The very common vaccine ingredient at the center of J&J, AstraZeneca drama

Adenoviruses are an obvious link, but a puzzling suspect in the dangerous cases.

Read the whole story

 

[Alex1234]

I'd be interested in the treatments given to those who presented with CVST and died to see what percentage were given heparin.

 

[emertonom]

There's a whole other factor involved in the US pause on these things, which is that all the US doses of the AZ vaccine and all the undispensed doses of the J&J vaccine were produced by a company called Emergent Biosolutions. (This is NOT the case for the J&J doses that *were* distributed, which came from a factory in the Netherlands.) They were never certified to produce these vaccines, and have a long history of problems in their factories, and had a high-profile incident last month where they destroyed 15 million doses of J&J by accidentally mixing in an ingredient from the AZ vaccine.

So even if there weren't questions about those two vaccines in a more general sense, it might make a lot of sense to be cautious about deploying the actual US stockpile of those vaccines.

 

[eoerl]

Amazing article, thank you

 

[watermeloncup]

I'd be interested in the treatments given to those who presented with CVST and died to see what percentage were given heparin.

Not sure about the AZ CVST cases, but here are all of the J&J CVST cases. Unfortunately the treatment for the person who died is listed as unknown. All but one of the remaining people were given herapin, however.

 

[azazel1024]

I'm pro-vaccine, but this false dichotomy is popping up everywhere and I'm disappointed to see it from Beth.

> Without question, the benefits of the vaccine outweigh the potential risks.

If your choice is to be injected with J&J vaccine or injected with Covid, the answer is obvious.

However, there is another choice. Many people can instead continue to practice social distancing and get their chances of getting covid to near zero. At that point, multiplying the chance of getting covid with the chance of a serious side-effect if you get it, it isn't "without question" that the vaccine is better.

Currently, I choose to be safe until I can get the pfizer vaccine or until more information comes out about the ones being investigated for blood clotting. If I had to work somewhere like healthcare or a grocery store, my decision might be different, but a large number of people aren't in that scenario.

Covid 19 is way, way, way too easily transmissible. Without vaccination YOU WILL BE infected. That is already a guaranteed outcome from a long term point of view.

There is simply no choice left to evade Covid. One way or another you will face it. Either through vaccination or through infection.

At least until it is globally eradicated, which is currently a distant pipedream.

Covid is not actually that easily transmissible if you follow basic precautions. And whether there's 100% chance over infinite time that you'd get it, the actual timeframes involved matter - and in the timeline before someone could get one vaccine over another, it is nowhere near 100%. I'd guess my chances are closer to 1/100 in the next year (maybe less, who knows) even if I don't get a vaccine (which I plan to do as soon as I can get a pfizer dose) as long as I continue to follow the general guidelines.

edit: also, I just realized I don't actually personally know anyone who's had covid, either, so it can't be *that* inevitable in the short term, though I admit I am an introvert.

I wouldn't list the precautions as 'basic' only because there's only so much you personally can do. My parents both got it pretty bad and had been maintaining precautions for almost a year when they got it, but my mom had coworkers that were young and didn't care; they were passing it around each other at work (they live in Alabama) and she eventually caught it despite sanitizing everything and wearing a mask.

Also a cluster infection where I live (Korea) that happened because one sick guy sat near the AC in Starbucks and it spread it for him to people (some of which were wearing masks the whole time and only getting take out).

Depending on where you live I'd guess that at least 1 person you know has had it but been asymptomatic.

And to add just within the US about 10% of the population has been diagnosed with it. I personally know several people who have (a coworker and her daughter are now recovering from it). I know several people who have had family members or friends die from it (I don’t directly know anyone who has died from it, but once removed, about a dozen people who have, not all elderly).

At a guess we probably have more like 20% of have really gotten it.

At least in the US and Europe and probably most of the world, unless you are going to be 100% shut in, quarantine everything for days before it enters your house and never expose yourself to another human, probably 80+% of people in countries where the spread just isn’t in control will be infected within 2-3 years the rate it is spreading about. Sooner for some countries, maybe later for others that are doing a slightly better job.

 

[Chuckstar]

Out of 6.8 million people, how many will have a clot in the next few weeks WITHOUT getting a vaccination?

High clotting combined with low platelet count among people not being treated with heparin? Basically zero.

 

[plugh]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Using the right N is important because the incidence of 6 in 2 million (18-50 yr old women) receiving the vaccine is still very troublesome.

six cases occurred among more than 6.8 million people in the US

However

all six cases have occurred among women below the age of 50

https://meincmagazine.com/science/2021/04 ... ood-clots/
Statista has ~60% of US woman are in that age range so .6*6.8/2= ~2 Million so that incidence is actually 6 out of 2 million. Moreover there maybe other risk factors involved and actually should reflect that populations in the States where J&J was given.

For greater accuracy, you must eliminate all under 18 from the statistics because they're not eligible for the vaccine. We don't how much the proportion of subjects skewed older because they were given earlier access (less impact with J&J b/c the other vaccines had a head start).

