Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye.
The vaccine hesitancy this engenders is likely gonna kill more than that one person.
https://twitter.com/NateSilver538/status/1381936112311148548
> Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. It might help if they sought out experts from economics, sociology, psychology, etc., instead of telling everyone to stay in the their lane.
* Hormonal birth control - years of research. Years of evidence and practice. Knowing what to do when this and that happens. Recommendations for women with known conditions not to take this and that hormonal birth control.
* Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet.
I'm fine with anyone to make a decision on them own to take these vaccinations. As someone with a not-so-uncommon mutation causing thrombosis easily, I'm happy I hesitated and haven't received either J&J or AstraZeneca.
That is completely untrue. This vaccine has been through several clinical trials for months. We know that there are no side effects that are common enough to be of real concern. The reason we are only seeing this one now is that it is so rare.
Sometimes the answer is easy.
> Hormonal birth control - years of research
This is kneejerk status quo bias.
> I'm fine with anyone to make a decision on them own to take these vaccinations.
Great, but the FDA is not. That's the issue here.
The "you woudn't care about women dying" narrative completely derails the essential discussion (aka when do we determine vaccine to be save) by selectively picking facts from a completely unrelated health area to turn it into an activist subject.
It reminds me on the magnet-troll-logic memes, only this one trying to come up with the completely insane narrative: "If you are concerned of a few more people dying because of a vaccine, you hate women."
The specific issue being observed is "cerebral venous sinus thrombosis (CVST)" in combination with "low levels of blood platelets (thrombocytopenia)" per the Joint CDC and FDA statement (1).
Low blood platelets means anti-clotting treatments can pose a substantial bleeding increase, making this already dangerous condition difficult to treat.
(1) https://www.fda.gov/news-events/press-announcements/joint-cd...
> Birth control pills can also cause thrombosis. So why is there all the fuss about the COVID-19 Vaccine AstraZeneca? > It is true that for birth control pills thromboses, even with fatal outcome, are known as a very rare side effect. They are listed in the Summary of Product Characteristics (SmPC). The birth control pill is available only on prescription. Every woman must be informed of this risk by the prescribing physician. For the COVID-19 Vaccine AstraZeneca, there is currently a suspected very rare side effect of sinus vein thrombosis with accompanying platelet deficiency, sometimes fatal. It is not listed in the SmPC.
https://www.pei.de/EN/service/faq/coronavirus/faq-coronaviru...
6 cases in 7 million over 3 months with mostly women being affected is exactly what we'd expect to see.
[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....
We 'spend' about one micromort of risk per day of being alive. Or you can spend one walking for 6 hours, or driving 250 miles (or 6 miles on a motorbike)
I just made a website to show all the other stuff we do all the time without worrying with the same (extremely low) level of risk
There is enough anti-vaccine & Covid rhetoric that we should all cool it a little bit and let the experts do their jobs.
I’m the opposite. Covid caused my trust in them to plummet. Perhaps made with the best of intentions, but all the noble lies have eroded my trust.
Same framework that's lead to all of the poor policy decisions over the past year.
> That said I trust that the government agencies know what they are doing here.
If 2020 didn't finally shatter that trust, is there anything that can? FDA was already obviously a regulatory capture vehicle for pharma. And CDC got nearly everything wrong in the ebola outbreak of 2014. Then, both of them blundered their way through this pandemic.
For example, we know from the email leaks that FDA felt it was under pressure from Trump to approve vaccines[0], and then never disclosed this fact to the public. That doesn't seem like dispassionate science and expertise to me.
By contrast, many of the medical journals, preprint houses, and academic institutions have looked like far more stable sources of knowledge.
It seems to me that the internet age asks us to replace our state institutions of expertise with something more thoughtful and genuinely connected to science.
Seeing US agencies halting J&J while continuing the other vaccines could even be reassuring. It shows that US agencies really are pretty cautious, and are willing to halt vaccines that show signs of problems.
