Can anyone sum up what’s going on with vaccines for me?

[Cornettoninja]

I don’t understand why this has emerged as the next problem.

So the government are saying that there are problems with supply; this makes no sense to me regarding the AZ one. It’s been reported for months that this has been in manufacturing throughout trials with the understanding it would all be binned off it didn’t work. The Pfizer one... I’m not sure about the supply issues with this one if I’m honest. I’ve read reports from both companies this morning that there is no issue their end with supply.

Secondly how is it possible that despite months of vaccines being ‘imminent’ (to be clear I’m using that term loosely) now there are issues with staffing a vaccine programme? Health settings have had protocols in place for months at the behest of the government so they could be ready to go.

Lastly, what the hell is this sudden redesigning of dosing regimes about? Pfizer have publicly distanced themselves from the UK’s plan to extend time between doses. Do it properly or not at all!

I would be incredibly pleased to hear that this isn’t just the latest balls up of our incompetent government thinking they know better than experts and gambling with our best chance out of this absolute nightmare. Unfortunately I suspect that is the case given their track record throughout that leaves the majority of the country saying WTF.

I would be incredibly pleased to hear that this isn’t just the latest balls up of our incompetent government thinking they know better than experts and gambling with our best chance out of this absolute nightmare.

I'm sure some people will tell you that. I won't be. It certainly is a gamble - they are claiming an efficacy that has no verifiable and trialled evidential base. And they are doing so by testing it on the British population. It may work, it may not. Nobody can say - certainly not the government or their advisors. It's bad enough that they are willing to go against the only available science (the trials) in a gamble that they are right, but to make the British public their guinea pigs is disgusting. I hope they are right - because if they are wrong they are endangering everyone. But if they are it does not in any way mitigate the risk they are taking. Especially since I very much doubt they will be the ones taking it. Want to lay bets that they have already had their two does and on the trailled basis?

Thanks moondust. The problems with logistics of distribution are almost understandable (though unforgivable given the length of time this has been on the cards) but this dosing adjustment is baffling.

I’ve pretty much written off any progress that may have been made with the Pfizer vaccine now. What a waste of time and resources.

Lastly, what the hell is this sudden redesigning of dosing regimes about?

You can read it: www.gov.uk/government/news/statement-from-the-uk-chief-medical-officers-on-the-prioritisation-of-first-doses-of-covid-19-vaccines

“The 4 UK Chief Medical Officers agree with the JCVI that at this stage of the pandemic prioritising the first doses of vaccine for as many people as possible on the priority list will protect the greatest number of at risk people overall in the shortest possible time and will have the greatest impact on reducing mortality, severe disease and hospitalisations and in protecting the NHS and equivalent health services.”

If any consolation, it’s clearly a decision made and agreed on by the JCVI and the CMOs, not by the politicians. Boris Johnson’s too lazy to do his own job let alone other people’s.

OP there have been a number of threads on this.

Here's one, where some posters are blindly and unquestioningly following the JCVI's decision. www.mumsnet.com/Talk/coronavirus/4121161-Are-2nd-doses-of-Pfizer-vaccine-being-cancelled

My viewpoint is precisely what Moondust has replied to you.
As well as not knowing how effective just one dose will be after 21 days, we also don't know whether just the one dose guarantees a milder infection if you do catch it. I don't understand how they can get away with it, and have outlined why on the thread I've linked, but it seems there are those 'in the know', or who certainly let on to be, who agree with the decision.

I'm done caring to be honest.

Thanks @GoldenOmber but honestly that doesn’t reassure me as much as I would like. I don’t think weak yet arrogant leadership is confined solely to our government unfortunately. I can’t get past the fact that the company who developed the vaccine have gone on record as saying they will not endorse this approach.

We’ve had no choice to take measures on the basis of projections and guesswork throughout this pandemic and now we’re seemingly disregarding actual evidence in favour of taking gambles. It’s desperation taking priority over doing something properly.

Thanks for the link @ObliviouslyIgnorant.

I’m also trying to unpick why we’re being told their are shortages of vaccines when AZ and pfizer are saying there isn’t a problem at their end. Is it the delivery, storage, manpower to distribute it?

I can see that the experts on Twitter are arguing about the dosing regimen. I guess the thing to understand is that, with the emergence of the new variant, the game changed hugely in an instant. This is a Hail Mary to prevent massive loss of life. It might be doubtful, but it could also save thousands of lives so some feel it would be wrong not to get some protection into as many as possible.

So from the Pfizer perspective there are multiple reasons why it would be in their interest to discourage this, financial and reputational.

I find it interesting how often the JCVI and the CMO's opinions are being rolled out as verifiable fact. These people are certainly experts in some fields. There are just two small problems with that. Experts can be wrong. And whatever else they may be experts in they did not undertake any part in the vaccine development and trials, and their opinions are based on no scientific facts. So they have no direct factual evidence or experience upon which to base their opinions. That isn't science. It's bullshit.

My concerns are twofold really - the first being that they have guessed wrong and this will lead to reduced efficacy (probably a bigger risk than reduced safety, which I don't think is a big concern, but there's always a risk) and not have the intended impact of bringing down numbers.

