What exactly is happening with AstraZeneca?

brickster69

Musefan wrote: »

I’m delighted to have been vaccinated with AZ, but wow, 24 hours post vaccine, the side effects are rough.

I did not get any of that, but i seem to be eating bananas like they are going out of fashion. I must of gone through 100 the last couple of days.

Dyr

Sam Russell wrote: »

You might consider the US FAA authorising the Boeing 737 Max aircraft and its subsequent worldwide grounding after two fatal crashes blamed on appalling design failures that were given the nod by the FAA based on false information from Boeing. National certifying authority approving home design based on faulty information is not a good thing.

The UK approval of the AZ vaccine was rushed. If the UK approval of the AZ vaccine had gone wrong, it would have been a disaster. Hopefully, that will prove to be a good decision with a good result, but it was risky. The people on the trials took a risk, and we should be grateful to them, but they knew they were taking that risk.

So, that's a "no" then. Still in the bunker going on about the Brits.

Sam Russell

Bambi wrote: »

So, that's a "no" then. Still in the bunker going on about the Brits.

All I am saying is that it was a risk to approve the AZ vaccine on the data they had. That is all, just as it was a risk to go for 'herd immunity' at the start. That 'herd' was not heard for long.

deeperlearning

Icantthinkof1 wrote: »

We were told at the vaccination centre to take paracetamol as soon as we got home
I know now why they said that- the side effects that I experienced were well gone though by 36hours
From what I am reading it seems people getting the rna vaccines develop side effects on the 2nd dose and those who get the AZ vaccine develop them on the 1st dose

The AZ vaccine was approved on Dec 30th in UK.

Few, if any, have received the second jab as the second jab is administered 12 weeks later.

Sam Russell

Sam Russell wrote: »

All I am saying is that it was a risk to approve the AZ vaccine on the data they had. That is all, just as it was a risk to go for 'herd immunity' at the start. That 'herd' was not heard for long.

More sour grapes.

Sam Russell

Aegir wrote: »

More sour grapes.

Not at all. I hope it works out because they are generating data on the various vaccines that can only help the worldwide battle against the Covid plague.

However, I am not impressed by the behaviour of AZ in this.

Stark

Aegir wrote: »

More sour grapes.

This is silly. I don't think there's anyone who isn't genuinely happy for the UK despite pointing out the risks taken with their approach. At the end of the day, they're our closest neighbours and share a land border with us so their success is our success.

Dyr

Sam Russell wrote: »

All I am saying is that it was a risk to approve the AZ vaccine on the data they had. That is all, just as it was a risk to go for 'herd immunity' at the start. That 'herd' was not heard for long.

Post you replied to was asking if our resident europhiles are now willing to accept that the EU made a balls of its vaccine strategy.
You started going on about the Brits, for some strange reason.

Fairly clear the answer is no, retaining a faith in Brussels that is absolute regardless of the circumstances.

Sam Russell

Sam Russell wrote: »

Not at all. I hope it works out because they are generating data on the various vaccines that can only help the worldwide battle against the Covid plague.

However, I am not impressed by the behaviour of AZ in this.

What was the risk Sam?

You seem obsessed with this, but haven’t said what you believe the risk to be.

It comes across as just sour grapes.

Strazdas

It's very possible that 'all' the narratives concerning this story are accurate :

a) European Commission made numerous mistakes in the procurement of vaccines (already admitted by VdL) b) AstraZeneca were a bit shifty and shady concerning the contracts b) The English right wing press have cynically hijacked the issue and engaged in vaccine nationalism to boost Johnson and the Tories.

astrofool

Stark wrote: »

This is silly. I don't think there's anyone who isn't genuinely happy for the UK despite pointing out the risks taken with their approach. At the end of the day, they're our closest neighbours and share a land border with us so their success is our success.

I'm happy we didn't take the risk, as with anything with vaccines, you have to get as much people on side as possible for them to have greatest effect (maybe the UK wrapping it in nationalism was actually an astute plan, but I think they more stumbled into it).

