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Short version: - Full FDA authorization takes time - We know a lot more about how these vaccines work than other vaccines so we're less nervous about them, bu
by danShumway 5y ago
Short version:
- Full FDA authorization takes time
- We know a lot more about how these vaccines work than other vaccines so we're less nervous about them, but that doesn't mean full FDA authorization doesn't still take time
- Since temporary authorization was granted, a huge number of people have gotten the vaccine, which gives us a lot of confidence since we effectively have a lot of case studies to look at. However, doesn't change anything about the fact that full FDA authorization still takes time.
- If Covid wasn't Covid, even knowing the above we might not have allowed temporary authorization, but we're managing relative risk, and the risk for nearly every population from Covid dwarfs the risk that there's a side effect from the vaccine that's worse. But, FDA authorization still takes time, it's not based on how dangerous the alternative is, so full authorization is still only gonna happen once enough time has elapsed for the vaccines to be evaluated using the normal process.
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I don't know if this will help with your family in specific, but I like to compare this to a change on a piece of software in an enterprise environment. Knowing for certain that the change is safe requires the change to be deployed on production hardware via a production build and run through a full set of full-stack tests, and then ideally monitored for a week to see if anything else jumps out as a regression.
So one day, imagine we notice a critical bug that's causing data loss for customers. I can argue:
- The change to fix this bug is in a part of the code that is well understood, all of our developers have looked it over and agreed that it's unlikely to have side effects.
- We've hotpatched this fix to multiple sites that were affected, and tested internally, and everything seems to be working well. We do have this code running in production for some customers, but we have not seen side effects.
- The risk of one of our customers randomly losing their data because of the bug is far higher than the risk of the fix causing additional problems, and it would be foolish for us to leave our customers in a state where they might lose data suddenly.
All of those are good arguments for bypassing the full set of tests and deploying the fix immediately (which is basically what the FDA did with the emergency authorization). BUT I still can't accurately claim that my fix has passed the full set of testing requirements. Independently of hot-patching sites and rolling out the critical fix, I also still want to run the full test suite and monitor the production hardware for a while longer.
That's basically where we are with the vaccine. We'd be foolish not to be deploying it now, but we still can't pretend or shortcut the process and just say that it's fully authorized (even though basically no one is expecting the authorization process to fail at this point). It hasn't passed the full test suite and sat on production hardware for a week yet. However, the risk of an issue at this point is small enough that for the vast majority of adults (even middle-aged and below), the risk of Covid complications are higher than the risk of vaccine complications.
The good news is that most timetables I've seen expect full authorization to be finished for Pfizer between September and December. I would not advise anyone to wait for that, but hopefully when it happens that will decrease vaccine hesitancy.