The FDA and the CDC have called for a halt to the Johnson & Johnson single-shot coronavirus vaccine because of six reported cases of a rare blood clot:
All six were women between the ages of 18 and 48 and all developed the illness within one to three weeks of vaccination. One woman died and a second woman in Nebraska has been hospitalized in critical condition....Nearly seven million people in the United States have received Johnson & Johnson shots so far.
The US population of women aged 18-48 is 65 million. About 2,000 have died of COVID-19 over the course of 12 months, or roughly 300 every two months. That's right around 5 per million.
The population of women who have received the J&J vaccine is presumably about 3.5 million. One has died of a blood clot over the two months the vaccine has been available. That's 0.3 per million. If the woman in Nebraska also dies, that goes up to 0.6 per million.
I just don't understand this. Even if it turns out that the J&J vaccine does cause blood clots, the mortality rate is less than a tenth of the mortality rate from COVID-19 itself. Why would you risk undermining public confidence in a vaccine for such a small danger? Especially when firm data will be available in just a few days?
Is there more here than meets the eye? Something I don't understand about these statistics? Or is it a belief among regulators that any risk, no matter how small, has to be made public immediately lest they be accused of being non-transparent? What's going on here?
Transparency is very important especially since we were lied to at the start.
But note, these are the rare and severe clots compared to most, and the standard treatment for blood clots actually worsens the outcome. So it makes more sense to pause it so they can make sure they communicate clearly what to look for, how to treat or whether to restrict it to certain demographics.
Crucially unlike the Euroes we have lots and lots of non Adenovirus vaccines, some 100 million given v 6 million, and so a brief pause to get our information straight in a country where only certain outbreaks are raging is much less damaging than a Europe where most of the continent is on fire.
Also while undermining public is a real concern, this doesn't effect the mRNA AND it communicates the health authorities are on alert rather than willing to kill people bEcAuSe tHeY kNoW BeSt.
Well, on reflection I don't think 1 in 7 million is the right number. The clots probably take a while to develop. If it's a week, then you have to ask how many people had J&J as of a week ago. But it takes a couple of days to sort this out and make an announcement, so that's maybe 3 days more. How many people had J&J as of then? I bet it's a lot less than 7 million. It might be 1 million. And it's very early days, so maybe we could see a lot more that just developed more slowly?
Also, lots and lots of Americans are looking for any excuse to avoid being vaccinated.
If you die of Covid-19, there's no one to sue; however, if you die of complications of a vaccine ....
Bingo. It's the American Way: Always look for someone to sue, and demand lots of cash, while announcing publicly that money can never compensate the family for its loss.
Cynical, but accurate . . .
Your family goes to vaccine court.
Yep Congress already though of that years ago and funded the Vaccine court to fairly compensate the rare folks who suffer adverse reactions to vaccines.
But the alternative (for most people) isn't J&J or COVID-19. It's J&J or two mRNA shot. At worst it's an mRNA shot next month instead of this month.
Given those calculations, the balance seems at least closer? Then weigh the effect of transparency.
Note, someone in my close family had an adverse reaction to Moderna, serious enough to spend a day in an ER. So she was supposed to get J&J. Now that's on hold. I'm not at all happy about that. But I still think it's for the best.
I had a J&J shot appointment for Saturday in LA County, but it was VERY easy to switch to getting a Moderna shot appointment for even earlier in the week. So, ultimately this sows chaos, but isn't necessarily a big deal.
Ease of rescheduling your appointment varies a lot by state. Not all jurisdictions have multiple vaccine options available, or an abundance of time slots for the other vaccine options available.
The article I read implied that one of the reasons for the pause is to communicate with the providers that these types of clots should not be treated with anticoagulants, which is the usual treatment for clots. I'll try to find the article and post a link.
