Biotech Values

[mcbio]

Re: DVAX/Heplisav

As previously reported, safety results from this trial demonstrated the safety profile of HEPLISAV and Engerix-B appeared similar. Subjects were randomized 3 to 1 to receive HEPLISAV or Engerix-B and one case of vasculitis was reported in each of the treatment groups. Following the report of the severe adverse event of Wegener’s granulomatosis, an uncommon form of vasculitis, HEPLISAV was placed and remains on clinical hold by the U.S. Food and Drug Administration. Dynavax is clarifying the remaining regulatory requirements for the potential development and licensure of HEPLISAV in the United States and Europe.

So Heplisav is more efficacious than Engerix-B, the licensed vaccine, requires fewer doses, and has similar side effects, including the one case of vasculitis. Does anyone else find it absurd that, given these facts, Heplisav would be on a clinical hold while the approved product remains on the market? And do you think Heplisav can eventually make it to market given what appears to be an advantage in efficacy and dosing?