 

[evighed]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Not to mention most Scandinavian countries are relatively homogeneous; the statement "small homogenous country with little in-or-out migration has out-of-scale results" sounds to me like a long way of saying "genetic bottlenecking happens".

We picked up lots of new genetics back when we kidnapped women from all over the UK and western Europe. Granted, it was a thousand years ago and it didn't make us very popular

You apparently didn't kidnap enough of them to increase your genetic diversity all that much though: https://www.genetics.org/content/204/2/711.

 

[numerobis]

How does it compare to aspirin? Because I grew up being told to prefer paracetamol, due to the potential adverse side-effects of aspirin.

Acetaminophen is safer than aspirin in the recommended dose.

The problem is that it got added to all sorts of OTC medications, on account of being safe. Which means it's not as rare as you'd like that people are taking a cold medication for their congestion plus a cough medication for their cough plus acetaminophen for their fever, not realizing the cold and the cough medicines also include it, and end up taking a triple-dose.

Which itself wouldn't be so bad except that a triple dose can be deadly after several days of taking the high dose. I don't know of any other OTC medication that can be deadly at a dose so close to the recommended dose.

As I understand it, ibuprofen has a much nicer safety rating. Just don't take large doses for months on end.

 

[adpenner@tpn]

We’re eligible for the second shot in four weeks; if things go well, we’ll have another three weeks of anxiety to look forward to, then be able to visit our parents in July.

It's more effective if you wait longer, upto 12 weeks.

Actually, that’s a more realistic timeline. We can start looking after four weeks, putting our names on waiting/on-call lists. There will likely be a lot of people still waiting for their first dose, so we’d be lucky to get that call before eight weeks.

 

[azazel1024]

How does it compare to aspirin? Because I grew up being told to prefer paracetamol, due to the potential adverse side-effects of aspirin.

Acetaminophen is safer than aspirin in the recommended dose.

The problem is that it got added to all sorts of OTC medications, on account of being safe. Which means it's not as rare as you'd like that people are taking a cold medication for their congestion plus a cough medication for their cough plus acetaminophen for their fever, not realizing the cold and the cough medicines also include it, and end up taking a triple-dose.

Which itself wouldn't be so bad except that a triple dose can be deadly after several days of taking the high dose. I don't know of any other OTC medication that can be deadly at a dose so close to the recommended dose.

As I understand it, ibuprofen has a much nicer safety rating. Just don't take large doses for months on end.

Generally that. Though it isn’t even necessarily a high dose. Just a prolonged dose. My mother was taking 400mg 3x daily for arthritis in her thumb. After about a year she developed and ulcer. Her Gastro is certain it was linked to her prolonged Ibuprofen use. Stopped taking it and the ulcer cleared up about a week or so after she stopped taking it.

Most stuff if you take enough or enough long enough can mess you up good.

 

[theradicalmoderate]

You would think that fear (or some would say caution) would be an evolutionary advantage, but it seems when it comes to risk analysis and rational decisions it does not apply?

No, it doesn't. See availability bias.

 

[Paul Jurczak]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Not to mention most Scandinavian countries are relatively homogeneous; the statement "small homogenous country with little in-or-out migration has out-of-scale results" sounds to me like a long way of saying "genetic bottlenecking happens".

It may be the best sample for a Caucasian of Nordic descent.

 

[croc123]

"Correlation does not equal causation". At the purported levels in the USA, EVEN IF the events are related the rate is so miniscule compared to the actual virus that stopping the J & J rollout is akin to trying to kill a flea with a very slow hammer. How many of those that had clots would have had them anyway? The issue here is not the clots, it is the investigation itself.

 

[IntermittentFailure]

Something to keep in mind is that while in the general population the benefits of the Astrazeneca vastly outweigh the risks, this is not necessarily true for certain subgroups such as women under 30.

The second point I would like to make is that we don't know whether the risk of these clotting disorders increases or decreases after the second shot. Therefore it seems wise to not use these adenovirus vaccines in the younger age groups since there are seemingly safer alternatives.

I believe these issues could potentially be fixed, but the immune system is mind bogglingly complex. Clotting is actually a very primitive innate immune response that is intricately linked to other parts of the immune system in ways we don't fully understand.

 

[xaxxon]

I'm pro-vaccine, but this false dichotomy is popping up everywhere and I'm disappointed to see it from Beth.

> Without question, the benefits of the vaccine outweigh the potential risks.

If your choice is to be injected with J&J vaccine or injected with Covid, the answer is obvious.

However, there is another choice. Many people can instead continue to practice social distancing and get their chances of getting covid to near zero. At that point, multiplying the chance of getting covid with the chance of a serious side-effect if you get it, it isn't "without question" that the vaccine is better.

Currently, I choose to be safe until I can get the pfizer vaccine or until more information comes out about the ones being investigated for blood clotting. If I had to work somewhere like healthcare or a grocery store, my decision might be different, but a large number of people aren't in that scenario.

Covid 19 is way, way, way too easily transmissible. Without vaccination YOU WILL BE infected. That is already a guaranteed outcome from a long term point of view.

There is simply no choice left to evade Covid. One way or another you will face it. Either through vaccination or through infection.

