The vaccines | vaxxed boosted unvaxxed? New poll

[Pogue Mahone]

Some of the contraceptive pills cause blood clots and people don’t bat an eyelid.

All of the contraceptive pills actually. They tend to cause single clots in ‘classic’ locations. Deep veins of lower leg. Or the lung. One of the issues that they’re concerned about in Norway is that they’re experienced multiple clots in atypical locations. Combined with the thrombocytopenia it’s an unusual picture.

Confusingly, covid itself can cause this presentation. I’m hoping that’s what’s going on. A cluster of false negative covid tests. We do know it’s relatively common for HCWs to get infected immediately after getting vaccinated.

 

[jojojo]

I'm going by this source that indicates phase 3 trials can take one to 4 years: https://www.antidote.me/blog/how-long-do-clinical-trial-phases-take

They take as long as it takes to get the funding, the clinicians, the number of trial volunteers and the case numbers to demonstrate efficacy.

They also provide baseline information on safety. In the case of vaccines, the overwhelming majority of safety issues are found in the first 14 days post vaccination. The trials collect data for at least 2 months before applying for "emergency use". By that stage, with the covid vaccines, the earliest volunteers had been fully vaccinated for around 6 months and the bulk of the P3 trialists had been vaccinated for three or more.

The fact is you could continue testing that same group of trialists for the next 5 years or 50 years and you won't find anything new.

What you can't guarantee from any kind of trial is what will happen when you move from 10 thousand people in a trial, to 10 million in a rollout. If there's a problem that's only seen in people with a particular gene, or taking a particular drug, or who catch some disease in the same week or whatever - you don't see it on trials. Even if you run them until the trialists die of old age, you're unlikely to see it, and if you do see it then you'll have seen it within a month or so of injection.

That's why they monitor the vaccines, and will keep monitoring the vaccines as they give them to more people.

 

[jojojo]

All of the contraceptive pills actually. They tend to cause single clots in ‘classic’ locations. Deep veins of lower leg. Or the lung. One of the issues that they’re concerned about in Norway is that they’re experienced multiple clots in atypical locations. Combined with the thrombocytopenia it’s an unusual picture.

Confusingly, covid itself can cause this presentation. I’m hoping that’s what’s going on. A cluster of false negative covid tests. We do know it’s relatively common for HCWs to get infected immediately after getting vaccinated.

Yep, it's the Norwegian cluster that's striking. But it's so striking that I'm sure every regulator (and every haematoligist) will be digging back through their records to see if there's a pattern.

Hopefully that will make the process really quick. Certainly in the UK, I'm guessing every hospital will be looking through their records. Admittedly it may be like trying to see the wood for the trees in the UK, with the recent number of covid cases/deaths. I'm sure all the heparin/warfarin clinics will be looking really hard as well - given that heparin can also trigger these kind of symptoms and covid may have masked any low occurrence upturn in problems.

 

[Cardboard elk]

Germany pausing as seven cases of cerebral vein thrombosis had been reported. Sweden pausing as a precaution.

 

[Wolverine]

Yep, it's the Norwegian cluster that's striking. But it's so striking that I'm sure every regulator (and every haematoligist) will be digging back through their records to see if there's a pattern.

Hopefully that will make the process really quick. Certainly in the UK, I'm guessing every hospital will be looking through their records. Admittedly it may be like trying to see the wood for the trees in the UK, with the recent number of covid cases/deaths. I'm sure all the heparin/warfarin clinics will be looking really hard as well - given that heparin can also trigger these kind of symptoms and covid may have masked any low occurrence upturn in problems.

For me I don't think its necessarily a cluster in terms of number but close proximity of events to each other temporally thats of clinical interest/worry.

Thrombophilia screens shouldn't be too difficult. The question comes is if these events - like a lot of what's seen in those clinics is what would usually be classified as unprovoked - a significant number from what i usually see in my patients who I monitor anti-coagulants on, and whether that would be then attributed to the vaccines. It will be tricky.

Reassuring though that this hasn't been seen elsewhere, or in bigger numbers even amongst that cluster of norway patients.

 

[11101]

Ronaldo's Mum Eh is another one in the same boat.

You seem to be under the impression that the slightest questioning of a vaccine equals a fervent anti vaccination stance.

