UKC

https://www.bbc.co.uk/news/amp/health-55145696
 

Rollout from next week, 10m (5m people’s worth) doses by the end of this year. 
 

Maybe the end is in sight!

Seems very quick! 

Hospitals start on Monday! 

Still seems to be confusion in some news articles about who gets it first. Last week I thought I saw articles saying hospitals would give it to their staff first due to the distribution issues, today the Bbc are still saying care homes are first as per the official priority list that was produced a while back.

Edit, sorry, read a bit more. Guardian included a quote from DHSC spokesperson that said the priority list would be published shortly.

YAY! Best news we could get just now! 

I am worried that people won't believe the government that it's safe, I think we need to get David Attenborough to do a public information announcement about it's safety. He seems to be the authority that people will listen to!

I still do some work in a care home... My arm is ready and waiting!

Thank f*ck for that, we'd be in serious trouble without a vaccine, we've already had far too many dead and are past the point where the 2008 recession looks quite trivial, I'm not sure how much longer we could keep going without vaccines now.

My understanding is that hospitals will get it first as they have the facilities to store the vaccine (most other places will not have the cold storage facilities).  However, that says nothing about who will be prioritised to actually get the vaccine.

That's one hell of a Christmas present .

Thanks Santa 

Surely hospital staff should be first since they are most likely to be exposed and pass on as well as causing the most harm to the NHS if they have to self isolate

Interestingly, my wife had a phone consultation with our superb GP and vaccines came up. GP stated "over my dead body" would she have the Pfizer one. She believes the method of manufacture of the Oxford one is safer as it's more akin to the usual flu jab. So I asked my consultant and he said "wait for Oxford".

Although not frontline NHS (I'm in the labs-backroom boy!) I'm gonna get pushed at some point. Here's 2 people I respect saying no. Bit more reading up for me.

Not sure GPs or your consultant should be saying that......seems irresponsible IMO.

In my experience some GPs have an overconfidence when it comes to matters scientific. Very few have any scientific training and a little knowledge is a dangerous thing. 

NB This also applies to many other fields of medical practice.

Hospital, over 85s, and care workers. 

’First’ is a bit of a misnomer. It’ll be done in parallel. Local authorities have been booking village halls and buying freezers for a couple of months now. 

With all due respect to GPs, they are also not really the ones to be able to judge the vaccine? 
 

I’m not qualified either. 

I was surprised at the GP, but I think I can have an honest chat with the person I work for. Why would you not? He's better qualified than a social media guru.

No, but the authorities who have authorised it are qualified! 

There’s a GP in my area who has discovered a new fundamental theory of physics that explains everything.

Much like any other field, it’s full of people and people are a diverse bunch.

My personal take is that I would prefer the Pfizer/BioNTech vaccine, having spoken with microbiologists in real life and on UKC and given my understanding of the mechanism of each, I know when seems cleaner and more bounded in terms of potential effects.  

Of course I’m just some random Internet person and it’s not matters I’ve been trained in professionally so take my opinion with a pinch of salt.  Then again, medical doctors as far as I’m aware aren’t microbiologists or immunologists either.  They also have professional standards to adhere to in their work conduct.

It's tremendous news. A friend is a GP in Derbyshire and they're ready to go, venue booked, storage capacity sorted etc. I'm delighted because my mum is in line to get it after frontline NHS/care homes.

Presumably the vaccine has been developed by experts though, so the Brexiteers won't be interested

Did they go to Oxford by any chance?

I'm guessing your consultant isn't an immunologist. 

I'll go with the view of the MHRA.......not my GP, a consultant or 'social media guru'.

Well apart from in medicine presumably?

Chris

So on the one hand we have the MHRA saying it's OK and on the other hand we have a random poster's wife's GP saying it's not OK. 

So on the one hand we have the MHRA saying it's OK and on the other hand we have a random poster's wife's GP saying it's not OK. 

Brilliant news. I want it soon

Now, a serious question, I'm not kidding around...... will the IDIOT anti-vaxxers refuse it in America? And will/ would their refusal affect public health in the US, in the world, and let the deadly virus wreak more harm??

Seems like stating the obvious and providing a useful opinion.

As I understand it the Oxford vaccine is more like conventional vaccines whereas the others are using more novel approaches.   The novel approaches may well prove to be superior but when there's not been time for long term testing then there's a reasonable argument that the more conventional approach holds fewer potential risks.

I am strongly pro-vaccine but I have concerns about the 'give it to as many people as possible as fast as possible' approach and especially if that means giving everyone who works in a key profession like medicine the same newly approved vaccine   I'd like to see some risk spreading and risk management rather than just blanket assertions there is no risk.

Medical training is not training in the scientific method.

My sister (mid 30s) and mom are against it. Granted, they live in a country that has had significantly fewer deaths and they keep claiming it’s “only old people with underlying health conditions that have died from COVID”. My sister also has a track record of treating her son with homeopathy up until he needed to be hospitalised and only then changed their mind. I tried to educate but it was fruitless... 

They also dismiss the fact that grandpa has been in hospitals for the better half of the year with two heart surgeries in 2020 and he’s not just at risk, but some healthcare, rehab and visiting opportunities are reduced because of the pandemic. They don’t seem to think that having a vaccine would let them visit a loved one. 
 

I don’t want to fight them. 

As one of the more considered people here, I appreciate a reasoned reply. What really surprised me was talking to a 50+ Sri Lankan whom I expected to be rolling up his sleeves in earnest and he wasn't. I've not said I wouldn't have it, i just started questioning his logic. Hence the comment more reading required by me, I'm interested. What are the side effects, contraindications? Every drug in the BNF has them.

Normally side effects from vaccines are exactly the same as the initial reaction you’d get from the virus but a lot less severe and don’t progress to disease. 
 

They recruited 40,000+ people for trials. These people aren’t randomly selected, they’re selected to give a good cross section of the population. One of the criteria has got to be that you’re likely to be exposed to the virus. Usually vaccines take a while to develop past phase 3 due to the lack of suitable volunteers. 
 

That’s what I have gathered through listening to my friends from GSK. 

I think the half dose "mistake" with the Oxford vaccine was discovered because the reactions were noticeably milder in that group.

I agree, and that's what made me sit up and listen to him. Especially given Oxford didn't initially come out with the best presentation of the figures. 

Yes. Even milder than mild. 

You may well have a point. As stated my consultants 50+, perhaps that's his reticence. But then there's many ongoing developments, it would seem odd to not embrace this. Gonna quiz him!

Everyone has their own opinions including GPs; and being wary of the new and the unknown is perfectly understandable - although I'm not sure if they should pass that kind of judgement on to their patients, given the authority attached to their word by their licensed medical status.

The Pfizer/BioNTech vaccine is the first of its technological kind to be licensed in the world, although the BioNTech technology platform (artificial vesicles loaded with mRNA) has undergone previous trials I think, and the scale of it's Phase III trial for Covid (along with some other Covid ones) is unprecedented.  That's very comforting to me.

I can certainly see why a GP - or anyone else - will be more cautious of something that's doubly new - a new technology platform and a new antigen.  Who am I to tell them what to do?  That's their choice and I respect their making it.  I'm not so sure they should be communicating it in the way they are, but no-one is a robot in their job.   Then again if I was 50+ I'd be clamouring for the first vaccine I could get my hands regardless as the virus is proven to be - basically - infinitely more lethal than the vaccine.

From a lay person's microbiology perspective, I think the mRNA vaccines are inherently safer than the equivalent "live" vaccine like the Oxford one - the intent of both is to get mRNA in to human cells to be turned in to the antigen (the spike protein I think for both here) to prime the immune system.  The Oxford vaccine introduces a live virus to do this, and the BioNTech platform doesn't.  I don't understand anything like enough about the production processes to estimate contamination risks, but the processes will be really quite different for the two.

I'm not going to have a problem taking the BioNTech vaccine, although as I've said before, the very low health risk to children from the virus vs the risk of the unknown unknowns with a new vaccine (any and all new vaccines, regardless of the technology platform) do not - to me - balance the medical scales in favour of mass immunisation of children before longitudinal studies (following individuals for a year or more after vaccination) are complete.   I think Pfizer/BioNTech just started such a study, and I expect it will be complete before the vaccines is available in sufficient quantity to consider offering it to healthy children.  

I’d expect the side effects to be published in the next few days. 

Personally, I will have whichever vaccine is on offer, as soon as I'm eligible.

I don't think vaccines are entirely risk-free, but you have to balance those risks against those that arise from getting the disease.  At my age, the risk of dying having contracted the disease is about 0.7%, which seems quite big enough to seriously worry about, and top of this there is what seems to be emerging as quite long lasting bad effects in a proportion of the survivors.  On the other hand, after 40,000 + having had the BioNTech vaccine for example, there have been no side-effects serious enough to require hospitalisation, with the main problems being fatigue and headaches.  

I'd be very happy to have one of the mRNA vaccines (BioNTech or Moderna), even though it's a novel type of vaccine.  The mechanism by which they work is very straightforward in principle (though a huge achievement to get to work in practise), and although it's the first time the principle has been used for a vaccine there are other drugs in clinical use which delivers RNA this way.

From a very basic point of view we are making a choice between injecting something that was studied and tested and produced in a lab to very stringent quality checks. 
 

And inhaling something that evolved in a cave in another species. 

I'm surprised no one's mentioned the true reason for the rush: it's going to cost a lot more after Jan 1. Of course, many people won't be bothered by this because they've welcomed, and even promoted, the idea of an increase in cost of living in the New Year (each to their own/lost on me, I'm afraid.)

There are a few siRNA drugs on the market that use the same delivery technology (Onpattro was the first I think).  

We’ve already paid for it. 

Yes, we, the taxpayers have already paid for a huge first batch. And we, the taxpayers will have to pay for more expensive future batches as they are required.

I didn't know that RNAi stuff had made it to market in drugs; that's cool.  It's reassuring that synthetic vesicles as a delivery vehicle have more history.

I'm about to start a crash course in RNAi so I'm not the idiot in the room at work.  Mind blowing levels of sub-cellular cleverness.  Little programmable seek-and-destroy machines.

Whilst life does of course already have a price on it, should lives be worth less? 

Whilst the vaccines aren't cheaper, neither is every week that furlough lasts, or the various other tax holidays businesses currently have. 

I think we’ve already paid for a load of other batches of vaccines as well. The Pfizer was the most expensive one. 

I haven't seen any info on the purchase agreements, if you have it would be good to see them.

I'd expect that like other countries, we'd have placed orders based for amounts of doses based on what's able to be manufactured. Potentially 6 billion people will want the vaccine so that's 12 billion doses. That kind of volume doesn't happen instantly and factories can only produce so much per week so no doubt there's been a lot of Argy bargy involved in getting a commitment from Pfizer for 20 million doses. I'd also imagine that the price was fixed for those doses and some money possibly paid up front to help get the production up and running but the final payment not bring made until the order is fully fulfilled. 

I also wonder what obligations companies have to giving first option on the vaccine to the country they're based in. It may be that Germany has priority on whatever is produced and everyone else comes after.

God, don't tell everyone that!

It is good news and I will be glad to get it. I have slight concerns about the newness of the technique and how quickly the tests took but the potential benefits outweigh the risks for me.

The trouble about polarisation is it stops nuanced debate. It is easy to be lumped in with the crazy anti vaxers if you raise concerns. One of my biggest concerns is if one of these vaccines does have a problem the damage to the general vaccine program (measles etc) will be enormous.

From what I understand, with the exception of the Pfizer vaccine they’ve been paid for upfront to fund the development and manufacture. This is one reason that they’ve been able to crack on and develop and test, they’ve not had to apply for funding and the go ahead for each trial. 
 

There was some discussion as to whether we’d be able to get our money back if vaccines aren’t forthcoming. But that definitely would be in the contract detail. 

The RNAi stuff is nothing to do with the vaccines.  I could have made that clearer!

there is some detail in this report.

https://launchandscalefaster.org/COVID-19

That seems to be the opposite of what I have seen so far elsewhere, the Oxford vaccine is less bounded in terms of potential ill effect given its using a chimpanzee virus. Also its efficacy seems to be very much inferior.

Some analysts even doubt that it will be approved in the US.

The main advantage of it though it’s that it’s easier to produce and can be stored in a regular fridge, so easier to distribute.

I think it's brilliant news, sure there will be a risk in taking it but I would rather chance an unknown risk than see my Mrs catch it with her health problems. 

