Vaccine Progress, Approval, and Deployment

[hwl]

Whilst German government has been threatening Astra Zeneca to increase deliveries of said vaccine, or else.

Not just the German government but the EU and threatening to look at exports (presumably of the Pfizer to us).

The reality looks like the subcontracted Belgian manufacturer of the Oxford vaccine for the EU only just recently fessed up about the problems they are having ramping up production.

Given the logistical challenges of the Pfizer vaccine, the Germans have been banking on the Oxford one to get most of their vaccinations done.

It was reported about Christmas that were no hospitalisations of Oxford or Moderna trial subjects more than 3 weeks after first dose, regardless of when (or if) they had the second dose. I imagine the media would give huge coverage to anyone who gets hospitalised more than three weeks after Oxford vaccine dose. The first doses were given on 28th or 29th December so its been possible for a week and a half.

Yes all there in the peer reviewed papers on the clinical trials but that is probably beyond most journalists!

Which doesn't stack up with the EU threatening an export ban, supported by him.

They want of much of it as they can get for the working age population. What he said was less effective in the older population and several papers made up some numbers. The papers quoted 8 to 10% effective in over 65s, what was probably said was 8 to 10% less effective in over 65s!

 

[Chester1]

Not just the German government but the EU and threatening to look at exports (presumably of the Pfizer to us).

The reality looks like the subcontracted Belgian manufacturer of the Oxford vaccine for the EU only just recently fessed up about the problems they are having ramping up production.

Given the logistical challenges of the Pfizer vaccine, the Germans have been banking on the Oxford one to get most of their vaccinations done.


Yes all there in the peer reviewed papers on the clinical trials but that is probably beyond most journalists!

They want of much of it as they can get for the working age population. What he said was less effective in the older population and several papers made up some numbers. The papers quoted 8 to 10% effective in over 65s, what was probably said was 8 to 10% less effective in over 65s!

That makes more sense.

Apparently 15 million out 40 million doses of Pfizer vaccine have already been delivered to UK, although much of it still needs to be packaged and checked. When the roll out started there were 18 million AZ vaccines in the UK for NHS use. Some is imported but the majority is produced in Oxford and Keele (and bottled in Wrexham). We have enough stock for 2 doses for 16.5 million people + whatever AZ that has imported or made in UK in the last month. Inevitably the Government would have to do its own export ban because we would be completely reliant on UK produced AZ for a while. If the EU bans exports then the 20 million high risk Brits should still get their doses to schedule, its the other 45 million of us who would be affected.

I fear the main losers of an EU export ban would be developing countries. Our government is obliged to look after its own citizens first and would do its best to get deliveries of Oxford vaccine made on licence in India, at the expense of deliveries to poor countries.

 

[HSTEd]

That makes more sense.

Apparently 15 million out 40 million doses of Pfizer vaccine have already been delivered to UK, although much of it still needs to be packaged and checked. When the roll out started there were 18 million AZ vaccines in the UK for NHS use. Some is imported but the majority is produced in Oxford and Keele (and bottled in Wrexham). We have enough stock for 2 doses for 16.5 million people + whatever AZ that has imported or made in UK in the last month. Inevitably the Government would have to do its own export ban because we would be completely reliant on UK produced AZ for a while. If the EU bans exports then the 20 million high risk Brits should still get their doses to schedule, its the other 45 million of us who would be affected.

I fear the main losers of an EU export ban would be developing countries. Our government is obliged to look after its own citizens first and would do its best to get deliveries of Oxford vaccine made on licence in India, at the expense of deliveries to poor countries.

I don't think we can expect to see any J&J vaccine any time soon, since the EU seems likely to interdict that.

But the Novavax vaccine is made in Sunderland, so if that works that will help the situation.

 

[Bertie the bus]

It was reported about Christmas that were no hospitalisations of Oxford or Moderna trial subjects more than 3 weeks after first dose, regardless of when (or if) they had the second dose. I imagine the media would give huge coverage to anyone who gets hospitalised more than three weeks after Oxford vaccine dose. The first doses were given on 28th or 29th December so its been possible for a week and a half.

The trial was absolutely tiny compared to the numbers who will receive the vaccine. It is simply not feasible that nobody given the Oxford vaccine will be hospitalised or die. I'm not sure where you get the idea there will be huge media coverage when it does happen from. People don't have their vaccination history and reason for admission to hospital tattooed on their forehead so how would the media know? I doubt they would get it from relatives because usually when an elderly relative is taken to hospital their first thought isn't to contact the press.

