I’m normally on team “the FDA is making everything too slow,” but in this case I actually think there’s good reason to be really careful with those Phase-1 vaccine development trials. You don’t need to be using a live vaccine to actively make things worse!
How long does testing for this problem actually take? I’m not sure.
If we were sure this was the only thing we needed to worry about (but I don’t think that it is)… getting a line of evidence where some vaccine takers are exposed deliberately some time after vaccination could maybe speed up weeding out vaccines that trigger worse Th-2 reactions. But if it turned out that time-since-vaccination or current antibody-titer are major factors underlying outcome, we may genuinely need the full period of safety-testing.
And asking people to deliberately expose themselves doesn’t strike me as a… safe cheap or easy thing to do.
This looks like a complicated immune effect, and it seems to be under-characterized. Overall, it looks hard to test in-vitro or in cell culture. I’m pretty sure you’d need animals or humans to do it. I’m not sure which is faster.
Informed volunteers would be heroes, but I think there are enough heroes to make vaccines available months sooner and to save millions of lives. At least it should be in the Overton window to ask for a voluntary trial with the understanding that there’s substantial risk.
While we should at least ask and assess that question...
Yes, it would be good to rule out those things that we do know to expect. And I think animal results* could check this one somewhat. But corners are already being cut, and I still expect some degree of surprises.
I do feel like there’s a lot we don’t know with this virus. I don’t know that the problems will be limited to the things we currently know to look for, and I’d be a little surprised if timing was not at least a bit of an influencing factor.
* Apparently they haven’t found/developed an easy animal that catches the virus, but they are doing animal testing in parallel to check the type of immune response? And the vaccine test result with the 4 macaques at least seemed promising, now up by another 10 macaques tested with that same inactivated-virus vaccine.
While it definitely helps that we have some experience with SARS-1, we can’t totally rely on what we know about SARS-1 and trust that it’ll apply to SARS-2.
(I think SARS-1 and SARS-2′s genetic similarity was said to be only ~80%? This is about as much as we share in common with cows. There can be meaningful differences between the two.)
Here’s just one example. Did you see the “UPDATE” I added to my answer above? Says something like “Oh hey, I guess it probably does make immune cells apoptose?” SARS-1 doesn’t do that thing. As in, the article specifically mentions that they tried with SARS-1 and SARS-2, and only SARS-2 gets into T-cells like this. And they weren’t sure which receptor was responsible.
It’s great to see a lot of science happening on this, but it’s also something of a marker of our vast uncertainties paired with its high priority.
I’m normally on team “the FDA is making everything too slow,” but in this case I actually think there’s good reason to be really careful with those Phase-1 vaccine development trials. You don’t need to be using a live vaccine to actively make things worse!
How long does testing for this problem actually take? I’m not sure.
If we were sure this was the only thing we needed to worry about (but I don’t think that it is)… getting a line of evidence where some vaccine takers are exposed deliberately some time after vaccination could maybe speed up weeding out vaccines that trigger worse Th-2 reactions. But if it turned out that time-since-vaccination or current antibody-titer are major factors underlying outcome, we may genuinely need the full period of safety-testing.
And asking people to deliberately expose themselves doesn’t strike me as a… safe cheap or easy thing to do.
This looks like a complicated immune effect, and it seems to be under-characterized. Overall, it looks hard to test in-vitro or in cell culture. I’m pretty sure you’d need animals or humans to do it. I’m not sure which is faster.
Informed volunteers would be heroes, but I think there are enough heroes to make vaccines available months sooner and to save millions of lives. At least it should be in the Overton window to ask for a voluntary trial with the understanding that there’s substantial risk.
While we should at least ask and assess that question...
Yes, it would be good to rule out those things that we do know to expect. And I think animal results* could check this one somewhat. But corners are already being cut, and I still expect some degree of surprises.
I do feel like there’s a lot we don’t know with this virus. I don’t know that the problems will be limited to the things we currently know to look for, and I’d be a little surprised if timing was not at least a bit of an influencing factor.
* Apparently they haven’t found/developed an easy animal that catches the virus, but they are doing animal testing in parallel to check the type of immune response? And the vaccine test result with the 4 macaques at least seemed promising, now up by another 10 macaques tested with that same inactivated-virus vaccine.
While it definitely helps that we have some experience with SARS-1, we can’t totally rely on what we know about SARS-1 and trust that it’ll apply to SARS-2.
(I think SARS-1 and SARS-2′s genetic similarity was said to be only ~80%? This is about as much as we share in common with cows. There can be meaningful differences between the two.)
Here’s just one example. Did you see the “UPDATE” I added to my answer above? Says something like “Oh hey, I guess it probably does make immune cells apoptose?” SARS-1 doesn’t do that thing. As in, the article specifically mentions that they tried with SARS-1 and SARS-2, and only SARS-2 gets into T-cells like this. And they weren’t sure which receptor was responsible.
It’s great to see a lot of science happening on this, but it’s also something of a marker of our vast uncertainties paired with its high priority.