FDA advisory panel sends out mixed signals on Sanofi's Dengvaxia

In a move that is not totally surprising, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) gave a mixed reaction following its review of Sanofi’s (Euronext: SAN) dengue fever vaccine.

The panel voted on the safety and effectiveness of Dengvaxia (dengue tetravalent vaccine) 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). However, in people 9 through 45, the Committee voted six to seven (with one abstention) on effectiveness and seven to seven on safety, which might result in a disappointing final decision from the FDA.