What exactly is happening with AstraZeneca?

stefanovich · 08-04-2021 03:08PM

astrofool wrote: »

The approvals aren't temporary, the mRNA vaccines no more "program" your cells than any other vaccine type.

Very simple to understand graphic is here to counter the misinformation above:
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

mRNA tech is a novel approach to vaccination which has never been used before. Do you dispute that?

The vaccines are approved for emergency use:
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

The drug companies have all liability waived too.

josip · 08-04-2021 03:17PM

I'm curious to see the range of age restrictions/suspensions/preferrals for AZ between the different countries.
Are they basing it on their own individual clotting data or global data?

UK - 30 and above
Germany - 60 and above
France - 55 and above
Belgium - 56 and above
Australia - 50 and above
Italy - 60 and above
Sweden - 65 and above
Finland - 65 and above
Iceland - 70 and above
Canada - 56 and above

Larbre34 · 08-04-2021 03:20PM

Their own interpretation of the global data and the balance of the relative severity of the disease versus supply available of all vaccines in their respective territories, I would imagine.

For me AZ is a bust now. I would expect refusal of it by recipients to increase rapidly over the next few weeks and for it to be discontinued soon thereafter rather than throw good money after bad.

astrofool · 08-04-2021 03:26PM

stefanovich wrote: »

mRNA tech is a novel approach to vaccination which has never been used before. Do you dispute that?

The vaccines are approved for emergency use:
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

You said the mRNA vaccines program your cells to create antibodies, that is not true, the immune response is generated in a similar way to previous vaccines.

stefanovich wrote: »

The drug companies have all liability waived too.

Again, not true, do your research(properly) man, and come back, if you come back claiming this again, everyone can laugh at you again. There is a good document you can read on conditional marketing approval and the differences to emergency approval that you can find by yourself and come back with your (no doubt misinterpreted, but that'll be a bit of fun to pull apart) findings.

odyssey06 · 08-04-2021 03:27PM

Larbre34 wrote: »

Their own interpretation of the global data and the balance of the relative severity of the disease versus supply available of all vaccines in their respective territories, I would imagine.
For me AZ is a bust now. I would expect refusal of it by recipients to increase rapidly over the next few weeks and for it to be discontinued soon thereafter rather than throw good money after bad.

Think it could play an important role for COVAX countries vaccinating over 60s.

stefanovich · 08-04-2021 03:32PM

astrofool wrote: »

You said the mRNA vaccines program your cells to create antibodies, that is not true, the immune response is generated in a similar way to previous vaccines.

mRNA enters your cells and causes them to create the spike protein. Your immune system responds to this. It is gene therapy not a traditional vaccination.

astrofool wrote: »

Again, not true, do your research(properly) man, and come back, if you come back claiming this again, everyone can laugh at you again. There is a good document you can read on conditional marketing approval and the differences to emergency approval that you can find by yourself and come back with your (no doubt misinterpreted, but that'll be a bit of fun to pull apart) findings.

As for liability, look up the Prep act in the US:
https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html

You can’t sue Pfizer or Moderna if you have severe Covid vaccine side effects. The government likely won’t compensate you for damages either

08-04-2021 03:37PM

stefanovich wrote: »

mRNA tech is a novel approach to vaccination which has never been used before. Do you dispute that?

The vaccines are approved for emergency use:
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

The drug companies have all liability waived too.

Lets do nothing new anywhere ever. I for one think leeches are the solution to this.

And its conditional marking authorisation in the EU. Which is full approval in other words

astrofool · 08-04-2021 03:43PM

stefanovich wrote: »

mRNA enters your cells and causes them to create the spike protein. Your immune system responds to this. It is gene therapy not a traditional vaccination.

Sure, but you said program your cells to try and make it sound scary, it doesn't do that, glad you agree.

stefanovich wrote: »

As for liability, look up the Prep act in the US:
https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html

At some point you just have to give up, here horse, this is water, read it:
https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390

Read the section carefully about liability and the differences between approvals.

stefanovich · 08-04-2021 04:18PM

astrofool wrote: »

Sure, but you said program your cells to try and make it sound scary, it doesn't do that, glad you agree.