At least until it is globally eradicated, which is currently a distant pipedream.

Covid is not actually that easily transmissible if you follow basic precautions. And whether there's 100% chance over infinite time that you'd get it, the actual timeframes involved matter - and in the timeline before someone could get one vaccine over another, it is nowhere near 100%. I'd guess my chances are closer to 1/100 in the next year (maybe less, who knows) even if I don't get a vaccine (which I plan to do as soon as I can get a pfizer dose) as long as I continue to follow the general guidelines.

edit: also, I just realized I don't actually personally know anyone who's had covid, either, so it can't be *that* inevitable in the short term, though I admit I am an introvert.

I wouldn't list the precautions as 'basic' only because there's only so much you personally can do. My parents both got it pretty bad and had been maintaining precautions for almost a year when they got it, but my mom had coworkers that were young and didn't care; they were passing it around each other at work (they live in Alabama) and she eventually caught it despite sanitizing everything and wearing a mask.

Also a cluster infection where I live (Korea) that happened because one sick guy sat near the AC in Starbucks and it spread it for him to people (some of which were wearing masks the whole time and only getting take out).

Depending on where you live I'd guess that at least 1 person you know has had it but been asymptomatic.

Your mom had no bubble if coworkers getting it impacted her. If you're in a bubble, then that's not a concern.

If people are indoors without ventilation, then there's no bubble.

These are basic precautions that a lot of people can easily take.

 

[zeroidea]

reads: anal swabs of children

thinks: that's a curious detail to include

checks byline: makes sense

#BethMoleFTW

 

[Hezio]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Not to mention most Scandinavian countries are relatively homogeneous; the statement "small homogenous country with little in-or-out migration has out-of-scale results" sounds to me like a long way of saying "genetic bottlenecking happens".

Which doesn't make the data irrelevant. If anything, it can help with risk assessment, since this would mean such countries might be better served with waiting for an alternative vaccine compared to others due to a higher risk. Yes, the risk of COVID is higher, but 1 in 26,000 odds are nothing to sneeze at either - especially if you have the infrastructure in place for remote work and a government that's actually supporting the population during such times, like most Nordic countries.

Or, if you have loved ones, think of it like this - you can stay shut in for a few more months until a lower risk vaccine is available, or you can take a 1 in 26,000ish odds of your wife or husband etc dying and being gone forever with your life completely changed in exchange for the chance to go out a few months early again.

As someone who has been in quarantine for over a year now, I personally don't mind just waiting more. At this point, what's a few more months.

 

[pds9]

This is a pretty rare side effect and easily missed if not looked for. In the UK, there were ZERO reports of this clotting (VITT) initially. After getting reports from other countries, they managed to get 30-some reports. After shaking the branches, so to speak, they found another 40-some.

The pattern of release of data in the UK suggests they are likely using the monthly clinical datasets to help identify and cross-check occurrences. Anyone suffering a serious clot would be treated in hospital (either as a self-referral to an Emergency department or via referral from a GP). All hospital clinical activity for a patient is recorded against that patient's NHS Number with symptoms, diagnosis and treatments all accurately coded using standardised clinical coding dictionaries. The clinical activity datasets from all hospitals are then submitted centrally on a monthly basis. Likewise, any vaccination details (date, manufacturer, batch, etc.) are also recorded against the NHS Number. Therefore, there will always be a slight delay whilst waiting for the monthly clinical activity dataset submissions to be provided by all the various providers (e.g. hospitals) and then any subsequent central analysis including cross-check of clot occurrence against vaccination.

 

[eivinds]

How many of those that had clots would have had them anyway?

This kind of blood clot? Probably no one.
This is no ordinary blood clot, but a rare combination of blood clots and bleeding at the same time, making them very hard to treat.

Also, absence of evidence is not evidence of absence. There might be more cases.

 

[baddcarma]

For the record, Gamaleya Institute, the developers of Gam-COVID-Vac vaccine (Sputnik V), stated that they didn't encounter any thrombosis so far:

https://www.rt.com/russia/521047-sputni ... trazeneca/

“A comprehensive analysis of adverse events during clinical trials and over the course of mass vaccinations with the Sputnik V vaccine showed that there were no cases of cerebral venous sinus thrombosis (CVST),” a statement read

The amount of doses given is less than AZ (somewhere between 12-14 million doses in Russia, CIS, Latin America, and European countries), so considering the rarity of the clotting condition, more data would be needed.

 

[tsudo]

Great write up as always.

 

[Rhodon]

I'm pro-vaccine, but this false dichotomy is popping up everywhere and I'm disappointed to see it from Beth.

> Without question, the benefits of the vaccine outweigh the potential risks.

If your choice is to be injected with J&J vaccine or injected with Covid, the answer is obvious.

However, there is another choice. Many people can instead continue to practice social distancing and get their chances of getting covid to near zero. At that point, multiplying the chance of getting covid with the chance of a serious side-effect if you get it, it isn't "without question" that the vaccine is better.

Currently, I choose to be safe until I can get the pfizer vaccine or until more information comes out about the ones being investigated for blood clotting. If I had to work somewhere like healthcare or a grocery store, my decision might be different, but a large number of people aren't in that scenario.

