5 ms·
I think you’re making a lot of assumptions that FDA approval/disapprovals are slow due to a sense of urgency. I’d like to see evidence for that, I’d personally
by azinman2 6y ago
I think you’re making a lot of assumptions that FDA approval/disapprovals are slow due to a sense of urgency. I’d like to see evidence for that, I’d personally assume it’s quite the opposite— they’re trying to get it as right as they can before doing something at scale that can’t be easily undone.
If 15 doses lead to issues compared to 10, then you jeopardize all those vaccines which are slow and difficult to make. You also give people false sense of hope and possibly either get lower effectiveness or build public distrust. These are tough balancing acts.
- zbrozek 6y agoIt's really hard to grok why 15-vs-10 doses in a bottle should be a problem. Sure you've got the out-of-fridge time, but that hardly seems like an issue when the population is itching to get vaccinated.
- mattzito 6y agoMy understanding is that they wanted to validate that the additional needle insertions through the vial doesn't damage the seal enough to cause contamination.
- zbrozek 6y agoIs the seal important if the vial is going to be fully used up ~now? Presumably the needle has to be clean regardless of whether the seal exists at all (e.g., it could be dirty inside the bore and the seal state would be irrelevant), so the seal's purpose is to prevent contamination from the environment when there is no needle present. That kind of contamination takes time to happen and more time to incubate, and if the open lifespan of the vial is only a few hours is that important? Seems like that minor uncertainty is a good trade for swifter execution.
- azinman2 6y agoI don’t know much about this issue, but from your comments it sounds like you don’t either. I’m not trying to be mean, but considering it wasn’t an automatic approval from the FDA that would suggest there’s legitimate concern to at least investigate. Be wary of Dunning-Kruger effect, especially when we’re talking about the healthcare of every person on Earth (the ideal scope of these vaccines).
- zbrozek 6y agoThis is a hollow appeal to authority (the FDA is infallible) mixed with an appeal to emotion (fear of death) with no attempt to provide concrete information or to present thinking towards a conclusion.