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VIMKUNYA® Chikungunya Vaccine Clinical Trials, Dosage, Efficacy, Indication, Side Effects 

Bavarian Nordic A/S VIMKUNYA® (Chikungunya Vaccine, Recombinant) CHIKV-VLP (PXVX0317) is a single-dose aluminum hydroxide-adjuvanted, non-live chikungunya virus-like particle vaccine (VLP) with a multi-protein structure that mimics the organization and conformation of naturally occurring viruses without the viral genome, promoting a more robust immune response and increased antibody production. Vimkunya vaccination triggers the production of neutralizing antibodies at 22 days and up to 183 days post-vaccination, which is expected to confer protection against chikungunya disease. Studies have shown that VLP vaccines are highly immunogenic, have a proven safety record, and typically elicit high-titer neutralizing antibodies, essential for protecting against the Chikungunya virus (CHIKV). The VLPs consist of CHIKV capsid protein (C) and envelope proteins E1 and E2 derived from the CHIKV Senegal strain 37997. VIMKUNYA™ is the first chikungunya vaccine to leverage VLP technology. It utilizes virus-like particles designed to mimic the chikungunya virus, but without the ability to infect cells, replicate, or cause disease. VIMKUNYA technology is licensed from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health (NIH).

On February 14, 2025, the U.S. Food and Drug Administration (FDA) approved VIMKUNYA for injection, the first VLP chikungunya vaccine in the United States, for individuals 12 years of age and older. Concurrent with the approval, the FDA awarded Bavarian Nordic (BN) a Priority Review Voucher (PRV) under the Tropical Disease PRV program, which the Company intends to monetize when appropriate. On August 13, 2024, BN announced that the FDA had accepted and granted a Priority Review and Fast Track for the Biologics License Application for CHIKV VLP for individuals 12 and older. The FDA posted the Briefing Document on November 8, 2019. The FDA's approval of VIMKUNYA was based on data from two phase 3 studies that assessed the vaccine's effectiveness by measuring anti-chikungunya virus neutralizing antibody levels in over 3,500 healthy participants aged 12 years and older. On June 26, 2025, Dr. Lyle Petersen of the U.S. CDC presented this information during the ACIP vaccine meeting.

On March 7, 2025, BN announced that the UK Medicines and Healthcare products Regulatory Agency had validated the marketing authorization application and accepted it for review of VIMKUNYA. On February 28, 2025, BN announced that the European Commission had granted marketing authorization for VIMKUNYA in Europe for active immunization to prevent disease caused by the Chikungunya virus in individuals aged 12 years and older. Bavarian Nordic will launch VIMKUNYA in key European markets in the first half of 2025. The European Medicines Agency (EMA) granted PRIME designation in January 2020 (EMEA-002656-PIP01-19). Vimkunya was reviewed under the EMA's accelerated assessment program.

On May 12, 2025, a Journal Article concluded that CHIK-VLP provides approximately 95% overall short-term seroresponse rates in robust trials among potential travelers to CHIKV endemic areas, with an onset of seroprotection that may be as short as 8 days. On August 15, 2025, a study published in The Journal of Infectious Diseases provides the first in vivo evidence that CHIKV directly infects cartilage-producing chondrocytes, offering insights into the mechanisms of alphaviral arthritis.

Bavarian Nordic A/S is a fully integrated vaccine company headquartered in Denmark that develops, manufactures, and commercializes life-saving vaccines. Gaithersburg, Maryland-based Emergent BioSolutions sold this vaccine to Bavarian Nordic A/S on May 15, 2023. As of November 14, 2025, revenue for the first nine months of 2025 increased by 32% to DKK 4,793 million, reflecting a strong performance in both Travel Health and Public Preparedness. Travel Health revenue increased by 23% to DKK 2,327 million compared to the first nine months of 2024, primarily driven by increased demand for rabies and Tickborne encephalitis vaccines, and supported by the gradual launch of the chikungunya vaccine, Vimkunya®. Vimkunya's revenue was DKK 42 million in the first nine months of 2025.

