Vaccine Progress, Approval, and Deployment

[Domh245]

We already have enough vaccine in the country to do groups 1-4, subject to fill and finish. The debate is over the rest of the adult population, where as far as vaccination is concerned, are of little interest to the programme to reduce deaths and hospitalisations.

It's groups 5-9 that are the 'bed blockers' though I thought, key to easing pressure on the healthcare system

I see that Pfizer have licenced a rival company to manufacture their vaccine on the continent. Could Astra not do the same thing ?

They have - in the UK it's being produced by Wockhardt in Wrexham and Cobra Biologics in Keele and indeed in the EU one of the main plants that has caused the issue by failing to achieve the desired yields is run by French firm Novasep. Pfizer on the other hand had chosen to run production fully in house (until recently). Licensing it out even more though doesn't solve the immediate issue of getting doses now given the long lead times involving in setting these things up

Depending on what the approval is for AZ by the EMA, there is some scope for the UK to come out of this looking rather good. If they do grant authorisation for the over 65s, then depending on how brave Boris is feeling we could send some of our domestic production to the EU to "help our dear friends" in return for being able to tap into their production later if necessary. On the flip side, if they do choose to only authorise for under 65s it makes it rather easy for us to decide to keep vaccines going into British arms at full speed

 

[hwl]

Unfortunately, it seems that we're not going to be allowed out of our doors even if categories 1-4 are vaccinated, so thats of limited practical value to the majority of us.

I see that Pfizer have licenced a rival company to manufacture their vaccine on the continent. Could Astra not do the same thing ?

Huge time lags - Sanofli's facility is only being loaned after July and then they have to get it up and running (which takes months). It looks like the aim is to get the younger adults or potential 12-18 market later on as well as non european customers.

 

[adc82140]

The timing of releases does seem though to be groups 1-4 + 3 weeks, so when they have immunity. Already the heat map is showing the average age of infections is dropping, so the vaccine is already having an effect. The bulk of hospital admissions have been in the 1-4 category. The public won't stand for restrictions if hospital admissions and deaths plummet

 

[hwl]

It's groups 5-9 that are the 'bed blockers' though I thought, key to easing pressure on the healthcare system

There aren't directly comparable ICU stats for groups 1-4 but circa 1/3rd would be about right based on some quick analysis and circa 80% for Groups 1-9

They have - in the UK it's being produced by Wockhardt in Wrexham and Cobra Biologics in Keele and indeed in the EU one of the main plants that has caused the issue by failing to achieve the desired yields is run by French firm Novasep. Pfizer on the other hand had chosen to run production fully in house (until recently). Licensing it out even more though doesn't solve the immediate issue of getting doses now given the long lead times involving in setting these things up

Depending on what the approval is for AZ by the EMA, there is some scope for the UK to come out of this looking rather good. If they do grant authorisation for the over 65s, then depending on how brave Boris is feeling we could send some of our domestic production to the EU to "help our dear friends" in return for being able to tap into their production later if necessary. On the flip side, if they do choose to only authorise for under 65s it makes it rather easy for us to decide to keep vaccines going into British arms at full speed

Yep what they want is vaccine now, not vaccine later. The EU are now staring at much longer restrictions (+ consequent economic damage) and the logistical challenges of much higher vaccination rates later to get the adult population vaccinated before winter.

The phase 3 vaccine trials in 12-18 age group start in Feb so interim results in May? and full in June /July? Which might see increased demand then.

The timing of releases does seem though to be groups 1-4 + 3 weeks, so when they have immunity. Already the heat map is showing the average age of infections is dropping, so the vaccine is already having an effect. The bulk of hospital admissions have been in the 1-4 category. The public won't stand for restrictions if hospital admissions and deaths plummet

3 weeks also happen to be a sensible time lag for looking at hospitalisation rate.
The main hospital issue is ICU capacity and 75% of Covid ICU admissions are under 70, hence vaccinating groups 1-4 won't have a huge effect on its own, the main driver will be case numbers for quite while yet (the mean age for covid ICU admission is 59, down from 60 which is probably due to vaccination).
There are also far more 60-70 year olds that 70-80 year olds and at the same time lots of second jabs will be needed so it might take longer to get there than people expect.

