Dynavax Hepatitis B Vaccine Could Get Comparative Post-Market Autoimmunity Assessment

14 Nov 2012

• By Cathy Dombrowski

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.

Members of FDA’s Vaccines and Related Biological Products Advisory Committee will weigh in Nov. 15 on whether a post-market observational study is sufficient to address lingering FDA concerns about the potential for autoimmune reactions to Heplisav (rHBsAg-1018 ISS), the hepatitis B vaccine from Dynavax Technologies Corp. that contains a novel adjuvant.

FDA did not formulate specific questions in its briefing materials for the panel, but rather said the meeting will focus...