COVID Vaccine !

[roubaixtuesday]

unshackled from its EU counterpart the EMA)

Take the politics out of this one.

The head of the MHRA herself pointed out it was incorrect.

 

[srw]

NB unshackled from its EU counterpart the EMA

No. You've only deleted one of the instances. When we were prepping we did it under EMA rules.

This is a government lie that needs to be stamped out.

 

[Ajax Bay]

Apologies to @srw and @roubaixtuesday for getting the relevance of the EMA and UK's changing relationship with it wrong. Edit: Please say whether I've now got it right below, or whether I have succumbed to one "government lie" or another.
I'll deal with the procurement arrangement first:
Letter from UK Ambassador to the EU to Secretary-General of the European Commission, July 2020
Extract (@mjr note first sentence - you commented on this earlier):
The [European] Commission has . . confirmed that it is not possible for the UK to pursue parallel negotiations with potential vaccine suppliers, meaning the UK would be required to stop its negotiations with manufacturers with which the EU launched negotiations. The Commission has also confirmed that it is not possible for the UK to have a role in the governance shaping decisions [EMA led] on which manufacturers to negotiate with, or the price, volume and delivery schedule negotiated.
The UK Government has [therefore] decided on this occasion not to join this internal EU initiative, [goes on to note full engagement on procurement of vaccines for the world, generally]
https://www.gov.uk/government/publi...19-vaccines-letter-to-the-european-commission
https://assets.publishing.service.g.../Letter_from_Tim_Barrow_to_Ilze_Juhansone.pdf

And the authorisation challenge:
The-roles-of-the-mhra-and-jcvi-in-covid-19-vaccines
Precis:
As part of the transition period up to 31 Dec, COVID-19 vaccine candidates could be licensed via the European Medicines Agency (EMA) and that authorisation will automatically be valid in the UK. [Observation: In the event the EMA managed to authorise the Pfizer vaccine about 20 days after the MHRA had qv]
If a suitable COVID-19 vaccine candidate . . . becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK [Think this is the point you were making @roubaixtuesday], based on the public health need. [For Pfizer: 2 Dec aiui, and in late Dec: Oxford-AZ]
In the event of a temporary authorisation for supply,
[and] once the MHRA has thoroughly reviewed the data, they will seek advice from the Government’s independent advisory body, the Commission on Human Medicines. The Commission will critically assess the data too before advising the UK government on the safety, quality and effectiveness of any potential vaccine.
Any COVID-19 vaccine candidate submitted after the transition period ended on 1 January 2021 will not need to go through a European marketing authorisation for use in Great Britain and will instead be assessed directly by the MHRA. [Moderna]

Please do not impute a leaver/remainer mantra to this, or view this through that lens. I'm trying to highlight how the UK has done well and the likelihood of it having done significantly worse if the UK had chosen to join and rely on the EU Commission (EMA-led) procurement scheme and if the UKMHRA had NOT gone for national authorisation but instead waited for the EMA to authorise Pfizer 3 weeks later, and Oxford-AZ 4+ weeks later (see below).
"The European Medicines Agency (EMA) has been conducting an ‘accelerated’ review of AstraZeneca/Oxford University’s COVID-19 vaccine. . . . and following the ‘accelerated’ review, it could issue an opinion on the marketing authorisation for the vaccine by 29 January, when its Committee for Medicinal Products for Human Use (CHMP) is due to meet."

 

[roubaixtuesday]

Apologies to @srw and @roubaixtuesday for getting the relevance of the EMA and UK's changing relationship with it wrong.
I'll deal with the procurement arrangement first:
Letter from UK Ambassador to the EU to Secretary-General of the European Commission, July 2020
Extract (@mjr note first sentence - you commented on this earlier):
The [European] Commission has . . confirmed that it is not possible for the UK to pursue parallel negotiations with potential vaccine suppliers, meaning the UK would be required to stop its negotiations with manufacturers with which the EU launched negotiations. The Commission has also confirmed that it is not possible for the UK to have a role in the governance shaping decisions [EMA led] on which manufacturers to negotiate with, or the price, volume and delivery schedule negotiated.
The UK Government has [therefore] decided on this occasion not to join this internal EU initiative, [goes on to note full engagement on procurement of vaccines for the world, generally]
https://www.gov.uk/government/publi...19-vaccines-letter-to-the-european-commission
https://assets.publishing.service.g.../Letter_from_Tim_Barrow_to_Ilze_Juhansone.pdf

