The Politics of a Health Crisis

[sexobon]

But of course, domestic Kobayashi Maru goes hand-in-hand with Cowboy Diplomacy. It's a given.

[Undertoad]

But historically, Phase III has always been expected by the FDA to take a bare minimum of 1 year.

one year is not "the rule" it's a guideline for vaccine development when not in a pandemic. the CDC link suggests 300-3000 participants, which you might expect if you don't have so many possible positive results because the studies are not done during a pandemic. but right now we do have plenty of data points. current phase 3 studies include 30,000 participants and more

[xoxoxoBruce]

Originally Posted by Undertoad

one year is not "the rule" it's a guideline for vaccine development when not in a pandemic. the CDC link suggests 300-3000 participants, which you might expect if you don't have so many possible positive results because the studies are not done during a pandemic. but right now we do have plenty of data points. current phase 3 studies include 30,000 participants and more

But Trump has castrated the CDC with all information and direction coming from Washington.
The FDA has the power of approval...



And the FDA says this is what you should do but it's nonbinding.



The wiggle room is explained in section VIII A & B. Right, section 8.




Translation - We told you the right way to do it.
But we like our jobs so when the word comes down we say, how high?

[Clodfobble]

More volunteers helps measure effectiveness more quickly, but the length of time itself is a critical function of the safety testing, just like 9 women can't make a baby in one month. If, say, a drug causes cancer, you won't know that in 3 months, no matter how many people take it. And it can certainly be argued that cutting corners is worth it, given that COVID is already killing people right now. But it can't be argued that corners weren't cut if the standard length of time for safety testing is shortened.

[Undertoad]

Originally Posted by Clodfobble

If, say, a drug causes cancer, you won't know that in 3 months, no matter how many people take it.

nor in a year. thread's yours.

[sexobon]

The standard length of time for testing isn't a lifetime; so, corners are already being cut. You can argue the probability of safety may change; but, not that corners weren't already being cut and now it's just a matter of degree. Look at all the approved drugs that were subsequently taken off the market.

[Clodfobble]

Originally Posted by sexobon

The standard length of time for testing isn't a lifetime; so, corners are already being cut.

Originally Posted by Undertoad

nor in a year.

Fair enough. Everyone has to balance their own risk, for sure.

[sexobon]

What does that have to do with the price of COVID-19 vaccine in China?

[tw]

Originally Posted by sexobon

What does that have to do with the price of COVID-19 vaccine in China?

Why does a price of tea in China have relevance?

[sexobon]

Why not?