Possible serious side effects from the Astra Zeneca vaccine discussion

[kabbes]

If the thing you want the drug to do isn’t the main thing it actually does (in terms of probability of happening and impact on the patient’s quality of life), then it either shouldn’t pass the licensing process or is unsuitable for the indicated condition.

That all medical interventions come with risks (some of them directly as part of the “main effect” of the drug, such as with anti-coagulants), is probably understated, but I think that is a matter of the issues in your final paragraph rather than one of etymology.

If you take, for example, a SSRI, you think that the ”main” thing it does is to reduce depression? A cholinesterase inhibitor’s “main” effect is to reduce Alzheimer’s?

 

[littlebabyjesus]

If the thing you want the drug to do isn’t the main thing it actually does (in terms of probability of happening and impact on the patient’s quality of life), then it either shouldn’t pass the licensing process or is unsuitable for the indicated condition.

That all medical interventions come with risks (some of them directly as part of the “main effect” of the drug, such as with anti-coagulants), is probably understated, but I think that is a matter of the issues in your final paragraph rather than one of etymology.

With vaccines, the major difference is that you're intervening with healthy people. I do think we're entitled to expect the risks involved to be very low, particularly if we're being asked to take the vaccine primarily for the benefit of others. It will be interesting to see how this works when/if they get down to vaccinating children.

 

[8ball]

If you take, for example, a SSRI, you think that the ”main” thing it does is to reduce depression? A cholinesterase inhibitor’s “main” effect is to reduce Alzheimer’s?

We are talking about effect in terms of the indication prescribed for.
This can change - I’m sure you’re aware that Viagra was originally developed to deal with high blood pressure (and a type of angina).

The same agent may be licensed and prescribed for multiple indications, in which case the “effect” of a drug for one indication may be listed as a “side effect” in the case of another.

Having worked in the pharma industry for two decades, I concede these meanings may be somewhat “baked in” in my case, but they don’t strike me as ambiguous or controversial. I think the average layperson understands well enough what side effects are.

It is a clinician’s responsibility to ensure that they (or someone with duty of care) does so when prescribing.

 

[8ball]

With vaccines, the major difference is that you're intervening with healthy people. I do think we're entitled to expect the risks involved to be very low, particularly if we're being asked to take the vaccine primarily for the benefit of others. It will be interesting to see how this works when/if they get down to vaccinating children.

Yeah, with vaccines there has always been that game theory dilemma. I’m a little surprised it hasn’t been mentioned more - it perhaps indicates higher levels of social cohesion than I had assumed.

 

[littlebabyjesus]

Yeah, with vaccines there has always been that game theory dilemma. I’m a little surprised it hasn’t been mentioned more - it perhaps indicates higher levels of social cohesion than I had assumed.

I think parents are entitled to expect the risk of vaccination for their child to be very, very close to zero because the risk to that child of dying of covid is very close to zero. One in a million is often used as the benchmark for 'really rare', and the risk to a healthy under-18-year-old of dying of covid is around that mark.

 

[bimble]

The AZ vaccine has literally saved thousands of lives already. Signals from the data need to be examined to determine if there is any causal relationship between the jab and getting ill. It's still far safer to get vaccinated than to get covid though.

Is that definitely true for, say, a healthy 30 year old woman ? I think you have to see getting vaccinated as not really all about your own personal health, or at least in part not about that. I'm quite scared of long covid, which is seemingly really common in my sex & age group, so its pretty clear to me that that's the higher risk, for me personally.

 

[8ball]

I think parents are entitled to expect the risk of vaccination for their child to be very, very close to zero because the risk to that child of dying of covid is very close to zero. One in a million is often used as the benchmark for 'really rare', and the risk to a healthy under-18-year-old of dying of covid is around that mark.

It’s a fair point, I agree that the justifications for vaccinating children need to be to a higher standard <matched to risk>.

Maybe we should also factor in the negative consequences to the child if it transmits a fatal dose of covid to its parents...

