Category Archives: COVID

Only one cheer for AstraZeneca

It’s becoming clear that the AstraZeneca (AZ) vaccine is second rate in comparison with certain other technologies, and in particular the Pfizer/BioNTech version. A recent peer reviewed study has shown that the Pfizer version has shown 94% effectiveness.

AZ were on the back foot from the outset, because the medical trials showed only a 62% effectiveness for their vaccine. Whereas the Pfizer vaccine is ineffective in 6 out of every hundred injected, 38 people taking the AZ vaccine will be at risk – more than 6 times as many.

Even this inferior performance was based on a second jab about 4 weeks after the first; but the UK government decided to take a jump into the unknown by extending that gap to 3 months, based on both guesswork and some unpublished data. This was, as the US regulator disbelievingly noted, ‘making it up as they went along’. Pfizer were alarmed enough to issue a statement to say they had no data to determine whether that strategy would be effective or not. Clearly the government believed it knew better than the vaccine’s inventors ; now there’s confidence for you.

The UK approach was based on a (valid) statistical reasoning that by extending the second dose period, more people would be vaccinated because of the limited supplied of vaccine. This was fine for the overall numbers, but the effect at an individual level was not potentially negative and not possible to assess.

These uncertainties were further compounded from the get go because AstraZeneca did not include any meaningful tests of the most at risk cohort, being those over 70. In other words, there was no data to support it having any effect, merely opinions that what worked in the sprightly goose would also work on the geriatric gander.

It’s too early to tell whether the reductions in infections as at this time (25 Feb 21) have been achieved primarily because of the lock down, or because of the vaccination of the first groupings at risk. More will data emerge as the personal mixing restrictions are loosened as Q1/21 progresses.

Boris and Co have inevitably been talking up this mediocre second rate product and praising the UK’s “world beating” science and research capability. It’s all rather dismal. Grumpy drew a short straw and got the AstraZeneca jab (damn) but the bottom line is that this really is one of those situations where something really is better than nothing, especially when ‘nothing’ is a iron lung then a body bag.

Bizarre COVID logic

The German vaccine commission has rejected the AstraZeneca (AZ) vaccine for people over the age of 65, based on the lack of available data about its safety or efficacy. Both the UK and AZ PR machines creaked into action to refute the assertions. Their response, however, was opaque and misleading and designed to obfuscate the real issues identified by the Germans.

The PR lines of defence were twofold. In the first, there was an admission of the factual basis of the German interpretation by Mary Ramsay, the Head of Immunisations at Public Health England (PHE) said “There were too few cases in older people in the AstraZeneca trials to observe precise levels of protection in this group” – aka “we have no idea”- but that admission was inevitable since it was a matter of record. She then went on to say that “immune responses were very reassuring”.

The second line of defence was rather more bizarre. To quote one source “Their (Grumpy: the Germans) assessment is that effectiveness is not yet demonstrated for over 65s. They have not said the vaccine is ineffective for over 65s“. This is rather like saying that “we have no data on whether drinking drain cleaner will harm you, but in the absence of any information to the contrary we feel it is reasonable to recommend doing so to all pensioners.” This is a variation on the the Bernard Russel ‘Teapot’ analogy that “absence of evidence is not evidence of absence”

As an example of the above, MHRA Chief Executive Dr June Raine said current evidence does not suggest any lack of protection against Covid-19 in people aged 65 or over”, which since there is no convincing evidence falls into the logical ‘proving a negative” trap.

Both defence lines were also made opaque by firstly conflation designed to mislead. Ramsay, at PHE said “both AstraZeneca and Pfizer … provide high levels of protection” implying that the two could be equated in terms of effectiveness; in fact AZ was only 62% effective in the age groups they did test, against more than 90% for the Pfizer version. They are not even vaguely comparable, and of course they have no sound data on whether it is effective in the over 70’s.

The second aspect of opacity was to couch all defences in qualitative terms, rather than references to quantitative data – always the refuge of those seeking to mislead. This is especially the case where the UK Medical Regulator relied on unpublished data in its decision to grant AZ authorisation. What does ‘high levels of protection’ or ‘reassuring’ mean ? No-one knows. It’s a “hooray” word used by politicians or their lapdogs to support the otherwise unsupportable.

