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FDA rejects new hep b vaccines

post #1 of 14
Thread Starter 
I'd kind of like to hide this away in mindful vax, but I couldn't think of a good excuse so here it is smile.gif

I just thought this was an interesting glimpse into the approval process for new vaccines.

http://www.medscape.com/viewarticle/779850
post #2 of 14

Is there a way to read what's at that link without signing up to the website? 

post #3 of 14
Thread Starter 
Oh I don't know! I didn't realize I was signed up.
post #4 of 14
Thread Starter 
post #5 of 14

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.  irked.gif

 

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? 

post #6 of 14
Thread Starter 
That's not really what happened. They were told todo more safety research. Also, just because there's not enough safety research for a really broad group doesn't mean there isn't for a more specific group.
post #7 of 14
Keep rationalizing. It's pretty clear what happened. I can read
post #8 of 14
Thread Starter 
I'm sure you can, I'm just wondering if you did.
post #9 of 14
Quote:
Originally Posted by Rrrrrachel View Post

I'm sure you can, I'm just wondering if you did.

Yes I did

post #10 of 14

Interesting insight into the process of licensing in the US Rrrrrachel. Thanks for posting. Good to see there's people involved in the process who are pushing to make sure the vaccines are as safe as possible. :) 

post #11 of 14
Quote:
Originally Posted by prosciencemum View Post

Interesting insight into the process of licensing in the US Rrrrrachel. Thanks for posting. Good to see there's people involved in the process who are pushing to make sure the vaccines are as safe as possible. :) 

Yes!!! Phew. I know I feel soooooooooooooooo much better about things now!!!

post #12 of 14
Quote:
Originally Posted by Marnica View Post

Yes!!! Phew. I know I feel soooooooooooooooo much better about things now!!!

Great. smile.gif Because after all, all we want is out kids (and kids in general) to be as healthy as possible. That's all this boils down to really. smile.gif
post #13 of 14
Quote:
Originally Posted by prosciencemum View Post


Great. smile.gif Because after all, all we want is out kids (and kids in general) to be as healthy as possible. That's all this boils down to really. smile.gif

yes so true so true. But we must keep in mind and respect the fact that other people may have a very different idea of how to achieve that goal than you/I do. As they say different strokes for different folks. 

post #14 of 14
Quote:
Originally Posted by Marnica View Post

yes so true so true. But we must keep in mind and respect the fact that other people may have a very different idea of how to achieve that goal than you/I do. As they say different strokes for different folks. 

I couldn't agree more. smile.gif
Edited by prosciencemum - 3/2/13 at 2:03am
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