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

by figaroniguzo • 6 years ago

21 15 6 years ago

reuters.com

_Microft• 6 years ago

And there goes the hope that they were just more efficient in working through the available data...

basicneo4• 6 years ago

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.

DanBC• 6 years ago

Some cultural notes: UK Conservative politicians have started claiming that our rapid approval was because of Brexit.

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?...

basicneo4• 6 years ago

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?

somewhereoutth2• 6 years ago

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.

corin_• 6 years ago

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.

Hickfang• 6 years ago

Dear EU, you don't get to tell us what to do anymore!

somewhereoutth2• 6 years ago

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.

zapzupnz• 6 years ago

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.

The_Amp_Walrus• 6 years ago

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"?

bobby_bob• 6 years ago

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/...

EU criticises 'hasty' UK approval of Covid-19 vaccine

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