I'm also happy that the risk has paid off for the UK, as the UK has found out, they need the world economy to do well for themselves to to do well, Europe and the US will follow closely behind them, and then the focus will shift to other countries, but the WHO is correct that Europe/US/UK/Israel are being selfish about their insistence to vaccinate their entire populations before providing vaccine for other countries, but I don't see the political will to do it any other way.

The UK also dealt with outbreaks pretty badly and have very high death counts per capita, made even worse if you factor in the forward planning they could have done while seeing the outbreaks and deaths in Italy and Spain, but they will provide very useful data for every other country to manage their vaccine rollout and restriction lifting (I also think a population vaccinated mostly with mRNA and J&J/Others will do better coming into next winter than a population vaccinated mostly with AZ, but maybe there will be mass follow up shots by then).

AZ themselves have messed up their relationship with the EU (and the US), and I don't think will have a good time of things post pandemic. They seemed ill equipped to handle rollout of one of the early vaccines, and ill equipped to carry out effective trials.

astrofool

astrofool wrote: »

I'm happy we didn't take the risk, as with anything with vaccines, you have to get as much people on side as possible for them to have greatest effect (maybe the UK wrapping it in nationalism was actually an astute plan, but I think they more stumbled into it).

I'm also happy that the risk has paid off for the UK, as the UK has found out, they need the world economy to do well for themselves to to do well, Europe and the US will follow closely behind them, and then the focus will shift to other countries, but the WHO is correct that Europe/US/UK/Israel are being selfish about their insistence to vaccinate their entire populations before providing vaccine for other countries, but I don't see the political will to do it any other way.

The UK also dealt with outbreaks pretty badly and have very high death counts per capita, made even worse if you factor in the forward planning they could have done while seeing the outbreaks and deaths in Italy and Spain, but they will provide very useful data for every other country to manage their vaccine rollout and restriction lifting (I also think a population vaccinated mostly with mRNA and J&J/Others will do better coming into next winter than a population vaccinated mostly with AZ, but maybe there will be mass follow up shots by then).

AZ themselves have messed up their relationship with the EU (and the US), and I don't think will have a good time of things post pandemic. They seemed ill equipped to handle rollout of one of the early vaccines, and ill equipped to carry out effective trials.

What risk did the U.K. take?

Stark

Aegir wrote: »

What risk did the U.K. take?

A) Approving Astrazenaca vaccine with insufficient data.
Using non-standard dosing regimens.

Thankfully both gambles paid off for them and the data gathered from them messing with dosing regimens has helped us to choose the best regimen which is really positive. But they were gambles at the end of the day.

Stark

Stark wrote: »

A) Approving Astrazenaca vaccine with insufficient data.
Using non-standard dosing regimens.

Thankfully both gambles paid off for them and the data gathered from them messing with dosing regimens has helped us to choose the best regimen which is really positive. But they were gambles at the end of the day.

What data did they have and what data did were they missing? What was the risk involved?

What does non standard dosing regimes mean? If no one is using the vaccine then there is no “standard”.

There was plenty of data from both trials for the four chief medical officers to decide the best course of action. This has since been accepted by most other countries as a good way forward.

Sconsey

Aegir wrote: »

What data did they have and what data did were they missing? What was the risk involved?

What does non standard dosing regimes mean? If no one is using the vaccine then there is no “standard”.

There was plenty of data from both trials for the four chief medical officers to decide the best course of action. This has since been accepted by most other countries as a good way forward.

Wasn't the phase 1, 2, and 3 trial based on a certain dosage delivered twice, four weeks apart? That would be the standard.

Sam Russell

Stark wrote: »

A) Approving Astrazenaca vaccine with insufficient data.
Using non-standard dosing regimens.

Thankfully both gambles paid off for them and the data gathered from them messing with dosing regimens has helped us to choose the best regimen which is really positive. But they were gambles at the end of the day.

Further to that, on the first day, they vaccinated a lady of 92 (I think) as the first candidate. Why not start with the young and healthy, like the trial volunteers were, at least for the first while.

Then, also on the first day, two recipients went into anaphylactic shock. These vaccines do not have zero side effects - even on the day of injection.

