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The vaccine

The home for all non-political Coronavirus (Covid-19) discussions on The Lemon Fool
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This is the home for all non-political Coronavirus (Covid-19) discussions on The Lemon Fool
monabri
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Re: The vaccine

#401688

Postby monabri » April 4th, 2021, 6:14 pm

dealtn wrote:
How are AZN blamed if it's the sub-contractor responsible (I haven't read the link)?


That's what I'm querying.....the error seems to be with the contractors EB screwing up. But the headlines seem to imply it was down to AZN

The Times headline
"AstraZeneca kicked out of US Covid vaccine factory after 15 million doses were contaminated"


The Terrograph's headline
"AstraZeneca kicked out of US factory over mix-up 'that ruined 15m vaccine doses'"

Remarkably similar...

Nimrod103
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Re: The vaccine

#401698

Postby Nimrod103 » April 4th, 2021, 7:16 pm

monabri wrote:
dealtn wrote:
How are AZN blamed if it's the sub-contractor responsible (I haven't read the link)?


That's what I'm querying.....the error seems to be with the contractors EB screwing up. But the headlines seem to imply it was down to AZN

The Times headline
"AstraZeneca kicked out of US Covid vaccine factory after 15 million doses were contaminated"


The Terrograph's headline
"AstraZeneca kicked out of US factory over mix-up 'that ruined 15m vaccine doses'"

Remarkably similar...


I would have thought grounds for a libel action.

9873210
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Re: The vaccine

#401708

Postby 9873210 » April 4th, 2021, 8:18 pm

dealtn wrote:
monabri wrote:Are AZN being blamed for the recent J&J screw up (15 million doses lost)?

"AstraZeneca has been kicked out of a production plant in Baltimore after a mix-up is thought to have contaminated 15 million doses of a coronavirus vaccine produced by Johnson & Johnson."

https://www.telegraph.co.uk/news/2021/0 ... ne-mix-up/

"The Oxford/AstraZeneca jab has yet to obtain approval from the US Food and Drug Administration, but production of the vaccine has started in anticipation of a green light. It was being produced by a sub-contractor at a plant operated by Emergent BioSolutions in Baltimore. The plant was also manufacturing Johnson & Johnson's vaccines and workers at the factory mistakenly mixed the ingredients."

:roll:


(Possibly also reported in The Times)


How are AZN blamed if it's the sub-contractor responsible (I haven't read the link)?


You are responsible for the actions of your sub-contractors.

Responsibility cannot be delegated. It can only be shared.

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Re: The vaccine

#401711

Postby Bouleversee » April 4th, 2021, 8:27 pm

But aren't Emergent Biosolutions primarily responsible? They have probably decided that it's too risky to be producing 2 vaccines at the same time and so have given AZ the heave-ho, even though it wasn't their fault.

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Re: The vaccine

#401712

Postby onthemove » April 4th, 2021, 8:31 pm

dealtn wrote:How are AZN blamed if it's the sub-contractor responsible (I haven't read the link)?


When it comes to pharmaceutical manufacturing, the 'regulated company' is responsible for the whole process, even if they sub-contract anything out.

I just did further training on the various US/EU laboratory and manufacturing regulations a few weeks ago as part of my employment; as a subcontractor company all we can do is support the regulated pharmaceutical companies in meeting the regulations; we aren't able to claim our products or services are 'compliant' with the regulations, because it all depends how the regulated companies use what we provide.

Only the regulated company can ensure compliance because it all depends on how the whole process fits together, and only the regulated company has the overall oversight.

I would presume (though the training I undertook was only looking at the technical implications, so didn't cover this aspect), that the 'regulated company' will be the one applying for the licence, etc. For the AZ vaccine, I'd guess this would be AstraZeneca (though I don't know for sure), simply because I doubt each manufacturing subcontractor will go about separately getting licenced, though I don't know any of the details at that level of applying for licences, etc.

Happy to stand corrected if others know more definite details - specifically in this case whether AZ is considered the 'regulated company', or the 'sub-contractor' is considered the 'regulated company', but it was definitely a main take away from our training that the 'regulated company' is ultimately responsible, and they can't pass the book to subcontractors (and vice versa, the subcontractor / supplier cannot claim 'compliance' for their products in isolation). The 'regulated company' are responsible for all validation tests, etc, etc, to ensure that anything provided by subcontractors meets necessary safety and any other standards, etc.

