FDA statement on following the authorized dosing schedules for Covid-19 vaccines

Re:FDA statement on following the authorized dosing schedule... by s1artibartfast on Tuesday January 05, 2021 @12:39PM (#25648229)

1) The FDA does not run clinical trials.

2) Trials must be large to see results because Covid is rare. The Moderna trial took 30,000 patients 3 months to get to 90 covid cases.

3) This could be a an interesting opportunity for challenge trials, but unfortunately, the key metric for vaccines is reduction in severe cases. Subjecting people likely to have a severe case is unethical when there chance of normally catching it is very low.

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Re:FDA statement on following the authorized dosing schedule... by enchiridion on Tuesday January 05, 2021 @10:35PM (#25654430)

Why not look for key indicators of immunity in the authorized dosage group, then compare against indicators in the reduced dosage group?

This is part of my complaint. Why is a large trial, or even a challenge trial (which I also support), the only way to get results here?

There is more to science than reading statistics from trials. They should be able to ask and answer very specific questions based on the working model proven far. Then scale those results to the broader problem.

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