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> Hmm, not necessarily no. This can be a simple imperfection in the manufacturing process, it happens. There is not necessarily anything very wrong, just defici
by meepmorp 6y ago
> Hmm, not necessarily no. This can be a simple imperfection in the manufacturing process, it happens. There is not necessarily anything very wrong, just deficient QA.
You don't sell medicines to people which don't meet the specs you made public about them.
> The vaccine is going to work essentially identically to if it wasn't able to replicate. The difference is that you might get an adenovirus infection, which is basically a cold.
They've made the vaccine demonstrably less safe, either through carelessness or because they don't care. Don't minimize that, or assume it's the only place where the reality of sputnik doesn't match up to the phase 3 data.
> This should be a pretty easy fix, actually.
The fix is Gamaleya taking their current production facilities offline figure out where the problem is and fix it. Unless you're suggesting that regulators should just go full YOLO on this and let it slide, which is a stupid idea.
- sudosysgen 6y ago>You don't sell medicines to people which don't meet the specs you made public about them. Sure, and I never said otherwise. But all things considered this is pretty minor. >They've made the vaccine demonstrably less safe, either through carelessness or because they don't care. Don't minimize that, or assume it's the only place where the reality of sputnik doesn't match up to the phase 3 data. Yes, this does make the vaccine marginally less safe. Not by much. Empirically, after millions of doses administered, the safety profile of the vaccine is more than acceptable as is. >The fix is Gamaleya taking their current production facilities offline figure out where the problem is and fix it. Unless you're suggesting that regulators should just go full YOLO on this and let it slide, which is a stupid idea. I literally say the exact same thing. In any case, Gamelaya right now is trying to get other people to produce the vaccines, but sure they should fix this issue. It will not be complicated.
- wbl 6y agoYou don't know that this is the same vaccine as what was injected before.
- sudosysgen 6y agoWhy is there any reason to think it wasn't? Replicant viruses are very easily explained by a QA failure, and Brazil doesn't claim that non-replicant viruses aren't there anymore.
- wbl 6y agoThat QA failure means the vaccine injected is different: they tested without reproduction competent in the trials. What else could they have missed along with this?