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

ACitizenErased

ACitizenErased wrote: »

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

Its actually explicitly stated in the regulations governing medicinal products within the EU, that the Qualified Person within a manufacturer cannot sign of batch for release prior to market authorisation. By asking them to deliver to the customer prior to authorisation you are essentially asking the QP to break the law.

Now there is nothing preventing the manufacturer moving product to its own distribution centres

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/v4_an16_201510_en.pdf

dan786

Two of my cousins in UAE in their mid twenties and perfectly healthy got the vaccine today. They are moving them really fast. One of them is only on a 6 month visit visa and got vaccinated.

ACitizenErased

[Deleted User] wrote: »

Its actually explicitly stated in the regulations governing medicinal products within the EU, that the Qualified Person within a manufacturer cannot sign of batch for release prior to market authorisation. By asking them to deliver to the customer prior to authorisation you are essentially asking the QP to break the law.

Now there is nothing preventing the manufacturer moving product to its own distribution centres

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/v4_an16_201510_en.pdf

As I said, its bizarre. Slows the whole process down.

Russman

Are we still expecting interim results from Janssen tomorrow ?
I seem to remember a report a few weeks ago giving 21st Jan as the date they'd have them....

ACitizenErased

ACitizenErased wrote: »

As I said, its bizarre. Slows the whole process down.

There are well documented reasons why the controls are in place. FDA have an almost identical system.

MerlinSouthDub

UK and Belgium mentioned in this article as looking for supplies of the Oxford vaccine from Serum Institute in India (apparently, India can manufacture 500 million doses per month!)

https://www.bloomberg.com/news/articles/2021-01-20/u-k-belgium-among-nations-seeking-cheaper-indian-vaccines?srnd=premium-europe

ACitizenErased

[Deleted User] wrote: »

There are well documented reasons why the controls are in place. FDA have an almost identical system.

I’m not on about why it’s in place, it’s ridiculous either way. Once in a lifetime pandemic to be fair.

MerlinSouthDub

ACitizenErased wrote: »

I’m not on about why it’s in place, it’s ridiculous either way. Once in a lifetime pandemic to be fair.

If ever there was time to change the rules, that time would be now. Thousands of lives lost every day in Europe due to Covid, every little bit you can speed up the vaccine roll-out will make a difference.

y2k2020

titan18 wrote: »

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

Does it really matter?

Do they even have enough supply?

ACitizenErased

MerlinSouthDub wrote: »

If ever there was time to change the rules, that time would be now. Thousands of lives lost every day in Europe due to Covid, every little bit you can speed up the vaccine roll-out will make a difference.

100% agree, it’s pure bureaucracy. No reason why they can’t be stored in warehouses in each country and shipped the minute it’s approved other than ridiculous red tape.

ACitizenErased

ACitizenErased wrote: »

I’m not on about why it’s in place, it’s ridiculous either way. Once in a lifetime pandemic to be fair.

Its not, really. And the usual naysayers would be on here saying we are bypassing safety protocols etc etc. The code of regulations for pharmaceutical products has been developed over many years. It cannot be allowable for a manufacturer to let product out of their control prior to market approval. For one there may be conditions attached that require them to withdraw. I could post a long list of examples of real harm to patients where the types of controls within the system were bypassed or that happened before they were in place.

From the outside, shipping to the customer may seem a good idea. But working in the industry it is simply not possible. Even if the EU bent the rules in this situation, the QP in the pharma company is legally obliged, under threat of criminal sanction, to comply with the rules.

Now if AZ have a DC they can store product in, that's a different story.

ACitizenErased

[Deleted User] wrote: »

Its not, really. And the usual naysayers would be on here saying we are bypassing safety protocols etc etc. The code of regulations for pharmaceutical products has been developed over many years. It cannot be allowable for a manufacturer to let product out of their control prior to market approval. For one there may be conditions attached that require them to withdraw. I could post a long list of examples of real harm to patients where the types of controls within the system were bypassed or that happened before they were in place.

