In the past, an extremely powerful research & development division was built up in the Company Euroimmun under my direction, which is also involved in the diagnostics of infectious diseases. Our scientists were among the first to develop reagents for the identification of a whole range of newly emerging infections, often in close cooperation with specialists from international research institutes for infectious diseases, for instance in Germany the Bernhard-Nocht Institute (Hamburg) and the Robert-Koch Institute (Berlin): Crimean Congo, West Nile, Japanese encephalitis, usutu, dengue, chikungunya, mayaro, MERS corona, zika, SARS 1, ebola.
Based on the extensive experience in the development of reagents used for the diagnostics of viral infections, we created and produced, in a fast and targeted manner, a recombinant antigen construct for reliable detection of antibodies against SARS-CoV-2. The construct is based on a receptor-binding domain (RBD, Arg319-Phe541) in the S1 subunit of the spike protein used by the virus to bind to receptors of the target cells. It was pretty clear for me that vaccination with this protein would provide protection from in the infection.
Some vaccinations have a large and some a very low risk potential. It makes a difference whether a healthy human being is injected with an attenuated virus or virus RNA or with a tiny inconspicuous recombinant protein that cannot cause much harm in the organism, except for specifically stimulating the immune system. For decades, recombinant antigens genetically engineered in culture cells have been used for vaccination against infectious hepatitis A and B. In earlier times, the vaccination antigen had been extracted from blood collected from persons with past hepatitis; the recombinant antigens, however, are artificially designed, easy to produce and do not harbour any infection risk – a great step forward. I myself have vaccinated thousands of my employees with this kind of vaccines. However, it is important to perform three injections in the first quarter and to determine the antibody titre every five to ten years, followed by a booster, if necessary.
This uncomplicated vaccination scheme, which has proven itself over decades and uses a readily available trivial antigen, would have been the order of the day in the case of Covid-19. To adopt completely new approaches, for instance, of introducing virus RNA into the body of vaccinees whose organisms first have to synthesise the vaccination antigen, may be effective but many people are scared because they fear that the virus RNA will take on a life of its own and cause unexpected harm their bodies. For this reason, lengthy vaccination studies had to be carried out, while the virus could spread like wildfire. Moreover, the vaccine is hard to produce, requires an unbroken cold chain from the manufacture to the application, many people have allergic reactions to the additive polyethylene glycol that is necessary for stabilisation and half of the vaccinated persons have to take sick leave after the second shot. Above all, however, the manufacturing requires years until the need is met and every single person is vaccinated. During this time, scientists are able to make their mark and patent owners can make very good money, while millions of humans are dying because they could not be vaccinated in time. “But woe to him who, hid from view, hath done the deed of murder base”! Who will follow hard upon his heels, I ask?
Similarly, coronaviruses produced in culture and inactivated thereafter are outdated as vaccination antigens in my opinion. With respect to hepatitis, they have long become obsolete. Why should they be used for corona? Similarly, nobody needs to be infected with vector viruses to introduce virus antigens into the body. I, for my part, use the ready-made, extracorporeally genetically engineered antigen, which carries virtually no risk. Until today, none of the one hundred persons I vaccinated in this way have become ill or had to take sick leave.
Some resistance has developed against my approach. People are unable or unwilling to recognise the great potential in the vaccination method that I suggested, although it is virtually risk-free, based on a dead vaccine, can be transported uncooled and stored in the fridge, does not introduce any scary genetic information of the virus into the body, does not contain an attenuated virus, does cause virtually no allergic reactions, and especially not against polyethylene glycol, can be administered in a doctor’s practice, is nearly risk-free and would therefore be much better accepted by the population. It can also be produced in large quantities, which makes it extremely suitable for mass vaccination. The first vaccination was rather trivial than heroic. There was no vector, no RNA, no inactivated coronavirus, but only a tiny peptide.
Take three times 15 microgrammes of recombinant RBD of the S1 subunit (Arg319-Phe541) for one person. As adjuvant I used alhydrogel from InvivoGen. Shake thoroughly and take up 200 microlitres of the mixture with a tuberculin syringe. Take up 10 millilitres of sodium chloride solution? with a larger syringe and add the 200 microlitres, mix well. Take 500 microlitres of the mixture per shot and mix with a portion of the antigen. Make sure everything is sterile.
With a single 2000-litres reactor, 35 g of antigen can be produced per day, which would suffice for 1 million persons. Using a high-density culturing system, five times as much can be yielded. Within half a year it would be possible to produce enough vaccine for 80% of the population in Germany in a medium-scale laboratory.
I have asked the Paul-Ehrlich Institute (PEI), which is the German Federal Institute for Vaccines and Biomedicines, for permission to carry out this simple vaccination as soon as possible with a larger number of volunteers to find out whether it would work as well as with me and my family and whether these volunteers would also remain free of secondary effects, including exposed persons. If the PEI had not opposed to my plan, we would already have been able to put a manufacturer into the position to supply and effectively protect the entire German population.
