Dynavax Technologies Corp. is eyeing narrower populations – including chronic kidney disease patients and individuals ages 40 years and older – as a potential route to approval for its novel, adjuvanted hepatitis B vaccine Heplisav now that FDA has issued a “complete response” letter for broad use in adults.
On Feb. 25, one day after the vaccine’s user fee date, Dynavax announced that FDA had declined to approve Heplisav (rHBsAg-1018 ISS) for adults ages 18-70 years