What We Learned from Operation Warp Speed

Townhall.com ^ | January 29, 2021 | Christina Herrin

[Captain7seas]

Read the FDA’s EUA Report. The reason they discredited HCQ Is because The FDA is under legal stipulations which they must meet prior to granting a vaccine emergency use authorization. One of those legal requirements is that there cannot be any available affective and approved alternative to the vaccine.HCQ met all three of those.

[Organic Panic]

” it is also necessary to showcase government’s successes”

Completely 100% backward. It showcased how absolutely useless the government is and screws up everything it touches. It was only with Trump brushing government aside that companies were able to work so fast.

[monkeyshine]

Well that is an interesting point, and I sort of knew that. They are much less likely to approve a second drug for the same disease unless it is shown to have better outcomes, or very different profiles or design or improves some other factor such as quality of life or side effects etc.

But AFAIK, this is just a policy not a law. They can re-write policy. And there is a major difference between treatment and vaccine. And fwiw, they never did “prove” HCQ or Ivermectin works - even though it is pretty damn obvious they work, afaik the FDA did not authorize any of the P1/2/3 trials for them. They should have, but again nobody stands to make any money off proving these generics are effective so who would bother to study them? In this case since they are proven safe and effective they could have theoretically jumped right into P3 trials. Trump’s proposed those drugs, but didn’t put $1 billion to study them. He should have. The Admin State would have still revolted, because they would gain nothing from approving these old drugs for CV19 treatment. But we could have avoided a lot of deaths and a lot of economic devastation if we had unleashed every weapon we had. The Admin State, and various governors and state medical/pharmacy boards put the kibosh on it. I blame them. They are immoral selfish people.

I do understand the need for the scientific method, but in an emergency situation you can’t tie your arms behind your back and go to fight.

[Paul R.]

Maybe I am wrong about this?

I was under the impression that in the Phase 3 trials, there is a large control group that receives no vaccine (or a placebo?), and another large group that receives the vaccine, but is otherwise as similar as possible. Then these 2 groups of subjects gradually accumulate infections, with each infected person monitored for antibody response and disease severity, and in particular numbers of infected persons who develop serious disease are tabulated.

Once a sufficiently large number of infections have occurred (plus time for serious disease to develop) to have high statistical confidence in the comparison of the number of serious cases in the two groups, that comparison is made. Additionally, throughout the process the subjects are monitored for undesirable side effects.

Since the testers are not lining up subjects to inhale lungfuls of virions, the process takes time for subjects to be infected out in the community. (I have no idea if subjects are or are not encouraged to mitigate infections.)

If the infection rate in the community is low (typical front end of a flu variant’s cycle), it takes quite a while for enough subjects to be infected to have confidence in the data. In the case of COVID-19, infections in the community were high, so infections in the test groups accumulated quickly, speeding the process.

No?

Please correct as appropriate.

[xzins]

And president Trump was 100% correct!