Covid 19 is way, way, way too easily transmissible. Without vaccination YOU WILL BE infected. That is already a guaranteed outcome from a long term point of view.

There is simply no choice left to evade Covid. One way or another you will face it. Either through vaccination or through infection.

At least until it is globally eradicated, which is currently a distant pipedream.

Covid is not actually that easily transmissible if you follow basic precautions. And whether there's 100% chance over infinite time that you'd get it, the actual timeframes involved matter - and in the timeline before someone could get one vaccine over another, it is nowhere near 100%. I'd guess my chances are closer to 1/100 in the next year (maybe less, who knows) even if I don't get a vaccine (which I plan to do as soon as I can get a pfizer dose) as long as I continue to follow the general guidelines.

edit: also, I just realized I don't actually personally know anyone who's had covid, either, so it can't be *that* inevitable in the short term, though I admit I am an introvert.

I wouldn't list the precautions as 'basic' only because there's only so much you personally can do. My parents both got it pretty bad and had been maintaining precautions for almost a year when they got it, but my mom had coworkers that were young and didn't care; they were passing it around each other at work (they live in Alabama) and she eventually caught it despite sanitizing everything and wearing a mask.

Also a cluster infection where I live (Korea) that happened because one sick guy sat near the AC in Starbucks and it spread it for him to people (some of which were wearing masks the whole time and only getting take out).

Depending on where you live I'd guess that at least 1 person you know has had it but been asymptomatic.

Your mom had no bubble if coworkers getting it impacted her. If you're in a bubble, then that's not a concern.

If people are indoors without ventilation, then there's no bubble.

These are basic precautions that a lot of people can easily take.

Indoors (in an office) in a shared space is definitely the problem. And not fixable under what would qualify as 'basic measures' that she can reasonably implement. (unless you count quitting your job as a basic measure? Bringing the issue to her boss also didn't work for the first month of people testing positive at her building until she got it.)

Here in Korea a couple call centers broke out despite having cubicle walls separating them and some other mitigations. Most people don't have the option to quit their job and in the call center's case the company didn't allow them to telework... Same for my mom's job actually... Again, not saying it's not controllable. I'm saying it's not a basic measure. Downplaying the massive amount of work that everyone needs to agree to do as 'basic measures' downplays the severity and amount of work people need to do to stop the spread.
edit:clarification

 

[Polykin]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Not to mention most Scandinavian countries are relatively homogeneous; the statement "small homogenous country with little in-or-out migration has out-of-scale results" sounds to me like a long way of saying "genetic bottlenecking happens".

We picked up lots of new genetics back when we kidnapped women from all over the UK and western Europe. Granted, it was a thousand years ago and it didn't make us very popular

Wasn't narcolepsy side effect also much more common in Nordic countries compared to the rest of Europe? I know that Sweden had some cases but I've never heard about any in Germany.

There were several cases of narcolepsy caused by the Pandemrix vaccine during the swine flu in 2009. From what I understand it didn't have anything to do with genetics; the occurrence was about 1 in 22 000 in both Norway and the rest of Europe.

The protein the vaccine protected against was from what I gather very similar to a protein related to narcolepsy, causing the immune system in some people attack it

I haven't read anything about narcolepsy as a side effect of any of the SARS 2/COVID-19 vaccines

 

[onkeljonas]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Quality of their registration. The combined estimate from Denmark and Norway is 1 in 40 000.

The estimated risk of deploying the AZ vaccine in Denmark is 5 ICU admissions due to side-effects for 1 potentially saved ICU admission due to Covid, given the relevant age groups, disease prevalence and availability of alternative vaccines.

I think the Danish health authorities gave a very good explanation for halting AZ vaccinations completely. Denmark has 200.000 AZ vaccine doses in storage right now.

1) The risk of clots is 1:40.000 (best estimate currently, could be higher or lower)

2) The epidemic is currently well controlled in Denmark. The expected 3rd wave didn’t happen (due to lockdowns), and we have relatively few COVID related ICU admissions (this is important because COVID mortality is significantly lower when there is sufficient ICU capacity).

3) Our vaccination program is well underway, with most high-risk groups vaccinated. Vaccination of the 65-69 age group will be delayed 2 weeks by halting the AZ vaccine.

4) Halting the AZ vaccine is expected to give about 1 extra ICU admission (remember the Danish population is <6 million).

5) Continuing the AZ vaccine is expected to give about 5 serious blodclots that are very hard to treat (that part is pretty important).

6) We are expecting more vaccines delivered than we need (from a range of preorders). We’re expecting 25 million doses actually delivered - to a country of 5.8 million.

7) A mass-vaccination program requires an extraordinary level of vigilance and caution to maintain public trust.
If the J&J vaccine turns out to have similar problems we aren’t looking quite as good (I think that’s the one we have the largest orders for), but we’ve just secured 650.000 more doses from Pfizer, so even that looks manageable.

It was also stressed that the AZ vaccine is a good vaccine, and given a different situation we might well continue using it. In a way our rather costly but pretty succesful lockdown for the last months have given us the luxury of being picky.

