FDA Advisory Committee votes on Sanofi’s Dengvaxia® vaccine candidate for prevention of dengue in the United States

Mar 7, 2019

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) today voted on the safety and effectiveness of Dengvaxia® (Dengue Tetravalent Vaccine Live Attenuated) for the prevention of dengue disease caused by serotypes 1 – 4 of the virus in persons living in endemic areas that experienced a laboratory-confirmed previous dengue infection.  In people 9 to less than 17 years of age, the Committee voted favorably on effectiveness (13 to one) and safety (10 to four).  In people 9 through 45, the Committee voted six to seven (with one abstention) on effectiveness and seven to seven on safety. 

We are continuing to work closely with the FDA, which is expected to make its decision by May 1, 2019.