• Login
  • Register
The Daily Sceptic
No Result
View All Result
  • Articles
  • About
  • Archive
    • ARCHIVE
    • NEWS ROUND-UPS
  • Podcasts
  • Newsletter
  • Premium
  • Donate
  • Log In
The Daily Sceptic
No Result
View All Result

German Regulator Prioritised Dream of ‘Vaccine Hub Germany’ Over Safety in COVID-19 Vaccine Development

by Dr Jürgen O. Kirchner
29 September 2023 7:00 AM

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’.

Robert Kogon


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.

So why, in this situation, was the Paul Ehrlich Institute’s knowledge of proven vaccines, such as those based on inactivated viruses or viral proteins, not used quickly to produce gene-free vaccines in Germany too?

The answer may lie in the economically-motivated dream of ‘Germany as vaccine hub for the world’, which was being dreamt by German politicians and institutions in the context of the Corona pandemic. (See, for instance, the February 25th 2021 article in the Wiener Zeitung titled ‘Corona Vaccine: How Germany Wants to Become Vaccine Hub’.)

After all, the future, as no one doubts anymore, will bring more pandemics and with them gigantic new markets. A German ‘vaccine hub’ cannot be achieved using proven vaccine approaches, however, because the pole position in this regard is already occupied by India, which as the ‘pharmacy of the world’ produces and markets 60% of all vaccines.

So, the German vaccine dream can only continue to be dreamed on the basis of a new patented vaccine approach. The approaches of the firms BioNTech and CureVac using mRNA technology thus form the basis for the ultimately economically-motivated dream of the ‘vaccine hub Germany’.

Excerpted and translated from David O. Fischer, Die mRNA Maschine ©Jürgen O. Kirchner. This excerpt may not be reproduced or reprinted without the express written consent of the author. Translated by Robert Kogon.

Tags: COVID-19GermanySafetyVaccine

Donate

We depend on your donations to keep this site going. Please give what you can.

Donate Today

Comment on this Article

You’ll need to set up an account to comment if you don’t already have one. We ask for a minimum donation of £5 if you'd like to make a comment or post in our Forums.

Sign Up
Previous Post

News Round-Up

Next Post

Britain is Leading the World in Committing Economic Suicide

Subscribe
Login
Notify of
Please log in to comment

To join in with the discussion please make a donation to The Daily Sceptic.

Profanity and abuse will be removed and may lead to a permanent ban.

14 Comments
Oldest
Newest Most Voted
Inline Feedbacks
View all comments

NEWSLETTER

View today’s newsletter

To receive our latest news in the form of a daily email, enter your details here:

DONATE

PODCAST

In Episode 35 of the Sceptic: Andrew Doyle on Labour’s Grooming Gang Shame, Andrew Orlowski on the India-UK Trade Deal and Canada’s Ignored Covid Vaccine Injuries

by Richard Eldred
9 May 2025
4

LISTED ARTICLES

  • Most Read
  • Most Commented
  • Editor’s Picks

Hugely Influential Covid Vaccine Study Claiming the Jabs Saved Millions of Lives Torn to Shreds in Medical Journal

10 May 2025
by Dr Raphael Lataster

NHS Nurse “Forced Out for Mocking Trans Flag” to Sue Hospital

10 May 2025
by Will Jones

Major British Chemical Plant Faces Closure as Energy Prices Soar

10 May 2025
by Will Jones

BBC Quietly Edits Question Time After Wrongly ‘Correcting’ Richard Tice on Key Net Zero Claim

9 May 2025
by Will Jones

Teenage Girl Banned by the Football Association For Asking Transgender Opponent “Are You a Man?” Wins Appeal With Help of Free Speech Union

10 May 2025
by Toby Young

Hugely Influential Covid Vaccine Study Claiming the Jabs Saved Millions of Lives Torn to Shreds in Medical Journal

26

Teenage Girl Banned by the Football Association For Asking Transgender Opponent “Are You a Man?” Wins Appeal With Help of Free Speech Union

21

News Round-Up

55

Major British Chemical Plant Faces Closure as Energy Prices Soar

14

News Round-Up

12

Declined: Chapter 18: The Unthinkable

11 May 2025
by Molly Kingsley

The Backlash to the War Against Boys

11 May 2025
by Noah Carl

Hugely Influential Covid Vaccine Study Claiming the Jabs Saved Millions of Lives Torn to Shreds in Medical Journal

10 May 2025
by Dr Raphael Lataster

Reflections on Empire, Papacy and States

10 May 2025
by James Alexander

Ed Miliband’s Housing Energy Plan Will Decimate the Rental Market and Send Rents Spiralling

10 May 2025
by Ben Pile

POSTS BY DATE

September 2023
M T W T F S S
 123
45678910
11121314151617
18192021222324
252627282930  
« Aug   Oct »

SOCIAL LINKS

Free Speech Union
  • Home
  • About us
  • Donate
  • Privacy Policy

Facebook

  • X

Instagram

RSS

Subscribe to our newsletter

© Skeptics Ltd.

Welcome Back!

Login to your account below

Forgotten Password? Sign Up

Create New Account!

Fill the forms below to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In
No Result
View All Result
  • Articles
  • About
  • Archive
    • ARCHIVE
    • NEWS ROUND-UPS
  • Podcasts
  • Newsletter
  • Premium
  • Donate
  • Log In

© Skeptics Ltd.

wpDiscuz
You are going to send email to

Move Comment
Perfecty
Do you wish to receive notifications of new articles?
Notifications preferences