Grumpy pointed out this lack of data and irrational authorisation based upon it in a post here . He concluded that post by saying “Readers should be clear; taking this juice and reverting to normal living if you are a pensioner, is a risk which is, in Grumpy’s view, simply not worth taking.” He stands by that view.

A fiasco in the making

When plans go wrong, it may well be that some unforeseen change in circumstances negated the (at one point) valid assumptions and logical processes used to create those plans. It may well be that the inevitable post mortem on the coming vaccination fiasco – for such it will be – attributes the virus mutation to the disruption of previously sensible preparations.

However, every item of evidence points to this not being the case in the planning by the hapless Matt Hancock for the COVID vaccination schedule. On 30.12 the government’s own website was still stating that two vaccine doses would be given between 21 and 28 days apart. It was on the basis of the results of rigorous tests of that regimen that the UK regulator (MHRA) approved both the Pfizer and Oxford vaccines. Yet just one day later, Hancock and his co-conspirators slipped out that this accepted regimen was to be abandoned. It was done surreptitiously without announcing the rationale for this up front, and it was left to the press and others to tease out the reasons.

Essentially, after having made statements about the rate of vaccinations and the deliveries of doses, it became clear that the inventory was not there to support that rate, and hence the change to pushing back the second doses to ‘up to’ (a common politician get out phrase) 3 months after the first – and making this retrospective for those already vaccinated. They also changed guidance to include mixing vaccines for the first and second doses.

Chis Witty and his fellow national medical chiefs shredded whatever little professional integrity they had left by issuing a statement which included the words “the great majority of the initial protection from clinical disease is after the the first dose of vaccine”. The wording is subtle as an attempt to prevent this from being an outright lie, but it is unequivocally intended to deceive. It was promptly disputed by the inventor of the Pfizer vaccine, which said they the 21 day gap they specified was because “the data tells us that is the best way to do it”. They went further and refuted Whitty completely and said there was “no evidence that any protection was given 21 days after the first dose”. So Whitty and Hancock know better than the vaccine developers ?

Professor Adam Finn of Bristol University was one of several sundry ‘experts’ recruited in a PR exercise to avoid more flak, and directly contradicted the makers and said that people who got the first jab would have 91% protection, which would rise only marginally to 95% after the second – but Pfizer’s press release makes it clear that that have no data to support that with a 3 month gap. As the US regulator put it, the UK government had abandoned science and were making it up as they went along.

Grumpy’s main complaint about this is that on 30.12 when Hancock was receiving plaudits for the vaccine delivery, stating that the country would “be out of it by Spring”, and would be performing two million inoculations each week from January 4th, he already knew that the inventory was not there to deliver that (as he announced the next day). Worse, the ‘army of volunteers’ to perform the jabs was already evaporating because they did not have certificates for their fire safety and anti-radicalisation courses required by the government – beyond belief.

Hancock’s utterings, and those of the discredited Witty are not simply spin or sophistry – they are lies, plain and simple as he knew when he uttered them. Disgraceful, and no wonder faith in British politics by the populace continues to decline.

Footnote : Part of the government disinformation campaign has officials and politicians stating that the Oxford Vaccine is 70% effective – read the test results as Grumpy has done. This is not the case; it was found to be either 62% or 90% effective, depending on dosing protocols – there is no such thing as 70% for an individual. In fact, since a full dose regimen will be used, that first does will provide just a 3 in 5 chance of warding off COVID, with no data about the effect of the 3 month gap thereafter.