VIMKUNYA Chikungunya Vaccine Availability 2025

As of 2025, VIMKUNYA is commercially available in various countries. VIMKUNYA is the first chikungunya vaccine approved in Europe, the UK, and the United States for individuals as young as 12 years old. As of November 2025, Vimkunya has also been launched in Sweden, Norway, Finland, Italy, and Spain in October.

On February 25, 2025, Bavarian Nordic announced a strategic partnership with Biological E. Limited to expand access to VIMKUNYA in low—and middle-income countries.

VIMKUNYA Efficacy

On April 19, 2025, The Lancet published results from a pivotal phase 3, randomized, double-blind, placebo-controlled, parallel-group trial, concluding that Vimkunya induces a rapid and robust immune response, supporting the potential for this vaccine to protect individuals aged 12–64 years from disease caused by the chikungunya virus.

U.S. CDC and VIMKUNYA

Bavarian Nordic announced on April 16, 2025, that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend VIMKUNYA for injection to prevent disease caused by the chikungunya virus. The ACIP recommends VIMKUNYA for individuals aged 12 and older traveling to a country or territory with a chikungunya outbreak. In addition, VIMKUNYA may be considered for persons traveling to or taking up residence in a country or territory without an outbreak but with an elevated risk for U.S. travelers, particularly if planning extended travel. The ACIP also recommends VIMKUNYA for laboratory workers with potential exposure to chikungunya. The HHS Secretary adopted these ACIP recommendations on May 13, 2025, and they are now official recommendations of the CDC.

VIMKUNYA Chikungunya Vaccine Indication

VIMKUNYA is indicated to prevent the Chikungunya virus, which is spread to people through infected mosquitoes. Symptoms lasting 3-4 weeks include high-grade fever, joint pain, headache, muscle pain, joint swelling, or rash. Chikungunya chronic arthralgia impacts a minority of patients but creates long-term health and work concerns. As of March 2025, Additional clinical studies are required to confirm the clinical profile of VIMKUNYA™, and confirmatory efficacy studies are also planned as part of the post-marketing commitments and requirements as agreed with the U.S. FDA.

VIMKUNYA Chikungunya Vaccine Dosage

VIMKUNYA is administered as a 40 µg dose by a muscular injection. VIMKUNYA is supplied as a single-dose, 1-mL glass prefilled syringe with a 0.8-mL dose volume. People with a lowered immune system, including people receiving medications that affect the immune system, may have a diminished response to VIMKUNYA™ vaccination.

VIMKUNYA Chikungunya Vaccine Side Effects

The most commonly reported adverse event in the clinical study was pain at the injection site, occurring in 12 (23%) of 53 participants who received the unadjuvanted vaccine (Group 1) and 111 (31%) of 356 who received the adjuvanted vaccine. No vaccine-related serious adverse events were reported. People should not receive VIMKUNYA if they are allergic to any of the vaccine ingredients or have had an allergic reaction following a previous dose of VIMKUNYA. 

VIMKUNYA Vaccination Recommendation

Chikungunya vaccination is recommended for adults traveling to a country or territory with a chikungunya outbreak. Since 2014, the U.S. CDC has reported Chikungunya virus disease cases among U.S. travelers returning from countries in the Americas where the virus is circulating. As of March 18, 2025, there have been Chikungunya outbreaks in numerous countries across Africa, the Americas, Asia, and Europe.

VIMKUNYA Revenues

Vimkunya's revenue from sales was DKK 5 million in the first quarter of 2025. The vaccine was launched in the U.S. in mid-March 2025, and the first European markets are expected to launch in the second quarter of 2025. On June 18, 2025, Bavarian Nordic announced that it had agreed to sell its Priority Review Voucher for a total cash consideration of $160 million, which will be recognized as other income.

VIMKUNYA Chikungunya Vaccine News

November 14, 2025 - Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: "Our travel health portfolio has shown continued strength, contributing to our best quarter for this business to date. 

July 31, 2025 - Bavarian Nordic A/S announced the completion of the sale of its Priority Review Voucher, for which the Company received a cash consideration of $160 million. 

July 22, 2025 - Paul Chaplin, President and CEO of Bavarian Nordic, said: "The regulatory submission and acceptance by Health Canada represent yet another highlight in our efforts to expand access to our chikungunya vaccine across the globe."