What I'm waiting for now is the conspiracy nuts, it's been developed in record time so I'm waiting for claims that they had it all along and covid was released so they could sell it. 

Don't like to pi££ on anyone's chips but the vaccine is made, I think, in Belgium. Part of Europe.

I hope the government has taken it's own advice to 'prepare for Brexit', because otherwise there's going to be artics full of the stuff stuck behind queues in Calais from 31st of this month.

But at least we'll be on control.

The virus doesn't exist, the vaccine actually sterilises the population apart from one genetic group....

Edit: Thats actually the plot of a C4 drama a few years back, but the nutters have seized on it already. It's actually quite interesting to watch it now.

https://en.m.wikipedia.org/wiki/Utopia_(British_TV_series)

I  doubt it makes any difference at all , because there is in place a transition arrangement until July for imports.Basically there are no additional border controls on the Uk side( which is where the delays would be). This was all preagreed ages ago. Even then goods can easily be fast tracked through.

I looked in virtual disbelief at the first five or so answers to my post, and felt a huge visual metaphor coming on:

https://depositphotos.com/38603779/stock-photo-business-man-misses-the-targ...

At least you get it.

Depends what you mean by 'live'.  The ChAdOX-1 vector is a functional virus in that it's able able to infect cells and have its encoded genes transcribed to mRNA and thence translated into immunogenic proteins, but doesn't have the genes required to replicate itself.

The 'priming the immune system' bit is a bit more complicated.   

In a way it's quite reassuring that the delivery problem is so hard - the body is very good at tracking down and destroying bits of foreign RNA.  But these delivery devices have been a couple of decades in development - first for gene therapy, then for siRNA, recently most of the effort has been in developing cancer immunotherapies.  There's some neat science in there - a "stealth " coating of short ethylene oxide chains to stop the particles from being recognised and cleared, and a pH switchable cationic lipid which both binds and unbinds the RNA, and disrupts the cell membrane enough to get the particle inside without killing the cell. 

But it's fundamentally a chemical system rather a biological one, and there's a lot of experience in systems that use similar components. 

That's a rabbit hole isn't it...  Thanks for the qualification/explanation.

The main reason I prefer the mRNA platform is that the adenovirus platform introduces the spike RNA into the body where other viruses may be circulating, and so has at least a theoretical window for recombinant effects with other viruses  although presumably the primers or other identifying codes needed for this are stripped and replaced with something else in the vaccine platform?

Yup!  That's about the must I trust myself to say on it without being wrong though...

The logic behind using a chimpanzee virus is that there's less chance of an immune reaction against the virus itself, rather than its payload, because people being vaccinated are unlikely ever to have been exposed to it previously.  To that extent adverse effects at the injection site are likely to be minimised (at least for the first injection).

As for the efficacy - we'll wait and see.  We haven't seen any peer-reviewed papers on any of the vaccines yet.  Everyone thought the original 90% efficacy of the BioNTech vaccine was amazing, until Moderna claimed 95%.  Then BioNTech (or, I suspect, more likely, Pfizer) found an extra 5% when the results were looked at more closely...  Anyway, we don't need complete sterilising immunity for everyone, limiting infections to a mild winter cold and preventing hospitalisation will do for me, thanks.     

Whether it's 60% or 90+% the Oxford-AZ vaccine is easily good enough and much easier to transport and store.

Some wonderful arguments coming up! e.g. (unless I’ve been dreaming, and or have entered some Monty Python sketch)

1. Don’t worry your silly little heads about prices going up because the main thing is that there won’t be any extra paperwork or time consuming formalities. Yippee!

2. Also, don’t worry because this won’t be happening until July, and that’s a nice sunny month, isn’t it? and so you’ll hardly notice the price increase. Oh, sorry, I hadn’t though of that, silly me, I’ll shut up.

3. And above all, don’t worry about it, because you can rest assured that these expensive goods will be fast-tracked. Phew, that is just so thrilling to me.

It's a good question about the risk of recombination - I'll try to find time to dig into that, but one answer might be that the vaccination is intramuscular and any other adenoviral infection is likely to be limited to the upper respiratory tract, so the chances of coinfection in the same cell would seem remote.

It's interesting that it isn't approved in Germany yet and that's where the developer is based.  The Brexiteers are claiming its a benefit of Brexit that the UK doesn't have to wait for EU processes, although the MHRA are saying they actually followed the EU processes.

On principle I think it is a very bad idea to get into a race to see who can be first to approve/qualify something you are going to make tens of millions of units of.  The UK government seems to be treating it as a race so as to make its usual 'world beating' claims.    My experience in tech companies is that it is a mark of competence and experience for management to incentivise the test guys to take their time and do it right and a mark of incompetence and inexperience to pressurize them to cut corners and go faster.

I am no medic, but have a background in virology and immune signalling. I would take whichever vaccine I was offered.

However, given a choice I would go for the more modern Pfizer / Moderna type.

The Oxford virus is grown in cultured cells, it is an altered chimp virus that cannot replicate in human cells, but is amazingly efficient at delivering its genetic information to target cells (this is what viruses have evolved for). Once in the cells the genetic information encoding the Coronavirus spike protein is it is translated into protein, triggering the desired immune reaction.

Any worries I have concern the packaging process and immune reactions against the packaging virus.

The mRNA vaccines package the genetic instructions not in a virus but in a synthetic droplet of lipids that can fuse with cell membranes, delivering the content to the interior of the cell.

This is an old hat for delivering DNA or RNA to cultured cells in the lab, but that process was for years not effective enough to deliver enough RNA to make enough virus protein to trigger a protective immune response.

Technology has made huge strides, though, and nowadays the delivery process is, as shown by the trials, sufficiently effective. The delivery systems as such are also used in (and have been previously safety tested for!) other types of therapies, where different kinds of RNA are directed into cells. So, even before the vaccine started to get development the scientists at Moderna and Biontech had treied and tested packaging systems they could take from the shelf.

To me, the absence of any additional genetic information and, viral proteins, or residues from the packaging cell line (which can in principle not be avoided!) is preferrable, but I would not be fuzzed if I was eventually offered the Oxford/AZ version.

CB

The clinical testing and regulatory affairs stuff will be all done by Pfizer, presumably world wide. That, and manufacturing and logistics is why a medium sized R&D company like Biontech still needs a big pharma partner.

VCB

Well, I've seen loads of tweets like the following. (But unfortunately, because they're tweets, unless you immediately copy the URLs they're v difficult to refind). Assuming the following is true, or roughly true (and one just can't be sure in this new Age of Dishonesty), I find it deeply dispiriting:

https://twitter.com/jdpoc/status/1333408894996123658?ref_src=twsrc%5Etfw%7C...

"Bit more reading up for me."

What's your background?

I've seen people question the moderna one and not pfizer when they are basically the same tech.

I'd certainly go with the two mRNA vaccines over the Oxford one. The efficacy is far better, the trials were more professionally carried out. They still don't quite understand the data. And as said its about as effective as a flu vaccine, 60-70% compared to 95% for moderna and pfizer (with near 100% protection from serious Covid).

And cheaper. I think we'll see pfizer go to high risk and the general population get the low cost, easier to transport AZ one. 

The main thing though is just quickly get a good 50% vaccinated. Even just the high risk will reduce pressure on ICU's and we can pretty much get back to schools, with masks on.

It's great news, we are going to have normality by the summer if all goes well.

Yes, it's amazing that RNA has got so much tougher in the last 20 years - when I was in the lab it degraded more or less in front of your eyes!

The little I've read about seems to suggest that it's not quite clear what the receptor for  ChAdOX-1 is, particularly on muscle cells (apparently not CAR or CD46), and maybe this is a bit of rate-limiting step.  It's possible that an intervening molecule (maybe Factor X) might be involved.  Although we usually think of viruses as the experts at getting nucleic acids into cells, perhaps, in this instance, LNPs might be better?

It should be the start of the end but it is just step one on a long treacherous road that will if we don't cock this up see us living with significant restrictions (which will be necessary yet increasingly toxic to defend) well into spring next year. They'll likely be easing significantly through the summer into autumn as the summer and developing herd immunity effects overlap.

Time for this government to rebuild some bridges and get into some serious and doubtless unpopular expectation management.

All being well we'll only have a crushing depression and brexit's lingering aftershocks to deal with by Christmas. Still, by 2020 standards that's an outstandingly cheery outlook.

jk

Imports are not the real issue.Never have been.

Can you please explain why you think there will be a price increase. I am not sure of where that comes in.I am intrigued.

I've posted and example above.

The economist is running an interesting piece on applying newly completed behavioural science research to improve covid vaccine uptake. The gist of it is vocal antivaxers are a waste of time but still few enough not to matter as individual herd members (not so as campaigners). Instead efforts should be focused on the more plentiful, worried, dubious, forgetful and the unmotivated who can quite easily be won or lost and upon whom the success of the endeavour does depend.

Personally I don't think it's going to be at all easy to reach enough people given the headwinds we're facing (neglected public scientific literacy, significant disinformation campaigns, the toxic legacy of anti-expert populist government etc).

jk

I cannot see a specific example other than supposition where you say it will be more expensive.

I reaaly doubt it other than for currency movements. There is as I understand an agreement on vaccines within the developed countries that there is no price differentiation to avoid countries outbidding each other etc etc, along with an agreement that less developed countries get it as cost.Basically we get it at the same price as Germany, France, USA etc etc.

Its one of the global isssues with vaccines, there is less profit in it that say a new cancer drug.

Boris has already had his vaccination. The nurse told him he'd feel a bit of a prick.

I kid you not I heard a woman on the radio today saying she was waiting for the Oxford  vaccine because it’s British...

I would be very surprised if people have a choice as to whi h vaccine they have.

I'd be very surprised if you couldn't get a choice by paying money or waiting until the initial rush is over.

Just out of interest Gordon. Will you be having the vaccine ??

So is BSE. I despair......

CB

Of course. Once they've all been properly tested. I'm prepared to wait a bit, even though I'm 70. Wait and see which is best.

It really doesn't matter. It's just best everyone is vaccinated ASAP. We may well need a second round of vaccinations but the main thing is we get towards herd immunity through a vaccination program as quickly as possible. I'm getting the first one offered, if that's a less effective one with 1-2 days of side effects so be it. mass vaccination of a vaccine with 60-70% efficacy will be fine.

Well

Well how about if I want all three? Would that give my crazy high immunity, or it doesn't work like that?

The difference is the UK gave emergency approval whereas some EU states wanted (including Germany) wanted to go through the normal procedure having weighed up the risk/benefit. Of course they don't need some good news to bury the disastrous Brexit negotiations.......

I think the pfizer and moderna vaccine are very similar, I'm not sure if they've used the same mRNA sequence but I assume its similar as they are both trying to create the spike protein.

It could just be as simple as the fact that with the NHS and NICE etc you have a reasonably standardised common procedure for the UK . Maybe the procedures are more fragmented elsewhere, who knows.I suspect most countries have the option of an emergency approval, from memory CB1294 ( or whatever) alluded to emergency approvals in posts a few months ago  being a good practise especially for those in high risk categories.

In a Flu jab its about 2/3 weeks before its effective, anybody know what the time the time period is on the Pfizer vaccines is?

They say a week after the second dose to reach full effectiveness. 

Lots of differing opinions on this subject.

I don't know that much about this vaccine apart from what I've read in the media and I don't know how much of that is true or bullshit, but I have some genuine questions...

What is the risk of dying (statistically speaking - even approximately), or developing serious and lasting complications following COVID infection, for someone like me - early 40s, good health...no other conditions?

Was the sample size in the phase 3 trial for the Pfizer vaccine 40,000 people?

Is there any data to suggest this vaccine reduced propagation?  Can a vaccinated person still carry the virus and pass on to others?

Do we have any idea whether the vaccine will provide lasting immunity - say., after 3 months, 6 months or 1 year etc....?

I am hoping the collective UKC wisdom (hmmm) can answer these questions.  I have a degree in pahrmacology and work in a field loosely related to pharmaceutical development so if you have links to sources and reliable data then all the better....I'd like to have a read around an find out more.  10 months from conception to approval seems remarkably fast and I'd like to weigh up the risks of a COVID-19 infection against being injected with something that may turn out to have some undesirable effect in the long term.  if there's data to show that my being vaccinated reduced the probaility of my passing on the virus to others, that obviously needs to be considered too....

Your risk of dying is about 0.15%, according to estimates from Imperial College.  I don't think there's good data yet on the prevalence of serious and lasting complications.

