Agus Linardi, 36, tries a DIY dengue fogging equipment at Kuripan village, in West Lombok, West Nusa Tenggara on March 25, 2021. (Antara Photo / Ahmad Subaidi)

Takeda to Submit Regulatory Filing for New Dengue Vaccine in Indonesia


MARCH 30, 2021

Jakarta. Takeda Pharmaceutical Company, one of the world's largest drugmakers from Japan, plans to submit a new dengue vaccine candidate to the Indonesian authority this year, marking a milestone in global combat against the disease that kills 20,000 people around the world every year. 

In Indonesia, dengue killed 661 people, with close to 95,900 cases recorded in the first 49 weeks last year, data from the Health Ministry showed.

The data also showed dengue, which often developed into a hemorrhagic fever, is particularly fatal to children. According to the ministry data, seven in 10 of Indonesia's dengue victims are between 0 to 14 years old. 

The company unveiled the plan after European Medicines Agency (EMA) accepted its filing for the vaccine candidate, called TAK-003, last week, the company said in a recent statement.

"With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines," Derek Wallace, a vice president and dengue global program leader at Takeda, said in the statement. 

"Takeda is committed to working with regulatory authorities and recommending bodies to support the evaluation of our submissions and achieve access for TAK-003,” he said. 

Apart from Indonesia, Takeda would submit regulatory filings in Argentina, Brazil, Colombia, Malaysia, Mexico, Singapore, Sri Lanka, and Thailand. 

Takeda has been conducting the vaccine's phase III clinical trial for 36 months in Brazil, Colombia, Panama, the Dominican Republic, Philippines, Thailand, and Sri Lanka, involving over 20,000 healthy children and adolescents aged four to 16 years. The EMA regulatory filings include data from the study, which Takeda also plans to publish in a peer-reviewed journal later this year. 

The vaccine phase II trial had shown the vaccine managed to induce immune responses against four viruses, called serotypes 1-4, that caused dengue among children and adolescents study participants. The phase II trials also showed the vaccine carries no important safety risk, Takeda said in the statement.  

The World Health Organization (WHO) listed dengue among the top 10 global health threats in 2019. About half of the global population were at risk of dengue which caused an estimated 390 million infections and around 20,000 deaths every year, Takeda said, quoting a 2009 study from the Natural Resources Defense Council (NRDC) a 2019 study from the Centers for Disease Control and Prevention. 

According to WHO data, only one dengue vaccine has been licensed so far, being marketed under the Dengvaxia brand. Lyon-based Sanofi Pasteur develops and produces the Dengvaxia vaccine. The company secured WHO and the United State's Food and Drug Administration's (FDA) approval for the vaccine in 2015. 

Today, there are five dengue vaccine candidates in clinical development, WHO said. Takeda's TAK-003 and another one developed by the US National Institute of Health and Brazil's Butantan Institute are the most advanced among the five candidates, with their phase III trials already ongoing.