4 ms·

Shipping and storage requirements were relaxed as manufacturers were able to complete additional studies. For example: https://www.fda.gov/news-events/press-an

• listenallyall 5y ago
  it said they "submitted data to the FDA", that is very vague as to whether it was actually further studies or some other type of evidence/data
  • 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.