 

[Philip]

There aren't directly comparable ICU stats for groups 1-4 but circa 1/3rd would be about right based on some quick analysis and circa 80% for Groups 1-9

Yep what they want is vaccine now, not vaccine later. The EU are now staring at much longer restrictions (+ consequent economic damage) and the logistical challenges of much higher vaccination rates later to get the adult population vaccinated before winter.

The phase 3 vaccine trials in 12-18 age group start in Feb so interim results in May? and full in June /July? Which might see increased demand then.


3 weeks also happen to be a sensible time lag for looking at hospitalisation rate.
The main hospital issue is ICU capacity and 75% of Covid ICU admissions are under 70, hence vaccinating groups 1-4 won't have a huge effect on its own, the main driver will be case numbers for quite while yet (the mean age for covid ICU admission is 59, down from 60 which is probably due to vaccination).
There are also far more 60-70 year olds that 70-80 year olds and at the same time lots of second jabs will be needed so it might take longer to get there than people expect.

Why will lots of second jabs be needed to reduce hospital numbers? So far the trials have indicated that the first dose provides the majority of the protection and so should stop prevent the vast majority becoming seriously ill.

 

[Chester1]

The EU has the power to block the export of Pfizer vaccine made in the EU and to put pressure on AZ, an Anglo-Swedish company, to do its bidding. Perfidious Albion's vaccination programme is likely to be derailed. Another benefit of Brexit!

Pfizer vaccine imports are likely to be delayed anyway. The ownership of the company doesn't make a difference. The Government will block exports of AZ vaccine when its contract isn't being met. Our domestic production is over 2 million doses per week. The EU can slow down the vaccination program but not stop it.

There are people both inside and outside who are desperate for the UK to fail because of brexit. Its not about that. For once the Government acted fast and made sure domestic production was ramped up and the supply chain secured. There is already enough vaccine in the UK to do everyone who is high risk twice. AZ had 18.5 million doses in the UK a month ago and should have produced another 8 million. About 15 million Pfizer doses have been delivered. That covers the 20 million people in high risk categories in the UK without manufacturing or importing anything.

 

[yorksrob]

We seem to be getting dragged into a bun fight with continental Europe regarding production, whilst the WHO are now wading in against vaccine nationalism.

I just hope the WHO are as vocal with their chums in Beijing when it comes to condemning vaccine nationalism, particularly given that India has already knocked out billions of doses of the Astra vaccine for regions other than UK/Europe.

 

[brad465]

Apparently the J&J vaccine findings will be released next week. Does anyone know roughly how many of the 30 million doses we've ordered are likely to be available, either now or from mid-February when, if the data is good, it might be approved?

 

[HSTEd]

Apparently the J&J vaccine findings will be released next week. Does anyone know roughly how many of the 30 million doses we've ordered are likely to be available, either now or from mid-February when, if the data is good, it might be approved?

Well Pfizer was approved in 8 days.

As to deliveries I wouldn't expect many, it appears the production facilities are in the EU and are likely to be seized as a result.

 

[yorksrob]

Well Pfizer was approved in 8 days.

As to deliveries I wouldn't expect many, it appears the production facilities are in the EU and are likely to be seized as a result.

I read that it was manufactured in Scotland, which isn't in the EU.....yet anyway.

 

[duncanp]

Oh dear, Germany's vaccination commitee has put the cat amongst the pigeons by saying that the Astra Zeneca vaccine should not be given to over 65s because there is insufficient data as to whether it is effective in older age groups.

Well if the vaccine is useless for older age groups Frau Fond Of Lying Von Der Leyen, you won't be wanting so much of it, will you?


