Tag Archives: BioNTech

January 30, 2021 · 21:26

When is a contract not one?

Yes, I have been bitching over the last few days in regard to the sales contract that the EU was crying about, and we all understand that at times things are a bit more complex than we think it is. We all get that (me too), yet what happens when we start comparing notes?

So the larger stage started yesterday with ‘The lever for the nipple for the trigger’, the story gave us a larger situation, a situation most of the media was shallow about, so as we went from the Reuters story (at https://www.reuters.com/article/us-health-coronavirus-vaccines-needles/analysis-russian-roulette-in-europe-as-needle-shortages-hamper-covid-19-shots-idUSKBN29Y10C) we ended up at the BBC where we see ‘EU-AstraZeneca disputed vaccine contract made public’. That story (at https://www.bbc.com/news/world-europe-55852698), well actually it does not, it makes matters worse. It starts with “Transparency and accountability are important to help build the trust of European citizens and to make sure that they can rely on the effectiveness and safety of the vaccines purchased at the EU level”, just after we were given “pharmaceutical company AstraZeneca has agreed to publish the redacted contract”, yes in the EU transparency and redaction go hand in hand, in some places it is known as filtered content (see the media).

Vaccines__contract_between_European_Commission_and_AstraZeneca_now_publishedDownload

So when we have a look at the file above, we see “Through the contract, all Member States are able to purchase 300 million doses of the AstraZeneca vaccine, with an option for a further 100 million doses”, I do not see this as a contract, it is an excuse and a poor one at that. In this, consider what you see here and then consider the Reuters quote that I used yesterday “So when we see ““accordance with locally approved labelling,” Pfizer said after the EU drugs regulator’s decision to shift to a six-dose label”, yet the question in my mind was “who, what, when, where, how and why was the setting of the change to a 6 dose label?”” I see this as the EU orders doses, after which an EU regulator allows the SAME VIAL to be used for 6 doses and then there is suddenly a syringe shortage, is anyone in the stage where the EU people are getting shafted by some EU regulators who seem to require their heads to be screwed on right?

Yet the EU get charged for the vial, regardless whether this gives the health care worker, 5 or 6 shots. An optional 16% wasted right off the bat. For a transparent organisation they are way too incompetent, in addition, I wonder if we see who pays for the new syringes, I am certain it will not be AstraZeneca, or darn, the article gives us that too. It gives us “BioNTech says it has procured 50 million needles that it can sell at cost to countries around the world, and is seeking to buy more”, so whilst a lot will be staring at the ‘at cost’, we seemingly forget that it was an extra expense, one that was not needed if the idiot EU regulator, would not have allowed for the label change from 5 doses to 6 doses on that same vial, my soft request is that this EU regulator is to get a dishonourable discharge dated to the day he allowed for that stupidity. At cost or not, BioNTech is making a killing on needles at present, because we might think it is at cost, it will come with a great tax option for them, and it is not that the EU do not need taxpayers, do they?

So whilst some are facing the call of coordination, we are (read: need to be) considering the impact of “In Germany, vaccine distribution is handled by the central government but its 16 federal states are responsible for obtaining the needles and syringes needed to inject them – with mixed results”, and that is merely one nation, set this to factor 26 and you see part of the mess the EU faces and in all this, how far will 50,000,000 needles get them and the rest, is that at cost as well or is that the surprise of the week? Are you still wondering why that EU regulator needs to be fired without benefits? I think the people in the EU have had enough of the gravy train, as this is going to cost lives, the people will catch on and demand the rolling of heads in the EU commissions, are you with me on this one?

Should you doubt me  consider the final quote “Saxony, on the Czech border, is also having to shop around as scarce supply forces up prices, said Lars Werthmann, regional head of vaccine logistics at the German Red Cross”, consider the earlier statement ‘at cost’ and now we see ‘scarce supply forces up prices’, so are the 50 million syringes used already? The EU is a fill your pockets organisation and that is also why I wanted the UK to leave the EU, the EU will not police itself or allow any policing of the gravy train and that is why I am happy that the UK left, the EU will learn that the cost of non-policing will come at a cost, I merely wonder if they can afford it, I think no, but in that I could be wrong.

