Moderna's experimental coronavirus vaccine shows promise in early-stage study
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@xenon said in Moderna's experimental coronavirus vaccine shows promise in early-stage study:
Does anywhere here think we shouldn't loosen the regular process - or at least tailor it to make it as fast as possible for this specific vaccine?
Yes.
Well if I ignore the last clause which makes it meaningless
Remember this is a virus with a 99% survival rate. Billions will take the vaccine. Can’t skimp on safety.
Treatments for severe cases, testing technology, etc. is where you skirt normal processes.
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@jon-nyc I have no idea what typical safety guidelines are for a vaccine and how they're made.
If this immunizes 9999/10000 and infects 1/10000 - is that good enough (I don't know). Where is that line drawn? I don't know.
Is 999/1000 good enough, is 99999999/100000000?
Is that even the right trade-off to think about?
My point statement about loosening any rules here would be relative the expected damage this disease is already poised to do.
Other than that - my second statement was the only thing I can think of off the top of my head that I would change.
The FDA process is one-size-fits-all. Set up a streamlined process to ensure that paper/pushing and reviews are never the bottleneck. (Similar to how the CDC was slowing stuff down on testing earlier to adhere to normal process)
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@xenon said in Moderna's experimental coronavirus vaccine shows promise in early-stage study:
@jon-nyc I have no idea what typical safety guidelines are for a vaccine and how they're made.
If this immunizes 9999/10000 and infects 1/10000 - is that good enough
It's more like what if it does severe brain damage 6 months after use?
FDA regulations are written in blood.
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@Copper said in Moderna's experimental coronavirus vaccine shows promise in early-stage study:
@xenon said in Moderna's experimental coronavirus vaccine shows promise in early-stage study:
@jon-nyc I have no idea what typical safety guidelines are for a vaccine and how they're made.
If this immunizes 9999/10000 and infects 1/10000 - is that good enough
It's more like what if it does severe brain damage 6 months after use?
FDA regulations are written in blood.
Enter in any safety metric you like. I don’t know what the FDA bar is.
How about brain damage after 3 years?
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Any government agency writes testing rules for a reason. In the FDA's case I assume a lot of those reasons are related to undesired side-effects.
A massive overreaction is really fun for the media and everyone loves telling a scary story.
Injecting people with a new vaccine is a different story.
I say they should do any and all normal tests. Maybe they can cut some red tape but the substantive testing should take place.
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I actually agree with copper. I mean, the FDA doesn't do any testing. But they should be pretty firm on what protocols they'll approve.
The good news is the vaccine manufacturers should have no trouble recruiting for this.
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@xenon said in Moderna's experimental coronavirus vaccine shows promise in early-stage study:
Sure - I'd actually agree with that. That's the right thing to do and he's doing it.
Though, I'm not sure if that's a super courageous action given the circumstances.
Does anywhere here think we shouldn't loosen the regular process - or at least tailor it to make it as fast as possible for this specific vaccine?
Would Obama or Bush be pumping the brakes here?
Also - given Trump's recent over-exuberance on drugs, would you rather have the "Trump seal of approval" or Phase IV trial results before you decide to inject yourself with this?
If it was super corageous, the Dems would have done it, and then I'm sure you would damn them with faint praise, also.
I'm sorry, your objective credit on Trump is shot. Thank you for playing, though.
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@xenon said in Moderna's experimental coronavirus vaccine shows promise in early-stage study:
@jon-nyc I have no idea what typical safety guidelines are for a vaccine and how they're made.
If this immunizes 9999/10000 and infects 1/10000 - is that good enough (I don't know). Where is that line drawn? I don't know.
Is 999/1000 good enough, is 99999999/100000000?
Is that even the right trade-off to think about?
My point statement about loosening any rules here would be relative the expected damage this disease is already poised to do.
Other than that - my second statement was the only thing I can think of off the top of my head that I would change.
The FDA process is one-size-fits-all. Set up a streamlined process to ensure that paper/pushing and reviews are never the bottleneck. (Similar to how the CDC was slowing stuff down on testing earlier to adhere to normal process)
The FDA process has had its butt kicked by Trump. I've never seen anything close to it.
Another star you have to give him, sadly.
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So the real question is what if the super rare outcome of pediatric inflammatory multi-system disease was one outcome of the vaccine? Something far less than 1/10 of 1% of all cases and generally treatable with 100% recovery... should the vaccine not be rolled out?
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@Loki said in Moderna's experimental coronavirus vaccine shows promise in early-stage study:
So the real question is what if the super rare outcome of pediatric inflammatory multi-system disease was one outcome of the vaccine? Something far less than 1/10 of 1% of all cases and generally treatable with 100% recovery... should the vaccine not be rolled out?
There is no such thing as a 100% safe vaccine.