I've just found these FDA guidelines for Covid-19 vaccine licencing https://www.fda.gov/media/139638/download , and there doesn't seem to be any clear separation between vaccine development vs. manufacture, so it would seem the whole vaccine development process will likely form part of any licence. So this further leads me to think that AZ will probably be considered the 'regulated company'.

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Re: The vaccine

#401717

Postby Nimrod103 » April 4th, 2021, 8:52 pm

I haven't read much about this, but wasn't it one contractor producing both AZ and Jansen vaccines, got the ingredients mixed up, and since the Jansen is approved by the authorities, while the AZ has not yet, the decision was taken to discontinue the AZ at the plant.

In which case, it was the contractor who messed up the Jansen vaccine. Must be Jansens's fault, lack of QC etc. AZ can hardly be held responsible for that.

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Re: The vaccine

#401719

Postby monabri » April 4th, 2021, 8:58 pm

Well, unless AZN demand apologies from the various papers for the headlines .......rolling over and having their tummy tickled!

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Re: The vaccine

#401850

Postby Bouleversee » April 5th, 2021, 12:32 pm

The headline in today's Times is "US hands AstraZeneca production site to rival" which is also rather misleading. It goes on to say that the Biden administration has stopped the Oxford AZ jab from being made at a manufacturing site where a production mistake ruined 15 million doses of another Covid vaccine. Johnson and Jonson, the US firm, will take charge of the plant in Baltimore after the error by Emergent Bio Solutions, a subcontractor, spoiled the output of its own vaccine last month. The mistake was caught before any affected doses were shipped out. J&J confirmed that they are "assuming full responsibility" for the facility, adding dedicated leaders for operations and quality and significantly increasing the number of manufacturing, quality and technical operations personnel. AZ has confirmed that it has stopped making its vaccine at the Baltimore site and it is now working with the Biden admin. to find an alternative production plant. However, it's by no means certain that the AZ vaccine will be used in the US as it is possible that even if it wins US regulatory approval, by then the US may have secured enough vaccine doses already.

AZN don't seem to be having much luck one way and another.

monabri
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Re: The vaccine

#401884

Postby monabri » April 5th, 2021, 4:10 pm

Bouleversee wrote:AZN don't seem to be having much luck one way and another.


I thought it went wrong early on when AZN mixed up the vaccine dosage......I thought to myself at the time that that mistake was not impressive.

monabri
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Re: The vaccine

#401886

Postby monabri » April 5th, 2021, 4:19 pm

Disappointing to see less than 100k vaccinations ( jab 1 & 2) yesterday. Yes, it was Easter Sunday but it was well down from the peak of 800k+. Is the UK running out of vaccine availability?

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Re: The vaccine

#401891

Postby Julian » April 5th, 2021, 4:39 pm

Mike4 wrote:
dealtn wrote:
Mike4 wrote:
My GP called me and asked if I could get to the Reading vaccination centre in half an hour, as they had a cancellation to fill. Obviously I said YES PLEASE, and the person calling me seemed utterly delighted!! I got the impression they had been on the fone for hours trying to fill vacant appointments at short notice with little success.



Glad to see your oft repeated lack of faith in being offered your second dose

viewtopic.php?p=396568#p396568

turned out in practice to have been unjustified.



It may have been offered, but it hasn't been administered yet. "Many a slip twixt cup and lip", as my mother used to say.

And of course, it provided little protection against the SA variant which I gather is now here in the UK.

The full situation re efficacy of the AZ vaccine against the SA variant is quite simply unknown I believe. Yes, there was one study in SA that demonstrated almost no efficacy against mild or moderate disease but since the cohort was so young there was no useful data about efficacy against severe and fatal disease because no one in either the active or the control group got anything more than moderate disease.

For efficacy of the AZ vaccine against severe and fatal disease arising from the SA variant I have consistently heard experts say that they expect the AZ vaccine to still be effective against the SA variant. How much of that assessment is based solely on immunological theory and how much support there is from in-vitro tests I have no idea (I have seen some in-vitro testing reported and assume that by now there is more).

On the one hand I find the fact that even after a few months most experts are still saying "expected to still be effective" re SA variant serious disease encouraging but then again the UK government is talking about booster jabs targeting variants of concern maybe starting as early as September. Maybe that is simply an abundance of caution given that we are still as far as I am aware dealing with "expected to still be effective" with no actual human trial or observational data to back that up. If that is the case I certainly would not criticise the government for such an abundance of caution; better safe than sorry.

