[oldgradstudent]

> No one who understood the vaccine said that. But deniers still claim they did.

This is historical revisionism.

The Pfizer and Moderna Covid vaccines were approved for a single indication, and a single indication only. Prevention of symptomatic Covid.

From the Pfizer vaccine package insert:

> COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. (1)

They were never approved for anything else because the trials were never designed to test for anything else.

https://www.bmj.com/content/371/bmj.m4037

In a functioning science, when reality (almost everyone got symptomatic Covid, regardless of vaccination status) conflicts with predictions (~95% efficacy in prenting symptomatic Covid), there would be some attempt to understand why the trials failed so miserably.

The obligatory Feyman quote comes to mind:

> For a successful technology, reality must take precedence over public relations, for Nature cannot be fooled

[jewayne]

The trials showed that 95% efficacy over the initial trial period -- about 3 months, as I recall. That wasn't a made-up number.

As time went on, it became apparent that while efficacy against symptomatic COVID faded quickly, efficacy against severe COVID (I believe defined by needing hospitalization) and also against all-cause mortality remained strong. You would have had them pull a life-saving vaccine from the market on a bureaucratic technicality? That's insane.

[oldgradstudent]

> You would have had them pull a life-saving vaccine from the market on a bureaucratic technicality? That's insane.

It is not a technicality.

There are no drugs, procedures, medical devices, or vaccines without adverse effects. It is always and everywhere a tradeoff between benefits and harms. If you intentionaly terminate a trial (breaking blindness is effectively terminating it), you cannot trade off the harms and benefits because you have no idea if there are harms, or whether the benefits last.

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

[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.

[revelio]

It actually was a made up number because they didn't measure correctly. They classified people as unvaccinated even for weeks after they took the shots. This is guaranteed to inflate effectiveness. Norman Fenton has made this point repeatedly and even written simulations to demonstrate it. With the delay period they used you get to 95% effectiveness for anything, including water.