From the Daily Telegraph live feed

AstraZeneca's Covid-19 vaccine should not be given to people over the age of 65, Germany's vaccine committee has said, citing a lack of sufficient data to recommend use in older age groups.

"There are currently insufficient data available to assess the vaccine efficacy from 65 years of age," the committee said in the resolution made available by the German health ministry on Thursday.

"The AstraZeneca vaccine, unlike the mRNA vaccines, should only be offered to people aged 18-64 years at each stage."

The European Medicines Agency is expected to make a decision on whether to approve AstraZeneca's Covid-19 vaccine on Friday.

Germany's announcement comes after after Michael Gove said that AstraZeneca vaccines that have been "planned, paid for and scheduled" will go to the UK, and not be diverted to the EU.

Yesterday Brussels had demanded that millions of British-made coronavirus vaccines were diverted from the UK to the EU in an increasingly bitter tug of war over the jabs.

 

[Domh245]

I read that it was manufactured in Scotland, which isn't in the EU.....yet anyway.

Are you sure that wasn't the Valneva vaccine that began mass production in Livingston today? I haven't seen anything suggesting the J&J vaccine would be produced in UK

Oh dear, Germany's vaccination commitee has put the cat amongst the pigeons by saying that the Astra Zeneca vaccine should not be given to over 65s because there is insufficient data as to whether it is effective in older age groups.

If they had any hope of trying to get British doses diverted, that puts the nail in the coffin (thankfully). I'm pretty sure the Pfizer trials had similarly huge confidence intervals in older age ranges, but hey

 

[yorksrob]

Are you sure that wasn't the Valneva vaccine that began mass production in Livingston today? I haven't seen anything suggesting the J&J vaccine would be produced in UK

Ah, that might be it. Good news potentially, anyway !

 

[brad465]

When it comes to who's supplying the J&J vaccine they'll be being produced both somewhere in the EU and somewhere in the US. Hopefully this supply row might get resolved soon so any supply from in the EU reaches us, as I wouldn't be surprised if the US keep all theirs for their won rollout initially. Where the suppliers actually are will likely become clearer once the phase 3 data is released.

 

[HSTEd]

The only vaccines that are going to be available soon enough to matter and are made in the UK are the Astra Zeneca one and the Novavax one.

 

[hwl]

When it comes to who's supplying the J&J vaccine they'll be being produced both somewhere in the EU and somewhere in the US. Hopefully this supply row might get resolved soon so any supply from in the EU reaches us, as I wouldn't be surprised if the US keep all theirs for their won rollout initially. Where the suppliers actually are will likely become clearer once the phase 3 data is released.

J&J

Bulk manufacture already set up:
Indiana
Maryland
South Africa (+Bottling)
India (+Bottling)

Future Bulk Manufacture + bottling announced in late December:
Spain

Bottling only:
Michigan (ex Indiana and Maryland)
Italy

The J&J US, UK and SA deals appear interesting as they recognise the key role of those governments in helping and organising clinical trials.

Initially no primary manufacture in EU to begin with so harder for the EU to commandeer.

The NovaVax deal also seems to prioritise the UK as again we helped with this one. Presumably Valneva too.

 

[brad465]

J&J

Bulk manufacture already set up:
Indiana
Maryland
South Africa (+Bottling)
India (+Bottling)

Future Bulk Manufacture + bottling announced in late December:
Spain

Bottling only:
Michigan (ex Indiana and Maryland)
Italy

The J&J US, UK and SA deals appear interesting as they recognise the key role of those governments in helping and organising clinical trials.

Initially no primary manufacture in EU to begin with so harder for the EU to commandeer.

The NovaVax deal also seems to prioritise the UK as again we helped with this one. Presumably Valneva too.

Interesting, hopefully our longstanding order will help us get some in place on hopeful approval. I don't expect all 30 million to arrive immediately but even just 5-10 million over 1-2 months would go a long way given it's a one dose only jab.