Also, I think we might get an update in about 20 minutes (5:00pm today) re number of cases of the SA & Brazilian variants (and possibly others too) found in the UK to date since Boris is due to do a press conference at 5:00pm today, I think to present the data for a go/no-go on the April 12th relaxations and one of the key pieces of data there was the situation with variants of concern.

- Julian

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Re: The vaccine

#401892

Postby Lootman » April 5th, 2021, 4:47 pm

monabri wrote:
Bouleversee wrote:AZN don't seem to be having much luck one way and another.

I thought it went wrong early on when AZN mixed up the vaccine dosage......I thought to myself at the time that that mistake was not impressive.

Yes, that was when I decided that I didn't want the AZN vaccine, and their bad "luck" keeps happening.

I had Pfizer; my wife had Moderna.

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Re: The vaccine

#401894

Postby swill453 » April 5th, 2021, 4:53 pm

monabri wrote:Disappointing to see less than 100k vaccinations ( jab 1 & 2) yesterday. Yes, it was Easter Sunday but it was well down from the peak of 800k+. Is the UK running out of vaccine availability?

It was well flagged up that after a "bumper" March there was going to be a dip in supply in April (but that targets would still be met).

Scott.

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Re: The vaccine

#401988

Postby XFool » April 6th, 2021, 11:40 am

EMA official links AstraZeneca vaccine and blood clots

RTE

"A senior official in the European Medicines Agency has said there is a link between the AstraZeneca coronavirus vaccine and blood clots."

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Re: The vaccine

#401992

Postby Bouleversee » April 6th, 2021, 12:02 pm

Article in The Times today headed "UK drugs watchdog 'considers restricting Oxford jab in young' mentioned 22 reports of cerebral venous sinus thrombosis (CVST) and 8 reports of other types of clotting combined with low blood platelet counts (including 7 deaths) after having the AZ vaccine but said they had not received any similar reports related to the Pfizer-B. vaccine. (So they can't have seen the report on here last week, then.) Nadhim Zahawi didn't seem aware of that on Today this morning either and both were encouraging people to continue to take the Oxford vaccine regardless of age. However, according to the Times article, Channel 4 News said sources within the MHRA had told it that there were "growing argumentts to justify offering younger people - below the age of 30 at the very least - a different vaccine." The European Medicines Agency has said that people being given the jab should be warned about the "remote possibility" of CVST whereas the WHO has urged countries to continue using it. Prof. Neil Ferguson said earlier that there is increasing evidence that there is a rare risk associated particularly with the AZ vaccine but it may be associated at a lower level with other vaccines and that it appears that it may be related to age and possibly also to sex.

So I think it could be quite a while before we have a clearer idea what is causing this clotting and low platelet count and who should be having which vaccine.

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Re: The vaccine

#402051

Postby bungeejumper » April 6th, 2021, 2:56 pm

bungeejumper wrote:
redsturgeon wrote:When did you have your first vaccine? Did you not get a date for the second at that time?

My wife was given a date for her second vaccination when she had her first. But I wasn't. The difference is probably that she was jabbed at a vaccination centre while mine was done at a doctor's surgery.

My faith has been restored. :D My surgery just sent me a second jab booking text, and within five minutes I'd been booked in for tomorrow evening. Obviously filling in a cancellation gap, or alternatively I could have had one for next Saturday. Super tidy, and very efficient. :D

BJ

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Re: The vaccine

#402088

Postby Julian » April 6th, 2021, 5:04 pm

monabri wrote:Disappointing to see less than 100k vaccinations ( jab 1 & 2) yesterday. Yes, it was Easter Sunday but it was well down from the peak of 800k+. Is the UK running out of vaccine availability?

Another disappointing day yesterday, just 40,744 first doses and 64,590 second doses just listed in today's report. Slightly better than the previous day that you called out, 105,334 yesterday vs 95,763 for Easter Sunday, but still not great.

Personally I suspect that these low numbers are down to Easter closedowns rather than vaccine shortages. I usually spend Easter abroad so I'd forgotten just how closed down the UK is on Easter Sunday until I tried to buy hot cross buns on Sunday, I think only Christmas day rivals it in terms of retail closing down so I wouldn't be at all surprised if the only vaccination facilities running over the weekend were in locations that tended to be open anyway.

