US agencies call for pause in Johnson & Johnson vaccine | Hacker News Reader

US agencies call for pause in Johnson & Johnson vaccine

bbc.co.uk

456 pointsbasisword1,059 comments

The risk of dying from a blood clot after receiving the J&J vaccine is six in 6,800,000 (6.8M). The world population is 7,900,000,000 (7.9B). If everyone on the planet got the J&J vaccine tomorrow, and if it is the cause of the clots, then 6,971 people would die from the vaccine.

Yesterday, Covid19 killed 8,803 people (according to worldometers).

We don't want anyone to die from vaccination, and we don't fully understand what the clotting issue is, so it probably makes sense to pause using J&J as long as the mRNA vaccines (Pfizer, Moderna) have not been implicated (which they haven't). OTOH, if this being in the news causes fewer people to get vaccinated, pausing it may be a mistake that will cause more overall deaths.

Now, your risk of dying either from vaccination or Covid19 depends on various demographic factors not accounted for in my math above. But, nonetheless, the risk of dying from the J&J vaccine is really, really, really tiny.

Like, if I knew there was a 0.00009% chance my car were going to explode every time I got in it and started it, I would not be at all nervous about starting my car everyday for the rest of my life. I'm way more likely, even accounting for my age demographic, to choke to death eating dinner tonight (5,051 deaths from choking in the U.S. in 2015 of which 2,848 were older than 74).

Edit: lifetime risk of car exploding assuming I start it every day for 50 years is about 1.6%. Okay, maybe I wouldn't play that game.

It's not just a "blood clot" or some "rare type of blood clot".

This was what I posted in this post about the European Medicines Agency acknowledging the AstraZeneca vaccine (which I was inoculated with) was linked to something never seen before: https://news.ycombinator.com/item?id=26725232

> "Zero surprises here. Both Norwegian and German research teams identified the /actual specific novel antibody/ that causes this /new previously unclassified syndrome/ that was effectively unheard of before the AstraZeneca COVID-19 vaccine existed. Also, both teams are phenomenally talented for identifying this antibody so quickly. Usually it is on “finding a needle in a haystack” level difficulty. BTW, I am probably going to get downvoted but I am definitely not an antivaxxer and I received the AZ vaccine as innoculation for COVID-19."

"Now, your risk of dying either from vaccination or Covid19 depends on various demographic factors not accounted for in my math above. But, nonetheless, the risk of dying from the J&J vaccine is really, really, really tiny."

Unless this is a repeat of AstraZeneca, where many were lamenting the interruption of vaccination and calculating the risk for the entire population of people injected with AZ. Meanwhile, in some countries, the risk of dying from the vaccine for young women was higher than the risk of dying from the virus.

After the concerns about AZ turned out to be justified and AZ being banned for certain age groups you'd think that people would get a clue about unconditional vaccine cheerleading.

6 obvious deaths that we're aware of. The risk of the vaccines is in their novelty and morbidity. An abundance of caution is required in this instance. It would be very bad to discover that there's a vanishingly small chance of blood clots within the first 3 months but a significant chance when paired with other events over the following decade.

I went to the emergency room for earth shattering headaches (no history of headaches like this) after getting the J&J vaccine last week. I mentioned I’d got the vaccine and asked if it was possible the two were linked. The doctor did everything but actually roll his eyes and thought that the headache being caused by the vaccine was ridiculous.

I bet if I went today he wouldn’t be so dismissive.

>The risk of dying from a blood clot after receiving the J&J vaccine is six in 6,800,000 (6.8M)

that we know of.

I suspect the lack of understanding about what is happening, and what other knock-on effects there might be is what is behind this.

If a wing falls off of one airplane in a million, we still stop and try to figure out what happened because as far as we know, wings are not supposed to fall off any airplanes, so there's something about the system we need to learn more about.

OTOH, if this being in the news causes fewer people to get vaccinated, pausing it may be a mistake that will cause more overall deaths

This is the reason people lost trust in the medical community during COVID.

Another factor to consider is that COVID is contagious but blood clots are not. The multiplicative (if not exponential) nature of COVID spread makes this a no brainer that the vaccine should be reinstated (and just monitored).

I suspect that what's happening is that these institutions don't think in consequentialist point of view. They are not comfortable with diverting the trolley even if the math checks out.

Nit pick sorry:

> Now, your risk of dying either from vaccination or Covid19 depends on various demographic factors

Your risk of dying, or other health injury, depends on your personal health factors specifically.

Demographic is the statistical data of a population.

Also, there is a clot risk for with COVID [1] that's much higher than the vaccine. The clot risk is the reason I've been indoors this whole pandemic, so I'll happily take my these ridiculously better chances with the vaccine.

1. https://www.cnbc.com/2021/04/13/blood-clots-more-likely-from...

Per Wikipedia: there are 7.3 deaths per 1 billion km driven in the USA. About 7 million J&J doses have been delivered. One person has died as a result of blood clots thought to be related to the vaccine.

If we assume an average of 32km round trip to get to a vaccination site (~10 miles each way). Statistically speaking at least one person has died driving in their car to get the vaccine. The same number as from the vaccine.

I couldn't find good stats on serious injuries per km driven, but I suspect it's an order of magnitude higher than deaths per km. Your risk of dying on your way to get the vaccine is the same as your risk of dying from the vaccine. You are, almost certainly, far more likely to be seriously injured on your way to get the vaccine than you are from the vaccine.

https://en.wikipedia.org/wiki/List_of_countries_by_traffic-r...

>> Yesterday, Covid19 killed 8,803 people (according to worldometers).

I'm certainly not denying Covid19, but I do take all the statistics with a grain of salt. It's important to understand that those people died with, not necessarily of Covid19. Also, why are so many positive tested persons without any signs of illness? I wonder what numbers would result in testing every death for other viruses.

The best, maybe only number we can properly compare is the total death rate. In doing so we see that Covid19 causes additional deaths, but it is far from as severe as the media and politics suggest.

With all due respect to the statistics lessons that usually follows news like this, if you are one of the 6,971 or the 8,803 for that matter, these numbers are not as comforting as you might imagine. It's like the time I was unemployed and I kept hearing from the government about how low the unemployment rate was.

I can avoid getting into my car and running that risk. It’s still there and can happen, but I can opt to not drive my car.

The vaccine is eventually going to be mandated to go back to the office, go places, etc.. That’s a risk that you can’t avoid and will have to take.

I’m all for vaccinations and get them when needed, I’m still not comfortable for vaccines that have not been approved. Right now, they all have emergency approval and not overall approval. According to the cdc, vaccines need at least ten years of data to be considered safe for use. We’re only a little over a year into the development of the vaccine. Not really safe in my eyes.

> if this being in the news causes fewer people to get vaccinated, pausing it may be a mistake that will cause more overall deaths.

Except for that the government covering up the MMR investigation instead of doing it openly is what caused the anti-vaxx movement in the first place. Compare that with the public rallying around J&J after their Tylenol recall.

0.00009% over a 30 year period means you have about a 1% chance of being blown up by starting your car. that's about the odds of catching HIV while having unprotected sex with someone who is HIV positive (depends on a lot of factors though).

The 6 are only those we know of. There could be others, because these cerebral blood clots can happen two weeks after receiving the vaccine.

As we analyze the data, and see if more data comes in the next two weeks, we'll have a better sense of the risk.

But you are having conflate for deaths from each of things. Rates in dying are not homogeneous in J&J vax versus corona. J&J vax maybe is received by many younglings who are not risking death so much from Corona for benefit of old. It is not yet being known for if J&J vax is having any greater risk for older people or younger people. So calculus is maybe not so simple. If I are healthy young person maybe it is not a beneficent risk for taking.

I read one of the six died. Has there been a news update that all six have died?

It's six bloot clots, and only ONE death, not six deaths:

https://pbs.twimg.com/media/Ey2oowQWgAApGnK?format=jpg&name=...

People don't think like that.

If there is solid evidence that a vaccine will kill people, it should not be used. It's intolerable that people die taking a prophylactic.

It's much, much worse to kill someone with a vaccine than to allow that person to perhaps die of a virus.

Thankfully, in this case, sanity prevailed.

Why is everyone worried about blood clots, and not that the J&J vaccine has a crap-tastic efficiency of 66.3%?

Would you want the chef at your local takeout to be vaccinated to 66.3% efficiency? or 94%?

Why was this vaccine even approved, instead of just having J&J produce the same vaccine Pfizer and Moderna are making, which would be in the best interest of the world? Is this some utterly idiotic capitalism bullshit that prevents J&J from making a 94% vaccine as well?

Why can't we just take $100B out of the $1T military budget, throw it at Pfizer and Moderna to shut up their patent lawyers, and then hand the formula to J&J to become a 3rd factory for a good 94% mRNA vaccine?

And then hand that formula to the rest of the world including Brazil, India, China, and other recent new COVID hotspots so that the virus doesn't boomerang back to the US in an evolved form?

At least that's what I would do if I was president.

"The incidence of cerebral venous thrombosis (CVT) varies between studies, but it is estimated to be between 2 and 5 per million per year. A recent study in the Netherlands with comprehensive ascertainment suggested a much higher incidence." https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0...

So the six reported cases in 6.8 million vaccinations seems low. Glad I read about all this because I got the J&J vaccine 12 days ago. No noticeable side effects so far. I exercise a lot and did a 5 mile hike four days ago that resulted in a slightly strained a calf muscle. I have been taking it easy the past few days, meaning sitting and reading a lot more than usual. So after learning about the blood clotting, have started exercising the legs frequently. My optimistic thinking is that even if the vaccine does cause an increased risk of CVST that risk can be eliminated via exercise.

It will be most interesting to learn if those six cases involved people at high risk, if they exercise regularly, etc.

If you’re doing the calf exercises to ward off a DVT, (and not to just stretch your strained calf!) you may be barking up the wrong tree.

The preliminary theories (backed by the thrombocytopaenia) are that, if there’s a vaccine induced thrombosis with thrombocytopenia, it is probably immune-mediated (similar to HITT - heparin induced thrombocytopenia and thrombosis).

And then there’s some weird thing that makes them form in your venous sinus.

But there were also reports of more typical blood clots (ie DVTs), the first European Medicines Agency advisory (0) said that this was within the level of noise (im now talking AstraZeneca, so apologies for shifting vaccine as generally they should be considered separately until the evidence catches up, although everyone is quickly drawing parallels between them)

(0) https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene...

