Shots:

• The approval was based on the results from the 19 P-I/II/III trials incl. 4 & a half yrs. of follow-up data from P-III trial (TIDES) evaluating 2 doses of TAK-003 across Latin America & Asia
• The P-III (TIDES) trial met its 1EPs & 2EPs i.e., the vaccine showed an overall vaccine efficacy by preventing 80.2% of symptomatic dengue cases @12mos., 90.4% reduction in hospitalizations @18mos. In an exploratory analysis, 84% reduction in hospitalized dengue cases & 61% of symptomatic dengue cases @ 4.5yr. of follow-up, was well tolerated with no evidence of disease enhancement in vaccine recipients
• The vaccine was approved in Indonesia in individuals aged 6-45yr. while regulatory filings continue to progress in other dengue-endemic countries in Asia & Latin America

Ref: Businesswire | Image: Takeda