 

[SheilaNaGig]

The effect of hair loss and vomiting with chemo isn’t a side effect, it’s a primary effect. It’s a consequence of what you want chemotherapy to do : stop cells dividing and reproducing. If your hair doesn’t fall out you're an outlier.

The way warfarin causes bruises isn’t a risk, it’s a given. Warfarin thins the blood, which leads to bruising.

Some people say “secondary effects” but I prefer “unwanted effects” . It’s clear, the patient understands the term and can say “yes, I’m glad my water tablets have brought down my blood pressure but I don’t like this dizziness” and then you can have a proper useful constructive conversation.

Calling the dizziness a side effect minimises the symptom and works to make the patient less likely either to bring it up in consultation, or less likely to take the medicine.

Acknowledging that such effects are unwanted allows the discussion to proceed.

The term “unwanted effects” allows the patient to describe their symptoms.

Saying “risks” makes them think of danger.

Saying “secondary effects” makes them feel like the medicine is too big, too indiscriminate. It’s also makes them feel like they shouldnt raise the problem, they’re making a fuss over something small and secondary, not primary.

Once their illness has been dealt with, all they’re left with is these unwanted effects. It makes people stop taking their meds. They don’t feel ill with the thing that took them to the doctor, they feel ill with the effects of the medication. From the patient’s perspective, it is not a secondary effect, or a side effect, or a risk. It is real, central, problematic, and unwanted.

The language used in papers often differs from the language used in clinic. If I were writing a paper, I would set out in the first paragraph an acknowledgment of the current language, and describe why I prefer to use the term “unwanted effects”.

 

[littlebabyjesus]

It’s a fair point, I agree that the justifications for vaccinating children need to be to a higher standard <matched to risk>.

Maybe we should also factor in the negative consequences to the child if it transmits a fatal dose of covid to its parents...

That raises a few questions, I would think. First, of course, the parents will mostly be vaccinated, and if all adults are vaccinated then we should have very decent population-level protection to keep cases right down (until a variant comes along to subvert the vaccine). But also, while I think it is reasonable to ask adults to 'take one for the team' and have the vaccination primarily for the cause of herd immunity, I think the case for asking the same of children is much weaker. We have a duty of care there and they can't make an informed choice for themselves.

There are also an argument I've read from virologists that it could be counter-productive to vaccinate kids as unnecessary vaccinations could accelerate the virus's evolution in particular nasty directions. That's a separate argument, though, and I don't quite understand it well enough to have an opinion on it.

 

[littlebabyjesus]

The effect of hair loss and vomiting with chemo isn’t a side effect, it’s a primary effect. It’s a consequence of what you want chemotherapy to do : stop cells dividing and reproducing. If your hair doesn’t fall out you're an outlier.

The way warfarin causes bruises isn’t a risk, it’s a given. Warfarin thins the blood, which leads to bruising.

Some people say “secondary effects” but I prefer “unwanted effects” . It’s clear, the patient understands the term and can say “yes, I’m glad my water tablets have brought down my blood pressure but I don’t like this dizziness” and then you can have a proper useful constructive conversation.

Calling the dizziness a side effect minimises the symptom and works to make the patient less likely either to bring it up in consultation, or less likely to take the medicine.

Acknowledging that such effects are unwanted allows the discussion to proceed.

The term “unwanted effects” allows the patient to describe their symptoms.

Saying “risks” makes them think of danger.

Saying “secondary effects” makes them feel like the medicine is too big, too indiscriminate. It’s also makes them feel like they shouldnt raise the problem, they’re making a fuss over something small and secondary, not primary.

Once their illness has been dealt with, all they’re left with is these unwanted effects. It makes people stop taking their meds. They don’t feel ill with the thing that took them to the doctor, they feel ill with the effects of the medication. From the patient’s perspective, it is not a secondary effect, or a side effect, or a risk. It is real, central, problematic, and unwanted.

The language used in papers often differs from the language used in clinic. If I were writing a paper, I would set out in the first paragraph an acknowledgment of the current language, and describe why I prefer to use the term “unwanted effects”.