Ps apologies for not referencing around HITTs and theories around antibody-mediation for CVT. Basically it’s all pretty noisy anyway at the moment and so my here-say from the medical tea rooms is as good a gossip as any, as long as everyone is aware that no one really has any definitive idea what may be going on yet

Agreed, I don't think anyone knows clearly what is happening. Some additional points that are related.

Thrombocytopenia has been a known complication of adenovirus vectors that researchers have worked to overcome in recent decades.

These incidents mirror HITT (women are at higher risk for HITT) and seem to be happening in the timeperiod where IgG titers spike post vaccination.

To me this indicates it's not unlikely something with the adenovirus vectored vaccines (J&J, AZ) is causing this issue. And because this thread seems to have gone to hell, I'll add that I support doing subgroup specific risk calculations and allowing vaccinations to proceed where it makes sense.

https://jvi.asm.org/content/81/9/4866 https://ashpublications.org/blood/article/109/7/2832/125650/... https://pubmed.ncbi.nlm.nih.gov/17148587/

Good take.

Arterial clots with thrombocytopenia is incredibly rare. Additionally the PF4 activity in these patients is very abnormal and appears to be to immune mediated. Lots of science and focus going into the mechanism around this now. The other recent NEJM articles around clots associated with the other adenovirus COVID vaccines are likely a similar phenomena.

2-5 per m per y is an incidence over the entire year. Assuming a uniform distribution over the 365 days, then the probability of getting it "on that day" becomes a probability of 1-2 per billion.

So the reported cases of are not comparable. They are really, really high.

And while I agree about the relative risk vs covid, again this is not a fair comparison. For many people who are isolating, then a person never leaving the house has a very low risk from covid, both personally and transmitting it. You are not asking people to exchange a very small risk from the vaccine vs a very high risk from covid. You are asking them to exchange a very small but roulette-like risk from the vaccine, versus a presumably equally small if not smaller risk from covid due to their circumstances.

Note, what I am "not" saying is that peoples shouldn't be vaccinated. I'm just saying artificially trivialising the risk further using bad math isn't doing anyone any favours.

"So the six reported cases in 6.8 million vaccinations seems low."

No, because those 6 cases are something more like "1 per day" rather than "per year". Or maybe "per week". But either way, you need to multiply the "per year" base rate by a large number to get the base rate for "coincidentally happened immediately after a particular event", for some definition of "immediately".

It's reports within 3 weeks, so something like 18 per million per year.. The larger danger is any interaction with an automobile to get to the appointment.

They also appear to cluster in young women and one young man (from the phase 3), do it’s quite probable that the “6 million” is not representative.

Using 1 per year is useless unless it's adjusted to a ratiometric form like percentage or per capita

My wife says this is not about exercise, while living a healthy lifestyle is good, apparently this specific condition causes clots to form in the brain itself as a result of low platelets.

CVST with Thrombocytopenia is the name.

Similar to AZ, all six were women between the ages of 18 and 48.

20% male (1 patient) in this report https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

seems like they were all young women. so let’s say young women make up 1/4 of those vaccinated.

for them it’s more like 1/250k

That’s what I keep saying! People are saying it’s 1 in a million chance, but unless all the people who got the vaccine were women than it’s not. The instance could be far higher but it’s not possible to know without knowing how many were given to men vs women

John Campbell suggested on his video the other day that perhaps this is happening because some injectors are not aspirating. What that means is that when an intramuscular injection is given you want to ensure that it goes into the muscle and not into a vein. So the proper way to do this is for the person doing the injection to first pull out the syringe (after it's been stuck into the arm) a bit to make sure there's no blood coming out. Then if not, the vaccine is pushed in. If blood is seen then a new site has to be chosen. Apparently Denmark has included aspiration in their directions for usage of the AZ vaccine.

Medical professionals are often taught these days that aspiration is not necessary for IM injections, particularly in commonly used sites such as the delts.

From the CDC [1]: Aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion but before injection) is not necessary because no large blood vessels are present at the recommended injection sites

[1] https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/admi...

That's interesting to know. When I got my Pfizer jab, the lady said "oops, I did it wrong" and blood came out. She didn't jab me again though and I just assumed it was good to go. Should she have done it again at a different site? I was told elsewhere that it doesn't make the vaccine any less effective, but I'm curious what others on here think now...

If this were the case it would be odd that this is happening a.) in a consistent subset of women 18-38 b.) that it would emerge in a 1-shot regimen rather than a 2-shot regimen, because it would seem more likely that any one individual would experience this more frequently with 2 chances for human error rather than 1

Injecting IM solution into a blood vessel is excruciating and you and the provider would notice it immediately if it happened. It is likely to cause an embolism and possibly kill you, but I don't think it would be unnoticeable and then cause a thrombus multiple days later.

There are also not a lot of major vessels near common injection sites, for this reason. It's possible and rather common to nick a surface capillary or something, and those can bleed quite a lot, but a vein or artery would be totally different. Swelling, horrible pain, likely a cough.

Source: inject myself with intramuscular estrogen every week.

Any theory on why this is occurring needs to have a solid explanation for why women under 55 are suffering this effect more than anyone else. Does John Campbell have one?

> Apparently Denmark has included aspiration in their directions for usage of the AZ vaccine.

Great, so not only will I have to wait 2-3 months to get vaccinated..

They'll also stick the needle in and pull out a few times just to sure I'm really feeling it!!!

Sorry, but I really hate needles :/

So this past year the government has been willing to let unemployment, suicides and drug overdoses jump due to isolation and loneliness caused by lockdowns, child abuse to skyrocket and mental health to plumment due to schools being kept closed, all because we needed to stop covid at any cost. Now one person dies out of almost 7 million who received the vaccine, and we need to stop administering the J&J vaccine "out of an abundance of caution"? I'm starting to think more and more that the shitty decisions regarding covid in the past year were because it was an election year.

Suicides decreased in 2020, btw: https://www.axios.com/suicide-decreased-in-2020-pandemmic-me....

The CDC only tracks actual suicides, not attempts. Suicidal thoughts and attempts are up: https://www.aappublications.org/news/2020/12/16/pediatricssu...

Besides, in the CDC table, "unintentional injuries" is up by way more than suicides are down. This includes things like car accidents, and is a little suspicious, like suicidal behavior led to a death that wasn't classified as suicide. Also note that the table is "deaths with covid or presumed covid", not "deaths by covid": https://jamanetwork.com/journals/jama/fullarticle/2778234

Deaths of despair increased though:

https://www.marketwatch.com/story/deaths-of-despair-during-c...

It is not stopped. It is paused for a few days while updated training is rolled out.

Government over-reactions to COVID19 have been disastrous. There would have been an economic hit for sure but things would have returned to near normal by August 2020 if they had respected freedom (or if people had disobeyed in mass).

Yeah. The US is apparently already at ~50% antibodies, not counting vaccination. So, there’s a floor on the upside of the vaccine: It did no more than halve deaths. We’re in the middle of a surge, and it looks like most of the remaining 50% will end up catching covid before being vaccinated, so the percentage saved by vaccination will continue to drop.

The ideal strategy without hindsight was conventional wisdom: Protect the vulnerable and stiff upper lip for the rest. That would have more than halved casualties.

With the benefit of hindsight, a 3 month shutdown while hospitals got their acts together (combined with protecting the vulnerable) would have roughly quartered the remaining deaths, but at far lower cost than the full shutdown.

This was predicted by some of the old-guard epidemiologists, which is why they were against the shutdown in the first place.

The cancel culture folks lumped them in with MAGA anti-vaxxers (I blame both sides) and got them censored by the big platforms. Here we are, with 100,000’s unnecessarily dead, trillions squandered, and many careers, businesses and educations ruined.

I suspect roughly zero people have learned a lesson from this. Hopefully I’m overly cynical.

> returned to near normal by August 2020

The problem is the virus, not the government reaction to it. Personally, I tend to think governments under-reacted in most Western countries. I'm not sure how things would have returned to "normal" if the virus was raging out of control. A good precentage of people would see the deaths and still avoid going out to shop or whatever. I'm assuming you mean by "normal" that people would return to some normal pattern of economic activity - and even if 10 or 20% of people changed their behavior that would still impact the economy.

How many dead people would that "normal" have been worth to you?

If, instead, people had behaved responsibly in mass and we had used the time we got from that to establish coherent contact tracing and testing, things would have returned to normal by August as well, only without many the deaths your way would cause.

Or if they just followed the plan for this exact scenario that was handed to them by the last administration, if we're talking about the US, where more than half a million people died preventable deaths.

I'd argue that the "response" at the Federal level was a massive under-reaction. Months of denial didn't seem to work out so well.

6 cases in 7 million doses over 3 months is exactly the rate that CVST would normally be expected at. While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time.

> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]

[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....

Over the past 2 weeks, the reported rate of these events associated with the AZ vaccine has gone from 1 in a million, to 1 in 30,000 [0].

[0] https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

The source you mention does not explicitly give a one in 30.000 figure, and it is not something that can be safely concluded from the data in the paper. The authors state that at the time 132,686 people had received their first AZ shot in Norway, of which five had developed thrombosis.

This is definitely not enough data to conclude a 1 in 30,000 figure. And neither does the cited paper conclude this.

The clots associated with the AZ vaccine aren't CVST.

There's the question of timing too. It's not clear if the number includes all CVST incidences or only those ocurring in a time window after vaccination. (Update: according to NYT these cases are 1-3 weeks after vaccination, so the background rate is too low to matter here). If there is a strong correlation in timing you can not simply use frequency data to rule out causation.

Of course the cases are shortly after vaccination, the data is symptoms reported shortly after vaccination which might be side effects. You're not going to have anyone who got a clot before the vaccine or long afterwards in the dataset, but those cases still did/will exist. There is no evidence yet of a correlation in timing.

> All six cases were in women aged between 18 and 48, with symptoms appearing six to 13 days after vaccination.

All the observed cases occurred shortly after vaccination, so I’m not sure 3 months is the right divisor to use in your comparison.

You are only looking at people a short time after vaccination. Anyone in the population who had a clot prior to being vaccinated or who will get a clot later this year have not been counted.

> While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time.

Except to the general public this overcautious behavior and resulting media hype raises vaccine suspicions, and will decrease public trust in J&J (and even vaccines in general) as a result. It’s already happening.

Public trust in J&J has been low ever since they got caught putting asbestos in baby powder

https://www.reuters.com/investigates/special-report/johnsona...

