[jewayne]

> There were drugs, devices, procedures, and even vaccines, whose massive harms were only apparent years after they were approved.

However, in this case "massive harms" were incurred when people WEREN'T vaccinated. We do know, from data collected around the world, that the vaccine lowered all-cause mortality. We know that vaccine hesitancy led to hundreds of thousands of deaths in the US alone.

You're right about one thing -- it's a tradeoff. And in this case the benefits were huge, and if there has been some great harm, I've yet to hear of it.

[oldgradstudent]

> However, in this case "massive harms" were incurred when people WEREN'T vaccinated

Even if it was true, do you suggest dismantling the current FDA efficacy and safety testing because it worked in one case? Is this a serious approach to risk management?

> We do know, from data collected around the world, that the vaccine lowered all-cause mortality. We know that vaccine hesitancy led to hundreds of thousands of deaths in the US alone.

The sad thing is that we know no such thing. Early termination of the trial made it impossible to know the real risks.

For example, it currently appears that myocarditis is diagnosed in one in 5,000 to 10,000 otherwise healthy young males (16-19 year olds)[1].

The vaccine has zero benefit in this population group because Covid is so mild in this group. In Israel, for example, exactly zero otherwise healthy 16-19 year olds died or were in any serious condition due to Covid.

In older people, and other risk groups (cancer, diabetes, obesity), the calculus is obviously different. But there was no reason to vaccinate otherwise healthy kids using a vaccine that was not tested properly.

[1] https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.0...

[jewayne]

From my understanding, the RCTs were never big enough to gauge the risks you're talking about in a statistically valid way. As your data suggests, even if the relative risk of myocarditis from the vaccine is very high, the absolute risk is quite small. Meaning that carrying on the RCTs for years would almost certainly have told us nothing of value.

[oldgradstudent]

> From my understanding, the RCTs were never big enough to gauge the risks you're talking about in a statistically valid way.

You can't know because the trials were cut short.

The RCTs were too small to detect that specific risk. However, the only reason it was discovered outside of the clinical trial was because the base rate of myocarditis for 16-19 year olds is so vanishingly low.

If the base rate was even slightly higher, much larger effects could not have been easily detected. Would you be able to detect an increase, say, of the diabetes rate in 1 in 100 after the vaccine has been released? what about 1 in 500?

It should be obvious that if your trials cannot detect adverse events that occur in 1 in 10,000, you should not vaccinate populations in which there is a significant benefit in less than 1 in 10,000.

> As your data suggests, even if the relative risk of myocarditis from the vaccine is very high, the absolute risk is quite small.

And sadly, a few thousand kids had their heart damaged (hopefully minimally) for no possible benefit whatsoever.

> Meaning that carrying on the RCTs for years would almost certainly have told us nothing of value.

BTW, hindsight is not a valid way to design vaccine safety studies.