But instead of agreeing to my suggestion, the PEI coolly sued me. May this was because they felt left out in their divine role – I had already done a trial on five (!) persons (which I am entitled to do as a doctor, being allowed to mix together for therapy whatever I deem right. He, who is so knowledgable when it comes to the law, should know this) – maybe to give an advantage to other applicants to whom they felt obliged? But I do not present myself as a manufacturer of vaccines; I do not have a profit motive. I have immediately gone public with my action on purpose and have not filed a patent application to prevent someone else from claiming this approach for themselves. The only thing I want is to show a safe and simple way of dealing with the pandemic in a quick and effective manner.
An emergency justifies unconventional means. With this pandemic we cannot wait for two years, as with other vaccines, until all doubts have been erased regarding potential secondary effects but we have to act quickly. In this respect, the PEI is found guilty of complete failure. The institute should have foreseen that the delivery of vaccines that they approved will take several years. In this situation, intelligent people would have examined all possible alternatives and supported their implementation. They would have thought immediately of the highly effective vaccination carried out in Lübeck and would have supported the project. By the end of 2021, the whole of Germany could be free of Covid-19! The vaccination of over a hundred patients with recombinant S1 RBD antigen in Lübeck was virtually without secondary effects and very effective. 95% of the vaccinees developed high concentrations of protective antibodies within six weeks.
The regulatory authorities are unable to cope. They can only act according to the book. They are helpless in the face of the catastrophe that they have caused themselves. They could and should have been the first to foresee the wildfire-like outbreak of the pandemic. If they had accepted my proposal straight away to vaccinate the population with such a simple antigen, the disease would have been prevented from spreading very quickly. Hundreds of thousands of people would not have been infected and ten thousands would not have died.
It is unbelievable how the PEI is payed court to, as if they were gods who like to take their time to approve a vaccine by determining, under certain conditions and by a lengthy and thorough examination of every tiny detail, whether every stamp is in the right place and every document is folded correctly, while the social life and the economy are breaking down. For me, these paralysing authorities are as bad as the disease itself and unworthy of carrying the name of Paul Ehrlich, whose achievements would have been impossible in the current environment of increasingly excessive bureaucracy. Entrepreneurial qualities are required instead of debilitating dirigisme and helpless stammering on TV. Our society would benefit from some competition for the PEI, something similar to the German Technical Inspection Association or the DEKRA.
In the current disastrous situation, no lengthy double-blind trials are required to clearly determine differences in the effectiveness. One should vaccinate the first thousand probands (ideally with the Lübeck method), thus making them immune straight away. If this succeeds, the next ten thousand people are vaccinated and, thereafter, the remaining population. But some clinicians always have an eye on their third-party funds, they want to proceed scientifically in the proven way and to first examine thoroughly if a vaccine candidate helps to develop more or fewer anti-covid antibodies. As not every vaccine, such as the one from Lübeck, will be able to induce very high concentrations of antibodies in 95% of patients that eliminate (neutralise) the coronavirus.
It is not necessary to first confirm a long-term effect by a time-consuming process. What is primarily required is to establish herd immunity as soon as possible and, in one or two years, when the pandemic has been largely contained it is decided how to proceed further. It should be mainly examined whether the side effects are within certain limits. This in particular is what takes too much time in RNA-based vaccines and co. With the Lübeck variant this question could be answered within six weeks.
Besides, my suggestion of a fast vaccination using the corona S1 antigen was received with great enthusiasm by several scientists. Others scolded the idea, criticising it without rhyme or reason: those who did not have the idea themselves or possibly get their research funds from (newly) established vaccine manufacturers. Some “scientists” might get so many third-party funds that they need to talk down my simple solution approach so as not to come away empty-handed. The manufacturers will indeed not permit a comparison because they fear that my vaccine might compete with their newly patented substances, making their patents worthless and putting into question their expected turnovers of hundreds of millions of dollars and euros. I do not rule out that our much admired godlike authority is not only hostile to innovation but, in closing their eyes to the simplest of solutions and suing me, might have acted for the account of someone else. And since so much money is at stake, I am even risking my life. “Ye corona victims who sweep through upper air, though hushed be every human breath, the tidings of my murder bear,” the victims of short-sighted “scientists”, cowardly sticklers for the letter of law and bureaucrats.
The claim of the PEI that a positive antibody result in the vaccination certificate should only be recognised if it was produced by an approved vaccine must surely be seen in the same light. Persons with a past corona infection, who have earned their antibodies in earnest, will then also require vaccination, apparently to avoid that the minions miss out on money?. Can someone please sue the PEI?
In order to counter the silly accusation of some of these “scientists” that my self-test has no evidential value, I have yielded to the entreaties of some of my colleagues and friends and vaccinated them according to my scheme in legal manner, as I did with my family last April. As a doctor I am entitled to do this without requiring approval by an authority. During our vaccination series from December 2020 to January 2021, no relevant undesired side effects have been found and we detected very high titres of anti-spike IgG in 60 of 65 patients in our laboratory in Lübeck. Five vaccinees will receive a booster soon and 64 exhibited virus-neutralising antibodies. None of the vaccinated persons had to take sick leave. All of those positive for vaccination-induced antibodies are very happy about their new freedom.