From the outside, shipping to the customer may seem a good idea. But working in the industry it is simply not possible. Even if the EU bent the rules in this situation, the QP in the pharma company is legally obliged, under threat of criminal sanction, to comply with the rules.

Now if AZ have a DC they can store product in, that's a different story.

They’re not “letting it out” though? It would be stored in each country’s vaccine distribution centre. I cannot defend it. Lives being lost every day and we’re saying ah shur we can’t do that...

MerlinSouthDub

Deleted User wrote: »

Now if AZ have a DC they can store product in, that's a different story.

Wouldn't AZ have a DC in pretty much every EU country though? Particularly given that storage requirements for this vaccine are not onerous.

ACitizenErased

MerlinSouthDub wrote: »

Wouldn't AZ have a DC in pretty much every EU country though? Particularly given that storage requirements for this vaccine are not onerous.

AZ have an office in liffey valley as far as i know

hynesie08

ACitizenErased wrote: »

AZ have an office in liffey valley as far as i know

An office is one thing, do they have storage capacity for vaccines?

ACitizenErased

hynesie08 wrote: »

An office is one thing, do they have storage capacity for vaccines?

That’s not the reason why it’s not being sent out so it doesn’t really matter whether they can install a regular fridge or not

hynesie08

ACitizenErased wrote: »

That’s not the reason why it’s not being sent out so it doesn’t really matter whether they can install a regular fridge or not

You're being disingenuous now, QC should absolutely be the priority, and for AZ, that's up until the second it leaves their facility.....

And sticking a fridge in an office doesn't make it a distribution centre any more than sticking a goal out my back makes it Dalymount Park.

ACitizenErased

hynesie08 wrote: »

You're being disingenuous now, QC should absolutely be the priority, and for AZ, that's up until the second it leaves their facility.....

And sticking a fridge in an office doesn't make it a distribution centre any more than sticking a goal out my back makes it Dalymount Park.

It’s going to be in fridges across the country in GP offices soon so I can’t really understand why you’re making that an issue

AdamD

I think a decision like this (if true), is precisely the red tape people do not want to see. This does nothing whatsoever for safety.

y2k2020

ACitizenErased wrote: »

It’s going to be in fridges across the country in GP offices soon so I can’t really understand why that is an issue

I agree

Can't see how anyone can disagree tbh

Micky 32

From RTE regarding the Israel efficacy claims:

“”Responding to Israel's claims that efficacy from the first dose of the Pfizer vaccine may be as low as 33%, Sir Patrick said studies showed that from day 10 after vaccination to 21 days and beyond, it was "much more like 89%". 

However, he added that "when you get into real-world practice things are seldom quite as good as clinical trials". 

He told told Sky News: "It probably won't be as high as that in practice, but I don't think it'll be as low as the figures you've just given." 

According to reports, scientists in Israel - where around a quarter of the population has already been vaccinated - studied preliminary data from 200,000 vaccinated people. 

The study reportedly suggests that a drop of 33% in positivity was seen in the vaccinated group on day 14 after vaccination. 

Professor Vallance said clinical study studies suggest that if you look at data from day zero, then the overall figure is around 50%. 

But he added that protection is not expected in the first 10 days because the immune system has not had the chance to build up, and some people may have been infected before they had the vaccine. 

"I don't know exactly what Israel are looking at - they're looking at the total period from day nought and that doesn't give an exact comparison. “”

hynesie08

ACitizenErased wrote: »

It’s going to be in fridges across the country in GP offices soon so I can’t really understand why you’re making that an issue

After all necessary QC and approval criteria have been met.

I'm as anxious as anyone to get this out there, but the final approval being given while the actual vaccines are sitting in a fridge in borris on ossery? I'll wait the 12 hours instead.....

ACitizenErased

AdamD wrote: »

I think a decision like this (if true), is precisely the red tape people do not want to see. This does nothing whatsoever for safety.