The Pfizer phase 3 trial had more than 40,000 people in it.  We'll have to wait for more data to be sure about duration of immunity and the degree to which the vaccine reduces propagation.

OK - thanks.

I have read this thread with a lot of interest as it appears that almost everyone here thinks the vaccine is amazing and large scale roll-out is just a great idea.  I wonder why public opinion is so different here in France (where 60 of people, according to surveys, won't volunteer to be vaccinated).

For the questions I asked it seems the responses are mostly "we don't know yet".  This sort of compounds the feeling that trying to vaccinate as many people as possible as rapidly as possible is probably not the best strategy - some sort of risk mitigated approach (as advocated by Tom, above) would seem more suited to the situation.  Having seen that that the UK has already ordered enough doses for 20M people it would seem that the "as many people as rapidly as possible" approach is being taken.  I hope they're right in their assessment of the risk and their determination that this is safe (and that is a genuine hope!).

Given the conversation/vote last week regarding disinformation on the UKC forums ... maybe there is a conversation to had about this post.

First things first:  I don't believe this post was sent with an malicious intent whatsoever.  I am not suggesting that of the poster at all.

However:

1. I think it certainly does reach the standard for misinformation.  Utterly unverifiable.
2. While perhaps not meeting the standard for disinformation, it certainly contains dangerous information that if it starts to circulate could result in lower numbers of people taking 'an' approved vaccine and as a result allow covid to circulate in the population for longer .. and as a result kill more people.

All major social media platforms are gearing up to limit the reach of vaccine nae sayers.  [1]

If UKC wanted to take a position on matters like this - suppressing vaccine deniers of any flavor (with malicious intent or not) - might not be bad position to take.  

I would have no issue if UKC suppressed (reduced visibility of/moved to the pub) threads that made the case against taking one of the vaccines approved by the UK Gov for Covid.

[1] https://www.theguardian.com/technology/2020/oct/13/facebook-vaccine-ads-ban

I have been told that anti vac  is more an issue in France. Whether that is true or not I do not know. 

Well you are way down on a priority list anyway. So no don’t when it’s your turn things will have moved on. 

Not from the people I have discussed it with.  They have all had pretty much the same vaccinations as we have in the UK and have had their kids vaccinated etc, yet they're still sceptical about this vaccine.  I genuinely wonder why that is and why it is almost unequivocally accepted as a great move in the UK.  i find it interesting that anyone who is even looking at the scientific data (or lack thereof, for some elements!) objectively and pointing out a lack of long-term safety data, or lasting efficacy etc, seems to be labelled some sort of conspiracy theorist or anti-vaccer  I'm undecided either way what to think about this vaccine, but it seems public opinion has been swayed, regardless of the science as I have read it.  I guess one just needs to "trust the govt policy" etc, but for various reasons I find myself hesitating there....not because I am a conspiracy theorist or an anti-vaxxer but because i like to look at the evidence and make my own choices based on said evidence.  I note the poster above indicates that there is some sort of campaign in place to pull threads where anyone might say anything that might discourage people from being injected with this vaccine - all seems very authoritarian to me...but then there could be good reason for such a semingly authoritarian approach.

I agree. This is actually typical "anti-vax" troublemaker approach. Similar to the "All Lives Matter" issue, it puts a seemingly socially acceptable phrase out to be adopted while undermining the original intention.

Even casually dismissing vaccine risks as okay due to other risks still puts unqualified risk in people's minds.

Vaccine components can result in adverse reaction - this can be quantified where components are not novel. It does not require 10 years of study, it is a small but possible risk. It is akin to risk of being killed while commuting. You could avoid vaccines and then die of a bee sting, or peanut reaction.

Vaccines can trigger immune response with consequences. This is something you should consider if the vaccine is for travel for example. You could avoid it and not travel. But Coronavirus is here, so you don't have that luxury. The risk of side effect from triggering your immune system with protein fragments or inactive monkey virus is lower than the same risk from the actual coronavirus.

To overcome what is a perfectly understandable fear of vaccination you need to put the astronomically low chance of side affect into perspective. As the world is vaccinated more people will die travelling to get the vaccine than will die from the vaccine. More people will die of coronavirus waiting to get a vaccine than will die from the vaccine.

If after all that you're unconvinced then accept that the alternative to not forming part of the herd immunity is that you take yourself out of the herd, for the next 12-24 months. And after that you still carry an elevated risk of death from C-19.

And what happened to free and open discussion?  

I am not anti-vaccination (in fact very far from it!).  I acknowledge the huge benefits vaccinations has brought to the human population globally for many diseases.

At the same time, I am a firm advocate of free expression and I think people should be able to ask questions of the science behind this vaccine.  if someone asking questions about long-term safety data (lacking, at best) or evidence that the vaccination limits propagation of the virus (also lacking, at best) or long term efficacy (lacking, at best) or efficacy in specific subgroups like the elderly (lacking, but improving).  

Any forced removal of social media threads discussing these issues is way too authoritarian for my liking.  I have the above questions in my mind and, if I get answers to them, I'll be putting myself in line for vaccination...because vaccines generally are very low risk.  Until then, as someone at very low risk from COVID itself and someone who understands the usual processes for vaccine development, and the reasons for them, I'll avoid it.  Any moves to stop people asking the above very pertinent questions won't encourage me or many others to be vaccinated before we know more....that's not misinformation or conspiracy theory - it's just free expression, free choice and free thought.

You may currently be at low physical risk from covid. Me too probably. Are you at low economic and political risk from another year or three of crippling restrictions if the vaccines aren't accepted. I'm not.

Jk

I trust a vaccine not to harm  me more than I trust the virus not to harm me.

A vaccine has been through safety trials.

The virus has not.

I am at economic risk if the current restrictions continue...yes, but that should not stop me looking objectively at the data and asking pertinent questions of it.  I genuinely hope the large scale (40 million doses ordered and more to follow) is the right thing to do.  Yes, mass acceptance of the vaccines is required for this programme to work (although there is no guarantee it will work, even with mass acceptance), but that in itself shouldn't remove the right for those interested to ask about the data and to do a risk assessment for themselves.  I'm ready to be convinced that population-wide vaccination is a good idea based on sound science - but not based on my own personal economic circumstances or fear of another lock-down etc. 

I have seen a trend that anyone asking pertinent questions about these specific vaccines is being lumped in with anti-vaxxers and conspiracy theorists.  Not a good thing in my view as there are many things that are different about this vaccination programme..it is an unknown and people should want to "know".  The technology is new for some of the vaccines.  They've been developed very quickly, with reduced sample sizes and no long-term safety evaluation.   The long-term study will be the UK's (and other early adopters') implementation of the Pfizer vaccine - if there are going to be problems, that's where we will see them...  People are right to be asking questions and I don't feel that there have been satisfactory answers as it seems MHRA acceptance is enough of a guarantee for most.   I'm sure those people have it easier in some ways. As I have said above, I am very pro-vaccination, but that doesn't mean I have to be pro all vaccines.  The situation with COVID-19 is unprecedented and has demanded a completely novel approach.   I'm cautious and interested in the science.  

Ultimately the modern world depends on trusting regulatory bodies, commercial organisations and suitably qualified people to do their jobs effectively and with integrity. We drive cars without first buying 100 spare copies and conducting our own crash tests. We fly in aircraft without questioning every step of the design, manufacture and certification process (maybe not a great example, given the Boeing 737 Max!) and we trust the food supply chain without demanding to check every chemical in every farm and look in every factory and restaurant kitchen.

If we applied the level of unfounded suspicion and conspiracy theory some people have of vaccines to other aspects of our lives where we have to trust others, we'd never get anything done.

I don't disagree, but if someone wants to find out more about the safety of any of the products they use then they should be able to.  If one of those products is not subject to any of the usual safety checks all other similar products are subjected to, and have been subjected to for decades, then all the more so.

I'm very clear on the fact that I think vaccines in general are a good idea and you seem to generalise ("conspiracy theorry some people have of vaccines") in your response.  Nothing I have posted constitutes conspiracy theory - I am more just an interested citizen looking for information about a subject that interests them.  Your response fits with some of the other things I have seen that are just quite dismissive and seem to refuse to acknowledge the reasons why some people are hesitant and cautious here.  They have reasons - why not acknowledge them, especially where they aren't conspiracy theories, and don't label them as such.  

For what it's worth I have some contact with pharmaceutical regulatory bodies in Europe and have to keep up to date with the drug development regulations etc, and this is what sparks my interest in this subject.  When normal procedure is thrown to the dogs and short-cuts are taken it isn't conspiracy theory to begin asking questions of the science and to try and weigh up if the chosen policy with regard to vaccine implemenation is justified scientifically, economically, or otherwise.  

Funnily enough I was just contemplating my evening meal, sourced from a local takeaway.   I haven’t the foggiest what goes in to it, what cooking oils they use, how often they change the oils or where they get their cat meat from.  I sort of trust the regulatory processes although I expect there’s be a lag from the kitchen going south to any enforcement action.

We don’t understand what half the stuff in food really does to the human body, let alone how different naturally occurring parts of foods can act as co-factors for unexpected results, or their interaction with the oral and gut microbiomes and how that feeds back to us.  Then you’ve got the wonderful world of unpasteurised dairy, illegal street drugs, tap water - my god the brown filth that comes out after a high pressure discharge stirs up the big mains pipes.  Not an eye lid batted.  

If I get the Pfizer/BioNTech vaccine, it will likely be the purest and most bounded set of chemicals to ever have gone in to me.

The vaccine will have been tested on many thousands of people and will have resulted in practically zero significant negative effects and hugely beneficial positive ones. How much more convincing do people want before they are prepared to help put an end to the social and economic destruction that's playing out with ourselves in the leading roles?

As I have said above, I am very pro-vaccination, but that doesn't mean I have to be pro all vaccines.  The situation with COVID-19 is unprecedented and has demanded a completely novel approach.   I'm cautious and interested in the science.  

Have you got a list of those vaccines you are OK with and those you won't take, and why? I'm interested in the science. Posters on here have been helpful in developing my understanding, but I would be kidding myself if I thought I had anything more than an extremely basic idea of what was going on. I had the flu jab today, I trust it safe due to the process it has been through, but I don't completely  understand the science behind it. 

I'm sorry - my post wasn't especially directed to you. I should have used reply to topic rather than to the last post.

No, I don;t have a list.  Like you, I trust the process for drug development and marketing authorisations etc, but in the case of the vaccines for COVID-19 large chunks of said process have been short-cutted or just not done, so I am specifically referring to the current COVID vaccine candidates.  I know a little about the normal process as I studied pharmacology and work in the pharma industry, but I am no expert....it is not my speciality.  I know enough to know that the process of vaccine development here has been very novel and much, much faster, with a lot of shortcuts.  There are a lot of "what ifs" that to my mind are justified here but perhaps not for other vaccines that have been through the process.  

I wonder (genuinely) if the drug-development process can't now be accelerated for any major killer disease...or anything new that comes along.  Is this the new "norm" - 10 months from conception/discovery to population-wide adoption?  It's a genuine question that people should be asking.  Sure....if we get it right with this one it has been a massive achievement...does that mean we were too slow with all those cancer drugs, malaria drugs etc.  I know, I know, COVID is currently a much bigger killer, but it hasn;t always been that way and will  not always be so, at least not in my opinion.  There will probably be another virus, and other diseases given our population density etc.  

You are right PeakDJ - you do have the right to free and open discussion.  You have the right to question the science, you have the right to question the long-term safety, you have the right to ask questions of the process behind it, you have the right to question how effective the vaccine will be and of course - you have the right not to get vaccinated.  

What you do not have any devine right to is to have UKC, or any other site, publish your attempts to undermine the impending vacination programme or for that matter give your posts equivalent prominence as other information.  

For your information - every other (reputable) social media company out there is working on how to put this sort of stuff down:

1. Facebook Antivax suppression policy - https://about.fb.com/news/2019/03/combatting-vaccine-misinformation/
2. Twitter blog to suppress antivax information - https://blog.twitter.com/en_us/topics/company/2019/helping-you-find-reliabl...
3. Youtube has pulled advertising from antivax content - https://mashable.com/article/youtube-anti-vaxxer-advertising/
4. Pinterest moved to block the abillity to search for antivax content - https://www.wsj.com/articles/next-front-in-tech-firms-war-on-misinformation...
5. Google's whitepaper on how it fights disinformation - https://www.blog.google/documents/33/HowGoogleFightsDisinformation.pdf

And of course ... if we end up with a widespread movement to avoid vaccination for covid you also have the right to own some responsibility that too.  

