DENGVAXIA

Proper Name: Dengue Tetravalent Vaccine, Live

DENGVAXIA (Dengue Tetravalent Vaccine, Live) is a sterile suspension for subcutaneous injection.

Advisory Board:

A Vaccines and Related Biological Products Committee (VRBPAC) meeting was convened on March 7, 2019. The committee’s concerns were discussed between Sanofi Pasteur and CBER after the March 7, 2019, VRPBAC meeting. Both CBER and Sanofi Pasteur agreed that additional studies relevant to the adult population in Puerto Rico would address the committee’s concerns and could support inclusion of individuals 17 through 45 years of age in the indication. Sanofi Pasteur informed CBER that they decided for this BLA submission to pursue an indication only for individuals 9 through 16 years of age and requested a revised indication that does not include individuals 17 through 45 years of age.

Indications: DENGVAXIA® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Key Regulatory Milestones:

05/01/2019 – PDUFA goal date

01/22/2020 – FDA approval date

Package Insert