People need to accept that this is a real effect. Denying it isn't helping anyone. It's happening, it's rare, but it's happening.

If it's statistically significant, the evidence showing so will emerge quickly and we can decide at that time how the increase in risk compares to that of remaining unvaccinated.

Otherwise, there isn't a whole lot of difference between "not real" and "real but so rare as not to matter."

For AstraZeneca and not J&J, but these slides from the University of Cambridge do a better job of communicating the balance of risks than I possibly could: https://assets.publishing.service.gov.uk/government/uploads/...

Yeah, the problem though is that we have a Tragedy of the Commons situation on our hands. There is a non-negligible portion of the population that wants to have its cake and eat it too – reduce the risk that they will suffer health consequences from COVID-19 by letting everyone else get the vaccine, but not getting the vax themselves, therefore putting their risk from vax at zero.

I think part of the thing that makes this more difficult is that some people already have practically no risk of suffering health consequences from COVID-19, and possibly (but also possibly not) do risk suffering health consequences from the vaccination.

That seems like it'd be easy to fix: the government just needs to say "as soon as you're fully vaccinated, you don't need to social distance or wear a mask in public anymore". Since that isn't their position, there's basically zero incentive for young, healthy people to risk the vaccine side effects.

(A) vaccination means less social distancing sooner. Lots of people are interested that.

(B) covid-19 might very well become endemic. Like how the common cold is always around. It's not so bad if we're vaccinated. But for those that don't get vaccinated hurd immunity might not cover them.

In practice: I think we just need to be honest about the risk of vaccines. And say that taking it is the patriotic thing to do :)

or just run PF4 for everyone concerned after adenovirus vector vaccinations

Both the AstraZeneca and J&J vaccines use an adenovirus to deliver DNA instead of mRNA wrapped in lipid (like Moderna & Pfizer).

Everywhere I read about the J&J vaccine, I see something like "the DNA vaccine doesn't alter your DNA". Can somebody please clear this up?

As far as I understand, the mRNA just stays in the cytoplasm of the cell and gets used up by the ribosome to create spike proteins. The adenovirus vector used in the J&J (and other vaccines) injects DNA in the cell's nucleus, which seems at odds with the widely circulated "it doesn't change your DNA" statement.

Do people make this claim because the cell displaying spike proteins is basically always eliminated by CD8 killer T cells?

Btw here's a nice high-level summary by the NYT about how all the vaccines work: https://www.nytimes.com/interactive/2021/health/how-covid-19...

I'm a bioengineer. Everyone that gives an answer mostly ignores epigenetics and the fact that RNA can permanently alter the _shape_ (or conformation) of how your DNA is tightly wound up. For example, RNA can direct methylation of DNA and alter histones, which can lead to transgenerational epigenetic effects on gene expression and phenotype [1]. The fact is, molecular cell biology is incredibly complex and the models we have are just that, models. Saying that these mRNA strands don't affect the genome long-term may be correct, but this is an educated guess based on theoretical models. There's a reason why FDA approvals traditionally took 10+ years, we normally verify our educated guesses empirically.

It almost certainly won't have long-term affects, but it may not be trivial to identify if mRNA vaccines have been altering epigenetics.

[1] https://en.wikipedia.org/wiki/RNA-directed_DNA_methylation

> we normally verify our educated guesses empirically

Love that quote! That's going to be my standard comment from now on when I see a pull request that doesn't include any test cases :-)

Wouldn't catching the virus itself also have these epigentic effects?

How would you test the extent of the mRNA's/DNA's impact within the cell?

Is it possible to do something like tagging the molecules with radioisotopes and following their path?

Here's an example: https://www.nejm.org/doi/full/10.1056/NEJM199001253220403

Follow-up question: Do these effects (which are very unlikely) differ between vaccine and the virus itself? Or maybe: Is the epigenetic risk higher/different?

Everything in life has potential epigenetic effects! Not sure what you are trying to communicate with your comment but it sounds like you are saying people should avoid the mRNA vax but then you also say “almost certainly no long term effects.” Your thesis seems to be that 10 years is enough time to know for sure that they are safe. Why is 10 years the right amount of time? Why not 50 years or 5? In other words what’s your model for relative risk/reward and why is it better than what is being done in terms of public health outcomes?

Would this be an advantage for the Novavax vaccine as it doesn't do anything to hijack cellular machinery to create the spike protein, it just (as I understand it) has a bunch of pre-made spike proteins.

Thank you for this explanation. I've been wondering this myself especially when it comes to methylation.

Everyone is the world is either going to be exposed to the spike mRNA from the vaccines or the virus.

Pointless FUD to worry about that or even bring it up.

Being in the nucleus and being integrated into your chromosomes so that they are copied during cell division aren't the same thing.

https://www.medpagetoday.com/special-reports/exclusives/9160...

> Adenoviruses -- even as they occur in nature -- just do not have the capacity to alter DNA. Unlike retroviruses such as HIV or lentiviruses, wild-type adenoviruses do not carry the enzymatic machinery necessary for integration into the host cell's DNA. That's exactly what makes them good vaccine platforms for infectious diseases, according to Coughlan.

> And, engineered adenoviruses used in vaccines have been further crippled by deleting chunks of their genome so that they cannot replicate, further increasing their safety.

This sounds a bit like a technicality. The DNA makes it into the cell nucleus and is used by the cell machinery to make proteins. The changes aren't carried over after cell division, but lots of cells in your body last your whole life (nerves, brain cells, eye cells, important stuff).

I think the argument hinges on the technicality that it's not splicing itself into the host genome, so no chance of it becoming a retrovirus or something like that (in the event that the cell's lineage is not extinguished by the immune system).

I'm not a genetic engineer (what a time to be alive, eh?), but I'm pretty sure an adenovirus that did permanently modify cell DNA would be more like CRISPR, including the risks that entails (such as the risk of incorrectly splicing the host genome and potentially creating a precancerous mutation)

I didn't want to put this into the parent comment because I didn't want to get just shoved into the "vax" vs. "anti-vax" bucket by the replies.

But there's a very well known case where DNA delivered via an adenovirus killed a teenager during a genetic engineering study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC81135/

>> "No one realized that the vector itself might pose a risk"

I'm sure the dosage, type of adenovirus, and modifications to the adenovirus are different. But there are obviously still risks we don't know about.

Whenever you catch a cold or flu those are generally DNA viruses (unless it's a coronavirus cold). Those don't alter your DNA.

Eh, yeah they do. We have tons of base pair sequences in our DNA that we suspect came from viruses.

https://newsroom.uw.edu/news/genes-%E2%80%98fossil%E2%80%99-...

Why didn't they stop the vaccinations in women under age of 60/65?

I'm a 40 year old man, if I were a woman I wouldn't take J&J or AstraZeneca, but as I'm a man, I think it's worth to take the risk of the side effects of the vaccination.

Using a machete when you should be using a scalpel (though to be fair at the time it looked like a filet knife was the tool for the job) has been more or less how this pandemic has been handled since day 1. Why would that change now?

Now you have the logistical challenges of shipping 2 vaccines to some small town. One for the men, another for the women. Additionally, that town needs the not insubstantial refrigeration capabilities anyway.

So what’s the point if you’re a public health admin? Just get the moderna or Pfizer and save yourself and your staff a lot of headache.

The logistical benefits of J&J mean that it’s only logistically beneficial if it can be used for everyone.

I wonder why all the clot victims are 100% female with J&J?

Also, only 1/3 of Astra Zeneca clot victims are male:

https://news.yahoo.com/astra-zeneca-vaccine-blood-clot-risk-...

Relevant tweet: https://twitter.com/robertwiblin/status/1381967753234411530

J&J doses delivered: 7 million.

Reported blood clotting events: 6.

Daily risk of dying of COVID19 in the US: 1 in 330,000.

CDC and FDA: Pause the J&J vaccine.

Draw your own conclusion on how aligned these folks are with your interests.

This is misleading. If you’re young and healthy, the chances of dying from COVID are basically zero. The chances of dying from a blood clot from a rushed vaccine are not. The people who died from blood clots probably would still be alive had they not taken the vaccine.

But there are 2 other vaccines that are still available so it's not like they're stopping all vaccinations. Another consideraton: J&J was/is having production problems so deliveries have been cut considerably - as such this probably won't be a very significant change to vaccination rates. I suspect the FDA will allow J&J vaccinations to resume in a couple of weeks. Maybe they'll recommend it not be used in women under 60 as has been done with the AZ vaccine in Europe. Even if they do that there would still be plenty of men eligible to get the J&J.

> Draw your own conclusion on how aligned these folks are with your interests.

What's this supposed to mean? Is the implication here that the CDC and FDA want to keep people from being vaccinated? WHy?

That tweet ignores that there are alternatives to the J&J vaccine, so implying that there is a binary decision between J&J or 1 in 330k death chance is flawed reasoning.

I think this is an illustration of an issue that has been seen throughout the entire pandemic. Medicine != Public Health Policy. In general, I would say medicine is too dogmatic to decide on public policy, and public policy is too loose to operate medicine.

Okay so I want to make something very clear here. The rule is to put it very very simply, is you can ship any drug that is approved but you have to list the side effects. This drug was approved under an emergency order and this side effect was not listed. This will get paused long enough for the side effects to be updated and then used again. The arguments about “well the birth control pill has a higher risk” are using a fact that while it is true, is not relevant as that data has no relationship to the rules that have to be followed. The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.

> This drug was approved under an emergency order and this side effect was not listed.

Sadly, this is the case. The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. In the EU this regulatory pause of AZ has likely killed thousands of people.

> The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.

Or, more generally, in the emergency-order regime, all decisions that can demonstrate a clear 10:1 improvement in expected deaths should be taken, regardless of regulatory red tape.

The FDA and other regulators have over-fitted their process for "minimize likelihood of another Thalidomide, for drugs which have a small chance of saving a life, and a very small chance of causing harm". This is defensible for testing a new statin, where we have existing safe drugs to choose from, and we're looking for incremental improvements. But it's shockingly harmful in an emergency.

One thing that has become very clear is that the FDA and other regulators are structurally incapable of making even rudimentary risk-based tradeoffs in emergency situations, and we need to fix this.

I don’t understand why you have to pause then restart. Just update the side effects as you go. Or pause for the affected groups.

It's really not clear at all that the incidence of this type of blood clots is actually higher in the vaccinated. So it seems early to call this a side-effect.

