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

lbj666

https://assets.publishing.service.go...05.01.2021.pdf

Page 53 at the bottom
"As good efficacy has been demonstrated in subjects with comorbidities and immunogenicity
results in the elderly population are broadly comparable to those of younger adults, there is
currently no indication of a significant loss of efficacy in this population."

The UKs review , remember its emergency authorisation. EMA have don't have that mechanism, but national authorities do.

JDD

lbj666 wrote: »

Its going to slow things down considerably, the older groups would be dependant on the supply of pfizer/moderna. And its more awkward to administer meaning the GPs may not be involved. It may not have more impact on the ultimate end date of the roll out, but our elders are going to have to wait a few months more to be jabbed now, meaning stricter restrictions than hoped for longer. Although given the supply issues with Astra Zeneca some of that was on the cards anyway.

Its sounds like the EMA are leaving it up the the national bodies to decide whether they want to give emergency approval to Astra Zeneca for over 65s ALA the UK. Emer Cooke alluded to that the other day.

You can guarantee that our regulatory body will give it emergency approval. Our entire vaccine strategy has relied on AZ providing the large bulk of the vaccinations. We're simply not set up to provide Pfizer/Moderna to all over 70's - which is a fair whack of people, approximately 800k.

is_that_so

Le Bruise wrote: »

A cynic would say Germany are announcing the over 65 news just to put the wind up the UK's vaccine plan after the perceived AZ shenanigans!

There's a strong feeling that the EMA will say the same thing.

JDD

Le Bruise wrote: »

A cynic would say Germany are announcing the over 65 news just to put the wind up the UK's vaccine plan after the perceived AZ shenanigans!

There could be a little bit of FU politics at play here alright.

Melanchthon

https://mobile.twitter.com/olivernmoody/status/1354781400071860230

This is relevant in terms of the German leak. Is this the only data the German regulator is working with.
Again why fuel vaccine skeptism by announcing before the EMA.

is_that_so

Melanchthon wrote: »

https://mobile.twitter.com/olivernmoody/status/1354781400071860230

This is relevant in terms of the German leak. Is this the only data the German regulator is working with.
Again why fuel vaccine skeptism by announcing before the EMA.

It is a fact that they didn't recruit too many over 65s. Ironically that data may now come from the UK vaccination programme.

lbj666

Melanchthon wrote: »

https://mobile.twitter.com/olivernmoody/status/1354781400071860230

This is relevant in terms of the German leak. Is this the only data the German regulator is working with.
Again why fuel vaccine skeptism by announcing before the EMA.

Do confidence intervals factor in trends continuing on from the other groups . I dont think it does, its just based on the sample size of that specific group.

Has any vacine just fallen off a cliff efficacy wise in older age groups? Phase 2 trials didnt see a significant decrease in antibodies.

You can understand such a black and white approach , but it is an emergency at the same time like the UK are treating it.

KrustyUCC

IrishStuff09 wrote: »

Total 1st Dose Vaccines Administered
147,700

Total 2nd Dose Vaccines Administered
13,800

Total: 161,500

How are we doing schedule wise?

CIARAN_BOYLE

KrustyUCC wrote: »

How are we doing schedule wise?

I think we are a little behind but we just had the week where we got a tiny amount delivered by Pfizer (they slashed production to sk an upgrade on their factory) so we are doing OK in general.

astrofool

CIARAN_BOYLE wrote: »

I think we are a little behind but we just had the week where we got a tiny amount delivered by Pfizer (they slashed production to sk an upgrade on their factory) so we are doing OK in general.

I think we're pretty much using up all vaccines as they arrive (minus safety net for second doses), barring the 120 wasted when the vials were left out of cold chain transport, which is probably as good as we can get at the moment.

Will be interesting to see what changes post AZ approval, and if/when J&J get results (and approval), till then it will be slow and steady.

We should also start seeing reduced death rates in the most vulnerable in the coming weeks, and hopefully reduced transmission rates in at risk locations (hospitals and care homes), which will inform the reduced restrictions plan.

And of course ongoing news about new strains, followed days later by pharma companies saying the vaccines still work because the spike protein hasn't changed.

lbj666

https://twitter.com/olivernmoody/status/1354805851924488199

ixoy

astrofool wrote: »

And of course ongoing news about new strains, followed days later by pharma companies saying the vaccines still work because the spike protein hasn't changed.

Followed by someone saying that it inevitably will change and it'll be pointless and kicking their glass over so that it's fully empty, instead of its usual half empty.

plodder

lbj666 wrote: »

https://twitter.com/olivernmoody/status/1354805851924488199

I think the referenced document is just saying the intended use of the product is "adults over 18", not whether it has been approved.

Melanchthon

lbj666 wrote: »

https://twitter.com/olivernmoody/status/1354805851924488199

So the German regulator has likely just given ammo to anybody looking to make the EU's rollout more awkward.