Yeah, I think this is totally fair. It's true with nobs on for various anti-psychotic drugs.

 

[SheilaNaGig]

We are talking about effect in terms of the indication prescribed for.
This can change - I’m sure you’re aware that Viagra was originally developed to deal with high blood pressure (and a type of angina).

The same agent may be licensed and prescribed for multiple indications, in which case the “effect” of a drug for one indication may be listed as a “side effect” in the case of another.

Having worked in the pharma industry for two decades, I concede these meanings may be somewhat “baked in” in my case, but they don’t strike me as ambiguous or controversial. I think the average layperson understands well enough what side effects are.

It is a clinician’s responsibility to ensure that they (or someone with duty of care) does so when prescribing.

When working with stuff as important as medicine, illness, health, vaccine safety, Covid security etc you need to make sure to include and allow for those who do not have a high level of literacy and comprehension.

A huge number people are desperately disenfranchised from medical orthodoxy and understanding.

Clinicuans are exhausted, overworked, strapped for time, and that’s the ones who are conscientiously doing their best. Plenty are lackadaisical about prescribing.

 

[8ball]

The effect of hair loss and vomiting with chemo isn’t a side effect, it’s a primary effect. It’s a consequence of what you want chemotherapy to do : stop cells dividing and reproducing. If your hair doesn’t fall out you're an outlier.

“Unwanted effects” doesn’t seem too problematic. Though it has its own issues. In early uses of Viagra one of the “side effects” was very much “wanted” and commented on by patients <these are cardiovascular patients and you’ll be aware that this can come with issues in the area I’m talking about>.

Also, mechanism is not relevant to intended outcome. Cancer patients do not care about whether their treatment affects cell division processes - they would be more than happy with a completely different mechanism- they just want to get better.

People joke with me sometimes about the list of side effect for their meds often ending with “...coma, death”. It doesn’t strike me that they are unaware that side effects may be severe.

If there is good evidence for the current language being a problem, I have no issue with changing it. I’m just not aware of any such evidence, or any supporting evidence for the best improvement.


I’m happy that the ‘enforcement’ of your holiday is being done with a light touch.

 

[SheilaNaGig]

Polypharmacy is a massive very expensive problem.
A lot of it results from the unwanted effects of one medicine not being dealt with, then causing greater problems rhat need to be medicated.

Reframing side effects as unwanted effects enables both the patient and the clinician to address them as something important and worthy of attention. This limits the endless cascade of polypharmacy.

 

[SheilaNaGig]

“Unwanted effects” doesn’t seem too problematic. Though it has its own issues. In early uses of Viagra one of the “side effects” was very much “wanted” and commented on by patients <these are cardiovascular patients and you’ll be aware that this can come with issues in the area I’m talking about>.

Also, mechanism is not relevant to intended outcome. Cancer patients do not care about whether their treatment affects cell division processes - they would be more than happy with a completely different mechanism- they just want to get better.

People joke with me sometimes about the list of side effect for their meds often ending with “...coma, death”. It doesn’t strike me that they are unaware that side effects may be severe.

If there is good evidence for the current language being a problem, I have no issue with changing it. I’m just not aware of any such evidence, or any supporting evidence for the best improvement.


I’m happy that the ‘enforcement’ of your holiday is being done with a light touch.

Yeah okay whatever.

I’m off.


Bye.

 

[8ball]

A huge number people are desperately disenfranchised from medical orthodoxy and understanding.

Clinicuans are exhausted, overworked, strapped for time, and that’s the ones who are conscientiously doing their best. Plenty are lackadaisical about prescribing.

Agreed. Also agree that optimal language could help if properly evidenced, but that’s obv a much bigger problem than can be managed by tinkering with definitions.

 

[8ball]

That raises a few questions, I would think. First, of course, the parents will mostly be vaccinated, and if all adults are vaccinated then we should have very decent population-level protection to keep cases right down (until a variant comes along to subvert the vaccine). But also, while I think it is reasonable to ask adults to 'take one for the team' and have the vaccination primarily for the cause of herd immunity, I think the case for asking the same of children is much weaker. We have a duty of care there and they can't make an informed choice for themselves.

