Sanofi’s Dengvaxia Receives FDA’s Approval to Prevent Dengue in Endemic Region in the US
Shots:
- The approval follows three studies assessing Dengvaxia vs PBO in 35,000 patients with 9 through 16 years of age with laboratory-confirmed dengue caused by serotypes 1–4 living in dengue-endemic areas including Puerto Rico, Latin America and the Asia Pacific
- Dengvaxia is not indicated for the patients who are not previously infected with dengue virus, prior dengue infection can be assessed through medical record/serological testing
- Dengvaxia is a live, attenuated vaccine administered thrice with initial dose followed by two doses at six & twelve months later and has received FDA’s PR & Tropical Disease PR voucher for tropical diseases with the approval in 19 countries including EU
Click here to read full press release/ article | Ref: US FDA | Image: The Munster Express