Does than not count as risky?

Dyr

Strazdas wrote: »

It's very possible that 'all' the narratives concerning this story are accurate :

a) European Commission made numerous mistakes in the procurement of vaccines (already admitted by VdL) b) AstraZeneca were a bit shifty and shady concerning the contracts b) The English right wing press have cynically hijacked the issue and engaged in vaccine nationalism to boost Johnson and the Tories.

Contract is in the public domain now, so you can point out where AZ where shifty in it.

Seems more like the EU bought a pig in a poke and then made a big show about contracts to cover their blushes. They "kicked too but that was all pride for soon you could see ’twas all over"

astrofool

Aegir wrote: »

What data did they have and what data did were they missing? What was the risk involved?

What does non standard dosing regimes mean? If no one is using the vaccine then there is no “standard”.

There was plenty of data from both trials for the four chief medical officers to decide the best course of action. This has since been accepted by most other countries as a good way forward.

While I'm assuming you're being facetious about what risks they took (as ultimately there is always a risk, and you're probably aware of them given your activity on the forum but), the greater than normal risks they have took and are taking:

• AZ not having a full set of efficacy data for elderly triallists
• Inconclusive dosing schedule for AZ after trials
• Not following manufacturer guidelines on Pfizer dosing schedule

Any one of them could have gone wrong for the UK, but there was a relatively high chance that they wouldn't.

The first point is still something that could cause them trouble in the medium term.

Sconsey

Bambi wrote: »

Contract is in the public domain now, so you can point out where AZ where shifty in it.

Seems more like the EU bought a pig in a poke and then made a big show about contracts to cover their blushes. They "kicked too but that was all pride for soon you could see ’twas all over"

AZ are definitely coming out of this looking like a bunch of chancers. The fact that the Belgian production plant had to come out publicly to deny the claims that AZ were making saying the problem was a production issues, is a disgrace.

mick087

Sconsey wrote: »

AZ are definitely coming out of this looking like a bunch of chancers. The fact that the Belgian production plant had to come out publicly to deny the claims that AZ were making saying the problem was a production issues, is a disgrace.

Will the EU be taking AZ to court?
If not why not?

Maybe AZ are not chancers maybe the EU was at fault.
This is best left for the courts to decide.

Sam Russell

Sam Russell wrote: »

Further to that, on the first day, they vaccinated a lady of 92 (I think) as the first candidate. Why not start with the young and healthy, like the trial volunteers were, at least for the first while.

Then, also on the first day, two recipients went into anaphylactic shock. These vaccines do not have zero side effects - even on the day of injection.

Does than not count as risky?

You mean the 90 year old woman given the Pfizer vaccine?

You’re getting confused.

astrofool

astrofool wrote: »

While I'm assuming you're being facetious about what risks they took (as ultimately there is always a risk, and you're probably aware of them given your activity on the forum but), the greater than normal risks they have took and are taking:

• AZ not having a full set of efficacy data for elderly triallists
• Inconclusive dosing schedule for AZ after trials
• Not following manufacturer guidelines on Pfizer dosing schedule

Any one of them could have gone wrong for the UK, but there was a relatively high chance that they wouldn't.

The first point is still something that could cause them trouble in the medium term.

So what was the risk? How could they have gone wrong?

The data (which the MHRA were getting at more or less the same time as both AZ and Biontech) was carefully studied, the responses to the vaccines checked and decisions made accordingly.

Like you say, there is a risk to everything. I’m not sure what miraculously happened in the four weeks between the MHRA approval and th EMA approval that makes you think Ireland or other EU countries aren’t taking a risk but the U.K. was.

astrofool

Aegir wrote: »

So what was the risk? How could they have gone wrong?

The data (which the MHRA were getting at more or less the same time as both AZ and Biontech) was carefully studied, the responses to the vaccines checked and decisions made accordingly.

Like you say, there is a risk to everything. I’m not sure what miraculously happened in the four weeks between the MHRA approval and th EMA approval that makes you think Ireland or other EU countries aren’t taking a risk but the U.K. was.

