FDA panel backs Dynavax’s hep B vaccine efficacy, not safety

(Reuters) – A U.S. Food and Drug Administration panel voted unanimously to recommend the effectiveness of Dynavax Inc’s hepatitis B vaccine Heplisav, but raised concerns about its safety, asking for more data from studies on a wider population. The views of the panel of outside experts were based on data submitted by Dynavax that compared the safety and immunogenicity, or ability to evoke an immune response, of its Heplisav with that of an older vaccine named Engerix B by GlaxoSmithKline Plc. …