Agree, it’s hardly like they’re releasing it for the public to buy freely like other pharmaceuticals

y2k2020

Micky 32 wrote: »

From RTE regarding the Israel efficacy claims:

“”Responding to Israel's claims that efficacy from the first dose of the Pfizer vaccine may be as low as 33%, Sir Patrick said studies showed that from day 10 after vaccination to 21 days and beyond, it was "much more like 89%". 

However, he added that "when you get into real-world practice things are seldom quite as good as clinical trials". 

He told told Sky News: "It probably won't be as high as that in practice, but I don't think it'll be as low as the figures you've just given." 

According to reports, scientists in Israel - where around a quarter of the population has already been vaccinated - studied preliminary data from 200,000 vaccinated people. 

The study reportedly suggests that a drop of 33% in positivity was seen in the vaccinated group on day 14 after vaccination. 

Professor Vallance said clinical study studies suggest that if you look at data from day zero, then the overall figure is around 50%. 

But he added that protection is not expected in the first 10 days because the immune system has not had the chance to build up, and some people may have been infected before they had the vaccine. 

"I don't know exactly what Israel are looking at - they're looking at the total period from day nought and that doesn't give an exact comparison. “”

Interesting

With that data they surely have to tell the vaccinated to self isolate for 10 day's upon being injected?

Data shows a massive efficacy improvement for 10 days and beyond

Did anyone get badly sick/die before those 10 day's?

Does it still protect from severe illness early on?

ACitizenErased

ACitizenErased wrote: »

They’re not “letting it out” though? It would be stored in each country’s vaccine distribution centre. I cannot defend it. Lives being lost every day and we’re saying ah shur we can’t do that...

Shur we will make an exception this time..and that time and the other time, and before you know it there are no regulations

braychelsea

AstraZeneca allowed UK to have vaccines in GP's before approval so it is obviously EU bureaucracy holding things up

ACitizenErased

[Deleted User] wrote: »

Shur we will make an exception this time..and that time and the other time, and before you know it there are no regulations

Don’t be ridiculous, it’s hardly some sort of groundbreaking exception to ship a vaccine early in a once in a lifetime pandemic. It’s pure and utter red tape, no other reason.

AdamD

hynesie08 wrote: »

After all necessary QC and approval criteria have been met.

I'm as anxious as anyone to get this out there, but the final approval being given while the actual vaccines are sitting in a fridge in borris on ossery? I'll wait the 12 hours instead.....

We're not talking 12 hours here. We're talking a delivery in mid-February versus having the vaccine ready to go on January 30th

ACitizenErased

ACitizenErased wrote: »

100% agree, it’s pure bureaucracy. No reason why they can’t be stored in warehouses in each country and shipped the minute it’s approved other than ridiculous red tape.

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/v4_an16_201510_en.pdf

4. THE RELEASE OF A BATCH
4.1 Batches of medicinal products should only be released for sale or supply to the
market after certification by a QP as described above. Until a batch is certified, it
should remain at the site of manufacture or be shipped under quarantine to
another site which has been approved for that purpose by the relevant Competent
Authority.
9
4.2 Safeguards to ensure that uncertified batches are not transferred to saleable stock
should be in place and may be physical in nature, e.g. the use of segregation and
labelling or electronic in nature, e.g. the use of validated computerised systems.
When uncertified batches are moved from one authorised site to another, the
safeguards to prevent premature release should remain.
4.3 The steps necessary to notify QP certification to the site where the transfer to
saleable stock is to take place should be defined within a technical agreement.
Such notification by a QP to the site should be formal and unambiguous and
should be subject to the requirements of Chapter 4 of EudraLex, Volume 4, Part I.

braychelsea

braychelsea wrote: »

AstraZeneca allowed UK to have vaccines in GP's before approval so it is obviously EU bureaucracy holding things up

No that didn't. Under EUA the regulator released individual batches rather than Market Approval