Sanofi’s Dengvaxia Receives FDA’s Approval to Prevent Dengue in Endemic Region in the US

 Sanofi’s Dengvaxia Receives FDA’s Approval to Prevent Dengue in Endemic Region in the US

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