I wish the health agencies were a bit more open about their thought processes. OTOH, the rate of incidence doesn't seem higher than baseline AFAIK, which seems absurd. It also seems absurd that the various health authorities around the world would all make such a big deal of if if there wasn't some elevated risk. So I don't really know what to make of it, but privately, I'm leaning towards the interpretation that the idea is to avoid backlash against the vaccines by being irrationally strict about any potential hazards.

Whether or not this is true, that is not what the messaging is.

This is a vaccine for a disease that has killed over half a million people in the US over the past year, not a new breast implant.

The rules are not some holy writ handed down from above, they are our way of trying to properly manage risk. When the situation changes, the rules can also change.

But is it really a side effect? If 6 people vaccinated are hit by a car, is that included as a side effect?

Are those side effects lists just a catch it all sort of exception where they throw anything there just in case? Honest question.

It's not about the rules, it's about the optics.

How many people will point to this or feel a bit hesitant about getting J&J vaccine now?

Umm maybe because the blood clot issue is being underreported because no one is looking for it? We’re essentially doing mass experimentation with gene-based vaccines on the US population, all the vaccines use either mRNA or DNA insertion. Caution here is the logical and ethical thing.

Also: the side effect profile for the moderna and pfizer vaccines in the clinical trials was far WORSE than the jnj vaccine.

Edit: gene-based not gene-therapy

The 9 day median length to development of the condition leads me to believe that this number will grow, and that they are smart to pause for a week or two to see what the real numbers are.

They also need to make sure the information is out there on how to identify and treat the condition if it does occur. Proper warnings and information are pretty important.

Meta-comment: The ratio of downvoting to discussion in here is rather worrisome. The current top thread isn't really even about COVID vaccines; it's primarily an argument of the "this isn't an argument, this is contradiction" variety about birth control, of all things.

It should be possible to have a mature, good-faith conversation about this, even on a pseudonymous web forum.

It should be possible, but for many people, another person's opinion on these vaccines is a binary value. It's either right or wrong, and if it's wrong the person is summarily dismissed as having any relevant input to the conversation. Worrisome is correct.

7 people out of 7 million dose's. That's why they stopped. My wife and I got the J&J shot on Saturday so I'm directly at risk and I'd take it everytime even if the risk was 10 times what it currently is. I've already seen a bunch of anit-vaxers referring to this in new articles this morning. So let's see, 1 in a million chance that the vaccine will make you sick (only 1 person has died so far, which is terrible but it's 1 out of 7 million) vs a worldwide pandemic that has killed millions. All these anti-vaxers talking about living in fear of a virus that has 98% survival rate are AFRAID of a vaccine that has a 99.999998% ( 7/7,000,000 == 0.000001) survival rate, oh and is 100% effective at stopping you from dying. Literally no one that has received the vaccine has died from COVID19. The fact that modern society can be SO smart some times and yet so incredibly idiotic is so frustrating to me.

I think it is a disservice to outright label people as anti-vaxers simply for questioning the risk-calculus of vaccines. The (1/7 million) is the current, unconditional and empirically observed adverse effect of the vaccine - this is a somewhat noisy measure of the true prevalence of this issue. It is okay to be cautious and there are legitimate concerns, and quite frankly, I trust the FDA have good reason to pause this if Moderna/Pfizer are readily available anywy. In countries where there are not alternative vaccines available, the risk calculations change, and as such, you might be better off taking J&J or AZ. In any case, to your earlier point of why they stopped it: they didn't stop it because (7/7 million), they stopped it because it was not observed in the trials and now they have to recalculate the risks for various age-groups and inform people, accordingly. If these events were observed in the trials and the prevalence was the same (in trial, and out of trial) then it would not be a cause for concern.

Edit: got the wrong agency, it was FDA, not CDC

The problem isn't 7 out of 7 million odds. It is that it is an unknown side effect that did not come up in the original studies.

We have approved vaccines with worse side effects before. The difference is that we knew what those side effects were and weighed the risk vs reward and made the call to use it.

Nobody has investigated 7 million doses, so its at least 7, but probably more. The UK incidence rate (for the same issue in the AZ vax) was like 10X what was initially reported.

And its probable that these incidents are concentrated in a small segment of the population (young & health maybe women). So your denominator is very inflated.

If you can save 20-40 lives by just giving young women Pfizer and using J&J on 50+ year olds (for whom the risk might be literally nothing) then its a no brainer.

Not doing so is killing 20-40 people for no reason.

They didn't pause it because they're considering cancelling it. They're pausing it so they can communicate to patients and providers what to look out for after they take it. Once processes are in place to handle future blood clot events, they will resume vaccinations.

Multiple advanced health care systems in the world are independently pulling these vaccines. I wouldn’t brush it off as the FDA being overly cautious. None of these vaccines have been tested in humans for more than 12 months. And you’re assuming that health authorities can wave a magic want and instantly know who is having some kind of undetected brain clotting? I think the risks are extremely unclear even though people are throwing statistics around like they mean anything.

I believe their concern is more of long term effects and not short term. A vaccine isn't meant to cause blood clotting, unless we know the specific mechanism of how that's happening it could be much more dangerous.

> That's why they stopped.

More to the point, they have temporarily paused because the usual treatment for blood clots can make this particular type of blood clot worse. So they are pausing to give the medical community enough lead time to get up to date on treatment protocols.

Vaccines are held to such a high standard. We wouldn't have approved even Aspirin if we applied the same standards.

If I have my numbers approximately right, getting the J&J vaccine is a bit safer than taking a plane trip, while getting COVID is about as safe as taking a trip in the space shuttle.

> I've already seen a bunch of anit-vaxers referring to this in new articles this morning.

So, take pause and examine the situation. Are these people actually anti-vaxxers, ie they oppose all vaccination due to weird paranoia about autism due to a discredited "study". OR are they against this one vaccine because of political affiliation.

I'm really concerned that if we call out the people who are afraid of this one vaccine as anti-vaxxers that we'll only succeed in introducing them to the wider world of being afraid of all vaccines.

Find a different term so that we don't introduce these two groups of people to one another and give them a reason to join forces.

On the medical benefits alone it seems obvious to continue giving J&J. The counter-argument I understand is that J&J's supply is severely limited due to manufacturing problems right now, so pausing it doesn't significantly slow down the vaccine rollout. There are a lot of people right now that saw headlines about J&J's manufacturing defects, and now this one death, and are convinced those are related. Visibly pausing something that is such a small percentage of the vaccine rollout might be a good political move.

Full disclosure: I took the J&J vaccine last Thursday, and would do so again right now.

We usually test vaccines for a decade because of the risk of unknown short term and long term side effects. If we don't know why people are getting blood clots from the vaccine, then we don't understand the vaccine and could be creating long term issues for many people.

It's not the risk of clots. It's the risk of vaccine hesitancy because people fear a cover up. I think that's outweighed by the increased vaccine hesitancy because people only hear this scary story and not the low numbers (see also AstroZeneca).

> a virus that has 98% survival rate

You know, for all the continual fear mongering about coronavirus last year, the constant reminders of who was most at risk, the hyper importance put on masks and cleanliness, etc it is shocking to see things put this way now.

I just made this website to show you how really, really small the risks are for the AstraZeneca vaccine which also has this ‘issue’.

It compares the risks of dying from a blood clot after the AZ vaccine (about 1 in a million) to the risks we happily take every single day.

http://whatoneinamillionmeans.com

If you're not willing to take 1 in a million chances, it's gonna be pretty hard for you to get out of bed today

It could be that the side effect has delayed onset, so there could be many people out there who are about to have the side effect but haven't showed up in stats yet. In that case I think it makes sense to pause for a while and wait for updated numbers

I wonder if we randomly select 7 million people (without vaccine) and observe them for couple of months - how many of them will get the blood cloths

> The fact that modern society can be SO smart some times and yet so incredibly idiotic is so frustrating to me.

The CDC and FDA both agree that use of the J&J vaccine should be paused so they can further study this previously unknown side effect.

Maybe someone here could help you get in touch with them since you clearly know something they don't?

You are mixing certain numbers. It absolutely makes sense for my grandfather to get any vaccine, because of his risk, but the age braket for me means that I am more at risk of dying from Astra-Zeneca than Covid, but I am also a man and those who have died so far have been women.

I haven't seen enough numbers for J and J, but you have to untangle the various risk factors before you can say anything about what you should do as an individual.

I know this pandemic is fustrating as hell, but if you call people who use science and numbers to see problems with the current vaccines anti-vaxers then you will be taken as seriously as you deserve.

7 people in a fairly specific demographic (women 18-38, I believe), when there are 2 other alternative vaccinations available.

Do we have any data on the total number of women 18-38 who received this vaccine? It may actually be fairly low given we may have selection bias to give these vaccines to an older population.

The outcome may simply be to recommend that members in this demographic avoid this particular vaccine until further analysis is done.

Modern society is not monolithic. It is a vast chaotic network, many nodes of which are surrounded by other nodes, all of which are misinformed.

I think that's not a very charitable take on "anti-vaxers". People are against injecting something new that has not stood the test of time. We have no idea what the actual frequency of this issue is (maybe more reports will come in), or if there are other lurking side effects waiting to be observed as a pattern, or if there are long-term effects. What if news of this spurs others to make the connection with the J&J vaccine and more such cases are reported to the CDC? Or looking at the other vaccines, what if in 30 years we somehow establish a link between mRNA vaccines and cancer?

I'm sure people will be tempted to jump in here and state their case as to why certain long term effects are not possible, and why this is conspiracy theory misinformation. But that's not the point. The reality is that humans regularly fail to understand infrequent or long-term consequences of new innovations, despite the best of intentions and despite the use of the best science available at the time. This has happened repeatedly in the past - see numerous prescription drugs that were recalled, or the use of phthalates in shampoos, or asbestos, or whatever else.

In the case of J&J, consider that this is happening against a backdrop of a continuously changing story about the AstraZeneca vaccine, increasing reports of COVID vaccines affecting menstruation (https://vajenda.substack.com/p/the-covid-19-vaccine-and-mens...), and a rushed emergency use authorization process that bypasses typical methodology for approvals of vaccines. The comparison isn't between the IFR of COVID-19 and the fatality rate associated with this vaccine. It's between the IFR of COVID-19, which is known to be very low, and the unbounded potential of near-term or long-term fatality or other side effects from the vaccine.

> oh and is 100% effective at stopping you from dying. Literally no one that has received the vaccine has died from COVID19.