No one is advocating "forced removal".  Move it to the pub, don't make it searchable, reduce the audience that sees it and kill off the thread after 6 months.  

https://www.ukclimbing.com/forums/off_belay/how_should_we_deal_with_extreme...

My (limited) understanding is that shortcuts haven't been made on the safety side. The bureaucracy and manufacturing has been much faster. Effectively we will be now taking part in a phase 4 trial, and I've agree in other that it shouldn't /won't  be used on children until the summer at the earliest.

The Pfizer vaccine has been tested on how many people in the most vulnerable age groups?  Let's say 75 and over.  How many were dosed?  How effective is it in this group, who are most at risk from dying from it?  This kind of data is normally known before a new drug is rolled out population-wide.  In no way is this intended to imply that this vaccine is no good - it;s just saying that we don't know that much about it and the sub-group sample sizes are actually quite small from what I have read.

The social and economic disruption has differed between country, as has the mortality rate, which suggests that the virus is still very novel to us and that the disruption caused largely results from policy decisions.  

See above my comments about the drug development process in general and the differences here - when the usual process is not followed people should be asking questions.  Isn't it more fitting to answer them as fully as possible, rather than imply they should not be asking those questions?  Is it a case of "I am convinced, therefore you should be too, because....well, I'm right."?

Put "what sort of stuff" down?  Would you care to point out exactly what I have said that you think represents misinformation or conspiracy theory about vaccines in general?

I think it is a case of "you have more of a right to express an opinion if it agrees with X"

Before a new medicine is approved for population-wide use there is normally substantially more safety data (and efficacy data) for specific population subgroups, comorbidities etc.  As you say, we are effectively now going to do the long-term safety study, which forms part of the usual process.

Again, out of necessity, i'll state that this is not intended to say that the vaccine is not safe, and that I genuinely hope out that it turns out to be very safe and very effective in all sub-groups, for the long term.  

That is a very bold claim to make.  I can’t find an interpretation of it with which I could agree.  Any policy decision open to the UK after we flew in a few thousand cases was going to bring significant disruption, the good options lay untaken in the past.

The mortality rate is not well quantified and not compatible between countries for the obvious reasons around asymptomatic spread and incomplete testing.

Just questioning the science ey?

Bring on the wall!!!

There was a semi smile on my face today with that news.

Since it started I've actually made it home for about 4 weeks as my wife is very high risk and I work a 14 day on / 14 day off rota, rest of the time in rented accommodation.

Something as simple as Christmas together means my wife and daughters having to live separately for 14 days, I've taken a week off work so I can can isolate for 14 days before returning home on Christmas Day. Not seen my eldest daughter since last Christmas as she studies in Belfast.

Been one of them years, at least I have maintained my job and live somewhere I can get out without meeting many other folk, even manage a socially distant wander and BBQ with my wife. Just be so glad when some normality can return to everyones normal day life.

I'll be at the front of the queue or at least my allocated slot for the vaccine.

Do you want another 12-18 months of varying levels of restrictions whilst all these checks you want are done? Can you imagine the state of the economy if we did that? 

Very good news.  Hopefully the gaps and success criteria in the trial design get filled with positive observations as time goes on.  Safety doesn't appear to be a concern so its only efficacy that's unknown given the pressure to get them out to market.

https://www.bmj.com/content/371/bmj.m4037

"The world has bet the farm on vaccines as the solution to the pandemic, but the trials are not focused on answering the questions many might assume they are.

But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.6

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7

Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus."

Is a vaccine likely to be more dangerous than Covid19? Y / N

Are there people dying directly from Covid19 and indirectly from the resulting restructuring of the health service? Y / N

Has the vaccine not thus far shown to be 95% effective at providing immunity? Y / N

Would you rather live in a country that can't afford to fight this pandemic? Y / N

Is your ego out of check today? Y / N

I get N.Y.Y.N.N - how about you?

The social and economic disruption has differed between countries. Some countries had long, full-on lockdowns and others did not, hence the differing social disruption.  Some countries shut down many businesses for longer than others...and they may suffer more economic disruption.   I don't disagree with the statement that the other options lay untaken in the past.

Your point about mortality rate is fair, but I believe there is also an impact of policy in different countries.  Some have more intensive care capacity than others etc.  it might have been a minor impact, but it's an impact.  But fair point.

If we now must rush a vaccine because we didn;t take those options that lay untaken in the past, that should not mean people should not wish to seek answers about the vaccines that are being rolled out, which is what I am doing. You don;t seem to have much info on that subject which is my main interest.  Feel free to disregard the comments you singled out/

Again how different to previous vaccines? A judgement call was made, by people who know far more than me, to check the data after 100 or so people had tested positive. How long would you have waited another year for 1000? The sample sizes for sub groups might be small, but has there been a problem with any?

sorry but this sounds like anti lock down  b#ll#cks or are you saying we need to hurry up with a vaccine before it mutates

Again I'm not sure what the differences to "normal" development are regarding safety.

Another social media commenter who insists on belittling and arrogance.  My "ego is  out of check" because I am looking for info you aren't interested in, and perhaps have a different opinion.  As you wish.

See comments above in response to wintertree.  Labelling what someone says as "bollocks" isn;t usually great form if you're really trying to engage with them.  Saying that the social disruption and economic disruption differed between countries largely because of policy decisions can be anti-lockdown if you wish, but that;s more your interpretation than my intent.

I didn't state anything just asked some questions. Sorry if that's arrogant.

Great information there - thanks

Its hard to interpret it otherwise.  

Country X didn’t lockdown because they weren’t heading for healthcare overload and 250,000 death in the next two months.  The UK locked down because it was hitting healthcare overload and every sign was for 250,000 dead in months if things carried on unchecked.  If the UK adopted policy from country X, the disruption would have been worse, not better.  The countries were differentiated by factors including demographics, prevalence of co-morbidities, potentially co-immunity from another virus for some other countries, the population’s level of trust/fear driven compliance  with advice and rules.  These were not and are not policy differences.

The social and economic disruption is because of a bloody lethal pandemic.  Some counties were in the lucky position to be able to take less stringent policy - but that was a consequence of other factors and to a first order those other factors are where the disparity lies, not the follow on policy.

I accept that was my interpretation, I was doing my best not to interpret

"I am very pro-vaccination, but"

to how "I'm not racist/sexist/homophobic, but" is often interpreted.

"Safety doesn't appear to be a concern so its only efficacy that's unknown given the pressure to get them out to market."

This is the sort of post which should be tagged FAKE news.

They've had this vaccine ready for months. Had they not been concerned with safety it could have been out months ago.

https://www.nih.gov/news-events/news-releases/promising-interim-results-cli...

"90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. There were 11 cases of severe COVID-19 out of the 95 total, all of which occurred in the placebo group."

And yes we don't know if vaccinated people will still shed viral particles. There's only so much you can study, that work is on going. We don't know how long it will last for either.

(Just wind it back a little bit.  It's day #1 that a vaccine has been approved for use in the UK that will save thousands of lives potentially, give many millions the life back that they had before and allow families and loved ones to spend time together again ... and here you are, literally within hrs of it being announced, picking it to bits.  I'm sure you aren't meaning to do this ... but you're coming across as a vaccine denier.  The increasing urgency with which you're acting to shut down anyone who calls you out for it alongside the very public way youre going about making your case is exactly what someone dead set on spreading disinformation about this would do.  I'm sure your questions are all very valid ... we'll all soon find out enought if the cure is worse than than the disease.  In the meantime you know you don't need to take anything you don't want to but maybe just don't try to convince others to follow you - the greater public good is served if the majority get vaccinated.)

Yes, and vaccines prevent 2-3 million deaths a year. If we get 10-20 side affects from them that's a price worth paying. For example vaccine derived polio has been documented with the polio vaccine. But we don't have kids in iron lungs anymore. It's hard to argue the Polio vaccine wasn't an incredible success.

Preaching to the converted.  hallelujah!!! 

I’m not anti-vaccine by any stretch but the fact the the UK approved the vaccine after only ten days of checking the data, in contrast to other reputable medicine agencies which are opting to wait for more data and do more robust checks, does raise eyebrows.

I guess there would be more trust in the first place if we did not have a government with a track record of putting exceptionalism before the wellbeing and safety of its people....

I acknowledge your stance on vaccinations but wholly denounce your stance on social media platforms. Vehemently.

Whilst  I am becoming increasingly exasperated at social media and the concentrated power they posses - ukc excluded - those who claim a right to spout shit on those platforms can f*ck off.

They are businesses. They exist for one reason, money making. They can pull what they want, when they want and if they don't like you they can bin you off. They are free services, no SLAs and only one thing is for certain, they have all the cards.

And we, the like-needy generation, have created these monsters and we have to suffer the consequences.

Why are the Eu waiting another month to approve the vaccine?  That misplaced caution will cost tens of thousands of lives!   Just to try to score some bizarre political point.

We in the UK now need to rubber-stamp the AZN vaccine super-quick too (and I mean this week) and start rolling it out ASAP.

The commentary coming out of some senior public health ministers etc in various EU countries is seems quite politically barbed against the UK.  Then again we’ve got our own ministers spouting jingoistic spaff that’s right up there with the president’s speech in Independence Day wot wot tally ho there’ll be bluebirds over the dry ice at Dover.

And if it doesn’t work as expected or isn’t safe you’ll have millions of people who will have lost trust in the system for the foreseeable future.

« You’re coming across as a vaccine denier »???

I’ve said at least 3 times that I am a massive advocate of vaccination and acknowledge the huge positives they can bring in reducing disease. I’ve been very clear in stating that I’m looking for info personally about the new batch of vaccines only and nowhere have I encouraged anyone else to either accept or refuse vaccination. I have also said that once thedata is in, I will be very much in the vaccine queue myself. Many of the tings you’ve stated ignore all of this...

i could respond similarly to your other points but as you don’t seem to read what I write and seem intent only on putting me down as another anti-vaxxer it probably isn’t worth it. Have a good evening and in terms of your hopes for this vaccine I genuine hope you’re right and it turns out to be effective and safe for the most long haul.  I’ve also said that twice previously in my posts on this thread ...rather bizarre for a vaccine denier, no?

From your expert stance, experience and education how long does it take to check vaccine data? And what more robust checks are they doing? I think you'll find approvals will all drop through in the next few days to weeks.

i think you misinterpreted what I said. I said that people should be able to ask Reasonable questions of the science behind these vaccines...I wasn’t making a general comment about being being able to post any of the sorts of things you seem to be referring to. 

My stance was purely that I should be able to ask the questions I have asked here without censorship.  I’m not claiming anyone should be able to post just anything.  What about what I have posted do you specifically disagree with...do quote me as I’d genuinely like to know 

Eh!?  What am I missing?  You are going to have to back up why it should be labelled "fake news". 

I think in a desire to label you as an anti vaxxer he omitted to properly read what you wrote.  I can see that you are clearly not...the difference being I read your post before jumping to my own conclusions...

I disagree with this statement you made...

FB etc need to sort it out. UKC have got it about right and have purged suspicious posts. I dont think you are suspicious but ultimately you have zero rights when on free internet sites.

Edit: for clarity, I did read your posts and dont think you are a weirdo anti-vaxxer.

I'm not trying to shut you down or calling you a crank. 

The point I'm making is there's a missing piece not on your virus vs vaccine balance, it's the wider economic consequences of continuing to control the virus without effective vaccines or worse, failing to while we wait for certainty which will never come.

Frankly what we know about each specific vaccine long term is bugger all. That is marginally less, just, than we know about the virus' long term effect on health. Short term they're clearly incomperable and we do know the technologies underpinning the vaccines reasonably well, even the novel ones. 

We can't afford to wait for longitudinal data, it's not fear of another lockdown (nearly inevitable anyway, politics and wishful thinking), it's fear of complete economic collapse and revolution, of famine and conflict. Most likely something in between of course but if we let our society rot unwilling to roll the dice on technology we know quite well to free us of a virus we only know well enough to say is crippling our society we get into a proper mess. The countries first out of this will suck funding away from the economic support programs of those left behind, it'll happen fast and it'll be really ugly. I don't like that but I can't change it, I am however willing to take a very small risk to avoid me and my family suffering its consequences. I've taken many greater just for the thrill.