Also, Moderna and Pfizer have stated that “mRNA COVID-19 vaccines are not interchangeable with either each other or with other COVID 19 vaccine products. The safety and efficacy of a mixed product series have not been evaluated. Both doses should be completed with the same product” Yet the UK regulator has issued guidance that mixing vaccine types is permissible, prompting a virus expert at Cornell University to say that the “UK are now just trying to guess themselves out of a mess”

Oxford obfuscation<<< updated on 31.12.20

It is the view of Grumpy that there has been significant intervention by the government to subvert medical opinions in the interests of avoiding political embarrassment. In response to the decision to have a 3 month gap between the first and second doses, Pfizer have issued a statement, as follows

“Data from the phase 3 study demonstrated that, although partial protection from the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide the maximum protection against the disease, a vaccine efficacy of 95%. There are no data to demonstrate that protection after the first dose is sustained after 21 days”

In other words, Matt Hancock is ignoring data from the inventor of the Pfizer vaccine that underlines there is NO evidence that a 3 month gap will provide any protection for the majority of that period. as set out below, this is driven by the vaccine delivery schedule and the need for political points. This has all the makings of a future scandal.

(Initial post as follows) Matt Hancock announced this morning (30.12.20) that the Oxford vaccine had been approved for use in the UK. Seemingly good news, but it very soon became apparent that the implementation plan was almost wholly driven by political considerations rather than a well planned strategy to reduce COVID. Further, given vaccination is planned to start in January, their are many outstanding questions about more or less every aspect of its use.

Dosage : It is as yet unclear as to whether the dosage regime will be a half dose (‘LD’) followed by a full dose (‘SD), or whether it will be two full doses. This is of more than academic relevance, since the SD+SD regime is only about 60% effective, which is way, way worse (although cheaper – perhaps a factor) than the competing Pfizer and Moderna vaccine alternatives. The alternative LD+SD option was stated to be up to 90% effective, but as it was not tested on anyone over 55, whether it will work at all for the most vulnerable 60+ years cohort of the population is just not known, as admitted by all parties. (See http://grumpy.eastover.org.uk/oxford-vaccine/ )

Protocol : All the tests submitted as a basis for approval for the vaccine to the UK regulator, the MHRA, were based on two doses 28 days apart. It has now been decided that the doses will be separated by 3 months. Grumpy can find no evidence of whether this regime, plucked from mid air, is as effective or not. Note how the LD / SD variation had a huge impact on effectiveness, so it is baffling how the MHRA approved a plan which had simply no material testing evidence to support not only its efficacy, but whether it was safe or would even work as assumed – and it is assumption. Previous documentation on the dosing has stated (as late as the date of this entry) that “two doses of vaccine, four weeks apart, are needed to to offer best protection”; when did this change, and why? The answer lies, Grumpy believes, in the fact that the government’s own numbers on vaccine delivery schedules and the rate of vaccination simply do not add up, and this is a fudge to avoid Hancock embarrassment over yet another failure.

Numbers : Hancock spoke on the BBC Today program on 30.12 and stated that 1m vaccinations per week would be done from January 4th. This implies that by February 4th, 4m people will have been vaccinated. However, bulk deliveries of vaccine (40m doses) will not be available for 2-3 months (according to AstraZeneca), so these numbers simply don’t add up, as the first delivery of 4m units does not have sufficient doses. The inevitable fudge comes from the sudden change in plan to separate the doses by 3 months, thus doubling the number of first shots available. The delivery schedule had already slipped back by many weeks, so Grumpy thinks that pulling back from the 1m per week target is all but inevitable – testing/tracking all over again. The switch to a 3 month gap for no stated medical reason is thus driven entirely by political motives, and Hancock sought to bury this the fanfare resulting from approval.

Timing : Pascal Soriot, CEO of AstraZeneca, stated on the Today program on 30.12 that the Company could deliver “up to” 2m doses per week. The population of the UK is 67m, so (assuming the 2m doses included both first and second jabs) the population would be vaccinated at best by April 2022. Allowing for the 30m Pfizer doses ordered (but not yet fully delivered) , that would bring completion forward somewhat, with the caveat that neither company has a record of delivering on time. That timing is far short of Matt Hancock’s less than credible statement on Radio 4 ‘s Today program that the UK would be “out of this by the spring.” This is surely a statement he will come to regret, but as Grumpy has pointed out before he has a habit of offering unnecessary hostages to fortune. (See http://grumpy.eastover.org.uk/foot-shooting/ )

Europe : The EMA (EU regulator) has not approved the Oxford vaccine, stating that there is no basis for granting even a conditional licence. Are the standards less demanding in the UK ? Does the European regulator know something the UK regulator does not, or is discounting?