The other one is that we are potentially wasting all the doses. By lengthening the period between doses we cannot be certain that the entire impact of the first dose will not have worn off by the time the second is received, and that the second dose then also wears off quickly. The fact is that not even the developers can swear that the effects of the vaccine as trialled will last even a year. Why not? Because not a single volunteer for the trials anywhere in the world has got to the one year mark! We have absolutely no idea how long the vaccine, when used as recommended, will work for. We won't know that for a long time. So if the changes reduce the efficacy, we could literally be throwing them all down the pan for nothing.

Moondust I don’t understand your point about them not directly taking part in the trials. They’ve got very detailed trial data.

So from the Pfizer perspective there are multiple reasons why it would be in their interest to discourage this, financial and reputational

I completely understand this aspect but I don’t think that takes away from the fact it’s a complete gamble that could make the whole exercise pointless.

There was a lot of concern about the AZ dosing following the manufacturer error that resulted in better results for a small subset of trial participants - how is it suddenly fine to give actual patients an unlicensed, untested regime in the hope it’ll work?

Hope isn’t good enough when we have actual results available proving an effective dose.

So from the Pfizer perspective there are multiple reasons why it would be in their interest to discourage this, financial and reputational.

I keep seeing people arguing that Pfizer have "interests" that mean they would discourage this. Of course they do. And if they didn't they'd be idiots. I'm not fan of big pharma, but any means. Nor of capitalism. But the world is structured in a way that says that the making of profit is a good thing and encourages the making of more and more of it. You cannot blame a company for following the prevailing economic model. AstraZeneca are also worth £billions - they are not a nice little non-profit, and please don't think they are making nothing out of this.

And as for reputational interests - not so much as liability concerns. They have not trialled using the drug in this way. If they agree to that use without trials, and it all goes horribly wrong, they will be sued Quite rightly, they are held accountable in law for their science. It will be nigh on impossible to sue a government. They have all sorts of immunities from prosecution, and would be only too willing to pass the buck to others anyway. And suing the CMO won't be very productive - they are not all that well paid that there will be anything to go around.

I don't particularly like a structural economic system that puts profit before welfare. But that is a different discussion and a different thread. But we cannot blame the system for being what it is and then acting like what it is.

It’s actually a logistical nightmare trying to deliver a vaccination program of this size. Yes we have known that we will be expected to staff it as hospital staff but we also all have our day jobs to do too. We don’t have spare staff or the funding for more and training. Which then leaves other areas of the department short.

The Pfizer vaccine has to be reconstituted by pharmacy staff before going to the vaccinators. One defrosted we have 120 hours to use up the whole box of vials. One reconstituted that time drops to 6 hours to use the vaccines and once drawn up in to a syringe you get 2 hours. It’s not a process that can be done too long before hand or in huge quantities as the window is so small you don’t want to waste any vaccines.

@ATieLikeRichardGere

Moondust I don’t understand your point about them not directly taking part in the trials. They’ve got very detailed trial data.

They have information given to them by experts that says that the drugs are safe and efficacious in these circumstances. Full stop. That information was produced by hundreds of experts in their field working directly on the trails. They have decided that a different set of circumstances, which has never been tested, are safe and efficacious without any evidence being presented that that is true. And the have presented no evidence that they have tested and verified their opinions (they can't because they haven't).

So what we have a a set of experts who have spent many months doing the science and producing the numbers, and another group of experts who have read that information and decided it says something else.

It’s not purely hope - there is some evidence and some reason to believe that this is likely to have useful effectiveness. Also, we know in general the vaccines are safe. I can’t argue that it isn’t a gamble. Experts are arguing over it. Here is one take mobile.twitter.com/Bob_Wachter/status/1344667655324585986

Us is not following U.K. they are sticking to the 2 dose schedule.

But what is causing the hold up in U.K. 3 days ago on vaccine calculator l was due to be done in May. I’ve now moved to December 2021. That’s a 7 month difference. And I’m in one of the priority groups. What about the rest of the population?😬

@ArseInTheCoOpWindow

Us is not following U.K. they are sticking to the 2 dose schedule.

But what is causing the hold up in U.K. 3 days ago on vaccine calculator l was due to be done in May. I’ve now moved to December 2021. That’s a 7 month difference. And I’m in one of the priority groups. What about the rest of the population?😬

Is there info out there of when we're due to be vaccinated?

I think there is some delay with filling the vials? There will be a certain amount of stability data in vials do they probably couldn't fill them too far in advance. Plus each batch will have to be tested to make sure it meets the quality required & then released. I suspect that's not all of the delay though! The government has proved hopeless in all other areas of this pandemic so I'm not sure why this would be any different.

Looking at the headlines and social media posting it would be hard to understand what is going on. It’s all just jumbled assumptions and fake news.

With regards to planning, this has been going on for months. But part of the planning couldn’t be finalised until the authorisation details were complete. The MHRA and regulator have agreed use under certain arrangements and these are different for each vaccine. These were only known after authorisation.