May 9, 2025 - Bavarian Nordic A/S announced its interim financial results and business progress for the first three months of 2025. Revenue for the first three months increased 62% to DKK 1,347 million, reflecting a strong performance in Travel Health and Public Preparedness.. Travel Health revenue increased by 52% to DKK 680 million.

April 16, 2025 - Paul Chaplin, President and CEO of Bavarian Nordic, stated: "The ACIP's recommendation of our chikungunya vaccine for Americans aged 12 and older represents a significant step forward in expanding access to this vaccine in the U.S."

March 27, 2025 - The Lancet published the results from a company-sponsored Phase 3 clinical study, which showed very positive outcomes.

March 18, 2025 - Lee Ann Kimak, Vice President of Commercial for North America at Bavarian Nordic, commented, "As the first virus-like particle single-dose, prefilled syringe chikungunya vaccine, VIMKUNYA™ provides a crucial new tool to help protect at-risk individuals traveling to regions where the virus is spreading."

March 7, 2025 - "Following the approvals of our Chikungunya vaccine in the US and EU last month, we are excited about the opportunity to expand its availability to European countries later this year," said Paul Chaplin, President and CEO of Bavarian Nordic.

March 5, 2025 - The Company stated: We have a leading commercialized portfolio of travel vaccines, and we continue to strengthen our position as a preferred supplier of mpox and smallpox vaccines to governments for public health preparedness.

February 28, 2025: Paul Chaplin, President and CEO of Bavarian Nordic, commented, "As we expand our presence across Europe, this vaccine will help further consolidate our leading position in travel vaccines. We look forward to making the vaccine available in key markets during the first half of 2025."

February 14, 2025 - Paul Chaplin, President and CEO of Bavarian Nordic, commented in a press release, "As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travelers and vulnerable populations."

January 31, 2025 - "The (EMA) recommendation of our chikungunya vaccine for approval in Europe marks a huge milestone in our efforts to deliver protection against this debilitating disease and, once approved, would represent a significant contribution to expanding the availability of vaccines to a broader population, including adolescents aged 12-17 years," said Paul Chaplin, President and CEO of Bavarian Nordic.

January 31, 2025 - Meeting highlights from the Committee for Medicinal Products for Human Use 27-30 January 2025.

August 13, 2024 - "The FDA review, along with the ongoing review of our CHIKV VLP vaccine by EMA, represents the first regulatory reviews of a chikungunya vaccine for adolescents, potentially providing a broader usage by populations at risk of this debilitating disease," commented Paul Chaplin, President and CEO of Bavarian Nordic.

July 18, 2024 - "The MAA submission and review marks a pivotal milestone for Bavarian Nordic in 2024, and we look forward to working closely with EMA throughout the evaluation process to make our chikungunya vaccine available to individuals 12 years of age and older at risk of chikungunya virus infection," said Paul Chaplin, President and CEO of Bavarian Nordic.

June 26, 2024 - "The MAA marks our second major submission in just a few weeks as part of our efforts to launch the Chikungunya vaccine next year in the U.S. and Europe," said Paul Chaplin, President and CEO of Bavarian Nordic, in a press release.

May 15, 2023: Bavarian Nordic acquired the rights to the development-stage Chikungunya vaccine candidate CHIKV VLP and manufacturing development facilities in Bern, Switzerland, and San Diego, California.

November 1, 2022 - Emergent BioSolutions Inc. announced results from a Phase 2 study evaluating the safety and immunogenicity of the CHIKV VLP vaccine candidate in prior recipients of other investigational alphavirus vaccines. The study demonstrated that the CHIKV VLP vaccine candidate was well-tolerated and immunogenic in alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus. 

May 26, 2021 - Emergent BioSolutions Inc. announced two-year persistence data from its Phase 2 clinical study. Two years post-vaccination, SNA responses were 19 times higher than pre-vaccination titers following a single adjuvanted 40 µg dose of the CHIKV VLP vaccine, supporting the persistence of the immune response. All subjects in the single-dose regimen remained seropositive at their one-year and two-year visits. The vaccine candidate was well-tolerated, and no significant safety concerns related to the vaccine were identified.

