Thursday, 10 December 2020

Covid & British Regulators: Makes You Proud ...

Seriously: this is one of our great competitive strengths.

 

2020 has not been a year of pride for this Brit.  Although it started well with the Greenwich Speech, on the scale of what matters I can't think of anything from Boris Johnson's government that has subsequently been greatly to his credit**, and an awful lot that is utterly disgraceful.  (Card-carrying Tory writing here.)

This is, until the lightning-fast regulatory approval and delivery of Covid vaccine, outstripping the rest of the Western world by, what - weeks?  months?  And how much slower still would they have been if we hadn't set the pace?

This is pragmatic regulation at its very best; and we may hope that it, and we as a nation, will be rewarded.  I have frequently lauded Ofgem, the regulator in my own specialist sphere, for its speed, flexibility, practice of consulting properly, willingness to experiment - and to admit shortcomings, and to reiterate swiftly, intelligently and without stupid pride of authorship.  

In absolute terms, when you are faced with what seems like a slow response from Ofgem, it's certainly possible to be frustrated.  That is, until you talk to anyone working in energy in the EU, where the regulators are slothful, inflexible, uncommunicative, stolid, obtuse and unresponsive.  I've lost count of the number of times I've heard continentals say, in open sessions, "they do this already in the UK", or "the British are so much better at this". 

It's pretty obvious that in the brave new Covid / "Zero Carbon" world, national flexibility is at a massive premium.  The vaccine approval, and a pretty impressive roll-out process, are deeply hopeful signs we are going to make new-found Brexit freedoms tell to our advantage - and in parallel, are going to make the obtuse, Civil-Code-bound federasts squirm.

That's my crumb of comfort at the end of a bleak 2020, and I'm sticking to it.  (For now.)

ND

_____________ 

** The defence spending & foreign aid announcements? - Ed 

48 comments:

Anonymous said...

https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML

I expect the consultancies will rip them off price wise as usual, but at least it shows someone has a brain and is getting their ducks in a row. I only found out the other day that the swine flu vaccine 2009/10 caused 100 UK cases of narcolepsy, no current treatment and a life-destroying aiment in that society is not structured for people who fall asleep at random intervals.

II.2.4)Description of the procurement:

The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed.

IV.1.1)Type of procedure
Award of a contract without prior publication of a call for competition in the Official Journal of the European Union in the cases listed below

The procurement falls outside the scope of application of the directive

Explanation:

For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool.

Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health.

Reasons of extreme urgency — the MHRA recognises that its planned procurement process for the SafetyConnect programme, including the AI tool, would not have concluded by vaccine launch. Leading to a inability to effectively monitor adverse reactions to a Covid-19 vaccine.

Events unforeseeable — the Covid-19 crisis is novel and developments in the search of a Covid-19 vaccine have not followed any predictable pattern so far.

Anonymous said...

It's dated October 23rd, any idea who got the contract? Hopefully not Serco, who can't get to grips with Excel never mind AI.

david morris said...


So, you are not just a teensy bit concerned that a public health crisis - manufactured and gamed-out before the initial outbreak in Wuhan, China – has been used to short-circuit long-held civil liberties, strengthen the authority of political leaders, collapse the economy, dramatically remake basic social relations, and impose absolute control over work, school, gatherings and recreational activities ?

But as long at the UK is in the van of vaccine disbursement that's OK ??

Really ???

Jan said...

I read somewhere only yesterday that somewhere in the Middle East (I think it is the UAE) have been rolling out a Chinese vaccine since Septemeber and RT have said the Russian Sputnik V Vaccine had also been in use for a few days before the release of the Pfizer vaccine.

Of course they may not have undergone the same testing and obviouly cannot be any good because we don't trust the Russians or the Chinese do we?

I don't know why we always have to be so superior. (Sorry if I burst your bubble Nick!)

Anonymous said...

