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FDA panel to probe safety of Dynavax HBV vaccine

July 26, 2017 11:34 PM UTC

In briefing documents released ahead of an advisory committee meeting to discuss an NDA for Heplisav-B from Dynavax Technologies Corp. (NASDAQ:DVAX), FDA reviewers said the vaccine led to "a robust immune response" in clinical studies, but considered whether data showing imbalances in adverse events suggest evidence of cardiovascular risk.

FDA's Vaccines and Related Biological Products Advisory Committee is to meet Friday to discuss whether the NDA supports the vaccine's approval to treat HBV infection. The committee will also address questions related to the company’s proposed pharmacovigilance plan to investigate the candidate’s safety profile...