There is something worth looking at with the AZ vaccine. Twelve countries don't pause a desperately needed rollout for no reason, and they have access to data none of us here do.

For me I don't think its necessarily a cluster in terms of number but close proximity of events to each other temporally thats of clinical interest/worry.

Thrombophilia screens shouldn't be too difficult. The question comes is if these events - like a lot of what's seen in those clinics is what would usually be classified as unprovoked - a significant number from what i usually see in my patients who I monitor anti-coagulants on, and whether that would be then attributed to the vaccines. It will be tricky.

Reassuring though that this hasn't been seen elsewhere, or in bigger numbers even amongst that cluster of norway patients.

There are now 7 cases in Germany too, all reasonably young females.

From France:
"The warning signs" about the AstraZeneca vaccine "are significant, more for the type of clinical and biological manifestations than for the number, which remains low compared to the number of people vaccinated. The onset of thrombosis with coagulation abnormalities, which we are not used to seeing in classic pulmonary embolisms, has been observed in some people."

Considering this has all happened very recently and is linked to specific batches it might point to a problem in the supply chain. That's why Italy put a stop on it, in case it's a recurring problem.

 

[Mickeza]

“The decision by Germany, France and Italy to suspend AstraZeneca’s COVID-19 shots after several countries reported possible serious side-effects is a “political one”, the director general of Italy’s medicines authority AIFA said on Tuesday.

“We got to the point of a suspension because several European countries, including Germany and France, preferred to interrupt vaccinations... to put them on hold in order to carry out checks. The choice is a political one,” Nicola Magrini told daily la Repubblica in an interview.

Magrini said that the AstraZeneca vaccine was safe and that the benefit to risk ratio of the jab is “widely positive”.”

My personal opinion is to delay vaccinations at a time when cases are rising across mainland Europe again is a bit bonkers. It’s only going to add to the hesitancy they’ve already caused about AZ when they inevitably give it the okay again on Thursday. Thankfully we didn’t see any more DNAs/cancellations than usual yesterday. Probably the only time the anti-EU sentiment within the older age group has been a positive

 

[Pogue Mahone]

“The decision by Germany, France and Italy to suspend AstraZeneca’s COVID-19 shots after several countries reported possible serious side-effects is a “political one”, the director general of Italy’s medicines authority AIFA said on Tuesday.

“We got to the point of a suspension because several European countries, including Germany and France, preferred to interrupt vaccinations... to put them on hold in order to carry out checks. The choice is a political one,” Nicola Magrini told daily la Repubblica in an interview.

Magrini said that the AstraZeneca vaccine was safe and that the benefit to risk ratio of the jab is “widely positive”.”

My personal opinion is to delay vaccinations at a time when cases are rising across mainland Europe again is a bit bonkers. It’s only going to add to the hesitancy they’ve already caused about AZ when they inevitably give it the okay again on Thursday. Thankfully we didn’t see any more DNAs/cancellations than usual yesterday. Probably the only time the anti-EU sentiment within the older age group has been a positive

That’s an utterly bizarre comment coming from the director of the agency who made that decision. If he genuinely believes the pause in other countries was politically motivated then why doesn’t he have the bollox to take a different stance in Italy?

 

[Ayush_reddevil]

This thread is getting a bit ugly now. This has been a great source for me to read about the newest updates & articles etc so would be nice if the vaccine anti vaxx stuff is nipped in the bud.

 

[Sky1981]

For what it's worth. Every vaccine will have incompatibility issues, a tiny percentage would be affected you can bet. Be it minor alergies to unfortunate death.

But when a very peculiar cause of death (blood clot) is reported in an alarming number then something must have gone wrong. If say 10 died from blood clot, what's to say 1000 have the same issue but didnt die or didnt have it severe enough to be detected.

Better safe than sorry. Too many similar cases in short time.

And yes, some politicians will milk it, some paper would use it as slight jab at others but the issue is real.

 

[prateik]

Doesnt the platelet count go down naturally with age? If it is an issue.. (IF), could it be something that affects the slightly younger age group(40-60) more than the older ones?
Because a lot of the reports I am seeing are mentioning the people affected are younger..

