- National Health Surveillance Agency (ANVISA) Approved QDENGA (TAK-003) for Use in Individuals Aged 4 to 601
- The Approval of QDENGA is Based on Results Across 19 Phase 1, 2 and 3 Trials with More Than 28,000 Children and Adults, Including Four and a Half Years of Follow-Up Data Showing Sustained Efficacy and No Important Safety Risks, to Date
- QDENGA is the Only Dengue Vaccine Approved in Brazil for Use in Individuals Without Need for Pre-vaccination Testing
- Marks the First Approval of QDENGA in Latin America
Takeda (TSE:4502/NYSE:TAK) today announced the company’s dengue vaccine, QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003), was approved in Brazil by the National Health Surveillance Agency (ANVISA) for the prevention of dengue caused by any of the four virus serotypes that can be found in individuals from 4 to 60 years of age.1 The use of QDENGA should be in accordance with official recommendations of the regulatory agency. QDENGA is the only dengue vaccine approved in Brazil for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing.1
“Brazil has a high prevalence of dengue, and the country needs effective and safe vaccine options to help manage the significant burden dengue places on its health care systems and its communities,” said José Manuel Caamaño, president of Takeda in Brazil. “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. Based on our clinical trial results, we are hopeful that QDENGA could have a positive impact on the incidence of symptomatic dengue in Brazil, including dengue cases that require hospitalization. Bringing QDENGA to countries around the world remains a top priority for Takeda, and this approval is a step toward our purpose to deliver better health for people, and a brighter future for the world.”
Dengue is a mosquito-borne viral disease that poses a significant global public health threat to half the world’s population, with risk of infection in over 125 countries including many in Latin America.2 Severe dengue has become a leading cause of hospitalization and death among children and adults in some of the countries within the region. 2 In 2022 Brazil saw more than 1.4 million cases of dengue and more than 1,000 deaths according to the Ministry of Health, a 162.5% increase in cases compared to 2021.3
“According to experts and general practitioners in Brazil, dengue outbreaks and resulting hospitalizations cause a considerable strain on our health care system – as dengue not only impacts those infected, but also the ability of clinicians to provide health care services to other patients,” said Dr. Vivian Kiran Lee, medical affairs director of Takeda in Brazil. “Approval of a safe and effective vaccine that does not require pre-vaccination blood testing is important to help reduce potentially critical barriers to large-scale access and administration of the vaccine for the Brazilian population. We believe that QDENGA, along with vector control methods, has the potential to become an important pillar of the National Program to Combat Dengue, benefiting eligible Brazilians exposed to the disease and helping reduce its burden on health systems.”
The approval of QDENGA is based on results across 19 Phase 1, 2 and 3 trials with more than 28,000 children and adults, including four and a half years of follow-up data from the global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. The TIDES trial met its primary endpoint of overall vaccine efficacy (VE) by preventing 80.2% of symptomatic dengue cases 12 months after vaccination.4 In addition, TAK-003 met its key secondary endpoint by preventing 90.4% of hospitalizations 18 months after vaccination.5 Efficacy varied by serotype (DENV-1 – 4).5,6 The TIDES exploratory analyses showed that throughout the four and a half-year study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall study population, which included both seropositive and seronegative individuals.6 TAK-003 has been generally well tolerated, with no evidence of increased incidence of severe disease in baseline sero-negative vaccine recipients, and no important safety risks identified, to date.7
Takeda is proud to make QDENGA available to health care providers and their eligible patients in Brazil and to work with ANVISA and local health experts to make the vaccine accessible to all those eligible in Brazil. Takeda continues to progress regulatory filings in other dengue-endemic countries in Latin America and Asia.
About QDENGA® ▼ (Dengue Tetravalent Vaccine [Live, Attenuated])
QDENGA® (TAK-003) is a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four dengue virus serotypes and is designed to protect against any of these serotypes.7
In Brazil, QDENGA is indicated for the prevention of dengue disease caused by any dengue virus serotype in individuals from 4 to 60 years of age and should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule pursuant to approved dosing regimen.1 The use of QDENGA should be in accordance with official recommendations.
About the Phase 3 TIDES (DEN-301) Trial
The double-blind, randomized, placebo-controlled Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial is evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents.8 Study participants were randomized 2:1 to receive two doses of TAK-003 0.5 mL or placebo on Months 0 and 3, administered subcutaneously.8 The study is comprised of five parts. Part 1 and the primary endpoint analysis evaluated vaccine efficacy (VE) and safety through 12 months after the second dose.8 Part 2 continued for an additional six months to complete the assessment of the secondary endpoints of VE by serotype, baseline serostatus and disease severity, including VE against hospitalized dengue.8 Part 3 evaluated VE and long-term safety by following participants for an additional two and a half to three years, as per World Health Organization (WHO) recommendations.8 Part 4 will evaluate efficacy and safety for 13 months following booster vaccination, and Part 5 will evaluate long-term efficacy and safety for one year after completion of Part 4.8
The trial is taking place at sites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) where there are unmet needs in dengue prevention and where severe dengue is a leading cause of serious illness and death among children.9 Baseline blood samples were collected from all individuals participating in the trial to allow for evaluation of safety and efficacy based on serostatus. Takeda and an independent Data Monitoring Committee of experts are actively monitoring safety on an ongoing basis.
Dengue is a mosquito-borne viral disease that spreads rapidly around the world and was one of the WHO’s top 10 threats to global health in 2019.2,10 Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes. It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue. The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.11 Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes might be associated with an increased risk of severe disease.2
Dengue is pandemic prone, and outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in parts of the continental United States and Europe.9,12 Approximately half of the world now lives under the threat of dengue, which is estimated to cause 390 million infections and around 20,000 deaths globally each year.2,13 The dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia.13
Takeda’s Commitment to Vaccines
Vaccines prevent 3.5 to 5 million deaths each year and have transformed global public health.14 For more than 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, COVID-19, pandemic flu and Zika. Takeda’s team brings an outstanding track record and a wealth of knowledge in vaccine development and manufacturing to advance a pipeline of vaccines to address some of the world’s most pressing public health needs. For more information, visit www.takeda.com/what-we-do/areas-of-focus/vaccines/.
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI), with expertise in immune and inflammatory diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.