COVID Vaccine !

[roubaixtuesday]

I have to say, to be honest, that the EU stance on the vaccines badly needs questioning. In particular what appears to have been slowness to respond, an unwillingness to go out on a limb, and worrying too much about costs.

The party line here is that initially the vaccine would be in short supply and we couldn't expect anything else. Fair enough. The chief of staff at the Chancellor's office was taking this line but was rightly and bluntly asked why is it that the Americans ordered the Pfizer vaccine towards the end of July, and it took the EU until towards the end of November? That's a long period of time. They were offered double the supply by BioNTech but turned it down. Why? It's likely that this is at last in part why there are insufficient supplies of vaccine available compared with the infrastructure to administer then, ready mid December. Those who risked ordering early are not suffering the lack of supply.

Why was (even!) Johnson's government able to start vaccinating nearly a month before continental Europe? The knock-on effect of this could be very serious with the new version now starting to spread and far too few vulnerable vaccinated.

I think this may be why the govt's handling of the virus has taken a marked turn for the worse here, with just over 50% dissatisfied. It would restore confidence if they were willing to admit they and the EU didn't get it right, and would take steps to deal with the supply situation more urgently.

I understand the EU wanting collective action, and of course I don't know all the ins and outs of how negotiations on procurement were conducted, and we now have hindsight, but ... I hope this wasn't von der Leyen going back to form and/or the medical agency taking its time slavishly following the rules in the face of a high rate of infection of the virus.

It hasn't turned me into a Brexiteer, but you really couldn't blame people for thinking if this is how the EU responds to such a crisis the British may not have been so silly to go it alone.

Don't disagree with any of that, but AZ, Pfizer and Moderna have essentially maxxed out production, and there has not been time to build whole new facilities.

So regardless of the various issues raised. There still would be no more capacity, just shared around a bit differently.

 

[tom73]

Pfizer just made the job that little bit harder as we've been so carful to get an extra dose out of each vial. They have now cut the number of vials per order. All to maximise profit the sooner we can bin it the better can't see us using this as the go to vaccine if this becomes a yearly thing.

 

[PK99]

It hasn't turned me into a Brexiteer, but you really couldn't blame people for thinking if this is how the EU responds to such a crisis the British may not have been so silly to go it alone.

You are not alone in thinking that.

 

[Ajax Bay]

name "Politico" as the source when you quote from it!

Was the best I could find on that. You do seem to prefer to criticise the source of a contribution (I don't believe the UK Ambassador(!)) rather than comment on its accuracy. Why not comment on the substance of what I shared (Germany argued for a EU-united procurement yet simultaneously made additional agreements with vaccine producers for extra doses (and kept it quiet for a while), in violation of agreed EU vaccination strategy: the EU agreed to allocate coronavirus vaccines by population and prohibited its states talking bilaterally with the companies.

Other more vaccine-sceptical countries decided to wait for conditional authorisation from EMA in the hope it would help bolster confidence there. In the end, it seems the approvals aligned but it could have become very very interesting if EMA had found some problem the UK MHRA emergency authorisation process missed.

"The (countries and EMA) approvals aligned." You mean they procrastinated in concert, delaying the start of vaccination by 3 weeks.
"very very interesting" An odd description. But remember the UK medicines regulation MHRA has a very strong reputation. Who would you rely on, if you could only choose one: the EMA or the MHRA?

 

[Ajax Bay]

Pfizer vaccine was only given EMA in the US on the 11th December last year. As far as I'm aware the UK followed that quite quickly.
https://www.fda.gov/news-events/pre...ng-emergency-use-authorization-first-covid-19

Think the UK MHRA authorised use of the Pfizer vaccine on 2 Dec, followed by the USA FDA on 11 Dec (and Bahrain and Israel, I think). Followed by the European EMA, reluctantly (they had planned to wait till 29 Dec) but political pressure forced them to consider it a week earlier.

 

[Ajax Bay]

Lancashire clearly doing well which matches my three elderly relatives' experience - intrigued by the "Healthier Lancashire" tag though

I guess some branding consultants got in there, early doors!
"Healthier Lancashire and [healthier] South Cumbria"
https://www.healthierlsc.co.uk/
Glad your relatives have been well served.

 

[roubaixtuesday]

"The (countries and EMA) approvals aligned." You mean they procrastinated in concert, delaying the start of vaccination by 3 weeks.
"very very interesting" An odd description. But remember the UK medicines regulation MRHA has a very strong reputation. Who would you rely on, if you could only choose one: the EMA or the MRHA?

Posing the question as "who would you rely on if you could only choose one?" isn't really meaningful. I'll try to explain why.

The way medicines approvals works in the EU is that there's a centralised review, with a lead country (rapporteur) and second country (co-rapporteur).

So review of files is shared amongst countries. The same applies to inspection of manufacturing facilities.

Individual country authorisations follow the central review.

The UK (MHRA) has historically been strong, particularly in oncology, so will be missed by the EMA.