January 13, 2020—Emergent BioSolutions Inc. announced that it had received an agreement from the European Medicines Agency to pursue its proposed development plan for its chikungunya virus-like particle (CHIKV VLP) vaccine candidate.

April 26, 2019 - Study published by PLOS: Vaccination with a chikungunya virus-like particle vaccine exacerbates disease in aged mice. Conclusions: Unadjuvanted CHIK VLP vaccination elicits immune responses that protect 100% of adult mice against CHIKV infection. However, an improved vaccine/adjuvant combination is still necessary to enhance the protective immunity against CHIKV in older people.

January 28, 2021 - A VLP vaccine for the epidemic Chikungunya virus protects non-human primates against infection.

CHIKV-VLP Clinical Trials

The CHIKV-VLP vaccine candidate is being investigated in various clinical trials in 2025. The approval of Vimkunya in 2025 was based on data from two phase 3 studies that assessed the vaccine's effectiveness by measuring anti-chikungunya virus-neutralizing antibody levels in over 3,500 healthy participants aged 12 years and older. Dr. Victoria Jenkins presented phase 3 clinical trial safety and efficacy data on CHIKV VLP at the Advisory Committee on Immunization Practices meeting on October 23, 2024.

On March 27, 2025, a company-sponsored Phase 3 study found that between May 12 and December 2, 2022, 413 participants were recruited and randomly assigned (1:1) to receive the Vimkunya vaccine (n = 206) or a placebo (n = 207). The coprimary endpoints of immunologic superiority were met, as measured by chikungunya virus SNA titers compared with placebo and the geometric mean titer at day 22. Vimkunya induced a protective seroresponse (SNA NT80≥100, considered the presumptive seroprotective antibody response) in 149 (82%) of 181 participants (95% CI 76·1–87·2) at day 15, in 165 (87%) of 189 participants (81·8–91·3) at day 22, and in 139 (76%) of 184 participants (68·9–81·2) at day 183. Although the early immune response was slightly higher in the 65–74 age group on day 15 than in the 75+ age group, the seroresponse rates on day 22 and day 183 were similar. There were no notable differences in adverse event rates between the groups; most adverse events were of grade 1 or 2 severity and had a short duration. No vaccine-related serious adverse events or deaths occurred.

The European Commission granted marketing authorization upon the recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency in January 2025. It was based on results from two phase 3 clinical trials that enrolled more than 3,500 healthy individuals 12 years and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine-induced neutralizing antibodies were present in up to 97.8% of the vaccinated individuals, and a rapid immune response began to develop within one week.

ClinicalTrials.gov, NCT03992872 - Phase 2 Findings: Between November 20, 2019, and January 19, 2021, 60 participants (20 [33%] female and 40 [67%] male; 40 (67%) White; median age 47·0 years [IQR 13·5]), 30 previous alphavirus vaccine recipients and 30 alphavirus vaccine-naïve controls, were enrolled, vaccinated with CHIKV VLP, and completed the trial. The anti-CHIKV neutralizing antibody seroconversion rate at day 22 was 100% (95% CI 88·6-100) in both groups. GMTs peaked in previous alphavirus vaccine recipients and alphavirus vaccine-naïve controls at day 22 (2032·5 [95% CI 1413·0-2923·6] and 2299·2 [1598·1-3307·8], respectively) and were similar between the groups on day 22 and all subsequent visits. A higher proportion of previous alphavirus vaccine recipients (93·3% [95% CI 78·7-98·2]) had a four-fold neutralizing antibody increase at day 8 than did alphavirus vaccine-naïve controls (66·7% [48·8-80·8]; p=0·021). There was no statistically significant difference in the incidence of solicited adverse events between the previous alphavirus vaccine recipients and the alphavirus vaccine-naïve controls (53.3% vs. 40.0%, respectively). However, the relatively small sample size of the trial limited the power to detect a significant difference. No serious adverse events were reported with the vaccine. Interpretation: The CHIKV VLP vaccine was well tolerated and demonstrated similar immunogenicity in alphavirus-naïve participants and those who had previously received a heterologous alphavirus vaccine. There were no significant differences in adverse events between the groups. The results of this study support the use of the CHIKV VLP vaccine in individuals with prior exposure to alphavirus vaccines.

