[Sparyjerry]

That is incorrect, the decision making numbers used to test vaccine effectiveness having nothing to do with lab antigen numbers, they are based on how much symptomatic illness is avoided. All of the results such as as 95%-96% efficacy for Phizer and Moderna and 66% for J&J are based on the % reduction of symptomatic illness only. Not the reduction in actual illness or based on lab tests of antigen response.

[hammock]

I believe you are incorrect. What you say was true for the initial adult trials but many recommendations for boosters and lower age groups have been based on antibody response, not clinical outcomes.

[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.

[cik2e]

I've read that the pfizer study compared rates of positive test cases between the two groups.

BUT, the tests were administered based on self-reported symptoms which were then evaluated by a staff member to decide whether a test was warranted. This absolutely blew my mind.

This kind of avoidable subjective decision making should not be happening in a clinical trial. All participants should have been tested at regular intervals.

[beerandt]

Equally... that when they repeat it and get different numbers, the failed trial will be ignored in favor of the passing trial, without first invalidating the previous results[0], and without using any increased burden of proof.

Passed+Failed = "Passed!"

[0] There will be a reason given to ignore that first trial, it just likely won't be a good one.

[tekknik]

How does one not self-report symptoms? Some will be externally obvious but how does someone know someone else has chest pain, or a sore throat?