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

is_that_so

plodder wrote: »

The "no data" statement you're quoting there is from the FT, not Pfizer/BioNtech.

Their data actually shows a strong level of efficacy from about ten days after the first dose.

There are dozens of other sources saying the same thing and quoting a statement by Biontech on Monday. This is where people ask you to back up your assertion with a credible link to your claim.

stephenjmcd

plodder wrote: »

The "no data" statement you're quoting there is from the FT, not Pfizer/BioNtech.

Their data actually shows a strong level of efficacy from about ten days after the first dose.

Nope not from the FT only, here is the joint statement from Pfizer & BioNTech.

"Pfizer and BioNTech's Phase 3 study for the COVID-19 vaccine was designed to evaluate the vaccine's safety and efficacy following a 2-dose schedule, separated by 21 days. The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,"

"Although data from the Phase 3 study demonstrated that there is a partial protection from the vaccine as early as 12 days after the first dose, there is no data to demonstrate that protection after the first dose is sustained after 21 days."

Im well aware there's efficacy in and around the 60% mark from dose one, however there isn't enough to support efficacy being sustained at that level outside of the trial period with the second jab pushed out.

If Pfizer and BioNTech are both saying we can't support this and there is no data to demonstrate sustained protection after 21 days, would you not agree is very risky? Its essentially another trial

GreeBo

chrisbonnie wrote: »

Italy's COVID commissioner, Domenico Arcuri, said that "with ReiThera Italy is aiming for vaccine independence

Going forward, we need to be looking into this as well, producing our own vaccine and paddling our canoe

+1

We should also look into producing our own sun and moon so we don't have to share with other countries.

franciscanpunk

nommm wrote: »

Seen as this has come up so many times ...

If Ireland started negotiating outside the EU block, what would stop the more powerful countries doing the same and blocking our supply? We need solidarity right now and are better off as part of EU agreement. Afterall, it is Germany who invested heavily in the Pfizer vaccine, they surely have more claim than us.

Nothing would stop them, Germany look to have already startwd thier initial plansfor this. Maybe if everyone started doing this though it would be increasing pressure on the countries trying to hold the EU together, mainly Germany, to push for even faster rollout in the EU.

I know we have little or no negotiating power by ourselves but we need to do something. Our cases are growing exponentially and we are already very conversative in our speed in easing restrictions. It alright for any of us sitting back on full salary wfh saying its lets just let the EMA go at whatever speed they need and we will get a proportionate share of the EU block deal but if you're business is tanking and you cant pay your mortgage or education costs its an emergency.

Even with Moderna approved today, it really wont make any difference to us overalll, even if we got 2% of the EU supply or 0.5%, it wont make any dent in the goal of quick vaccination of the critical mass, need oxford approved for this or a supply outside the EU deal(which is probably impossible at this stage)

is_that_so

timsey tiger wrote: »

I guess they must not be holding back, 50% for the second dose? Otherwise they are getting proportionally significantly more than we are.

They started on the 27th December and are getting 48K a week so it's proportional. Like everyone else they are spooked by the current massive surge in infections and want to get people done as fast as they can.

AdamD

marno21 wrote: »

If we had offered Pfizer what we're going to spend on this Lockdown the fridges in Citywest would be overflowing at the minute.

Hopefully the European Union collectively can work towards accelerating vaccine production and distribution in any way possible.

And if we had done that, other European countries would have followed causing a bidding war. The EU strategy in this regard makes perfect sense. The length of time its taking their approvals process however..


Also seeing a lot of suggestions that Ireland should go on its own and buy more of Pfizer etc. - surely any new order put in now goes to the back of the queue which wouldn't benefit us in any way?

GreeBo

The Continental Op wrote: »

We have massive big pharma operations in Ireland all due to generous government grants so doubt we are lacking the capability within the country to produce a vaccine.

That's a bit like saying that because I have a garage full of paint I should have the capability of painting the Sistine chapel.

GreeBo

marno21 wrote: »

If we had offered Pfizer what we're going to spend on this Lockdown the fridges in Citywest would be overflowing at the minute.

Hopefully the European Union collectively can work towards accelerating vaccine production and distribution in any way possible.

Overflowing and being spoilt? Awesome plan chief!

It's an incredibly difficult vaccine to rollout, hence everyone bring in the other simpler ones (ignoring the obvious issues with Ireland trying to bid against all the larger EU countries...)

stephenjmcd

AdamD wrote: »

Also seeing a lot of suggestions that Ireland should go on its own and buy more of Pfizer etc. - surely any new order put in now goes to the back of the queue which wouldn't benefit us in any way?

