Trump threatens to step on FDA efforts to tighten COVID-19 vaccine requirements

[jnug]

Hahn at FDA is such a useless idiot.

So it should have been clear to anybody with a brain that the time line was too tight for any real evaluation of DATA from the Stage 3 vaccine trials from any of the competing companies. Nobody even had 30,000 test subjects chosen before mid-August. I would guess they might have had enough of them to start first injections by end of August. There is one company claiming to have a one injection solution. That remains to be seen. Two others both have two injection vaccines with a 28 day waiting period between the two injections.

So lets say they started injections early in September and completed first injections maybe last week. with second injections scheduled to start early October. What "DATA" is Hahn talking about reviewing by Nov 3rd? The reason Stage 3 trials are historically a year long or longer is to observe the test subjects. Even that process can be extended if you simply do not end up with enough subjects exposed to the virus during the trial period. So I have no idea what "DATA" Hahn ever thought he was talking about.

So now..... NOW, Hahn figures out that he is once again making an IDIOT of himself and announces more stringent approval requirements. He has obviously seen that "some" of the contesting companies watch BOZO the President and are now trying to march to his timeline. Hahn is now trying to head them off at that pass when in fact he should have been upfront with the American People when it was obvious early on that there would be no real data to review by late October making an announcement before of any credibility before Nov 3rd impossible. Too late Dr Hahn. Donnie Boy has the bit between his teeth and he simply does not care that its vaccinations that save lives, not vaccines and come hell or high water, he wants his vaccine announcement before Nov 3rd regardless of how few Americans might be willing to take it or how unprepared we are to ramp up a distribution chain that allows vaccines to store properly at between 70 and 94 degrees below 0. Oh by the way even if you can store them at the right temperature, their shelf life is only a few days at best. So Trumpy announces that he might just have to step on FDA's more stringent vaccine approval requirements. I assume he will rely on the opinion of his RADIOLOGIST member of the WH COVID team, that IDIOT Dr Atlas for advice on the subject.

 

[jnug]

So FDA is looking for two months to acquire and review data from the Stage 3 vaccine trials. Now that is still historically sparse for issuing an Authorization. However there will be no data to review before Election Day, Nov 3rd. Hence it would be hard for FDA to contend that they were making a data based decision before Nov 3rd which I pointed out in the OP. The timing simply does not work for an Authorization that soon and it NEVER was going to work simply given the timing of securing subjects and giving them two injections spaced 28 days apart.

In effect they are saying that issuing an Emergency Approval for a vaccine based on no data at all would be ludicrous and dangerous and providing an actual Authorization before late Dec early Jan would be as ludicrous and dangerous as an Emergency Approval would be. Remember, this is a vaccine. Vaccines are given to HEALTHY people. in large volume. So if you screw up with a vaccine you have really screwed up.

Trump immediately responded that FDA is trying to politicize the issue which is again ludicrous as Trump has politicized the vaccine issue from day 1.