According to a study presented in October 2023, the researchers assessed anti-CHIKV serum-neutralizing antibody titers at designated time points throughout the study. They determined the seroresponse rate (SRR) in the two cohorts. In total, 3,254 participants were enrolled in the adult and adolescent trial, of whom 2,790 received a CHIKV VLP dose and 464 received a placebo. The data showed an SRR of 98% on day 22 for the vaccine and 1% for the placebo. A rapid antibody response was also observed in the vaccine group, with an SRR of 47% on day 8 and 97% on day 15. These responses remained durable through day 183, when the SRR reached 86%. For the older adult trial, 413 participants were enrolled — 206 received CHIKV VLP, and 207 received a placebo. On day 22, the SRR was 87% for vaccine recipients and 1% for placebo recipients. By day 15, a rapid antibody response was also observed in the CHIKV VLP group, with a seroprotection rate (SRR) of 82%. Additional data from the study revealed a favorable safety profile for the vaccine, with most adverse events being mild to moderate in severity. The most common adverse events were myalgia, fatigue, and headache.

On June 20, 2023, the Company announced the phase 3 study results, which included 413 participants enrolled and randomized 1:1 to receive either a single intramuscular injection of CHIKV VLP or a placebo. The initial results up to Day 22 post-vaccination showed that CHIKV VLP was immunogenic in healthy adults ≥65 years of age, as demonstrated by a strong induction of CHIKV neutralizing antibodies in 87% of vaccinees with neutralizing antibody titers exceeding the threshold agreed with authorities as a marker of seroprotection, thus meeting the primary endpoints of the study. Notably, most subjects (82%) also had seroprotective neutralizing antibodies on Day 15 post-vaccination, demonstrating a rapid onset of protection for the VLP-based CHIKV vaccine candidate.

On August 6, 2023, Bavarian Nordic (BN) announced positive topline results from a Phase 3 clinical trial (NCT05072080). PXVX0317 met all the coprimary endpoints and was highly immunogenic in the majority of subjects 22 days after a single vaccination. A rapid and durable response was confirmed, with high immunity levels at 2 weeks and 6 months post-immunization.

On November 14, 2022, the Company announced that a planned post-approval multicenter Phase 3b clinical study will evaluate the vaccine candidate's efficacy in preventing CHIKV disease and assess the utility of a model-guided disease surveillance framework to optimize the execution of a field efficacy trial using CHIKV as a model emerging pathogen.

On November 1, 2022, the Company reported a Phase 2 parallel-group study—a gender-matched, open-label study evaluating the safety and immunogenicity of an adjuvanted CHIKV VLP vaccine candidate in individuals who had previously received experimental alphavirus vaccines, compared with a cohort of individuals naïve to alphavirus vaccines. The study enrolled 60 healthy adults at two U.S. sites. The vaccine candidate was well-tolerated, with no notable difference in the incidence of adverse events between the groups. The majority of solicited adverse events were mild or moderate. The most common adverse event was local injection site pain. The seroconversion rate 21 days post-vaccination was 100% in both groups. A higher percentage of prior alphavirus vaccine candidates showed a fourfold or greater increase on study day eight, narrowing the difference between the alphavirus vaccine-naïve group.

A randomized, double-masked, parallel-group, Phase 2 study was conducted at three U.S. sites involving 445 participants. Eligible participants were healthy CHIKV-naïve adults aged 18–45 years. The primary endpoint was the geometric mean titer of the anti-CHIKV neutralizing antibody on day 57 (28 days after the last vaccination). Safety was also assessed.

VPM1002 Tuberculosis Vaccine

The VPM1002 vaccine candidate is a genetically modified recombinant Bacille Calmette–Guérin (BCG) vaccine derived from the Mycobacterium bovis BCG Danish 1331P (rague) strain, characterized as rBCGäureCHly+. VPM1002 contains weakened tuberculosis (TB)-like bacteria. These are genetically modified so that immune cells can better recognize them. 