You have also got your timings wrong. It normally takes 2 - 3 weeks after infection before someone is seriously ill enough to be hospitalised, therefore it will be mid-Feb before anybody who has been infected 3+ weeks after vaccination ends up in hospital.

 

[158756]

Probably Das Bild is it, about as good as our gutter press and as keen on scaremongering. I'm sure those that developed and tested it may know slightly more than the press?

Bild does have it, but it's also the top story on the Handelsblatt webpage, which I understand is rather more reliable. The reports say the effectiveness is 8% in over-65s.

According to my very rough interpretation Bild says the German vaccine strategy is threatening a fiasco, but if that's true there how would they describe our situation? How many millions have already been given this vaccine? And if export bans are coming where are we going to get alternative vaccines to fix the problem?


And if these reports from Germany are true can we trust any other product the MHRA has approved?

 

[HSTEd]

According to my very rough interpretation Bild says the German vaccine strategy is threatening a fiasco, but if that's true there how would they describe our situation?

We have a river of vaccines that the EMA apparently thinks are perfectly suitable for under 65s?
They are going to have to be vaccinated anyway, so at worst we just divert Astra Zeneca vaccines to the 65-60 age group and remaining priority medical staff and carry on as before?

How many millions have already been given this vaccine?

Even if evey single dose administered up to now was an Astra Zeneca vaccine and was administered solely to over 65s, and neither of those thigns are true - its about three weeks worth of production at the production level meant to be reached in three weeks time.
It's far from a catastrophe.

At worst we are going to lose something like a week and a half of production.

And if export bans are coming where are we going to get alternative vaccines to fix the problem?

Assuming J&J all gets interdicted by the EU, we still have Novavax hoping to finish its trial relatively soon.
We control the manufacturing plant for that after all.

And if these reports from Germany are true can we trust any other product the MHRA has approved?

Because MHRA made a calculated choice to proceed based on efficacy data for younger people and tests showing similar immunogenecity in old and young people.
That was a calculated risk and is entirely defensible.

It would be highly unexpected for this result to be correct however, and I am not sure where the data that the Germans use to make this claim came from since the MHRA apparently don't have it.

 

[daodao]

Not just the German government but the EU and threatening to look at exports (presumably of the Pfizer to us).

If there is a vaccine shortfall in the EU, I would expect that the EU will commandeer vaccines produced within the EU for use solely within the EU. They can over-rule any commercial agreement between manufacturers and a 3rd country such as the UK. It is in their interest to take a less than friendly approach to Perfidious Albion, given its arrogance in leaving the modern version of the Holy Roman Empire.

This will cause particular difficulties for individuals within the UK who have received the first dose of the Pfizer vaccine and whose 2nd vaccination is not due for up to 12 weeks.

 

[35B]

Bild does have it, but it's also the top story on the Handelsblatt webpage, which I understand is rather more reliable. The reports say the effectiveness is 8% in over-65s.

According to my very rough interpretation Bild says the German vaccine strategy is threatening a fiasco, but if that's true there how would they describe our situation? How many millions have already been given this vaccine? And if export bans are coming where are we going to get alternative vaccines to fix the problem?


And if these reports from Germany are true can we trust any other product the MHRA has approved?

What though is the source of the claim being reported?

 

[Domh245]

It would be highly unexpected for this result to be correct however, and I am not sure where the data that the Germans use to make this claim came from since the MHRA apparently don't have it.

One theory is that the 8% is the lower bound of a very large confidence interval for efficacy in the 65+ age group, stemming from the small numbers of relevant participants in the trial. It does stink of politicking IMO

 

[adc82140]

One theory is that the 8% is the lower bound of a very large confidence interval for efficacy in the 65+ age group, stemming from the small numbers of relevant participants in the trial. It does stink of politicking IMO

It seems the journo got a little confused (bless him). The 8% comes from the amount of over 65s in the vaccine trial.

 

[hwl]

If there is a vaccine shortfall in the EU, I would expect that the EU will commandeer vaccines produced within the EU for use solely within the EU. They can over-rule any commercial agreement between manufacturers and a 3rd country such as the UK. It is in their interest to take a less than friendly approach to Perfidious Albion, given its arrogance in leaving the modern version of the Holy Roman Empire.

