- Japanese drugmaker Takeda on Tuesday opened a new plant in Singen, Germany that will manufacture the company's experimental dengue vaccine, which is newly supported by Phase 3 results that appear to show the shot is effective in guarding against the mosquito-borne viral disease.
- The pharma has invested more than $140 million over the past three years as it built the facility, which will employ as many as 200 people once operational.
- Takeda first began construction in 2016, and the plant is now ready for packaging production, the company said in a Nov. 5 statement. End-to-end production of the vaccine, known as TAK-003, will be ready nearer to when Takeda expects to secure licensure of the drug.
Takeda is trying to tackle a viral disease that puts, according to the World Health Organization, as much as half the world's population at risk. Dengue causes about 390 million infections and 20,000 deaths a year, Takeda said.
Researchers tested Takeda's vaccine in a study of more than 20,000 children aged 4 to 16, with two-thirds getting the vaccine and the rest receiving a placebo. They found the vaccine was roughly 80% effective in protecting against dengue infection among patients who were administered both doses of the vaccine, according to results published in the New England Journal of Medicine.
Takeda said patients generally tolerated the vaccine well, with "no important safety risks observed to date." The study found nearly equivalent levels of protection for participants who had never been infected previously.
That data is notable given the controversy that's followed French drugmaker Sanofi's dengue vaccine, which won limited approval from U.S. regulators earlier this year. Following earlier clearance in countries like the Philippines, data suggested it may increase the risk of severe dengue in some patients who weren't previously infected.
Researchers plan to present results from the primary endpoint analysis and 18-month follow-up at a medical meeting later this month, Takeda said. Overall, the company plans to keep measuring the safety and efficacy of the vaccine over four and a half years.
"These results support a potential benefit regardless of previous dengue exposure or age, and the onset of some protection after the first dose suggests that the vaccine may be useful in the context of outbreak control or travel vaccination," the NEJM authors wrote.
"[H]owever, reported variation in serotype-efficacy needs careful consideration," they added, referring to differing levels of protection against each of the four serotypes against which TAK-003 is designed to protect.