After two prior rejections, the FDA has approved a new, two-dose vaccine for hepatitis B for adults ages 18 and up: the recombinant, adjuvanted Heplisav-B, .
The two doses are given over the course of a month -- in contrast to the current HBV vaccine, Energix-B, which requires three doses over 6 months.
In the three pivotal trials (out of a total of 11 trials) that ultimately led to approval, Heplisav-B offered significantly better protection than Engerix-B, and the data finally convinced an FDA advisory committee in July that it had good safety, too.
Safety concerns -- which had been the vaccine's stumbling block during past FDA evaluations -- included a larger number of deaths and serious heart problems in patients given Heplisav-B compared with Energix-B, though the overall numbers and rates of such events were low.
To remedy those concerns, the company will conduct a post-marketing study at Kaiser Permanente in California, focused on acute myocardial infarction and immune-mediated diseases, a Dynavax spokesperson told ľֱ.
The cardiac study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for one year. The immune-mediated disease analysis will enroll an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.
Both will be expected to report out in about 2.5 years, the company said.
Dynavax, based in Berkeley, California, said theirs is the first HBV vaccine approved in 25 years. The most common adverse reaction was injection site pain (23% to 39%), and the most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).