[beerandt]

Correct or incorrect is sort of irrelevant, because it's a problem itself if they aren't including severity of symptoms in the study.

If they are ignoring symptoms to approve a vaccine who's primary remaining benefit is ... reducing severity of symptoms ... then how exactly has the trial proved anything?

Since antibodies are no longer a reliable indicator of immunity or of preventing transmission, then reduced severity is the primary remaining benefit.

Ideally they'd be looking at a cumulative risk/prevention assessment, but I don't see how they do that while excluding observed symptoms.

If they are using antibody levels as a proxy for this when they could just ... directly observe symptoms... then there would be a bigger problem with the study than just a failure to show sufficient efficacy.

[hammock]

Take it up with the FDA. You're preaching to the choir

[beerandt]

I get it.

It's just a fine line between arguing what would justify FDA "approval" vs what merits have changed that actually increase the risk-versus-reward assessment.

Put another way, when the biggest excuse for not getting vaccinated was "it's experimental and not approved", it became a straw-man-esque "gotcha-trap" of a battle to achieve "approval", even though that approval process looked nothing like any before it (no matter how many times "full fda approval" is repeated).

When the metric becomes the goal, it's no longer a metric, and all that.

We get bogged down arguing whether criteria of a definition or standard are being met, while the regulators end up just redefining things.

And we're supposed to pretend the teacher applying a curved grading scale actually represents a difference in the students performance.