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Vaccine Progress, Approval, and Deployment

HSTEd

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MHRA does seem to be at least somewhat willing to consider societal utility however.

Some level of harmful side effects from vaccines are considered acceptable in other diseases, the classical example being Smallpox.

Given that these signals didn't show up until many millions of doses had been distributed, they can't be very common.
 
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Domh245

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MHRA does seem to be at least somewhat willing to consider societal utility however.

Some level of harmful side effects from vaccines are considered acceptable in other diseases, the classical example being Smallpox.

Given that these signals didn't show up until many millions of doses had been distributed, they can't be very common.

I'm not sure that MHRA are making a call on the societal utility so much as just acting on the data they have, and the fact that MHRA (11 pages) are authorising it on a more stringent basis than EMA (annex 2B - 2 pages) are - especially the conditions around batch release/quality where they (or at least, one of their bodies) is involved

The smallpox vaccine is a fair point, though as I noted, with society's apparent decreasing risk appetite what was once acceptable may not be now.

I'm increasingly convinced (though probably without good reason) that it was a bad batch, which is why it hadn't been seen until now - in either trials or the real-world numbers. It isn't the number of cases detected that's the issue, it's that there was a sudden load of them with the common factor of receiving this vaccine.
 

hwl

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MHRA does seem to be at least somewhat willing to consider societal utility however.

Some level of harmful side effects from vaccines are considered acceptable in other diseases, the classical example being Smallpox.

Given that these signals didn't show up until many millions of doses had been distributed, they can't be very common.
Clotting etc. issues in the UK:
15 cases in those vaccinated with Pfizer cases and 13 cases for those vaccinated with Oxford / AZ with over 10million first doses for each vaccine so far.

There are very good statistics on clotting etc issues vs age/sex in general and the number of issues in those vaccinated are lower than those stats would suggest.
 

notlob.divad

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I'm increasingly convinced (though probably without good reason) that it was a bad batch, which is why it hadn't been seen until now - in either trials or the real-world numbers. It isn't the number of cases detected that's the issue, it's that there was a sudden load of them with the common factor of receiving this vaccine.
I have a feeling, (maybe not convinved) that if there is any slight issue (not that I think there is), it will be batch specific. Which makes it even more frustrating watching BBC World broadcasts throwing large numbers of European doses given (including all UK doses) vs small incidence rate, and drawing immediate conclussions that European countries must be in the wrong, (or even worse amplifying the words of Tory MPs who claim it is a European Commission conspiracy to undermine the UKs vaccination efforts). No these are individual sovereign European countries making a call on their own data and that shared with them by neighbours.

As we have been made acutely aware, by the disparity in distribution, the rest of Europe and UK vaccines are manufactured in different facilities, with different supply chains. There is clearly a desire in certain countries to maintain/build confidence in the processes (even if the result is a risk of slightly denting confidence in one specific vaccine).

To be clear, none of what I have written is intended to amplify any theory that there is a problem with any of the approved vaccines, and if offered I encourage anyone to take one. I am just annoyed and frustrated at the rhetoric that appears to be constantly designed to say the UK is doing the best at this and so any country choosing to go about this in a their own way, must therefore be inferior.
 

bspahh

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Derek Lowe is a highly respected and trustworthy blogger He's a medicinal chemist at Novartis in the US. I met him at a conference a few years ago.

He has just written this article on the travails of the AstraZeneca vaccine.

 

MikeWM

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Ely
So over the past two weeks I've had

- Two texts from my doctors surgery (fair enough)
- One text from the other doctors surgery in Ely (?)
- Two texts from another doctors surgery many miles away (???) (I had to look up where it was, I'd never even heard of it)
- One text from some central NHS organisation

and one phone call from my doctor (that I couldn't answer as I was in a meeting at the time).

That seems... a little excessive, and not terribly well organised.

In particular, I'm somewhat concerned that my personal information has apparently been sent to/accessed by two different GP practices that I am not registered with (or have ever been registered with). Has anyone had similar?
 

HSTEd

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That seems... a little excessive, and not terribly well organised.

Would you prefer that people got approached multiple times or not approached at all?

There is no point risking people falling through the cracks like that.
Text messages ultimately cost almost nothing.
 

MikeWM

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Would you prefer that people got approached multiple times or not approached at all?

I'd prefer them to get their records straight, and not be sharing my personal information with organisations that I have no association with - which for starters doesn't feel entirely legal.

