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  • Despite Safety Concerns, Dynavax's Heplisav Should Receive FDA Approval [View article]
    That's exactly right. From our perspective, the efficacy of Heplisav is obvious, and should not be a primary focus of the Advisory Committee. We expect the Advisory Committee will instead focus on safety, and in particular the vasculitis case we mention. Given the large number of potential vaccine recipients, it will be especially critical to determine how to properly extrapolate from the trial data. One case of Wegener's granulomatosis out of 2,000 patients may seem insignificant and, in fact, might not be significant from a statistical standpoint. However, if the vaccine were given to 50 million people, and 1 out of 2,000 of those patients were to develop a severe form of systemic vasculitis, that's 25,000 cases of severe vasculitis, which is clearly unacceptable. Even if the numbers are more innocuous, and only 1 out of 10,000 patients develop severe vasculitis, that's still a lot of cases--5,000 to be exact. The question then becomes how much weight should be given to a single, likely incidental, case of Wegener's vasculitis. Is it, or is it not, representative of a true public health risk? We think the benefit of this hepatitis B vaccine, which has vastly improved efficacy over existing alternatives, outweighs its safety risk. But there is still risk, and that risk should be a heavily debated topic during the Advisory Committee meeting.
    Nov 7 03:44 PM | Likes Like |Link to Comment
  • Despite Safety Concerns, Dynavax's Heplisav Should Receive FDA Approval [View article]
    Hi Theodore,
    Thanks for your comment. As outlined in the above response to RajasriD, publicly available information actually does not indicate that Wegener's granulomatosis occurred in both arms of the study. The case of systemic vasculitis in the Engerix-B group was classified, relatively non-specifically, as "systemic vasculitis." It remains unclear whether or not these two cases of systemic vasculitis are similar to one another in terms of severity.
    Nov 7 02:40 PM | Likes Like |Link to Comment
  • Despite Safety Concerns, Dynavax's Heplisav Should Receive FDA Approval [View article]
    Hi RajasriD,
    You make a point worth further discussion. Systemic vasculitis is a broad group of diseases that share a common thread: they all involve inflammation of blood vessels resulting in tissue injury. Wegener's granulomatosis is a particular type of systemic vasculitis that has especially severe patient outcomes. A 2002 study suggests that, per year, more than half of all Wegener's granulomatosis patients become hospitalized due to their condition. From publicly available information, it is not clear, in terms of severity, how comparable the Wegener's granulomatosis case is to the reported systemic vasculitis case in the Engerix-B group. This may well be an item of debate for the Advisory Committee.
    Nov 6 06:37 PM | 1 Like Like |Link to Comment
  • Despite Safety Concerns, Dynavax's Heplisav Should Receive FDA Approval [View article]
    Hi printedit,
    Please see the above reply to Hattie's post. Thanks for reading our article.
    Nov 6 01:19 PM | Likes Like |Link to Comment
  • Despite Safety Concerns, Dynavax's Heplisav Should Receive FDA Approval [View article]
    Thanks for your comment, Hattie. As the article discusses, we believe Heplisav will, in fact, receive a positive vote during its advisory committee meeting. However, given the large number of people who would receive the vaccine upon FDA approval, the Advisory Committee will necessarily take extrapolation of the trial results very seriously.

    Additionally, to your point regarding our credibility: we are not money managers, but rather medical scientists who have trained at Harvard and MIT. We are sharing our unbiased opinion, and hope you found it informative.
    Nov 6 01:17 PM | 3 Likes Like |Link to Comment
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