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

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

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  • 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

Ref: US FDA | Image: The Munster Express

Click here to­ read the full press release 

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