Tag Archives: AstraZeneca

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government decided to take a jump into the unknown by extending that gap to 3 months, based on both guesswork and some unpublished data.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.

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.