Merged: Covid vaccines - supply, distribution and rollout / Beginning of the end

[Darat]

Originally Posted by dann

When people have actually had the vaccine and it has caused a certain number of real cases as well as deaths, then we are no longer talking about risk. It has already happened and it is as actual as it can possibly be.
You surely understand that, don't you?!

Which matters not at all.

[Cosmic Yak]

Originally Posted by Planigale

There is some uncertainty, the younger population vaccinated is predominantly those employed in health and social care which are predominantly women, so that more women are affected may just mean more women of a younger age were vaccinated. UK figures suggest there is not a big sex difference.

Conversely auto immune conditions which is what this seems to be are usually more common in women (why this might be is another question), so it would not be surprising if this condition which seems to be based on developing anti-platelet antibodies would be more common in women.

Just off the top of my head here, and I may be completely wrong, but could there be a connection with contraceptive pills?
These already carry a risk of clots. Could having two clot-risk factors in your blood increase the chance? Could there even be some kind of interaction/synergy between them?
As I say, I'm well outside my field of knowledge here: I'm asking, not suggesting.

[lomiller]

Originally Posted by Skeptic Ginger

These are the adenovirus vector vaccines though they use different adenoviruses in their production.

We've seen this same reaction before as an extremely rare incidence after heparin therapy. I've done some reading.

Heparin-induced Thrombocytopenia: Pathophysiology, Diagnosis and Management

There is an alternative anticoagulent that can be used.

It is also interesting to note there are similar processes that can go on with COVID disease. It might turn out this allergic reaction gives us insight into the clotting issues with some COVID patients. Note especially we are seeing more coag issues in younger patients with COVID.

There's a nice rabbit hole here for me to dive into.

Is it a rabbit hole or is the whole point of pausing the J&J vaccine to disseminate this type of information to doctors?

I haven't run across anything directly from the CDC but the impression I'm getting is that the underlying reason for pausing the use of the vaccine is to inform clinicians of the symptoms of HIT and to advise them not to use Heparin in these cases because they don't know if it would make it worse. Like I said though, this is just what I'm inferring from the way it's being covered in the popular press, so it may not be 100% accurate.

[Planigale]

Originally Posted by Cosmic Yak

Just off the top of my head here, and I may be completely wrong, but could there be a connection with contraceptive pills?
These already carry a risk of clots. Could having two clot-risk factors in your blood increase the chance? Could there even be some kind of interaction/synergy between them?
As I say, I'm well outside my field of knowledge here: I'm asking, not suggesting.

The mechanism is completely different. So whilst women are more prone to blood clots probably due to oestrogen, the mechanism and type of clots are completely different and I suspect if women are more often affected then this will be because women are more susceptible to auto-immune conditions.

[Planigale]

Originally Posted by lomiller

Is it a rabbit hole or is the whole point of pausing the J&J vaccine to disseminate this type of information to doctors?

I haven't run across anything directly from the CDC but the impression I'm getting is that the underlying reason for pausing the use of the vaccine is to inform clinicians of the symptoms of HIT and to advise them not to use Heparin in these cases because they don't know if it would make it worse. Like I said though, this is just what I'm inferring from the way it's being covered in the popular press, so it may not be 100% accurate.

Certainly all UK doctors have received the protocol for diagnosis and treatment (linked to above), the contact email for the expert group who review and advise on every suspect case, and the consent information for the associated research project. (It will probably take longer for the policy to be agreed in the US than if it can be than it would to disseminate the advice once agreed. One advantage of a national health system is that it is relatively easy to promulgate a policy.)

[Oystein]

Originally Posted by dann

Then it's good that nobody has created a panic, isn't it?

Well, Denmark seems to have panicked enough to stop using AZ altogether.

Originally Posted by dann

And it's good that the articles that were published (at least the ones I saw) mentioned how small the number of cases of the rare blood-platelet side effect was.

The ones you linked did not say that the numbers are that small.

Originally Posted by dann

And even though you don't seem to think so, it is also good to mention the actual number of vaccinations and the actual number of discovered cases of the rare side effect.

You should read my posts and the articles you linked to again, to find out that the precise opposite is the case of what you are insinuating here:
Your articles did NOT mention the the numbers of AZ vaccinations, and I explicitly said they should have.

Originally Posted by dann

I don't think it's good to panic and issue statements that there are no (serious) side effects at all.

Well good then that no one does this - least of all I.
Strawman.