If you compare CV19 with the Asian flu outbreaks of 1958 and 1968 the contrast is remarkable. Then 100,000 or so excess deaths but life just went on as normal.

I guess in those days we looked forward to getting mumps/measles/rubella/chicken pox as soon as possible, even though there were casualties (a great aunt died pre-dialysis when measles took out her kidneys, I had a girlfriend whose hearing was badly damaged by mumps). Polio and TB were the only things we were vaccinated for. Was there a whooping cough vaccine too?



dearieme said...

What if the US or the EU rejects the BioNTech vaccine?

I suppose on nationalistic grounds they are likelier to reject the Oxford one.

Oli said...

Jan - of the rushed vaccines on offer at the moment, would you rather take one of the Russian/Chinese ones, or the ones the MHRA has approved? There's a reason why we tend to feel superior...

I was waiting for someone to carp that actually under EU legislation we could still have done our own rapid approval, based on emergency powers we already had. That's true but it misses the point. We *wouldn't* have done, woudl we? Without Brexit we'd have fallen in line with the EU regulator, of course, just like all the other 27 have. Brexit gives impetus, not just opportunity.

Thud said...

Dave, we will deal with your problems real or otherwise, just let us get out of the friggin house first.
Jan, if the Chicoms were sure of their vaccine don't you think they would be crowing about saving the world? instead sneak it out and see what happens as what is a million Chinese more or less to them?

E-K said...
This comment has been removed by the author.
Old BE said...

No wonder the French are rattled

Anonymous said...

One can only keep all our fingers crossed that this Pfizer vaccine does not have any serious long term side effects.

Hopefully not like the swine flu vaccine of 2009/10 GSK Pandemrix, which originally approved was given to 6 million UK citizens and later withdrawn as not safe due to serious side effects.

Or indeed we must hope it is not as bad as another 450+ worldwide medicines that also were approved and later withdrawn in the last few decades, due to serious side effects. (Data from a report -(Oxford centre for evidence based medicine)

And we must hope that it doesn’t suffer the fete of other Pfizer medicines of late, that have led to massive law suits, many still pending, because of serious side effects after having been “approved” by regulators around the world.
One such law suit being the second highest in history at $2.3 billion, after GSK at $3 billion.

Luckily for all these vaccine providers, doing so in less than 10% of the normal time, for a totally new technology that’s NEVER been used before on humans - they all have a government signed and sealed get out of jail free card from prosecution or most compensations.

Speaking of compensations the UK governments own VACCINE DAMAGES ACT has paid out £75 million pounds in compensation for vaccine side effects to almost 1000 UK people this far since it’s formation.

Now all the above IS true and available online, and does not emanate from some dodgy web site with a stupid science fiction agenda.
Much of it was actually previously reported by the BBC a few years ago, when they employed journalists.

I would say, being a scientist, I have an an enquiring mind to know both sides of the argument.

Thud said...

Anon, stop moaning, they work, celebrate and lets move on.

Anonymous said...

There will be no legal challenges to the Pfizer vaccine as they have been given an indemnity by the government. Reasonable since it is too early to have the safety data usually required.

On the other hand, there is an AI contract floating about to analyse the "yellow cards" (lots expected) which GPs send in detailing side effects.

Anonymous said...

@anon 9:53

Pandemrix wasn't withdrawn because of side effects, GSK didn't reapply for a licence.

And, as is common with anything we stick in out bodies, there is a risk of side effects and these generally get known as more and more people get said stuff stuck in their bodies.

In the case of Pandemrix, both the rare and very rare side effects were pretty unpleasant, and then there's the narcolepsy which affected 0.005% of those who were given it.

I've seen on social media the same people use that as a reason for not having the covid vaccination, who are also apparently happy to let a disease with a ~20 times greater chance of killing them than the Pandemrix giving them narcolepsy, let rip.

Fucking mental.

Elby the Beserk said...