Is there any reason apart from internal politics for them to have released this ahead of the EMA :mad:

lbj666

plodder wrote: »

I think the referenced document is just saying the intended use of the product is "adults over 18", not whether it has been approved.

From the guardian,

Public Health England said that AstraZeneca’s Covid-19 vaccine provides reassuring immune responses in elderly people even if data on the precise level of protection is patchy, Reuters reports.

AstraZeneca’s Covid-19 vaccine should only be given to people aged between 18 and 64, Germany’s vaccine committee said in a draft recommendation, a day ahead of a decision by European regulators on whether to approve the drugmaker’s shot.

“Both the AstraZeneca and Pfizer/BioNTech vaccines are safe and provide high levels of protection against Covid-19, particularly against severe disease,” Mary Ramsay, head of immunisations at PHE, said in a statement. “There were too few cases in older people in the AstraZeneca trials to observe precise levels of protection in this group, but data on immune responses were very reassuring.”

Immune response meaning the antibody tests.

Mark1916

https://www.faz.net/aktuell/wirtschaft/unternehmen/astra-zeneca-will-mehr-impfstoff-liefern-17169846.html

Based on a loose translation, looks like there might be some white smoke between the EU and AstraZeneca “originally there was a volume of 80M for the first quarter, at the weekend the company reduced this to 31M”

“It is not likely we will end up with 80M but it should be significantly more than 31M”

is_that_so

Mark1916 wrote: »

https://www.faz.net/aktuell/wirtschaft/unternehmen/astra-zeneca-will-mehr-impfstoff-liefern-17169846.html

Based on a loose translation, looks like there might be some white smoke between the EU and AstraZeneca “originally there was a volume of 80M for the first quarter, at the weekend the company reduced this to 31M”

“It is not likely we will end up with 80M but it should be significantly more than 31M”

Which is where this was always likely to end. Pity AstraZeneca didn't anticipate the inevitable reaction to their 31m.

DaSilva

Why are people pretending the lack of efficacy data is a political point, its not.

The current batch of AZ data is nearly useless. It is generally the older population who end up with severe covid and / or hospitalised. Their data does not reassure me that my parents will be safe with the AZ vaccine, why cant we just use the Moderna/Pfizer vaccines that DO have good data on the elderly for them and the AZ one on every under 65? Why are HCW (of all ages) pretty much the only people who will get the vaccine which is proven to work in the elderly (the group who needs it most)?

This aint political, this is scientific. Give me the AZ vaccine fine, but I want my parents getting the Pfizer/Moderna until AZ get some real data to prove it works.

I am not making the suggestion that the AZ vaccine has some magical property that might make it not work in older folk, I'm saying their numbers don't really inspire confidence when the age group reported on don't end up in hospital that often anyway

ACitizenErased

DaSilva wrote: »

Why are people pretending the lack of efficacy data is a political point, its not.

The current batch of AZ data is nearly useless. It is generally the older population who end up with severe covid and / or hospitalised. Their data does not reassure me that my parents will be safe with the AZ vaccine, why cant we just use the Moderna/Pfizer vaccines that DO have good data on the elderly for them and the AZ one on every under 65? Why are HCW (of all ages) pretty much the only people who will get the vaccine which is proven to work in the elderly (the group who needs it most)?

This aint political, this is scientific. Give me the AZ vaccine fine, but I want my parents getting the Pfizer/Moderna until AZ get some real data to prove it works.

I am not making the suggestion that the AZ vaccine has some magical property that might make it not work in older folk, I'm saying their numbers don't really inspire confidence when the age group reported on don't end up in hospital that often anyway

Can you send on the data? Mad that the EMA have sent it to you

cameramonkey

I think what the Germans are saying is that there is no data on the over 65 cohort which seems to be a correct statement. In those circumstances I think it is fair enough of them to withhold approval until the data becomes available.

KrustyUCC

Ireland’s coronavirus vaccination programme likely to miss 700,000 target

Ireland’s Covid-19 vaccination programme is likely to miss its target of inoculating 700,000 people by the end of March, the Dail has heard.

Minister for Health Stephen Donnelly said the “indicative target” was heavily caveated and dependant on vaccine supplies from AstraZeneca.

Mr Donnelly said it is “very frustrating” that AstraZeneca may not be delivering the full amount anticipated by Government.

https://www.breakingnews.ie/ireland/irelands-coronavirus-vaccination-programme-likely-to-miss-700000-target-1071863.html

TBF very hard to hit the target with such the expected shortfall from AstraZeneca

ixoy

Would the vaccinations in the UK be sufficient to meet the criteria for a trial given it wouldn't be monitored to quite the same degree? Does it need a greater degree of confidence or, will the sheer numbers, overrule everything?

bilston

76% of over 80s have as of yesterday received their first jab in NI...now I don't know the breakdown of what percentage got Pfizer and who got Astrazeneca, but the point is we should know in 3-5 weeks how useful Astrazeneca is in Over 80s and therefore over 65s.

