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.