The VPM1002 vaccine candidate, expressing listeriolysin and deficient in urease, is generated in the gCG Prague genetic background, which offers a better safety profile than other BCG versions due to the absence of the RD2 genome segment. This vaccine's urease C gene replaces the listeriolysin O encoding gene from Listeria monocytogenes. By reducing urease C, phagosome acidification can occur, promoting phagolysosome fusion while also providing the optimal low pH for listeriolysin O stability.

VPM1002 was created in response and investigated for preventing pulmonary TB in newborns and TB recurrence in adults through post-exposure immunization. VPM1002 facilitates mycobacterial antigens being released into the cytosol while also triggering autophagy, inflammasome activation, and apoptosis because of antigens and bacterial DNA being released into the cytosol of the host cell due to Listeriolysin O expression in this vaccine. In addition, mycobacterial antigens that access the cytosol also improve antigen presentation.

The results from a double-masked, randomized, active-controlled phase 2 study were recently conducted in South Africa and published in The Lancet Infectious Diseases on June 27, 2022. The researcher's Interpretation: VPM1002 was less reactogenic than BCG. Both vaccines were immunogenic, although higher responses th the BCG vaccine.

Serum Institute of India Pvt. Ltd. (SSI) VPM1002 is based on a BCG vaccine developed at the beginning of the 20th century. In 2004, the Max-Planck-Gesellschaft granted Takzine Projekt Management (VPM) the license for the vaccine candidate. In 2012, the company began developing the vaccine with the SSI, which acquired a majority stake in VPM. VPM1002 is currently being studied for efficacy and safety in multiple centers in three clinical trials.—DrugBank Accession Number: DB15801.

Serum Institute of India was founded in 1966 by Dr. Cyrus Poonawalla to manufacture life-saving immuno-biologicals.

VPM1002 Indication

BCG vaccination activates the human immune system against viral infections, reducing the risk of severe disease progression and, in turn, lowering the death rate. VPM1002 is indicated to prevent tuberculosis recurrence. The WHO Global TB Report 2021 provides a comprehensive and up-to-date assessment of the TB epidemic. Previous Global TB reports are accessed at this WHO link.

VPM1002 Dosage

A single dose of VPM1002 calculates the vaccine's efficacy against TB recurrence.

VPM1002 Side Effects

A phase 2 study found that VPM1002 was not associated with serious safety concerns.

VPM1002 Vaccine News 2023

December 1, 2022 - "We decided from the beginning to improve classical BCG genetically in a way to exploit all its advantages. VPM1002 has turned out not only to be specific against the TB pathogen but also to have he ability to train the immunity," commented Prof. Dr. Stefan Kaufmann, the inventor of VPM1002 and head of the Emeritus Group Immunology at the Max Planck Institute for Multidisciplinary Sciences in Goettingen, Germany, in a press release.

June 27, 2022 - The Lancet Infectious Diseases published: A next-generation BCG vaccine moves forward.

April 13, 2022 - University Health Network, Toronto - Efficacy and Safety of VPM1002.

January 28, 2020 - Bacillus Calmette-Guérin Therapy for Bladder Cancer: An Update.

July 27, 2020 - The Serum Institute of India is conducting a phase III clinical trial of BCG vaccine candidate VPM1002 to evaluate its ability to reduce infection and severe disease outcomes.

April 23, 2020 - About 6,000 high-risk individuals will enter a phase 3 clinical trial to test the recombinant BCG vaccine. The Drug Controller General of India approved this study in India.

February 20, 2020 - A clinical study (SAKK 06/14) under the direction of Cyrill A. Rentsch, University Hospital Basel, Switzerland, together with the Swiss Group for Clinical Cancer Research (SAKK), is now investigating whether it is possible to avoid removing bladders from patients who have cancer of the bladder by using VPM1002. 

January 21, 2021 - IAVI announced it is partnering with the study sponsor, Serum Institute of India Pvt. Ltd., and Vakzine Projekt Management GmbH, a German development consulting firm for the pharmaceutical industry and a subsidiary of SIIPL, to conduct the Prime study. A multicenter, double-blind, randomized, active-controlled Phase III study to evaluate the efficacy and safety of the vaccine candidate VPM1002 compared to BCG for preventing Mycobacterium tuberculosis infection in HIV-exposed and HIV-unexposed newborn infants. Study sites are in Gabon, Kenya, South Africa, Tanzania, and Uganda.