Originally Posted by dann

Have you looked into how many cases of the same syndrome, but not vaccine-related, occur on average in a population of, say, one million, in one year?

I could again copy&paste my previous post, as you seem to have not read it.
I explained that comparing to an "average in a population of, say, one million" would be WRONG, as the sub-population that has been vaccinated is NOT - I repeat: not - representative of the population at large, nor of people aged 20-59, nor of women, nor of women aged 20-59, so any such comparison would be fools errand, missing important comfounding variables such as education levels, family status, work environment, stress levels, employment status etc etc etc etc.

[Oystein]

Originally Posted by dann

No, the article doesn't leave out all denominators:However, it should obviously have been the number of AZ vaccinations, specifically.

Well, exactly.
Thanks for agreeing with the important bit of my message.

[Planigale]

Originally Posted by Oystein

Well, exactly.
Thanks for agreeing with the important bit of my message.

The UK figure for AZ vaccine for the highest (youngest) risk group ie <30 is about 1:100,000 reactions; mortality is about a third (probably less now that a treatment protocol exists). This phenomenon seems to mostly (always?) occur following the first vaccination. The UK figures do not convincingly show a sex difference.

For comparison the very similar condition HIT occurs in about 1:10,000 people given heparin. Heparin is a very widely used treatment that nearly everyone admitted to hospital will be given. People (including Danes) are not talking about stopping use of Heparin. (To be clear alternatives to heparin without this risk do exist, so heparin use could be stopped almost completely.) The benefits of heparin are probably less than the benefits of AZ vaccination. Clearly if there is an alternative vaccine that is available without impacting speed of vaccination then doing so is reasonable. If not using AZ vaccine prolongs a period of risk then this is problematic. I accept that the Danes may argue Covid infection in Denmark is so low in prevalence that they do not need to be in a hurry to vaccinate.

[dann]

Originally Posted by Planigale

The mechanism is completely different. So whilst women are more prone to blood clots probably due to oestrogen, the mechanism and type of clots are completely different and I suspect if women are more often affected then this will be because women are more susceptible to auto-immune conditions.

Women only seem to be more affected. It all depends on the vaccination strategies in different countries. In Denmark (and I think in Norway, too) the majority of people vaccinated with AZ were health-care workers, i.e. more women than men, all of working age. In countries where the AZ vaccine was administered to other segments of the population, elderly men had the side effect, too.

[dann]

Originally Posted by Oystein

Well, Denmark seems to have panicked enough to stop using AZ altogether.

Yes, Denmark has stopped using AZ, but there has been no panic whatsoever.* Latvia and Czechia have offered to buy it,** but until further notice the AZ doses will be kept in the fridge. They won't be destroyed, but it hasn't yet been decided what will happen.

Quote:

The ones you linked did not say that the numbers are that small.

That small?!

Quote:

You should read my posts and the articles you linked to again, to find out that the precise opposite is the case of what you are insinuating here:
Your articles did NOT mention the the numbers of AZ vaccinations, and I explicitly said they should have.

See answer earlier in the thread.

Quote:

Well good then that no one does this - least of all I.
Strawman.

AZ did that. So much for your strawman.

Quote:

I could again copy&paste my previous post, as you seem to have not read it.
I explained that comparing to an "average in a population of, say, one million" would be WRONG, as the sub-population that has been vaccinated is NOT - I repeat: not - representative of the population at large, nor of people aged 20-59, nor of women, nor of women aged 20-59, so any such comparison would be fools errand, missing important comfounding variables such as education levels, family status, work environment, stress levels, employment status etc etc etc etc.

Health-care workers tend to be pretty well educated and healthy. In the current situation, many of them are obviously more stressed than they would usually be, but less so in Denmark and Norway than in most other countries. In this case, the obvious thing to look for would have been if any of them had received Heparin treatment. That would have been a confounding variable.
You didn't try to find out how rare this disease is, did you?!


ETA:
*6 grunde til, at vi dropper AstraZeneca-vaccinen (DR.dk)
6 reasons why we drop the AstraZeneca vaccine
**Tjekkiet og Letland vil købe Danmarks AstraZeneca-vacciner (DR.dk, April 14, 2021)
Czechia and Latvia want to buy Denmark's AstraZeneca vaccine

[Planigale]

As ever an excellent piece by Tim Harford

https://www.ft.com/content/090f1b3c-...c-ba3a7f290fee

Quote:

An educated guess, based on UK data, is that being vaccinated with the AstraZeneca jab carries a one-off risk of death of one in a million — not much higher than the risk of dying in an accident while travelling to a vaccination clinic. If that guess is correct, vaccinating the entire UK population with a dose of this particular vaccine would give 67 people fatal blood clots.