I've no issue with the surgery I am registered with getting in touch, but why am I getting contacted by others?
 

HSTEd

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I've no issue with the surgery I am registered with getting in touch, but why am I getting contacted by others?
To hedge against failings in the notification system?

For one thing, SMS messages are not guaranteed delivery.
 

Bantamzen

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An interesting, and potentially revealing comment from a French MEP this afternoon (taken from the BBC's live feed @ 13:29)


Véronique Trillet-Lenoir, who is a French oncologist and an MEP, is asked by BBC News why the AstraZeneca vaccine is coming under more scrutiny than other authorised vaccines such as the Pfizer vaccine.

"We have maybe a specific regard on AstraZeneca. As you know, the firm did probably not fulfil all the commitments [it] made in the contracts with the EU. The vaccine is not that effective on the South African variant, so there are some warnings on these vaccines, which probably led the governments to be even more cautious on it."

On the suggestion that the decision might be seen as a political move, she says that as a medical doctor, she tries to "stick to the scientific evidence" and hopes the suspension will be lifted if the vaccine is shown to be safe for specific populations.
Of note to me is the reference to contractual commitments, which really does seem to suggest that there is a lot of bitterness in Brussels over previous arguments with AZ. As much as I am still a supporter of the principal of the EU, such petty bureaucracy is exactly what the Brexiteers were harking on about. The EU needs to get itself back in order & stop acting like a spooked deer in the forest.
 

MikeWM

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To hedge against failings in the notification system?

For one thing, SMS messages are not guaranteed delivery.

I've had 6 text messages and 1 phone call, so I don't think that's the part that's failing!
 

duncanp

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And now the EU medicines regulator says that there is no indication that the Oxford/Astra Zeneca vaccine causes blood clots, and that similar numbers of blood clots have been seen after the Pfizer and Moderna vaccines.

Oh dear, Napoleon Emmanuel Macron won't like that.

Now then, I wonder if the EU will suspend use of the Pfizer and Moderna vaccines as well

There is "no indication" the AstraZeneca vaccine has caused blood clot incidents, the director of the European Medical Agency (EMA) has said.

Emer Cooke, executive director of the EMA, said: "We are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risk of these side effects."

The number of thromboembolic cases seems to be no higher than that seen in the general population, she added.

An estimated 17m AstraZeneca vaccines have been administered across Europe.

Meanwhile, an Imperial College London professor has warned the halting of the Oxford/AstraZeneca vaccine is a 'disaster' for the vaccine rollout in Europe.

Peter Openshaw, professor of experimental medicine at Imperial College London said: "I think it is very clear that the benefits of being vaccinated at the moment so far outweigh the possible concern over this rather rare type of blood clot."

Emer Cooke, executive director of the European Medicines Agency (EMA), said that other EU-approved vaccines, the Pfizer and Moderna jabs, appeared to be linked to similar numbers of blood clots as the suspended AstraZeneca jab.

Ms Cooke said that there was "no indication" at present that AstraZeneca vaccines caused blood clots and that the benefits of the jab outweighed the risks of side effects.

The EMA will announce the results of its investigation into the Oxford University jab on Thursday.

"We are looking at adverse events associated with all vaccines," Ms Cooke said after newspaper reports in the US linking the other vaccines to thrombosis.
 

Horizon22

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Would you prefer that people got approached multiple times or not approached at all?

Well surely by being approached multiple times, someone else is therefore not being approached. That might be overly simplistic but if different practices are messaging the same person, doesn't that each mean they have the capacity to vaccinate? And if that one person obviously only goes to one site, then there is vacancy for a vaccination. Again, I'm not sure that's entirely how it works

As someone towards the end of the range with family in Europe we are keen to visit, this duplication ultimately delays the process through the priority groups.

An interesting, and potentially revealing comment from a French MEP this afternoon (taken from the BBC's live feed @ 13:29)



Of note to me is the reference to contractual commitments, which really does seem to suggest that there is a lot of bitterness in Brussels over previous arguments with AZ. As much as I am still a supporter of the principal of the EU, such petty bureaucracy is exactly what the Brexiteers were harking on about. The EU needs to get itself back in order & stop acting like a spooked deer in the forest.

Yes I noticed that. If this is purely a medical issue, there's absolutely no need to even discuss contracts.
 