This is misinformation (and I call it that because it is being widely repeated in major new sources). It's an improper generalization from what was observed in a very small sample of confirmed Covid cases in the vaccine trials.

https://www.forbes.com/sites/brucelee/2021/04/11/3-breakthro...

By not stopping it will forever by 7 out of 7 million.

By stopping they can at least find out if it's 5000 out of 7 million (and more deaths).

This really is a sad, sobering reality. "6 cases in 6.8 million", ~0.00000089% chance of death via J&J vaccination. Extremely disheartening to see, but rather telling, where priorities lie. Politics aside, this is sheer stupidity, as you mentioned. Brace for another year as mutations continue to develop throughout the developing world while we waffle over infinitesimally minimal risk.

Question for you, if you like those odds, why get the vaccine at all? If you're not obese covid won't do anything to you except give you a lil flu.

Curious about your answer.

> All these anti-vaxers talking about living in fear of a virus that has 98% survival rate

Please cite a source here. Survival rate usually means IFR not CFR, and even the CDC's own number (the CDC is going to be incentivized to overstate risk) puts it at around a 99.4% general survival rate. Other estimates put it closer to 99.7% or even higher.

An utterly appalling decision by CYA bureaucrats or innumerate idiots. The leadership of the CDC and FDA must be replaced.

Whether it's .0000000001 or .001 chance of dying it's a non-zero chance of dying.

So where does one draw the line?

What level of shutting something down is justifiable in the name of safety?

Who is allowed to make that subjective decision?

It's a slippery slope.

It's arguable that we should wear masks FOREVER because they reduce death rates for every respiratory disease.

This feeling. Of why are shutting down because of these few lives.

Is exactly how people have felt about shutting down the whole economy over the small-ish fatality rate of Coronvirus.

There's just different levels of risk tolerance.

Who is the more moral person?

Birth control is already severe blood clots at 1:1000 . Only affects people with uteruses. That's cool.

This is 1:1000000 of a severe event, but affects men as well. HOLD THE LINE - It affects a.... Man!

Here's a question for someone smarter than me. Is there a chance that this number (six cases in seven million doses) will rise as regulators comb through previous reports of adverse effects?

Not an expert in but one of those expert drug regulators is my friend.

1 per million adverse effects is nothing. If that would be a solid fact, there would be no reason to pause vaccinations. The pause happens very early so that experts have time to check the data and methodology and verify that it's all that there is.

When a new drug is given for emergency evaluation or a new side effect is discovered he works 14 hours per day 7 days a week with a team going through a massive amount of data and documentation to verify and check everything.

The media and most commentators don't understand why decisions can take weeks. Why you don't have the scheduled emergency approval meeting just now. They fail to understand that fact-finding is not happening in the meeting just by people giving their expert opinions. Experts work around the clock without taking any time off to figure out what is happening. But lazy bureaucratic regulators, right?

I'm probably not smarter, but based on what happen with AZ I don't think it will rise. AZ clot cases rised after people became more aware of the issue so it was reported more often as the vaccine side effect

Yes, but not from previous reports. See the other responses about how previous reports are handled. I would expect cases to rise as unreported things get reported, and as doctors start to ask the right questions when they see these events and report things that previously wouldn't have been reported but probably should have. Not to mention that with these reports I expect doctors to ask the right questions and so previously misdiagnosed events get diagnosed correctly (some of these might be unrelated to the vaccine though making the data messy).

6 cases doesn't seem high enough to rise above the baseline incidence rate that I would expect for a population of millions that have received the vaccine.

The reported data simply doesn't explain stopping use of this vaccine. It seems like either:

1) They are overreacting based on sparse data, which will cast doubt on the validity of their actions.

2) There is information being withheld that implicates, though perhaps without certainty, that the vaccine is the specific cause of these issues.

Either way, the net result will be more distrust & greater reluctance to get vaccinated. There has to be a better way to handle this problem.

This vaccine is similar to the AZ one which seems to have an elevated rate over a much larger sample size. Thus a pattern here that matches patterns we expect of the AZ vaccine suggests this has the same problem even though if we take the data alone it is still within the range of normal.

As such 1 is no longer correct, if we didn't have a compare these numbers are high but within expected chance. However these numbers are looking like within the range of the compare even more than normal.

> The US has by far the most confirmed cases of Covid-19 - more than 31 million - with more than 562,000 deaths, another world high.

The BBC is usually pretty good about sticking to relevant information (at least compared to US media), so I was a bit disappointed to see this blurb - especially since it's only the fourth sentence in the article. What does it add? It has nothing to do with the subject (ie the safety of the J&J vaccine) and isn't even particularly useful data in almost any other context aside from half-baked political jabs between nations.

It also ignores differences in population. Several European countries have more deaths per capita than the United States. So far, the UK had 200 more deaths per million (11% more). The Czech Republic had 900 more per million (53% more).

The section I have italicized here stood out in the statement from the FDA/CDC, in my opinion. This is not about putting vaccinations with the Johnson & Johnson vaccine on hold infinitely. For a good part, it seems to be about being aware of and prepared for this serious adverse effect, not to avoid it at all costs.

"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.", from https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.htm...

Well this seems stupid.

The thing I'm trying to understand is whether Johnson & Johnson and AstraZeneca are meaningfully different. All the media just assumes they are (until proven equivalent), but is the genetic code publicly known so we can compare? The Pfizer and Moderna ones are extremely similar. Now, I imagine the adenovirus ones have an order of magnitude more genetic material, but is the code publicly know to compare?

As far as I can tell, they both should have been approved ages ago, if only to depress prices and get more redundancy.

J&J uses a very rare human adenovirus, AZ uses a more common chimpanzee adenovirus. J&J also has the so-called 2PP modification on the Spike protein compared with the AZ vaccine. Good writeup here: https://berthub.eu/articles/posts/genetic-code-of-covid-19-v...

One difference is that J&J has been tested for only one shot and AZ is tested for two shots. Also the amount of vaccin you get shot in your arm could be different. The clotting incidents between the two are certainly different, AZ has much more at the moment.

Does the fact that they're made in the same lab mean anything when it comes to these side effects? Are the fillers/stabilizing materials the same?

Yes, they are meaningfully different. For one, Pfizer and Moderna are mRNA vaccines, while J&J and AZ are not.

It's interesting to me seeing the direct data-based reactions to the pause on the J&J vaccine. For example, Nate Silver of 538 wrote (https://twitter.com/NateSilver538/status/1381925025964515330):

> 6 cases out of 7 million people. What a disaster. This is going to get people killed. And it's going to create more vaccine hesitancy. These people don't understand cost-benefit analysis. They keep making mistakes by orders of magnitude.

I am seeing this argument from people of all political views this morning, but I am most surprised to see it from the political left. Why isn't the same data-driven approach used when we're talking about policing, or gun violence, or traffic deaths? In all these cases, the frequency of negative outcomes (policing deaths of unarmed black people, homicides committed with guns, traffic fatalities per mile traveled) is very low and when weighed with the positive outcomes, it is clear that people are acting irrationally when they try to defund police, or ban firearms, or restrict driving. And yet, the data is never brought up so directly in those conversations by either everyday people or news media.

The J&J vaccine issue is frankly less alarming to me than this open hypocrisy or disconnect in our societal discourse.

Interesting to find out if this is again correlated to blood type. Type O has a lower risk of clots from COVID in general, thought to be related to the amount of von Willebrand factor in the blood:

"...since the ACE2 receptor belongs to the renin-angiotensin system (it regulates blood pressure), the virus cannot but affect the blood vessels. Apparently, it is capable of causing local inflammation of the walls of blood vessels and capillaries. This results in an increased release of VWF into the blood, which, in turn, provokes clotting." [0]

[0] https://www.news-medical.net/news/20200706/COVID-19-complica...

I see a lot of arguments that are basically "people are too stupid to understand risk". That, in turn, comes from the fact that the FDA/CDC/NIH has not covered itself in Glory the last many years. Covid just uncovered the rot, while Trump danced around it, and poured gasoline on the fire.

The best thing to get people to understand risk is to actually follow the process in the EUA. Pause, evaluate the outcomes, change the labels and dosing. Which this does.

At the same time, the FDA/CDC need to start taking other countries data into account. At this point, there is no excuse not to be using a UK style "first dose first" strategy, especially if mRNA is all we have for a while.

I’m not sure I understand your argument (and I’m guessing the downvoters aren’t either). This is a situation where the process will definitely, unambiguously, kill more people than moving forward with the vaccine.

I guess you’re suggesting culling a small fraction of the population might encourage better behavior at the voting booth? We already have plenty of historical evidence suggesting that’s not true.

"Killing people to teach them about risk" seems like a bad decision, especially if the endgame is to save lives.

Given COVID prevalence in my state (approx 1 out of 10,000 people test positive each day, so assume 20 out of 10,000 are infectious at the moment), and the IFR for those under 50 of about 0.01% (1 out of 10,000 coincidentally), I would have to come into close contact with 20 people over the time from when I could get the J&J shot to when I could get Pfizer or Moderna.

That's not anti-vax denialism, those are the actual numbers. A one in a million risk isn't a good deal for the individual when case rates and IFR are low.

This would be a good deal if you were in Michigan, or if you were over 65.

Birthday paradox means ten not 20 and while I MIGHT be able to go two weeks without encountering ten others my oldest son works at a restaurant, my wife at a school, and my youngest son is full-time HS student. They meet 20 people a day easily and live with me at home.

It's a very interesting dilemma indeed. Obviously, if it's 7 out of 7 millions, then pausing it for the duration of the investigation does way more harm than good, given how many infections happen these days.

On the other hand this extra cautiousness shows how robust the safety of the system is: even minor glitches get caught and examined which practically pretty much rules out that there are side effects of orders of magnitudes more likely that we don't realize. And that may indeed worth it overall. Though in practice it would still make more sense if they continued until it reached a higher threshold (if it is ever to reach it).

Unfortunately, while this should be seen as very reassuring WRT the safety and the level of trust we can have in the vaccines, fear is irrational and for some people it proves that the vaccines are not safe.

E.g. here in Hungary, we have the EMA licensed vaccines (same as the FDA licensed ones) and also a Chinese (Sinopharm) and a Russian (Sputnik-V), with a permission from the Hungarian authorities. Now when the blood clotting issue emerged with AstraZeneca, some started to say "see, that's how much the EMA license is worth. BUT the Sputnik-V is good because you never heard about such issues with it". Which is, needless to say, completely upside down. (Not suggesting that the Sputnik does have the same problem, though I wouldn't be surprised, since it's the same technology as the AZ and the J&J. Also, I wouldn't be surprised if all vaccines had the same issue as the virus itself causes clotting.)

