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To: ReaganGeneration2

Animal models are always imperfect. They’re designed and intended to be a first-look basic test for safety and efficacy. If you give a new medicine to a bunch of rhesus monkeys and half of them die, that’s really bad news. That might not entirely translate to humans, but it’s enough of a risk that your trials are over; you aren’t moving on to humans.

The other thing you can do with animals that you usually can’t do with humans is challenge trials, where you test how well the vaccine works after an intentional exposure. You often can’t do this with humans because some of them may die. Same reason you can’t do clinical trial testing on pregnant women or children until far, far into the process: the risk is just too high. So there’s a process that’s been built out over decades. You start with animals and see how that goes. Animals having problems? Don’t go forward. Animals all fine and medicine seems to work with them? Great, now move on to a small group of humans (Phase 1 clinical trial) so you limit the amount of risk. Here you just check safety. You don’t even care if it works; your entire trial exists only to confirm that this small group shows no signs of problems. That went okay? Great, expand the group (Phase 2 clinical trial). Here you can begin to look at how well it works, but 95% of what you’re doing is still solely focused on seeing if any ill effects show up. Still good? Now the big one: Phase 3 clinical trials. This is where you check for both safety and effectiveness in a massive group of people (thousands to tens of thousands). This is where 90% of new medicines fail. They’re safe in small groups, but in larger groups, problems emerge. Or it’s just not as effective as you expected.

You typically have to track all these people for quite some time (a year or two most often) after you’ve gathered all the FDA’s required data. You do this to ensure that the situation doesn’t change later. But at some point, you have to reach a point where you say “we’re good now” because the alternative is that we never get another medicine out of trials ever again. We just perpetually test everything; never actually releasing anything. Given decades of experience with tens of thousands of different medicines, there are established timelines for what constitutes the end of testing.

The COVID-19 vaccines have all gone through animal trials and full Phase 1, Phase 2, and Phase 3 clinical trials. That happened before the EUAs got issued. The first humans got COVID-19 vaccines back on March 16, 2020. Over a year ago. Two of the vaccines will be fully FDA approved by the end of this summer or early fall. And there’s nothing abnormal about that. They’re still on all the normal paths that medicines go on every year. Dozens of new medicines get an EUA every year. Dozens gain priority review. There are two other accelerated pathways through FDA as well which are routinely used to speed up availability of new medicines, but they ALL have strict testing guidelines they must pass to get there.

But to respond to your first point, yes, I’m completely against forced vaccinations. I find that to be an affront to the dignity of a human being and an assault on individual liberty.


164 posted on 05/17/2021 8:22:28 AM PDT by 2aProtectsTheRest (The media is banging the fear drum enough. Don't help them do it.)
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To: 2aProtectsTheRest

“The COVID-19 vaccines have all gone through animal trials”

Ok, but are you saying the results, from a safety standpoint, wouldn’t be relevant to publish? Or indeterminate? Or is it simply that none of us have found them?


180 posted on 05/17/2021 9:32:24 AM PDT by ReaganGeneration2
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