This will cause particular difficulties for individuals within the UK who have received the first dose of the Pfizer vaccine and whose 2nd vaccination is not due for up to 12 weeks.

A big issue (the biggest) is that the EU procured on based on getting the cheapest price e.g ~£1.80 for the Ox/AZ (vs target price of £3 with mostly £2.80 in reality) similarly for Pfizer and Moderna etc. Other countries procured on a more mixed basis of priority and cost with Israel focusing on being 1st in the queue but paying a huge lot more for that.

The EU massively screwed up when signing up for cheap deals all round and is now trying to rectify that through brute legal force. The low price means focusing just on cost and not dates for AZ's subcontractor.

Italy is also putting a lot of pressure on Pfizer.

It just wouldn't be the UK in trouble if Pfizer got commandeered, all the non-US supply of the Pfizer vaccine comes from the Puurs factory (including Canada).

 

[takno]

If there is a vaccine shortfall in the EU, I would expect that the EU will commandeer vaccines produced within the EU for use solely within the EU. They can over-rule any commercial agreement between manufacturers and a 3rd country such as the UK. It is in their interest to take a less than friendly approach to Perfidious Albion, given its arrogance in leaving the modern version of the Holy Roman Empire.

This will cause particular difficulties for individuals within the UK who have received the first dose of the Pfizer vaccine and whose 2nd vaccination is not due for up to 12 weeks.

In the unlikely event that they decided to do that, they'd probably do a swap of Pfizer for some of ours in order that everybody can get their second vaccination. Highly unlikely they'd want to do it though, since there's large numbers of places where the storage requirements of Pfizer make it really impractical.

 

[Domh245]

It seems the journo got a little confused (bless him). The 8% comes from the amount of over 65s in the vaccine trial.

That's very embarrassing on Handelsblatt's behalf! It also explains a little more why EMA seem hesitant to approve it for over 65s, as there was essentially so little data on it, although it strikes me as letting perfect get in the way of the good - if I were in the EU's shoes I'm not sure I'd be so choosy about things

 

[adc82140]

That's very embarrassing on Handelsblatt's behalf! It also explains a little more why EMA seem hesitant to approve it for over 65s, as there was essentially so little data on it, although it strikes me as letting perfect get in the way of the good - if I were in the EU's shoes I'm not sure I'd be so choosy about things

They are also focusing too much on effeciecy with regards to infection, whereas it really should be effeciecy with regards to hospitalisations and death.

 

[Richard Scott]

Quoting the German Health minister that it was less effective.

That's slightly different to it doesn't work.

 

[daodao]

In the unlikely event that they decided to do that, they'd probably do a swap of Pfizer for some of ours in order that everybody can get their second vaccination.

The second vaccination needs to be done using the same brand of vaccine to be adequately effective and boost the immune response; it is not scientifically valid to "mix and match".

 

[Bertie the bus]

A big issue (the biggest) is that the EU procured on based on getting the cheapest price e.g ~£1.80 for the Ox/AZ (vs target price of £3 with mostly £2.80 in reality) similarly for Pfizer and Moderna etc. Other countries procured on a more mixed basis of priority and cost with Israel focusing on being 1st in the queue but paying a huge lot more for that.

The EU massively screwed up when signing up for cheap deals all round and is now trying to rectify that through brute legal force. The low price means focusing just on cost and not dates for AZ's subcontractor.

Italy is also putting a lot of pressure on Pfizer.

It just wouldn't be the UK in trouble if Pfizer got commandeered, all the non-US supply of the Pfizer vaccine comes from the Puurs factory (including Canada).

I doubt we would be in any trouble. There was a report recently, I think on the BBC, about how many doses each country would be producing this year. We are expected to produce almost 1 billion doses of the AZ vaccine. If we lose a few Pfizer ones we could retaliate and prevent exports to the EU.

The EU are just trying to blame the manufacturers for their incompetence. Even member states have no confidence in it as shown by Hungary unilaterally approving and ordering the Sputnik vaccine from Russia.

 

[Yew]

That's very embarrassing on Handelsblatt's behalf! It also explains a little more why EMA seem hesitant to approve it for over 65s, as there was essentially so little data on it, although it strikes me as letting perfect get in the way of the good - if I were in the EU's shoes I'm not sure I'd be so choosy about things

It is interesting that we've kept our standard procedures for pharmaceutical interventions, yet seem to be happy to run around like headless chickens with damaging non-pharmaceutical interventions.