 

[Pogue Mahone]

Doesnt the platelet count go down naturally with age? If it is an issue.. (IF), could it be something that affects the slightly younger age group(40-60) more than the older ones?
Because a lot of the reports I am seeing are mentioning the people affected are younger..

I think the focus in on the younger cases because being hospitalised by unexpected medical illnesses is much less likely for young people.

I’m starting to think there’s a momentum building here which is moving away from sensible pharmacovigilance towards being overly influenced by decisions in other countries. The Norwegian cluster did sound concerning but this seems to be getting mixed in with other, much less worrying, incidents.

As I’ve said a few times, being this cautious should reassure people that whatever vaccine they are eventually offered has been carefully monitored and is extremely safe. Unfortunately, it carries a risk of having the exact opposite effect.

Thankfully, we haven’t yet seen any similar concerns about any of the other vaccines. If we get similar pauses for all the vaccines that would be an absolute nightmare.

 

[Wibble]

You seem to be under the impression that the slightest questioning of a vaccine equals a fervent anti vaccination stance.

There is something worth looking at with the AZ vaccine. Twelve countries don't pause a desperately needed rollout for no reason, and they have access to data none of us here do.




There are now 7 cases in Germany too, all reasonably young females.

From France:
"The warning signs" about the AstraZeneca vaccine "are significant, more for the type of clinical and biological manifestations than for the number, which remains low compared to the number of people vaccinated. The onset of thrombosis with coagulation abnormalities, which we are not used to seeing in classic pulmonary embolisms, has been observed in some people."

Considering this has all happened very recently and is linked to specific batches it might point to a problem in the supply chain. That's why Italy put a stop on it, in case it's a recurring problem.

A handful of countries have paused but the evidence seems to be MIA

https://www.theguardian.com/austral...dical-officer-says?CMP=Share_AndroidApp_Other

 

[Pogue Mahone]

A handful of countries have paused but the evidence seems to be MIA

https://www.theguardian.com/austral...dical-officer-says?CMP=Share_AndroidApp_Other

Not a single one of those countries has said that these events are causally related to the vaccine. So the comments from the Aussie regulator are kind of redundant. The issue here isn’t a lack of evidence, it’s the need to thoroughly investigate a potential safety signal before coming to a definitive conclusion. Which is what’s happening.

 

[jojojo]

Thrombophilia screens shouldn't be too difficult. The question comes is if these events - like a lot of what's seen in those clinics is what would usually be classified as unprovoked - a significant number from what i usually see in my patients who I monitor anti-coagulants on, and whether that would be then attributed to the vaccines. It will be tricky.

One thing about the warfarin clinic groups is that they are under routine surveillance anyway, albeit not directly for platelets. It did strike me that, when looking at a large number of people, there may be clues if dosage changes are bigger/more frequent than normal. Probably just a random idea on my part, and even if there was something there, it might have nothing to tell us about the broader picture of sudden severe cases - particularly those Norwegian ones.

 

[Pogue Mahone]

One thing about the warfarin clinic groups is that they are under routine surveillance anyway, albeit not directly for platelets. It did strike me that, when looking at a large number of people, there may be clues if dosage changes are bigger/more frequent than normal. Probably just a random idea on my part, and even if there was something there, it might have nothing to tell us about the broader picture of sudden severe cases - particularly those Norwegian ones.

It’s a clever idea but I’m fairly sure warfarin works on a completely different coagulation pathway!

The fact these issues relate to coagulation is presumably one of the reasons they’re being taken very seriously. We know for a fact that the virus can play merry hell with our coag pathways. So it’s not impossible that a vaccine which stimulates an immune response to viral components could have similar consequences.

Ultimately, though, if these serious incidents are are as rare as it seems and it really is just a coincidence that there seems to have been clusters in some countries then we shouldn’t be too worried.

 

[Wolverine]

One thing about the warfarin clinic groups is that they are under routine surveillance anyway, albeit not directly for platelets. It did strike me that, when looking at a large number of people, there may be clues if dosage changes are bigger/more frequent than normal. Probably just a random idea on my part, and even if there was something there, it might have nothing to tell us about the broader picture of sudden severe cases - particularly those Norwegian ones.

That's a good shout. Although there's been a big change now to switch to the novel anticoagulants but INR derangement with regards to warfarin and whether there's a link post-vaccine if you did a large enough survey might be able to spot a trend - or rule one out.

