[roenxi]

The COVID vaccines were rolled out on the basis that they were more-or-less safe and probably efficacious. A lot of them turned out not to be as safe as anticipated - eg, the blood clotting issue in the Astra-Zeneca virus or the myocarditis issues in the Moderna vaccine that have gotten its use limited in Scandinavian countries [0]. It turns out that the evidence that was collected at speed wasn't actually enough to justify the actions taken.

That was a good standard and an appropriate thing to do. But that standard is lower than what the medical regulators usually accept. As you point out, Phase 3 trials are good to do but it is going to make it a lot harder to get a vaccine to market if people have to take them seriously. Vaccine makers should be allowed to sell vaccines that are merely safe and effective; they shouldn't have to pass a higher standard than that to sell the things with a disclaimer label.

As an aside I'd also question the efficacy results as the vaccines are probably a lot less effective now. It appears the virus has mutated quite substantially. But that hasn't changed the vaccine approval status, raising interesting questions around why efficacy is even a requirement to sell the thing. Why not just a safety study with the requirement that efficacy data will be collected and made available? We need to figure out if something is efficacious, but there will be more money to do that - and better data - if it is allowed to go to market. As we can see from COVID, jabs in arms and money are the two things missing to make vaccine development fast. The normal regulatory framework makes both those things hard to get.

> If you want more vaccines, tell some of these multi-jillionaires to quit fucking around with virtual crap like Bitcoin and Twitter

Didn't most of the wealthy people in Bitcoin make their money in Bitcoin? There weren't a lot of ultra-wealthy people putting serious money behind it as I recall.

[0] https://www.reuters.com/world/europe/finland-pauses-use-mode...

[tsimionescu]

You're completely ignoring just how big of a threat Covid was, which is a part of the risk-to-benefit ratio of a Phase III trial. The same vaccines, with the same P3 results, may well have not been approved for, say, a mild cold virus, but would have also been approved for Alzheimer's.

The reality of drug approvals is that they always take into account proven benefits and risks (including some room for yet-unknown risks) compared to the available alternatives (including other vaccines, other medication, or even not treating the disease at all).

This calculation was not necessarily changed for Covid in some special way. The bug difference with Covid was that governments pumped billions into getting the research done, as did the companies themselves knowning that they will likely be able to literally sell tens of billions of doses of this vaccine if they make it work even a little bit.

[roenxi]

Fair enough. This may be where there is nothing more to say. But just in case - why is it necessary to centralise the decision for making risk-to-benefit ratio assessments? Everyone has different risk profiles and may have reasonable disagreements about how dangerous the risks are vs the benefits. We've learned that several widely used vaccines were more damaging than the health authorities realised, but nearly nobody has a problem with them having been rolled out to the masses. This suggests the standards of the health authorities are unreasonably high. When they lowered their standards for COVID there was barely any extra damage done, we're measuring the incidents in single digit cases per million.

A lot of people - dare I say most - have a higher tolerance for risk than the health authorities do. Why is it necessary to hold back progress because of nervous bureaucrats? We could make faster progress by letting people willing to take risks take risks.

[tsimionescu]

The decision is not as centralized as you make it out - various governments and other super-national bodies can and have taken different decisions, based on various assessments and, at least to some extent, the will of their populace (though I'll be the first to point out that representative democracy and technocracy make the effect very indirect).

The argument for not making this decision fully decentralized is that assessing the risk-to-benefit ratio requires a significant level of expertise, both in the subject matter itself (were the studies conducted well? what possible blind spots may they have methodologically? what plausible effects could these blind spots have on public health?), and in the more political/social side (are the doctors running these studies trustworthy? are the results being accurately reported between observation and collation? will this medicine be over-sold to patients in disregard of the studied benefits/risks? what is the cost/benefit estimate for using this in public hospitals?).

Now, it would be possible in principle for the state to provide the current centralized verification services, but then only give consultation-level opinions to the populace, doctors (and/or the public health system). But given the strength of PR and direct-to-consumer marketing, this seems to be extremely risky in terms of people ending up swindled to spend huge amounts for terrible medication sold by unscrupulous corporations (a free-for-all version of the opioid crisis).

[bsder]

> A lot of people - dare I say most - have a higher tolerance for risk than the health authorities do.

You don't get to claim this and also simultaneously make claims about low prevalence myocarditis from Covid vaccines. Sorry, I'm not letting you get away with that rhetoric.

People like to think they have higher risk tolerance--until their bet comes up snake eyes. At that moment, you find out what their risk tolerance really was.

Lots of anti-vaxxers thought that they had high risk tolerance about Covid and vaccines--until they came down with Covid and landed in the hospital. Suddenly, their risk tolerance went out the window and they all wanted lots of heathcare treatment and suddenly were asking for the vaccine (without the understanding that the vaccine was now useless).

[roenxi]

> You don't get to claim this and also simultaneously make claims about low prevalence myocarditis from Covid vaccines. Sorry, I'm not letting you get away with that rhetoric.

I took a dose of the AZ vaccine after the blood clotting issue was on the radar. Turns out my risk tolerance for vaccines was relatively high.

> People like to think they have higher risk tolerance--until their bet comes up snake eyes. At that moment, you find out what their risk tolerance really was.

You find out what their response is to being unlucky. If I lost all my money in an investment I'd be fuming and ranting for a few days but that doesn't tell us anything about my risk tolerance.

> Suddenly, their risk tolerance went out the window and they all wanted lots of heathcare treatment

Did you expect them to be hospitalised and refuse medical treatment? Again, you're finding out someone's response to being unlucky, not getting a read on their risk tolerance. I agree that most people are bad at judging personal risk; but people should have a right to make their own mistakes.