At some point you just have to give up, here horse, this is water, read it:
https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390

Read the section carefully about liability and the differences between approvals.

But it does enter your cells. The mRNA enters your cells causing them to create spike proteins. It is gene therapy, this is not disputed.

I was referring to the US whilst you are talking about the EU.

stefanovich · 08-04-2021 04:21PM

astrofool wrote: »

Sure, but you said program your cells to try and make it sound scary, it doesn't do that, glad you agree.

At some point you just have to give up, here horse, this is water, read it:
https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390

Read the section carefully about liability and the differences between approvals.

Oh, and I advice you read up on the detail of the contract with AZ.

https://www.politico.eu/article/coronavirus-vaccine-europe-commission-contract-astrazeneca-ties-hands-lawsuits/

The EU contract also says the Commission can't sue if there are any unforeseen issues with the safety or efficacy of the vaccine, or if there are problems with the storage, transport or administration of the vaccine.

The only exception is if AstraZeneca fails to meet "Good Manufacturing Practices," or if a claim "arises from AstraZeneca's wilful misconduct or failure to comply with EU regulatory requirement."

Russman · 08-04-2021 04:22PM

Not sure if this has been posted but it seems like we’ve likely had our first case. Thankfully the girl will be ok eventually it seems.
https://www.irishtimes.com/news/health/medicines-regulator-investigates-first-irish-blood-clot-case-after-astrazeneca-jab-1.4532265

fin12 · 08-04-2021 04:28PM

Russman wrote: »

Not sure if this has been posted but it seems like we’ve likely had our first case. Thankfully the girl will be ok eventually it seems.
https://www.irishtimes.com/news/health/medicines-regulator-investigates-first-irish-blood-clot-case-after-astrazeneca-jab-1.4532265

Oh no this is very bad. So far I’ve had no major symptoms, but I know it will be like nearly 10 days till u are out of the woods.

08-04-2021 04:38PM

Russman wrote: »

Not sure if this has been posted but it seems like we’ve likely had our first case. Thankfully the girl will be ok eventually it seems.
https://www.irishtimes.com/news/health/medicines-regulator-investigates-first-irish-blood-clot-case-after-astrazeneca-jab-1.4532265

It was only a matter of time sadly. I hope she makes a full recovery.

Up until now we were being told there were no cases in Ireland, even though this lady was admitted to hospital a week ago. We're only hearing about it because her sister contacted a newspaper.

I really hope we'll follow the lead of most countries in Western Europe and place some age restrictions on this vaccine.

josip · 08-04-2021 04:43PM

Flying Fox wrote: »

It was only a matter of time sadly. I hope she makes a full recovery.

Up until now we were being told there were no cases in Ireland, even though this lady was admitted to hospital a week ago. We're only hearing about it because her sister contacted a newspaper.

I really hope we'll follow the lead of most countries in Western Europe and place some age restrictions on this vaccine.

Will we follow the UK and limit it to 30 and older, or will we follow every other country and limit it to at least 50 and older?

08-04-2021 04:45PM

josip wrote: »

Will we follow the UK and limit it to 30 and older, or will we follow every other country and limit it to at least 50 and older?

I hope it's the latter, but I don't have confidence that we'll take any action at all.

fin12 · 08-04-2021 04:46PM

Flying Fox wrote: »

I hope it's the latter, but I don't have confidence that we'll take any action at all.

It’s actually not fair to be forced into taken this vaccine . I’m early 30s and female so now very worried.

08-04-2021 04:50PM

fin12 wrote: »

It’s actually not fair to be forced into taken this vaccine . I’m early 30s and female so now very worried.

Totally agree, it's ridiculous.

LLMMLL · 08-04-2021 04:52PM

fin12 wrote: »

It’s actually not fair to be forced into taken this vaccine . I’m early 30s and female so now very worried.

Nobody has been forced.

begbysback · 08-04-2021 04:54PM

PCeeeee wrote: »

I dispute it. Define gene therapy?

