In an earlier article, I pointed to the cozy relationship between BioNTech, the actual owner and legal manufacturer of what is more commonly known as the ‘Pfizer’ COVID-19 vaccine, and the German vaccines and medicines regulator, the Paul Ehrlich Institute or PEI for short. It was the PEI which authorised the first clinical trial of BioNTech’s COVID-19 vaccine, allowing the German company to abridge or even skip preclinical safety testing which would ordinarily have been a precondition for the latter.
Such behaviour suggests that the PEI acted more as enabler than regulator of BioNTech, and these suspicions are certainly not allayed by German Minister of Health Karl Lauterbach cheerfully tweeting a picture of himself and PEI president Klaus Cichutek “in the room in which the efficacy of the BioNTech vaccine is tested”, adding: “Without the PEI, vaccines would have been authorised much later… Thank you PEI!”
Cichutek, as discussed in my previous article, has coauthored a paper on developing a coronavirus vaccine with none other than BioNTech CEO Ugur Sahin, and he is also the “product development coordinator” of the German Centre for Infection Research, which has conducted research in partnership with BioNTech on “RNA-based vaccines for selected virus families”.
But even if Cichutek and German authorities more generally may have been tempted to exploit the COVID-19 pandemic to promote a German firm and help to realise the dream of a ‘vaccine hub Germany’, as suggested by Jürgen O. Kirchner here, surely there would have been checks-and-balances at the EU level to put a stop to any such machinations. Even if, blinded by German mercantile interests, the PEI had lost sight of its role as regulator, the European Medicines Agency (EMA), which would ultimately be responsible for authorising the BioNTech vaccine, could surely be relied on to put the health and safety of Europeans first.
Well, maybe not. Thus in a February interview with the German Medicines Manufacturers’ Association (BAH), none other than PEI president Klaus Cichutek unabashedly declared: “We are the EMA.” Without having even been asked about the PEI’s relationship to the EMA, Cichutek offered:
We have, so to say, been playing the leading role for vaccines and medicines in the regulatory process coordinated by the EMA office for at least a decade. This is why I like to say: we are the EMA, since we’re doing the scientific work there.
If the PEI plays the leading role in the EMA – if it “is” the EMA, as Cichutek “likes to say” – then this means that the German regulator has not only been largely responsible for the authorisation of the BioNTech-Pfizer vaccine in the entire European Union, but also, incidentally, in the United Kingdom. For the U.K. authorisation, as the relevant MHRA documents duly note, depended on the EU decision under what is known as European Commission Decision Reliance Procedure. (See here, for instance, page 3 for the original conditional authorisation or here, page 2, for a more recent fully authorised version of the drug.)
Translations from the German by the author. Hat-tip: Seven of Nine, MD.
Robert Kogon is the pen name of a widely-published journalist covering European affairs. Subscribe to his Substack and follow him on X.
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All the regulators have become enablers. Where there was a gate and a drawbridge, there’s now an open road. Produce some highly toxic poison, claim it’s a medicine (having had limited trials) and jab the population with resulting carnage depending on batch. I am looking forward to the day when we can see all these people, like Lauterbach, in the dock. I just don’t get how he can be so obtuse and not see the alternative narrative one little bit. Is he mentally deficient, unable to think or see clearly, because he is surrounded by people like him who can’t see or think, or is he genuinely evil? It’s a question that I can apply to many others.
A question my Mum used to ask when particularly annoyed with me for ignoring her instructions: ‘Are you deaf, daft or stupid?’
Following orders, in all likeliness.
Independent review or corrupt? Take your pick. I take the latter, and it seems to me that their attitude to the concept of “safe” or “efficacy” is a bit weird compared to many other industries involved in either manufacture or the provision of products/services of non-pharmaceutical output.
A related publication: “Safe and effective” – anybody seen a poster or two with that slogan on in recent years? https://www.youtube.com/watch?v=gdeYzaTZsOA&list=WL&index=7 is a copy of a speech in the House of Commons by Ester McVey, and related commentary, by John Campbell.
Every country in the world authorised the jabs.
So clearly there is a unofficial authority above the PEI that is the actual “regulator”.