It does, you wouldn't get them until after EU order had been completed.

Speaking of new orders, negotiations already underway to double the order with the same again after this order is fulfilled

https://www.bloomberg.com/news/articles/2021-01-05/eu-seeks-up-to-300-million-more-pfizer-biontech-vaccine-doses

GreeBo

stephenjmcd wrote: »

Nope not from the FT only, here is the joint statement from Pfizer & BioNTech.

"Pfizer and BioNTech's Phase 3 study for the COVID-19 vaccine was designed to evaluate the vaccine's safety and efficacy following a 2-dose schedule, separated by 21 days. The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,"

"Although data from the Phase 3 study demonstrated that there is a partial protection from the vaccine as early as 12 days after the first dose, there is no data to demonstrate that protection after the first dose is sustained after 21 days."

Im well aware there's efficacy in and around the 60% mark from dose one, however there isn't enough to support efficacy being sustained at that level outside of the trial period with the second jab pushed out.

If Pfizer and BioNTech are both saying we can't support this and there is no data to demonstrate sustained protection after 21 days, would you not agree is very risky? Its essentially another trial

Agreed, going to be huge problems for many countries if the vaccine wears off after 3 months, especially since this vaccine doesn't prevent anything, covid will still be active in the community.

timsey tiger

GreeBo wrote: »

That's a bit like saying that because I have a garage full of paint I should have the capability of painting the Sistine chapel.

Or paint it green, from a garage full of tins of red paint.

GreeBo

ixoy wrote: »

Since the Pfizer vaccine can be stored at 2-8c for five days, is there no way for it to be shipped to some GPs too or is it just not worth the hassle of driving around refrigerated containers as that itself is a logistical headache?
What about even more local distribution hubs from which GPs could get it?

Or is it, storage requirements aside, also more complex to inject for some reason that someone could explain.

The more you divide it up the more that will be spoilt and have to be destroyed.

E.g if you have 1 centre you open 1 case at a time and then destroy the remainder of that case after 5 days.
If you have 10 centres then each has an opened case that needs to be destroyed after 5 days.

It's also easier to guarantee a supply of recipients in s smaller number of centres than a larger one.

stephenjmcd

https://twitter.com/EMA_News/status/1346747793432522752?s=19

GreeBo

The bottom line is that until we get a vaccine that can be shipped and stored in regular refrigeration the rollout will be slower than we want.

As a country we have demonstrated that we are perfectly capable of administering vaccine rollout quickly and effectively (flu vaccine every year)
The "slowness" is down to the logistics of the single vaccine we currently have available and the government are rightly only using the facts on their public schedules.
I am 100% sure they have other models for each of the pending approval vaccines, but going public with these prematurely would be a mistake.

Melanchthon

nommm wrote: »

Seen as this has come up so many times ...

If Ireland started negotiating outside the EU block, what would stop the more powerful countries doing the same and blocking our supply? We need solidarity right now and are better off as part of EU agreement. Afterall, it is Germany who invested heavily in the Pfizer vaccine, they surely have more claim than us.

Considering that Germany already went against the agreement and negotiated buying extra doses of the Pfizer vacine without repercussions I think that this is just being used as an excuse to not attempt it.

Second to this fact because the reply will be that German will get these doses after the initial EU distribution, if this is the case why did Germany receive ten times the number of doses than countries such as Italy in the first days of the trial.

These facts seem to keep being ignored and downplayed for some reason.

timsey tiger

There really is no need for this, with people queuing out the door for vaccines. Metaphorically speaking or figuratively, whichever applies here.

Hmmzis

Melanchthon wrote: »

Considering that Germany already went against the agreement and negotiated buying extra doses of the Pfizer vacine without repercussions I think that this is just being used as an excuse to not attempt it.

Second to this fact because the reply will be that German will get these doses after the initial EU distribution, if this is the case why did Germany receive ten times the number of doses than countries such as Italy in the first days of the trial.

These facts seem to keep being ignored and downplayed for some reason.

Germany gave money to BioNTech for development of the vaccine, it would be among the reasons why they got more doses initially (it's also a German company).

plodder

stephenjmcd wrote: »

Nope not from the FT only, here is the joint statement from Pfizer & BioNTech.

