Takeda Pharmaceutical recently announced that the European Drug Administration (EMA) has accepted the declaration of its dengue vaccine TAK-003, which is developed for people between the ages of 4 and 60 to prevent dengue caused by any serotype of dengue virus. The company plans to submit regulatory documents to Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka, and Thailand in 2021. Takeda also plans to submit regulatory documents in the US later, and then other countries in Asia and Latin Americ
TAK-003 is an attenuated tetravalent dengue vaccine based on the attenuated dengue serum type 2 virus (DENV-2) that provides a genetic skeleton for all four vaccines. Data from phase II clinical studies in children and adolescents showed that TAK-003 induced neutralizing antibodies against four serotypes of dengue virus across all age groups, both seropositive individuals and seronegative individuals, which was safe and well-tolerated. The key phase III TIDES trial reached the primary endpoint of overall vaccine efficacy (VE) for virologically confirmed dengue (VCD) at 12 months of follow-up and all secondary endpoints at 18 months of follow-up, including VE for hospitalized dengue fever and VE in baseline seropositive and baseline seronegative individuals. The VE of TAK-003 varies with serotypes. The results show that TAK-003 was well tolerated and no significant safety risks have been observed so far.
Regulatory documents of TAK-003 include data on the long-term safety and effectiveness of the ongoing phase III dengue tetravalent immunization efficacy study, the (TIDS) trial, which has been in progress for 36 months. Takeda plans to release details of the 36-month data at a scientific conference this year and in a peer-reviewed journal.
Dengue fever is an acute insect-borne infectious disease caused by dengue virus transmitted by mosquitoes, of which the clinical manifestations are high fever, headache, severe soreness of muscles, bones and joints, rash, bleeding tendency, lymph node enlargement, leukopenia, thrombocytopenia, and so on. Dengue fever, commonly known as “broken bone fever (breakbone fever)”, is one of the main causes of death of children in Southeast Asia, and one of the top ten threats to the global health of the WHO in 2019. Dengue fever is mainly transmitted by Aedes aegypti, followed by Aedes albopictus. Any of the four serotypes of dengue virus can cause dengue or severe dengue fever. The prevalence of individual serotypes varies by geography, country, region, season, and overtime. Recovery from one serotype infection only produces lifelong immunity to that serotype, and subsequent exposure to any other serotypes may still cause serious illness.
Dengue fever is prevalent in the tropics and subtropics, and recently in parts of the United States and Europe. About half of the world’s population is now living under the threat of dengue fever. It is estimated that dengue virus infects 390 million people and kills about 20,000 people worldwide each year, which can infect people of all ages and is the leading cause of serious illness in children in some countries in Latin America and Asia.