What exactly is happening with AstraZeneca?

josip · 08-04-2021 09:32PM

micks_address wrote: »

Anyone done the maths on how much slower it will be if they pull Astra? I think I seen only 600k of it due before end of June? Even if there’s a risk of one person dying from Astra side effects wouldn’t it make sense to wait a few weeks? If someone said to me hey you can have Astra now or a different one four weeks later I’d probably wait

It won't have any impact on the end date for fully vaccinating everyone if they pull AZ.
The 12 weeks dosing interval and being only 20% of our supply means that Pfizer/J&J/Moderna July doses will more than compensate.

FileNotFound · 08-04-2021 09:34PM

josip wrote: »

It won't have any impact on the end date for fully vaccinating everyone if they pull AZ.
The 12 weeks dosing interval and being only 20% of our supply means that Pfizer/J&J/Moderna July doses will more than compensate.

Based on figures on RTE yesterday not much impact if they can say get 300k J&J doses a month later.

Seems a potentially wise call given the bad press.

astrofool · 08-04-2021 09:47PM

Aegir wrote: »

Can you point to the part of the contract that states this, because all I can see is the EU giving an indemnity with no mention of it being subject to anything other than willful misconduct or a breach of cGMP guidelines.

Because the approval they went for specifically means that AZ are liable, they wouldn't be able to go for CMA and ignore the bit about being liable because of a contract they signed, if they wanted to stick with that part of the contract (which was written before they had data about any risks for the vaccine, so would be a standard clause) then they would not have gone for CMA, they would have gone for emergency approval.

You have to remember that the contracts were written before safety of the vaccines or efficacy was known, so they covered a large number of variables, there is a scenario where the vaccine could have had higher risks, but the need for a vaccine was so high due to a high COVID death rate that emergency approval would be all that they would submit for and the governments administering the vaccine would take on all the associated risk. As multiple vaccines proved successful, this ended up not being required, and vaccines that showed increased risks or lower efficacy rates stopped development, the bar has been set very high (thankfully), which also means that the anti-vax chant of big pharma not being liable, is not true (at least within the EU).

micks_address · 08-04-2021 09:47PM

josip wrote: »

It won't have any impact on the end date for fully vaccinating everyone if they pull AZ.
The 12 weeks dosing interval and being only 20% of our supply means that Pfizer/J&J/Moderna July doses will more than compensate.

Let’s do that so

micks_address · 08-04-2021 09:50PM

FileNotFound wrote: »

Was just watching BBC news and they had a piece on the risks of AZ vaccine.

Essentially for every 100k in current UK climate

In 60-69 age group 14.1 people would enter ICU without vaccine but only 0.2 will develop serious blood clots if vaccinated.

Then for the 20-29 age group, 0.8 people would enter ICU without vaccine but 1.1 will develop serious blood clots if vaccinated.

Doesn't seem great when looking at younger age groups.

Realistically it would just mean use AZ in the slightly older groups. Hard to get someone young and healthy to be happy with a shot that carries similar or potentially more risk than covid!!

What about 30 to 60 age group?

astrofool · 08-04-2021 09:51PM

josip wrote: »

It won't have any impact on the end date for fully vaccinating everyone if they pull AZ.
The 12 weeks dosing interval and being only 20% of our supply means that Pfizer/J&J/Moderna July doses will more than compensate.

It does lengthen the time to first dose for all adults, and would have a knock on effect on reopening of the economy.

Repeat after me, the second dose is for increased efficacy and longevity of the protection. A couple of weeks after the first dose of all vaccines, the risk of having COVID is reduced greatly, and the risk of having a severe case of COVID is reduced even more. Not fully proven yet, but the rate of transmission also drops significantly after the first dose.

FileNotFound · 08-04-2021 09:52PM

Read in some article that AZ was as little as just over 10% effective against SA strain. Some US trial I believe.

Between efficacy concerns, the availability and supply of better alternatives and the blood clotting concerns. It really might be worth considering gifting the AZ to others and some of us waiting that bit longer for a jab

FileNotFound · 08-04-2021 09:59PM

astrofool wrote: »

It does lengthen the time to first dose for all adults, and would have a knock on effect on reopening of the economy.

Vaccine passport plan will make this issue redundant.

Let's those who've had a shot out and about. Open the economy, the rest (me included) continue to work from home and wait a few weeks longer.

08-04-2021 10:01PM

astrofool wrote: »

Because the approval they went for specifically means that AZ are liable, they wouldn't be able to go for CMA and ignore the bit about being liable because of a contract they signed, if they wanted to stick with that part of the contract (which was written before they had data about any risks for the vaccine, so would be a standard clause) then they would not have gone for CMA, they would have gone for emergency approval.