September 19, 2020 - The Recombinant Bacille Calmette–Guérin Vaccine VPM1002: Ready for Clinical Efficacy Testing.

August 6, 2019 – The Indian Council of Medical Research announced it had launched India's first large-scale clinical study for new TB vaccines. The TB vaccine in this new clinical study offers a chance to contain the accelerating spread of multidrug-resistant TB. Treating TB requires a multi-drug course of treatment lasting up to 6 months and longer when treating drug-resistant TB.

VPM1002 Vaccine Clinical Trials

The vaccine is being tested in a Phase III clinical trial involving adult volunteers in India. In mice, VPM1002 gave better protection than BCG against aerosol infection with M tuberculosis and improved survival in severe combined immunodeficiency mice. The study by Cotton and colleagues bridged from the original hygromycin-resistant formulation of VPM1002 to a hygromycin-sensitive formulation.

June 2022 - Safety and immunogenicity of VPM1002 versus BCG in South African newborn babies: a randomized, phase 2 non-inferiority double-blind controlled trial - Between June 4, 2015, and October 16, 2017, 416 eligible newborn babies were randomly assigned and received the study vaccine. Seven (2%) of 312 participants in the VPM1002 group had a grade 3–4 vaccine-related adverse reaction or lymphadenopathy of 10 mm or greater in diameter compared with 34 (33%) of 104 participants in the BCG group (risk difference −30·45% [95% CI −39·61% to −21·28%]; pnon-inferiority<0·0001); VPM1002 was thus non-inferior to BCG for the primary outcome. Incidence of severe injection site reactions was lower with VPM1002 than BCG: scarring occurred in 65 (21%) participants in the VPM1002 group versus 77 (74%) participants in the BCG group (p<0·0001); ulceration occurred in one (<1%) versus 15 (14%; p<0·0001); and abscess formation occurred in five (2%) versus 23 (22%; p<0·0001). Restimulated IFNγ concentrations were lower in the VPM1002 group than in the BCG group at week 6, week 12, month 6, and month 12. The percentage of multifunctional CD4+ T cells was higher in the VPM1002 group than the BCG group at day 14 but lower at week 6, week 12, month 6, and month 12. The percentage of multifunctional CD8+ T cells was lower in the VPM1002 group than the BCG group at week 6, week 12, and month 6, but did not differ at other time points. Interpretation: VPM1002 was less reactogenic than BCG and was not associated with any serious safety concerns. Both vaccines were immunogenic, although higher responses th the BCG vaccine. VPM1002 is currently being studied for efficacy and safety in a multicenter phase 3 clinical trial in babies in sub-Saharan Africa.

TAK-426 Zika Vaccine

Takeda's TAK-426 (PIZV) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate. The absence of specific treatment makes a prophylactic Zika virus vaccine an unmet medical need, according to a recent study published by The Lancet. The vaccine was tested in a phase 1 study called PIZV or TAK-426 adjuvanted with aluminum hydroxide. TAK-426 was found well tolerated, with an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults.

The peer-reviewed Journal of Infectious Diseases reported on December 9, 2022, on the two-year persistence of immune response to TAK-426 compared with that observed after natural infection. TAK-426 at 10-μg had an acceptable safety profile in FV-naive and FV-primed adults up to 24 months after dose 2. Seropositivity for neutralizing antibodies was 100% at one year and 93.8% and 76.2% at two years in FV-naive and FV-primed groups, respectively. TAK-426 responses were comparable in magnitude and kinetics with those elicited by natural Zika virus infection. These phase 1 study results support the further clinical development of TAK-426 for both FV-naive and FV-primed populations.

In February 2016, the World Health Organization (WHO) declared the Zika outbreak a Public Health Emergency of International Concern. On January 29, 2018, Takeda's Zika Vaccine candidate received U.S. FDA Fast Track Designation. On July 27, 2023, Takeda confirmed to support the expansion of our pipeline and the development of our programs, we have entered into partnerships with government organizations in Japan and the U.S. and leading global institutions.

Osaka, Japan-based Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. 