Maybe, Nick, maybe not. Prior to this, no coronavirues vaccine has succeeded. All prior versions have also been extensively tested on animals, with serious problems arising on the way. Which is why, until now, there has been no Coronavirus vaccine that works - as evinced by the annual 'flu jab which is to all intents and purposes useless. And of course, the vaccine for Swine Flu brought about significant number of cases of Narcolepsy. The Pfizer 0 and others, I believe, have undergone NO animal testing.

I'm with you for smart and rapid regulation. But I'm passing on this. Many many medics are horrified by the rapid certification. Many state that problems with the vaccine may not be met till recipients meet another form of coronavirus - as seems to have happened in Wuhan, Lombardy, and NYC with catastrophic consequences - check out "Cytokine Storm" - which is what happens when the above comes into play.

Mind, none of this need have happened had we governments that weren't well, words fail me.

Read and weep. The corruption of the mortality rates and figures is an utter disgrace.

https://www.satrakshita.com/Books/Corona_False_Alarm.pdf


Authors

Karina Reiss was born in Germany and studied biology at the University of Kiel where she received her PhD in 2001. She became assistant professor in 2006 and associate professor in 2008 at the University of Kiel. She has published over sixty articles in the fields of cell biology, biochemistry, inflammation, and infection, which have gained international recognition and received prestigious honors and awards.


Sucharit Bhakdi was born in Washington, DC, and educated at schools in Switzerland, Egypt, and Thailand. He studied medicine at the University of Bonn in Germany, where he received his MD in 1970. He was a post-doctoral researcher at the Max Planck Institute of Immunobiology and Epigenetics in Freiburg from 1972 to 1976, and at The Protein Laboratory in Copenhagen from 1976 to 1977. He joined the Institute of Medical Microbiology at Giessen University in 1977 and was appointed associate professor in 1982. He
was named chair of Medical Microbiology at the University of Mainz in 1990, where he remained until his retirement in 2012. Dr. Bhakdi has published over three hundred articles in the fields of immunology, bacteriology, virology, and parasitology, for which he has received numerous awards and the Order of Merit of Rhineland-Palatinate



Elby the Beserk said...

Anonymous said...
If you compare CV19 with the Asian flu outbreaks of 1958 and 1968 the contrast is remarkable. Then 100,000 or so excess deaths but life just went on as normal.

I guess in those days we looked forward to getting mumps/measles/rubella/chicken pox as soon as possible, even though there were casualties (a great aunt died pre-dialysis when measles took out her kidneys, I had a girlfriend whose hearing was badly damaged by mumps). Polio and TB were the only things we were vaccinated for. Was there a whooping cough vaccine too?
=========================================================

Yes there was, and very dodgy it as as well. Not to mention the contaminated polio virus vaccine in Africa that actually gave people Polio.

I have four now adult kids. None had the standard childhood disease vaccinations, just the nasties like diptheria. We did this with the full support of our GP, who was clear that healthy kids were fine without them. All got one or two of these diseases, and rode them out as we did as kids as well.

Vaccines are a huge advance in medicine and responsible for saving millions of lives worldwide. But not all are reliable. I'm certainly not taking any chances with one for Covid-19 as matters stand

Unknown said...

"the annual 'flu jab which is to all intents and purposes useless"

It has worked for me for about ten years. By having an annual flu jab, I've avoided a great deal of unpleasantness.

Perhaps I'm fortunate in not being scared of needles.

Don Cox

Jan said...

"I'm certainly not taking any chances with one for Covid-19 as matters stand"

I'm with Elby on this and no I wouldn't be keen on either a Chinese vaccine or Sputnik V either.

Old BE said...

Flu isn’t a coronavirus! Jeebus.

Old BE said...

Also, all these “it’s just flu” idiots obviously have never had flu. It’s horrible. I had it in my 20s as a fit person and it screwed me up horribly. I wouldn’t wish that on anyone.