 

[cerberusTI]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Which number is more statistically reliable? The incidence seen in a hundred thousand shots or the incidence seen in millions of shots?

In this case? The hundreds of thousands. That is an actual study, published in a medical journal.

The incidence reported out of millions is not reported as an incidence rate by any medical authority as far as I am aware, as it is unfortunately a misapplication of basic statistics. We do not actually have the sample size claimed, as many of those are not long enough out to have seen the side effects.

The number who are past the time they would develop clots is much smaller. Also complicating this is that until recently, mostly elderly were eligible for vaccination. They do not seem as affected.

The mass vaccination drives at universities started last week here, so we do not have an indication how that worked out yet, despite it being a good chunk of those millions of shots.

It’s a study, but simply a case study of some people.
It makes no attempt to quantify the incidence rate and makes no claim of such.

You are correct that it is not a study specifically of this, however they do report numbers, and they did attempt to look at all of the cases.

If you are attempting to calculate the rate yourself, it is a much better starting point, even if it will not be exact.

The total distributed vaccines in the US vs correctly diagnosed emergency room visits too soon after many of those have been given is not a good starting point. It does not really tell you much other than putting a floor on how many cases there could be. There will no doubt be much better results in a few weeks, but due to the way our medical system works here in the US it will likely be less reported and not diagnosed correctly in some cases. It almost requires a dedicated study here, so we probably do want to look at nations with better reporting and an expectation that most of those with problems will seek medical attention.

Almost everyone who appears willing to look at this and ballpark a number is saying more like 1 in 100k, or possibly even less rare for some demographics. That ranges from everyone's favorite chemistry blog, to the implied result in this study, to a rough back of the envelope on my part. It is still rare, and in the US we should likely continue (with some precautions), but it is common enough that it is a real problem.

 

[Stromlo]

Beth - this was an incredibly well written article!

 

[aleph_nought]

Side note, the NYT article on Jessie Gelsinger mentions that he was put on an ECMO machine after his lungs failed and he developed a severe immune response to an Ad5-based treatment. ECMO was also used as a last resort, first in Wuhan and later elsewhere, when COVID patients had an immune response that wrecked their lungs.

 

[ThinkingMore]

They shouldn't have paused it. I think people really don't understand how many people die from complications of medications every year and nothing special is done about those cases.

For instance Tylenol kills around 80 to 150 people every year in the US and send 80 thousand to the Hospital. The difference between an okay dose and a liver destroying dose is just a few mg. DO NOT TAKE MORE PILLS THAN WHAT THE BOX SAYS EVER!!!
https://www.propublica.org/article/tyle ... s-directed

I've heard that Tylenol would never have been made over the counter today and the only reason it's still available is it's basically grandfathered in.

You're absolutely right. It's nasty stuff. It results in "112 000 poison center calls, 59 000 ED visits, and 38 000 hospitalizations annually in the US" according to this analysis

For the non-Americans, Tylenol is a brand name for acetaminophen, or what we call paracetamol in the UK.

And it is indeed nasty stuff if you take too much. I believe it's a pretty awful way to die.

It's the reason you can no longer buy it in large bottles of 50 like we used to have when I was a kid. I think most places will limit how many you can buy in one go without talking to a pharmacist, although the law only limits it to 100 pills. Certainly most non-pharmacies will limit you to just a couple of packets, and those will only have 16 pills.

It's also in Calpol, but the doses are carefully controlled. You should always stick to the doses listed in the instructions.

How does it compare to aspirin? Because I grew up being told to prefer paracetamol, due to the potential adverse side-effects of aspirin.

Interestingly, as an aside, aspirin has been considered a possible treatment for HIT

https://link.springer.com/article/10.1007/BF00321211

That would be cool if you could just take some aspirin after getting the vaccine, but other studies show it may have no real preventative effect.

https://pubmed.ncbi.nlm.nih.gov/15726594/

And of course none of this may apply to the specifics of the J&J vaccine. The human body is too damn complicated.

 

[Carewolf]

The math would have been good to provide within the article so that the real safety risk is understood. Out of 25 million (25,000,000) people in the EU & UK that have taken the AstraZeneca vaccine...

3.44 per one (1) million have experienced blood clots
7.2 per ten (10) million have died due to to blood clots.

I would take the AZ or J&J vaccine now, later for a booster shot next fall/winter, again in 2022, etc. The current mortality rate around me is:
County: 1.842 per 100.
State: 1.932 per 100.
Country: 1.797 per 100.

Much better odds taking a jab than waiting.

1.8 of EVERY person or 1.8 of people who get COVID? There's a *huge* difference. Pretty sure it's the latter - as we haven't had nearly 2% of the population die.

I don't think so. See https://www.worldometers.info/coronavirus/ and sort by deaths per million. Though I do think the original poster forget a 0, the going rate is about 1-3 per thousand not per hundred.