HSTEd

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Well surely by being approached multiple times, someone else is therefore not being approached. That might be overly simplistic but if different practices are messaging the same person, doesn't that each mean they have the capacity to vaccinate?

They will just notify a bunch of people nad keep notifying people until enough people sign up, first come first serve.
They will just generate more text messages until enough people book appointments.
 

Horizon22

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They will just notify a bunch of people nad keep notifying people until enough people sign up, first come first serve.
They will just generate more text messages until enough people book appointments.

Well hopefully - communications logistics slowing down the vaccine isn't ideal!
 

YorkshireBear

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And now the EU medicines regulator says that there is no indication that the Oxford/Astra Zeneca vaccine causes blood clots, and that similar numbers of blood clots have been seen after the Pfizer and Moderna vaccines.

Oh dear, Napoleon Emmanuel Macron won't like that.
If this is true then it truly is appalling state of affairs by those countries. I won't say by the EU as their medicines regulator has at no point said to stop giving vaccines.

I fear we are in a downward spiral of relations.
 

packermac

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16 Sep 2019
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Swanage
So over the past two weeks I've had

- Two texts from my doctors surgery (fair enough)
- One text from the other doctors surgery in Ely (?)
- Two texts from another doctors surgery many miles away (???) (I had to look up where it was, I'd never even heard of it)
- One text from some central NHS organisation

and one phone call from my doctor (that I couldn't answer as I was in a meeting at the time).

That seems... a little excessive, and not terribly well organised.

In particular, I'm somewhat concerned that my personal information has apparently been sent to/accessed by two different GP practices that I am not registered with (or have ever been registered with). Has anyone had similar?
I personally see nothing wrong with it. If you had said yes the only conflict would be the NHS Central system with known surgeries. Most surgeries including mine seem to say you will be or may have already been contacted by the central system. Most people want the vaccine so would regard this as a good thing. You have expressed on here many times why you do not. That is your choice so I suggest you let your surgery know so they stop contacting you, that is what my letter said, my surgery avoided texts totally.
Regarding others having your data unless you opted out I remember everyone being asked if your data could be shared on an NHS database in case you were involved in an accident somewhere and hospitals could look up your history. If you opted out then I would take that up with the surgery as well.
Do not see it all as some big conspiracy.
 

MikeWM

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Ely
I personally see nothing wrong with it. If you had said yes the only conflict would be the NHS Central system with known surgeries. Most surgeries including mine seem to say you will be or may have already been contacted by the central system.

Yes, I have no issue with that, given some are being done by surgeries and some by the big hub places.

I do have an issue with being contacted by surgeries with whom I have never had any relationship whatever, and wonder how they have obtained my details.

Most people want the vaccine so would regard this as a good thing. You have expressed on here many times why you do not. That is your choice so I suggest you let your surgery know so they stop contacting you, that is what my letter said, my surgery avoided texts totally.

I will when I get around to it; expect I'll get another phone call from my own surgery in due course, hopefully I'll be in a position to answer that time. Not yet at the letter stage; I'm sure that will be soon.

Regarding others having your data unless you opted out I remember everyone being asked if your data could be shared on an NHS database in case you were involved in an accident somewhere and hospitals could look up your history. If you opted out then I would take that up with the surgery as well.

I did opt out, though it appears it doesn't have much effect...

Do not see it all as some big conspiracy.

I don't think *this* is, and it isn't really the end of the world. I maintain that it is rather odd though, and am interested if others have had a similar experience.
 

Dr Day

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@MikeWM Not all individual surgeries are offering the jabs - at least in my neck of the woods they are partnering with others so the surgery giving the jab may be getting in touch if your own one is not offering it? I have still had texts from both NHS and my own surgery (even thought they are not administering the job themselves) but they are clearly joined up as the NHS one knew I had been offered a jab from my surgery.
 

hwl

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Yes, I have no issue with that, given some are being done by surgeries and some by the big hub places.

I do have an issue with being contacted by surgeries with whom I have never had any relationship whatever, and wonder how they have obtained my details.



I will when I get around to it; expect I'll get another phone call from my own surgery in due course, hopefully I'll be in a position to answer that time. Not yet at the letter stage; I'm sure that will be soon.



I did opt out, though it appears it doesn't have much effect...