You have to remember that the contracts were written before safety of the vaccines or efficacy was known, so they covered a large number of variables, there is a scenario where the vaccine could have had higher risks, but the need for a vaccine was so high due to a high COVID death rate that emergency approval would be all that they would submit for and the governments administering the vaccine would take on all the associated risk. As multiple vaccines proved successful, this ended up not being required, and vaccines that showed increased risks or lower efficacy rates stopped development, the bar has been set very high (thankfully), which also means that the anti-vax chant of big pharma not being liable, is not true (at least within the EU).

So are you saying there is an amendment to the purchase agreement that states that the indemnity doesn’t apply?

I don’t think it makes a big difference. I can understand why AZ would want an indemnity and why the EU would give one. It makes the roll out far simpler and would have a big impact on the cost of AZ were liable for any claims.

Turtwig · 08-04-2021 10:16PM

Wolf359f wrote: »

At the moment the vast majority of AZ is going to a very high risk group 18-69. Then anyone aged 65-69, then high risk 65-69 and followed by high risk 18-64.
All of those mentioned are at risk from covid complications and death, so I believe the benefits outweigh the risk.

Once we start getting down to younger groups, then yes I would expect an age restriction on AZ or we may have a better idea of what's the main underlying factor for the rare brain clots etc...

There is a different risk analysis between a healthy 20 year old and a 20 year old with severe underlying illnesses. Restricting it via age may not be the best idea until all people with underlying conditions are done.

Agree with your assessment. I'm optimistic the relevant risk factors for this event will be better understood in due course too.

The problem now is how many of cohorts 4 to 7 will take the vaccine if offered?

Strazdas · 08-04-2021 10:29PM

josip wrote: »

It won't have any impact on the end date for fully vaccinating everyone if they pull AZ.
The 12 weeks dosing interval and being only 20% of our supply means that Pfizer/J&J/Moderna July doses will more than compensate.

Pulling AZ completely would probably be too drastic a step. You could certainly make a case though not to give it to under 50s or whatever.

Goldengirl · 08-04-2021 10:30PM

Turtwig wrote: »

Agree with your assessment. I'm optimistic the relevant risk factors for this event will be better understood in due course too.

The problem now is how many of cohorts 4 to 7 will take the vaccine if offered?

This is what I was saying yesterday based on what the UK had worked out ,risk benefit ratio for younger age groups .
AZ is already a hard sell for cohorts getting it now ,( I know should be happy to be getting it but some are worried enough after the year they have had ) something will have to be decided as regards younger age groups .
Here's hoping J&J will be there to take up that slack when those age groups getting vaccinated .

murphaph · 08-04-2021 10:32PM

https://blogs.lse.ac.uk/europpblog/2021/03/25/has-the-uk-really-outperformed-the-eu-on-covid-19-vaccinations/

The gentleman is a law professor so the contract stuff he should have a good handle on.

Wolf359f · 08-04-2021 10:33PM

Turtwig wrote: »

Agree with your assessment. I'm optimistic the relevant risk factors for this event will be better understood in due course too.

The problem now is how many of cohorts 4 to 7 will take the vaccine if offered?

I'm cohort 7 and I'd gladly take it. I know there's a tiny risk, but the risk from covid is far far higher for me.
There has been people here saying they won't take it. Obviously it's completely their own choice, but hopefully it's not too big an amount.

Strazdas · 08-04-2021 10:34PM

Goldengirl wrote: »

This is what I was saying yesterday based on what the UK had worked out ,risk benefit ratio for younger age groups .
AZ is already a hard sell for cohorts getting it now ,( I know should be happy to be getting it but some are worried enough after the year they have had ) something will have to be decided as regards younger age groups .
Here's hoping J&J will be there to take up that slack when those age groups getting vaccinated .

There's no huge rush to make a decision anyway. If I were them, I would carry on vaccinating with AZ for the moment (currently high risk of Covid people) and only when they start coming down towards the younger age groups, then make a decision what to do with it.

astrofool · 08-04-2021 10:37PM

Aegir wrote: »

So are you saying there is an amendment to the purchase agreement that states that the indemnity doesn’t apply?

The approval they put themselves forward for means they take liability, it's as simple as that. Whatever the contract says cannot change the approval type they went for, they cant go for CMA and then point to a contract that says they don't have liability, they could have gone for emergency approval and kept to that section of the contract, but they chose not to.

I'm sorry if you don't understand this, others do.

