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Comment by monkeypizza | Hacker News Reader

> It's not appropriate to start experimenting on the general population based on a hunch.

By varying the parameters of the situation, could you be induced to change your view? i.e. vary CFR up to 1%, 10%, 50% - given that you acknowledge that the natural experiments we are observing from single-dose administration suggest most of the immunity granted by a vaccine is in the first dose - at what point do you budge?

If you admit that for a 50% CFR, you would not insist on following the established standard of care, then the question is where is the border for you, where your recommendation flips, and you consider early end to quarantine, reduced life loss, to be worth moral hazard of ad-hoc decisions, or not following the standard of care would bring?

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Here's the thing... they did budge. Alex is so caught up in dunking on the FDA that you might miss the fact they just approved a one-shot... within days of hsi last article dunking on them for not doing it.

Presumably, that approach was being studied all along (in the three months that it's even been a decision.

Everyone assumes the FDA are being rigid and bureaucratic regardless of what they actually do. How do you write an article ripping them for magical thinking as they do the thing you're saying they should do? The fact that the FDA didn't pull a u-turn on the same day a"maybe this" thought occurs to a welfare economics professor is enough to accuse them of negligence every week.

Now, it doesn't even seem like even doing what he thinks they should do is enough. They're still caught up in "magical thinking." What for, giving any weight to clinical trial design at all.

Sure, Alex should update his criticism, but it's still valid to look back at why it took this long; First Doses First has been out for a while - it's been 2 months since, for example, Tony Blair publicly advocated for it.

I think the gains we would get from even a single day earlier application of First Doses First probably outweighs the pain caused to the FDA by Alex criticizing them.

https://www.businessinsider.com/blair-one-covid-19-vaccine-s...

It's not about advocating for a position. It's about having a shred of humility, and decency.

What Alex is doing is ragebaiting. That's not noble.

Anyway, it's far from established that either strategy is superior, at this point. There are a ton of factors including execution factors that have nothing to do with clinical trials.

My point is this: It seems like unless the FDA conforms exactly to Alex' opinion on any given day, they are corrupt quacks. It's so arrogant, and a case in point for poisonous discourse. This flavour of rhetoric shots down openness. All you can do is hide behind vague press releases and say as little as possible in public.

If I were working on vaccine development, approval or deployment, I would be trying to stay anonymous. These "open society" people are at the helm of an assault on open discourse.

> at what point do you budge?

Around the same time that you dispense with phase 3 trials entirely. It was more likely than not that the Pfizer/Moderna vaccines were effective by the time they'd completed phase 2 studies. If that is our standard, then we ought to have begun vaccinating at-risk individuals on a volunteer basis then -- in Fall of 2020.

To me, it's inconsistent to both say we need a full phase 3 clinical trial to grant authorization to a vaccine, but then to ignore the protocol of that phase 3 trial when distributing it.

Alternative is to have a more detailed and parameterized protocol.

Regardless, the real solution should have been early human challenge trials and we would have had the vaccine already in the beginning of the summer most likely.

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