New mutation : As of 30.12, AstraZeneca informed Reuters that its Covid-19 vaccine is potentially effective against the new coronavirus variant, with studies underway to fully analyse the impact of the mutation. Studies underway ? They don’t know yet whether it will work on a variant pushing daily cases over 50,000 or not? Is this one more element of evidence pointing to the the UK regulator being premature, which raises the issue of government pressure and interference to get it approved ?

So, in summary, here are the questions to ask

  • Will the dosing regime be LD+SD or SD+SD ? This has a huge impact on how the individual should plan his/her lifestyle post vaccination
  • If the dosing is LD+SD, will more tests be done to confirm its effectiveness (or otherwise) before rolling it out to the 60+ cohort, or do the government plan to use the next batch of 70+ citizens as test mice?
  • Why was the gap between doses suddenly changed to 3 months, when all tests were done on 28 days ? Is there any quantitative evidence (certainly none is published) that this would be an effective protocol, or even work ?
  • How can the conflict between stated delivery schedules of Oxford vaccine and the claimed rate of vaccination be explained ?
  • Given the CEO of AstraZeneca’s statement on the ceiling on dose deliveries, how does the implied time to complete UK vaccination reconcile with Hancock’s optimism on being “out of it by the spring” (whatever that might mean) ?

Avoid the (ineffective) Oxford Vaccine

Anyone over the age of 70 should seek, if possible, to be vaccinated with the Pfizer or Moderna varieties of COVID vaccine. The Oxford vaccine essentially condemns anyone in that age group to continue to isolate from society at large for a significant time, unless they wish to adopt a ‘Russian roulette’ approach to a virus which kills 200 times as many of their cohort than its does citizens in their twenties.

As of the second week of December 2020 it is clear that the Oxford vaccine is significantly less effective than the alternatives. The drive to introduce it is hidden in words which appear in several of the utterances by its advocates, and they are ‘cost / benefit’. It’s cheap, and justifiably so since for oldies it is potentially not only inferior, it is inferior only on the basis of assumption and not fact. In the words of one industry reviewer “that from the interim analysis of these trials, we cannot yet infer efficacy in older adults, who are the group at greatest risk of severe COVID-19 outcomes.” In other words, on the potential eve of its introduction, the medical profession has no solid evidence to show it works with the very first targets they plan to vaccinate; the 70 – 80+ age group.

Read that again. The bottom line here is that for the 70+ cohort, the medics simply don’t know whether it will work or not, or if even if it does have an effect, whether that is for only 1 in 100 having the jab. With that knowledge, any sane and rational person will accept the jab as a gamble, but would continue to isolate for 2021, or until the incidence of COVID in the population at large has dropped to a comparatively insignificant level (probably 2022).

With standard vaccine dosing, the Oxford version was 62% effective as opposed to the 92% efficacy for the Pfizer vaccine. However, the testing regime did not include volunteers over the age of 55. Further, as a result of a mistake in dosages (not exactly encouraging confidence in the Oxford team) an alternative regimen was found to be much more effective (up to 90%). That sounds good, but peer reviewers of these results were highly critical, as there was no acceptable explanation for the difference, especially as it was a very small number of volunteers and could have been a fluke. The medics are saying “we have no idea why this works, if indeed it does” and this is not a reason for anyone to inject anything into ones body.

However, UK agencies responsible for licensing (and presumably under political pressure for better numbers) allowed the results of the two regimes to be averaged, resulting in a net apparent efficacy of around 70%. This time, some 500 older people had been included, but none over 70.

Think what this averaging means. If, in the extreme, half the volunteers had a vaccination dosage A which had 0% effect, and the other half vaccination dosage B which had 100% effect (i.e. one dud, one perfect) the ‘average’ efficacy would be 50%. However, there is no such thing as an ‘average’ dose in real life. In this example, it either works or it doesn’t. For an individual, it’s a spin of a coin as to whether you’re safe-ish, or could have been injected with water. Even at the stated efficacy the vaccine will have no effect at all on 2 out of every 5 people.