I did a vascular surgery rotation once and I remember how much of a ball ache it was to investigate atypical coagulopathies. From CT scans, echocardiograms, biochem, genetic testing and immunochemistry that took ages to come back and interpret. Wouldn't surprise me if regulators who are more concerned about that cluster/cohort want to give themselves more time to look into it if they are worried enough, especially in norway.

 

[jojojo]

Thankfully, we haven’t yet seen any similar concerns about any of the other vaccines. If we get similar pauses for all the vaccines that would be an absolute nightmare.

In the UK they've had reports of Thrombocytopenia on the Pfizer vaccine as well, including one death. That's not to say either of the UK deaths (one AZ or one Pfizer) was actually caused or triggered by the vaccine, just that is in the possible adverse report list.

That's based on the data accumulated until the end of February, with roughly 20m first doses dispensed - about half of each type.

 

[Wibble]

Not a single one of those countries has said that these events are causally related to the vaccine. So the comments from the Aussie regulator are kind of redundant. The issue here isn’t a lack of evidence, it’s the need to thoroughly investigate a potential safety signal before coming to a definitive conclusion. Which is what’s happening.

True although the evidence they are examining seems scant at best. Under normal circumstances would this trigger a pause?

 

[Penna]

Thinking about it from another angle, we know that people can get severe and unexpected reactions to any vaccine. I'm sure the Covid ones won't be any different.

Hundreds of thousands of people are all receiving the Covid vaccine at the same time, in many different countries, so these unexpected and rare reactions are coming up in small numbers, but over a short period of time and are therefore highly visible.

People do need to be aware that anyone can have a bad reaction to a vaccine. The neurologist I saw recently said to me that it's impossible to predict who those people might be, and the fact that you've had a bad reaction to one vaccine doesn't make you more likely to have one with a different vaccine. I assume the reverse also applies.

 

[jojojo]

It’s a clever idea but I’m fairly sure warfarin works on a completely different coagulation pathway!

The fact these issues relate to coagulation is presumably one of the reasons they’re being taken very seriously. We know for a fact that the virus can play merry hell with our coag pathways. So it’s not impossible that a vaccine which stimulates an immune response to viral components could have similar consequences.

Ultimately, though, if these serious incidents are are as rare as it seems and it really is just a coincidence that there seems to have been clusters in some countries then we shouldn’t be too worried.

It was just a musing.

There's a history of thrombosis in my family. It killed my dad in his 70s, and my sister in her 50s, having almost killed her (seemingly out of the blue) in her early 40s. My brother needed femoral artery surgery for it.

My sister in law's INR changed for the first time in over a year, a couple of weeks ago, a couple of weeks after her jab. It's one of those stories that has caught my attention, and my random thoughts tend to follow...

 

[Pogue Mahone]

True although the evidence they are examining seems scant at best. Under normal circumstances would this trigger a pause?

Really hard to know as these are far from normal circumstances! Usually a pause is much more problematic than this because you have people taking the medicine already. Stopping/switching can have all sorts of negative consequences. It’s far from unusual to have a medicine referred to the PRAC because of new safety concerns and, as I said earlier, the cluster we’re discussing here definitely merits referral. Usually the advice would be to keep taking the medicine and contact your HCP if any concerns. This seems to happen almost once a year with various contraceptive pills (which have long been associated with blood clots)

I think the reason for a pause is because there’s theoretically not much downside in delaying new vaccinations by a week or so. Especially in the younger cohorts that this vaccine is currently being reserved for. Although I also think there are unintended consequences re vaccine hesitancy that haven’t been fully thought through. It’s a tough one though. To keep on injecting people with a vaccine that is having an urgent safety review opens them up to a load of criticism as well.

 

[Pogue Mahone]

It was just a musing.

There's a history of thrombosis in my family. It killed my dad in his 70s, and my sister in her 50s, having almost killed her (seemingly out of the blue) in her early 40s. My brother needed femoral artery surgery for it.

My sister in law's INR changed for the first time in over a year, a couple of weeks ago, a couple of weeks after her jab. It's one of those stories that has caught my attention, and my random thoughts tend to follow...