Old BE said...

“My kids were fine” - lucky them. What if everyone was as ornery? Would everyone be fine? Of course not. Antivaxxers are some of the most destructive people around.

My GP for whatever reason advised my parents not to immunise me as a young child. I had measles and mumps and count myself lucky I did catch them young as they can be a disaster if you get them as an adult. Mumps was particularly egregious.

Anonymous said...

Thud, the scientist.

Anonymous said...

Anon @ 9.37

'let rip'

Why do you lot always lie ?

A fraction of 1% of the population will die of CV-19 and 99% of those will be very old and very ill.

Yet you lot want to mask, impoverish and inject the WHOLE population.

It's you who are MENTAL.

Anonymous said...

"the annual 'flu jab which is to all intents and purposes useless"

It has worked for me for about ten years.

Not having a flu jab worked for me for ten years, because I don't think I've ever had flu in my life, or I'm resistant. Most years, working in a busy office/large town I pick up "man-flu" which flattens me for two days of sweaty fever, then it's done. Had the flu jab for the last 2 years simply because I have elderly relatives and don't want to pass it on.

Swine flu I have had, and that was a bugger. Mind, I lost half a stone. Is covid worse than swine flu?

Anonymous said...

@anon 10:47

I was describing a certain set of people - so you either self-identify with people who can't understand math, or you have the reading comprehension level of a drunk or a child.

Given the rest of your post sounds like that of a petulant infant, I'm guessing the latter.

Elby the Beserk said...

Unknown said...
"the annual 'flu jab which is to all intents and purposes useless"

It has worked for me for about ten years. By having an annual flu jab, I've avoided a great deal of unpleasantness.

Perhaps I'm fortunate in not being scared of needles.

Don Cox

11:55 am
====================================

So YOU knew YOU would get 'flu WITHOUT the jab?

Wow!

Lottery numbers this weekend please.

ps. Never had the jab. Never had flu.

Elby the Beserk said...

Whoa there...


https://www.conservativewoman.co.uk/the-pfizer-vaccine-a-headlong-rush-into-the-unknown/


My concerns from the ‘Information for Healthcare Professionals’ document make a long list:

1. Adverse effects from the injection which the trials identified as ‘very common’ were pain at injection site (more than 80 per cent of participants); fatigue (more than 60 per cent); headache (more than 50 per cent), joint pain (more than 20 per cent), muscle pain (more than 30 per cent); chills (more than 30 per cent); fever (more than 10 per cent). These ‘were usually mild or moderate in intensity and resolved within a few days’. Based on looking at many vaccine SPC documents, these percentages of adverse effects are alarmingly high. If ‘moderate’ in intensity, most of them would require time off work for potentially several days. None of them can honestly be dismissed as minor symptoms.

2. No drug interaction studies have been undertaken (although, actually, this is the norm with almost all pharmaceutical drugs). But with a traditional, viral-based vaccine, past experience will probably give researchers an idea of possible interactions whereas, in this case, we have absolutely no idea of even what type of drugs might interact unfavourably.

3. No animal reproductive or development toxicity tests been carried out, so we have no clue as to potential problems with reproduction or foetal development.

4. Safety of the vaccine during pregnancy has not been determined, which is why Section 4.6 states: ‘For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.’

5. It is not known whether the vaccine is excreted in human milk, which is why Section 4.6 also states that it ‘should not be used during breast-feeding’.

6. Section 4.6 also states, under the heading ‘Fertility’, that ‘It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.’

Unknown said...

"So YOU knew YOU would get 'flu WITHOUT the jab?"

Having suffered from flu a number of times before the vaccine was available, I judged that it was much less likely that I would get flu if I had the vaccine.

And so it has proved. There are no doubt some figures around for the overall response among tens of thousands of people.

Vaccination is a powerful tool. It isn't, and should not be, compulsory. But I do wonder why the taxpayers should pay for intensive care of those who refuse to be vaccinated and develop a bad case of Covid-19.