"Pfizer and BioNTech's Phase 3 study for the COVID-19 vaccine was designed to evaluate the vaccine's safety and efficacy following a 2-dose schedule, separated by 21 days. The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design,"

"Although data from the Phase 3 study demonstrated that there is a partial protection from the vaccine as early as 12 days after the first dose, there is no data to demonstrate that protection after the first dose is sustained after 21 days."

Im well aware there's efficacy in and around the 60% mark from dose one, however there isn't enough to support efficacy being sustained at that level outside of the trial period with the second jab pushed out.

If Pfizer and BioNTech are both saying we can't support this and there is no data to demonstrate sustained protection after 21 days, would you not agree is very risky? Its essentially another trial

It's possible to agree that "there is no data to demonstrate that protection after the first dose is sustained after 21 days" but still have good reasons for believing that it is, from Pfizer and Moderna's own data.

There doesn't appear to be any noticeable change in the curves (attached image) between days 21 and 30. If anything, they are still rising, which is not what you would expect.

And look at how the AZ optimal regimen was arrived at. Deciding what regimen to test is far from an exact science. I'm not saying we should do what they are doing by the way. I'm not qualified to say whether it's very risky or not, but I'd say the public health experts in the UK, Denmark etc think the risk is worth taking. We seem to have gone in the complete opposite direction - holding doses back in the fridges to avoid even the risk of some people missing their second dose after three weeks due to supply risks rather than policy (which I understand is only a temporary measure).

Melanchthon

Hmmzis wrote: »

Germany gave money to BioNTech for development of the vaccine, it would be among the reasons why they got more doses initially (it's also a German company).

They aren't meant to though, I have never seen it stated that their funding of the vaccine means that they receive extra doses , it is meant to be an equal and proportional distribution according to the EU agreement.
If funding of the company research allows one to sidestep the EU agreement that's not on.

I agree that this is what's happening and why Italy is making the noises it is because they obviously didn't know this either (because it's against the agreement), I am highlighting how narrative that it would be mad to also work outside the EU agreement is false and not backed up.

lbj666

Melanchthon wrote: »

Considering that Germany already went against the agreement and negotiated buying extra doses of the Pfizer vacine without repercussions I think that this is just being used as an excuse to not attempt it.

Second to this fact because the reply will be that German will get these doses after the initial EU distribution, if this is the case why did Germany receive ten times the number of doses than countries such as Italy in the first days of the trial.

These facts seem to keep being ignored and downplayed for some reason.

There's downplayed and theres overplayed

Just to be clear some people seem to have the impression that Germany are jumping up the que here, not really, Spahn said so himself. The additional Germany deal will be fulfilled after all of the EU deal is fulfilled, Pfizer said last week that would be September i dont know does that allow for Marlberg plant opening or the more recent additional orders.

But really if they are not getting it til mid summer at best, its really a contingency or backup order or preparation for a 2nd rollout of vacinations.

https://www.reuters.com/article/us-health-coronavirus-eu-pfizer/eu-seeks-more-doses-of-pfizer-vaccine-as-germany-outlines-earlier-deal-idUSKBN29916N

"Health Minister Jens Spahn has said national deals were possible with the same vaccine makers once the EU has concluded its own contract and as long as supplies to EU countries were not disrupted."

funnydoggy

Didn't Dolly Parton donate some funds to the Moderna vaccine or was that a different vaccine?

lbj666

funnydoggy wrote: »

Didn't Dolly Parton donate some funds to the Moderna vaccine or was that a different vaccine?

Yep the moderna one

funnydoggy

lbj666 wrote: »

Yep the moderna one

She is an absolute saint of a person.

McGiver

Too many Euro-bashers around here. "Monday morning quarterback" is very apt here.

Note: The EU equals Ireland, it's not a separate entity. Mairead McGuinness makes decisions, Taoiseach and Minsters make decisions, MEPs make decisions.
Ireland was part of the negotiation with Pfizer, AZ, Sanofi, GSK and Moderna.

And in terms of EMA - it's one of the best regulators of one of the largest markets in the world. It won't rush anywhere with approvals.

Can we focus on the vaccine and situation in Ireland instead of spreading Eurosceptic agendas?

Melanchthon

lbj666 wrote: »

There's downplayed and theres overplayed

Just to be clear some people seem to have the impression that Germany are jumping up the que here, not really, Spahn said so himself. The additional Germany deal will be fulfilled after all of the EU deal is fulfilled, Pfizer said last week that would be September i dont know does that allow for Marlberg plant opening or the more recent additional orders.