Workforce: Assumptions could be made about the numbers and qualifications that might be needed but these don’t firm up until the last minute. With Pfizer more HCP and a lot of pharmacists were used because of the handling of the vaccine. Additional training requirements was set for vaccine handling and anaphylaxis. Additional clinical workforce had to be identified for supervised observations at the last minute due to anaphylaxis risks. With Oxford there is the potential to shift to using non HCP as vaccinators but this needs a regulatory change. It’s not quite in place yet in England. Until it is the GP and hospital sites are the best staffed.

Delivery Operations; The UK was really the first country that started to test the safety of moving the Pfizer vaccine around in refrigeration. This took a bit of time. The storage of the vaccine really limits the scope of its use. Lots of ducks need to be a row for this vaccine.

Site Operations: these were planned based on the known characteristics of the vaccines. But these changed. Most significantly in relation to observations which were originally required, then not and then reinstated but with the need for clinical observation. That all impacted on the space requirements and meant some sites couldn’t be used. The flow of patients wasn’t really known until it happened. Sites reported problems with patients turning up very early and en masse. This meant they needed more space and marshalls.

Vaccine supply to sites. Many sites are eager to do more and want to be supplied with more. But it’s important the current supply is fairly and evenly distributed. This is what is happening. The supply we have is sent out fairly not on demand. That frustrates some who run to papers. It’s also important to be aware that there is only one supplier. With flu there are multiple suppliers able to feed more sites, although this is uneven and inconsistent.

Vaccine manufacturer: the manufacturers are ramping up volume but are not at the peak. There are also notorious problems with vaccine manufacturing which will disrupt supply, see Pfizer. But discounting that factor the supply is building up worldwide along with demand. Orders are phased and we were never going to get 100m doses in one go. The UK expects peak Oxford supply in February.

Recording of information. GP and mass sites will use one system to record vaccinations which will be linked to a GP record or NHS number. The default will be GP record because most people don’t know their NHS number but do know their GP or other personal details. However some people live chaotic lives and we don’t have a national ID system. It’s likely that these people will be confused about their vaccination history and provide inconsistent personal details that can’t be matched. There aren’t many of these people but there are enough. When they present there is a risk to be mitigated. The mitigation is to vaccinate and give protection rather than sending them away.

Did I dream that Tony Blair was ridiculed a few days before this was announced, for suggesting one dose?

For those interested in more details about the Pfizer trial this is an interesting read.

Vaccines and Related Biological Products Advisory Committee Meeting
December 10, 2020
www.fda.gov/media/144245/download

This is the vaccine calculator

www.omnicalculator.com/health/vaccine-queue-uk

I thought they were doing the rest of the population to age 16/18 after vulnerable groups?

Thanks for the replies, particularly @LemonTT - I will read properly when I haven’t got a cabin fevered 5yo talking at me

I did note mention of Blair - I agree that his view was widely disregarded at the time. Does he have access to a group of experts our advisors don’t?

What's your speciality @Moondust001 out of interest?

@Porcupineintherough

What's your speciality *@Moondust001* out of interest?

I don't believe that she said or implied that she had any relevant speciality?

Isn't "hypersensitivity-related adverse events" another name for anaphylaxis?

pfizer are saying there isn’t a problem at their end. Is it the delivery, storage, manpower to distribute it?

Supply issues of the Pfizer vaccine reported elsewhere in Europe:

28 December -
BioNTech-Pfizer has postponed the delivery of new batches of its coronavirus vaccine to eight European nations including Spain, the Spanish health ministry said on Monday.

The hold-up is due to a "problem in the loading and shipment process" at its plant in Belgium, the health ministry said in a statement, citing the Spanish branch of Pfizer."

www.dw.com/en/biontech-pfizer-delays-covid-vaccine-deliveries-to-8-eu-nations/a-56074466

30 December -
Three German states, including Berlin, have been forced to suspend their coronavirus vaccine campaigns for at least a week owing to shortages in doses, German media reported Wednesday. The news comes barely four days after the first vaccine was administered in Germany. ...

An order of around 30,000 doses of the BioNTech-Pfizer vaccine due to arrive by January 4 was cancelled, according to several German media outlets. The reasons for the cancellation were not immediately clear. The BioNTech pharma company, which played a key role in developing the product, is based in the German city of Mainz.

www.dw.com/en/coronavirus-german-states-say-vaccinations-delayed-due-to-shortage/a-56097728

Vaccine production target cut by half;

8 December -
According to a Pfizer spokeswoman, challenges in the company’s supply chain played a role in its decision to cut its 2020 COVID-19 vaccine production target by half.

Recently, Pfizer announced it expected to produce 50 million doses of the BNT162b2 COVID-19 vaccine candidate this year–this is half the target of 100 million doses it set earlier in 2020.

The spokeswoman said in an interview with Reuters that the scale-up of the supply chain for raw materials used in the production of the COVID-19 vaccine had taken “longer than expected” and “played a role” in the enterprise’s decision to reduce the 2020 production target. She also added that the later-than-expected results from a clinical trial also impacted the decision.

www.europeanpharmaceuticalreview.com/news/135830/supply-chain-challenges-cause-pfizers-covid-19-vaccine-production-target-to-be-slashed/