I don't think *this* is, and it isn't really the end of the world. I maintain that it is rather odd though, and am interested if others have had a similar experience.
Typically between 3 and 7 surgeries from within a single health authority area (hence covered by data sharing within a CCG that is non opt-outable) will team together to run the vaccination effort locally usually at the biggest site or two. The other surgeries will be acting on behalf of your own surgery.

I was told that a few surgeries had got together but my texts were all badged as my actual surgery
That depends on how good their IT skills are...
 
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Had mine yesterday, brain fog and headaches this morning but functioning at work. I had two other work colleagues who were vaccinated yesterday as well, and both have the same side effect symptoms. Another work colleague goes today who has had his appointment brought forward by 2 weeks yesterday afternoon. We are all 50 - 55. Looks like things are speeding up.
 

XAM2175

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I do have an issue with being contacted by surgeries with whom I have never had any relationship whatever, and wonder how they have obtained my details.
Is it possible that your number could have been used by somebody else in the past, or that somebody could have accidentally given it as their own - or are they actually directed at you (ie by name)?
 

MikeWM

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Is it possible that your number could have been used by somebody else in the past, or that somebody could have accidentally given it as their own - or are they actually directed at you (ie by name)?

Don't think so - each of them addresses me by surname.

Typically between 3 and 7 surgeries from within a single health authority area (hence covered by data sharing within a CCG that is non opt-outable) will team together to run the vaccination effort locally usually at the biggest site or two. The other surgeries will be acting on behalf of your own surgery.

I suspect that is it, yes. I suppose in the end it doesn't matter all that much in the great scheme of things, just seemed rather odd as I've never heard anything from these surgeries previously. Perhaps under certain other circumstances I would have done.

@MikeWM Not all individual surgeries are offering the jabs - at least in my neck of the woods they are partnering with others so the surgery giving the jab may be getting in touch if your own one is not offering it?

Fairly sure mine is, if the local press is to be believed (hmm, now I think about it, that's not exactly reliable information :)
 

Nicholas Lewis

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Had mine yesterday, brain fog and headaches this morning but functioning at work. I had two other work colleagues who were vaccinated yesterday as well, and both have the same side effect symptoms. Another work colleague goes today who has had his appointment brought forward by 2 weeks yesterday afternoon. We are all 50 - 55. Looks like things are speeding up.
Wife just had a text saying her second dose has been bought forward two weeks. Clearly have plenty in the stockroom they need to use up. Seriously this is suggestion that the goals the roadmap was based on are continuing to be out performed so opportunity to accelerate must be a possibility, although unlikely, it won't be any earlier than first review before they show their hand.
 

kristiang85

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Wife just had a text saying her second dose has been bought forward two weeks. Clearly have plenty in the stockroom they need to use up. Seriously this is suggestion that the goals the roadmap was based on are continuing to be out performed so opportunity to accelerate must be a possibility, although unlikely, it won't be any earlier than first review before they show their hand.

If there is anything accellerated, it will be in late April, so it will be fresh in peoples' minds when they go to vote in early May.
 

YorkshireBear

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Seems wieerd that after bringing all these appointments forward there will be a massive drop off in supply during April. That is a shame as it looks like the acceleration we have been discussing in this thread is definitely dead in the water.

I thought moderna was due soon? Not sure about the Johnson and Johnson one or novavax, which I think might be for delivery in June.
 

cuccir

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Yes disappointing - they're talking about a 4 week period so if it does push back that much, it's worth remembering that a few weeks ago projections had accelerated by about that amount topo so this really only brings us back to the timeline (all adults first shorts by mid-July) that we were on when England's roadmap was announced.

-
In fact if this Financial Times projection is accurate, we're still on for all adult first shots by mid-June which I think is a bit ahead of where we were aiming a few months ago

https://twitter.com/SebastianEPayne/status/1371178161510170624/photo/1
 

Dent

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Seems wieerd that after bringing all these appointments forward there will be a massive drop off in supply during April. That is a shame as it looks like the acceleration we have been discussing in this thread is definitely dead in the water.

I thought moderna was due soon? Not sure about the Johnson and Johnson one or novavax, which I think might be for delivery in June.

Another drop? We've only just come out of the last drop, which was supposed to be only two weeks but vaccinations were actually slow for about a month. There was supposed to be a massive increase after the last drop, which has not materialised.
 

RomeoCharlie71

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I don't think Matt Hancock was briefed about the letter before this press conference... He is trying to downplay it at the moment!
 

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