Takeda to Submit Regulatory Filing for New Dengue Vaccine in Indonesia

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 Jakarta. Takeda drug company, one among the world's largest drugmakers from Japan, plans to submit a replacement 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 per annum. 


In Indonesia, dengue killed 661 people, with on the brink of 95,900 cases recorded within the first 49 weeks last year, data from the Health Ministry showed.

The data also showed dengue, which frequently developed into a hemorrhagic fever, is especially fatal to children. consistent with 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 corporate said during a recent statement.

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"With limited options to stop the disease, there's a pressing need for widely available dengue vaccines," Derek Wallace, a vice-chairman and dengue global program leader at Takeda said within 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 clinical test |phase III|clinical trial|clinical test"> 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 during a peer-reviewed journal later this year. 

The vaccine phase II clinical 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 clinical trial trials also showed the vaccine carries no important safety risk, Takeda said within the statement. 

The World Health Organization (WHO) listed dengue among the highest 10 global health threats in 2019. About half the worldwide population were in danger of dengue which caused an estimated 390 million infections and around 20,000 deaths per annum, 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, just one dengue vaccine has been licensed thus far, being marketed under the Dengvaxia brand. Lyon-based Sanofi Pasteur develops and produces the Dengvaxia vaccine. the corporate secured WHO and therefore 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 foremost advanced among the five candidates, with their phase III clinical trial trials already ongoing.

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