The amount of data supplied to MHRA was less that what was supplied to the EMA, you know this, it was explained to you many times. Because it was for emergency approval, the amount of data supplied (and likely available) is lower, because it's emergency approval, the levels of risk and efficacy associated with the medicine aren't as fully understood as they are at non emergency level, otherwise they wouldn't have different approval levels, and all medicines would only go for emergency approval.

And we're still missing the full set of efficacy data for the AZ vaccine, hence a lot of countries prioritising younger people for AZ. If that data turns out not good, then the UK is in a sticky situation (I personally think it will turn out within ~10% of Novavax in the elderly), there is still 2 other risks they are taking that you haven't covered.

Sconsey

mick087 wrote: »

Will the EU be taking AZ to court?
If not why not?

Maybe AZ are not chancers maybe the EU was at fault.
This is best left for the courts to decide.

So are you saying it was ok to make up a story about a problem in factory, that never actually happened, to cover up their supply issues?

astrofool

astrofool wrote: »

The amount of data supplied to MHRA was less that what was supplied to the EMA, you know this, it was explained to you many times. Because it was for emergency approval, the amount of data supplied (and likely available) is lower, because it's emergency approval, the levels of risk and efficacy associated with the medicine aren't as fully understood as they are at non emergency level, otherwise they wouldn't have different approval levels, and all medicines would only go for emergency approval.

And we're still missing the full set of efficacy data for the AZ vaccine, hence a lot of countries prioritising younger people for AZ. If that data turns out not good, then the UK is in a sticky situation (I personally think it will turn out within ~10% of Novavax in the elderly), there is still 2 other risks they are taking that you haven't covered.

So what was the missing data?

What is the difference between the authorisation the EMA have and the one granted by the MHRA?

brickster69

mick087 wrote: »

Will the EU be taking AZ to court?

No

If not why not?

They are not allowed to EU waived it's rights to take legal action

.

astrofool

Aegir wrote: »

So what was the missing data?

What is the difference between the authorisation the EMA have and the one granted by the MHRA?

You're asking me what data AZ put together in addition to the data they sent to the MHRA? (edit: I should note that it is stupendously simple to look up what the differences are for the 2 types of approval, but alas)

Let's start with these 2 simple questions:
Do you believe that both agencies used exactly the same data, and that AZ delayed submitting the data for 4 weeks just because?

Do you believe that the level of data on efficacy is currently sufficient for the AZ vaccine to be used on the elderly, and that: Ireland, Germany, France, South Africa (among many others), are not giving the vaccine to certain groups for political reasons?

astrofool

astrofool wrote: »

You're asking me what data AZ put together in addition to the data they sent to the MHRA?

Let's start with these 2 simple questions:
Do you believe that both agencies used exactly the same data, and that AZ delayed submitting the data for 4 weeks just because?

Do you believe that the level of data on efficacy is currently sufficient for the AZ vaccine to be used on the elderly, and that: Ireland, Germany, France, South Africa (among many others), are not giving the vaccine to certain groups for political reasons?

I don’t know. You tell me.

You’re the one claiming that the U.K. took risks and you’re glad that Ireland didn’t.

Yet you seem unable to back this claim up.

brickster69

astrofool wrote: »

Do you believe that the level of data on efficacy is currently sufficient for the AZ vaccine to be used on the elderly, and that: Ireland, Germany, France, South Africa (among many others), are not giving the vaccine to certain groups for political reasons?

Well the EMA did. Efficiacy is nothing at the moment compared to not being harmful, not causing severe disease, hospitalisation or death.

Not giving older people that safety which will cost lives, is the biggest failure of states. But that will all come out in due course.

On a political level, if each of those states received the same data and Germany & France approved it for all ages are you telling me those other countries would reject it ?

astrofool

Aegir wrote: »

I don’t know. You tell me.

You’re the one claiming that the U.K. took risks and you’re glad that Ireland didn’t.

Yet you seem unable to back this claim up.

If you don't know the answers to the questions, I doubt you'd understand the differences in the approval methods (which, as I noted before, are publicly available and very easy to look up).