As a physician (albeit a retired one), an issue like TTP leading to cavernous sinus thrombosis is a very worrisome thing if it attacks younger healthier patients. It can be devastating - perhaps because I've had a co-worker die of this (years ago) and it was a terrible death of a young person. Yes it's only one case now confirmed, but many more may be in the works (or unrecognized). This is something that is extremely rare to begin with so it sticks out like a sore thumb. It's entirely rational to pause now. That being said, given the huge number of skeptics out there (about government, vaccine, 5G, etc.), it will dent the vaccination campaign no matter what. Given the issues with Astra-Zeneca and its likely relationship to similar cases, it is reasonable to think that there may be a possible link. The population may suffer, but the individuals that potentially could be affected may have less risk. It's a trade-off, and not a hard call to me. Waiting for dozens of cases to show up would be worse, and we have very good alternative choices. It may be that the factory screw-up back east is a good thing.
So, not definitive but this article: https://vitals.lifehacker.com/what-you-need-to-know-about-the-j-j-vaccine-blood-clot-1846672700
Contains this:
"These cases are unusual because they involved CVST and low platelet counts, and occurred 6 to 13 days after receiving the Johnson & Johnson vaccine. They are particularly concerning because the normal treatment for blood clots is to administer anticoagulants like heparin—but heparin can be harmful to people with CVST, so the FDA and CDC want providers to be aware of this rare condition and to know they must treat it differently."
Well, we can't have an effective government that works for/with the people if the people don't trust it.
Trust is an important but invisible resource. Never waste it.
Think of all the trust frittered away on the conduct of the Vietnam War, for example. Just chronic government lying.
Lying is easy at the time but the trust doesn't come back easily.
Welcome to the trolley problem. People *believe* that death caused by action is vastly more problematic than one caused by inaction.
Now is this a sensible attitude? IMHO no. But the arc of the Western World is that we basically allowed (or submitted to) people in charge who were willing to make tough calls, to accept that nothing's perfect, that some may have to suffer today for the sake of a communal better future.
IMHO this is basically knocking down the ladder from those in the future. We live like kings today because of the ignominies of the past, but are unwilling to accept such suffering (even voluntary!) to allow for an even better future.
People care more (VASTLY MORE) about criticizing anything that goes wrong than about praising anything that goes right. We are living in the end stages of that societal attitude controlling anything and everything...
Why do the AZ an J&J vaccines lead to so much bad math?
There is no reason to believe that J&J went to only women under age 50. So dividing the total number of vaccinations by two doesn't work. We also dont know how many women are currently developing clots. Vaccine distribution among people under age 50 is also a more recent phenomenon, meaning there are likely many younger women in the total number of recipients who are still within the 2 week window for possible blood clot risk.
Deaths among women in that age group from covid are also not evenly spread among all women. We know that there are specific risk factors that greatly increase your risk of death from covid. A woman with kidney disease, diabetes, and obesity may well want to risk J&J, especially if she has to work in a job where she encounters members of the public.
But many, many women in that age group have few or no risk factors for serious disease, and also no heightened risk factors for catching covid. What is the likelihood that they die of covid in the next month or two compared to dying from this particular vaccine? That is not something we have the math for yet.
We aren't talking about never vaccinating. We are talking about postponing vaccination until either more information is available or an alternative vaccine is available to that particular demographic. We are also talking about a disease that can be prevented through behavioral choices, so we can absolutely wait a bit.
People's trust in vaccinations is an extremely delicate thing. As humans we have a tendency to overestimate the risk of events that occur very rarely, while underestimating the risk with things that happen more often. Hence, the irrational higher prevalence of fear of flying compared to traveling by car, and also the fear of these rare vaccination side effects compared with the potential side effects of e.g. paracetamol or aspirin.
Also, for the individual you have to compare the situation where you are completely healthy as you take the vaccine, actively exposing yourself for the risk of side effects, with the potential situation of getting infected with the corona virus.