And the authorisation challenge:
The-roles-of-the-mhra-and-jcvi-in-covid-19-vaccines
Precis:
As part of the transition period up to 31 Dec, COVID-19 vaccine candidates could be licensed via the European Medicines Agency (EMA) and that authorisation will automatically be valid in the UK. [Observation: In the event the EMA managed to authorise the Pfizer vaccine about 20 days after the MHRA had qv]
If a suitable COVID-19 vaccine candidate . . . becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need. [For Pfizer: 2 Dec aiui, and in late Dec: Oxford-AZ]
In the event of a temporary authorisation for supply, [and]
once the MHRA has thoroughly reviewed the data, they will seek advice from the Government’s independent advisory body, the Commission on Human Medicines. The Commission will critically assess the data too before advising the UK government on the safety, quality and effectiveness of any potential vaccine.
Any COVID-19 vaccine candidate submitted after the transition period ended on 1 January 2021 will not need to go through a European marketing authorisation for use in Great Britain and will instead be assessed directly by the MHRA. [Moderna]

Please do not impute a leaver/remainer mantra to this. I'm trying to highlight how the UK has done well and the likelihood of it having done significantly worse if the UK had chosen to join and rely on the EU Commission (EMA-led) procurement scheme and if the UKMHRA had NOT gone for national authorisation but instead waited for the EMA to authorise Pfizer 3 weeks later, and Oxford-AZ 4+ weeks later (see below).
"The European Medicines Agency (EMA) has been conducting an ‘accelerated’ review of AstraZeneca/Oxford University’s COVID-19 vaccine. . . . and following the ‘accelerated’ review, it could issue an opinion on the marketing authorisation for the vaccine by 29 January, when its Committee for Medicinal Products for Human Use (CHMP) is due to meet."

Kudos for responding so.

Whilst I do think the UK has done a lot right on vaccines, as their availability is limited by manufacturing capacity at the moment, if the whole of the EU had done what we did, there would be no more vaccines across the continent, they'd just be spread differently, and Pfizer would have more cash. We're not safe until everyone is safe.

And of course, as you say, we would be equally free to respond as we did inside the EU.

Just as an aside, our policy on new Medicines authorisation for the next two years is to follow EMA authorisations.

 

[mjr]

Letter from UK Ambassador to the EU to Secretary-General of the European Commission, July 2020
Extract (@mjr note first sentence - you commented on this earlier):
The [European] Commission has . . confirmed that it is not possible for the UK to pursue parallel negotiations with potential vaccine suppliers, meaning the UK would be required to stop its negotiations with manufacturers with which the EU launched negotiations.

I would rather read what the EU actually said, rather than what the UK ambassador says they said. The ambassador is not a neutral reporter there, or may have been misinformed by gov.uk.

And if this was true, how did Germany negotiate its own supplies in addition? https://apnews.com/article/europe-virus-outbreak-germany-science-77602589aa8e6132732ac50cbea97d2d

 

[Ajax Bay]

I would rather read what the EU actually said, rather than what the UK ambassador says they said. The ambassador is not a neutral reporter there.
And if this was true, how did Germany negotiate its own supplies in addition?

Fill your boots: go and find out what the European Commission (says they) said. I am a bit surprised you think a British diplomat would obfuscate or be economical with the truth in a published letter. Perhaps the Commission changed its 'rules' after the UK had decided not to join in - which allowed Germany to complies with the spirit [if not the letter] of the EU vaccine agreement qv.
I don't know the tos and fros of the German frustration approach. Go and find out (in the same way as I've sought to establish the UK to EMA relationship after @roubaixtuesday and @srw pointed out I'd got it wrong. Perhaps they (shock, horror) broke EU 'rules'.
I couldn't restrain myself Here's what I found reported about the additional German procurement:

"When it comes to EU vaccine solidarity, Germany is looking to have its cake and eat it, too.
"While Berlin championed the bloc's joint purchasing of coronavirus vaccines while holding the European Union's rotating presidency in the second half of 2020, it simultaneously made additional agreements with vaccine producers — including BioNTech/Pfizer and CureVac — for extra doses. And it's now purchasing additional vaccines other EU countries didn't want.
"Germany’s actions are technically a violation of the Commission’s vaccination strategy, as the bloc agreed to allocate coronavirus vaccines by population and not talk bilaterally with the companies it was negotiating with. But a Commission official said it complies with "the spirit of the EU vaccine agreement" because Germany’s extra doses will come after the Commission’s supply."