Readers should be clear; taking this juice and reverting to normal living if you are a pensioner, is a risk which is, in Grumpy’s view, simply not worth taking.

Academic and journalistic Harlots

COVID-19 has underlined that with any set of complex social or political problems there will be a range of views – often diametrically opposed in nature – about how to resolve them. Broadly speaking, COVID has seen a triumvirate of parties claiming they are the best equipped, most knowledgeable and objective to address the challenges, namely politicians, academics and journalists. There are some sideline players with less of a voice; the general populace, who generally express their view by doing whatever suits them anyway, and big business, which tends to work behind the scenes and in the Pall Mall clubs. This is further compounded in that the three groupings all tend to be divided anyway, without any consensus even in the members of their set.

They can’t all be right, so who should drive the bus? In Grumpy’s opinion, there is only one rational answer, although it does not inspire confidence; it has to be the elected party in the Executive. Of course the ruling party should take input from all sides, but It was interesting to note two opposing headlines in the Daily Mail this week in which Boris was accused of ‘giving in to the scientific advisers’ and simultaneously ‘not following the science’. Not much consensus there, then.

The key essential, for Grumpy, is that when decisions of such magnitude are taken, it is essential that they are made in full knowledge that bad decisions – failure – will be subject to sanctions. It focuses the mind if an error means the gallows, so to speak. The problem listening to – or worse, adopting the solutions of – academics or journalists is that if they get it wrong they just shrug and carry on with their research (academics) or swear they never proposed it (journalists). Just like the harlots cited by Stanley Baldwin in 1931 (but selling brains rather than body) they are free from responsibility for any actions taken at the behest of their proposals.

The ideas of business can largely be disregarded as their criteria is solely about finance; merely looking back at the history of cigarette and drug industries shows that general social well being isn’t at the top of the list.

Professor Carl Heneghan, a perfectly respectable academic issued a lengthy document saying the government’s approach was wrong (in common with many others) and that he knew better. Grumpy view was that many of the proposals proposed were demonstrably not possible in any time frame needed for a solution. Grumpy also noted that all “men with answers” can’t resist veering off topic and picking on some favourite axe to grind at the same time (women’s rights / education / the NHS / TfL / BAME etc). In Heneghan’s case he repeated again the old trope about waiting a century for men and women to be paid equally. He is knowledgeable enough to know that for 50 years since the Equal Pay Act of 1970 and the subsequent Equality Act of 2010 it has been illegal to pay women differently for the same job. He thus wilfully deliberately conflates this with the gender pay gap (an entirely different issue) , which is pure and deliberate sophistry; this rather detracts from paying serious attention to any of the other points he made.

Sarah Whine

Grumpy scans the Daily Mail to catch up on vital news the paper is so focussed on (what the Kardashians are doing ?) and speed reads Sarah Vine’s column therein from time to time. In spite of having chosen to marry Michael Grove, Sarah Vine is presumably a rational and educated individual.

Grumpy’s irritation at her article on 11.10.20 has catalysed to him to comment thereupon. Given the nature of her job, filling a page with something as mundane as facts or rational analysis would be too dry; thus she (albeit in common with other commentators) needs to seek to dress content up with misguided opinions, hyperbole, barbs and lavish criticism of more or less anybody.

The piece in question is a carping, whining narrative about fundamental freedoms being violated by procedures introduced to contain COVID. Amongst a list of illogical examples she exhibited particular faux outrage at being asked for contact details when entering a cafe, followed by a bizarre extension to pose a rhetorical question on whether permission would be required to urinate in future. (Unlikely, Sarah).

VIne has presumably heard of and understands what a “notifiable disease” is. COVID-19 is on the statutory list of same, along with smallpox, plague, rabies and TB. It is there for a reason, as a highly contagious and lethal virus contracted by (at the time of writing) 590,844 UK citizens, of which 9.7% have died. Mortality is highly skewed by age, and 200 times more of those infected of Grumpy’s age die than the drunks ignoring the law so prominently routinely depicted in the Daily Mail.

