Sure, but we do have prior probabilities based on other vaccination campaigns and studies. We also have some understanding of the causal mechanism of this vaccine, so there is other evidence. It’s just not a direct randomized control. People fixate on statistical testing under randomized control, but there’s a lot more information out there that can be used to assess probabilities.

Given that we've never before studied an mRNA vaccine, how do any of the numerous other studies apply to either the Moderna or Pfizer vaccine?

> You seem to think this is just a balancing of risks.

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.