European Regulator Backs Approval Of Takeda's Dengue Vaccine

European Medicines Agency's Committee for Medicinal Products for Human Use recommended approving Takeda Pharmaceutical Co Ltd's TAK dengue vaccine candidate, TAK-003.
In August, Indonesia approved Takeda's dengue vaccine, Qdenga, for individuals six to 45 years.
The recommendation covers the dengue vaccine candidate to prevent dengue disease caused by any serotype in individuals four years of age and older in Europe and dengue-endemic countries.
The Committee's positive opinion was supported by results across five Phase 1, 2, and 3 trials with over 28,000 participants.
This includes four and a half years of follow-up data from the global, pivotal Phase 3 TIDES trial, consistent with the World Health Organization's recommendation to obtain three to five years of follow-up data after completing a primary dengue vaccination to assess safety and efficacy accurately.
TIDES exploratory analyses showed that throughout the four and a half years of study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall population.
TAK-003 has been generally well tolerated, with no evidence of disease enhancement in vaccine recipients.
Price Action: TAK shares are up 0.31% at $12.92 on the last check Friday.
Photo by Himas Rafeek from Pixabay