The online argument about this is raging about whether this is a stupid decision and I’d like to side step that well-trodden path of vitriol to ask more broadly: what’s the deal with Covid and blood clotting?

I know personally a long hauler who has blood clotting issues and low platelets. They fall into the demographic of concern with the JJ and AZ vaccine. Anecdotally we have lost both a close relative and a young and healthy friend to Covid blood clotting related issues.

Again, I’m not weighing in on the FDA’s job. But just saying: as someone who’s anecdotally been hyper-aware of the blood related aspects of Covid, this thread has picked up my ears and I’m really interested in finding out what the linkage here is.

decent layman's explanation - basically similar to heparin induced thrombocytopenia and you should be able to find more describing that:

https://www.theguardian.com/world/2021/apr/13/astrazeneca-bl...

Related: The J&J Vaccine Is Safer Than the Birth Control Millions of Women Take Every Day

https://www.vice.com/en/article/z3xbk9/johnson-and-johnson-c...

I think that simple news reporting inadvertently screws up how the general public perceives low-probability events.

Whether it's an airplane crash or a blood clot caused by a vaccine, human minds simply can't 'feel' that a phenomenon is rare when it is repeated over and over again in their newsfeed.

Is there an understanding of why the vaccines cause the clots?

The theory is that it is the same reaction that a tiny percentage of people have to heparin (AZ vaccine in this study but mechanism presumably the same) There is a treatment but imperative that doctor knows that this is the cause for appropriate response. https://www.nejm.org/doi/full/10.1056/NEJMoa2104840

As for the AZ vaccine, we are still learning: https://www.nejm.org/doi/full/10.1056/NEJMoa2104840

The paper details several cases (and index case in more detail) as well as a plausible mechanism behind the thrombotic events. Even better, there are some therapeutic possibilities as well arising from the heparin induced analogue condition.

I haven't seen any news articles provide a point of comparison of how the number of people receiving the J&J vaccine and experiencing this particular kind of clotting. The first academic-ish article on the subject I could find indicated a typical baseline of 15.7 cases per million (https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0...). If that's true, I don't get it - why would we stop roll out of any vaccine when the baseline (15.7) is higher than the problem that is being claimed (1 per million)?

These vaccines have only got emergency approval . It is true that reliability of vaccines have caused some nervousness in society and that is obvious because no vaccine in history is out so early for use Must read https://www.weforum.org/agenda/2020/06/vaccine-development-b... Whole world is going through tough time. I hope suffering ends sooner than later

From the CDC, updated today...

"Over 189 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through April 12, 2021. During this time, VAERS received 3,005 reports of death (0.00158%) among people who received a COVID-19 vaccine."

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/ad...

Honestly I think they should have had their meeting before telling the public. It seems unnecessary to pause it before figuring out if its worth it unless theres something else they're not telling us, which in that case it's also hurting trust in the system.

No matter what they come back with, the JnJ vaccine is done. We might as well start shipping them out to other countries that desperately need them, especially if we supposedly have enough mrna vaccines coming for everyone.

As is typical for this comment thread, in this comment I will claim that pausing the Johnson & Johnson vaccine will lead to hundreds of thousands of deaths because that is how many people will die if we do not have a vaccine. All this to save 1 out of 7 million lives. In passing I would like to call everybody involved in the decision idiotic.

As is typical for this comment thread, in this top-voted [0] reply to this comment I will point out that pausing one vaccine is not the same as stopping the entire vaccination program forever. I would in addition like to point out that once cannot simply compare the risks because they can vary wildly across populations, and that the one out of seven million might not be a reliable estimate. Might it not be good to wait until we know the actual risk, given also the abundance of other types of vaccine?

[0] one can hope

As is typical for this comment thread, in further replies we can happily claim the effect that this has on the anti-vaxxing crowd, whose thinking we are all extremely familiar with. Of course, since we are all careful people we will also balance the effects of the decision to pause the vaccine against the decision not to pause in the face of potential blood clotting issues.

Nobody seem to discuss that this issue appears around 10 days after getting the vaccine. And I believe most of the doses have been given over the last 10 days. So we actually don't know yet the real incidence of this issue. It makes sense for the FDA to be cautious here, there are other vaccines which are fully available.

Covid itself causes blood clotting in many seriously ill patients. A friend, who was in ICU in March 2020, was given Herparin (due to clotting concerns), and was told to take aspirin at home after release.

Is it surprising that the vaccines cause clotting too? Isn't this sort of obvious?

Vaccines for tetanus don't cause lockjaw. Vaccines for measles don't give you bumps all over your body. Most vaccines, except for those that used to work by actually infecting you with a related virus, do not cause the same symptoms as the diseases they treat.

No this is a very different form of clotting caused by auto antibodies that causes both clotting and low platelet counts. It's similar to HIT. Giving heparin in this situation would make things worse.

https://en.wikipedia.org/wiki/Heparin-induced_thrombocytopen...

Why are women adversely affected?

Med Student here so possibly wrong but...

There is a well established link between oestrogen and increased blood coagulability. Whilst it is possible females are more affected by the vaccine I suspect one factor is that their baseline coagulation risk increases their likelihood of thrombus due “reaction induced coagulability” compared to males.

CVST normally affects women at significantly higher rates than men.

[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....

If it’s an autoimmune reaction, autoimmune diseases generally are more common in women.

That’s not an explanation, of course, I don’t know the reason. But it places this in a larger category.

I read there is a bias in the data due to young women being the moat common demographic for nursing jobs.

Interesting. Almost definitely something to do with adenoviruses then. I would imagine that Sputnik probably also has this side-effect. I wonder if "wild" adenovirus infection does this too.

Deciding whom to give these vaccines to is a complicated decision for each country to make and depends on:

a) The incidence rate for each demographic of CSVT-type clotting from the vaccine[s].

b) The expected distribution of clinical outcomes from those events, making reasonable assumptions about likelihood of early detection and outcomes with treatment for heparin induced thrombosis.

Those two give you the clinical cost.

Then you compare those with the clinical benefit from:

1) The relative likelihood of infection for a person, given their demographics, personal exposure profile etc.

2) The absolute likelihood of infection in the country / region in question based on assumptions about the future of the pandemic

3) The expected distribution of clinical outcomes from infection given the person's characteristics

(2) is important because you're comparing a one-time risk of side-effects with a time-related risk of infection.

Clearly, the same person in Manaus or Adelaide is not really making the same trade-off even if in the abstract, the side-effects and IFR are the same.

You also need the counterfactual: If you decide not to give an ad vectored vaccine, you are not deciding never to vaccinate, you are deciding that this person will get a different vaccine, probably later. How much later depends on the location. If you're in the US, you've got Moderna and Pfizer/Biontech coming out of your ears so it might only delay any individual vaccination by a few weeks. If you're a healthy 25 year old who can work from home, the risk trade-off of having to wait an extra 6 days is very different than that same person if they have to wait another 6 months.

As a result, different countries, looking at the same data will rationally make different decisions. The US has lots of mRNA vaccines so will choose one thing, the EU has been badly hit by the failure of Sanofi/GSK to deliver a working vaccine (and by AstraZeneca scaling problems) but has quite a lot Pfizer production capacity, the UK has used up its Pfizer stocks and will now only use it for second shots. CureVac and Novavax may be able to supply some doses at some point but aren't in the picture yet. Several European countries are negotiating to get Sputnik but that is also ad vectored so may have the same problem. That changes the risk calculation because it changes the time that people will remain unvaccinated in the counterfactual where ad vectored vaccines are not used for their age group.

All of this is before the complicated public health element of keeping messages for the public simple and the issues caused by changing that message frequently.

I don't know to what degree countries that had set relatively high minimum ages for the use of AZ had been counting on J&J for younger people. In many cases, AZ deliveries were sufficiently slow due to yield problems that it was "free" from a scheduling point of view to restrict it to only the oldest since the expectation was that they would only receive enough for those anyway and could use other vaccines for younger groups. If J&J was a big part of that, then they now have to update that calculation because the counterfactual to using AZ for those people is no longer "do them with J&J next week". That may be hard to communicate to people who had been told that a particular vaccine was not safe in their age group previously but may now be asked to take it anyway.

I'm glad that I don't have to make these decisions. They are not easy ones.

I was planning on getting the J&J because I will most likely only be able to get one dose. Is a single dose of the mRNA vaccines effective in any meaningful way?

Yes, perhaps around 80% effective after one dose of mRNA: https://www.cnbc.com/2021/03/29/cdc-study-shows-single-dose-...

It has similar efficacy as the single dose J&J

We’ve completely transformed human civilization in a desperate attempt to slow down the spread of this virus that kills 1 in 200 people, and now we don’t want to use one of the miracle cures because of a literal one in a million chance of issues.

People are absolute garbage at thinking about scale.

> kills 1 in 200 people

It kills less than that in the demographic in question, not to mention that is only of those who contract the virus.

> People are absolute garbage at thinking about scale.

I don’t think it is that, I think it is that for better or worse humans tend to view wrongs through inaction as less atrocious than wrongs through action. Additionally - they already have better alternatives and plenty of supply in the US (Moderna and Pfizer vaccines) so they are opting to just use those at the moment.

First, it’s closer to 4 in 200 [1]

Second, there’s evidence that even if people don’t die, there can be long term neurological effects [2].

Third, even if we accept your number, 1 in 200 would still be 1.5 million Americans dead, not even considering the rest of the world. I am personally not comfortable doing nothing to stop that number.

I agree that being super worried about a 1 in a million blood clot might be short sighted, especially since the death rate from catching the virus is 2 in 100.

[1] https://coronavirus.jhu.edu/data/mortality

[2] https://www.reuters.com/article/idUSKBN2BT2ZI

It’s not a sim city decision. In young healthy people the risk of covid death is much lower than 1/200 , so you gotta see why this would make people hesitate.

Deaths from COVID aren't seen as the direct 'fault' of the regulatory bodies. Deaths from a vaccine will be... and fundamentally, regulatory bodies aren't really incentivised to take risks anyway.

If they follow your line of thinking and it's all fine... no-one's going to be writing articles praising them.

If they follow your line of thinking and more people die form blood clots... people will write articles attacking them. Questions will be asked, and careers may be harmed. Etc.

