COVID-19: Vaccine and testing procedures Megathread Part 2 [Mod Warning - Post #1]

PCeeeee

jackboy wrote: »

Yeah likely yield issues are real. If they don’t want to give more details there may be a reason for that like maybe they are having quality issues at their manufacturing sites. They may not want regulatory agencies descending on their sites, looking at everything, including their other products.

If there is something wrong at one of their sites that a regulatory body would deem it necessary to investigate then it is already incumbent on the site to inform the regulatory body.

Water John

Well there in the spotlight now and the EU have not been happy with the non answers at today's meeting. I think there's a follow up meeting later today.

Dempo1

nommm wrote: »

The problem is that the EU paid AZ a load of money to secure a stockpile of vaccines prior to approval, AZ accepted this money. The production of these vaccines was funded by the EU so if the vaccines have found themselves to another country, it is a breach of contract.

Yes, fair point but I find it hard to believe a Pharma companies lawyers have not crossed the T"s as it were. Paying for a product is one thing, being 100% garenteed of delivery and at an agreed time an entirely different matter particularly when the EU itself could neither gaurentee approval, let alone a time when approval would be issued at the time the contract was agreed. As it stands, we are still unsure of an approval date. This is a cock up and I don't believe the company at fault here. The EU"s aggressive stance is certainly not helping the situation.

jackboy

PCeeeee wrote: »

If there is something wrong at one of their sites that a regulatory body would deem it necessary to investigate then it is already incumbent on the site to inform the regulatory body.

Not really. They could have material not meeting specifications and are dumping that material or reprocessing. That would lead to lower yields and they would not need to inform regulatory bodies. That kind of thing is commonplace in the pharma industry.

is_that_so

chrisbonnie wrote: »

Did the brits not basically fund the whole Oxford vaccine, no?

They ordered 100m doses, so to an extent. Here's a Q&A with Andrew Pollard, where he addresses that variant question amongst other things.

https://www.bmj.com/content/372/bmj.n86

E mac

I'd have to laugh if Astra Zeneca came out and said the reason for the delay is because the 60% promised is rerouted to Germany so ya EU do your worst...

marno21

Ireland now at 2.92 per 100, putting us at 8th worldwide (behind Israel, UAE, UK, Bahrain, US, Malta & Denmark).

Really wonderful that we have seen an evaporation of the HSE bashing.

Gael23

Is the press conference being live streamed?

PCeeeee

jackboy wrote: »

Not really. They could have material not meeting specifications and are dumping that material or reprocessing. That would lead to lower yields and they would not need to inform regulatory bodies. That kind of thing is commonplace in the pharma industry.

I don't doubt it. As such with it being normal why would it be cause for a visit from a regulatory body?

Water John

Gael23 wrote: »

Is the press conference being live streamed?

NPHET ? always broadcast on RTE News Channel.

brickster69

chrisbonnie wrote: »

Did the brits not basically fund the whole Oxford vaccine, no?

No the USA put a fair chunk in as well as others. You would be quite sure that one of the worlds largest pharma companies would not protect themselves against possible supply chain disruptions that were not foreseen.

Frank Bullitt

https://twitter.com/newschambers/status/1353769662136397824

Oh yay, I really wonder if the EU are sharpening their lawyer knives for AZ. Sounding a tad dodgy now.

is_that_so

Also From Richard Chambers, an update on nursing homes, some of which still haven't been done.

https://twitter.com/newschambers/status/1353770666131148802

Gael23

is_that_so wrote: »

Also From Richard Chambers, an update on nursing homes, some of which still haven't been done.

https://twitter.com/newschambers/status/1353770666131148802

That’s the procedure if there is an active outbreak in a facility.
The update from
AZ doesn’t really change anything

jackboy

PCeeeee wrote: »

I don't doubt it. As such with it being normal why would it be cause for a visit from a regulatory body?

