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U.S. FDA to tighten coronavirus vaccine authorization standards ahead of election - paper


webfact

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How many people will die if the vaccine waits 2 more months?  How many kids with Stephen Johnson’s will get brain damage?  How many people will get cardiomyopathy and have a poor heart the rest of their lives?  How many people will have lung scarring and will shorten their life span and give them lifelong lung problems. Recovered does mean recovered. It means did not die. There is s big difference. 
Look, we all know that the US FDA is the slowest moving body of it’s kind anywhere in the world. 
My 88 year old mother has locked herself in her house since January. I would give her a vaccine if the phase one trial went well in our current pandemic. How many new people will get infected and die?  Under the Emergency Measures Act the drug manufacturers have immunity. 
Russia and China are at full steam. If problems arise then stop that one drug. We The People have a constitutional given right to chose our future (as a whole). Why not, why not put the power to take that risk into the hands of the people?  We are not looking to move at a pace of a new cough syrup. This is a Pandemic men. 

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1 hour ago, geworthomd said:

How many people will die if the vaccine waits 2 more months?  How many kids with Stephen Johnson’s will get brain damage?  How many people will get cardiomyopathy and have a poor heart the rest of their lives?  How many people will have lung scarring and will shorten their life span and give them lifelong lung problems. Recovered does mean recovered. It means did not die. There is s big difference. 
Look, we all know that the US FDA is the slowest moving body of it’s kind anywhere in the world. 
My 88 year old mother has locked herself in her house since January. I would give her a vaccine if the phase one trial went well in our current pandemic. How many new people will get infected and die?  Under the Emergency Measures Act the drug manufacturers have immunity. 
Russia and China are at full steam. If problems arise then stop that one drug. We The People have a constitutional given right to chose our future (as a whole). Why not, why not put the power to take that risk into the hands of the people?  We are not looking to move at a pace of a new cough syrup. This is a Pandemic men. 

The stakes are very different between drugs and vaccines. It's not a big deal to decide an emergency authorisation for a drug such as Remdesivir. It will be given to a relatively low number of people (in the order of x thousands), who may not have other alternative choice. The potential impact in case if side-effects is low.

It's very different for a vaccine. It will be inoculated to (hundreds of) millions of people. In case of unexpected dangerous side-effects it can be devastating, even worse than the pandemic itself. That's why labs and health authorities are so cautious (except maybe in authoritarian countries).

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