1 in 200 people? Maybe if you're above the age of 75 and have significant comorbities. If it was 1 in 200 for all age groups you wouldn't have to convince people that lockdowns and maskwearing isn't all theater, they'd be so scared you wouldn't have to convince them of anything.

Despite our attempts at containing it, it has killed roughly 3 million people worldwide. I'd say it's cause for concern.

> now we don’t want to use one of the miracle cures

We want if there are safer options. Not all vaccines are equal. Important question is why we unable to scale up production of mRNA vaccines?

I like how BBC calls the vaccine made in the UK the Oxford-AV vaccine but can't call this correctly the Janssen vaccine.

It probably works the same in most places. In the Netherlands it's usually called Janssen, while the Oxford one is called AstraZeneca. I'm guessing in the US they usually leave out BioNTech, while in Germany BioNTech comes before Pfizer.

Just a hunch but I suspect there may be more than “6” cases of blood clotting with the vaccine in the US.

Our entire political leadership is focused on risk mitigation, and it’s entirely tiresome.

Everyone posting here confidently saying that the FDA is clearly wrong is pretty disappointing to me.

I think of all the comments about how "MBAs" and "marketing people" just don't get software development. And then I look at software development people who seem to think they clearly get medical research and regulation.

The problem is with how they are handling their data. You don’t have to know anything about biology per se to see the issue. It is entirely mathematical. By the way, the medical establishment has a terrible track record surround use of and understanding of statistics. I don’t think it’s right to suggest that self described experts are somehow infallible.

I just made this website to show you how really, really small the risks are, and how they compare to risks we happily take every single day.

whatoneinamillionmeans.com

If you're not willing to take 1 in a million chances, it's gonna be pretty hard for you to get out of bed today.

This vaccine seems to have about the same rate, which makes sense as I think it uses the same technology.

I appreciate what you’re doing but I’m still avoiding the vaccine as long as I can. I’ve got a class 1 medical , a PPL and I hope [ha] one day to get paid to fly planes. I really don’t want another Pandemrix because with my luck I’d end up with the side effect. Also I’m MASSIVELY allergic to certain drugs and I get the NHS third choice for antibiotics and anti inflammatories.

Thanks! Now I'm never leaving the house again.

That's a good website. I had a chuckle at some of those.

I'll gladly accept additional micromorts (I do dangerous things often) but it must come with an appreciably worthwhile reward. My chances of dying from COVID (if you include the risk of catching it weighted by dying from it) isn't large enough to make the "gap" worth it. It may not be pro-social but there's no requirement in society to be pro-social.

"That’s the same risk as driving London to Liverpool"

This was the first one your website presented and I have no idea what it means.

I got the Johnson and Johnson vaccine and I feel fine but this news troubles me.

Awful decision. Everyone involved should be fired or removed from office for grotesque lack of judgement leading to a significant net increase in mortality.

I personally had an adverse reaction to this vaccine. I had a fever and extreme fatigue for 2 days. I am a relatively healthy 30-year-old male.

I think this is an example of where government transparency would greatly aid the discourse and build trust.

Where is the math that suggests that pausing the J&J vaccine is prudent? Inputs being risk of getting covid, risk of getting a blood clot, risk of injury/death from covid, risk of a new covid variant appearing, etc.

Without that transparency we’re all just guessing.

I'll guess that you might be aware this is the reason, but just in case, I'm pretty sure the reason is that nobody who makes these decisions is actually doing any cost-benefit analysis (aside from the costs and benefits to them personally and their organization, maybe).

The comment by Barleyman on the Ars Technica article on this [1] has a graphic from someplace called the Winston Centre for Risk Analysis that shows the benefits in COVID reduction vs the harms from the AZ vaccine by age group.

According to that graphic, if you are in a time of medium COVID infection rates (60 per 100k per day), the risk from COVID outweighs the vaccine risks in that age group. If you in a time of low rates (20 per 100k per day) the vaccine risks outweigh the COVID risks.

The vaccine risk goes down as patient age goes up, and the COVID risk goes up as age goes up.

The J&J risks will probably follow a similar pattern and it also appears that the J&J clots require unusual treatment. That suggests a pause to at least figure out where the risk curves cross and to make sure that doctors and hospitals are prepared to recognize and treat the J&J clots.

[1] https://arstechnica.com/science/2021/04/us-cdc-fda-call-for-...

An analysis of the relative risks is obviously the objectively correct answer from a rational perspective, but most people aren't making decisions based on that kind of statistical reasoning (though we'd doubtless have better outcomes if they did). There's a serious risk that problems like this can spark a backlash against all COVID vaccines if not handled conservatively--there are plenty of people just waiting to have their anti-vaccine confirmation biases triggered. How to handle these events is as much a question of social behavior and public relations as it is of science.

Looks like it was 6 cases after about 7 million doses. Even if it were caused the vaccine, the risk there is incredibly low. Much lower than the risk of an adverse COVID case, I would think.

Does pausing to investigate such an incredibly rare occurrence increase the public's trust in vaccines (because they see the government is being extra careful with safety data) or decrease it (because skeptics will use this as evidence that there are problems with the vaccines)? I feel like it's mostly the latter, but I dunno.

Not to mention all the COVID cases that might have been prevented while the rollout is paused to investigate a potential side effect that's less than one in a million.

And not just for the vaccines, but the choices made in Covid policies and mandates.

Massachusetts DPH has now shutdown administering J&J vaccines (of which MA got a large batch last week) and have been cancelling J&J appointments:

https://twitter.com/MassDPH/status/1381947053287354368?s=20

> “This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” White House Covid-19 response coordinator Jeff Zients said in a statement.

At least they have alternatives. Meanwhile, in Europe ...

... JJ stopped to deliver to Europe due to the decision which has been taken in the US.

We allow people to receive no vaccination at all. But we won't allow them to get this vaccine if they want it?

This reminds me about all those governments that allow people to buy and sell cigarettes, but ban the sale of raw milk.

Can we just name this "Raw Milk Syndrome"?

I think it's more an application of the principle of non-maleficence. (https://en.wikipedia.org/wiki/Primum_non_nocere) Consider this a temporary pause while they make sure they understand the relative risk factors.

Cigarettes and raw milk are, regrettably, a specious comparison. In the USA, the rules concerning both are handled by different governing bodies. For the longest time, cigarettes had been explicitly excluded from the FDA's jurisdiction, according to a law passed by Congress, and confirmed by a Supreme Court decision. And rules concerning raw milk vary from state to state, but are generally also set by legislatures. In both cases, what you see there is political interests come into conflict with, and perhaps override, the more level-headed, science-driven, technocratic approach that the FDA is theoretically expected to take.

J&J must not be paying the right people...

I'm trying to understand why this isn't ridiculous, and I'm not sure what that reason could be.

The disease left to its own accord has the potential to kill millions (someone please correct me on this). Why would we pause a vaccine because 6 people in 7 million got blood clots? Why would we do that and risk fueling anti-vaccine viewpoints?

I'm baffled, but perhaps I'm a fool.

Yes, but the risk is death and there are alternatives that do not appear to have this risk. Why not pause until it is more well understood?

In the US, the other vaccines are starting to become really readily available.

What you may be overlooking is that this is a biology problem, not a physics problem, so you cannot assume a uniform population of spherical humans with identical characteristics. :-)

COVID risk goes up with age. In the other COVID vaccine with a clotting issue (the AZ vaccine) clotting risk goes down with age. If that turns out to also be the case with J&J, then for a lot of people in the US (up to 20% or so) at the current levels of COVID the vaccine has a good chance of being more of a danger to them than COVID.

A short pause to determine if they should add a minimum age (possibly a variable minimum age that depends on the overall COVID rates) for J&J is prudent.

> Why would we pause a vaccine because 6 people in 7 million got blood clots?

Because J&J isn’t the only vaccine in the inventory, and the others don’t have that problem (or, IIRC, the same level of other adverse reactions), and because:

> Why would we do that and risk fueling anti-vaccine viewpoints?

What risks fueling anti-vaccine viewpoints is ignoring adverse impacts which are known and plowing forward, especially giveb that people often don’t have a choice of which vaccine they are administered.

I suppose they don't know what is the cause and what's gonna happen in the future(6 now, 10 000 in a few years).

The communication that public gets is outrageously bad.

It's bad policy. But it's important to get the analysis right: the choice here isn't between a very safe vaccine and an unvaccinated world population facing a pandemic to completion (which matches "the potential to kill millions").

It's between "continued rapid vaccination with all three approved US vaccines" and "somewhat delayed vaccination with one of the three approved US vaccines". That's not remotely a million-person delta, though the number is surely much higher than the 1/1M case rate on these blood clots.

Honestly the worst effect isn't with the vaccinations per se, it's the potential that this may delay vaccine acceptance rates among people sitting on the edge, due simply to fear.

For many people the risk of serious complications from COVID is similar. I am a young, healthy introvert working from home and enjoying the social isolation in a location that does not have explosive spread right now. The product of "probability of getting COVID" * "having serious long term effects or death" is in the same ballpark for me.

I would still get this vaccine (or the AZ one) if offered because I consider it my duty to be part of the herd immunity. But not everyone will do that, and the moment you have people in privileged position refusing one of the vaccines, you start (1) exacerbating inequalities (2) fueling conspiracy theories, mistrust, and vaccine hesitancy.

If you assume that the world is perfectly rational, then you are right, but it is a running joke on HN to point out how economists used to make that same mistake and derive silly conclusions.

From the article:

“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.

so, let me get this straight. you have vaccines that use a new tech (mrna) that are awesome and vaccines that use “old tech” and at least 2 of then produce blood clots?

something is weird here. i’m not saying this is due to mass hysteria generated by people that don’t want the vaccine but this does sure look like a case where we don’t understand relative risk.

i may be ignorant and not understand all the factors but I don’t see the data that allows me to understand if suspending this vaccine is a good thing or nkt.

The J&J and AstraZeneca vaccines are both based on adenovirus vectors. This platform has a little more history, having been used in a recent ebola vaccine, but the number of doses administered has been relatively tiny. I'd say both vector-based and mRNA very new, pioneering tech.

Behold, the vaccine experts of Hacker News!

Who are just as accurate, trustworthy and impartial as the technology experts on the 5pm news and the life coaches of Reddit.

Are we not allowed to discuss something unless we have a PhD in that field?

Six cases in seven million administered doses. One death.

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.

This is kneejerk statistics 101 reaction.