That sounds bad — as does any sentence containing the phrase “fatal blood clots”. Yet in the UK the death toll from coronavirus was never below 67 per day between mid‑October and late March — and sometimes headed for 67*per hour. In other words, for the entire winter wave, a single day’s delay to being vaccinated has been riskier than the vaccine itself.

[Sherkeu]

I got the J&J vaccine last Friday and received a text message from CVS with this link:
www.cvs.com/j29z8WrNc8

Quote:

Our records show that you recently received the Johnson & Johnson (Janssen) vaccine. We want to update you on information about this vaccine provided by the CDC and FDA on April 13th. Read the full CDC and FDA statement.

What led the CDC and FDA to recommend pausing the use of the Johnson & Johnson (Janssen) Covid-19 Vaccine?

As of April 12th, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson (Janssen) vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.

[Segnosaur]

Originally Posted by dann

Women only seem to be more affected. It all depends on the vaccination strategies in different countries. In Denmark (and I think in Norway, too) the majority of people vaccinated with AZ were health-care workers, i.e. more women than men, all of working age.

Do you have any references showing exact numbers? And when you say 'the majority' were health care workers, are you talking about a large majority (like >90%) slim majority (like 51%)? And of those that were health care workers, how was the demographics breakdown?

It certainly isn't impossible that the greater number of blood clots younger women is due to who actually received the vaccine (rather than some biological reason), but vague references to 'majority' and 'more women' make it difficult to really assess things.

[Ulf Nereng]

The Norwegian researchers have published this article in The New England journal of Medicine:

https://www.nejm.org/doi/full/10.105...=featured_home

[Skeptic Ginger]

Originally Posted by lomiller

Is it a rabbit hole or is the whole point of pausing the J&J vaccine to disseminate this type of information to doctors?

I haven't run across anything directly from the CDC but the impression I'm getting is that the underlying reason for pausing the use of the vaccine is to inform clinicians of the symptoms of HIT and to advise them not to use Heparin in these cases because they don't know if it would make it worse. Like I said though, this is just what I'm inferring from the way it's being covered in the popular press, so it may not be 100% accurate.

The rabbit hole I referred to was my own because I give a lot of vaccinations and I had not heard of this reaction in relation to vaccinations. I might need to ask my patients if they reacted to any COVID vaccination(s).

As for the pause, it's pretty standard. You have an emergency use approval. A potential adverse reaction occurs. The FDA/CDC need time to collect and assess the information on this adverse reaction. Use of the drug is halted while they do that. I think people that had appointments already were allowed to keep them but I wasn't paying attention, they could have said something else.

[Skeptic Ginger]

Originally Posted by Sherkeu

I got the J&J vaccine last Friday and received a text message from CVS with this link:
www.cvs.com/j29z8WrNc8

Did they just leave you hanging like that? No advice on what to do?

[Skeptic Ginger]

Originally Posted by Segnosaur

Do you have any references showing exact numbers? And when you say 'the majority' were health care workers, are you talking about a large majority (like >90%) slim majority (like 51%)? And of those that were health care workers, how was the demographics breakdown?

It certainly isn't impossible that the greater number of blood clots younger women is due to who actually received the vaccine (rather than some biological reason), but vague references to 'majority' and 'more women' make it difficult to really assess things.

If it was similar, the vast majority here in the US during the early roll-out were female in the identified age group as health care workers had early priority to get the vaccine. We weren't using the suspect vaccine at that time. But of the people in the particular age group, probably most of them were women. The other group getting vaccinated at that time were the elderly.

We need more data to really get a good idea on the demographics of the at-risk groups.

[RecoveringYuppy]

Originally Posted by Skeptic Ginger

Did they just leave you hanging like that? No advice on what to do?

Check the link, it says what to do.

[Sherkeu]

Originally Posted by Skeptic Ginger

Did they just leave you hanging like that? No advice on what to do?

I didnt include the last part about symptoms and reporting (I never paste too much of a page into a thread but probably should have in this case).

Here is the rest of it:

Quote:

What are the symptoms to be concerned about and what should I do if I experience these symptoms?