08-04-2021 10:41PM

astrofool wrote: »

The approval they put themselves forward for means they take liability, it's as simple as that. Whatever the contract says cannot change the approval type they went for, they cant go for CMA and then point to a contract that says they don't have liability, they could have gone for emergency approval and kept to that section of the contract, but they chose not to.

I'm sorry if you don't understand this, others do.

The type of approval is irrelevant, if the purchasing entity has agreed to take on those liabilities by giving an indemnity.

The purchase agreement does not make any conditions on the indemnity other than those already mentioned. The type of approval is irrelevant as far as the purchase agreement goes.

Turtwig · 08-04-2021 10:44PM

Goldengirl wrote: »

This is what I was saying yesterday based on what the UK had worked out ,risk benefit ratio for younger age groups .
AZ is already a hard sell for cohorts getting it now ,( I know should be happy to be getting it but some are worried enough after the year they have had ) something will have to be decided as regards younger age groups .
Here's hoping J&J will be there to take up that slack when those age groups getting vaccinated .

I don't think J & J can be a viable alternative though. I'm open to correction but iirc their trials on over 65s and immuno compromised individuals were just a little over 40% effective.

There is a two dose trial ongoing. It may simply be case those with weaker immune responses could require a booster.

As it stands I would think J and J should be reserved for the minority groups and homeless. Then used in the healthiest cohort. With MRNA reserved for risk cohorts that AZ for whatever reason isn't viable for.

We may even have more vaccines on stream then.

astrofool · 08-04-2021 10:53PM

Aegir wrote: »

The type of approval is irrelevant, if the purchasing entity has agreed to take on those liabilities by giving an indemnity.

The purchase agreement does not make any conditions on the indemnity other than those already mentioned. The type of approval is irrelevant as far as the purchase agreement goes.

The purchasing agreement cannot trump the approval type they got from the EMA that allows them to distribute the medicine, if they are approved via CMA, they accept liability for the medicine they supply under that approval. If they didn't want to take on liability, then they could have gone for emergency approval. If a company can apply for CMA and then make the purchaser take on the liability, they would lose CMA and would have to reapply for approval.

FileNotFound · 08-04-2021 10:56PM

Turtwig wrote: »

I don't think J & J can be a viable alternative though. I'm open to correction but iirc their trials on over 65s and immuno compromised individuals were just a little over 40% effective.

There is a two dose trial ongoing. It may simply be case those with weaker immune responses could require a booster.

As it stands I would think J and J should be reserved for the minority groups and homeless. Then used in the healthiest cohort. With MRNA reserved for risk cohorts that AZ for whatever reason isn't viable for.

We may even have more vaccines on stream then.

Isn't the J&J while lower on symptomatic efficacy extremely effective at reducing hospitalisation and death?

My understanding was that this was its true genius is. And if you don't really suffer natural immunity will exist post fighting covid off.

Below is the first thing to come up on Google when I double checked.

"While J&J's vaccine has 66.3% effectiveness overall and 74.4% effectiveness in the United States, it has “100% efficacy against hospitalization and death from the virus,” said Dr. Irons. “That's really what we have to focus on.”26 Mar 2021"

appledrop · 08-04-2021 11:12PM

FileNotFound wrote: »

Was just watching BBC news and they had a piece on the risks of AZ vaccine.

Essentially for every 100k in current UK climate

In 60-69 age group 14.1 people would enter ICU without vaccine but only 0.2 will develop serious blood clots if vaccinated.

Then for the 20-29 age group, 0.8 people would enter ICU without vaccine but 1.1 will develop serious blood clots if vaccinated.

Doesn't seem great when looking at younger age groups.

Realistically it would just mean use AZ in the slightly older groups. Hard to get someone young and healthy to be happy with a shot that carries similar or potentially more risk than covid!!

Thanks so much for posting this. This is exactly what I thought your putting yourself as more risk by getting vaccine jab if in younger cohort.

Also in cases like this what your seeing around you will also influence your decision. Of the people I personally know in 20-50 year old cohort who have had Covid not one of them thankfully has been hospitalised so why would you risk your life with AZ vaccine?

I'm not downplaying Covid I know how serious it is especially for older age group but risks for younger cohort-v- AZ jab just don't add up.

Then after all that if you meet the SA variant it won't even work!

I'm out, its one of other vaccines for me or none at all.

08-04-2021 11:14PM

astrofool wrote: »

The purchasing agreement cannot trump the approval type they got from the EMA that allows them to distribute the medicine, if they are approved via CMA, they accept liability for the medicine they supply under that approval. If they didn't want to take on liability, then they could have gone for emergency approval. If a company can apply for CMA and then make the purchaser take on the liability, they would lose CMA and would have to reapply for approval.

