No I don’t. I was saying that the kind of balancing you mention is out of scope for FDA to answer. The fact you can’t find anyone to answer the question you want answered is not the FDA’s problem.
I said go off-label if you want to (although off-label might be slightly the wrong word in this case). Good luck finding a politician that wants to tie themselves to recommending that, in case it turns out wrong.
I wish that these decisions wouldn't need to be deferred to politicians. So many of them are selfish idiots.
I'd more trust the vote of relevant medical specialists. I'd rather that these specialist provide the public the best/concise information they have and let people make informed decisions for themselves, or even have a referendum on one dose versus two, and prioritizing.
Politicians have already turned the world upside down for something that looks like it will kill two out of a thousand people when all is said and done, mostly older. Half the population is dumbfounded by their lack of perspective, the other half is scared shitless.
The suggested dosing is obviously unproven because it has not had a nice large scale study done. Shouldn't this be where they conduct a few rapid small scale experiments?
That data, the existing trials, along with a deep bench of knowledge should be enough to make a well justified determination.
2) Trials must be large to see results because Covid is rare. The Moderna trial took 30,000 patients 3 months to get to 90 covid cases.
3) This could be a an interesting opportunity for challenge trials, but unfortunately, the key metric for vaccines is reduction in severe cases. Subjecting people likely to have a severe case is unethical when there chance of normally catching it is very low.
This is part of my complaint. Why is a large trial, or even a challenge trial (which I also support), the only way to get results here?
There is more to science than reading statistics from trials. They should be able to ask and answer very specific questions based on the working model proven far. Then scale those results to the broader problem.
The statement said there was insufficient data to make that calculation definitively. If you want to take a course of action not borne out by the study, the FDA doesn’t go after you or your doctor for off label use. The FDA is clarifying that the unproven route is, well, unproven.
The FDA is all about medical risk vs provable results. They can’t intelligently comment on the uncontrolled unknown beyond saying that that you’re entering that territory. If you want odds on rolling the dice outside that space, they’re irrelevant to you. So stop looking there.
edit: what you want is a politician with the balls to say whether we should do it anyway and convince other politicians that they should own making that decision even if they turn out to be wrong. But Washington is full of cowards too cowardly to even go to bat for sticking to the studied regime beyond milktoast deference to science so you’re here expecting the FDA to start exceeding their role.