Jk

Ah, thanks.  That would explain it.    Yes, I'm not anti only found the design and end-points being measured interesting but not being covered in the news. 

Hmm, I'd be careful what they wish for!

That's a huge claim and it flies in the face of my understanding of what's happening. Obviously the UK certification is for emergency use (seems justified to me, we're in deep trouble) but do you really expect regulators across the rest of Europe to reject it? Perhaps the French press is telling a different story to the British. Very interested to see if this stands up. 

My understanding is the shortcuts have all been around paralleling the various stages of the usually linear and budget-cautious  development pipeline by taxpayers bearing the risk.

Itv's not about it being a bigger, killer, it probably isn't as a disease. Malaria is a big killer. Dysentery is a big killer. Poverty is a massive killer. None of them threaten to upend the fragile systems billions depend upon for the meagre food and security they currently provide. Covid could.

Jk

Yes, we, the tax payers have already paid out £850 million so people could go out to f*cking restaurants.  I wish I could've afford to have taken advantage of that.

What's the Pfizer cost to date? £600 million I believe, for something that's actually useful.

Don't know what you're on about extra cost apres 1/1/2021, but, according to The Independent, Vacc No1 is going for cost price: "Pfizer/BioNTech is making its vaccine available not-for-profit."
https://www.independent.co.uk/news/health/pfizer-vaccine-who-gets-first-mad...

There was a scientist on TV today who said that usually a vaccine is tested and then all of the data is presented for examination.

However, this process was changed and the data has been presented to the authorities as the vaccine trials have progressed.

So instead of wading through tons of data in one go at the end of the trials, the authorities have been able to examine the data in smaller chunks over a longer period of time.

Thus the appearance of a rushed process is, in fact, no such thing.

According to the scientist on TV anyway.

Is it that hard? That safety wasn't a concern.

We all know this already, all the others agencies have been doing exactly the same, whether it’s the fda ot EMA, but the simple fact is that the primary efficacy results weren’t know to Pfizer themselves until 2 weeks ago.

You simply can’t unseal the blinds until you get a threshold number of infections to ensure you get a minimum of statistical significance on efficacy. So you simply can’t « drip feed » this efficacy data early.

Jeez, now your an expert on vaccine trials?

Is there no end to your talents?

Or google skills?

The point the TV are studiously avoiding is that you can't find long-term problems without long term data. 

Doing different parts of the process in parallel and the regulator starting its work before the trials are finished is all well and good and it will obviously bring the total time required down but the fact that there is a lower elapsed time between the vaccine being available to test and approval being granted inherently means there's less time for problems to emerge.

The other thing is that if the UK is approving under emergency use rules the requirements may be less stringent than full approval as other countries are going for.  Clearly there is an emergency and emergency rules are appropriate but you also need to think about whether something approved under emergency rules should be used in a gung-ho 'give it to everyone as fast as possible' manner or more carefully until there is longer term data. 

To be fair, what they seem to be actually doing is giving it to the most vulnerable and oldest first, which is completely sensible, rather rather than the way they are talking which is that everyone should be queueing up to get it straight away.  

I listened to Adam Boulton(?) on Sky news interviewing two scientists this morning. He tried really hard to find a negative angle but couldn’t. The scientists seemed totally unconcerned by any safety fears and were very upbeat about the vaccine.

As a layman I was already convinced that the vaccine is a good thing and today’s interviews only reinforced my beliefs.

If there are any scientists out there who think that the vaccine shouldn’t be used then I’m more than willing to listen to them.

Hahaha, were it any other country than the UK, he'd be on the tree tops shouting praises.

He's just boring old UK hater material.  Ignore him.

No, just basic math, knowing the principle of a double blind study, and reading the Pfizer press release.

The very basics.

How's your stash getting on?
You must be getting on for buying half of Cyprus up by now with your amazing playing the markets skills.

Show me then where I have been shouting the praises of China and Russia, which have authorised vaccines earlier. Please.

I have not even said the UK approach is wrong, I am simply pointing out that all the others highly reputable western medicine agencies have decided to take more time. Very clearly the UK authorities have  chosen a lighter approval process than their western counterparts, why they made this decision needs to be understood.

It’s quite amazing that such a common sense observation seems to offend your over-sensitive sense of national pride.

Personally I’m delighted the UK approved the vaccine.

Ha ha excellent  I am going to use that with anti vaxxers if its ok with you

Of course the vaccine is a 'good thing' and should be used.

But the question is a lot more complex than that.  There are multiple vaccines based on different technologies, with different efficacies and with different prices.  There are many different ways the vaccines could be used.

What I am saying is that rushing to give the maximum amount of people the most novel of the vaccines as fast as possible is not necessarily the best or the safest approach.

For example, if they are going to immunise all the staff in the NHS - which is a good idea! - then why not use three different vaccines and randomise who gets which one.  That way, if one of the vaccines has an unexpected and nasty side effect it will only affect 1/3 of the doctors in the country rather than all of them.

And why not wait say three more months before vaccinating young people or people with low contact to others because e.g. they work from home.     Three months will almost double the length of experience with the vaccine and maybe multiply the sample size of people who have had it by 100.

None of your business, and why would you even care ? How does that even relate to the topic ?

There is no need to be so unpleasant.

Even the Moron Number One admitted it'll take months to vaccinate the top vulnerable, well into next year.  Other vaccs will come into play, Pfizer's will be monitored, The MRHA's word is good enough for me.  Basically, are you questioning MRHA's conclusions, as an independent body, or, are you suggesting that they have been pressurised into a pass rsult by Moron No1's cronies.

I believe that there are still better people out there.

It works, get jabbing.

If you're worried about medication, have a shufty at the data sheet that comes with a simple pack of aspirin or paracetamol, you're going to die from the side effects!

Not enough is known about this or any other COVID vaccine.

Why not?

Because the trials are blinded. Even the company top exec aren’t allowed to know how many or which of the infections belong to the placebo or vaccine group, until enough cases are recorded to infer efficacy.

I am sure that there is a lot of accompanying data though that probably can be drip fed beforehand.

My understanding is given the importance of this, the regulators have been reviewing the data and manufacturing process etc on a real time basis, hence they’ve been able to roll out the approvals faster than usual (both here and soon enough in the EU). It’s not just the efficacy data, there are various other things which get reviewed and it sounds like a lot or that could be accelerated. 

I don’t think anyone in government is talking in terms of everyone lining up to take it, simply because there aren’t enough doses available and roll out will be slow due to the transport and shortage requirements of the Pfizer vaccine. I suspect mass roll out won’t really be feasible until the Oxford vaccine is available, assuming it’s approved.

You are right that there is no long term data yet. There will me medium term data by the time they get to the younger age groups. The other thing to bear in mind, as someone pointed out above, is there’s no long term data on Covid yet either. All these people who had a mild illness and seem to have recovered - we don’t actually know what it means for their long term health prospects. For example, if someone gets Covid in their 20s and recovers quickly, what’s not to say that they end up being at higher risk of respiratory complications by the time they reach their 60s? We just don’t know.

Absolutely agree  I said the same there is loads they can review in advance. However when it comes to efficacy data there is, by the nature of double blind trial and simply the time it takes to reach the numbers of infections required, no way to review this early in the process.

By any standard all of the agencies have been going at light speed. But it is quite striking that the MHRA started the rolling review of the Pfizer vaccine three weeks later than the EMA did and granted it’s approval almost a month before the EMA expect to.

MHRA is clearly doing something differently and taking a lighter approach than its overseas equivalent, and/or cutting corners. And this may be a good decision but it would be interesting to know why and what.

"MHRA is clearly doing something differently and taking a lighter approach than its overseas equivalent, and/or cutting corners. "

I really don't think you know that to be the case. You are talking days difference. 

We are talking 1.5 month difference out of three.  So yes, we know that to be the case.

 One out of three of the points you make could be fact, the other two are utter conjecture on your part, so "clearly" is absolutely not the right word. 

Doing something different you say. Well maybe, but they also could be doing the same things quicker or with greater resources?

Lighter approach, and or cutting corners? There is no basis for either of those statements. 

I don’t have much time to respond to all your points in full but it’s worth saying that you seem to be one of the few people who has actually read and correctly interpreted what I wrote, and to then respond respectfully and articulately.  I broadly agree with many of your points and this is the sort of intelligent thinking and debate I was looking for.  So thank you.

I am genuinely coming from a standpoint where I don’t know. Much of what I posted was phrased as questions, and they were just that.  If I recall correctly, I started off by saying I don’t know much about this situation.  I am not against the idea of these vaccines but had a lot of unanswered questions, which I articulated here.  Your stuff about economic risk etc is pre perfectly true and helps swing the balance towards the idea that these new vaccines are probably a good thing for most people.

I find it disappointing that so many here are so intent on just putting someone down as an antivaxxer, without even bothering to find out more or to engage in  decent discussion to find out about the motives for  person’s questioning.  There’s too much supposition and it’s mostly in the realm of supposition that one is right and the other is wrong. I don’t approach things in that way and it’s been refreshing (in contrast to the rest of the posters here) to read your well made points which challenge, complement and influence my own thinking.  
I am bowing out of this discussion as it’s too polluted with supposition and self-righteousness to be of much more use.Cheers for your input.

That all makes good sense and from what I have seen, that is indeed the plan. The Oxford vaccine was described by the lady who leads the research as being a covid targeted variant of a technology that they have been working with for years.  So safer? I have no idea as I am a builder not a scientist,  but it sounds possible. 

Our Blunderer in chief has said the Oxford one, when approved, is the one which will be used in bulk. That's what our order for vaccines reflects too.

It will be her decision,  but I would rather my COPD suffering mum had the Pfizer one now rather than risk another indeterminate period when she could catch covid which absolutely would kill her.

It's as huge as their claim that lockdown was the reason we had social and economic disruption, which ignores the massive social and economic disruption that was happening due to the rising disruption of the hospital system and the tidal wave of businesses kicking people out of the premises or having staff walk out in the two weeks before the lockdown, and ignoring how the situation could have got 5x to 10x worse had we not locked down.

"Some countries had long, full-on lockdowns and others did not, hence the differing social disruption.  Some countries shut down many businesses for longer than others...and they may suffer more economic disruption."

Another pretty huge claim from them was the one that drug discovery could be accelerated to a 10-month period like vaccine development, questioning why we don't do this.  I'd expect them to understand the difference between developing this vaccine and drug development given their background.

• Vaccine development - spike proteins were known to be a key part of novel coronavirus variants before this pandemic came along, and the techniques to identify and sequence the spike on the new coronavirus are well known and robust.  So the target was readily identified.  The delivery platforms for that target are all pre-existing and can be adapted without that much trouble (thank the gods).
• Drug development for disease X - there's far more detective work and design work to do.  What is the target for the disease?  Where are things going wrong within a cell?  There's no virus to isolate and culture up, it's a broken piece of machinery within our cells.  The problem has to be identified.  A lot of Alzheimer's trials are suggesting that identifying plaques as a target may not have been helpful, and that they may be downstream of other problems for example.  Having identified a problem, you have to figure out how to fix it.  What cellular signalling pathways - the target - can be prodded to achieve a therapeutic effect around the problem?  When you've got a target, you need to develop a compound to hit it.   This is chemistry and needs to make a compound with the right shape, polarity, chirality and so on to bind to a receptor (a part of the target) in the cell, that doesn't get metabolised away too quickly by the cell, and that shouldn't have toxic effects.  Over a hundred variant compounds may be designed to test against a cellular assay for a therapeutic drug - each with their own chemical synthesis routes.  Then you've got to move to mammalian testing to study the effect of the compound on the target and off-target effects including accumulation in organs etc; this is because you're introducing a totally new chemical to a mammal, where-as the vaccine is introducing a small part of what a live, high prevalence virus is introducing.
• For a virus vaccine the problem is obvious - the virus.  The target is obvious - the immune system.  The compound is identified through a robust set of methods and already exists in a near-ideal form for delivery in to a cell - proteins present on the outside of the virus that the cell itself can make with a robust DNA or RNA sequence provided by nature.  The delivery mechanism is standard - a virus genetically engineered for antigen delivery, or the emerging mRNA synthetic vesicle delivery platforms. 
• It's worth keeping in mind that something like 99% of therapeutic drugs fail to make it through the development pipeline.  It's hard to get anything like an exact figure as companies don't publish much about the failure rates of the earlier stages of their pipelines.  Good reading here [1] 

This isn't to denigrate the amount of work and uncertainty in vaccine development (very hard, very expensive) but to my mind there's an order of magnitude more of that to developing therapeutic drugs for disease and that can't be cured by just throwing money at existing processes.  Shortening the development times needs new methods and new processes that work to shorted the multi-year timelines of individual parts of the pipeline.

