German biologist Jürgen O. Kirchner recently made headlines, including here on the Daily Sceptic, for having submitted five German batches of the BioNTech-Pfizer vaccine for analysis and discovering massive levels of DNA contamination. Kirchner already raised the alarm about the risk of DNA contamination of the vaccine last year in his book Die mRNA Maschine (The mRNA Machine), which he published under the pen-name David O. Fischer.
The German regulatory agency, the Paul Ehrlich Institute, has played a key role in the regulatory history of the BioNTech-Pfizer vaccine, being the first agency to approve a phase 1 clinical trial of the product and still serving as the official control authority for batch release of the vaccine not only in Germany but throughout the European Union.
In the below translated excerpt from his book, Jürgen O. Kirchner shows that the Paul Ehrlich Institute narrowly focused on the mRNA ‘platform’ as the way-out of the COVID-19 pandemic within just weeks of the first reported case in Germany and then, shortly thereafter, focused even more narrowly on the German company BioNTech’s mRNA vaccine. Asking why it did so when other proven and non-genetic options were available, Kirchner suggests that the answer may lie in Germany’s economically-motivated aspirations to become the ‘vaccine hub of the world’.
Day 1 of the Corona pandemic in Germany was January 27th 2020. This was the day on which the first COVID-19 case was reported. Just three months later, on April 27th 2020, the Science Media Centre Germany held an event for the press on mRNA vaccines entitled ‘RNA vaccines: The fastest route to vaccine protection against SARS-CoV-2?’ This was likely the starting shot signalling German media to pay particular attention to mRNA vaccines, since the mRNA vaccine of BioNTech was presented as virtually the ideal solution to the Corona problem at the event.
The Science Media Centre is a project of the Klaus Tschira Foundation and prepares topical information for science journalists. The invited experts were Uğur Şahin, the CEO of the mRNA vaccine manufacturer BioNTech, Klaus Cichutek, the President of the Paul Ehrlich Institute – the German regulatory agency – and Mariola Fotin-Mleczek, head of the Epidemiology Department of the Helmholtz Centre for Infection Research.
On March 6th 2020, the Science Media Centre had already held a prior event for the press on the subject ‘A vaccine against the novel coronavirus: What hurdles still need to be gotten over?’ One could have expected that all relevant options for vaccines against COVID-19 would be compared and discussed here. But this did not come to pass. Instead, the President of the Paul Ehrlich Institute, Klaus Cichutek already stressed at this early date that gene-based vaccines were the great hopes for developing vaccines against SARS-CoV-2: “We also hope that certain platforms like DNA, RNA platforms, maybe also vector platforms in a certain way, are particularly well-suited to being reoriented now.” And he continued: “Yes, so the question is: What time savings could be achieved thanks to a universal vaccine platform? …The time savings thanks to a vaccine platform which has been authorised in general would of course be enormous.”
The remarks are astonishing, since there were already vaccine platforms which were very successful. The gene-free approaches, which reliably trigger a human immune response based on inactivated viruses or protein vaccines using recombinant pathogen proteins are particularly worthy of mention. Both approaches have been used for decades against the flu and hepatitis B, for example, and were recently also quickly and very successfully adapted to SARS-CoV-2 in other parts of the world.
Germany, however, focused on the mRNA-based genetic vaccine of BioNTech. In this spirit, at the March 6th 2020 Science Media Centre event, Klaus Cichutek said:
But if we now further define this in terms of the RNA platform for vaccines. If we really managed to pull an RNA-based vaccine product against SARS-CoV-2 through to authorisation, with the required care, sensibly collecting and also testing the data, then we have a good basis for this platform, and this would be precisely the RNA [platform] with the related lipophilic or liposomal nanoparticles, which could be the basis for the next vaccine using a different virus antigen gene.
Klaus Cichutek’s verbal contributions to the Science Media Centre events make clear that the Paul Ehrlich Institute and its President were largely responsible, already very early on, for the German focus on gene-based vaccines.
But there is a crucial catch to talk of an authorised vaccine platform. Klaus Cichutek had this to say about it: “We always talk about the authorisation of a particular vaccine product.” In practice, this means that the active substance is only one of a whole series of components which are covered by the authorisation. These include all the excipients and even the packaging and the package insert. Regardless of the underlying approach or what is referred to as the vaccine platform, every new vaccine has thus to be authorised as an independent medicinal product. And this is always done on the precondition of new clinical studies or at least comparative animal studies. The applicable legislation does not provide for a ‘platform authorisation’ and there cannot be such an authorisation, since it would mean that changes had to be accepted by regulators without independent testing of their influence on efficacy and safety. The law does not allow this for good reason.
If the change in a vaccine is a matter of replacing the original pathogen with a newer mutation, this, however, can happen relatively quickly. This is the case for flu vaccines almost every year. But the example of flu vaccines shows in turn that the proven gene-free types of vaccines already have the desired flexibility. The Paul Ehrlich Institute knows these relationships better than any other institution in Germany. The Paul Ehrlich Institute even has its own ‘Product Development Unit’, which assists pharmaceutical companies in developing vaccines and setting up production facilities. But services of this kind can only be provided if there is profound knowhow. The latter, however, can only relate to experience with proven vaccines, including vaccines based on inactivated viruses or recombinant proteins, but not to such new approaches as mRNA vaccines for mass vaccination, since there had hardly been any experience with these – and even less for public agencies which were not themselves involved in developing the products.