Pharma companies don’t tell regulatory bodies about issues until they have to. They prefer to investigate in house which can take a huge amount of time, especially the documentation side of things. Then if an auditor spots something down the line the company has the information ready, on their terms. Regulatory agencies on site during an investigation would be a nightmare.

Due to the high profile nature of the vaccine, any hint of an issue and the regulatory bodies would be on site quickly. The regulatory bodies are being highly scrutinised and are under massive pressure at the moment also. I can only imagine the stress.

PCeeeee

jackboy wrote: »

Pharma companies don’t tell regulatory bodies about issues until they have to.

Agreed.

stephenjmcd

Statement from Donnelly saying AstraZeneca delivery for February within expected range, March not so much. Community vacination begins in February with 85+ and working down from there in the 70+ age range.

"For the moment, people do not need to take any specific action. The next stage of our vaccine programme will begin with those aged 85 years and older and will be administered initially through GPs in their surgeries. The HSE is preparing a public information campaign that will provide all necessary details in advance and ensure that everyone knows when, where and how to access their vaccine.

If the February delivery is within range then there's a little more time for the EU and AstraZeneca to get something sorted there I'd say, not to forget either that we should have larger quantities of Pfizer from February so that will add more.

Gael23

stephenjmcd wrote: »

Statement from Donnelly saying AstraZeneca delivery for February within expected range, March not so much. Community vacination begins in February with 85+ and working down from there in the 70+ age range.

"For the moment, people do not need to take any specific action. The next stage of our vaccine programme will begin with those aged 85 years and older and will be administered initially through GPs in their surgeries. The HSE is preparing a public information campaign that will provide all necessary details in advance and ensure that everyone knows when, where and how to access their vaccine.

If the February delivery is within range then there's a little more time for the EU and AstraZeneca to get something sorted there I'd say, not to forget either that we should have larger quantities of Pfizer from February so that will add more.

That means setting up hospital clinics presumably?

titan18

Oh boy - AZ vaccine

https://app.handelsblatt.com/politik/deutschland/pandemie-bekaempfung-rueckschlag-bei-corona-impfstoff-astra-zeneca-vakzin-wirkt-bei-senioren-wohl-kaum/26849788.html?ticket=ST-10814667-cHstmaDoJfkceLKSb2sv-ap1

According to information from the Handelsblatt from coalition circles, the federal government only expects an effectiveness of eight percent among the over 65s.

Gael23

Gael23 wrote: »

That means setting up hospital clinics presumably?

UK did use larger GPs for Pfizer at the start, maybe primary care centres could be used. You could even use things like community centres or schools (if they are still closed). Utilise the same teams that have been doing the nursing homes.

namloc1980

titan18 wrote: »

Oh boy - AZ vaccine

https://app.handelsblatt.com/politik/deutschland/pandemie-bekaempfung-rueckschlag-bei-corona-impfstoff-astra-zeneca-vakzin-wirkt-bei-senioren-wohl-kaum/26849788.html?ticket=ST-10814667-cHstmaDoJfkceLKSb2sv-ap1

According to information from the Handelsblatt from coalition circles, the federal government only expects an effectiveness of eight percent among the over 65s.

Were older people part of the trials?

Azatadine

titan18 wrote: »

Oh boy - AZ vaccine

https://app.handelsblatt.com/politik/deutschland/pandemie-bekaempfung-rueckschlag-bei-corona-impfstoff-astra-zeneca-vakzin-wirkt-bei-senioren-wohl-kaum/26849788.html?ticket=ST-10814667-cHstmaDoJfkceLKSb2sv-ap1

According to information from the Handelsblatt from coalition circles, the federal government only expects an effectiveness of eight percent among the over 65s.

Saw that on Reddit but surely that info would have been released and been headline news before now? The UK is in big trouble if that's true. I find it hard to believe.

titan18

Azatadine wrote: »

Saw that on Reddit but surely that info would have been released and been headline news before now? The UK is in big trouble if that's true. I find it hard to believe.

Ya, that's where I saw it.