Sarah Whine is arguing for the ‘freedom’ to kill vulnerable people she comes into contact with should she be be COVID positive. Stupid, lightweight, bigoted and self-obsessed don’t even start to describe the woman.

Why whinge now ? For over 130 years there has been legislation and mechanisms in place for the notification of incidences of such diseases and procedures (such as contact tracing and even forced detention) for their containment. VIne is presumably aware of this and her comments are simply trying to be ‘clever’ in a supercilious manner rather than to contribute any intellectual input to the challenges that face the country. It is writers like her that encourage the less well informed to pack bars and ignore the legal restrictions set out to protect them, and more importantly, their elders who they will infect and possibly kill.

There is a twofold irony here. Firstly, in 2001 hubby Michael Gove contracted H1N1 (responsible for the 1918 pandemic), possibly from some idiot journalist sitting next to him in a cafe.

Secondly, maybe she should speak to her husband about these procedures – he is the Government Minister in charge of what …. COVID Operations.

Delusional Sadiq Khan’t

Boris Johnson’s attempt to ease lockdown is confusing, opaque, and above all, contradictory; but nowhere more than for London. However, his efforts to perplex people have been totally eclipsed by the irrationality and logical contradictions in the response by the wholly inadequate Mayor of London, Sadiq Khan.

In summary, BoJo urged people to return to work where possible as part of the easing of COVID restrictions, but to avoid public transport in so doing. The reason for this last restriction was simply because social distancing is obviously impossible for London commutes at the best of times, but on the highly reduced current train, tube and bus services even more so. What he didn’t explain is how this would work for the 750,000 workers who normally commute daily into Central London by train. So Bojo’s edict is is fine for commuters in Cumnor, Oxfordshire (pop 5,700), but patently impossible for London.

Numbers first. Taking Government figures, the average London commute is over 70 minutes. In normal times, around 750,000 to 800,000 passengers arrive in the morning peak in the London Terminal stations, to then filter through to their place of work. The fact that they have arrived by train surely indicates that these citizens did not live within walking or cycling distance – in fact, the same Government figures show the average London commuter journey to be 13 miles each way.

Now to Sadiq, with ultimate responsibility for commuter infrastructure in London. On 15/05/20, he stated in a tweet “Londoners will not be able to use TfL in anywhere near the same numbers for the foreseeable future. That’s why we’re finding new ways for people to cycle and walk, including creating one of the largest car-free areas in any capital in the world.” His fascination with cycling probably results from rendering TfL to be near bankruptcy as a result of a £2 billion hit from his freezing fares for the last 4 years. His approach is exemplified by his recent extortion of a further £1.5 billion from the taxpayer to fund his unworkable transport schemes.

Ok, so perhaps those returning to work could drive into town ? Well, first of all, the Congestion Charge is to be hiked to £15 per day, just to deter those contemplating not walking or cycling the average 13 miles into work. However, to underscore this, Sadiq is to ban cars from those very areas where commuters are most likely to be bound for. However , (polluting diesel) buses will be allowed in the car free zones, but of course not many of them. (“not … anywhere near the same numbers”)

None of this is remotely coherent, and the statements by both BoJo and Khan (who probably lives with ambling distance of City Hall in some grace and favour pad) are conflicting at best and downright meaningless in their implausibility of implementation.

Assume that 40% of those isolating who work in central London go back to work, just how do either of these blustering, sound bite driven, con men expect some maybe 400,000 commuters to get to work? Having largely eradicated the possibility of car, tube, or bus, it seems that walking or cycling 13 miles to work every day apparently remains the only option offered for the significant majority.

How Sadiq Khan’t imagines, even in his wildest fantasies, a few hundred thousand commuters at average distances can really cycle or walk (4.3 hours each way for the average commuter) into the city? He is either delusional or incapable of understanding commuter demographics – the man is, simply put, not up to the job.

BoJo recently had a near death physical experience at the hands of a virus. When these two inept politicians are eventually (as they will be) put to the popular vote, they may well expect political eradication at the hands of rational voters tired of their inability to convert a punchy strap line into workable and coherent strategies.