40 ms·
Ya, sorry I used "studies" in the shitty industry jargony way where it (as opposed to clinical study) can mean just about any type of experiment. For shelf lif
by icegreentea2 5y ago
Ya, sorry I used "studies" in the shitty industry jargony way where it (as opposed to clinical study) can mean just about any type of experiment.
For shelf life and storage, FDA typically very much prefers real-time rather than simulated/accelerated data. For the time interval listed here (1 month at fridge), they certainly would have done a real-time study.
I've only worked in diagnostics (and any reagents needed for that), so I don't know if the FDA would require these studies to have an actual human efficacy/safety component, or if these vaccines just passing some sort of QC test (presumably the same screen they use to manufacture) is enough.