Azatadine

Azatadine wrote: »

Saw that on Reddit but surely that info would have been released and been headline news before now? The UK is in big trouble if that's true. I find it hard to believe.

It doesn't really match up with the trial results, 100% of participants showed antibody response after first dose and 100% showed neutralising activity after the second dose regardless of age.

https://www.astrazeneca.com/media-centre/articles/2020/covid-19-vaccine-azd1222-is-better-tolerated-in-older-adults-than-younger-adults-with-similar-immune-responses-across-all-age-groups.html

Cork2021

More good news from Israel

https://twitter.com/coronavirusgoo1/status/1353794261083435008?s=21

nommm

Azatadine wrote: »

Saw that on Reddit but surely that info would have been released and been headline news before now? The UK is in big trouble if that's true. I find it hard to believe.

Could 8% be the lower bounds of the confidence intervals? I think I remember the confidence intervals for certain groupings being extremely wide. 8% overall effectiveness is not really possible, is it?

titan18

More news coming in

https://m.bild.de/bild-plus/politik/inland/politik-inland/regierung-fuerchtet-impfstoff-rueckschlag-keine-astrazeneca-zulassung-fuer-senio-75065640,view=conversionToLogin.bildMobile.html###wt_ref=https%3A%2F%2Fwww.reddit.com%2F&wt_t=1611605096969

Only being approved for under 65s apparently

nommm

When are EMA issueing verdict? Its not acceptable for stuff like this to be leaked to German tabloids.

DaSilva

Deleted User wrote: »

It doesn't really match up with the trial results, 100% of participants showed antibody response after first dose and 100% showed neutralising activity after the second dose regardless of age.

https://www.astrazeneca.com/media-centre/articles/2020/covid-19-vaccine-azd1222-is-better-tolerated-in-older-adults-than-younger-adults-with-similar-immune-responses-across-all-age-groups.html

I think there is a good chance the OxAz vaccine will work in the elderly population, but from what I read on their paper published in early December it couldn't be stated as fact. Their whole trial was a mess, not just that part about the dosing mistakes, but the fact that a large percentage of the trial and efficacy results were based on people aged <55 who in general have less severe disease.

I was hoping that they would come forward to the EMA with more data for the approval process, or I hoped that the EMA would reject their approval for those aged 55 or older as I would really not like to see the EMA bow to pressure and approve something that does not have the data to back it up.

The group at fault here is Oxford/AstraZeneca, their trial has been a bit of a joke compared with the very clear cut results and trial design from Pfizer/Biontech and Moderna.

I am no anti-vaxer, or lockdown merchant. I see vaccines as our way out, and previously expressed annoyance at seeing young health care workers getting the Pfizer/Moderna vaccines as I had a suspicion this Oxford/AZ vaccine wouldn't pan out for the elderly. I don't begrudge healthcare workers getting priority access to vaccines by the way, just that Ox/AZ might end up being constrained to younger populations and perhaps we should not "waste" Pfizer/Moderna on younger people when there are more elderly in more dire need of the vaccine

DaSilva wrote: »

I have to be honest, I am happy the EMA are showing hesitancy with approval for the Oxford vaccine on over 55s, demonstrates they still have scientific integrity. If you read Oxford's paper from early December their results were very unconvincing for over 55s. This is why I am somewhat frustrated seeing young medical workers getting the Pfizer / Moderna vaccines considering their risk is limited already by age (though I understand the general prioritization of medical workers, just that Ox vaccine would be fine for them). I'd rather see early approval for Oxford asap and its use exclusively for under 55s and save all the Pfizer/Moderna for over 55s in all groups.

I'll take the Oxford vaccine, but I want my parents to get either the Pfizer or Moderna one.

I do hope the Oxford vaccine will end up being fairly effective in the elderly also, but the data just isn't there yet.

Really the blame here lies with Oxford/Astrazeneca and their bizarre approach and messy numbers

titan18

nommm wrote: »

When are EMA issueing verdict? Its not acceptable for stuff like this to be leaked to German tabloids.

Wednesday or Friday I think