EU criticises 'hasty' UK approval of Covid-19 vaccine(reuters.com)
reuters.com
EU criticises 'hasty' UK approval of Covid-19 vaccine
https://www.reuters.com/article/us-health-coronavirus-britain-eu/eu-criticises-hasty-uk-approval-of-covid-19-vaccine-idINKBN28C1B9
22 comments
Some cultural notes: the UK is in a culture war, and some will shine the most negative light on anything the opposing side do.
Taking a more charitable approach... is it possible those suggesting Brexit has allowed a quicker rollout aren't referring to regulations?
Perhaps the early rollout is facilitated by UK doing their own deals with vaccine manufacturers, rather than as as a package deal with EU (and thus having to wait for their slower and safer process). Is that it?
Taking a more charitable approach... is it possible those suggesting Brexit has allowed a quicker rollout aren't referring to regulations?
Perhaps the early rollout is facilitated by UK doing their own deals with vaccine manufacturers, rather than as as a package deal with EU (and thus having to wait for their slower and safer process). Is that it?
No that's not it.
UK is getting this vaccine first because MHRA approved it before EMA did (and any EU country is allowed to use this shortcut that MHRA is so far the only one to have used), not because we have a deal to get it first.
UK is getting this vaccine first because MHRA approved it before EMA did (and any EU country is allowed to use this shortcut that MHRA is so far the only one to have used), not because we have a deal to get it first.
[deleted]
"I'm not convinced that if [the UK] had been part of that European buying programme they'd have had quite the speed and flexibility to do it." -- Hugo Fry. (Pharma head, who happens to be a remain supporter.)
https://web.archive.org/web/20201203131008/https://www.teleg...
What leads you to such confidence in what looks like an uncertain matter?
https://web.archive.org/web/20201203131008/https://www.teleg...
What leads you to such confidence in what looks like an uncertain matter?
It's not a culture war. It is the war against barbarity, against fear, against xenophobia, against aggression, against ignorance. The same war as it always was. Choose.
That is exactly what is a culture war, as you assert a set of beliefs and perspectives ought to be warred against. The term culture war does not necessarily suggest equivalence, though of course both sides in your country use grandiose and reduced language. Here’s a quick summary of the term. https://en.m.wikipedia.org/wiki/Culture_war
In another comment in this post you say:
> Actually a deal is currently being negotiated to determine exactly how much they can tell us what to do, in return for avoiding the total destruction of our economy
"Total destruction"? The brexiteers aren't the only ones invoking fear.
> Actually a deal is currently being negotiated to determine exactly how much they can tell us what to do, in return for avoiding the total destruction of our economy
"Total destruction"? The brexiteers aren't the only ones invoking fear.
> Choose.
If I must. Not yet - not quite yet.
"Whoever thinks I'm with them or against them, I'm against them."
If I must. Not yet - not quite yet.
"Whoever thinks I'm with them or against them, I'm against them."
What are the object-level facts here? This article is very abstract and is mostly concerned with what various parties are saying.
"They are rushing!"
"No we are not rushing, we are going a good job"
"No! Too fast! We are being more thorough than you because we are waiting for more data."
"We are being rigorous"
The closest we get to any kinds of concrete statements about the review process is:
"The EMA started a rolling review of preliminary data from Pfizer trials on Oct. 6, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data. The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA."
It's still not clear what "the data" is, what a "rolling review" is and what any of this means from a practical decision-making standpoint. Should UK citizens take the vaccine? What issues could be missed given the UK regulator "analysed less data"?
"They are rushing!"
"No we are not rushing, we are going a good job"
"No! Too fast! We are being more thorough than you because we are waiting for more data."
"We are being rigorous"
The closest we get to any kinds of concrete statements about the review process is:
"The EMA started a rolling review of preliminary data from Pfizer trials on Oct. 6, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data. The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA."
It's still not clear what "the data" is, what a "rolling review" is and what any of this means from a practical decision-making standpoint. Should UK citizens take the vaccine? What issues could be missed given the UK regulator "analysed less data"?
MHRA give more details of the approval process on their site[1]:
> This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.
> The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.
> The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality.
The information sheet for doctors gives a long list of "we don't know yet" about safety and efficacy for certain populations[2].
[1] https://www.gov.uk/government/news/uk-medicines-regulator-gi...
[2] https://assets.publishing.service.gov.uk/government/uploads/...
> This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.
> The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.
> The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality.
The information sheet for doctors gives a long list of "we don't know yet" about safety and efficacy for certain populations[2].
[1] https://www.gov.uk/government/news/uk-medicines-regulator-gi...
[2] https://assets.publishing.service.gov.uk/government/uploads/...
And there goes the hope that they were just more efficient in working through the available data...
What has led you to conclude the UK hasn't been more efficient with the data?
The head of the regulatory agency refers to a "rolling review". Perhaps they are confident enough so far that they are willing to roll this out to the most vulnerable, if they've found that their risk of side effects (even with high error bars) is lower than their risk of getting coronavirus.
That would then buy more data which will inform continued rollout to the less at-risk population.
The head of the regulatory agency refers to a "rolling review". Perhaps they are confident enough so far that they are willing to roll this out to the most vulnerable, if they've found that their risk of side effects (even with high error bars) is lower than their risk of getting coronavirus.
That would then buy more data which will inform continued rollout to the less at-risk population.
Dear EU, you don't get to tell us what to do anymore!
Actually a deal is currently being negotiated to determine exactly how much they can tell us what to do, in return for avoiding the total destruction of our economy.
I'm not sure what Brexit has to do with this. The European Medicines Agency's criticism is entirely legitimate; they're criticising the emergency approval procedure to rush a vaccine into widespread application rather than not rush it.
Given Johnson and his government's inconsistent, perhaps even lackadaisical, response to the severity of the Covid-19 pandemic, it's not unusual that this emergency rushing be treated with skepticism — is it a good faith move to help immunise Britain or a way to save face for failing to properly implement lockdown quickly and early?
Any agency from around the world, not just in the EU, might hold the same skepticism and provide such criticism. It's only due to Brexit and modern Britain's tenuous relationship with the EU that such a knee-jerk rejection of such criticism might occur — but, given the actual topic of discussion should not be world politics but world health, it does seem inappropriately off-topic.
Given Johnson and his government's inconsistent, perhaps even lackadaisical, response to the severity of the Covid-19 pandemic, it's not unusual that this emergency rushing be treated with skepticism — is it a good faith move to help immunise Britain or a way to save face for failing to properly implement lockdown quickly and early?
Any agency from around the world, not just in the EU, might hold the same skepticism and provide such criticism. It's only due to Brexit and modern Britain's tenuous relationship with the EU that such a knee-jerk rejection of such criticism might occur — but, given the actual topic of discussion should not be world politics but world health, it does seem inappropriately off-topic.
awssucs(1)
UK med regulators have said that's bollocks. They say the med was approved under existing EU regs.
MHRA say that no corners were cut. They claim the rapidity of the decision was because all parties were in alignment: they want a safe vaccine, so all funding was available when it needed to be and all evidence was rapidly assessed.
https://twitter.com/ShaunLintern/status/1334078198318059520?...