Edit: got the wrong agency, it was FDA, not CDC
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.
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.
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.
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.
Full disclosure: I took the J&J vaccine last Thursday, and would do so again right now.
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.
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
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?
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.
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.
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.
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 stopping they can at least find out if it's 5000 out of 7 million (and more deaths).
Curious about your answer.
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.
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?
This is 1:1000000 of a severe event, but affects men as well. HOLD THE LINE - It affects a.... Man!
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.
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."
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.
I bet if I went today he wouldn’t be so dismissive.
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.
This is the reason people lost trust in the medical community during COVID.
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.
> 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.
1. https://www.cnbc.com/2021/04/13/blood-clots-more-likely-from...
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...
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.
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.
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.
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.
https://pbs.twimg.com/media/Ey2oowQWgAApGnK?format=jpg&name=...
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.
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.
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 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.
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.
Are those side effects lists just a catch it all sort of exception where they throw anything there just in case? Honest question.
How many people will point to this or feel a bit hesitant about getting J&J vaccine now?
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
People are absolute garbage at thinking about scale.
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.
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.
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.
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?
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.
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
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.
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".
CVST with Thrombocytopenia is the name.
for them it’s more like 1/250k
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...
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.
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 :/
> 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....
All the observed cases occurred shortly after vaccination, so I’m not sure 3 months is the right divisor to use in your comparison.
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.
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.
What's this supposed to mean? Is the implication here that the CDC and FDA want to keep people from being vaccinated? WHy?
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.
This was the first one your website presented and I have no idea what it means.
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.
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-...
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.
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...
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
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.
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)
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.
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.
> 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....
That’s not an explanation, of course, I don’t know the reason. But it places this in a larger category.
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.
In the US, the other vaccines are starting to become really readily available.
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.
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.
The communication that public gets is outrageously bad.
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.
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.
Also, only 1/3 of Astra Zeneca clot victims are male:
https://news.yahoo.com/astra-zeneca-vaccine-blood-clot-risk-...
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?
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 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.
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.
[0] one can hope
Is it surprising that the vaccines cause clotting too? Isn't this sort of obvious?
https://en.wikipedia.org/wiki/Heparin-induced_thrombocytopen...
It should be possible to have a mature, good-faith conversation about this, even on a pseudonymous web forum.
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.
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 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.
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.
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.
https://www.theguardian.com/world/2021/apr/13/astrazeneca-bl...
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.
At least they have alternatives. Meanwhile, in Europe ...
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"?
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.
"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...
> 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.
"...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...
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.)
https://www.vice.com/en/article/z3xbk9/johnson-and-johnson-c...
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.
"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...
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.
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 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.
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.
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.
So this should actually give you more confidence in vaccine safety, because if there are problem, you will be informed.
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.
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.
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.
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.