Musing is good! And I don’t think anyone fully understands exactly what part of the coag pathway the virus messes with. Low platelets does affect a different pathway to warfarin (I think?) but there could well be more to these cases than low platelets. So some sort of survey of the INR (or dose of warfarin) of everyone vaccinated would actually be quite clever.

 

[Schmeichel's Cartwheel]

going to risk being called an anti vaxxer and a selfish prick! careful with your words.

I’m not anti-vax, nor am I selfish. I just think this is being rushed & want to wait & research a bit before putting something in my body. I would argue the selfish ones are the people trying to pressure unsure people into getting it right away. WHO are now reviewing the Oxford vaccine which was “perfectly safe” less than a week ago. This is not like an MMR jab, there is new information all the time. If people want to call me “anti vax” I really couldn’t give a shit. We get one body, of course I’m careful about what I put into mine. Others should be the same. I’m not having a go at anyone for taking it without asking questions, which to me is stupid, because I believe in each to their own. If people wanna take it, great, if people don’t wanna take it, great. Lets make our own choices & not bully people who disagree.

 

[Grinner]

This thread is getting a bit ugly now. This has been a great source for me to read about the newest updates & articles etc so would be nice if the vaccine anti vaxx stuff is nipped in the bud.

Really? I'm finding it to be far more informative than anything I'm seeing in the papers.

 

[Wibble]

Really hard to know as these are far from normal circumstances! Usually a pause is much more problematic than this because you have people taking the medicine already. Stopping/switching can have all sorts of negative consequences. It’s far from unusual to have a medicine referred to the PRAC because of new safety concerns and, as I said earlier, the cluster we’re discussing here definitely merits referral. Usually the advice would be to keep taking the medicine and contact your HCP if any concerns.

I think the reason for a pause is because there’s theoretically not much downside in delaying new vaccinations by a week or so. Especially in the younger cohorts that this vaccine is currently being reserved for. Although I also think there are unintended consequences re vaccine hesitancy that haven’t been fully thought through. It’s a tough one though. To keep on injecting people with a vaccine that is having an urgent safety review opens them up to a load of criticism as well.

Agreed. And normally a small pause for evaluation wouldn't even be noticed by the general public.

 

[Wibble]

This thread is getting a bit ugly now. This has been a great source for me to read about the newest updates & articles etc so would be nice if the vaccine anti vaxx stuff is nipped in the bud.

Anti-vax nutbaggery won't be tolerated. I think letting less severe forms being challenged is informative in of itself.

 

[hmchan]

Thinking about it from another angle, we know that people can get severe and unexpected reactions to any vaccine. I'm sure the Covid ones won't be any different.

Hundreds of thousands of people are all receiving the Covid vaccine at the same time, in many different countries, so these unexpected and rare reactions are coming up in small numbers, but over a short period of time and are therefore highly visible.

People do need to be aware that anyone can have a bad reaction to a vaccine. The neurologist I saw recently said to me that it's impossible to predict who those people might be, and the fact that you've had a bad reaction to one vaccine doesn't make you more likely to have one with a different vaccine. I assume the reverse also applies.

This isn't completely true. Quite a portion of anaphylaxis after vaccination is due to hypersensitivity reactions towards PEG or polysorbate, which are common additives in vaccines. If one has a history of adverse reaction after vaccination, he should figure out the cause and check if the allergen is present in the vaccine he's going to take.

 

[Ayush_reddevil]

Really? I'm finding it to be far more informative than anything I'm seeing in the papers.

That's what I meant in terms of information provided . I don't really check other news sources . Just that there seems to be more personal arguments & agendas coming in now

 

[Penna]

This isn't completely true. Quite a portion of anaphylaxis after vaccination is due to hypersensitivity reactions towards PEG or polysorbate, which are common additives in vaccines. If one has a history of adverse reaction after vaccination, he should figure out the cause and check if the allergen is present in the vaccine he's going to take.

I appreciate that - I was seeing him about autoimmune reactions, rather than allergic ones. The problem with the former type of reaction is that the cause seems to be unknown. My sister with many allergies has been advised by her endocrinologist to have the AZ jab. It's a bit of a lottery and we just all have to hope for the best!