However, the MHRA does not remotely have the resource to fully review all applications, so will simply follow the EMA for the first two years:

For a period of two years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure.

Beyond that, you can expect the UK to essentially follow either EMA or FDA. That's the reality for most countries outside of EU and US now.

Additionally, guidance on requirements for approval will come from EMA, FDA and to a lesser extent PMDA (Japan) and CDE (China). Guidance is harmonised through the activities of the ICH (International conference on harmonisation). The MHRA will have far less influence here than the big agencies.

So, the reality is that you don't have an option to choose; we'll continue to rely on EMA review of files into the future anyway, and will lose most of our influence on future guidance on what companies need to include in filings. Companies will design their development programmes to meet the needs of FDA, EMA, PMDA, CDE, and smaller authorities like UK, Switzerland, and developing countries will either accept those data or not get the new medicines coming through.

I hope that makes some sense. It's quite a good exemplar of how Brexit works out in the real world.

 

[SpokeyDokey]

I have to say, to be honest, that the EU stance on the vaccines badly needs questioning. In particular what appears to have been slowness to respond, an unwillingness to go out on a limb, and worrying too much about costs.

The party line here is that initially the vaccine would be in short supply and we couldn't expect anything else. Fair enough. The chief of staff at the Chancellor's office was taking this line but was rightly and bluntly asked why is it that the Americans ordered the Pfizer vaccine towards the end of July, and it took the EU until towards the end of November? That's a long period of time. They were offered double the supply by BioNTech but turned it down. Why? It's likely that this is at last in part why there are insufficient supplies of vaccine available compared with the infrastructure to administer then, ready mid December. Those who risked ordering early are not suffering the lack of supply.

Why was (even!) Johnson's government able to start vaccinating nearly a month before continental Europe? The knock-on effect of this could be very serious with the new version now starting to spread and far too few vulnerable vaccinated.

I think this may be why the govt's handling of the virus has taken a marked turn for the worse here, with just over 50% dissatisfied. It would restore confidence if they were willing to admit they and the EU didn't get it right, and would take steps to deal with the supply situation more urgently.

I understand the EU wanting collective action, and of course I don't know all the ins and outs of how negotiations on procurement were conducted, and we now have hindsight, but ... I hope this wasn't von der Leyen going back to form and/or the medical agency taking its time slavishly following the rules in the face of a high rate of infection of the virus.

It hasn't turned me into a Brexiteer, but you really couldn't blame people for thinking if this is how the EU responds to such a crisis the British may not have been so silly to go it alone.

My guess is that once the inevitable post-crisis rationalistion takes place across the globe that all Governments and organisations will be found wanting in some areas and mistakes will have been made.

Whilst there is no delight in reading about issues such as the above in other countries it does show what a tough beast this virus is to get to terms with.

In my mind I have Germany earmarked as a pretty slick country in most respects (based on media reports and one visit to Koblenz many years ago) and I shudder to think of what is happening in some countries across the globe where the political and operational infrastructure is somewhat shaky.

 

[mjr]

Don't disagree with any of that, but AZ, Pfizer and Moderna have essentially maxxed out production, and there has not been time to build whole new facilities.

So regardless of the various issues raised. There still would be no more capacity, just shared around a bit differently.

AZ will be using the Vaccines Manufacturing Innovation Centre in Oxfordshire once it is open for another 70m doses a year, plus has signed manufacturing deals in New Hampshire, Japan and Russia, in addition to the Indian one.

So capacity is being built and what countries are paying more for is essentially earlier access... which does not matter as much if outbreaks can be suppressed because, as someone wrote a few pages ago, this is not a race between countries and we are not really safe until we are all safe.

 

[Mo1959]

77 cases of the South African strain in the UK which they think might be 50% more resistant to vaccine so hope the research is ongoing to keep on top of things.

 

[Ajax Bay]

they think might be 50% more resistant to vaccine

Where do you get this from, Mo? Who is 'they'? Or is this "they don't know whether it will be (insert figure here)% more resistant"?
Would this drop the two dose Pfizer regime efficacy down from 95% to 47%?

 

[Mo1959]

Where do you get this from, Mo? Who is 'they'? Or is this "they don't know whether it will be (insert figure <100 here)% more resistant"?
Would this drop the two dose Pfizer regime efficacy down from 95% to 47%?

Just a link to a newspaper, but it is quoting Matt Hancock?

https://www.bbc.co.uk/news/uk-scotland-55793063

 

[srw]

Would this drop the two dose Pfizer regime efficacy down from 95% to 47%?

No. 95% to 92.5%. 5 cases in 100 become 7.5.

 

[lane]

77 cases of the South African strain in the UK which they think might be 50% more resistant to vaccine so hope the research is ongoing to keep on top of things.

77 cases they know about.

 

[lane]

No. 95% to 92.5%. 5 cases in 100 become 7.5.

Thanks for the clarification. 50@% more resistant sounds a lot worse.