And you have the specific conditions that relate to the CMA given to AZ that you can share with us?

Strazdas · 08-04-2021 11:17PM

appledrop wrote: »

Thanks so much for posting this. This is exactly what I thought your putting yourself as more risk by getting vaccine jab if in younger cohort.

Also in cases like this what your seeing around you will also influence your decision. Of the people I personally know in 20-50 year old cohort who have had Covid not one of them thankfully has been hospitalised so why would you risk your life with AZ vaccine?

I'm not downplaying Covid I know how serious it is especially for older age group but risks for younger cohort-v- AZ jab just don't add up.

Then after all that if you meet the SA variant it won't even work!

I'm out, its one of other vaccines for me or none at all.

But the only problem with that is that you may bump yourself down the waiting list. You are within your rights to refuse a vaccine, but declining one when invited to go for vaccination tells them you don't see receiving one as a priority and you could end up waiting months for one. They're not going to ring you after two days and offer you a Pfizer or Moderna instead.

Miike · 08-04-2021 11:21PM

Aegir wrote: »

And you have the specific conditions that relate to the CMA given to AZ that you can share with us?

https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390

What is the difference in liability between EU Conditional Marketing Authorisation vs Emergency Use Authorisations?

Under an EU Conditional Marketing Authorisation (CMA), liability is with the holder of the marketing authorisation. The marketing authorisation holder will be responsible for the product and its safe use.

appledrop · 08-04-2021 11:21PM

Strazdas wrote: »

But the only problem with that is that you may bump yourself down the waiting list. You are within your rights to refuse a vaccine, but declining one when invited to go for vaccination tells them you don't see receiving one as a priority and you could end up waiting months for one. They're not going to ring you after two days and offer you a Pfizer or Moderna instead.

I'm OK with that, I'm already bumped down the list now anyway as now age related I but think that might be in my favour because by time gets to me Pfizer/ Modena will actually be a possibility where at at the moment all kept for over 70s and rightly so but they will all be well done by then.

Strazdas · 08-04-2021 11:24PM

appledrop wrote: »

I'm OK with that, I'm already bumped down the list now anyway as now age related I but think that might be in my favour because by time gets to me Pfizer/ Modena will actually be a possibility where at at the moment all kept for over 70s and rightly so but they will all be well done by then.

If you don't mind waiting, then it is not a problem at all. You would definitely think though that anyone who refuses an AZ vaccine when called for it is pushing themselves well down the "queue" and may end up waiting months.

FileNotFound · 08-04-2021 11:27PM

appledrop wrote: »

I'm OK with that, I'm already bumped down the list now anyway as now age related I but think that might be in my favour because by time gets to me Pfizer/ Modena will actually be a possibility where at at the moment all kept for over 70s and rightly so but they will all be well done by then.

I'll be way down the list, age, good health and wfh job.

My guess is that a lot of low/no risk will get the J&J vacc due to the handy admin.

Just a guess though but if it goes that way I'd be happy. One shot and done.

Turtwig · 08-04-2021 11:34PM

appledrop wrote: »

Then after all that if you meet the SA variant it won't even work!

This is not true.
There are concerns the vaccine may not be as effective. It's still anticipated to be more effective than no vaccine at all. There is nothing to suggest AZ doesn't prevent serious illness and death against the SA variant.

Pussyhands · 08-04-2021 11:41PM

Maia Dunphy telling us My Body My Choice doesn't work for vaccines because covid effects other people!

Well first of all, no one is forced to come into contact with me if I choose not to get the vaccine.

Secondly, are fathers not affected by a womans choice when getting an abortion?

i won't be getting a vaccine. It took them months and months to find the AZ clot effect. What else hasn't been found yet and what else will manifest itself longer term?

FileNotFound · 08-04-2021 11:49PM

Pussyhands wrote: »

Maia Dunphy telling us My Body My Choice doesn't work for vaccines because covid effects other people!

Well first of all, no one is forced to come into contact with me if I choose not to get the vaccine.

Secondly, are fathers not affected by a womans choice when getting an abortion?

i won't be getting a vaccine. It took them months and months to find the AZ clot effect. What else hasn't been found yet and what else will manifest itself longer term?

Months and months is hilariously dramatic, its been out for a whole 3 of them haha and we've known of a potential issue for almost a month.

So should that be month and month in singular??

This blood clot issue is no excuse to go mad anti vax. If anything it shows the transparency and continuous careful monitoring especially in EU nations.

What exactly is happening with AstraZeneca?

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