COVID Vaccine !

[Ajax Bay]

"Completely understandable from here"! Depends on your comprehension level, I suppose.
I bet the UK Government would do no such thing. Italy's behaviour is myopic, peninsular and politically inward-facing. Will Italy also prevent the export of Ox-AZ vaccine - next week, say - to adjacent countries from the Rome factory? And if not, where does the rationale differ?

 

[mjr]

Canada approved Ox-AZ only for under-65s https://www.thestar.com/news/canada...mmittee-says-in-split-from-health-canada.html

Let's face it, the decision on who to include in the clinical trials may have satisfied the UK MHRA quickly, but it's not seeming to cut it with other regulators, and surely no-one can credibly claim that Canada is trying to punish the UK for something just now?

 

[roubaixtuesday]

Canada approved Ox-AZ only for under-65s https://www.thestar.com/news/canada...mmittee-says-in-split-from-health-canada.html

Let's face it, the decision on who to include in the clinical trials may have satisfied the UK MHRA quickly, but it's not seeming to cut it with other regulators, and surely no-one can credibly claim that Canada is trying to punish the UK for something just now?

On a point of clarification, it's not a regulatory decision.

Health Canada are the regulator. They have approved it.

It's a policy decision, equivalent of JVCI here I think.

 

[mjr]

"Completely understandable from here"! Depends on your comprehension level, I suppose.
I bet the UK Government would do no such thing.

That is a safe bet because there's not much chance that we're going to find out.

Italy's behaviour is myopic, peninsular and politically inward-facing. Will Italy also prevent the export of Ox-AZ vaccine - next week, say - to adjacent countries from the Rome factory? And if not, where does the rationale differ?

Politically, their neighbours part of a common purchasing system with Italy and have helped earlier in the pandemic, so it would be easier to sell as reciprocation, but it's not completely impossible that the Draghi government of national unity might try to block shipments if the one of the three right-wing parties demanded it. Maybe @marinyork or someone can opine whether the others — PD, Italia Viva or Art.1 — would threaten to bring down the government to support internationalism?

Practically, I suspect the EU would object, which they can as the single market regulator, but these would be murky waters to sail into. I would expect both Italy and the EU would launch a new round of criticism of AZ rather than each other.

 

[roubaixtuesday]

I bet the UK Government would do no such thing. Italy's behaviour is myopic, peninsular and politically inward-facing

Myopic and inward facing is a perfect description of UK foreign policy for the past 5 years. Our foreign policy has been designed to appease an extreme faction of the Conservative party.

Which is in no way to support Italy here; I don't know much about exactly what's gone on, but it seems petty and political rather than health driven.

 

[Ajax Bay]

I suspect Oxford-AZ regret not having a wider age range in their Phase 3 RCT and the MHRA 'in bed' with them during the set up of that trial missed a trick. Consequently the efficacy of the Ox-AZ candidate vaccine in over 65s could not be evidenced directly.
The UK MHRA are world class. Other regulators must follow their own star. But in UK the approach has saved many, many lives and the real life UK data now available allow other regulators to use those as evidence of effectiveness.
No, Canada is neither "trying to punish" nor "punishing" anyone. It may be they have sufficient supply of other makes of vaccine to jab their aged, and keep the efficacious Ox-AZ for their lucky health care workers.

 

[mjr]

On a point of clarification, it's not a regulatory decision.

Health Canada are the regulator. They have approved it.

It's a policy decision, equivalent of JVCI here I think.

Health Canada are the licensing regulator. NaCI inform the provincial vaccination program regulators, which all seem to be following suit: Ontario, PEI, Saskatchewan and Alberta, and so on.

It doesn't really matter which regulator of what made the decision. Practically, Ox-AZ still ain't going into the arms of Canadians over 65.

 

[mjr]

The UK MHRA are world class. Other regulators must follow their own star. But in UK the approach has saved many, many lives and the real life UK data now available allow other regulators to use those as evidence of effectiveness.

It is bittersweet, though, as it looks like those UK lives may have been saved at the expense of lives lost elsewhere as a result of slower approvals and fuelling hesitancy among some of the most vulnerable to covid.

 

[roubaixtuesday]

It is bittersweet, though, as it looks like those UK lives may have been saved at the expense of lives lost elsewhere as a result of slower approvals and fuelling hesitancy among the most vulnerable to covid.

You're saying hesitancy elsewhere is as a result of the MHRA accepting immunological bridging for older subjects?

Even though the EMA took the identical decision?

If you say so.

 

[johnblack]

I suspect Oxford-AZ regret not having a wider age range in their Phase 3 RCT and the MHRA 'in bed' with them during the set up of that trial missed a trick.

I reckon that AZ probably regret submitting its vaccine for approval in the EU at all, and entering contract to supply, especially as it is doing so without the profit margin of the other vaccine suppliers, the grief they seem to be faced with, will make them think twice for future approvals.

 

[Ajax Bay]

it looks like those UK lives may have been saved at the expense of lives lost elsewhere as a result of slower approvals and fuelling hesitancy among the most vulnerable to covid.

Please share your thinking towards a conclusion that the UK's approach has influenced the "slowness of [other nations'] approval" mechanisms or has "fuelled vaccine hesitancy".
Who are you identifying as "the most vulnerable to covid" please?

 

[mjr]

Please share your thinking towards a conclusion that the UK's approach has influenced the "slowness of [other nations'] approval" mechanisms or has "fuelled vaccine hesitancy".

The regulators of Germany, France, Greece, Denmark, the Netherlands, Sweden, Poland, Austria, Italy, Belgium and Spain all initially cited lack of data about over-65s (over-55s in some!) as a reason not to approve it above that age at first. Some have modified that since. Some have not. So it seems likely that including more older subjects in the third phase would have avoided that, even if it was not necessary to please the UK regulator.

Who are you identifying as "the most vulnerable to covid" please?

Older people. It was missing a "some of" which has been added.

In other news, Sky News claims at the end of https://news.sky.com/story/astrazen...ut-in-the-eu-but-how-did-it-play-out-12236052 (without sources) that the export-blocked vaccines will be distributed across the EU, not kept only in Italy.

 

[oldworld]

If the UK saw shipments of vaccines leaving as exports and their contract with the supplier wasn't being fulfilled, then no one would think the UK was acting unreasonably if they stopped these exports.

 

[roubaixtuesday]

So it seems likely that including more older subjects in the third phase would have avoided that, even if it was not necessary to please the UK regulator.

It was not, though, a "UK approach".

It was clinical trial ethics, avoiding exposing older subjects until more data was in on younger subjects.

Nothing to do with the UK per se - the trial was run across geographies.

The only "UK" approach here was to accept the phase 2 bridging data to older subjects on immunological response rather than outcome.

And the EMA accepted this too.

There's no blame here for the UK in European vaccine hesitancy.

 

[mjr]

It was not, though, a "UK approach".

Yes, thank you, good spot. @Ajax Bay switched slickly from discussing "the approach" of the Ox-AZ trials to calling it "the UK's approach" and I failed to notice, so continued discussing the trial participant selection.

It's interesting that 240 out of 560 second phase trial participants were 70+.