I am generally a deeply cynical person when it comes to politics, but there is a part of me that is always trying to have a little bit of faith that they will get it right. That faith is rarely rewarded. In most cases giving the benefit of doubt upfront is just a recipe for future disappointment. I remind myself often to try – at least try – to give it anyway.
Waking up to the news that the Johnson & Johnson COVID vaccine has been put on hold due to what is being called a "rare disorder" involving blood clots in six recipients was pretty deflating. I think the vaccination drive can be successful with or without any specific company's product (it might take longer, but losing one brand wouldn't bring the whole process tumbling down) so even if it ends up withdrawn entirely I think we'll get past that. What is upsetting is the certainty that this will reinforce anti-vax sentiments in those already inclined toward skepticism, and no amount of data and reason will convince people that six reactions out of seven million (!!) recipients is lightning-strike level odds.
I am trying very hard to have faith that there was a good reason for this decision, and the CDC/FDA did not withdraw one of the vaccines over such a small number of reported adverse reactions. Because if that's truly all there is to the story, the harm they will do in giving fuel to anti-vax skepticism will outweigh any good they might do by studying these reactions. In my best impression of an optimistic person, here is the benefit-of-doubt version of why they might have good reason to do this: we are focusing on the wrong denominator. The total number of JNJ shots in the data pool is nearly 7 million, and 6 cases out of that is very few. However, if all six of the cases are from a specific sub-group in the population, it *may* be reasonable to sound some alarms.
Information is conflicting but it appears that these blood clots occurred in women age 18-50. That's a big demographic, but it's only a part of the overall population of data. This is especially true given that the elderly have been prioritized so far and are almost certainly overrepresented (maybe by a lot!) in the data. To take this to the point of being ridiculous, imagine that there were 6 blood clots out of 6,800,000 shots, but that all six occurred in left-handed 21 year old male Jews. There are obviously only a handful of people meeting that description in the pool, so six adverse reactions out of that small group could be legitimately worrying.
Now. The natural reaction is, OK why not keep giving the vaccine to everybody other than women 18-50. It seems unlikely that an announcement that a certain vaccine is dangerous for certain people would be ignored by the rest of the population. "There may be a problem with this vaccine" is a statement that most people will hear and draw conclusions without waiting for qualifiers. Even if reactions so far are limited to a sub-group, they may be playing it safe and taking it as a potential sign of larger problems.
That's the goodwill interpretation. I assume – I have to assume – that the people in charge of these decisions have a very good reason for having done this. The problem is, I think their risk modelling is entirely based on clinical data and might not account for the very real possibility of consequences beyond that – namely that the withdrawal could fuel a wave of negative sentiment among people on the fence about getting vaccinated. It doesn't require much in the way of an excuse to allow people to talk themselves out of something they don't really want to do anyway.
Ideally "Is this going to look bad?" isn't THE guiding principle for medical decision-making, but public health has the word public in it for a reason. Perceptions matter. If it does turn out that six adverse reactions was enough to prompt this kind of decision in the middle of a public health crisis, that will be…extremely unfortunate. That will seem, at least from our armchairs, like a bad or at least questionable decision. Introducing an element of doubt and distrust about the safety of vaccines into this equation is very costly, and I'd be willing to bet there's a raft of prescription drugs with a higher incidence of side effects. Yet those drugs are approved because it has been determined that the benefits outweigh the risks and costs. In this situation the risks and costs include perception, like it or not. And while I doubt the CDC models for skepticism and doubt – How could they? – it has to be considered here. The damage that is done in this case will be permanent, and no statements of reassurance later will wash away the now-durable perception that one of the vaccines is unsafe.
Cackalacka says:
This is a promising development, as it indicates a close eye and control of this vax. The cases are astronomically small in the general population, but they’re not calling timeout for a humbug.
There are adverse events of special interest for every experimental medical product. It should be noted that all 4 products offered in the west/developed world are still experimental. These nominal cases have similar demographics. Not having access to the data or being familiar with JJ vax’s protocol, will rely on those that do guide this.
If six were six thousand, the borderline skeptics would be going full Wakefield, and my social media thread would be filled with folks reposting Hoover Institute quackery HCQ nonsense.
This will generate some heat and noise, and sure will make a significant folks who are reluctant more reluctant, but it is an amazing feat of science and logistics that we’re at this stage already.
democommie says:
Good post, Ed:
I take 3 different meds for my hypertension, a statin, an low-dose antidepressant/pain med, and a low dose of flexaril. I also take several supplements. There is synergism going on at some level. Add into that the Covid Vaxx and the ATP jab that I just got and it's not at all surprising to me that something might go awry.
The first Covid jab did bother me; some upper arm/shoulder pain and some feeling not great for a day or two. Second Covid jab and the Tetanus booster (16 days out from the second Covid dose) I experienced no problems that I'm aware of.
Then, this morning, my bp was much higher than normal, it seems to be coming down slowly, I'll be checking it every several hours for the next day or two to see if it was just a temporary anomoly or a seachange.
