In this case, the manufacturer itself is behind the decision, and at least part of the reason is to get information out to doctors and proper advice for giving the vaccine. If it should not be given to certain demographics, that needs to be worked out. And current informed consent information and documents needs to be updated. In addition they need to consider how to treat the complication. Standard rapid treatment for a brain clot is a blood thinner, which will make this type of clot worse.*
Here in the US, delays from switching to another vaccine are small. People deserve to be presented with accurate information for informed consent purposes, and the risk of waiting to get Pfizer or Moderna instead is not huge. Janssen has not been a huge part of our vaccination effort so far, and numbers of shots available just dropped anyway due to supply issues.
And so far, numbers look to be around 1 per million, but we know with scrutiny, similar numbers in Europe for AZ evolved into about 1 per 100,000. So pausing to get a handle on things does not seem like an overreaction to me. Again, I think the experts should be given the benefit of the doubt as having much much more information, knowledge, and expertise.
*I believe that, when a clot is suspected in the ER, heparin may even be given immediately, because rapid treatment for the by far more common type of clot is so tremendously beneficial, and this type of clot is so rare. If the incidence of this type of clot is changing due to it being a vaccine complication, treatment decisions might be impacted, and it could cause additional harm and deaths not to have a very good handle on the incidence of CVST.
Yes, standard treatment for most blood clots is heparin, but this is a really weird kind of clot, sometimes seen when people become allergic to heparin (iirc) and giving heparin would make it worse.
And if this is really just a pause to make sure that all doctors, especially all ER doctors, know how to deal with it and to gather more info, then I withdraw my objections to it.
You know that clots in the legs often migrate to other places and cause problems, right? My dad died of a clot that originated in his leg and ended up in his lungs.
So no, this isn’t exactly the same kind of clot as what you can get from estrogen. And yes, incidence per incidence, these clots are nastier. But the risk of dying from an estrogen-induced clot is likely higher, due to the much greater underlying risk.
Yes, it would be. And that happens. If you look up the risk of stroke from birth control, and from hormone supplementation after menopause, it’s not negligible. And I’m pretty sure that risk is greater than the risk of these weird clots from the J&J vaccine. And I’m taking the hormones anyway, knowing that risk.
Not only does the estrogen make me feel better, the all-cause mortality appears to be slightly better if I take it. The additional risk of dying from a stroke or breast cancer is offset by the reduced risk of dying from a broken hip and some other stuff.
Similarly, the risk of being damaged from these vaccine-induced clots needs to be compared to the risk of being damaged by covid. My son’s J&J shot was scheduled for today, and has been cancelled. But when he didn’t yet know for certain that he couldn’t get it, he planned to try to get it despite the clot risk, and I supported that.
Ok, how about you show me why “the risk of dying from an estrogen-induced clot is likely higher, due to the much greater underlying risk.” Because I’m missing that link.
But the reality here is that the alternative is to beta test COVID. I’d rather beta test something developed by humans using all our ingenuity to make it as safe as possible and test it as extensively as possible within the time constraints available given the extremely high cost of delaying rollout, than beta test something developed by bats.
Because the risk of getting a clot AT ALL due to estrogen birth control is pretty high. But I’m not feeling like spending any more time researching this. If you know anyone who recently purchased birth control pills you can look at the package insert. (at least, in the US) I read that package insert a lot of times back in the day.
Blood clots are dealt with successfully every damn day with a variety of blood thinners and other interventions. You are making a logical leap from more common to more dearhs. But feel free to spend no more time on the subject
I find that a little hard to read as anything but rather willful misinterpretation. What I’m saying is a rare blood clot in the brain is not the same as extremely common blood clots in your leg. You might want to look up the “blood brain barrier” if you want to understand why this is rather an important distinction.
Plus, I don’t know if it has been pointed out upthread, but it’s also the case that every time you take a medicine you’re beta testing it. That’s what pharmacovigilance is. If you weren’t beta testing it, the adverse events listed in the pack insert would never be updated.
Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials , where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine’s authorisation, it has been tested in a relatively small number of selected patients for a limited length of time.
After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances.
It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.
The risk is likely somewhere around 1 in 100,000. No medicine has had testing in trials that would reveal that rare of a risk. All new medicines have a chance of this kind of side effect showing up when it enters the market. Unless you are in your 20s and in an extremely low risk area for Covid, or are totally isolating with your entire household, you are almost certainly better off getting whatever vaccine is available to you.
People deserve information to make informed decisions, so I support a short pause in the US for that and the other reasons I mentioned. But if someone declined vaccination at all, or puts off vaccination for months until there’s a longer track record for the vaccines, they are making the wrong bet.
Even the risk band charts that have been posted are about risk of Covid per 12 weeks. The shot is a one-time risk for long-term protection against Covid and all of its consequences (not just death). (All DVST incidents so far have been from the first shot.).
This is complicated, and worth discussing with one’s doctor if there are concerns, but one liners like, “I don’t want to be a beta tester” do not capture a valid reason to delay vaccination.
The problem that’s been documented isn’t clots outside of the circulatory system, it’s cerebral venous sinus thrombosis seen in combination with low levels of blood platelets.
This is a clot in the vessels that normally drain blood from the brain. (per the embedded wikipedia link)
So the blood-brain barrier isn’t really relevant here. And fyi, the wikipedia article lists the common causes as
Rummaging around, trying to find a summary of all VITT cases (I failed) I came across something called Brief19 - so far as I can tell it hasn’t been posted here before; if it has I apologize. But it looks very useful - here it is:
Doesn’t that just sound like the sort of thing we’ve been crying out for?
Its immediate relevance to this thread is this summary:
From which:
The upshot is that in a few instances, the AstraZeneca/Oxford vaccine appears to be causing a condition now being called “vaccine-induced immune thrombotic thrombocytopenia,” or VITT. That’s science jargon for: the vaccine can cause an immune reaction that lowers platelet counts which can potentially cause or worsen dangerous blood clot formation. To some, this might sound paradoxical. After all, platelets help us make blood clots. Why would a condition that lowers platelet levels cause more clots? The answer is that when platelets are attacked by the immune system, the platelets release particles—a kind of molecular shrapnel—which then cause blood clots to form or worsen. These blood clots can be harmless and sub-clinical, or they occur or travel to areas of the body where they can do great harm by literally blocking the rest of the blood from reaching its intended destination. In the lungs, large blood clots inhibit the rest of the blood from getting oxygen. In the brain, blood clots stop blood from returning to the heart. The ensuing traffic jam first causes damage around the veins where they occur, but eventually cause a stroke, because oxygenated blood eventually can’t reach that part of the brain. The reason that scientists worked this new vaccine-related phenomenon out so quickly is that this condition appears to be related to another similar and well-known problem, caused by a medication called heparin, a commonly used blood thinner.