[1] https://www.ddw-online.com/media/32/04.fal.failure-rates-in-drug-discovery-...

This point of there’s questioning why we don’t put the same effort in to saving lives from other diseases is ignoring the absolutely pivotal point that none of this is primarily about saving lives, it’s about preventing a novel virus sweeping across the population so rapidly that it would break healthcare and therefore break society.

For someone asking genuine questions it’s unfortunate that they’re hitting so many tropes associated with another group - lockdown is responsible for the disruption, we are spending far more on saving lives from covid than on any other disease etc. 

I do not think they have taken any short cuts just on the principle that if the vaccine did not work ( which is by far the biggest risk) the whole thing would be an abject failure.

The Uk prior to Covid was also building a catapult centre for vaccines. Anybody in manufacturing will be aware of these( there are quite a few of them in the UK in other processes( automation, lean, nuclear and so on). So there was already alot of work being done to create an environment where they could be brought to market reaaly quickly.I have a view that this will have helped.

I am sure right at the start of this making the safe and fast regulatory approval was a examined as a process. If you do alot of planning then these things can usally be sorted out.

Parallell assessment of the vaccine will also have eliminated alot of delays( I suspect its also very expensive to do it this way).

Has it been trialed on pregnant woman to investigate if there any effect on the unborn child. Seems unlikely within the timescale.

John

Of course they were pressurised, as was the similar body in the US by Trump.  They are moving faster than similar bodies in other countries.  But to be fair to MHRA what they have issued is an emergency use authorisation - which I have absolutely no problem with since there clearly is an emergency and there has been quite a bit of testing. 

It is absolutely no secret that both administrations are a. determined to rush it and b. have no clue how to manage scientific/technical endeavours.    This is the point I made before: a top class CEO in a tech company with a novel product puts pressure on the test people to check everything and be sure, a poor one with a sales/accounting background just assumes the tech is fine (because they don't usually see the earlier parts of the process where its not) and puts pressure on to tick boxes and finish fast.

The fundamental point is you can't get long term data without a long term test.   For me it isn't about 'do I want to get vaccinated'  its about which vaccine and whether to wait for a few more months.

Governments committed to ordering in advance (even if a vaccine did not work?) so companies could commit the money for trials and manufacture before stage 1,23 trial results fully known and before final approval. It's worked incredibly well and cost peanuts (mere billions) compared to the other costs.

I assume pregnant women would be specially excluded from the trials.

Van Tam is answering questions. Turn on your TV now if you can or try iPlayer later.

Vaccination for pregnant women and children not recommended at the moment - Van Tam as reported on BBC website this morning.

I suggest you do a bit more research into what was going on as regards pandemic planning prior to Covid and also this catapult centre.The need to bring a vaccine to market very quickly was already being worked on prior to Covid.If you have done the plannning, it is one hell of alot easier to do.Step back and think as to why Oxford "brewed" up a vaccine incredibly quickly. It was not by chance ( whatever people may think)

A " few more months" is not reaaly long term data. 10 years probably is for all I know.

What long term data do you want to see? 

Individuals 'waiting' sounds reasonable but my question is for what exactly, what is another three months of study likely to tell you? What is the cost of that choice to you, prolonging your exposure to a known dangerous pathogen? What is the cost when scaled to millions of people making similar choices, delaying and disrupting the national vaccination program, prolonging social and economic restrictions, dragging our economic support programme out into a period where interest rates are likely to start increasing as better lead nations/economies recover, undermining each other's trust in the regulator's impartiality and capability?

What is the long term impact of a non-lethal covid infection?

jk

I'd like to see if there were significantly different/worse side effects from one vaccine choice than the others.  

I'd like to have how long the protection from each of the vaccines lasted quantified.

I'd like a little more confidence that there are no 'unknown unknowns' such as an immune over-response on the various vaccines.   When it comes to unknowns you can never be certain but 10 million people and 6 months total testing gives more confidence than 40k people and three months testing.

I'm looking at this from the perspective of someone who works from home and comes in contact with relatively few people.  

It's been stated repeatedly that the priority for the Pfizer/BioNTech vaccine is to protect those at greatest risk of death or serious long term consequences from the virus.  The questions being raised up thread absolutely do not apply to this cohort.

If it ever gets deployed on low risk people in their early 40s, it will be half a year or more down the line and there will be longitudinal data on the clinical trials group > 3x as long as now, and a lot more population level data.  There will be data on how much it suppresses the spread of the virus - as oppose to protecting individuals.  All the questions being raised up thread will have a lot more data by there time they are relevant.  As it stands, it's more likely that more conventional vaccines could be used the lower risk adults, making some of those questions irreverent.

As I said in my post to Elsewhere, I think by the time people in your situation - and mine - have routine access to vaccines things will have moved on a lot.  

Right now, it's about protecting those at highest risk of death over the coming winter, and in doing so, creating a third choice between putting catastrophic pressure on healthcare and putting increasingly damaging pressure on the economy.  The fatality rate is so exceptionally high compared to other risks for any given age over 55; the questions being raised here vs the evidence from the trials don't seem very relevant in the context of the fatality rates in the age groups to be offered the vaccine.

All valid points.  Let's see how it all pans out over the next year.  In 12 months time there will have been millions of people dosed and we will have a much better idea about medium and long-term vaccine efficacy and any safety concerns in sub-groups of the population.  Interesting to watch it all unfold in any case and if it does all work out perfectly then a great human achievement for sure...

There are differences but not significant enough to stop roll-out. We are in a luxury position of having more than 1 vaccine. If there was only one vaccine would you be questioning this? 

It’s going to be at least 16 weeks, antibodies don’t hang around for long in any case. It’s an immune response you’re after so without very long term follow up (not trials, we don’t do long term trials in any vaccines) you’ll not find that out.

Do you not think we will start to see problems as they monitor the mass roll out and they’ll stop if they have concerns?

Are you in the first cohort likely to be offered the vaccine? What age are you? Do you normally have a flu jab?

It is completely improbable that all the other western agencies are 100% less efficient than the MHRA, and resourcing isn’t the issue as this will be on the top of their priority list for all agencies anyway.

This is an evidently absurd alternative  which is easily discounted.

To be clear I am not saying it is bad. They may  just be taking a different view on the risk/reward of not waiting for more data and taking a bit longer.

All I am asking is that they explain their reasoning and be transparent. So far all they said is “we are not cutting corners” but of course they will never say they are so it’s kind of useless.

Yo'll know that as soon as the next one is approved.

What if it's years, will you wait to be sure? What if it's only one year and you need boosters, will you wait that year and will it stop you getting imunised?

What are the unknown unknowns for a covid infection? Obviously we don't know for sure. What's the risk covid poses of complications or death to people like you? For people like me it looks like IFR is very roughly 1/10000 which is a lot worse than, at worst, 1/40k What is the cost of the self imposed restrictions necessary to keep the probability of getting covid before you choose a vaccine x the probability of covid harming you under the probability of a tested and approved vaccine harming you and how long do you plan to live like that?

I'm looking at this from the perspective of someone who can't get on with normal life until X% of the population is vaccinated. Needless delays cost.

jk

That’s not true. 
 

They have been reviewing the data as it has been coming in over the last few months. They’ve not waited for all the data and then started. 
They have the same data, if not more, than they’d usually have because they’ve been able to recruit more applicable volunteers in a shorter timescale than normal. 
Many people have been reviewing the data over many hours per day. ie more man hours over a shorter time span. Parallel processing. 
 

Vaccines are usually checked for 2 months for side-effects. After that there are unlikely to be any. It’s a one off (with booster) injection. It’s like eating a bad pie. You either get sick pretty quick, or you don’t. 

For some it apparently is.

I think there could be mis-communication at work here.

Your statement "Safety doesn't appear to be a concern" can be interpreted in two almost opposite ways.

1. The data does not raise any concerns over safety 
2. The regulators are not concerning themselves with safety

I wonder if you mean one of these and Roadrunner6 read the other?

It's amazing how unfit for purpose the English language is.

Asking for an explanation would be fine but you are going further than that by expressing an ill informed opinion that the process must be lighter in touch or involved cutting corners.  Please share any evidence you have of either of those things happening?

You think nothing you are saying is bad? So cutting corners as a phrase is to be taken as a positive?

From what very little I know the approval is a process of data analysis, and processes can be speeded up or indeed slowed down by many things. As in this case, limitless funds unlock a speedier process.

Speculation about cutting corners is really unhelpful creating noise and stopping people asking perfectly reasonable questions about what was done and how. 

I don't disagree with any of that, I think it is absolutely the right thing to do and I think that general Tory incompetence and vaccine availability will probably constrain the rate they can vaccinate people enough to address my concerns.

The fact that its an 'emergency use' authorisation suggests that some elements of the normal process are not complete.   As I understand it some countries are waiting until they can give it the full authorisation and that's why the UK is first.

I am 69  years old with a nasty form of heart disease and I truly welcome this vaccine, but that doesn't mean that I do not have concerns for the rest of the population worldwide. If we are to safely inoculate the whole population within a reasonable timescale vaccine testing needs to started here and now on all people. 

John 

Thanks and I agree.  There is miscommunication but in the context of the BMJ article it was clear in the article no concerns over safety were raised.  Yes, without reading the article you could interpret as point 2, but the assumption is it would be read before rushing with a definitive declaration. 

The response for clarification was disappointing given the accusation levelled - how was I to know they hadn't read it.  The article is interesting and now likely a whole bunch of people are missing out.

Yes, English can be amazingly imprecise; hence, usually effort is made to seek clarification where there could be ambiguity.

I'm just over 55 so bring it on I say! I have far greater trust of a new vaccine that has been through accelerated trials and approval than a new virus subject to no trials or approval process.

Or it could be that all other authorisations for other vaccines are put on hold and this one is the first at the top of the pile on peoples intray/desks/labs......with a stamp saying "Priority" in big red ink letters...........

I’ve just read some ‘nonesense’ on Twitter regards the spike protein in the virus being targeted by the vaccine, being the same as a spike protein used by the placenta. 
 

Now initially that concerned me, but even more of a concern is if the vaccine is going to make people sterile, then surely the virus will as well? And we aren’t vaccinating young women.

It’s bewildering what these people come up with. This is apparently being touted by Mile Yeardon.

Mind blown. 

"Vaccines authorised using the emergency procedure are given 'Conditional Approval'. This means that, although the vaccine's benefits outweigh its risks, the data used to support the authorisation are not yet comprehensive. The authorisation is granted on the condition that the company will supply the additional information requested, such as the results of further studies, once the vaccine is on the market."

https://www.ema.europa.eu/en/authorisation-procedures

As usual - the regulators are being clearer than the politicians about the situation.  The section on that page about monitoring safety after authorisation is the sort of thing politicians and media should be saying instead of blanket assertions.

It’s not an opinion, it’s a fact, I have already  explained why three times.

I don’t see a problem with cutting corners if the risk/reward balance of doing so justifies it.

So your only counter argument is that MHRA has been able to conduct the data analysis to the same level 100% faster than all other western agencies, with less data available to them.

As I have pointed out earlier, this is just completely absurd. Pretending to have zero common sense to win an argument is not a strategy.

There wouldn’t be such speculations if there was trust that there hasn’t been political interference in this process.

Unfortunately given the haste of the government to make cheap political points out of the rapid approval (“we got it faster because of brexit” etc etc) I am afraid I have zero trust.

Have we not left the EMA?

Apparently the vacine is being approved in the UK before in the EU as British scientists are better

https://www.theguardian.com/society/2020/dec/03/gavin-williamson-britains-a...

words fail me

No, we haven’t. We are in the transition period EU law applies.

When you listen to such exceptionalist jingoistic bullshit coming from a member of the government, how can than not raise red flags ?

You are very good at telling me what my argument is when I haven't attempted to speculate or indeed argue anything?

Your comments and negative allegations are just that. Unfounded and not supported by any evidence. If you dont think that cutting corners as a phrase is a negative,  then I suspect that you are in a minority. 

Ask questions and challenge,  fine. Doubt our wonderful HMGov and their motives,  fine with that too. 

The MHRA made clear that this vaccine was approved under EU rules.  We are still in transitional period.

