Dynavax Technologies Corp. is planning to resubmit its hepatitis B vaccine – Hepislav-B – to FDA at the end of the first quarter after amassing what it thinks are enough safety data to satisfy the concerns in a complete response letter from early 2013.
Hepislav-B includes the 1018 ISS adjuvant, a synthetic cytosine phosphoguanine oligodeoxynucleotide that boots immune response to the vaccine’s antigen. It is meant to be more potent than other hepatitis B vaccines and to be given in fewer doses