TAK-426 Vaccine Indication

The TAK-426 vaccine candidate prevents the Zika virus, which is caused by a virus transmitted by Aedes aegypti and Aedes albopictus mosquitoes. The Zika virus was first reported in continental South America in Brazil in May 2015. Zika virus is a flavivirus associated with congenital malformations and neurological complications. According to the World Health Organization (WHO), symptoms of Zika may include mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise, or headache.

TAK-426 Vaccine Dosage

In a phase 1 study, TAK-426 was administered by intramuscular injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 4). Three different vaccine doses containing different protein concentrations (2, 5, or 10 micrograms [mcg]) will be given as a two-dose schedule to flavivirus-naive and primed healthy adults. Based on a recent study, the 10 μg TAK-426 dose was selected for further clinical development.

TAK-426 Vaccine News

December 8, 2022 - Researchers wrote: In conclusion, we confirm that PIZV has an acceptable safety profile in healthy adults aged 18–49 years, with no vaccine-related SAEs through 2 years after vaccination. Two vaccinations elicited immune responses that persisted at high titers (GMTs >100) comparable to those observed in convalescent ZIKV-infected patients up to 2 years after vaccination in FV-naive and FV-primed adults. These safety and immunogenicity profiles of the high dose (10-µg) PIZV confirm its suitability for further clinical development.

November 19, 2021 - The company presented: Measurement Of Zika Virus-Specific Antibodies Using A Microsphere-Based Competitive Immunoassay. 'Collectively, our data suggest that the assay can differentiate ZIKV-specific antibodies from antibodies to other FVs elicited by natural infection or vaccination. Availability of a ZIKV-specific antibody-based immunoassay will improve differential diagnosis, serosurveillance, and support development and implementation of ZIKV vaccines in FV endemic regions.'

May 18, 2021 - Study Interpretation: TAK-426 was well tolerated,hadh an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults. Based on the safety and immunogenicity profiles of all TAK-426 doses assessed, the 10 μg TAK-426 dose was selected for further clinical development. Study Funding: Takeda Vaccines and the US Biomedical Advanced Research and Development Authority.

August 26, 2019 – A recent Zika study focused on eliminating the mosquito and sexual transmission of the Zika virus with a preventive vaccine.

January 29, 2018 - Takeda Pharmaceutical Company Limited announced that the U.S. FDA had granted Fast Track designation to TAK-426, Takeda's purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

September 2, 2016 - Takeda announced that BARDA, the Biomedical Advanced Research and Development Authority, has selected Takeda's Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions worldwide. Initial funding from BARDA, which is a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services, is for $19.8 million to cover the vaccine development through Phase 1, with potential funding of up to $312 million if all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application in the USA. 

TAK-426 Clinical Trials

The Journal of Infectious Diseases reported that a randomized, observer-blind, placebo-controlled, dose-selection, phase 1 trial was conducted in 18–49-year-old adults at nine centers (7 in the United States and 2 in Puerto Rico) from 13 November 2017 to 24 November 2020. The primary objectives were safety, tolerability, and immunogenicity of 3 increasing doses of TAK-426 administered as two doses 28 days apart to flavivirus (FV)–naive and FV-primed adults. Here, we report on the safety and persistence of immunity up to 2 years after primary vaccination with 10-μg TAK-426, the highest dose, and compare neutralizing antibody responses with those observed after natural infection. Results: TAK-426 at 10-μg had an acceptable safety profile in FV-naive and FV-primed adults up to 24 months after dose 2. Seropositivity for neutralizing antibodies was 100% at one year and 93.8% and 76.2% at two years in FV-naive and FV-primed groups, respectively. TAK-426 responses were comparable in magnitude and kinetics with those elicited by natural Zika virus infection.

On September 21, 2021, The Lancet reported the findings of this clinical trial. Between Nov 13, 2017, and Oct 24, 2018, 894 volunteers were screened, and 271 enrolled (125 flavivirus-naive and 146 flavivirus-primed participants). All TAK-426 doses were well tolerated with no deaths, no vaccine-related serious adverse events, and similar rates of mainly mild to moderate adverse events. Interpretation: The researchers concluded that TAK-426 was well tolerated,hadh an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults. Based on these results, TAK-426 will continue to be tested in clinical settings.

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.