 

[yorksrob]

Good to have your finger in many pies, as the saying goes !

 

[hwl]

Interesting, hopefully our longstanding order will help us get some in place on hopeful approval. I don't expect all 30 million to arrive immediately but even just 5-10 million over 1-2 months would go a long way given it's a one dose only jab.

J&J seem pretty positive about the UK role's in helping them

Why will lots of second jabs be needed to reduce hospital numbers? So far the trials have indicated that the first dose provides the majority of the protection and so should stop prevent the vast majority becoming seriously ill.

Doing second jabs means fewer first ones are done in lower age groups.

 

[HSTEd]

J&J

Bulk manufacture already set up:
Indiana
Maryland
South Africa (+Bottling)
India (+Bottling)

Future Bulk Manufacture + bottling announced in late December:
Spain

Bottling only:
Michigan (ex Indiana and Maryland)
Italy

The J&J US, UK and SA deals appear interesting as they recognise the key role of those governments in helping and organising clinical trials.

Initially no primary manufacture in EU to begin with so harder for the EU to commandeer.

The NovaVax deal also seems to prioritise the UK as again we helped with this one. Presumably Valneva too.

Would you happen to have a source for this handy?
I've been looking for data for this for a while.

 

[hwl]

Would you happen to have a source for this handy?
I've been looking for data for this for a while.

I went through J&J's press releases or specialist pharma industry news websites, their subcontractors are usually quite happy to to put out quite a bit of detail e.g. the Maryland plant has been mostly mothballed for few years.

There is also a unnamed J&J plant in Europe doing manufacture (possibly Switzerland).

The less good news is that the Moderna bottling is in Spain for Europe (made in US).

The government is also building a manufacture and fill plant in Braintree for the long term.

 

[RomeoCharlie71]

News coming through that the Novavax trial has 89.3% efficacy against covid-19. https://news.sky.com/story/covid-19...oronavirus-vaccine-is-89-3-effective-12201756

UK phase three trials of the experimental Novavax COVID-19 vaccine have found it demonstrated 89.3% efficacy against the virus.

Preliminary analysis showed the new UK variant was detected in more than half of the coronavirus cases recorded in the trials, with the vaccine candidate shown to be 95.6% effective against the original strain and 85.6% effective against the variant.

The study involved more than 15,000 participants aged 18 to 84, with 27% aged over 65.

Prime minister Boris Johnson called the result "good news".

"Our medicines regulator will now assess the vaccine, which will be made in Teesside. If approved, we have 60 million doses on order," he said.

(my bold)

 

[Domh245]

The government is also building a manufacture and fill plant in Braintree for the long term.

They're also financing one in Oxford, although both won't be coming online until (hopefully!) too late for anything other than exporting and booster shots

 

[takno]

They're also financing one in Oxford, although both won't be coming online until (hopefully!) too late for anything other than exporting and booster shots

So many boosters we've got on order. Typical Bill Gates - even when he invents an injectable mind-control chip*, it still has to be constantly updated...
(This is not intended to be taken seriously. He didn't invent a mind-control chip. The vaccines are a good thing, and the boosters are probably even better)

 

[brad465]

So many boosters we've got on order. Typical Bill Gates - even when he invents an injectable mind-control chip*, it still has to be constantly updated...
(This is not intended to be taken seriously. He didn't invent a mind-control chip. The vaccines are a good thing, and the boosters are probably even better)

If there is one thing that proves the vaccines are safe, it's that if they were not, a load of super rich people wouldn't have been flying to Dubai to jump the vaccine queue, spending luxury time in-between doses there (with the help of the Knightsbridge circle). However the latest news on a UAE travel ban may prevent that happening further.

 

[YorkshireBear]

Positive news again tonight but doesn't appear that, even if approved tommorow, there will be many jabs in arms before July. Most stories refer to second 6 months of the year.

 

[HSTEd]

(This is not intended to be taken seriously. He didn't invent a mind-control chip.

