Tag Archives: Vaccination

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) ?