The whole Brexit let us do it thing is bullsh*t, they used a provision in the EU rules.

The EMA are not meeting until 29th December to decide whether individual member states can license the vaccine. That’s a political process. 

That means at least another 5 weeks before any country in the EU can decide to vaccinate.

We have changed legislation here so we don’t have to wait for them. The U.K. licence is temporary.

There are some papers showing spike viral protein being detectable in trophoblast cells.  It's known that severe C-19 complicates pregnancy.  At first glance the histology looks a bit odd to me and I'd like to go though it more carefully but if it's known that placental tissue is infectable (it expresses ACE2 and TMPRSS2) it's no surprise that viral proteins should be detected in infected cells.

However, any suggestion that placenta normally expresses viral spike protein is nonsense.    

Nice backpedaling. But you did make a counter argument to mine. You suggested an alternative explanation to the fact that MHRA somehow managed to approve twice as fast with less data.

The problem is that it our alternative explanation twice is highly improbable.

You keep denying the facts: but the facts are that MHRA started the review 3 weeks later than the EMA and finished one month earlier than EMA planned to.

Therefore their approval is based on less data and a shorter analysis. This implies that they are following a lighter process, or are cutting corners.

And I am fine with it as long as they justify why.

Thanks. I thought so.
 

The more I think about it, if it did express spike proteins, then the body would not recognise the virus as a virus using the spike protein. Unless our immune system can distinguish between placenta proteins in one place and not another. 

The emergency use authorisation the UK used is an EU procedure - you can see it on the EMA link I provided.  Other EU countries could use it if they wanted.  They are choosing to wait a few extra weeks and get a full authorisation before injecting millions of people.

There is no wrong or right here anyway.

It is a question of judgement: deploy the vaccine quickly with all its risks but with the chance of containing the virus.
The main concern is that that judgement has not been tarnished by political pressure.

That is what is hazy in our case. We just can’t tell.

Woah, no back peddling,  read what I said. You made comments about lighter touch and cutting corners.  In a reply later you changed tack to seeming to want questions answered.  That bit I agree with. Likewise politicians using the news for their agenda, I also agree borders on the cynical. 

However you started out by making unfounded negative comments about the approval process. Evidence to back these? No, thought not. 

And then incorrectly you present  arguments for me. No thanks.  I can present my own ta.

Been here before with you in this way before, so not going to waste any more time. Cheers.

That's easy. Williamson is such a complete f*cking idiot it's very safe to assume that he has absolutely no idea what he is talking about. Discounting everything he says is generally a safe approach. 

I suspect that’s a political decision. Who is financially underwriting the safety?

That's generally good logic, although... trophoblast is very unusual tissue and the immunology of the materno-foetal interface is pretty much a discipline in itself!  It has ways of locally suppressing the normal rules of immunology to protect the foetus, which is 50% 'non-self'. 

I had looked at the same. 70 days for emergency authorisation. ( against 210 normal]. 

So MHRA were probably just quicker of the mark.
 

We aren't stupid, let the UK be the experiment!

Ah, sorry apologies Druss, we were on different wavelengths. I took it the other way.

But the UK won't be. EU authorization will come in days, the US will authorize it on the 10th. No other data will come in by then (long term implications anyway).

Vaccines do have risks but those risks are demonstrably far less than the disease. But probably, we won't know how successful or risky the vaccine is for 3-5 years. However it will almost certainly be successful in massively reducing Covid cases.

It'll almost certainly successfully reduce covid deaths.

I suspect the effect on cases here will be quite the opposite. Vaccination rightly focused initially on the very old (and medical/care workers) who are already generally pretty socially isolated will do nothing for wider herd immunity and transmission rate. Once vaccination of the elderly causes hospital occupancy and death rates to fall it gets much harder for a weak populist government to justify maintaining social control measures. A third wave that is not killing the very old will be able to get much much bigger before it causes enough carnage* to re-trigger restrictions.

*mostly this time among the older working poor

jk

We'll see. Once we start to vaccinate 20-30% of the population, plus the 10-15%* who have it, we'll start moving towards herd immunity. It's not a sudden point but gradually happens as there are less and less susceptible people in the population. We could be there by the early Spring.

*By late August 6% have been documented as having it which is almost certainly an underestimation, add those infected since then and we are likely already above 10%.

Your humour detector has broken

My point is the limited first wave of vaccine goes to the people most likely to die of covid but also least likely to be circulating in wider society vaccinated or not, it creates a double whammy doing almost nothing to disrupt transmission chains in the more mobile socially inter-connected parts of society while creating a short lived illusion of 'problem solved' likely to cause more and less careful socialisation.

Our society isn't homogeneous, like the atmosphere it's stratified, I hardly even meet people under 30 or over 80 let alone socialise with them. Stopping deaths and transmission in one strata has negligible impact on transmission in another which may still contain many vulnerable people.

jk

Fauci reckons they were rushing...   I have no idea but, in general, I don't like it getting treated like a race.

https://www.independent.co.uk/news/world/americas/covid-vaccine-fauci-trump...

I've heard all sorts of bullshit surrounding this, not that yours is. I think the best so far was, "the RNA they inject into you will combine with you DNA and mutate".

Hopefully these dullards will weed themselves out of the gene pool without taking down too many of the good ones.

We'll see. The thing is as Spring hits and we vaccinate we should see the dual impact of more outdoor living combined with greater vaccinations. I can't see us changing many restrictions before March.

Maybe we're just quicker readers.

I listened to a religious US talk show yesterday. We should be taking dried oregano not the vaccine as millions will be given the virus and will get hospitalized.. or millions will have their DNA irreparably altered. 

As a science teacher it's horrific.

In fact this is going to be my review when I get my bio class back next quarter. We did DNA to protein synthesis last quarter so it'll be nice to use the mRNA vaccine to review this.

The mRNA vaccine technology might be relatively untested in terms of long-term effects but so is Covid and we didn't do any safety studies or quality control work on Covid before that got released! 

Can any experts help me with this question: should long-term ill effects be unlikely because the mRNA decays quickly? So it's a quick burst of spike protein production, the immune system works out how to make the antibodies, the mRNA and the spike proteins are broken down and everything is normal again? Is this why we shouldn't worry about ill effects years down the line, or are we just saying that Covid is more likely to give you ill effects years down the line? 

Spring will help take the edge off but it's still hit and miss here into June.

The first wave of vaccination combined with what is in effect a light ongoing nationwide lockdown should massively reduce this wave of covid deaths by early-mid Jan' at which point the government isn't going to be willing to quell its rebellion. It's a weak populist government heading up a party of MPs specifically selected for their willingness to pursue bad policy in-spite of contrary evidence. The lobbyists have done their work and it's already very fractious despite high hundreds still dying daily and hospitals creaking.

Come January as the reality of brexit's disaster bites they are going to be *desperate* for distracting crowd pleasers. That won't help.

jk

I think they'll either stop or the problems will get into the media.  Which is why I'd prefer to wait three months to see if that happens rather than be at the head of the queue (which makes no difference in practice because nobody is going to put me at the head of the queue anyway).

Three or four months out there may also be more data about which vaccines are working best or have fewer side effects.  

I don't have a cause dude, I accepted the result of the referendum and am cheerfully cracking on with my life. It was just a little wry humour. Apologies if I've upset anyone.

I think it's really important to distinguish between the rapidity of the approval once the MHRA got the data (which would have been the same data that the EU and US regulators received), and the extraordinary speed of the development process.  

On the regulators, a report in the Washington Post says "Drug regulators in Britain have a global reputation for being tough but fast, employing a system of continuous "rolling review" of incoming data from drug companies."  The same article suggests that part of the reason the US regulator is slower is that it needs to have public meetings.

The speed of development really is just a function of the extraordinary amount of money that governments have thrown at it.  For example, the US government directly spent $2.5 billion getting the Moderna vaccine to market.  Whereas normally you'd wait for the results of each stage of testing to come in before beginning the next, here everything has been done in parallel.  The phase 2 trials - which check whether the vaccine is safe, but not whether it actually works - were done in the summer, and before the results of that had come in, they had started spending money on the much more expensive phase 3 trials, manufacturing the 10's of thousands of doses they needed for that, as well as starting to build the factories for full scale production. Large scale manufacture of the millions of doses for full scale roll out would have started well before they had found out from the phase 3 trial that the vaccine actually works.  

This only happened because governments were prepared to take on the risk of wasting billions on a vaccine that might not actually work, but it does mean that even though the speed has been much faster than usual, the same amount of actual testing has been done.

I don't really understand the criticism that the UK regulators rushed the approval. I bet despite the fact that some US and EU officials criticized the speed of the UK approval, they will approve it anyway so it will have made no difference. Maybe the UK gov realises how truly f*cked we are, a 'won't recover for decades' level of f*cked, so they are doing everything as fast as is possible. 

Well you could easily argue..... he would say that......... it’s strange that people forget that we have been saying for  a few weeks that early December was the start of the rollout date. So not surprised at all. 

The UK government certainly pinned a lot of hopes on vaccines; it's pre-bought more doses per head of population than most other countries.  It's also (sensibly) spread the risk a bit by not pinning all its hopes on one particular vaccine; it's bought not just the BioNTech mRNA vaccine, but also the Novavax recombinant protein vaccine as well as building manufacturing facilities for the home-grown Oxford/AZ viral vector one.  There's a huge amount to criticise in the UK's pandemic response, but in fairness the vaccine development aspect hasn't gone too badly.

Yes I agree. The UK gov must be so relieved about these vaccines. Without them we are stuffed. This second lockdown has further destroyed the economy and put more people out of a job (furlough is a life-support for a zombie economy and only postpones the inevitable). Even with lockdowns we can only get R0 to slightly below 1 and the moment things are relaxed it surges again (look at wales), so despite the economic damage, which kills people, we have achieved very little. Without the vaccines we would be properly shafted. And I'm not putting the economy before lives; the NHS is funded by taxes on wages. Imagine the feelings of relief in the government!

Yes, it's a lucky break for the government (and the rest of us).  The way social distancing and lockdowns have been handled has been a debacle, test and trace has been a shambles, our diagnostics capability has been exposed as much weaker than anyone thought, we've found out how fragile our supply chains for PPE and basic pharmaceuticals are, the ongoing disaster of our social care system has been cruelly exposed ... but we did ok and got lucky on vaccines.  

That's effectively true, yes. In fact, for any vaccine, the most common and most severe adverse events take place over a very short time period (allergic reactions, most commonly). Long term ill-effects are extremely rare in vaccines in general (immunology PhD and in a former job ran clinical trials for vaccines).

OK thanks. On the face of it the mRNA technology sounds a bit scarey: it's reprogramming the cells to make a foreign protein! But I guess Sars-Cov-2 does that anyway just without any safety testing or QC? I'm probably talking b*llocks here but is there any risk of long term effects from the RNA interacting strangely with the human DNA and damaging it, so something bad happens years later? Or does the mRNA go straight to the ribosome? I am not really sure what I am talking about though, I'm in no way claiming that this will happen! 

Yes, if any country was saved by the bell it's probably us! Getting through this probably horrible winter will be a lot easier now there is an end in sight. 

Pretty much. Every time a gene in our cells is turned on, a stretch of DNA it will be converted into an mRNA ("transcribed"), which is then exported from the nucleus and translated into protein. All mRNAs are deliberately unstable and will be degraded after some time in order to limit the amount of protein that is made from one transcription event.

The main worry about mRNA vaccines was therefore whether a single delivery of mRNAs would last long enough to make enough protein to trigger a sufficiently strong immune response.

Fortunately, some molecular biology wizardry increased the stability of the mRNA and the efficiency of that delivery mode, so these vaccines do work.

If you were infected by a live virus, the same mRNA encoding spike protein would be made, just not from the artifical vaccine mRNA but by transcription of the virus genome. No difference there.

I have no idea how people got the idea that the viral RNA or the artificial mRNA used in vaccination could alter the DNA genome of our cells: There simply is no mechanistically plausible way for that to happen. Very, very maybe if there were a double infection with the virus (or the vaccine) and a retrovirus like HIV, but even then....

Of course things can go wrong with vaccinations, just think of the rare cases of the Pandemrix swine flu vaccine that in very rare instances caused a terrible autoimmune reaction that killed off certain neurons in the brain, resulting in narcolepsy.

However, you have to weigh this risk against unexpected or rare side effects of the disease that will be prevented by the vaccination.