If you have received the Johnson & Johnson (Janssen) vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination you should contact your health care provider, or seek medical care. Report adverse events following receipt of any COVID-19 vaccine to Vaccine Adverse Event Reporting System.

eta: I used to have Occipital Neuralgia in a very specific spot in the back of my head (occipital lobe, one side). I have not had to take any meds for that for the last 3 years.....but it came back for about 4 hours on Saturday, the day after the shot. It is pretty unmistakable as I obviously know the precise location it happens. Pain is gone now- but still concerning. I suppose I may always have it laying there, waiting for a trigger.

[Oystein]

Originally Posted by dann

...
Health-care workers tend to be pretty well educated and healthy. ...

I am a health care worker (nurse in a long term care residence), and I can emphatically proclaim that this is not so, and perhaps quite the opposite: Almost no one here has gone to university nor would qualify for university, and the rate of colleagues calling in sick is astounding at times.

Originally Posted by dann

You didn't try to find out how rare this disease is, did you?!
...

Of course not - for reasons provided: No existing statistic could match the vaccinated populations in confounding variables.
I am not the fool who would go on that errand. You are welcome to try, though.

[Vixen]

Originally Posted by Planigale

The UK figure for AZ vaccine for the highest (youngest) risk group ie <30 is about 1:100,000 reactions; mortality is about a third (probably less now that a treatment protocol exists). This phenomenon seems to mostly (always?) occur following the first vaccination. The UK figures do not convincingly show a sex difference.

For comparison the very similar condition HIT occurs in about 1:10,000 people given heparin. Heparin is a very widely used treatment that nearly everyone admitted to hospital will be given. People (including Danes) are not talking about stopping use of Heparin. (To be clear alternatives to heparin without this risk do exist, so heparin use could be stopped almost completely.) The benefits of heparin are probably less than the benefits of AZ vaccination. Clearly if there is an alternative vaccine that is available without impacting speed of vaccination then doing so is reasonable. If not using AZ vaccine prolongs a period of risk then this is problematic. I accept that the Danes may argue Covid infection in Denmark is so low in prevalence that they do not need to be in a hurry to vaccinate.

The administration of Heparin is not a good analogy to the application of Az/J&J. Heparin is for the use of people already hospitalised to treat their chronic existing serious underlying condition.

[Vixen]

Originally Posted by Planigale

As ever an excellent piece by Tim Harford

https://www.ft.com/content/090f1b3c-...c-ba3a7f290fee

Oh gosh:

"An educated guess, based on UK data, is that being vaccinated with the AstraZeneca jab carries a one-off risk of death of one in a million — not much higher than the risk of dying in an accident while travelling to a vaccination clinic. "

Not the 'chances of being run over by a bus' line again.

[Vixen]

Originally Posted by Oystein

No.

I could copy&paste my previous post here.

ETA: The Germans seem to think that 3 million is barely sufficient to conclude much.

One problem is that the populations thus far vaccinated are far from a random sample of population at large. Consider the women under 60, who seem to show significantly high incidence rates of this blood clotting:
The vast majority of those vaccinated with AZ are nurses and others in health care facilities. This implies certain distributions of educational levels, personal histories, daily work schedules (e.g. working shifts is highly prevalent, as is working while standing or walking), family situations (it is rather typical for woman to enter a career in nursing after having taken a professional timeout for some years of child rearing - perhaps recent mothers are overrepresented?). So lots of confounding variables that may affect the background incidents of these types of trombosis.

Bottom line is: We don't really know if those very low numbers of reported blood clots are significant after all.

it's good that Norway raised the alarm, it's good that research is focused on the issue. It's good that recommendations are out not to give the AZ to women under 60 for the time being and reshuffle resources of the several available vaccines.
It's NOT good to create a panic and communicate that AZ is dangerous and increases your risk of dying! It's NOT good to revert time and again to the number from the small population where the small number (6) may well be a likely statistical outlier (Germany had 1 in 46,000, or 3 in 130,000). \ETA

You have this upside down. It is the responsibility of the vaccine manufacturers and developers to ensure their product is safe, not for states to vaccinate large numbers of people and wait and see how many have an adverse symptom. Now, a sore arm, a brief headache and fever for a couple of days, that is minor and to be expected. A rare CVST is not. It doesn't matter whether it is one-in-a-hundred or one-in-a-million, it is something that needs to go back to the drawing board.