Originally published at: CDC recommends pause in Johnson & Johnson vaccine use after six blood clot reports | Boing Boing
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My take is that they want doctors to be aware of the treatment for clotting as it is counterintuitive to any other clot.
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That’s likely true, but it’s also important to realize that clotting can also cause a number of non-fatal issues like micro-strokes that are difficult to detect, but can have a big impact on the quality of life. (Yes, obviously covid can cause lots of lingering non-fatal health issues too.) The good news is that two other vaccines are widely available in this country and both are more effective than the J&J vaccine anyway. I don’t think it’s unreasonable for the CDC and FDA to recommend this pause while they try to get a better understanding of the stroke situation and potential treatments. If nothing else it will help maintain public confidence that they’re not just turning a blind eye to inconvenient evidence of side effects.
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This is debatable at best. The J&J trials were held under very different conditions and can’t be compared directly to the mRNA results. Notably, the J&J trials included South Africa and Brazil with variants present.
It’s really hard to overstate the utility that having a one and done vaccine provides.
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Especially one that can be shipped and stored with existing infrastructure. The Moderna and Pfizer vaccines limit accessibility to areas where robust modern medical infrastructure exists. As another BBSer pointed out when J&J was approved; this is the one they can throw full crates of into a truck and go into remote communities around the globe.
Unfortunately, at least part of this is meant to assuage so-called “vaccine hesitancy”, but in reality it will likely exacerbate it.
I use scare quotes because the only reason “vaccine hesitancy” exists is because of decades of disinformation. The most common thing I hear friends say now is they want to “wait and see” how people react. We are now at 46% first doses in the US with zero deaths or serious hospitalizations; the only thing to wait on is their own mind to shuffle off all of the bullshit they’ve been fed.
Obviously, this sentiment doesn’t apply to people with legitimate health concerns like people with a history of anaphylaxis.
Edited for clarity.
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I’m biased by working with hematologists and critical care doctors, but I don’t get the sense that the connection between thrombocytopenia (low platelet count) and clot formation would catch doctors unaware. The combination can arise when clots form throughout the body. Incorporation of platelets in all of those little clots actually depletes the supply of circulating platelets. Notably, this occurs in lots (possibly a majority) of COVID deaths. If you’re an intensive care doctor, you’ve seen the combination of clotting and thrombocytopenia plenty over the past year.
Based on the European Medicines Agency release on the AstraZeneca side effects, this was a primary concern and a major reason for pausing AstraZeneca vaccination for review: Low platelet counts and cerebrovascular clots can indicate that patients have sub-detection clotting events throughout the body. Look for mention of “disseminated intravascular coagulation” (DIC) here: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets | European Medicines Agency
But that pause showed that this side effect is rare. I’m in agreement with others here pointing out that the risk from the J&J and AstraZeneca vaccines is small and the risk from COVID is large. I’ll add to that by saying that the side effect in question also shows up in a ton of COVID cases, where it causes higher mortality due to the many other awful things COVID does to humans.
ETA: @agies Good point downthread about the differences between the J&J vaccine and the Pfizer/Moderna vaccines. The J&J can do more good than the publicized numbers may indicate.
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I received the J&J vaccine a week ago at the Oakland Coliseum and have not had a stroke. I like that it is one shot instead of two, but not enthused about the lower efficacy figures than Pfizer and Moderna. I feel sorry for Astra Zeneca.
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I was under the impression that the decisionmakers are politicians and pundits.
I’m not familiar with CDC regulations and thinking, but I’m not surprised by the FDA one.
If someone detects a pattern of problems, it’s not unusual for the FDA to say “Stop. Everyone look at your patients for this problem. Tell us what you see.” Happens with cleared and approved products, but especially for emergency approved. That’s to get a handle on the magnitude of the problem to decide if it should still be used. It’s just usually not this public.
But to the FDA’s credit, they’ve become more nuanced in the last decade. Rather that just shut things down, they also take into account if yanking the product, even temporarily, will cause greater harm. For example, a chemo drug that causes diabetes in some unknown percentage (not known before approval). Yank it, all those patients die of cancer. Allow it to be used while cautioning everyone and investigating, and you have a less terrible outcome. The FDA leans towards the later now whereas they might have demanded a recall in the past.
That appears to be what is happening with the J&J vaccine. It’s not being yanked because that would be worse. But a red flag is out there to be cautious and collect data until some solid conclusions are made. It might only take a couple days, but it makes sure everyone is informed, cautious, and collecting data during that time.
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Sadly, this is absolutely true. The antivaxxers are already running with this, suggesting that the other vaccines are as, or even more, “dangerous” than the J&J.
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The worst part of the “vaccine hesitancy” issue is there is misinformation being spread anyway. So deaths and other side effects are being claimed where they don’t exist. If you’re inclined to believe vaccines aren’t safe then there’s plenty of people inclined to reinforce that notion.
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Meanwhile, are they recommending a pause in PB&J sandwiches, because those are far more dangerous?
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Drugs made available via the Emergency Use Authorization process at the FDA are subject to a higher level of scrutiny than drugs that have attained the traditional market approval. Side effects aren’t all well understood because the full phase 3 program wasn’t performed. This means that the emergency use dosing essentially becomes a very large phase 3 unblinded trial. And just like in every phase 3 trial, if new and/or potentially severe side effects are reported, the trial is paused until root cause is understood and risk/value is reassessed.
I’m sure that once the root cause is understood, J&J and FDA will make the right choice about whether to restart dosing.
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Me too, but in LA. It just gave me a headache for a day or so.
This is the same fatality rate as driving ~15 miles on American roads.
This is an untruth that is propagated by people who don’t understand how data works and why the data from each vaccine study can’t be directly compared.
For instance, how do you measure effectiveness/success? Is it a decrease in hospital visits or deaths or numbers of symptomatic cases?Each of these studies had different endpoints that defines success.
How do you define covid? Each study did this differently. Is it the original strain of covid, whichever strains are rampant in the environment at the time of testing, or some? Each of these studies took place at different times so different mixes of variant strains of covid were moving through the population.
Do you measure the effectiveness against each strain individually or do you lump them together? Vaccines are more effective against some strains than others. Some of the studies varied here as well.
What population are you measuring? People in different parts of the world, due to genetics and diets and a few other variables created varied responses during drug trials. The studies all had different populations and that makes it hard to compare them.
Those are just the four variables off the top of my head that demonstrate why it is difficult to just compare cable news headline data to cable news headline data.
~ works in R&D/Regulatory Affairs in Pharma and helped to get one of the covid vaccines into people arms.
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Fair enough. I suppose what I should have said is that per the efficacy rate that the CDC states on their website this appears to be somewhat less effective than the others. I understand that accurate and direct comparisons of effectivity can’t easily be made between the different vaccines due to differences in when, where and how the trials were conducted, but if that number really means nothing at all then the CDC needs to find another way to share the data. Even Dr Fauci made it clear in his public statements that, while he thinks it’s a very good vaccine, that the apparent efficacy was lower.
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As I see it, the pause is justified as there seems to be some link between the cases. Figuring out exactly what that link is justifies a few days delay, making it safer to use once we know just who is at risk, and how this could be avoided. Not knowing yet still plowing ahead just feels irresponsible and/or callous.
Again, it’s a breather, not a full halt.
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Trump criticizes FDA on Johnson & Johnson vaccine pause | TheHill
Trump argued the FDA should not be permitted to enact such a restriction over what he called “possibly political reasons, or maybe because their friends at Pfizer have suggested it.”
The fact that Trump has criticized the move pretty much makes up my mind that it was the right move. You know, “WWTND.” (What Would Trump NOT DO?")
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