Come in here gene, sit down there on the couch and tell me how ye are feelin

stephenjmcd · 08-04-2021 04:55PM

fin12 wrote: »

It’s actually not fair to be forced into taken this vaccine . I’m early 30s and female so now very worried.

Nobody has been forced, you can say no.

Sure you know this you've already said you've had your first dose.

08-04-2021 04:56PM

LLMMLL wrote: »

Nobody has been forced.

Not forced, but being told to get to the back of the queue rather than being offered a vaccine that's not killing people.

fin12 · 08-04-2021 04:56PM

LLMMLL wrote: »

Nobody has been forced.

Well I feel like I was yday cause I was told u won’t be called for months again and very good chance I would be offered the same vaccine again. And ya we all are forced if u want to get back to living normally , Covid passports will be coming.

astrofool · 08-04-2021 04:57PM

stefanovich wrote: »

Oh, and I advice you read up on the detail of the contract with AZ.

https://www.politico.eu/article/coronavirus-vaccine-europe-commission-contract-astrazeneca-ties-hands-lawsuits/

Again, that would only have applied if they had gone for emergency approval, under conditional marketing approval, the manufacturer takes on the liability, as outlined in the conditions for the approval, AZ, Pfizer and Moderna all had the option to go with emergency approval in the EU, but chose to go with the higher standard of CMA.

edit: and I see you go picking and choosing sources to suit your argument again.

LLMMLL · 08-04-2021 04:58PM

Flying Fox wrote: »

Not forced, but being told to get to the back of the queue rather than being offered a vaccine that's not killing people.

Why should you be at the front of the queue for one of the other vaccines that have a restricted supply? It’s a very egocentric attitude.

appledrop · 08-04-2021 05:00PM

Fair play to her family for coming out and speaking about it.

She is a healthy 40 year old woman.

I'm sure we would have been waiting a while otherwise to hear about it.

There has also been 18 other blood clots in Ireland, not this rare strain but still it's too many.

I wouldnt take this vaccine if they paid me.

LLMMLL · 08-04-2021 05:00PM

fin12 wrote: »

Well I feel like I was yday cause I was told u won’t be called for months again and very good chance I would be offered the same vaccine again. And ya we all are forced if u want to get back to living normally , Covid passports will be coming.

That’s not what forced means. Forced means you have no choice.

You had a choice. You made the choice. You’re going to be fine.

What you’re actually saying is you want special treatment. You want the vaccine that is in short supply and is being used in the over 70s.

stefanovich · 08-04-2021 05:00PM

astrofool wrote: »

Again, that would only have applied if they had gone for emergency approval, under conditional marketing approval, the manufacturer takes on the liability, as outlined in the conditions for the approval, AZ, Pfizer and Moderna all had the option to go with emergency approval in the EU, but chose to go with the higher standard of CMA.

That part of the contract was conditional based on the type of approval? I certainly doesn't seem that way from the article.

astrofool · 08-04-2021 05:02PM

stefanovich wrote: »

That part of the contract was conditional based on the type of approval? I certainly doesn't seem that way from the article.

The EMA approval process is independent of the supply contracts with the EU (hence why there is a rolling review of Sputnik which isn't part of the EU negotiated supply), keeping the regulator independent is a good way of ensuring that there is a level playing field and keeping politics out of medicine as much as possible

stephenjmcd · 08-04-2021 05:05PM

LLMMLL wrote: »

That’s not what forced means. Forced means you have no choice.

You had a choice. You made the choice. You’re going to be fine.

What you’re actually saying is you want special treatment. You want the vaccine that is in short supply and is being used in the over 70s.

Absolutely this.

Well said.

08-04-2021 05:05PM

LLMMLL wrote: »

Why should you be at the front of the queue for one of the other vaccines that have a restricted supply? It’s a very egocentric attitude.

AZ is making up a fifth of our supply this quarter, so what are you talking about?

I'm not asking to jump the queue, just to keep my place in the queue.

There is a reason why so many countries are restricting it to older age groups, it's hardly an unreasonable view. No need for the insults.

What exactly is happening with AstraZeneca?

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