* 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.

I'm not saying your calculus is wrong but this does make an assumption that all clots are created equal and I don't believe that is the case.

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...

There's lots of other things to compare it to as well. It's a roughly 1 in a million chance of dying - which is called a Micromort https://en.wikipedia.org/wiki/Micromort

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

https://whatoneinamillionmeans.com

Note that in EU it also started with 7 cases ~1 month ago. Then doctors went through the records and now there are 200+ sick, 25 people dead from CVST alone (clotting that causes bleeding in the brain) with incidence in Norway 5 out of 130000 vaccinated. If you look at women only it will probably go even higher. And if you compare that to CFR from COVID for person <50 years old without diabetes and hypertension it will be within an order of magnitude

www.medscape.com/viewarticle/949108

Possibly they are nervous because it could signal deeper problems. If there is anything people should have learned from the pandemic is that it takes a few months for the medical profession to sort themselves out when new data appears on the scene.

I doubt the correct communication strategy is obvious. Rumors about people dying from a vaccine can be worse than a pause.

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.

People keep saying this will add to vaccine hesitancy but I'm not convinced. The vaccine-hesitant are already skeptical of authorities and aren't going to be especially reassured just because US agencies say it's fine, when it's already hit the news that European agencies have halted J&J.

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.

Seems like a “damned if you do, damned if you don’t” kind of scenario. If you don’t pause the rollout, there will be news articles that the government ignored deadly side effects, resulting in lack of trust and vaccine hesitancy. If you do pause the rollout, you get vaccine hesitancy.

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.

This take seems a little short-shrift to me.

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.

This article [0] mentions 50% more blood clots observed during vaccine trials, which at the time was characterized as a slight numerical imbalance (15 blood clots versus 10 in the placebo group, in a trial of 20k people)

[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...

The obvious difference is that the vaccine is being forced upon people. A woman can talk to her doctor, understand the risk, and decide to take birth control or not.

The vaccine was given to people, under threat of exclusion from society, without knowledge of the side effects. Not comparable.

Put another way, you're about 38 times more likely to develop a blood clot than win the UK's national lottery.

Why is it relevant? So far nobody forces me to take birth control and threatens for exclude me from the society if I refuse to do so (UK wants to require vaccine passports to go to cinema, for example). Nobody paints me as stupid anti-vaxxer if I just say I don't want to take BC pills. Nobody tells me that I won't be able to travel unless I agree to take BC.

People keep repeating this myth of birth control. I don't know how doctors do their job in other countries but if they look at the patients health history this number is a myth. Luckily health officials here (ETA: Denmark) inform about these myths on television whenever the government holds a press conference about new Covid-19 measures but this isn't so everywhere so please stop spreading FUD.

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).

Seriously I can't believe this is that simple. There is no way public health bureaucrats don't understand this common sense logic. Otherwise they would all become vaccine deniers.

I agree that on the surface these numbers are not alarming. That said I trust that the government agencies know what they are doing here. If anything there is tremendous political pressure to NOT scrutinize the vaccines.

There is enough anti-vaccine & Covid rhetoric that we should all cool it a little bit and let the experts do their jobs.

Something that has fascinated me about the last year is that the pandemic has sped up the feedback loop on decisions like this. Seeing the impact of this decision won't take years and the outcome won't be unclear. In another few weeks, we'll very likely know that this was an overly cautious call that directly led to even more vaccine hesitancy, and lives lost as a result.

Paraphrasing one famous science commenter, we're playing Pandemic Trolley Problem and running over hundreds of people because we're not sure if the other path has one or two persons.

It's ridiculous.

Or as per someone that actually knows statistics: https://twitter.com/NateSilver538/status/1381925025964515330

Why do people keep posting this nonsense?

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.

A pause on vaccines will cause far more deaths than a 1 in 1 million chance of blood clots.

> A pause on vaccines will cause far more deaths than a 1 in 1 million chance of blood clots.

Its not “a pause on vaccines” it’s a pause on one vaccine. And its not 1 in 1 million, because many of the 6.45 million doses administered of J&J are still, or even not yet, within the 1-2 week window after administration where this complication has been observed. And the pause is to get information to healthcare providers and permit them to establish appropriate protocols for handling the clots, not for open ended study. And it coincides with the timing of a short-term supply drop (-80% from prior week) in J&J vaccines that was going to force a sharp drop in the rate of adninistration at some point in the very near future anyway.

It's unethical to give people a vaccines that can cause a blood clot without informing them first of the risk.

It doesn't matter that globally it could cause more deaths. It's not the job of the FDA or CDC to act as your parent and decide for you what risk is and isn't acceptable.

Informed consent is a cornerstone of medical policy.

What will happen is they will modify the consent form to let people know about the risk, and let them decide for themselves.

Message to anti-vaxxers: As you can see the government is very carefully tracking any kind of safety issues with vaccines. They are being open and telling you about issues despite people fearing it would cause vaccine hesitancy.

So this should actually give you more confidence in vaccine safety, because if there are problem, you will be informed.

Unfortunately I think the anti-vaxxers can twist the logic however they want. The government is putting on a show about how transparent they are to win trust... etc.

I'm not sure how to get through that... from what I understand it takes alot of effort and time per person.

I see this as making the safety of the specific vaccines an unfalsifiable proposition. If the absence of side effects proves that it's safe to vaccinate and the identification of side effects proves it's safe to vaccinate, what could ever prove that a specific vaccine is unsafe?

The CDC and FDA have done a terrible job in my opinion with the pandemic. They are prime example of government institutional decay. The consiquentalists will win because the J&J vax helps more people than it hurts. This will only add to vax hesitancy. When the dust settles this decision will kill more people than it saves. I had the J&J vax. I got side effects but I now have some immunity to COVID-19 and it's worth it.

I love how people are complaining about this decision without addressing the fact that there are two other vaccines that don't have this issue that have been used orders of magnitude more.

Why wouldn't you pause J&J? It's just a drop in the bucket in total vaccinations anyway and the other two don't have this issue.

According to the article, 6.8 million people in the US have received the J&J shot. Without the J&J vaccine, those people (6.8 million others) would not be vaccinated due to lack of supply.

The US CDC website[1] currently says the 7-day death rate per 100k people is 1.4. Without the J&J vaccine, that's almost 100 additional people dying per week - and just in the US.

[1] https://covid.cdc.gov/covid-data-tracker/#cases_deathsper100...

Isn't this why Europe pushed pause on Astra Zeneca's vaccine?

J&J was the best option for those who didn't want to dabble in experimental vaccine tech. Now there is no choice.

Makes sense.

Given there are some organizations that are forcing you to get a vaccination. 1 in a million chance of dying from something you were forced to do is different than 1 in a million chance of a pseudo-random event. Makes no sense to continue with J&J given the other two don't have this issue at the moment.

Of course, the utilitarian approach is to simply continue vaccinating with J&J since surely more people are helped than harmed. I'm sure they'll reverse this decision soon enough.

As of today about 560,000 people in the US have died of COVID, or roughly 1 in 574. I think it’s safe to say the odds are higher than “1 in a million”.

> different than 1 in 150 chance of contracting and dying from COVID

Fixed that for you.

The others are way more expensive though. Allegedly artificially expensive to milk those in despair.

What organizations are forcing you to get vaccinated. I’ve heard a lot of speculation and honestly there should be more forceful, but I’m not aware of any. Plenty of jobs force you to drive which is absurdly risky

I trust the experts here in the FDA and the CDC. These are people that have been working their entire lives in vaccines and vaccine approval. They understand the medicine, the understand the policy.. if there's anything that most people here could think of, the odds are astronomically low that they haven't considered it.

It is very encouraging that this appears to be a science led decision.

Unsure why I've been downvoted, but if you've worked in FAANG level tech and with scientific staff of the CDC/FDA, you would not think that the caliber of people on either side was much different. There are a very, very large number of Moderna and Pfizer/Biontech doses going out at this point. The bigger risk is 501Y.V2 and company evolving to escape the vaccine, and that is not going to be fixed by a week long pause in J&J/Jannsen to identify the source and treatment for the errant platelet response.

I must say, the general state of discourse on HN has severely deteriorated over the past year (mostly in line with other online platforms, I suppose)

COVID is the single worst thing to happen to civil discussion in my lifetime. The virus is obviously a risk. So are the vaccines. Acting any other way is just downright disingenuous.

At the end of the day, any person with a working brain is free to calculate those risks on their own. No persuading, name-calling, or outright rudeness is needed. (Yes, the top 5 comments I'm talking about you)

In times like this, I'm reminded of most historical calamities...in which a small minority stood on one side, another small minority on the other, but the vast majority simply stood in the middle and thought "Please let this end"

Please upvote this if you're just an average person waiting in the middle.

The pandemic is one of those scenarios that challenges the soul of a nation like the US.

Oh, your society believes, at a deep ethical and philosophical level, in individual freedoms, personal responsibility, and general laissez-faire attitude regarding behaviors that do no harm to others? Okay. Here's an invisible threat that is on average low-probability fatal but with wide error bars and a step-function if enough people decide to ignore it. If enough people take collective actions that are uncomfortable, inconvenient, and in some cases heavily disruptive (possibly resulting in loss of individuals' livelihoods), the odds of dying from it are minimized for everyone (but nonzero). If not enough people do these things, the odds spike up (hard to say by how much). In terms of personal responsibility, you don't know if you're spreading the disease and if someone catches it and dies, we only have probabilities to estimate responsibility regarding who it came from.

Oh, and a handful of the mitigations might also have nonzero risk of harm or death, with some noteworthy error bars on the estimates.

... and all this on top of a population that barely understands what probability is in general, let alone error bars. Most citizens are, in fact, not nearly educated enough to calculate those risks. But they sure want to think they are, because we put personal responsibility for one's health on the person.

It's like the crisis was hand-tuned to be everything Americans hate.

I don't think most people are looking for the truth anymore. They are more interested in finding out what team you're on and who else says what you believe and what team they're on. A logical argument with references means absolutely nothing to most people these days. Questioning certain "truths" will quickly get you banned on many social media platforms and the list of "truths" gets longer every day.

I was in a zoom call with a large number of people I consider educated. They were talking about the California propositions and they didn't want to talk about what they said or to argue for or against, they just wanted to know who supports and opposes which one and if they were on the right team.

Being very conservative with vaccine rollout means more people will die. I think the risk-averse folks that approved of harsh lockdowns may want this harsh measure as well.

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