http://www.fiercevaccines.com/story/after-rejection-dynavax-shoot-limited-hep-b-vaccine-approval/2013-02-25
what is happening with this vaccine is scary to me. So they reject licensing it for 18-70 year old based on insufficient safety data. (Meaning there could be some serious safety concerns) but instead of actually doing what they should do like conducting further and better safety studies, they just want to limit the target pool and this somehow makes it ok? This is bullshit. Why ANYONE would think this is acceptable is truly beyond me. It really is all about the money.
Quote:
But the company may not need to conduct more safety tests--a factor that could reduce potential approval from years to months. And Cowen & Co analyst Phil Nadeau told Reuters the vaccine could gain approval for a more limited population late this year or in the first half of 2014.
and this:
Quote:
We are going to have to do some work to assemble all [the data] and make sure that it fits the FDA's requirement."
translation: we are going to have to do some work to tweak the avaliable safety data (which is woefully inadequate) to "fit" into the requirements so this crap can be passed. 
Their rational makes no sense either. So it's potentially unsafe for 18-40 year olds but thats suddenly ok for the 40-70 demographic? I would argue that their point that 40-70 year old often have more compromised immune systems is more reason to NOT license this for approval based on lack of acceptable safety data. I mean do people not see how twisted this is?
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