I still think there is an element of politicking here...the nonsense about 8% efficacy being a case in point.

That said I dont think there has ever been any argument that Pfizer appears to be the stronger vaccine.

DaSilva

ACitizenErased wrote: »

Can you send on the data? Mad that the EMA have sent it to you

They published it back in December mate, open access, anyone can view it. The UK's MHRA also publicly released their updated data when they gave it authorization. Both of these public papers have been quoted in this thread, with even the UK's MHRA paper admitting a lack of data on the elderly. I don't have access to the latest data that the EMA have, but everyone is hoping they will publish that too.

Listen if the data comes out and shows efficacy in the 65+ group, I'm happy. I'm just not content with my parents getting a "a sure it will probably be grand" type vaccine. I'd rather they just get the one that we know works that we have already instead of some 20 year old medical worker.

The number of COVID-19 cases (2) in 660 participants ≥65 years old were too few to draw conclusions on efficacy. However, in this subpopulation, immunogenicity data are available, see below.

From https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca

Melanchthon

DaSilva wrote: »

Why are people pretending the lack of efficacy data is a political point, its not.

It's not the lack of efficiacy data that is making people wonder if it's a political point.
It's that they published this a day ahead of the EMA.

What non political reason is there too jump the gun like that? The vaccine isn't in use at all in Germany so there is no reason not too hold of on publishing for a day.

Seriously what non political reason is there to publish it today?

firemansam4

bilston wrote: »

76% of over 80s have as of yesterday received their first jab in NI...now I don't know the breakdown of what percentage got Pfizer and who got Astrazeneca, but the point is we should know in 3-5 weeks how useful Astrazeneca is in Over 80s and therefore over 65s.

I still think there is an element of politicking here...the nonsense about 8% efficacy being a case in point.

That said I dont think there has ever been any argument that Pfizer appears to be the stronger vaccine.

Did this 8% figure not just come from bad reporting from a German tabloid there? or did it come from more official sources?

DaSilva

Melanchthon wrote: »

It's not the lack of efficiacy data that is making people wonder if it's a political point.
It's that they published this a day ahead of the EMA.

What non political reason is there too jump the gun like that? The vaccine isn't in use at all in Germany so there is no reason not too hold of on publishing for a day.

Seriously what non political reason is there to publish it today?

The lack of data on elderly has been reported on since early December when the original figures came out from AZ, so this is not new information. Second, I'd imagine the reason for the German vaccine committee are doing is feeling a sense of responsibility. They obviously conclude what everybody has been concluding from the AZ data which is, it's not good enough yet. Maybe the EMA will come out and approve it for all ages tomorrow and show their data or reasoning for it, that would be fantastic, but I have a feeling they are going to come out and say, it looks good for 18-55 year olds, but we don't know enough for older age groups, but we are approving it anyway and its up to each state to decide what to do.

CIARAN_BOYLE

firemansam4 wrote: »

Did this 8% figure not just come from bad reporting from a German tabloid there? or did it come from more official sources?

I assume this is how it came about

CIARAN_BOYLE wrote: »

I can see I conversation in my head now.

German ministry official: We are very concerned about the efficacy of the Astra Zenaca Vaccine among older people.

Journalist: Why are you concerned. How low do you suspect the efficacy among older people to be?

Official: Only 8%

Journalist hangs up

Official: of the participants are older people and we cannot be confident in the value of the results.

Melanchthon

DaSilva wrote: »

The lack of data on elderly has been reported on since early December when the original figures came out from AZ, so this is not new information. Second, I'd imagine the reason for the German vaccine committee are doing is feeling a sense of responsibility. They obviously conclude what everybody has been concluding from the AZ data which is, it's not good enough yet. Maybe the EMA will come out and approve it for all ages tomorrow and show their data or reasoning for it, that would be fantastic, but I have a feeling they are going to come out and say, it looks good for 18-55 year olds, but we don't know enough for older age groups, but we are approving it anyway and its up to each state to decide what to do.

The responsible thing is to publish after they have looked at the data and reasoning behind the EMA's decision, publishing before is both pointless, as you say this data has been available in Lancelet I think for a while, and the conversation for even longer, and counter productive or even dangerous if the EMA has additional information that the RKI does not.

DaSilva

Melanchthon wrote: »

The responsible thing is to publish after they have looked at the data and reasoning behind the EMA's decision, publishing before is both pointless, as you say this data has been available in Lancelet I think for a while, and the conversation for even longer, and counter productive or even dangerous if the EMA has additional information that the RKI does not.

I can't know for sure, but I have a feeling the German's have access to the same data as the EMA.

My gut feeling on all of this is part of why Germany recently bought all that antibody treatment. They are going to try reduce deaths in elderly with that treatment while exclusively using the Pfizer/Moderna on their elderly population while vaccinating the rest with Oxford, and I have a feeling they have been thinking about this for a while.