Don Cox

Elby the Beserk said...

Don,

So you have no natural immunity from 'flu. Fair enough. Get vaccinated. Me? I have never had 'flu in my life, nor suffered from any of the however many 'flu type pandemics of my 9 years.

Were I satisfied the vaccine was safe, I'd have it. Indeed, just a few months back I had the PPV inoculation, having looked hard and deep into the ingredients to satisfy myself of its safety. Indeed, it's a real old school jam with nothing more than the many types of pneumonia that occur. However I will not accept a seriously new vaccine with no proper animal testing that many many medics are concerned about.

As for banning/charging? Sure. As long as we charge the obese, alkies, and everyone else who has brought a disease upon themselves.

Alternatively, an insurance system, such as the many in Europe which work so much much better than the hopeless NHS.

Maybe in a couple of years ... btw, this is the FIRST Coronavirus which is claimed to be successful. And the first NOT to undertake animal testing, which brought to the fore many problems.

And who do my family sue if this wrecks me? Not Pfizer. So?

Elby the Beserk said...

69! Not 9.

Charlie said...

Don Cox: "I do wonder why the taxpayers should pay for intensive care of those who refuse to be vaccinated"

Happy with that, as long as we don't have to pay for smokers' lung transplants, alcoholics' liver transplants, fat people's diabetes drugs and cancer treatments, injuries sustained while playing sports etc etc.

I'm not an anti-vaxxer - me and my kids have had all our jabs. But there's barely any risk presented to me, and none to them, by Covid, so they won't be having the vaccine, and I won't be having it either. We don't know the long-term health consequences, and I just couldn't forgive myself if, having ignored my gut, they had the jab, then ended up suffering some rare, life-changing side effect.

Covid doesn't touch kids who aren't already gravely ill. We simply don't know if the vaccine is or isn't. Some tiny risk is bigger than no risk. I am unsure as to why this is such a controversial view.

Anonymous said...

Anon @ 9.35

I really do rest my case.

You have lost your temper - as has Thud.

E-K said...

I have kept myself really fit. I mean REALLY fit. Not some stupid Joe Wicks early-morning cardio routine but mud running, hill sprints, puke making sandbag, chinning bar and 32k kettle-bell workouts.

I begrudge having to take a vaccine though I see CV-19 as being an extremely low threat to me personally.

I will take it nonetheless. To get our economy and our country up and running again.

No. I don't trust the Government. Nor do I trust the pharma companies which I have done so much to avoid their services... and to get out of wearing this FUCKING mask.

Whitty is a cadaverous cunt who will be the death of us all. Why can't you see it ?

Elby the Beserk said...

@E-K

Whitty is a cadaverous cunt who will be the death of us all. Why can't you see it ?
=============================================

See it clear as daylight, EK! The problem is that Whitty clones permeates vast swathes of the higher echelons of the public sector, which is still piling on employees, still bloated, still unbelievable inefficient.

Nor do I see it getting any better under these sham conservatives. I really cannot see me ever voting again unless it's to keep out some crazed cretin like Corbyn. And we don't do that down here anyway...

Sick of the whole bloody lot of them.

Anonymous said...

@Elby - those side effects are common in vaccines. They elicit an immune response, it's what they do, and that immune response has an effect on the body. No such thing as a free lunch, etc, etc, etc.

Points 2-5 are reasonable though, 6 is pretty standard for when there is no expectation of an effect there due to how a medicine functions.

Anonymous said...

@anon 11:37 - no, I've lost my patience.

But a victory of sorts seems important to you, so take one, you win the internetz.

Go make yourself a pretty badge and feel validated.

AndrewZ said...