The EMA, PEI, MHRA, are just layers of shit covering up where actual power resides. Not very well, it must be said.
Didn’t they all pretty much rely on the FDA, which in turn relied on pfisser’s garbage data?
What this really shows is why centralisation is so bad. In a not that distant past, countries like the UK, NL and Germany would have done their own research, their own due diligence and most likely would never have passed this garbage. By having a ‘higher authority’ to carry the load, they can all sign off on something and when tshtf, they can all blame the higher authority, which in turn says everyone had their own individual choice and responsibility – exactly how the EU works as a whole.
Good to see open acknowledgment of the PEI’s negligence – this garbage should never have been signed off and the PEI is openly admitting it expedited. Was it the PEI that said keep stabbing, even after the EMA expressed doubts about 4 shots of this garbage and such trivial things as immune exhaustion?
I’m pretty sure the FDA is just another layer of shit acting on orders.
https://www.conservativewoman.co.uk/how-uk-government-advisers-helped-pfizer-win-5-95billion-us-covid-contract-part-3/
Jane, this puts a slightly different slant on things.
Paula Jardine at TCW yesterday.
Both the FDA and the MHRA are owned by big pharma. My point was that as long as one entity can point to x number of others and say they were all doing it too, this deflects attention from ‘why’ they were doing it too, where were the safeguards. Far too many people believe that if all of them were doing it, it had to be the right thing to do. Just as far too many people still believe that if the vaxx were truly that dangerous it would have been withdrawn – they hear the stories, they have a sense of unease, hardly anyone is taking this poison – even here in NL, where the most recent one was only offered to those over 60, I think the uptake in that group has been around 10%, compared to 92% before. They just don’t want to believe everyone involved has been corrupt, criminal or negligent.
What I find far more interesting now is why was pfisser being pushed so hard? It wasn’t just because of the mrna tech, as moderna has it too, but moderna was pretty much sidelined. If I’m not mistaken, moderna doesn’t contain SV40 fragments…
It depends on how optimistic, or maybe gullible, one is. There have been a few well known dodgy drugs that were authorised for use in the UK well before the EU came to life, e.g. At least one of them was invented by a German firm as well – Distaval (Thalidomide).
Yes, of course. I wasn’t meaning to say they would always function properly, but I think we’d have seen less ‘lockstep’ approval of the vaxx.
Thalidomide being a case in point, which the FDA refused to approve for use on the US market, back in the day.
At least when one national agency has to account for their decision, it is more difficult to point to another agency and say ‘he made me do it’, which is what they will all be doing now.
NL never wavered in its position that children were not at risk – no face rags on children under 12, from the outset children under 12 were encouraged to play together, engage in sports, etc., no group size restrictions. I was surprised when the vaxx was accepted for use in under-12s – but the same week they were going to start stabbing kiddies, the health authority stated that as Omicron was so mild, parents should think about whether they believed their kids needed to get the vaxx. That is the Dutch way of saying ‘don’t do it’ without openly disagreeing with the political authorities that pushed this on them. I don’t think the Dutch health authority would have approved the vaxx for kids under 12 of its own accord, just as I don’t think they would have advised it to be given to anyone other than those over 65, the vulnerable and health care workers had they not been put under pressure to do so. I’m not excusing it, I’ve said before the head of the public health authority should have made a big song and dance of stepping down. Too late, they are now throwing him under the bus.
I think Distaval was the UK brand name for thalidomide, sold by the Distillers Company, licensed by the German manufacturer Chemie Grunenthal
Have we forgotten about Operation Warp Speed again? The tail never wags the dog and no German minister of anything will do something with international consequences unless authorized or even ordered by the higher-ups. Lauterbach is a guy who got degrees in medicine¹ and – that’s much more important – health management and policy from two different US universities and then, came back to Germany and talked himself into his current position by relentless COVID-fearmongering on German state TV.
Almost needless to say, he’s also a climate change activist and has written a book about the upcoming catastrophe if not … !
¹ This strongly suggests that his school grades weren’t good enough to study medicine at a German university and that the family sent him overseas to a location where admissions could be bought instead.