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Takeda opens new dengue vaccine manufacturing plant in Singen, Germany

In November this year, the Japanese pharmaceutical firm Takeda inaugurated its first dengue vaccine manufacturing plant in Singen, Germany. The Singen vaccine plant ultimately aims to offer end-to-end production of the vaccine, including formulation, fill, finish and secondary packaging of the current Takeda dengue vaccine candidate. This plant is located on the premises of one out of 34 production sites of Takeda’s extensive network in 20 different countries serving a wide range of products across numerous fields including oncology, gastroenterology, rare diseases and neuroscience.

Takeda has invested some 130 million euros in this project, which will employ over 200 staff in the vaccine manufacturing process. This site was selected based on the substantial experience of site employees in liquid and semi-solid dosage forms, including lyophilization technology (freeze drying) which will be essential to the manufacturing of Takeda’s dengue vaccine candidate. Singen is an industrial city in the very south of Baden-Württemberg in southern Germany and near the German-Swiss border, with a strong heritage in manufacturing and industry.

There has been a substantial commitment to data-driven and digital approaches in the design and engineering of this manufacturing plant, combining a high degree of automation, real-time monitoring and Industry 4.0 approaches, with the ultimate aim of ensuring a high degree of assurance to the quality and consistency of the product delivered to patients from this facility.

At this point, production of packaging is ready at the Singen site, as Takeda awaits further licensure. Takeda’s current dengue vaccine candidate (TAK-003) is in phase-III trials and has been designed with the aim of protecting patients from all four serotypes of dengue .

In November, Takeda shared some very promising updates of the 12- and 18-month efficacy and safety data from the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate. Overall, these showed protection against dengue in children aged 4 to 16, regardless of previous dengue exposure, although some gaps remain in the protection against one of the four strains of dengue, namely dengue 3, particularly in those children who had previously never contracted any of the strains of dengue. The aggregated data showed that the vaccine appeared to be about 80% effective at preventing any dengue infections in vaccinated children 12 months after receiving the second dose of the vaccine, [WR1] and 73% effective 18 months after the second dose, regardless of previous exposure to dengue. The risk of hospitalization for dengue was reduced by 95% at the 12-months mark, and 90% after 18 months.

The gaps in protection against the dengue 3 strain and the lack of data on the dengue 4 strain, which was not widely present in the countries where the trials were conducted, need to be investigated further. Takeda is also developing a pipeline of vaccines to tackle other tropical and infectious diseases including Zika and norovirus.


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