 

[zing]

Really? I'm finding it to be far more informative than anything I'm seeing in the papers.

agreed - this thread is fantastic

 

[Sassy Colin]

This is fecking mental, thousands of people are dying every single day and they are putting thousands more at risk for the sake of 37 possible reactions in 17,000,000 cases. It's minuscule compared to the risk of dying from Coronavirus. I am not sure what the death rate from Coronavirus, but half a percent of 17,000,000 is 85,000. Kind of puts in perspective, doesn't it? Take the fecking vaccine, it's a no brainer.

Can't help thinking there is a political angle on this to do with Brexit.

 

[RoyH1]

EMA press conference going on right now. EMA head Emer Cooke saying they believe Astra Zeneca is absolutely safe. Says they're investigating if there might have been a single bad batch there somewhere.

 

[Don't Kill Bill]

Not a single one of those countries has said that these events are causally related to the vaccine. So the comments from the Aussie regulator are kind of redundant. The issue here isn’t a lack of evidence, it’s the need to thoroughly investigate a potential safety signal before coming to a definitive conclusion. Which is what’s happening.

Just watched the science editor on ITV news ( Tom Clarke) state that there is no difference in case numbers between AZ and Pfizer vaccines which is what you would expect if the cases had no relationship to the vaccine. Should we halt the roll out of Pfizer too?

We are getting close to the original anti-vax panic over autism now. Once you put this in the arms of millions of people there are going to be cases where people get ill afterwards. Its meaningless information without context. Halting the roll out of vaccines which are safe and have been proven to be safe because of this looks like an over reaction or politically motivated bollocks.

I had the AZ vaccine 10 days ago and can't wait to get the second jab and start to get back to normality. I just hope the EU vacillation does not stop or delay the UK from reaching vaccinated herd immunity through its fear mongering.

 

[Pogue Mahone]

Just watched the science editor on ITV news ( Tom Clarke) state that there is no difference in case numbers between AZ and Pfizer vaccines which is what you would expect if the cases had no relationship to the vaccine. Should we halt the roll out of Pfizer too?

We are getting close to the original anti-vax panic over autism now. Once you put this in the arms of millions of people there are going to be cases where people get ill afterwards. Its meaningless information without context. Halting the roll out of vaccines which are safe and have been proven to be safe because of this looks like an over reaction or politically motivated bollocks.

I had the AZ vaccine 10 days ago and can't wait to get the second jab and start to get back to normality. I just hope the EU vacillation does not stop or delay the UK from reaching vaccinated herd immunity through its fear mongering.

Dude. Read the thread. This isn’t about the headline numbers of thromboembolic events overall. It’s about specific clusters of events. With their own distinct and unusual characteristics. Which is a different type of concern.

I’ve never heard about Tom Clark but it’s a worry that anyone who calls himself the science editor at a national broadcaster has such a scanty grasp of the actual science.

 

[lynchie]

By way of some less bleak news, the UK gave 440k vaccine doses yesterday (387k first doses, 53k second), the highest numbers for a Monday so far, and a strong signal that the anticipated ramp up is becoming a reality.

 

[F-Red]

By way of some less bleak news, the UK gave 440k vaccine doses yesterday (387k first doses, 53k second), the highest numbers for a Monday so far, and a strong signal that the anticipated ramp up is becoming a reality.

10m doses of AZ arrived from India over the weekend, so the ramp up over the next few weeks will be very significant.

 

[horsechoker]

This is fecking mental, thousands of people are dying every single day and they are putting thousands more at risk for the sake of 37 possible reactions in 17,000,000 cases. It's minuscule compared to the risk of dying from Coronavirus. I am not sure what the death rate from Coronavirus, but half a percent of 17,000,000 is 85,000. Kind of puts in perspective, doesn't it? Take the fecking vaccine, it's a no brainer.

Can't help thinking there is a political angle on this to do with Brexit.

I can't see what they'd have to gain. Some EU countries are looking very silly right now

 

[Classical Mechanic]

I can't see what they'd have to gain. Some EU countries are looking very silly right now

Creating a scapegoat for their own failings? The slow EU roll out was due to the AZ, the UK, safety concerns about the vaccines etc.

 

[11101]

A fairly definitive statement from the boss of the EMA:

The benefits continue to outweigh the risks, but this is a serious concern and it does need serious and detailed scientific evaluation

The politics is in the press angle from both sides of the channel and the manufacturer themselves, the regulators are doing what they're supposed to do.