Elby, the response to the flu outbreaks of 1958 and 1968 was very different for practical reasons as well as cultural ones. Back then, a much higher percentage of the population worked in industrial jobs. Without computers and broadband internet connections, very few office workers could work from home either. They'd have to visit the office so often to collect and return their paperwork that it would be completely impractical. A 2020-style lockdown would have caused total economic collapse within weeks.

This is an example of how new technology creates new possibilities, which then become the subject of debate and political conflict about which option is best. In 1958 and 1968, people just carried on as normal because they didn't have any other options. We do, so public opinion is divided about which choice would be best and even in hindsight there will never be complete certainty about what the optimal choice really was.

Anonymous said...

Anon @ 9.58

Now you're resorting to sarcasm.

We are going to inject those who are healthy and not at any real risk from the virus and do it on a monumentally huge scale.

This had better be good.

Unknown said...

@Elby

The point of animal testing is to pick up serious or fatal side effects before beginning any trials with human volunteers. Now that thousands of humans have been vaccinated the time for animal trials is long past.

Don Cox

Unknown said...

And in fact the RNA vaccines were tested on animals.

https://apnews.com/article/fact-checking-afs:Content:9792931264

Don Cox

Elby the Beserk said...

AndrewZ said...
A 2020 style lockdown would have caused total economic collapse within weeks

11:59 am
======================================================

So 2020 style we have a horribly damaged economy, but worse, the effect on our population in terns of severe illness, dreadful mental health and all that comes with it is just as bad. Never mind the government I voted for showing itself to be incompetent, but worse, deeply authoritarian.

As for "saving the NHS". Words fail me. We pay them to save US.

Biggest shit storm of my 69 years and it hasn't really started yet. Never mind the Great Fucking Reset. This is an utter disaster for our society and may well have broken it for ever.

And there's no vaccine for that.

andrew said...


Broken is too strong a word. Changed.

Over 2020 we have been teaching small children to not play with each other, to wear masks, to do as you are told - and other things.

What lessons will be learned from that I do not know and as people are complicated, I doubt anyone really does or will for many years.

DJK said...

So far, 60-80,000 dead in the UK (depending on how you count it); 230,000 in the USA. What will be interesting will be to find how how many fewer babies get born over the coming year. We're coming up to the point where the first babies conceived during the pandemic will be born. It's possible that enforced lockdown produced more pregnancies, but I strongly suspect that the uncertainty caused people to put off conception.

Elby the Beserk said...

andrew said...

Broken is too strong a word. Changed.

Over 2020 we have been teaching small children to not play with each other, to wear masks, to do as you are told - and other things.

4:09 pm
============================================================

That's a badly broken society by definition what has been done to kids this past month. Changed and much for the worse. The problem now will be to get the govt to roll back this crap, not only the utter contempt for civil liberty but what they have done to all of us.

AndrewZ said...

DJK, you are probably right. People often respond to uncertainty by putting off big decisions - on spending or life choices - until they know which way things are headed. Since we're currently dealing with COVID uncertainty, the COVID recession and Brexit uncertainty, there will probably be a huge backlog of economic and personal decisions piling up. If so, the eventual return of confidence could well trigger an economic boom, a baby boom, a marriage boom and a general period of exuberant optimism.

Graeme said...

Don Cox is so funny.. He reminds me of Colin Compton at the Wheel tappers and Shunters

AndrewZ said...

One more thought about the possibility of a post-COVID boom. The government recently published legislation to repeal the Fixed-term Parliaments Act, which would allow the Prime Minister to call an election whenever he wanted. A post-Brexit snap election seems unlikely when it's less than two years after the last one and the government has a large majority. So, perhaps they are also expecting an economic boom once normality returns and want to be in a position to take advantage of it.

Anonymous said...

Don't need it, don't want it, don't understand the evangelical adoration heaped on it by true believers, however I respect your right to take it.

Let's see how much my right not to take it will be respected, whether by hard force (Unlikely to happen) or soft force...

Want that broken leg cast? Ooh, sorry, you're going to need the vaccine...