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January 30, 2021 · 00:17

The lever for the nipple for the trigger

It is a setting that made me giggle, I had not heard this for decades, I reckon the last time I heard it was in the 70’s, the full phrase was “the lever for the nipple for the trigger that sets the button is out of stock”, a stage that we see in a complex environment where all the eyes are fixated on the engine, and everyone forgot about the control panel that activates the engine. That was the sentiment when I was confronted with ‘“Russian roulette” in Europe as needle shortages hamper COVID-19 shots’. The article (at https://www.reuters.com/article/us-health-coronavirus-vaccines-needles/analysis-russian-roulette-in-europe-as-needle-shortages-hamper-covid-19-shots-idUSKBN29Y10C) gives us “Laurent Fignon, a geriatric doctor in the south of France, is having to improvise as he gives shots of the COVID-19 vaccine from Pfizer and BioNTech to care home residents and health staff because supplies of the right needles and syringes are short”, a stage where everyone sees the need of the vaccine and there is seemingly a national stage (all over Europe) a stage Reuters warned us about a week earlier with ‘EU scrambles for syringes to avoid wasting Pfizer vaccines and extra cost’ yet a lot of people have not caught on, as people scrambled to get their share of 3,000,000,000 vials. Exactly by whom and where do we see the order of a similar amount of syringes?
So when we see ““accordance with locally approved labelling,” Pfizer said after the EU drugs regulator’s decision to shift to a six-dose label”, yet the question in my mind was “who, what, when, where, how and why was the setting of the change to a 6 dose label?” An important setting as we are faced with an seemingly speculated option that the people got shafted for 16% of all vaccines, especially when we consider the quote “It was initially sold in the EU in vials meant to deliver five doses, but a global shortage of shots and a viability assessment on dosage convinced the EU drugs regulator to approve on Jan. 8 the extraction of six doses from the same vials”, so which yahoo was the ‘EU drugs regulator’ approving this part? That person might have valid reasoning, but when I look back at the times when a 60 people life-raft held 61 people, that one person to stay alive basically condemned the other 60 to death, but the people tend to overlook that part too easily. And as we get to “The decision increased availability, prompting Pfizer to raise its output targets for this year to 2 billion vaccines from 1.3 billion initially envisaged”, so who is looking into the 16% shift to account towards the 60% shortage of doses, or is the 16% step a way to hide the fact that matters were much worse? I am merely asking, because either way shows that I have been right since mid 2020, and is it not interesting that it took the media this long to catch on (which is not their fault in this case, mind you)? 

So when we see everyone shout for vaccines and we are confronted with “Similar shortages are cropping up elsewhere in Europe, complicating a stuttering start to vaccination efforts”, we need to take a look at their syringe orders as well. So when we see “Pfizer now forecasts it will produce 2 billion doses this year, but this assumes it will be possible to extract the full six from each vial. It charges by the dose, meaning the cost of a vial has gone up 20%” we now get to the question “was the vial created to set 6 doses? As such was it bigger, if not, and we give the people merely 96% of the dose, does it still work properly? More important, when you realise that getting 100% out of a vial is almost impossible, just like the 61st passenger on a lifeboat, how many will be endangered by this? Should the danger be 0% (which is always possible) then why are several EU members making such a ruckus on this? Is it to hide the possibility that they forgot to order the syringes?

And as Reuters gives us “The European Commission is pressing Pfizer and German partner BioNTech to deliver more of the low-dead-space needles to extract the extra dose” we get to the heart of the matter. A mere approach to flim-flam the numbers and how many needles were ordered and more important when were they ordered? Yet in all this, looking at numerous sources, we see a lack of explanation where we get ‘meaning the cost of a vial has gone up 20%’, is that merely the needle? I don’t think so, the numbers are debatable and no one is looking, nw I will be the first to admit that this is not my field of expertise, and optionally it was a Reuters interpretation of the facts (which is optionally not wrong), and it could have been handed to Reuters in this way, but the lack of questions on all this is staggering. 

You see, the first in a whole range of questions is seen with “For buyers of the vaccine, however, there was a drawback because EU states face the prospect of paying the price of six doses for each vial, regardless of their ability to extract a sixth shot”, from my point of view I would grasp back to the original sales contract in three cases already the stage was set to emotion, all whilst we are facing the raw sales deal and EU politicians seem to rely on emotion rather than the contract that was drawn up, I wonder why.

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October 31, 2020 · 21:37

As jobs become available

Yup, there is always good news if we know where to look, even as we see a setting where over 50% of all coronavirus cases are in the USA, India and Brazil, we need to think hard of what numbers are not shown. Even as India has well over 3 times the population of the US, there is no way that the numbers add up, with the US having over 9 million cases and India barely passing 8 million, the stage is not completely seen. The population pressure and environment should give India a lot more than the US, so the stage is not clearly seen. I have less doubts (but some) with Brazil, there are over 5 million there and that number seems off (I am emphasising on seems), when we consider the 211 million people there, the pressures in Rio and Sao Paolo, the number seems low, more important, the mortality rate on Brazil merely seems high, in my personal view, either there are a lot more cases, or the mortality rate is skewed, optionally from connected complications. So as more people die, more jobs open up (one would hope). In this stage we could say that every silver lining is the foundation for a new dark cloud.

