Takeda to establish dengue vaccine manufacturing facility in Germany

The company's decision follows the start of phase 3 clinical trial of the Tetravalent Immunization against Dengue Efficacy Study (TIDES), the global phase 3 clinical trial to assess the efficacy of a two-dose schedule of Takeda’s dengue vaccine candidate.

Takeda said the plant will be crucial in prevention of the mosquito borne disease as 40% of the world’s population under the threat of dengue as per the World Health Organization.

The Osaka headquartered company first used the vaccine in September during the TIDES trial.

TIDES is a double-blind, randomized and placebo-controlled trial designed to evaluate vaccine candidate’s efficacy.

It enrolled around 20,000 healthy children in the age group of 4-16 years living in dengue-endemic regions across Latin America and Asia.

The phase 3 trial will evaluate the efficacy in protecting subjects against symptomatic dengue fever that can come through any of the four dengue virus serotypes, irrespective of age and whether the subject had prior exposure to the virus.

It will also evaluate the safety and immunogenicity of the vaccine by subjecting the participants with two doses of the dengue vaccine candidate or placebo with a gap of 90 days.

Takeda Vaccines president Rajeev Venkayya said: “The progress of the dengue TIDES clinical trial, our partnership with the Bill & Melinda Gates Foundation to eradicate polio, the recent initiation of the world’s first field efficacy trial for a norovirus vaccine, and our work with the U.S. Government to develop a Zika vaccine, together demonstrate how Takeda is dedicated to developing and providing vaccines to protect people in need wherever they are.”