This is a highly unusual situation insofar as phase III monitoring is far from complete and there is no 'phase IV' (confirmatory) trial data at all yet. In the normal course of research, this is how we'd catch rare but consistent adverse effects.
So, if we had complete trials on a normal timeframe, then obviously there's a different calculus to apply.
But given what we know at this moment, these six incidents might actually be far more normal than the crude use of six as numerator and seven million as a denominator.
A pause to assess the data and allow any lag to resolve seems prudent.
And, while this will be very difficult to quantify until much later, if then, I surmise that this will only create temporary vaccine hesitancy and only outside the high-risk tier, which is perfectly rational.
For people in the low-risk tier, there's nothing wrong with waiting until the conclusion of the RCT monitoring in the first place, even if adverse events weren't the basis of that decision.
I don't disagree. But I will observe that many people in the low(er) risk tier are going to be traveling, eating out, having parties, etc. sooner rather than later--vaccine or not. In my very Blue state people are very obviously relaxing a whole lot more. So the question isn't whether things open up or not. It's whether people are vaccinated when they do. (Which doesn't mean all vaccines are equally safe.)
I don't think the drug safety system is set up to effectively evaluate the cost/benefit of the pause itself in a pandemic scenario.
ETA: I see you made ninja edits to your comment....
Edit 2: So now you replied that you only added a word or two and then deleted you comment while I were replying. Your comment was only half as long when I replied (all the Twitter stuff wasn't there for example).
> A joint statement from the FDA and CDC clarified that the blood clotting was cerebral venous sinus thrombosis (CVST).
I don’t believe birth control is associated with CVST at a rate of 1/1000. It feels very misleading to use it as a point of comparison.
It's ridiculous.
Or as per someone that actually knows statistics: https://twitter.com/NateSilver538/status/1381925025964515330
Build a dam, which if it broke would kill hundreds-of-thousands, or let millions die for lack of water? Oh, we'll just over-engineer it, now we can't afford to buy food to keep the people alive long enough to need the dam; or the lead engineering firm embezzles the money and installs dodgy iron.
We can't wait around for long term studies, whatever point we decide to start vaccines - where they can still be effective for the current population - it's always possible we should have waited a bit longer.
www.medscape.com/viewarticle/949108
Per https://vaccinetracker.ecdc.europa.eu/public/extensions/COVI..., that's 30M AZ doses. You're still talking about one in a million chance of death here.
> And if you compare that to CFR from COVID for person <50 years old without diabetes and hypertension
Add a few more exclusions and no one dies of COVID, sure.
Even today Physicians still think the body is Art, or a combination of Art and Science.
And the only reason we don't have a science based alternative to the Physician cartel is that they spent literally $400,000,000 on lobbying/bribery in the last 30 years.
Edit- for further reading look up "evidence based medicine debate"
Who cares how many clots birth controls produce? What matters is the outcome compared to the thing birth controls prevent - pregnancy.
Do you get more blood clots from being pregnant or from being on the pill? It's order of magnitudes more from being pregnant, therefore if you're sexually active it's safer to be on the pill compared to not.
How is this the top post? People have no knowledge of basic Bayesian statistics.
Same with the vaccine.
> Do you get more blood clots from being pregnant or from being on the pill?
Again, same with the vaccine. COVID itself causes clots, in a very substantial percentage of hospitalized patients.
"The benefits of this medical intervention are worthwhile, despite the risks, given the alternative" is precisely the point being made.
A legitimate reason for the pause is to assess whether the people impacted have anything else in common. There are alternative vaccines that can be used if a commonality is identified.
As far as hesitancy, the idiot media already does a story for every vaccinated person that gets sick, this isn't going to tip huge swaths of people in either direction.
Agreed that if everyone is rational/good at math the optimal outcome is proceed with dosing, but sadly that is not the world we live in and the “broken trust” scenario might be more damaging.
[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
The vaccine was given to people, under threat of exclusion from society, without knowledge of the side effects. Not comparable.
