COVID-19: Vaccine and testing procedures Megathread Part 3 - Read OP

Red Silurian

I had a look this lunch time at the EMA's rolling review process and how long it took from the beginning of rolling review to approval

Biontech - 72 days (1st October to 12th December)
Moderna - 52 days (16th November to 6th January)
Oxford/AZ - 122 days (30th September to 29th of January)
Jansen (J&J) - 100 days (1st of December to 11th of March)

There are obviously factors to consider but Under rolling review at the moment are

Novavax - Started rolling review on 3rd of February
Curevax - Started roling review on 12th of February
Sputnik V - Started rolling review on 4th of March

Assuming all the above are accepted by the EMA (no guarantee obviously) the EMA should have them approved between 52 and 122 days from Rolling Review start meaning -

Novavax - 8th April - 17th June
Curevax - 17th April - 26th June
Sputnik V - 25th April - July 4th

Melanchthon

Red Silurian wrote: »

Novavax - Started rolling review on 3rd of February
Curevax - Started roling review on 12th of February
Sputnik V - Started rolling review on 4th of March

Assuming all the above are accepted by the EMA (no guarantee obviously) the EMA should have them approved between 52 and 122 days from Rolling Review start meaning -

Novavax - 8th April - 17th June
Curevax - 17th April - 26th June
Sputnik V - 25th April - July 4th

Said it before, will say it again, there's no evidence of any agreement with Novavax having been concluded with the EU despite it being really really promising. Somebody needs to ask Maread McGuiness or Micheal Martin to enquire about it at this stage.

Stark

Don't think you can infer anything from when the rolling review started. They're totally dependent on if/when the final data arrives and if/when the supplier makes the application for approval.

Red Silurian

Red Silurian wrote: »

I had a look this lunch time at the EMA's rolling review process and how long it took from the beginning of rolling review to approval

Biontech - 72 days (1st October to 12th December)
Moderna - 52 days (16th November to 6th January)
Oxford/AZ - 122 days (30th September to 29th of January)
Jansen (J&J) - 100 days (1st of December to 11th of March)

There are obviously factors to consider but Under rolling review at the moment are

Novavax - Started rolling review on 3rd of February
Curevax - Started roling review on 12th of February
Sputnik V - Started rolling review on 4th of March

Assuming all the above are accepted by the EMA (no guarantee obviously) the EMA should have them approved between 52 and 122 days from Rolling Review start meaning -

Novavax - 8th April - 17th June
Curevax - 17th April - 26th June
Sputnik V - 25th April - July 4th

Novovax are likely to seek UK and US approval before any submission to the EMA, I would presume as well given the AZ debacle they'll be very careful on the terms of any contract with the EU.

titan18

Melanchthon wrote: »

Said it before, will say it again, there's no evidence of any agreement with Novavax having been concluded with the EU despite it being really really promising. Somebody needs to ask Maread McGuiness or Micheal Martin to enquire about it at this stage.

Ya, haven't seen anything that we actually have stuff ordered there.

is_that_so

titan18 wrote: »

Ya, haven't seen anything that we actually have stuff ordered there.

About a month ago it was "very close" to agreement. The EU have a provisional deal anyway. Has the AZ situation prompted a review/pause I wonder?

josip

josip wrote: »

But if Anagni has 16m doses already there destined for the EU, why break it into 2 tranches and delay 6m vaccines getting into arms?
Something about that 6m in April seems fishy.

Batch release takes time and done on a batch by batch basis, with testing to be completed to ensure it meets predefined criteria. They dont just stick it in a vial and ship.
The qualified person is an individual within a pharma plant who is responsible with ensuring all batches released meet the requirements fully. There are criminal consequences to that individual with not fulfilling those requirements

is_that_so

Deleted User wrote: »

Novovax are likely to seek UK and US approval before any submission to the EMA, I would presume as well given the AZ debacle they'll be very careful on the terms of any contract with the EU.

Novavax is under rolling review with the EMA, like CureVac and Sputnik V.

josip

Deleted User wrote: »

Batch release takes time and done on a batch by batch basis, with testing to be completed to ensure it meets predefined criteria. They dont just stick it in a vial and ship.
The qualified person is an individual within a pharma plant who is responsible with ensuring all batches released meet the requirements fully. There are criminal consequences to that individual with not fulfilling those requirements

How many doses in a typical batch? 1m, 10m, more?

josip

josip wrote: »

How many doses in a typical batch? 1m, 10m, more?

That was in general - based on pharma regs I would say it would be defined by the quantity of usable vaccine yielded from a single "mix", however there are lots of ways to define a batch, very few would include product from multiple runs however and would be based on the start quantity, not a defined number of finished units

is_that_so

RavenBea17b wrote: »

Didn't they say that two or three months now in a row. I wonder what the sticking points are ? ?? Perhaps delivery schedule amongst others.

I last saw it in about mid-February and it was "imminent". I believe they are stockpiling it anyway and Poland have done a deal with them.

Melanchthon

is_that_so wrote: »

About a month ago it was "very close" to agreement. The EU have a provisional deal anyway. Has the AZ situation prompted a review/pause I wonder?

What does a provisional deal mean though. As I understand they have an agreement to reach an agreement

The envisaged contract with Novavax would provide for the possibility for all EU Member States to purchase 100 million doses, and they could further purchase up to 100 million more doses

https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2305
That's the last official thing I can find, the stuff from the start of February was all "sources". I don't know anything really about contract law though but has there been any indication of if money has been handed over in terms of preliminary funding, as in say look at the UK and Astra Zeneca there was all that funding and agreements but not a final contract early.