 

[ColdWetDog]

For the record, Gamaleya Institute, the developers of Gam-COVID-Vac vaccine (Sputnik V), stated that they didn't encounter any thrombosis so far:

https://www.rt.com/russia/521047-sputni ... trazeneca/

“A comprehensive analysis of adverse events during clinical trials and over the course of mass vaccinations with the Sputnik V vaccine showed that there were no cases of cerebral venous sinus thrombosis (CVST),” a statement read

The amount of doses given is less than AZ (somewhere between 12-14 million doses in Russia, CIS, Latin America, and European countries), so considering the rarity of the clotting condition, more data would be needed.

Absence of evidence isn't evidence of absence (refrain....)

It is rather unclear if the countries that Sputnik V (and SinoVac, another adenovirus based vaccine) are capable of reporting these sorts of rare events. At least in anything resembling near time.

We are fortunate that these rare side effects are occurring in medical systems with reasonably good reporting systems (they could be better).

 

[timber]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Quality of their registration. The combined estimate from Denmark and Norway is 1 in 40 000.

The estimated risk of deploying the AZ vaccine in Denmark is 5 ICU admissions due to side-effects for 1 potentially saved ICU admission due to Covid, given the relevant age groups, disease prevalence and availability of alternative vaccines.

I think the Danish health authorities gave a very good explanation for halting AZ vaccinations completely. Denmark has 200.000 AZ vaccine doses in storage right now.

1) The risk of clots is 1:40.000 (best estimate currently, could be higher or lower)

2) The epidemic is currently well controlled in Denmark. The expected 3rd wave didn’t happen (due to lockdowns), and we have relatively few COVID related ICU admissions (this is important because COVID mortality is significantly lower when there is sufficient ICU capacity).

3) Our vaccination program is well underway, with most high-risk groups vaccinated. Vaccination of the 65-69 age group will be delayed 2 weeks by halting the AZ vaccine.

4) Halting the AZ vaccine is expected to give about 1 extra ICU admission (remember the Danish population is <6 million).

5) Continuing the AZ vaccine is expected to give about 5 serious blodclots that are very hard to treat (that part is pretty important).

6) We are expecting more vaccines delivered than we need (from a range of preorders). We’re expecting 25 million doses actually delivered - to a country of 5.8 million.

7) A mass-vaccination program requires an extraordinary level of vigilance and caution to maintain public trust.
If the J&J vaccine turns out to have similar problems we aren’t looking quite as good (I think that’s the one we have the largest orders for), but we’ve just secured 650.000 more doses from Pfizer, so even that looks manageable.

It was also stressed that the AZ vaccine is a good vaccine, and given a different situation we might well continue using it. In a way our rather costly but pretty succesful lockdown for the last months have given us the luxury of being picky.

Just by reading common newspapers news and officials statements we get the sense that the whole EU is preparing to stop using both AZ and J&J.
Pfizer/BioNTech will almost surely be picking up the vacancies with some Moderna and eventual new stuff just for some sense of competition.
That decision is made easier by the fact that the first massively under delivered (not much stockpile to run down) and the latter hasn't even properly began (the same).
As you properly pointed out for Denmark it just makes sense to do it both in a clearer and faster way.

 

[torp]

Well, even if AZ and J&J fix their problems, the damage to their reputation is done.

A few EU countries are considering giving up on AZ entirely because no one is coming to get vaccinated with that any more (Bulgaria said it officially).

In Romania where I am, there's a national vaccination queueing system, but you can choose a specific location to queue for. Each location only has one type of vaccine, and it is known which. Pfizer/Moderna centers are fully queued for a month or two, while AZ centers report hundreds of free spots.

I blame OMS/EMA, when the first cases of blood clotting made the news, they put out public statements after only a few days (not enough time to figure out anything), basically saying that the risks outweigh the rewards, go get vaccinated, but the language disclaimed any responsability for their statements. The result is that very few people trust AZ any more, in spite of those clotting incidents being extremely rare in reality.

 

[Dave Fernig]

The Novavax vaccine, which uses a protein based antigen purified from SF-9 virus, shares the advantages of not being a virus itself, just a protein with very high protection in the UK phase III trial and only requiring refrigeration. It should be fairly straightforward to produce as well. I'm not sure what is the holdup other than waiting for a US trial to complete, but it could replace the adenovirus vaccines in developing countries.

Production bottleneck: a shortage of the the large sterile plastic bags used for growing the cells. I am sure the production engineers are working 24/7, but production is as difficult as the R&D that went into the vaccines in the first place.
The protein vaccine has the advantage that unlike the nucleic acid ones, the antigen and the adjuvant (stuff that stimulates the immune system) are independent, so you can combine multiple strains in 1 jab. This is not possible with the =mRNA or viral vector vaccines, since the antigen and adjuvant are one and the same. You would have to put in 2x for two strains and that would not be safe.
So a lower tech to develop, but likely the one the world will rely on in the longer term.

 

[baddcarma]

For the record, Gamaleya Institute, the developers of Gam-COVID-Vac vaccine (Sputnik V), stated that they didn't encounter any thrombosis so far:

https://www.rt.com/russia/521047-sputni ... trazeneca/

“A comprehensive analysis of adverse events during clinical trials and over the course of mass vaccinations with the Sputnik V vaccine showed that there were no cases of cerebral venous sinus thrombosis (CVST),” a statement read

The amount of doses given is less than AZ (somewhere between 12-14 million doses in Russia, CIS, Latin America, and European countries), so considering the rarity of the clotting condition, more data would be needed.

