Takeda’s dengue vaccine, QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003), has been 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.
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.
“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. Severe dengue has become a leading cause of hospitalization and death among children and adults in some of the countries within the region. 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.
“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.
In addition, TAK-003 met its key secondary endpoint by preventing 90.4% of hospitalizations 18 months after vaccination. Efficacy varied by serotype (DENV-1 – 4). 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. 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.