What's interesting is searched again there too see if anymore news and saw this.

https://mobile.reuters.com/article/idUSKBN2AV19O

"It has also secured eight million doses of Novavax's vaccine as part of EU joint purchases. " But that's weird, Reuters is normally good but isn't that for the exploration talks? Also it's strange to see figures for the Polish government giving money to build up production but no mention online of EU funds to Novavax unless I am missing it somewhere?

is_that_so

Melanchthon wrote: »

What does a provisional deal mean though. As I understand they have an agreement to reach an agreement

https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2305
That's the last official thing I can find, the stuff from the start of February was all "sources". I don't know anything really about contract law though but has there been any indication of if money has been handed over in terms of preliminary funding, as in say look at the UK and Astra Zeneca there was all that funding and agreements but not a final contract early.

What's interesting is searched again there too see if anymore news and saw this.

https://mobile.reuters.com/article/idUSKBN2AV19O

"It has also secured eight million doses of Novavax's vaccine as part of EU joint purchases. " But that's weird, Reuters is normally good but isn't that for the exploration talks? Also it's strange to see figures for the Polish government giving money to build up production but no mention online of EU funds to Novavax unless I am missing it somewhere?

I'd see it as meaning agreement in principle without committing either party to legal binding positions. After AZ they may well want to make sure the contract is watertight. Novavax already stockpiling vaccines will help everyone.

BlakeS94

Got a text earlier today giving me an appointment time for my first dose vaccine tomorrow,wasn't expecting it but I'd say I'm in with the over 80s due to a health condition, not much notice but I will attend. Anyone else on the thread with a condition get the vaccine?, if so, how did you get on afterwards?

is_that_so

is_that_so wrote: »

Novavax is under rolling review with the EMA, like CureVac and Sputnik V.

Rolling review means feck all until the company actually make a formal submission, which Novavax haven't done yet.

embraer170

Apogee wrote: »

https://twitter.com/lidl_ireland/status/1374381763066089487

Nice, but I think there should be an obligation to test and to report the results.

Micky 32

https://twitter.com/jamespurvis21/status/1374791499934797829?s=21

:pac::pac:

embraer170

I am getting very confused by the whole vaccine roll out.


My father 86 got his first dose on 18 February and his second dose on St Patrick’s Day. All good.

My mom (same GP) who turned 75 in early March has no news at all. She has a wide range of underlying conditions including three strokes. She called the doctor yesterday to ask and was told her first dose would not be before mid/end-April (!!).

Asking about left-over doses from cancellations (willing to go at very short notice, and I read that living with an 85+ year old puts you on a priority list for cancellations), she was brushed off saying they never have any cancellations (hmmmm).

All a bit frustrating.

Galwayguy35

is_that_so wrote: »

I last saw it in about mid-February and it was "imminent". I believe they are stockpiling it anyway and Poland have done a deal with them.

So if Poland can do a deal and Hungary did one a few months back why can't Martin grow a pair and do the same

thecretinhop

zzzzz

Bubbaclaus

I wonder will we start getting our first 20k+ days in the data this week. Any update on latest deliveries?

thecretinhop

btw i got a batch sticker lol bit like getting dog shots.

Str8outtaWuhan

embraer170 wrote: »

I am getting very confused by the whole vaccine roll out.


My father 86 got his first dose on 18 February and his second dose on St Patrick’s Day. All good.

My mom (same GP) who turned 75 in early March has no news at all. She has a wide range of underlying conditions including three strokes. She called the doctor yesterday to ask and was told her first dose would not be before mid/end-April (!!).

Asking about left-over doses from cancellations (willing to go at very short notice, and I read that living with an 85+ year old puts you on a priority list for cancellations), she was brushed off saying they never have any cancellations (hmmmm).

All a bit frustrating.

time to find a new GP

CIARAN_BOYLE

Bubbaclaus wrote: »

I wonder will we start getting our first 20k+ days in the data this week. Any update on latest deliveries?

It all depends. Astra Zenaca have promised massive deliveries in late q1. I don't know if it will come or when it would come if it does.

We could have a 50k day if AZ make the deliveries that were talked about as late q1.

I think it depends on approval of the Dutch factory though and the UK has said that they want the Dutch doses.

beggars_bush

Str8outtaWuhan wrote: »

time to find a new GP

Not much the GP can do if the doses don't arrive

thecretinhop

Str8outtaWuhan wrote: »

time to find a new GP

friends father in law cancelled. they rang at 5pm 1 left get there so guff.

Red Silurian

Melanchthon wrote: »

Said it before, will say it again, there's no evidence of any agreement with Novavax having been concluded with the EU despite it being really really promising. Somebody needs to ask Maread McGuiness or Micheal Martin to enquire about it at this stage.

I can see your point but why ask for a rolling review if you're not going to try to sell your product in the EU? Seems like effort wasted

[Deleted User] wrote: »

Rolling review means feck all until the company actually make a formal submission, which Novavax haven't done yet.

Rolling reviews is how authorisation starts, companies have to apply for the rolling reviews so it's at least a sign of intent to supply vaccines

Micky 32 wrote: »

https://twitter.com/jamespurvis21/status/1374791499934797829?s=21

:pac::pac:

I think he's taken the wrong Pfizer product

lbj666

Micky 32 wrote: »

https://twitter.com/jamespurvis21/status/1374791499934797829?s=21

:pac::pac:

Keep in mind restriction play a part in this too, We are what? down 66% from peak?

embraer170

Str8outtaWuhan wrote: »

time to find a new GP

Not really that easy.

11521323

Can someone explain to me exactly how some nations in the EU are way ahead of us currently and in their timelines when we should all be getting the same supply per capita?