 

[yorksrob]

Whilst I've no doubt that something will be worked out with regard to getting second jabs of the pfizer vaccine, this sort of situation does illustrate the value of having on-shore manufacturing capability.

 

[takno]

The second vaccination needs to be done using the same brand of vaccine to be adequately effective and boos the immune response; it is not scientifically valid to "mix and match".

Which is why, as I said, they would be reasonably happy to swap enough of the relevant vaccines with us to do the second injections. They're struggling to get their own Astra-Zeneca production going, and have plenty of people who would benefit from having some supplies of a vaccine that's easier to handle and store.

 

[HSTEd]

The second vaccination needs to be done using the same brand of vaccine to be adequately effective and boos the immune response; it is not scientifically valid to "mix and match".

Well from first principles we would still expect it to work.

Whether it actually does or not is another question.

But it looks like Johnson and Johnson expect to have results next week (Twitter)

J&J CFO tells @CNBC he expects to release vaccine results next week. "We're optimistic. We think we're going to have a very robust data set."

MHRA approved Pfizer in 8 days from the dataset being available.
That implies administration can commence in mid February if the EU doesn't seize the supply.

 

[The Ham]

The second vaccination needs to be done using the same brand of vaccine to be adequately effective and boost the immune response; it is not scientifically valid to "mix and match".

Given that we could probably just wait 12 weeks and then give 2 doses (with the appropriate gap between) of another vaccine and it have limited impact on the overall speed of vaccinating everyone (the last 7 day total is about 2.5 million doses, so it might move the end date* from early to mid September).

*Calculated up thread on a 2.3 million doses a week rate.

 

[HSTEd]

By late spring we are going to buried in an avalanche of vaccines.

We can just scrap vaccination courses and restart if necessary at that time,

 

[Domh245]

I must say that the EU/Astrazeneca soap opera* is certainly proving to be quite entertaining, although I'm growing increasingly worried that the EU is going to do something stupid!


*Since the last posts about it on this thread, Handelsblatt/unnamed german health ministry source have doubled down on their 8% efficacy story, with increasing rumours that when the EMA approve the vaccine it'll be for under 65s only. The current main talking point seems to be the EU threatening to either block (/require tracking of) vaccine exports, or require AZ to divert vaccines produced in the UK for the UK to the EU to cover for the failure of the dedicated EU plants to ramp up production as had been hoped. Some of the various accusations flying around include vaccines being removed from the EU stockpile to supply the UK in December, AZ having a 'guaranteed delivery' contract rather than the 'best-efforts' contract they are saying they have, the EU commission trying to haggle an "at price" vaccine for 3 months delaying AZ from beginning to scale production. It does increasingly smell like the EU commission trying to mudsling and obfuscate how poorly they've handled vaccine procurement, I really cannot help but feel sorry for the Germans, French, Italians & Dutch who did the legwork on the deal and have seen the EU seriously drop the ball on it (and of course, all the other European vulnerable awaiting their jabs)

 

[adc82140]

I must say that the EU/Astrazeneca soap opera* is certainly proving to be quite entertaining, although I'm growing increasingly worried that the EU is going to do something stupid!


*Since the last posts about it on this thread, Handelsblatt/unnamed german health ministry source have doubled down on their 8% efficacy story, with increasing rumours that when the EMA approve the vaccine it'll be for under 65s only. The current main talking point seems to be the EU threatening to either block (/require tracking of) vaccine exports, or require AZ to divert vaccines produced in the UK for the UK to the EU to cover for the failure of the dedicated EU plants to ramp up production as had been hoped. Some of the various accusations flying around include vaccines being removed from the EU stockpile to supply the UK in December, AZ having a 'guaranteed delivery' contract rather than the 'best-efforts' contract they are saying they have, the EU commission trying to haggle an "at price" vaccine for 3 months delaying AZ from beginning to scale production. It does increasingly smell like the EU commission trying to mudsling and obfuscate how poorly they've handled vaccine procurement, I really cannot help but feel sorry for the Germans, French, Italians & Dutch who did the legwork on the deal and have seen the EU seriously drop the ball on it (and of course, all the other European vulnerable awaiting their jabs)

Handelsblatt must be hurting now as they have been well and truly called out for being idiots. They are cornered and lashing out. The reason that the AZ vaccine may not be licenced for the over 65s is the perceived lack of data. Nothing else, no matter what Handelsblatt think.