If we don't learn anything else from the pandemic, we should learn that there are approximately 325M different test beds as each of has a body/blood chemistry that is unique in some aspects. Modern pharmaceuticals are tested and tested and tested and STILL we will have things like this happen.
I've got neighbors who, in their own words, don't really give a fuck what the CDC or Dr. Fauci say in public announcements. I won't really miss most of them.
Leslee says:
Meanwhile, birth control has blood clotting rates of 1 in 1,000, yet no one seems concerned or surprised about that fact because women’s healthcare always has a lower priority than men’s.
robert e says:
This isn't happening in a vacuum. The EU stopped AstraZenca shots because of exactly the scenario you're describing–within certain demographic groups, the incidence of blood clots were abnormally high, in some cases by an order of magnitude. Now a similar pattern with J&J? And the thing is, data is imperfect–there may be more cases out there that haven't been reported or were misdiagnosed. It was a tough choice, I'm sure.
mojrim says:
And as for the optics portion, Ed, you have failed to consider the inverse case. What happens when it is discovered that the CDC allowed a vax to go forward when it is almost certainly killing (a very tiny percentage of) people? What will the anti-vax crowd make of that?
Inkberrow says:
A discrete cadre of government officials and media allies wants to maintain the morality play or melodrama component of the pandemic as long as possible, perhaps to condition Americans for compliance in the face of designated public emergencies going forward.
For Dr. Fauci's part, everyone's favorite equivocating martinet marks his celebrity transition, perhaps to "Dancing With The Stars" or "The Masked Singer", perhaps to a heartwarming but pull-no-punches sitcom alongside New York Governor Andrew Cuomo, "Paisanos!".
Jonas says:
They pretty much have to do this. Informed consent in medicine is the law for good reason. If there is a certain group at risk, they need to know about the risk and what symptoms to look for. They also need to inform the medical community, because in these cases, the normal treatment for blood clots actually makes these vaccine-associated clots worse. A pause for a few days is fine. We know that there are blood clots associated with oral contraceptives and can inform women and allow them to make a choice and health care providers can ask women if they are on oral contraceptives if they present with symptoms of blood clots.
On top of all this, this is vaccine is not FDA-approved. The clinical trial is still ongoing and has an EUA, not an approval. The symptoms can take a couple weeks to manifest, so it's really 6 out of how many were vaccinated two weeks ago, so there are probably more cases out there, now that we know what we're looking for. A few days pause to reorient things and educate everyone involved is just fine and what should be done.
Net Denizen says:
There is absolutely no scenario where someone inclined towards anti-vax views will suddenly get less anti-vax as the science improves. They got that way because people they think they can trust on the subject told them to be skeptical. There's no reaching some of them. The March for Science group tried this a year or two ago, and I think their success rate of convincing people who claimed to be on the fence was probably on the order of this blood clotting issue with the J&J vaccine.
Tim H. says:
At least the know-nothings turning their bodies into walking bio-reactors should keep legions of virologists busy for decades.
MS says:
The statement "we are withdrawing the AstraZeneca vaccine" will kill many more than six people. In fact, it will kill many more than six people *from blood clots*, which is one of the major causes of COVID death.
That statement is a public health disaster.
mojrim says:
@Net Denizen @MS
The goal of debate is not to convince your interlocutor but the undecided in the audience. There are many people who, though not exactly anti-vax, harbor suspicions, especially vis covid. Anything short of absolute transparency or public displays of oversight will drive a certain percentage of them over the edge. That will contribute to an ongoing public health disaster far bigger than slowing vaccine delivery.
Stormcrow says:
I ran across a piece about the clotting issue on the daily link farm at Mike the Mad Biologist's blog. Here's the link: Hard choices emerge as link between AstraZeneca vaccine and rare clotting disorder becomes clearer.
The bottom line is still in conjecture territory, so for Pete's sake don't take it for more than it is. But here's the conjecture:
The root cause may be related to the fact that both the AZ and J&J vaccines were built on an adenovirus platform. Adenoviruses are double-stranded DNA viruses, and the way Andreas Greinacher's team is thinking, the clots may be due to an immune reaction to the extracellular DNA they contain. The only way that appears to be possible, would be if some of the adenoviruses actually broke up and released their DNA.
If that's on target, then the clotting has nothing to do with the Covid genome at all. The issue is purely the adenovirus that's being used as the carrier.
democommie says:
Dear Inkblot:
You're a lying sack of shit and everybody who wades through one of your comments should consider self-isolating for, well, at LEAST 2 weeks.
Fuck off, troll.
Safetyman! says:
An unfortunate reality is that some of the doctors and heathcare administrators involved are themselves (somehow) antivax or otherwise adherents of one of the conspiracy theories floating around regarding Covid. Ed, you are supposing that all involved have good intentions and are not deliberately trying to sabotage the Covid response. Even on this blog all you have to do is reference Inkberrow to see this in action.