There are also an argument I've read from virologists that it could be counter-productive to vaccinate kids as unnecessary vaccinations could accelerate the virus's evolution in particular nasty directions. That's a separate argument, though, and I don't quite understand it well enough to have an opinion on it.

I’m just going to go with “yeah, it’s complicated”.

 

[Sue]

Is that definitely true for, say, a healthy 30 year old woman ? I think you have to see getting vaccinated as not really all about your own personal health, or at least in part not about that. I'm quite scared of long covid, which is seemingly really common in my sex & age group, so its pretty clear to me that that's the higher risk, for me personally.

Is it though? What's 'really common'..?

 

[bimble]

Is it though? What's 'really common'..?

It’s not well understood yet but I think in middle aged women seemingly around a quarter have long post-infection symptoms. Something like that.

 

[Sue]

It’s not well understood yet but I think in middle aged women seemingly around a quarter have long post-infection symptoms. Something like that.

I haven't looked at the stats and this seems to be a snapshot but:

'Rates of self-reported long Covid were highest in those aged 35-69, females, those living in the most deprived areas, those working in health or social care and those with a pre-existing, activity-limiting health condition. Among study participants who tested positive, 14.7% of females had ongoing symptoms 12 weeks later, compared with 12.7% of males.'

Long Covid: snapshot poll finds more than 1m people with symptoms in UK

ONS estimates 1.1m people in community had ongoing symptoms in four weeks to 6 March

www.theguardian.com

 

[bimble]

Yep, the numbers are all over the place, other studies suggest women, admitted to hospital for covid, are 5 times more likely to have long term symptoms than men. I think its too soon to know much really, and for another thread.

 

[littlebabyjesus]

I haven't looked at the stats and this seems to be a snapshot but:

'Rates of self-reported long Covid were highest in those aged 35-69, females, those living in the most deprived areas, those working in health or social care and those with a pre-existing, activity-limiting health condition. Among study participants who tested positive, 14.7% of females had ongoing symptoms 12 weeks later, compared with 12.7% of males.'

Long Covid: snapshot poll finds more than 1m people with symptoms in UK

ONS estimates 1.1m people in community had ongoing symptoms in four weeks to 6 March

www.theguardian.com

Massive increase from the initial 'one in 50' estimates last year. Totally agree with the article about it being treated as an occupational disease for health workers. Shite that this isn't already the case for infections generally if you work in a hospital.

The numbers on vaccine hesitancy are encouraging, though. If something close to 90% of 18-29s intend to have it, we're in a pretty good place.

 

[kabbes]

I’d also caution against assuming vaccine hesitancy automatically translates to not having the vaccine (except in the way that the WHO defines vaccine hesitancy, which is behaviourally rather than attitudinally — they take it as the proportion of people for whom a vaccine was readily available but who did not have it). In the attitudinal sense — we know that what people actually do tends to only have a loose correlation with what they say and think they’ll do. So just because somebody professes an intention not to take a vaccine, doesn’t mean that when their local doctor phones them to call them in, they’ll actually say no.

 

[Riklet]

With vaccines, the major difference is that you're intervening with healthy people. I do think we're entitled to expect the risks involved to be very low, particularly if we're being asked to take the vaccine primarily for the benefit of others. It will be interesting to see how this works when/if they get down to vaccinating children.

I'd definitely agree with this. That said, I dont know of this "for the benefit of others" discourse is very helpful, it seems to echo the advice given early in the pandemic that turned out to be quite wrong. Plenty of younger people have been badly affected (me too unfortunately) and some have died, not to mention the huge economic/social impact of lockdowns on mental and physical health. And the more the virus mutates the greater the risk, right? Especially if it can evade immune response better etc.

Also, let's be clear, feeling shit for a few days is definitely something most people can deal with and see as being 'worth it'. But if there are rare but still common serious side effects/deaths with AZ that could definitely fuel vaccine hesitancy, especially among younger folk. There's definitely a "it's too soon to be sure, I'll wait and see how it all turns out" attitude seemingly in some other countries already.

