–66.7) efficacy at 3 years and 61.2% (95% CI, 56.0–65.8) at 4.5 years.

As of June 9, 2022, through four and a half years, TAK-003 demonstrated 84.1% vaccine efficacy (VE) (95% CI: 77.8, 88.6) against hospitalized Dengue, with 85.9% VE (78.7, 90.7) in seropositive individuals and 79.3% VE (63.5, 88.2) in seronegative individuals. TAK-003 also demonstrated an overall vaccine efficacy (VE) of 61.2% (95% CI: 56.0-65.8) against virologically confirmed Dengue (VCD), with 64.2% VE (58.4-69.2) in seropositive individuals and 53.5% VE (41.6-62.9) in seronegative individuals. Observations of VE varied by serotype and remained consistent with previously reported results. TAK-003 was generally well tolerated, and no critical safety risks were identified. No evidence of disease enhancement was observed during the 54-month exploratory follow-up analysis.

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Manufacturer:

Takeda

Reviewer:

Robert Carlson, MD

Vaccine:

QDENGA Dengue Vaccine

VIS:

PDF

Availability:

WHO Prequalified - Indonesia, Europe, UK, Brazil, Thailand, Argentina, Switzerland

Generic: