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

Hmmzis

Some data on Monderna's and Pfizer/BNT's vaccines against the new variants:

https://www.biorxiv.org/content/10.1101/2021.01.15.426911v1.full.pdf+html

They're holding up which is great news, but it would be wise to start looking at updates and multivalent constructs.

Probes

Hector Savage wrote: »

Exactly .... too quick will become longer and longer ...

But... reality flies in the face of what you are suggesting. The government opened early to try and keep the economy going, they want to open up, they don't want restrictions.

What is it you are trying to say here? Are you saying they lifted restrictions too early on purpose so that cases would rise? So they can keep us locked down indefinitely? What's the purpose of that?

NaFirinne

Probes wrote: »

But... reality flies in the face of what you are suggesting. The government opened early to try and keep the economy going, they want to open up, they don't want restrictions.

What is it you are trying to say here? Are you saying they lifted restrictions too early on purpose so that cases would rise? So they can keep us locked down indefinitely? What's the purpose of that?

To allow the fear factor of the disease to allow them to introduce further severe restrictions and push out experimental gene therapies that have been some how redefined as vaccines along with introducing extreme control measures on every aspect of peoples lives.


We see the big tech companies getting far too much control over the media and silencing whomever the like. We see small and medium businesses dying. We see America on the brink of civil war and we see china becoming the greatest and most influencing super power in the world.


Wasn't the timetable for all this released in Canda back in August....it's being followed pretty well so far.

plodder

McGiver wrote: »

https://infogram.com/table-covid-vaccination-tracker-1hnp27mm7womn2g

7th in the EU, which is great.

Saying that. This is a long run not a sprint. I suspect large population centres (the Pale basically) will be done quickly, but then it will slow down. Low population density and poor infrastructure/public services will play a role.

That's not been the experience so far, with hospitals outside "the pale" getting most of the early stock. And despite what some would say, we have first world infrastructure as regards GPs and pharmacies and roads even. Population density would only be an issue if the vaccines had to be delivered to people at home.

leahyl

Did anybody see this in the main Covid thread:

http://twitter.com/friedberg/status/1351789902065590273?s=20

:(

El Weirdo

dominatinMC wrote: »

Can you put that in layman terms Hmmzis?

Hmmzis wrote: »

At least when it comes to a natural infection, something in the virus is throwing off our immune system from a lot of important parts (neutralization epitopes) of the spike protein. For some reason most people only develop a very narrow and highly specialized response to one or two of those important parts. This is the reason for the loss reactivity of convalescent serum against the SA (and Brazil, as it's almost the same changes there) variant as the one or two sites are poorly conserved and even small changes lead to drastic alterations of the shape of that part (the RBM is a very flexible loop).

The preferable way for our immune systems to respond would be to target most if not all of the available important sites and in a broader manner.

After a few rounds with various types the immune system should 'get the message' what to target better as it prefers repetitive signals over ones that change from type to type.

This could have implications for any vaccine updates and future vaccine designs.

Micky 32

leahyl wrote: »

Did anybody see this in the main Covid thread:

http://twitter.com/friedberg/status/1351789902065590273?s=20

:(

Some over there on that thread would love those kind of tweets. The main thing is the current vaccines still work against the current strains apparently . Also vaccines like the flu get tweaked all the time.

ixoy

Micky 32 wrote: »

Some over there on that thread would love those kind of tweets. The main thing is the current vaccines still work against the current strains apparently . Also vaccines like the flu get tweaked all the time.

I think the concern is more that, as variations deviate more, the more ineffective a vaccine might get so it's in our best interest to get vaccinations out worldwide as quickly as possible, including a process for tweaking it. The sooner, the better.

Micky 32

ixoy wrote: »

I think the concern is more that, as variations deviate more, the more ineffective a vaccine might get so it's in our best interest to get vaccinations out worldwide as quickly as possible, including a process for tweaking it. The sooner, the better.

Oh i totally aggree.

Morries Wigs

leahyl wrote: »

Did anybody see this in the main Covid thread:

http://twitter.com/friedberg/status/1351789902065590273?s=20

:(

click bait-the vaccines work

IRISHSPORTSGUY

From the I.T

Covid-19: AstraZeneca has told HSE vaccine deliveries can be expected by mid-February
Donnelly tells Cabinet colleagues there is a clear protocol in place for Covid-19 vaccinations

The European Commission has said that Covid-19 vaccines cannot be delivered before they get regulatory approval, denting Ireland’s hopes of securing early supplies of the AstraZeneca shot.

Minister for Health Stephen Donnelly said last weekend that discussions were under way on securing early deliveries of the vaccine to enable it to be rolled out immediately following regulatory approval.

In response to queries from The Irish Times, a European Commission spokesman said: “Vaccines cannot be delivered before EMA [European Medicines Agency] delivers its recommendation for authorisation and the commission then grants marketing authorisation. This is a requirement as per the Advance Purchase Agreement.”

Asked about the early rollout of of the AstraZeneca on RTÉ on Tuesday night, Mr Donnelly said that it was an “ambitious ask” to get the supplies in early, and that it would have to be agreed with both the company and the European Commission as “it would have to be done on an EU basis”.

It comes as Ministers were told during a Cabinet meeting on Tuesday that AstraZeneca has advised the HSE that deliveries of the vaccine can be expected by mid-February, but that firm delivery timetables have not yet been finalised.

On Monday Mr Harris said the situation in the Coombe suggested there either there was a protocol about distributing excess doses of the vaccine in place that was not followed, “or more concerning, if there isn’t a protocol in place as to what you do if there are so-called spare vaccines”.

Multiple sources said Mr Donnelly told colleagues that while there had been commentary about there being no protocols in place to deal with these situations, there were in fact two, and urged his colleagues to come to him with questions on it directly if they had any.

One of the protocols was not published at the time of the Coombe incident.

While some Government sources were of the view that it was “very clearly” a response to Mr Harris’s comments, others present at the meeting said they did not see it that way.

Clinics
Cabinet was told preparations were being made for a significant scaling up of the vaccine programme in the weeks ahead, with doses administered growing from 165,000 in January to 770,000 in March. The expansion will rely on the GP and pharmacist network, with vaccinators working in clinics as well as in mass vaccination centres.

Mr Donnelly told Ministers that planning was under way to mobilise mass vaccination centres and the vaccinators working in them across the State from early February in order to facilitate an increase in supply.

The Cabinet was also updated on the IT system being used to record vaccinations, with Ministers told it was now operating across hospitals and long-term care facilities.

While some functions, such as self-registration and the capture of consent and other clinical details, are now live, it is intended that the capacity to schedule second doses will soon be brought on stream.

The Dáil heard last week that as the system was being rolled out, operational issues meant some information had to be recorded using pen and paper before being transferred digitally.

Sources have said the problem centred on the online profiles that were to be set up for individual healthcare practitioners through which they would input data on the vaccines they had administered and the batch numbers.

Problems were encountered at an early stage when these workers could not set up their own profiles for various reasons.

lucernarian

IRISHSPORTSGUY wrote: »

From the I.T

Is there a good reason the EU would withhold deliveries until any approval by the EMA? This doesn't reflect well on the EU and its agreement if not.

ixoy

ixoy wrote: »

I think the concern is more that, as variations deviate more, the more ineffective a vaccine might get so it's in our best interest to get vaccinations out worldwide as quickly as possible, including a process for tweaking it. The sooner, the better.

Given that the developers were already well on the path to having a working vaccine by March last, its likely detailed assessments of the required updates for any new strains are well underway, possibly before most of us had even heard of new strains. Any modifications don't need to go through full approval as safety and effectiveness of the delivery mechanism has already been demonstrated. They will just need to demonstrate any additional claims made for the modified version. Likely largely lab data with a bit of in vivo

trellheim

That is codswallop. The APA is not public - The Commission could say anything they want to

https://www.asktheeu.org/en/request/covid_19_advance_purchase_agreem

plodder

In response to queries from The Irish Times, a European Commission spokesman said: “Vaccines cannot be delivered before EMA [European Medicines Agency] delivers its recommendation for authorisation and the commission then grants marketing authorisation. This is a requirement as per the Advance Purchase Agreement.”

That will have Johnson and the Brexiteers patting each other on the back. Exactly what they wanted to get away from.

ixoy

lucernarian wrote: »

Is there a good reason the EU would withhold deliveries until any approval by the EMA? This doesn't reflect well on the EU and its agreement if not.

Is it a matter of trust? Fearing that governments would break open the vaccines if they were in warehouses and start administering them without approval. I don't quite understand it otherwise as I assume the EMA aren't looking at the logistics end of delivering the vaccine to a country.

plodder

ixoy wrote: »

Is it a matter of trust? Fearing that governments would break open the vaccines if they were in warehouses and start administering them without approval. I don't quite understand it otherwise as I assume the EMA aren't looking at the logistics end of delivering the vaccine to a country.

How would it be any different from the "rolling review" principle that the EMA itself used?

trellheim

EMA <> EU commission. EMA independently decides which vaccines are safe and issues approvals.

European Commission negotiates for all EU27 an advance purchase agreement from the manufacturers.

GreeBo

If the results from Israel continue to show that the single dose approach isnt as effective as previously though, at what stage to the UK and others change their strategy and pull in the dates for the second dose?

titan18

lucernarian wrote: »

Is there a good reason the EU would withhold deliveries until any approval by the EMA? This doesn't reflect well on the EU and its agreement if not.

It's stupid bureaucracy imo. The EU Commission are making themselves look like idiots with it, and as someone said above, Boris and the Brexiteers (and anti EU people in current countries) will latch on to it now. They should be enabling countries to get people vaccinated as fast as safely possible. This is just a delay for the sake of a delay.

Hopefully one of the stronger countries kick up on it, as no chance Donnelly will. If German government kick up, might get it changed

MerlinSouthDub

titan18 wrote: »

It's stupid bureaucracy imo. The EU Commission are making themselves look like idiots with it, and as someone said above, Boris and the Brexiteers (and anti EU people in current countries) will latch on to it now. They should be enabling countries to get people vaccinated as fast as safely possible. This is just a delay for the sake of a delay.

Hopefully one of the stronger countries kick up on it, as no chance Donnelly will. If German government kick up, might get it changed

Yep, it makes absolutely zero sense not to allow deliveries to happen in advance of approval (to be used only when approval happens). It creates a totally unnecessary delay, and the only defence the EU seem to have for the approach is "this is the way we said we'd do it", rather than any logical rationale.

Le Bruise

So on the one hand the EU commission are calling for all EU states to accelerate their roll out and vaccinate 70% of their population by the summer....and on the other they're standing in the way of early delivery of one of the major vaccines that will enable the countries to do this? Counter productivity at its finest!

Deenie78

Is there any reason to think they might not approve the vaccine and that's why they won't allow early delivery? (I know it's unlikely, but just asking)

GreeBo

titan18 wrote: »

It's stupid bureaucracy imo. The EU Commission are making themselves look like idiots with it, and as someone said above, Boris and the Brexiteers (and anti EU people in current countries) will latch on to it now. They should be enabling countries to get people vaccinated as fast as safely possible. This is just a delay for the sake of a delay.

Hopefully one of the stronger countries kick up on it, as no chance Donnelly will. If German government kick up, might get it changed

Isnt it tied into the costs though?
I believe the EU only has to pay in the event the vaccines get approved, arranging delivery before approval might compromise that agreement.

Is there any evidence that the suppliers are willing to deliver without payment for example?

CIARAN_BOYLE

Deenie78 wrote: »

Is there any reason to think they might not approve the vaccine and that's why they won't allow early delivery? (I know it's unlikely, but just asking)

Approval is not a slam dunk obvious case.

I expect approval but I have questions about what dosage regiment will be recommended.

If there is data due on a particular dosage I could see approval delayed until that data comes in.

If we take delivery and its not approved there could be problems. Why did we take delivery, why are we paying to store etc. Why are we taking delivery when we can't use it.

This is why delivery is not supposed to happen until its approved by the ema. Its not actually approved until the European commission signs off after ema approval.

GreeBo wrote: »

Isnt it tied into the costs though?
I believe the EU only has to pay in the event the vaccines get approved, arranging delivery before approval might compromise that agreement.

Is there any evidence that the suppliers are willing to deliver without payment for example?

I belive the EU had to pay a certain amount in advance and even if it didn't get approved the EU wouldn't get that back (the buying in advance was to help fund development).

CIARAN_BOYLE

CIARAN_BOYLE wrote: »

Approval is not a slam dunk obvious case.

I expect approval but I have questions about what dosage regiment will be recommended.

If there is data due on a particular dosage I could see approval delayed until that data comes in.

If we take delivery and its not approved there could be problems. Why did we take delivery, why are we paying to store etc. Why are we taking delivery when we can't use it.

This is why delivery is not supposed to happen until its approved by the ema. Its not actually approved until the European commission signs off after ema approval.

Placing strategic stock in distribution centres at risk prior to approval is common in the industry -would need to remain in control of the manufacturer however

MerlinSouthDub

GreeBo wrote: »

Isnt it tied into the costs though?
I believe the EU only has to pay in the event the vaccines get approved, arranging delivery before approval might compromise that agreement.

Is there any evidence that the suppliers are willing to deliver without payment for example?

The Astra Zeneca vaccine is very cheap, a couple of euros a dose. Pay the supplier, and get moving. Very little lost even if it doesn't get approved (it's possible approval might be delayed, but very unlikely it won't be approved). It's time to put health and lives ahead of costs and bureaucracy.

ACitizenErased

Very disappointed the EU would not allow delivery before approval. Bizarre.

titan18

MerlinSouthDub wrote: »

The Astra Zeneca vaccine is very cheap, a couple of euros a dose. Pay the supplier, and get moving. Very little lost even if it doesn't get approved (it's possible approval might be delayed, but very unlikely it won't be approved). It's time to put health and lives ahead of costs and bureaucracy.

Yup, with the rolling reviews and only about a week to go until the date they have, they surely know how likely it is or not is to be approved. If they know it's going to be approved then, they should allow delivery

Godot.

MerlinSouthDub wrote: »

The Astra Zeneca vaccine is very cheap, a couple of euros a dose. Pay the supplier, and get moving. Very little lost even if it doesn't get approved (it's possible approval might be delayed, but very unlikely it won't be approved). It's time to put health and lives ahead of costs and bureaucracy.

The EU love talking about money saved by buying the vaccine as a bloc, but that is dwarfed by the amount lost because of every week countries spend in lockdown.

"Penny-wise, Pound-foolish"