Edit: After @mjr pointed out I'd not noted the source of the above text was Politico, I came back and added this. I note that wikipedia says: "According to a 2020 Knight Foundation study, Politico is generally read by a moderate audience, leaning slightly toward the left.[63]
. . . and a 2012 study found that the percentage of Politico readers who identify as Democrats—29%—is equal to the percentage who identify as Republicans."
I'm afraid I have no idea what 'axe' Politico might have 'to grind' but its reporting gives an insight into Germany's (imo very sensible almost 'French') approach to sort things out for themselves when the EU mechanism can be seen to be weak, and likely to cost German lives.

 

[mjr]

It would be nice to name "Politico" as the source when you quote from it! And they have no axe to grind whatsoever(!)

 

[Unkraut]

Whilst I do think the UK has done a lot right on vaccines, as their availability is limited by manufacturing capacity at the moment, if the whole of the EU had done what we did, there would be no more vaccines across the continent, they'd just be spread differently, and Pfizer would have more cash. We're not safe until everyone is safe.

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.

 

[lane]

And many are children so won't be vaccinated

My numbers were for adult only.

 

[lane]

Third day in a row now with over 400k vaccinations (as at 23 Jan).

Only 8k short of half a million on the day @ 491 970

Total first dose now at 6 353 321 and second dose @ 469 660
Sky News (Breaking Live) reporting this:

Matt Hancock says 75% of all over-80s in the UK have been vaccinated so far

(Not checked this in the official data yet.)

That's excellent if we can maintain around half a million a day we will make rapid progress

 

[lane]

I was responding to a post that quoted the number of adults at 4m (I assumed that was an accurate validated figure). Presumably many have very mild/transient/seasonal symptoms and may not even need regular treatment And may be almost no more at risk than the non asthma population

Figure from Google. One would assume diagnosed and receiving some treatment. Adults. If we assume asthma in group 6 I see no reason not to assume something like that many will be included less those already in older age groups etc.

 

[mjr]

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.

The UK could start earlier because it granted emergency use authorisation and expected its more vaccination-comfortable population to be OK with that. 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 B117 variant may be a side effect of the UK policy of betting everything on vacc, not keeping case numbers down, and thereby giving the virus too many chances to mutate. So in addition to buying up vaccine, gov.uk farked over the rest of the world a second time.

 

[classic33]

The UK could start earlier because it granted emergency use authorisation and expected its more vaccination-comfortable population to be OK with that. 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 B117 variant may be a side effect of the UK policy of betting everything on vacc, not keeping case numbers down, and thereby giving the virus too many chances to mutate. So in addition to buying up vaccine, gov.uk farked over the rest of the world a second time.

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

 

[Blue Hills]

This shows how the various parts of England have done (provenance of data unstated and as at 17 Jan):
View attachment 570454
Worth noting that, like the other COVID-19 reporting, there is a weekly cycle of vaccinations delivered, so the 7-day rolling average will start being a more useful metric, now that we've got to well over 2M a week and, I sense, stabilising.

thanks.
Lancashire clearly doing well which matches my three elderly relatives' experience - intrigued by the "Healthier lancashire" tag though - can't immediately see that tag on any other counties/areas and my mum certainly isn't healthy.

 

[srw]

In particular what appears to have been slowness to respond, an unwillingness to go out on a limb, and worrying too much about costs.

I genuinely don't know, but I do wonder whether this has something to do with it.

https://www.ema.europa.eu/en/news/ema-now-operating-amsterdam

If the figure of 25% staff loss is right, that will have been an enormous disruption to the work of the EMA. A pandemic a year later is just about the worst possible timing.