FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Vaccines Advisory Committee Splits on Safety, Effectiveness of Sanofi’s Dengvaxia

March 14, 2019

An FDA advisory committee voted narrowly against the effectiveness of Sanofi’s dengue virus vaccine and split evenly on its safety, except for children aged nine to 16.

The Vaccines and Related Biological Products Advisory Committee voted seven to six against Dengvaxia’s effectiveness, with one abstention, and split seven to seven on the question of the drug’s safety.

The committee voted 13 to one in favor of the drug’s effectiveness for patients between ages nine and 16, and voted 10 to four in favor of the drug’s safety for that age group.

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