I will certainly be watching the rest of this week's data very closely though to see if rates do bounce up very dramatically, starting I hope from tomorrows report which should show the number of vaccinations being performed today.

- Julian

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Re: The vaccine

#402090

Postby redsturgeon » April 6th, 2021, 5:09 pm

Julian wrote:
monabri wrote:Disappointing to see less than 100k vaccinations ( jab 1 & 2) yesterday. Yes, it was Easter Sunday but it was well down from the peak of 800k+. Is the UK running out of vaccine availability?

Another disappointing day yesterday, just 40,744 first doses and 64,590 second doses just listed in today's report. Slightly better than the previous day that you called out, 105,334 yesterday vs 95,763 for Easter Sunday, but still not great.

Personally I suspect that these low numbers are down to Easter closedowns rather than vaccine shortages. I usually spend Easter abroad so I'd forgotten just how closed down the UK is on Easter Sunday until I tried to buy hot cross buns on Sunday, I think only Christmas day rivals it in terms of retail closing down so I wouldn't be at all surprised if the only vaccination facilities running over the weekend were in locations that tended to be open anyway.

I will certainly be watching the rest of this week's data very closely though to see if rates do bounce up very dramatically, starting I hope from tomorrows report which should show the number of vaccinations being performed today.

- Julian


At the present rates they will struggle to get any more first doses done in the next two months.

John

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Re: The vaccine

#402092

Postby Julian » April 6th, 2021, 5:19 pm

redsturgeon wrote:
Julian wrote:
monabri wrote:Disappointing to see less than 100k vaccinations ( jab 1 & 2) yesterday. Yes, it was Easter Sunday but it was well down from the peak of 800k+. Is the UK running out of vaccine availability?

Another disappointing day yesterday, just 40,744 first doses and 64,590 second doses just listed in today's report. Slightly better than the previous day that you called out, 105,334 yesterday vs 95,763 for Easter Sunday, but still not great.

Personally I suspect that these low numbers are down to Easter closedowns rather than vaccine shortages. I usually spend Easter abroad so I'd forgotten just how closed down the UK is on Easter Sunday until I tried to buy hot cross buns on Sunday, I think only Christmas day rivals it in terms of retail closing down so I wouldn't be at all surprised if the only vaccination facilities running over the weekend were in locations that tended to be open anyway.

I will certainly be watching the rest of this week's data very closely though to see if rates do bounce up very dramatically, starting I hope from tomorrows report which should show the number of vaccinations being performed today.

- Julian


At the present rates they will struggle to get any more first doses done in the next two months.

John

Yes. After my last post I just came across this - https://www.theguardian.com/politics/20 ... sage-warns

It directly supports your comment and seems to come from official Cabinet Office information intended to guide the Sage SPI-M modellers so presumably not just a media rumour but based on Government visibility of expected vaccine supply over the coming few months. One can only hope that HMG low-balls this data so that it has a chance of exceeding expectations and modelling is more likely to be worst-case than over-optimistic but it is still a concern.

- Julian

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Re: The vaccine

#402661

Postby dealtn » April 8th, 2021, 4:53 pm

Julian wrote:
monabri wrote:Disappointing to see less than 100k vaccinations ( jab 1 & 2) yesterday. Yes, it was Easter Sunday but it was well down from the peak of 800k+. Is the UK running out of vaccine availability?

Another disappointing day yesterday, just 40,744 first doses and 64,590 second doses just listed in today's report. Slightly better than the previous day that you called out, 105,334 yesterday vs 95,763 for Easter Sunday, but still not great.

Personally I suspect that these low numbers are down to Easter closedowns rather than vaccine shortages. I usually spend Easter abroad so I'd forgotten just how closed down the UK is on Easter Sunday until I tried to buy hot cross buns on Sunday, I think only Christmas day rivals it in terms of retail closing down so I wouldn't be at all surprised if the only vaccination facilities running over the weekend were in locations that tended to be open anyway.

I will certainly be watching the rest of this week's data very closely though to see if rates do bounce up very dramatically, starting I hope from tomorrows report which should show the number of vaccinations being performed today.

- Julian


Back up to around 500k doses today, so presumably more down to the holidays than supply issues (although a single day is too few an observation to really make that kind of claim).


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