These numbers are important, especially as the EU goes into a new lockdown. There is the larger issue. We see Spain and France being at 1.2 and 1.3 million. Nothing wrong with that, but a similar setting of populations is seen in Germany with only 510K sick, these numbers do not add up, especially hen you consider that Germany has 83 million, France has 65 million and Spain has 46 million. The German numbers are as I see them off. This matters, because if the numbers are too surreal, the lockdown will merely be a pro forma exercise that does close to nothing in too many places. The problem is that I can see that these lockdowns are the best we can get until there is an actual vaccine, and there is not date on that. One source gives us “On Tuesday, front-runner Pfizer revealed in an earnings call that the first interim analysis in its Phase 3 clinical trial has not yet occurred. That means there hadn’t yet been enough Covid infections among the trial participants to take a first stab at analysing whether the people randomly assigned to receive vaccine were infected at a lower rate than people who were assigned to get a placebo injection”, so consider that phase three is not done and this needs to come and be confirmed before we have a setting where manufacturing can begin. And it is even earlier ‘the first interim analysis in its Phase 3 clinical trial has not yet occurred’, that implies that we get to a stage where any solution would not be here before January 2021, and that is if the second analyses of clinical trials those who precede towards ‘a vaccine is working’ is well over 8 weeks away, making the earliest stage of manufacturing would start on January 2nd, if a solution if found by coming Monday. Are you feeling frisky yet? And all this before the realisation starts that 2 billion doses will take more than a few days. I got (from Vaccine Europe) “On average, it takes between 12-36 months to manufacture a vaccine before it is ready for distribution” and on top of that Sanofi is one source stating that they can make 2.5 million doses a day. This gets us to the 2 billion shots, taking 800 days to make and that is if everything goes right the first time. So there will be a waiting list that is well over 2 years and that is WHEN a vaccine is a reality. Now consider it takes another 12 months before a vaccine is a reality, implying that Covid-19 will be around until January 2024 at the very least. At what stage will we learn that masks are a good idea, and I am happy to set the stage that lockdowns are some proof, but what proof remains the issue, do you still think those Swedes were nuts? 

And in this, consider the news that CNBC gave us in June ‘AstraZeneca is aiming to produce 2 billion doses of a coronavirus vaccine — and it could be ready by September’, do you still think that I was crazy saying that the media is a much larger cause of all the fake news we get?

I am not stating that I know when there is a solution, I am not proclaiming that I have all the answers, yet the numbers are clear and they tell a few stories, and in all those stories we see that some of the reflections offered to us are incorrect, incomplete and dazzled with issues. On the upside, my 5G IP has benefits under Covid (and lockdowns) but they were not designed as such, it is merely an upside to it all. And when we look on, we might see the corporate needs, but they are merely in it to keep their heads above water, and I do not begrudge them that, but a lot of the actions are made on incomplete views and more incomplete data, that much is certain. 

I get it when some state that there is an overreaction, yet some setting (like face masks) are never a bad idea, it makes sense that some lockdown measures are essential, yet how will that ever work in Mumbai, which is 4% the size of Sydney, but has close to 300% of the population, and people under why I doubt the Indian numbers? They test 500 a day, even as they had until recently 100,000 new cases a day. That it’s why the numbers make no sense. And this is merely getting worse, as economic barriers collapse, the setting will continue to degrade. I believe that India is in a much worse state, but that does not absolve Europe (or the US), this will get worse and those governing will be seeing the inside of courts, defending the stage, the setting and their actions. The media (even those with ludicrous headlines) they all want their digital media coin, so they will rely on hardline after headline and it will be about creating flames, not information. That is how I see it and feel free to disagree.

And as November is a mere 2 hours away, consider the time line I gave. Then consider the headline that the Guardian relied on yesterday ‘‘It’s possible’: the race to approve a Covid vaccine by Christmas’, unless the vaccine is properly tested by Friday, that deadline cannot be kept. So when you see “Kate Bingham, who heads the UK’s vaccine taskforce, said the UK was in “a very good place”. But there are still hurdles to clear in the coming weeks” (at https://www.theguardian.com/world/2020/oct/30/its-possible-the-race-to-approve-a-covid-vaccine-by-christmas), and when we see “It could be Oxford University, partnered with drug company AstraZeneca. It could be Moderna in the US. Or it could be Pfizer and the German company BioNTech. All three have either recruited the last of the tens of thousands of volunteers they need for the critical final trials or will shortly do so”, in this I merely wonder whose trumpet she is blowing. I am not blaming her or the three, they have a hard job, yet unrealistic time lines are hard on us and they are facilitating for those trying to manage bad news and that is not right, not in this case (well, most often not in any case).

So if you are hoping or relying on a vaccine, think again. The numbers do not add up, on several sides and the media is not asking questions, so I am.

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