 

[hwl]

I must say that the EU/Astrazeneca soap opera* is certainly proving to be quite entertaining, although I'm growing increasingly worried that the EU is going to do something stupid!


*Since the last posts about it on this thread, Handelsblatt/unnamed german health ministry source have doubled down on their 8% efficacy story, with increasing rumours that when the EMA approve the vaccine it'll be for under 65s only. The current main talking point seems to be the EU threatening to either block (/require tracking of) vaccine exports, or require AZ to divert vaccines produced in the UK for the UK to the EU to cover for the failure of the dedicated EU plants to ramp up production as had been hoped. Some of the various accusations flying around include vaccines being removed from the EU stockpile to supply the UK in December, AZ having a 'guaranteed delivery' contract rather than the 'best-efforts' contract they are saying they have, the EU commission trying to haggle an "at price" vaccine for 3 months delaying AZ from beginning to scale production. It does increasingly smell like the EU commission trying to mudsling and obfuscate how poorly they've handled vaccine procurement, I really cannot help but feel sorry for the Germans, French, Italians & Dutch who did the legwork on the deal and have seen the EU seriously drop the ball on it (and of course, all the other European vulnerable awaiting their jabs)

The 2 UK primary production facilities (Oxford and Keele) were named as being able to provide volume to the EU subject to other contracts already in place (which is why they have got their hopes up). What the EU probably didn't realise was 100M doses @ a minimum of 2M per week to the UK before any goes abroad was in one of the other contracts.
It looks like they focused too much on price (which they got the lowest of any one on). I suspect the EU's understanding of legal English may not be quite what they thought it was.

I suspect Handelsblatt etc will end up with egg on their face when more data comes through on the Ox/AZ vaccine. If I was that journalist I would be updating CV in a hurry. The suspicion in Germany is that it was hatchet job by a junior coalition partner who wants the undermine the health minister (who is generally well regarded).

All the manufacturers are having issues ramping up production or have trials delayed too so the this does look like the EU had privately reckoned that the Oz/AZ vaccine was the best bet for vaccinating the most people in the first 6 months of the year (at least) and then got told some bad news.

 

[Chester1]

The 2 UK primary production facilities (Oxford and Keele) were named as being able to provide volume to the EU subject to other contracts already in place (which is why they have got their hopes up). What the EU probably didn't realise was 100M doses @ a minimum of 2M per week to the UK before any goes abroad was in one of the other contracts.
It looks like they focused too much on price (which they got the lowest of any one on). I suspect the EU's understanding of legal English may not be quite what they thought it was.

I suspect Handelsblatt etc will end up with egg on their face when more data comes through on the Ox/AZ vaccine. If I was that journalist I would be updating CV in a hurry. The suspicion in Germany is that it was hatchet job by a junior coalition partner who wants the undermine the health minister (who is generally well regarded).

All the manufacturers are having issues ramping up production or have trials delayed too so the this does look like the EU had privately reckoned that the Oz/AZ vaccine was the best bet for vaccinating the most people in the first 6 months of the year (at least) and then got told some bad news.

UK imports of Pfizer are at risk of drying up due to production issues, the EU doesn't have much leverage to obtain UK AZ supplies. If they pressure AZ into transfering stock at the expense of the UK order then the Govermment would surely block it. If the EU responded by blocking export of Pfizer then the Government would respond by blocking all AZ exports. The wiggle room is UK AZ production above the contractual 2 million doses per week. AZ could agree to transfer that and the Government would find it difficult to object to. Its maybe half a million doses a week e.g. close to what Pfizer was due to send the other way (an average of 800,000) per week but won't manage that for a while.

 

[daodao]

UK imports of Pfizer are at risk of drying up due to production issues, the EU doesn't have much leverage to obtain UK AZ supplies. If they pressure AZ into transfering stock at the expense of the UK order then the Govermment would surely block it. If the EU responded by blocking export of Pfizer then the Government would respond by blocking all AZ exports. The wiggle room is UK AZ production above the contractual 2 million doses per week. AZ could agree to transfer that and the Government would find it difficult to object to. Its maybe half a million doses a week e.g. close to what Pfizer was due to send the other way (an average of 800,000) per week but won't manage that for a while.

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!

 

[adc82140]

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.

 

[yorksrob]

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.

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 ?