I think it's ridiculous. It appears as if all the cases are limited to child-bearing age females on birth control who also suffer from thrombocytopenia. That is a really specific set. I would have much preferred to see them temporarily contraindicate the vaccine for women on birth control while they investigate. My fear is that people already thought this was a "second class" vaccine, and now there's going to be a needless safety stigma. Not handled well, in my opinion.
Not only this as a "second class" vaccine, there are already huge amounts of vaccine hesitancy around the whole thing. It's a very specific grouping. I knew they were all the right age has it been confirmed all were on birth control? And has it been confirmed all had thrombocytopenia? Definitely could have been handled better though I don't think it's necessarily the worst handling either. Restricting some instead of restricting all would be great, but the vaccine also isn't FDA approved yet, it's under EUA approval so they need to act quickly and with conviction with a stringent eye for safety. Not sure what normal vaccine approval is like but I know it's a horrendous process. Not sure what the normal course of action would be with something like this during trials, but I'm not sure how out of the ordinary their reaction truly is.
So... "women of childbearing age on hormonal birth control with a low platelet count" is kind of half our clientele. As I understand it, thrombocytopenia is basically just a cut-off; a line in the sand that all these women happened to be on one side of. It's likely to be a condition you don't even know you have, or were told you had but forgot the name of because it didn't matter. It's like my wife and Gilbert's - her parents look like Wisconsin stock while she looks vaguely Mediterranean for some reason because her liver doesn't process bilirubin that great but other than the blood bank freaking out every time she donates and her rolling her eyes at them, it's never really mattered. So this is actually kinda concerning to me, especially when I see that both the J&J and the Astra-Zeneca are adenovirus vaccines, as opposed to mRNA vaccines, but it's primarily concerning because I'm truly reaching for comprehension here. As Galbraith said, "there are two kinds of forecasters, those who don't know and those who don't know they don't know" and I try to be the former. So I'd welcome your further thoughts on the matter. We're gonna get asked. And we're gonna get asked a lot.
Yes, the clinical definition of thrombocytopenia is low platelets. Like many clinical definitions, it says nothing about the cause of the condition, and I'm sure that's what the FDA and J&J want to investigate. I wouldn't pretend to want to give advice on how to deal with patients, but I will says this: adenovirus vectors are very common in the world. They cause colds, and they've been used to develop other vaccines. So I doubt that it's the AAV causing this problem. It is probably more likely that the spike protein antigen is stimulating the immune system in a similar way that the covid virus does, as clotting is an all too common complication of covid--it's one of the main drivers of the cardiovascular issues that have affected so many people. So for me, I wouldn't want to scare anyone off of AAVs generally. All that said, I'm also not going to pretend to understand something I inherently don't. Just reading up on the other AAV vaccines that have been studies over the years, it looks like they don't generally see the side effect profile that the J&J vaccine evokes. So there's clearly something weird here. Our bodies, as you know first hand, really hate this spike protein. I think the prudent thing here is to remember we're talking about 6 serious adverse events and 1 death out of about 7 million total doses given. I don't know the proportion of women from 20-50 in that cohort, but let's say it's 20% for argument's sake, which would mean we're talking about 6 out of 1.5 million, or about 1/250,000. If you're a betting man you take those odds. If you're a pregnant patient, maybe you just wait for the RNA vaccines to become available to you.
Adenovirus vectors may be common, but adenovirus vector vaccines are not. That's what killed Jesse Gelsinger back in '99, which basically stopped recombinant DNA therapy stone cold in its tracks for fifteen years. Adenovirus vector vaccines were tried against ebola in 2014 and 2015 but they're still pending approval while the mRNA vaccine kicked up in the wake of the 2014 outbreak has already been approved. This is what bit genentech and the rest in the ass in 1999: adenoviruses are everywhere so adenoviruses should be no problem. But they have been in the past. My buddy Dr. Strangelove actually did his thesis on replacing adenoviruses with ebola for gene therapy so no wonder he ended up at Ft. Detrick. I have my suspicions that neither the AstraZeneca nor the J&J would have been approved so quickly if we weren't under emergency conditions, which also increases my concern - if these are the side effects we're catching now, what side effects aren't we catching a year from now? I agree - vanishingly small percentage impacted, much higher stakes, but we might end up saying "you'll almost certainly be fine, we happen to know your platelet count, but if you're totally freaked out we'll write you a note to try and increase your chances of getting the Pfizer or Moderna" as if it'll actually do anything. We've definitely got more anti-maskers among our clients than we do those with chronically low platelets, and we've been gleefully pointing out that "pregnancy" has been a "preexisting condition" warranting cutting the line for the past couple months.
As I understand it the Ebola vaccines haven't elicited much in the way of terrible side effects, but the trouble is that they've been given to thousands, not millions of patients. I think it's weaker efficacy, and not safety that have held up their approvals. Clearly with an ultra rare complication such as this one, it takes a hell of a lot of subjects to see a signal. Again, if it were me, I'd take the vaccine without hesitancy. We should expect the adverse even rate to decrease, not increase a year from now, because the AAV is not replication competent. Only time will tell though. This whole saga only seems to get stranger with time.
I listened to the call, I didnt hear them mention anything about the patients all being on birth control, just that they are all women ages 18-48. The thrombocytopenia is a side effect in combination with the blood clots as well. Not a pre-existing condition in these cases