These factors combine to make the human mind confused and less able to actually comprehend and weigh the different risks. This study evaluates the risk-benefit of the AZ vaccine, based on British numbers:
https://wintoncentre.maths.cam.ac.uk/news/communicating-potential-benefits-and-harms-astra-zeneca-covid-19-vaccine/
The results are interesting, showing that only for the age group 20-29, and only in a low spread situation, is the risk potentially higher than the benefit of taking the vaccine. The study did not take gender into the equation (probably the right decision since as far as I know it is still not known whether the gender difference may be due to the fact that more care staff are female than male, hence more females among the younger people already vaccinated).
So, J&J is ten times less dangerous than having a police encounter?
"First, do no harm." As long as there is sufficient supply of other vaccines I see no reason why the J&J vaccine should not be halted if there is a risk of causing blood clots.
Isn't the issue not just the deaths but the potential long term effect in people who do not die of whatever condition it is that causes the deaths?
If the vaccine dramatically limits the platelets available in the blood of a large number of people that could be a major issue.
This looks a lot like the European medical agency with AstraZeneca. For prudential reasons you really do have to stop and try to figure out what's going on, because after all with the vaccine you're introducing something new to the situation (and it's that, not absolute risk of alternatives, that really matters to most people, Nate Silver notwithstanding).
You also have to stop the presses so ordinary workaday GPs and PAs and some ER docs far from the covid front lines will know not to automatically turn to heparin, but find out if J&J is in the recent picture of someone who shows up with clotting symptoms.
On the other hand, you can't dither like the Europeans did. You halt, investigate, resume when you have enough of a handle on what's happening.
You do have to be candid. But, I don't think that means laying on the medical language with a trowel. It's okay if Fauci is technical. He's known to be, and one person doing technical-speak is okay for confidence. But outside of conference calls with public health people, and talking with scientific press, I think they really need to put things in terms ordinary people can understand-- let's say about 10th grade?
Otherwise what happens is people feel like they're getting double-talked and hackles go up. It's insane that they get upset when medical people do that to them, but that so many are perfectly happy to get obviously flim-flammed by the likes of the former guy. But I think that's how it works. I'd bet most people actually don't like or trust doctors all that much, and maybe that's something to be surveyed.
The people involved with this stuff every day often forget what the public is really like. This administration has been better than most, but things really have to be pitched to the median voter, not to biomedical BS graduates. Especially with something this delicate.
And they shouldn't really be doing triumphal talk about administration progress in the context of this halt-- that's kind of how I heard Zients in the 1:00 press briefing. There are times to toot the horn, and times to just say soberly "we have plenty of other vaccines in hand to get us through a period of evaluating J&J" and just leave it at that. There really is a lot to crow about, but this occasion is the wrong place for it.
I’ll be interested to see what Rachel Maddow thinks about this. She indicated the other night that she had received a J&J vaccine. She is a 48 year old woman.
Pingback: Look, y'all, there's enough vaccine for every American even without J&J – HotAir - The Republican Ballot
Pingback: Look, y'all, there's enough vaccine for every American even without J&J – HotAir - KANE NEWS NETWORK
If the total US death toll from Covid is 560,000, I don't see how it could be possible for women ages 18-48, if they make up about 20% of the total population, to only be 2000 of that. A decimal point got moved somewhere.
(Anyway the accurate number would only bolster your take here.)
The virus is far less lethal for younger people. The number of deaths for women over 48 years old will be around 278,000.
Pingback: Viewpoint|The trouble with the Johnson & Johnson vaccination time out - Newspostalk - Global News Platform
Pingback: Opinion | The problem with the Johnson & Johnson vaccine pause - Pehal News
Pingback: Biden on blood clot debacle: Look, y’all, there’s enough vaccine for every American even without J&J – #BLEXIT
Pingback: Biden on blood clot debacle: Look, y’all, there’s enough vaccine for every American even without J&J – politics-99.com
Pingback: Look, y'all, there's enough vaccine for every American even without J&J – HotAir -
Pingback: Look, y'all, there's enough vaccine for every American even without J&J – HotAir - US Liberty News
Yes, why is the CDC not being transparent about why they "paused" J&J?