Dynavax’s Heplisav Heads To Advisory Panel, But Will It Drudge Up Old Safety Issues?
This article was originally published in The Pink Sheet Daily
Company says its hepatitis B vaccine, which had been placed on clinical hold at one point during its Phase III trials, will be discussed at a FDA advisory committee in November.
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FDA’s Vaccines and Related Biological Products Advisory Committee recommended 8 to 5 with one abstention that Dynavax acquire more safety data pre-licensure for its hepatitis B vaccine.
The observational study would look at Dynavax’s Heplisav and GlaxoSmithKline’s Energerix-B, according to FDA briefing materials for the Vaccines and Related Biological Products Advisory Committee’s Nov. 15 review of Heplisav for adults 18 to 70 years of age.
FDA agreed to infer GSK’s H5N1 vaccine’s effectiveness from the effectiveness of the adjuvanted H1N1 vaccine; agency’s Vaccines and Related Biological Products Advisory Committee will weigh in – and consider Dynavax’s hep B vaccine Heplisav – on Nov. 14.