No, like most Microsoft/Bill Gates products, its just a ripoff of an earlier technically superior option with inferior marketing!

(also not serious)

Positive news again tonight but doesn't appear that, even if approved tommorow, there will be many jabs in arms before July. Most stories refer to second 6 months of the year.

It is unclear how manufacturing is going.

Most had not expected the trial to conclude any time soon.
It's beaten J&J to a read out!

Manufacturing deals were signed a significant time ago however.

 

[brad465]

Positive news again tonight but doesn't appear that, even if approved tommorow, there will be many jabs in arms before July. Most stories refer to second 6 months of the year.

Yes I saw that, hopefully the Oxford, Pfizer, Moderna from April and possibly J&J ones will be enough to lift restrictions, then maybe the Novavax one could either keep it going for the youngest people, and/or act to revaccinate the oldest if it needs redoing ahead of the next winter.

 

[Chester1]

The only vaccines that are going to be available soon enough to matter and are made in the UK are the Astra Zeneca one and the Novavax one.

Yes I saw that, hopefully the Oxford, Pfizer, Moderna from April and possibly J&J ones will be enough to lift restrictions, then maybe the Novavax one could either keep it going for the youngest people, and/or act to revaccinate the oldest if it needs redoing ahead of the next winter.

I agree with @HSTEd that the EU will block exports. Its in a desperate situation and its not just exports to the UK, its Canada and other countries.

The UK appears to have sufficient stock to get 20 million people both doses on schedule but most of the Astrazenica needs its filler and to be bottled (in Wrexham). Assuming an EU export ban then Pfizer stocks would be mostly used for second doses and Moderna wouldn't arrive to either the EU or US lifted export bans. US rollout should finish during the summer. Without any of new vaccines there will inevitably be a slow down in giving of first doses in second quarter.

Back of fag packet calculations:

UK production of Astrazenica is 2 million doses per week (finished product). 7 million doses of Pfizer have used, imported or should be imported while EU takes a week or so to introduce an export ban. That is a total of 59 million doses available in first half of this year in event of EU export ban. That should be 2 doses for the 20 million high risk people (approximately one in first quarter and one in second quarter) and 19 million first doses. Third quarter Astrazenica doses would need to be mostly dedicated to people who got their first dose in second quarter. UK made Vaneva and Novavax should be used from July, along with J&J (only requires one dose) and Moderna imports. That means the remaining 28 million people should also be fully vaccinated by end of third quarter (but with shorter interval between doses). Production and imports in the third quarter should significantly exceed the first two quarters combined.

 

[hwl]

I agree with @HSTEd that the EU will block exports. Its in a desperate situation and its not just exports to the UK, its Canada and other countries.

The UK appears to have sufficient stock to get 20 million people both doses on schedule but most of the Astra Zenaca needs its filler and to be bottled (in Wrexham). Assuming an EU export ban then Pfizer stocks would be mostly used for second doses and Moderna wouldn't arrive to either the EU or US lifted export bans. US rollout should finish during the summer. Without any of new vaccines there will inevitably be a slow down in giving of first doses in second quarter.

Back of fag packet calculations:

UK production of Astra Zenaca is 2 million doses per week (finished product). 7 million doses of Pfizer have used, imported or should be imported while EU takes a week or so to introduce an export ban. That is a total of 59 million doses available in first half of this year in event of EU export ban. That should be 2 doses for the 20 million high risk people (approximately one in first quarter and one in second quarter) and 19 million first doses. Third quarter Astrazenica doses would need to be mostly dedicated to people who got their first dose in second quarter. UK made Valneva and Novavax should be used from July, along with J&J (only requires one dose) and Moderna imports. That means the remaining 28 million people should also be fully vaccinated by end of third quarter (but with shorter interval between doses). Production and imports in the third quarter should significantly exceed the first two quarters combined.

For Europe Moderna is made in the US and filled in Spain hence offering an option if we can find a bottling plant.