But really if they are not getting it til mid summer at best, its really a contingency or backup order or preparation for a 2nd rollout of vacinations.

https://www.reuters.com/article/us-health-coronavirus-eu-pfizer/eu-seeks-more-doses-of-pfizer-vaccine-as-germany-outlines-earlier-deal-idUSKBN29916N

"Health Minister Jens Spahn has said national deals were possible with the same vaccine makers once the EU has concluded its own contract and as long as supplies to EU countries were not disrupted."

Why did Germany receive 10 times the initial order that Italy received? Theres a reason the Italians are talking about vaccine nationalism.

Also this isn't exactly a ringing endorsement from the EU commission.

A spokesman for the EU Commission said he had no information on Germany’s bilateral deal with BioNTech and declined to comment on whether it was in breach of EU agreements.

He said, however, that EU countries had made a political commitment to avoid parallel negotiations with the same pharmaceutical companies to secure COVID-19 vaccines. This was meant to avoid competition among EU states.

Thanks for the article by the way hadnt seen it and obviously a sign that my impression that this isn't just simple Eurosceptic point scoring isn't wrong.

[quote="McGiver;115822615"
Note: The EU equals Ireland, it's not a separate entity. Mairead McGuinness makes decisions, Taoiseach and Minsters make decisions, MEPs make decisions.
Ireland was part of the negotiation with Pfizer, AZ, Sanofi, GSK and Moderna.

---
Can we focus on the vaccine and situation in Ireland instead of spreading Eurosceptic agendas?[/quote]

This does effect Ireland we are closing education and construction this week two huge steps and there is strong indications that the initial distribution was not equitable if the EU really does equal Ireland or Italy

McGiver

Melanchthon wrote: »

Considering that Germany already went against the agreement and negotiated buying extra doses of the Pfizer vacine without repercussions I think that this is just being used as an excuse to not attempt it.

Second to this fact because the reply will be that German will get these doses after the initial EU distribution, if this is the case why did Germany receive ten times the number of doses than countries such as Italy in the first days of the trial.

These facts seem to keep being ignored and downplayed for some reason.

Stop the "Germans are bad" thing, it goes across many of your posts in multiple forums. What did Germans do to you, provided that Ireland didn't even fight WW2? Even if you wanted to go back to WW2, which is ridiculous in 2021. The German-bashing is tiresome really. Germany the universal boogeyman. It's the fúcking research, manufacturing and finance hub of Europe and it will always be the case due to the size and good governance etc. Either try to replicate their success or be quiet :cool:

Melanchthon

McGiver wrote: »

Stop the "Germans are bad" thing, it goes across many of your posts in multiple forums. What did Germans do to you, provided that Ireland didn't even fight WW2? Even if you wanted to go back to WW2, which is ridiculous in 2021. The German-bashing is tiresome really. Germany the universal boogeyman. It's the fúcking research, manufacturing and finance hub of Europe and it will always be the case due to the size and good governance etc. Either try to replicate their success or be quiet :cool:

So you can't refute my points then, if the German actions weren't in breach surely the commission would have directly said it and put the matter to bed rather than fueling sceptics by the non response

Apogee

JP Liz V1 wrote: »

Has any been rolled out in Limerick and Kerry yet?

Started on Tuesday:

The Kerryman wrote:

A thousand doses of the Covid-19 vaccine arrived at University Hospital Kerry (UHK) on Tuesday with vaccinations of front-line staff set to beginning almost immediately.Frontline medic, consultant anaesthetist Dr Niamh Feely made history as the first recipient of the life-saving jab in the county, administered by vaccinator and nurse Sadie Evans on Tuesday afternoon to widespread applause and relief in UHK and beyond.

https://www.independent.ie/regionals/kerryman/news/its-the-beginning-of-the-end-39936263.html

McGiver

Melanchthon wrote: »

So you can't refute my points then, if the German actions weren't in breach surely the commission would have directly said it and put the matter to bed rather than fueling sceptics by the non response

Germany - bad. EU - bad. Ireland - good. Same old. No substance. :pac:

McGiver

Melanchthon wrote: »

This does effect Ireland we are closing education and construction this week two huge steps and there is strong indications that the initial distribution was not equitable if the EU really does equal Ireland or Italy

You better focus on why the Irish Gov is failing to quickly distribute what it got/gets/will get from Pfizer and Moderna instead of speculating about what it could have done if it received more.

The reality is - if Ireland received more as of now, it wouldn't be able to organise quick enough distribution. So wthat's the point getting more vaccines if you can't deliver them quickly and they just lay somewhere unused.