CB

OK thanks. Sorry I was talking nonsense! I just wanted an expert to tell me so. I suppose that I either get the spike protein mRNA from a well-tested vaccine or from a random bat virus, so given the choice I'd go for the vaccine.

Yes, imagine this happening 20-30 years ago....we'd have been absolutely screwed. 

That is not true because MHRA started the rolling review of the Pfizer vaccine of the 26th of October. The EMA one for the same started on the 6th of October.

It isn’t that MHRA started earlier, it just that they were about 100% faster.
So it is completely logical to ask what compromises have been made and steps have  been skipped, and most importantly, whether these choices have been made scientifically or have been tainted by politics.

Exactly! Reprogramming our cells to make foreign stuff is what viruses do. Any virus based vaccine (like the Oxford one) would do this as well, the difference is in the delivery.

Anyway, getting our cells to make the foreign stuff is the whole point: Cells constantly present short samples off their protein production line on the surface, so that monitoring immune cells can see whether an infected cell starts making foreign stuff.

CB

No need to apologize!

CB

Yes I think 20 years ago we would be at this point and, realising that lockdown 2 didn't get R0 much below 1 at all, we would probably have to go with some version of 'let it rip'. With the continuation of the wet markets. battery farming and encroachment into bats' habitats I think really fast vaccine production is the only thing that will keep the world economy going over the next 100 years or so. Sars-Cov-2 is relatively mild and look at the damage it has done. Maybe it will end up being seen as a painful but useful dress rehearsal for countries like ours that assume nothing bad will ever happen to them? 

The EMA is working with experts from EU member countries, the German ones come from the Paul Ehrlich Institute, our national regulator for vaccines and biological medical products.

I have seen how they dealt with applications for cell based clinical trials by colleagues at my old university. A Kafkaesque bureaucratic nightmare would be a mild way to describe this process.

Everything is passed from committee to committee to special working group.....

The whole point of the exercise is to dilute responsibility on the regulatory side until everybody has covered their arses sufficiently that no individual fault can be assigned anymore in case something goes wrong.

Their entire raison d' etre is to avoid taking responsibility, not to get things done.

I used to run clinical trials, and specifically clinical trials for vaccines (most recently the Cervarix cervical cancer vaccine). That's not longer my job, but I wanted to comment on this.

Firstly, the trial we are hearing back from now was not the first trial.  It was a phase III trial, which I will come back to in a minute. Before a phase III trial can be carried out, phase I and II trials must have been carried out.  These finished several months ago and the data has been available for a while.

Phase I trials are purely safety trials, they don't look at efficacy at all. They run with small groups of people, usually in a hospital setting. There is no blinding in these trials. Small groups are given the drug or vaccine, sometimes at increasing doses, while being monitored closely for any adverse events.  The aim of these trials is to ensure that the drug is broadly safe in the population with no common reactions that might prevent it from going in to general use. Regarding the mRNA vaccines, it should be noted that several other mRNA vaccines using the same system have also been through phase I clinical trials.  In most cases they were shown to be safe, but did not make it to market because efficacy trials did not show them to be more efficacious than other vaccines against the same infection already available.

Phase II trials are larger, the focus is also on safety and dosing, but they may also begin to look at efficacy and compare against a placebo.

The trial being reported now is a phase III trial. Here, it has already been established that the vaccine is broadly safe. The focus is on efficacy. The purpose of blinding is to assess whether or not the drug under trial is more efficacious than either a placebo or another drug already on the market. Given the much larger group size in these trials, they are also used to look for rare adverse events, however a phase III trial would not be carried out if the vaccine was not already shown to be generally safe. The other point to make here is that you can look at overall safety data in phase III trials before unblinding. If there are no adverse events across the entire cohort (that is treated and placebo), then you already have some data. Additionally, individual participants will be unblinded early if they suffer severe adverse events. After unblinding, you can dig into the distribution of minor adverse events a bit further, but you can get a good sense for safety long before that.

Phase IV trials cover long-term monitoring, however it is standard that these are carried out after a vaccine is made available to the general population. The phase IV trial for Cervarix, for example, is still running although the vaccine has been available to the public for over a decade now.

I also wanted to comment that because of the nature of vaccines, long terms side effects are exceedingly rare for any vaccine. They don't build up in your system and cause problems years later. In the vast majority of cases, any side effects happen with a couple of days. These are usually flu-like symptoms caused by you body doing what the vaccine is intending it to do - raise an immune response. The most common serious side effect is an allergic reaction, which will take place within a couple of minutes. 

Lastly, I will quite happily take the Pfizer vaccine if offered it, and equally happily take the Oxford vaccine when approval for that one comes through.

I was about to reply to this, but I see cb294 already got there. He explains it well

To be fair to Wiiliamson, he was utterly goaded into a stupid statement by Nick Ferrari. Try to catch the video of the interview if you can. He started with a much more measured response, but shouldn't have responded to Ferrari's bollocks.

And, trust me, I have no love for Williamson or any of his cabinet colleagues.

Thanks very much for that post, I had heard most (but not all) of that before, but it is good to have it communicated clearly by someone with first experience. Up thread it was stated

"For what it's worth I have some contact with pharmaceutical regulatory bodies in Europe and have to keep up to date with the drug development regulations etc, and this is what sparks my interest in this subject.  When normal procedure is thrown to the dogs and short-cuts are taken it isn't conspiracy theory to begin asking questions  "

my understanding is that hasn't been the case. The reason for the "record speed" has been explained by richardj at 16:45

I don’t know what R became during lockdown 2.0, but the half-life for cases, hospitalisations and deaths is very good right now, and all measures are now decreasing significantly.  In late November.  With people sick of lockdown and compliance allegedly less than the first one.  With a weaker lockdown than the first time around.  We’re pretty sure old T3 sends cases in to decline and if we’d gone for T3 in more places before lockdown 2.0, said lockdown wouldn’t have been needed.

I don’t think the outlook sans vaccine is so black, and the actual outlook with them now - bring on summer 2021.

The US are predicting an announcement on 10 December. 19 days before EMA even have their first meeting. 
 

The EU are going to be 5 weeks behind us with cases and deaths mounting up...

Perhaps their  process is more efficient in general rather than quicker on this occasion? You really need to consider how quickly MHRA authorises a product normally vs EMA or FDA and then see if it scales.

If my customer wants a job done in two days instead of a week, we drop everything else, move everyone onto one job, treble the labour into 3 shifts a day and work round the clock. Of course it costs him double but he has that option. 

fair enough - but I guess the reasonable question the customer might ask is will the work be done to your usual high standard?

my point to Rom is that MHRA have the reputation of being faster than EMA or FDA in normal times, and that may colour the analysis of how quickly they achieve things now.

Yes. It’s done to the same standard, you increase the amount of resources available. It wouldn’t be if you rushed it by not assigning the resources. 

Maybe - but now you are "working around the clock" and have an imposed time pressure greater than normal - will your team perfom as well as usual?

Yes. There are three teams sharing the work. 

Presumably the final data is just stats cut this way and that, that’s a matter of days not weeks to review. 

Does the team doing the night shift normally work those hours?

Yes. In our case.
 

But in the case of research and data analysis those teams don’t all need to be working on the same bit of equipment in the same 10ft square space in the same building.

If you put 3 teams on a job that would usually only have one team, or even one team working part time on it. It will be finished in a third of the time. Put 10 teams in it and they take a 10th of the time. 
 

Basic parallel processing with lots of communication and cross team co-operation. 

I think you are over optimistic 

I’d like to know why an ex Pfizer doctor has advised not to take this vaccine. Anyone know ?

If there was no reason given, who cares?If there was, you know already.

Jk

Don’t be stupid. 

I can't change that. Address my reasoning. 

Jk

Of course but it’s really strange to suggest that only MRHA wound have prioritised Covid vaccines. Presumably the FDA is doing the same and so does the EMA.

In my experience scaling like that on data projects works only in the mind of the most wretchedly simple minded middle manager.

In the real world it looks more like a Pareto distribution with 20% of the staff doing 80% of the work. It makes it really hard to scale.

But I guess this is highly task specific, if it is repetitive work then yes you can scale quite well.

I don’t think this is a simple as that and that’s even without considering aspects of data integrity and quality.

Do you mean Mike Yeadon?

Send me a PM and I’ll tell you what I think.  Mean time before you attach too much importance to his view, google his spinout from Pfizer and what happened after its phase 2b clinical trials.  Funny how he mentions Pfizer in his bio but not the half billion dollar failure.

Good point but 100 faster isn’t really possible without quite a different process. And this isn’t only speed, remember they have made their assessment based on less data.

To be clear personally I am delighted they approved it in this particular case, I don’t fully trust they that their decisions aren’t tainted by political pressure. I m particular I’ll be looking closely at what they do with the AZN vaccine relative to other agencies as this one looks a bit « dodgy » (botched trial, less than transparent data) but there is immense political pressure to claim it a success.

According to the BBC one of the reason the MHRA is faster is because they rely more on reports from the company themselves instead of reviewing the raw data. The FDA basically reruns the analysis independently from the raw data.

I’m just trying to find out what his problem is with the vaccine. I’ll form an opinion then. Don’t know who this doctor is and I don’t know how credible he is but he gave an interview to a UK media outlet this week. I want to read the interview. Haven’t found it online yet.

Thanks for the reply and appreciate the offer. Not sure if it’s Mike Yeadon. 

That is the most utter nonsense.  You are assuming that you can simply split complex research and analysis tasks up and most of the time you can't.   

The trial results appear to get announced after about 100 Covid cases in trial participants. The maths id the same for everyone - I guess 100 is enough to tell you 50 in each vaccinated group, 50 in unvaccinated group - it does not work or 90 in unvaccinated group, 10 in vaccinated group - it does work.

A reason I expect the trials have been quicker because it's been quicker to recruit collaborators to run the trials and quicker to recruit volunteers to participate in the trials to get those 100 Covid cases. This has not been an obscure bit of medical research.

This one isn't difficult and you can evaluate it for yourself.

Yes it is Mike Yeadon - yes he has had a distinguished career though he appears to have scammed Pfizer out if £300 million, whether on purpose or accidentally seems unclear.

You can judge for yourself how valid his judgement is, he has been adamant that the pandemic has been 'effectively over' since I think July. You can count for yourself the cases and corpses since then and judge for yourself. At the moment he seems more Andrew Wakefield than Edward Jenner.

Oh, and just out of interest, someone is putting quite a bit of effort into whitewashing Yeadon's past. If you google 'Ziarco', there are quite a few references which no longer exist, including Wikipedia. Somebody seems to have put a lot of effort into hiding the fiasco that seems to have been Ziarco. 

Real 1984 stuff: 'Who controls the past, controls the future: who controls the present, controls the past…'

Yes, the trials like this have defined endpoints, which is usually a particular number of cases. It's important to note that this will have been agreed in advance with some regulatory authorities (notably the FDA), and probably at least discussed with others. 

Yes, recruiting for clinical trials can be difficult, both getting clinicians and patients involved. In this particular case, I suspect getting clinicians involved would have been much much easier than usual, and patients were also keener than usual to volunteer because this is a very public matter. Another factor here is that I suspect that eligibility criteria for volunteers weren't particularly strict. For many clinical trials, half the battle is finding enough patients who are eligible in the first place.

However. The research into a vaccine has been shared between the pharmaceutical companies across the world since November. They’ve all been working together. This is unprecedented. 
 

Why the regulators can’t do this I don’t know? I assume you have a better understanding of what they do. 

I think a few academics here have commented in the past that most of broken links and old references just die. Especially in academia as new websites get introduced  and new staff don’t archive old historical articles properly. 
 

I have a Wordpress site that I’m about to archive that goes back to 2011. If anyone wants specific information they’ll have to contact us directly. 
 

It’s more likely to be due to that than due to any malicious hiding. 
 

There do seem to be a lot of people who understand epidemic theory quite well and claim that what we see can be predicted very well. I can only assume that lockdowns are interfering with their models and preventing them from studying a novel virus behaviour in the wild. Some people are psychopaths to a certain degree and some are on the autistic spectrum. People dying are just numbers and statistics for them to study. 

Who says?

They've been vaccinating animals for coronaviruses for years.

What are your credentials (and how are they better than the credentials of the regulators) and what don't you like about Pfizer's data?

Yes, there's a huge amount of arrogance being shown by people who say 'i haven't seen the data yet' 

What they mean is they've not heard someone say what they want to hear. Every year they trust their lives in planes they have no idea about.