Obviously the vaccine results so far seem really good, and it helps (even assuming the worst) that the UK has ordered various other vaccines, not all hope is pinned on AZ. But quite a lot is, what with the "Oxford" branding and the sizeable national investment made, plus obviously the fact it's being sold at cost.

 

[BigMoaner]

I like seeing things that way too. The whole of the lockdowns, its been possible to look at the closed pubs and empty pavements and (if you squint just a little bit) see selflessness and sacrifice for the benefit of total strangers.

Yes, and seeing people wear masks. A marker of basic humanity and solidarity.

 

[cupid_stunt]

Various media outlets are suggesting the MHRA could be close to changing their advice on the AZ vaccine, possibly restricting it's use to the over 30s, with an announcement this week.

The UK vaccines regulator is reportedly considering advising against young people, at least those under 30-years-old, taking the AstraZeneca Covid vaccine.

The Medicines and Healthcare products Regulatory Agency (MHRA) is said to be reviewing its guidance amid concerns the risk of extremely rare blood clots could be marginally higher among younger people.

Channel 4 News reported two senior sources had revealed the MHRA was being urged to ban the jab, developed with Oxford University, in younger people - with a decision expected as early as this week.

Speaking on Monday, Prof Ferguson said the development of blood clots in people who had been given the jab raised questions over whether young people should be given it.

The adviser, who has had the AstraZeneca jab, told Today: "In terms of the data at the moment, there is increasing evidence that there is a rare risk associated, particularly with the AstraZeneca vaccine but it may be associated at a lower level with other vaccines, of these unusual blood clots with low platelet counts.

"It appears that risk is age related, it may possible be – but the data is weaker on this – related to sex.

"And so the older you are, the less the risk is and also the higher the risk is of Covid so the risk-benefit equation really points very much towards being vaccinated.

"I think it becomes slightly more complicated when you get to younger age groups where the risk-benefit equation is more complicated.”

Vaccines minister urges all to get Covid jab as regulator reviews clot risk | ITV News

According to reports the MHRA is considering changing its advice on whether young people, at least those under 30, should be taking the AstraZeneca jab. | ITV National News

www.itv.com

 

[Supine]

Various media outlets are suggesting the MHRA could be close to changing their advice on the AZ vaccine, possibly restricting it's use to the over 30s, with an announcement this week.

Vaccines minister urges all to get Covid jab as regulator reviews clot risk | ITV News

According to reports the MHRA is considering changing its advice on whether young people, at least those under 30, should be taking the AstraZeneca jab. | ITV National News

www.itv.com

that all seems to have come from the channel 4 report last night. Which didnt mention who was pressurising mhra to make the change...

 

[cupid_stunt]

that all seems to have come from the channel 4 report last night. Which didnt mention who was pressurising mhra to make the change...

Well that, and the hints from Prof Ferguson on the Today programme.

 

[William of Walworth]

Is it bad of me to suspect that a ban against Oxford/AstraZeneca for all under a certain age is unnecessary?

Given that the blood-clot figures still seem pretty tiny??

And has any direct causal link yet been proved?

 

[cupid_stunt]

Is it bad of me to suspect that a ban against Oxford/AstraZeneca for all under a certain age is unnecessary?

Given that the blood-clot figures still seem pretty tiny??

And has any direct causal link yet been proved?

All we can do is wait and see, although there does seem to be a drift towards more caution, here's another hint -

A top official in the European Medicines Agency said in an interview published Tuesday that there is a link between the AstraZeneca coronavirus vaccine and blood clots.

EMA head of vaccines Marco Cavaleri told Italy's Il Messaggero newspaper that "in my opinion, we can say it now, it is clear there is a link with the vaccine", although it was not clear what caused such a reaction.

He implied the link would be confirmed by the agency in the coming hours.

LINK

 

[Aladdin]

16 reports of blood clots following AZ vaccine - HPRA

www.google.com

About time.