Absence of evidence isn't evidence of absence (refrain....)

It is rather unclear if the countries that Sputnik V (and SinoVac, another adenovirus based vaccine) are capable of reporting these sorts of rare events. At least in anything resembling near time.

We are fortunate that these rare side effects are occurring in medical systems with reasonably good reporting systems (they could be better).

Agreed, although such critical condition as both clotting and bleeding would definitely be captured by most medical systems, in my opinion. Problem is to see if it is related to the vaccination.

Also, just a note, people who registered in Russia to get a vaccine shot through the local e-government portal, are asked to fill out a self-assessment diary, so quite a bit of data is being captured through self-reporting.

 

[The Lurker Beneath]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Quality of their registration. The combined estimate from Denmark and Norway is 1 in 40 000.

The estimated risk of deploying the AZ vaccine in Denmark is 5 ICU admissions due to side-effects for 1 potentially saved ICU admission due to Covid, given the relevant age groups, disease prevalence and availability of alternative vaccines.

I think the Danish health authorities gave a very good explanation for halting AZ vaccinations completely. Denmark has 200.000 AZ vaccine doses in storage right now.

1) The risk of clots is 1:40.000 (best estimate currently, could be higher or lower)

2) The epidemic is currently well controlled in Denmark. The expected 3rd wave didn’t happen (due to lockdowns), and we have relatively few COVID related ICU admissions (this is important because COVID mortality is significantly lower when there is sufficient ICU capacity).

3) Our vaccination program is well underway, with most high-risk groups vaccinated. Vaccination of the 65-69 age group will be delayed 2 weeks by halting the AZ vaccine.

4) Halting the AZ vaccine is expected to give about 1 extra ICU admission (remember the Danish population is <6 million).

5) Continuing the AZ vaccine is expected to give about 5 serious blodclots that are very hard to treat (that part is pretty important).

6) We are expecting more vaccines delivered than we need (from a range of preorders). We’re expecting 25 million doses actually delivered - to a country of 5.8 million.

7) A mass-vaccination program requires an extraordinary level of vigilance and caution to maintain public trust.
If the J&J vaccine turns out to have similar problems we aren’t looking quite as good (I think that’s the one we have the largest orders for), but we’ve just secured 650.000 more doses from Pfizer, so even that looks manageable.

It was also stressed that the AZ vaccine is a good vaccine, and given a different situation we might well continue using it. In a way our rather costly but pretty succesful lockdown for the last months have given us the luxury of being picky.

Just by reading common newspapers news and officials statements we get the sense that the whole EU is preparing to stop using both AZ and J&J.
Pfizer/BioNTech will almost surely be picking up the vacancies with some Moderna and eventual new stuff just for some sense of competition.
That decision is made easier by the fact that the first massively under delivered (not much stockpile to run down) and the latter hasn't even properly began (the same).
As you properly pointed out for Denmark it just makes sense to do it both in a clearer and faster way.

In Ireland the Tanaiste (effectively co-Taoiseach i.e. PM in the current coalition) announced this morning that anyone refusing AZ will go to the back of the vaccine queue. (Of course, who knows whether that will change in days or hours.)

 

[timber]

If you’re going to talk about the actual risk at this point, don’t trivialize it - the incidence rate in Norway was 5 in 130.000: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Why pick Norway as the sample population given figures are available for a much larger n?

Quality of their registration. The combined estimate from Denmark and Norway is 1 in 40 000.

The estimated risk of deploying the AZ vaccine in Denmark is 5 ICU admissions due to side-effects for 1 potentially saved ICU admission due to Covid, given the relevant age groups, disease prevalence and availability of alternative vaccines.

I think the Danish health authorities gave a very good explanation for halting AZ vaccinations completely. Denmark has 200.000 AZ vaccine doses in storage right now.

1) The risk of clots is 1:40.000 (best estimate currently, could be higher or lower)

2) The epidemic is currently well controlled in Denmark. The expected 3rd wave didn’t happen (due to lockdowns), and we have relatively few COVID related ICU admissions (this is important because COVID mortality is significantly lower when there is sufficient ICU capacity).

3) Our vaccination program is well underway, with most high-risk groups vaccinated. Vaccination of the 65-69 age group will be delayed 2 weeks by halting the AZ vaccine.

4) Halting the AZ vaccine is expected to give about 1 extra ICU admission (remember the Danish population is <6 million).

5) Continuing the AZ vaccine is expected to give about 5 serious blodclots that are very hard to treat (that part is pretty important).

6) We are expecting more vaccines delivered than we need (from a range of preorders). We’re expecting 25 million doses actually delivered - to a country of 5.8 million.

7) A mass-vaccination program requires an extraordinary level of vigilance and caution to maintain public trust.
If the J&J vaccine turns out to have similar problems we aren’t looking quite as good (I think that’s the one we have the largest orders for), but we’ve just secured 650.000 more doses from Pfizer, so even that looks manageable.

It was also stressed that the AZ vaccine is a good vaccine, and given a different situation we might well continue using it. In a way our rather costly but pretty succesful lockdown for the last months have given us the luxury of being picky.

Just by reading common newspapers news and officials statements we get the sense that the whole EU is preparing to stop using both AZ and J&J.
Pfizer/BioNTech will almost surely be picking up the vacancies with some Moderna and eventual new stuff just for some sense of competition.
That decision is made easier by the fact that the first massively under delivered (not much stockpile to run down) and the latter hasn't even properly began (the same).
As you properly pointed out for Denmark it just makes sense to do it both in a clearer and faster way.

In Ireland the Tanaiste (effectively co-Taoiseach i.e. PM in the current coalition) announced this morning that anyone refusing AZ will go to the back of the vaccine queue. (Of course, who knows whether that will change in days or hours.)

That is exactly the same policy used here and rightly so in my opinion.

 

[xaxxon]

I'm pro-vaccine, but this false dichotomy is popping up everywhere and I'm disappointed to see it from Beth.

> Without question, the benefits of the vaccine outweigh the potential risks.

If your choice is to be injected with J&J vaccine or injected with Covid, the answer is obvious.

However, there is another choice. Many people can instead continue to practice social distancing and get their chances of getting covid to near zero. At that point, multiplying the chance of getting covid with the chance of a serious side-effect if you get it, it isn't "without question" that the vaccine is better.

Currently, I choose to be safe until I can get the pfizer vaccine or until more information comes out about the ones being investigated for blood clotting. If I had to work somewhere like healthcare or a grocery store, my decision might be different, but a large number of people aren't in that scenario.

Covid 19 is way, way, way too easily transmissible. Without vaccination YOU WILL BE infected. That is already a guaranteed outcome from a long term point of view.

There is simply no choice left to evade Covid. One way or another you will face it. Either through vaccination or through infection.

At least until it is globally eradicated, which is currently a distant pipedream.

Covid is not actually that easily transmissible if you follow basic precautions. And whether there's 100% chance over infinite time that you'd get it, the actual timeframes involved matter - and in the timeline before someone could get one vaccine over another, it is nowhere near 100%. I'd guess my chances are closer to 1/100 in the next year (maybe less, who knows) even if I don't get a vaccine (which I plan to do as soon as I can get a pfizer dose) as long as I continue to follow the general guidelines.

edit: also, I just realized I don't actually personally know anyone who's had covid, either, so it can't be *that* inevitable in the short term, though I admit I am an introvert.

I wouldn't list the precautions as 'basic' only because there's only so much you personally can do. My parents both got it pretty bad and had been maintaining precautions for almost a year when they got it, but my mom had coworkers that were young and didn't care; they were passing it around each other at work (they live in Alabama) and she eventually caught it despite sanitizing everything and wearing a mask.

Also a cluster infection where I live (Korea) that happened because one sick guy sat near the AC in Starbucks and it spread it for him to people (some of which were wearing masks the whole time and only getting take out).

Depending on where you live I'd guess that at least 1 person you know has had it but been asymptomatic.

Your mom had no bubble if coworkers getting it impacted her. If you're in a bubble, then that's not a concern.

If people are indoors without ventilation, then there's no bubble.

These are basic precautions that a lot of people can easily take.

Indoors (in an office) in a shared space is definitely the problem. And not fixable under what would qualify as 'basic measures' that she can reasonably implement. (unless you count quitting your job as a basic measure? Bringing the issue to her boss also didn't work for the first month of people testing positive at her building until she got it.)

Here in Korea a couple call centers broke out despite having cubicle walls separating them and some other mitigations. Most people don't have the option to quit their job and in the call center's case the company didn't allow them to telework... Same for my mom's job actually... Again, not saying it's not controllable. I'm saying it's not a basic measure. Downplaying the massive amount of work that everyone needs to agree to do as 'basic measures' downplays the severity and amount of work people need to do to stop the spread.
edit:clarification

Yeah, a lot of people can work from home.

The point isn't that not everyone can, the point is that for those who can saying "everyone getting a shot that can give you blood clots is better" is wrong. For some it is. For others it's not.

> [Article] Without question, the benefits of the vaccine outweigh the potential risks.

This is not universally true

 

[Frosty Grin]

Absence of evidence isn't evidence of absence (refrain....)

It is rather unclear if the countries that Sputnik V (and SinoVac, another adenovirus based vaccine) are capable of reporting these sorts of rare events. At least in anything resembling near time.

We are fortunate that these rare side effects are occurring in medical systems with reasonably good reporting systems (they could be better).

We still don't know what exactly causes these side effects. Maybe it isn't the adenovirus at all. What we have now is basically correlation. Not evidence that adenovirus-based vaccines necessarily cause issues. The article is extremely illuminating in that it brings up the historical cases of heavy immune response - but we still don't know how universal it is.

Edit: I do believe that the existing cases need to be investigated, and it may be reasonable to suspend vaccination. The common attitude along the lines of, "You're more likely to get eaten by a shark", is wrong. Vaccination is a deliberate decision, not a random event.