In the past, under my leadership, an extremely efficient research and development department was established at Euroimmun, dealing, among other things, with the diagnostics of infectious diseases. Our scientists were among the first to create reagents for the detection of a number of emerging infectious diseases, often in collaboration with specialists from international infectious disease research institutions, in Germany including the Bernhard Nocht Institute in Hamburg and the Robert Koch Institute in Berlin: Crimean-Congo, West Nile, Japanese Encephalitis, Usutu, Dengue, Chikungunya, Mayaro, MERS-Corona, Zika, SARS 1, Ebola.
Based on our extensive experience in reagent development for the diagnosis of novel viral diseases, we have rapidly and accurately created and recombinantly produced an antigen construct that can reliably detect antibodies against SARS-CoV-2. It is based on the receptor-binding domain within the S1 subunit of the spike protein, which the virus uses to bind to receptors on target cells. To me, it stood to reason that immunization with this protein would provide a protective effect against infection.
There are vaccinations with a large potential danger and others with a very small one. There is a difference between injecting a healthy person with attenuated viruses or viral RNA and injecting a small inconspicuous recombinant protein that cannot do much in the organism except for specific immune stimulation. For decades, recombinant antigens genetically engineered in culture cells have been used in immunization against infectious hepatitis A and B. In the past, the immunization antigen was obtained from blood donations of people formerly suffering from hepatitis, but the recombinant antigens come from the retort, they are easy to produce and carry no risk of infection - a major advance. I myself have immunized thousands of my employees with them. However, you have to take three injections in the first quarter of the year, then measure the antibody level every five to ten years and give a booster vaccination if necessary.
This uncomplicated vaccination scheme, which has been tried and tested for decades, with a trivial antigen that has long been available, would be the order of the day in the case of Covid-19. The fact that completely new approaches are being pursued here, such as introducing viral RNA into the body of the vaccinated person, which is supposed to synthesize the immunization antigen in the person's own organism first, may be very effective, but many people are afraid of this because they fear that the viral RNA will take on a life of its own in the body and cause unexpected damage. Lengthy vaccination studies have therefore had to be set up, during which the virus has been able to spread through the population like an avalanche. And the active ingredient is very difficult to produce, requires a continuous deep-freeze chain from production to vaccination, many people are allergic to the polyethylene glycol additive needed for stabilization, and half of the vaccinees report sick after the second injection. Above all, however, it takes years to manufacture the vaccine until demand is met and everyone is immunized. Scientists can make a name for themselves and the patent holders can make a lot of money, while millions of people die because they cannot be vaccinated in time. "Woe, woe, whoever stealthily commits the murderous deed!" Who attaches himself to his soles?
Likewise, culture-produced and inactivated coronaviruses are obsolete for me as vaccine antigens, with hepatitis such a thing is long outdated, what is the point then with corona? It is also not necessary to infect anyone with vector viruses in order to introduce viral antigens. I apply the ready-made, extracorporeally genetically engineered antigen, which poses virtually no danger. And so far, none of the more than one hundred vaccinated people has become ill, none has been incapacitated.
Some resistance has developed to my approach. People are not able or willing to recognize the potential of the vaccination I propose, but it is virtually risk-free, based on an inactivated vaccine that can be shipped unrefrigerated and kept in a refrigerator, that does not introduce the dreaded genetic information of the virus, that does not contain an attenuated virus or vector, that causes few allergic reactions, much less to polyethylene glycol, that any doctor can administer in his office, virtually risk-free, and that would therefore be far more acceptable to the public. And which can easily be produced in large quantities. Excellent for mass vaccination. The first vaccination was anything but heroic, but banal. No vector, no RNA, no inactivated coronavirus, just a small peptide.
Take 15 micrograms of recombinant RBD of S1 subunit (Arg319-Phe541) three times for one person. I used Alhydrogel from InvivoGen as the adiuvant: Shake properly and draw up 200 microliters of it with the tuberculin syringe. Draw up 10 milliliters of saline into a larger syringe and add the 200 microliters, mix. Of that, 500 microliters per shot to mix your portion of antigen with. Everything pretty sterile.
A single 2000-liter reactor can produce 45 grams of antigen per day, which would be enough for 1 million people. A high-density culture system can produce five times that amount. Within half a year, vaccine for 80% of the population of Germany could be produced in a medium-sized laboratory.
I have asked the Paul Ehrlich Institute for permission to immediately replicate this trivial immunization with a larger number of volunteers to see if it works as well as it did for me and my family, and if there are no side effects in them either, including exposed individuals. If the PEI had not objected, we could long ago have put a manufacturer in a position to supply the whole of Germany and provide effective protection.
Instead of responding to my proposal, the Paul Ehrlich Institute coldly sued me. Perhaps because they felt ignored in their divine function - after all, I had already carried out a trial on five (!) people (which I am entitled to do as a doctor, so I can mix together whatever I think is right for my therapy: Who knows so well with the paragraphs, should actually know that) -, perhaps to give an advantage to other applicants, to whom one feels obliged? But I do not act as a vaccine manufacturer, I have no profit intention in this matter. I deliberately went public with my action right away and did not apply for a patent, so that no one else would claim this way for themselves, but I only want to show a simple and harmless way to counter the pandemic quickly and effectively.
Necessity justifies unconventional means - in the case of this pandemic, one cannot wait two years until the last doubts about possible side effects have been resolved, as is the case with other vaccines, but action must be taken quickly. In this respect, the Paul Ehrlich Institute must be accused of complete failure. They had to foresee that the delivery of the vaccines that were granted approval would take several years. In this situation, sensible people would examine all possible alternatives and support their implementation. People would have immediately come up with the highly effective immunization in Lübeck, would have supported the project, and by the end of 2021 the whole of Germany could be virtually free of Covid-19! The vaccination of over one hundred patients with recombinant S1-RBD antigen in Lübeck was almost free of side effects and extremely effective, 95% of the vaccinees developed protective antibodies in high concentration within six weeks.
The regulatory authorities are overwhelmed. They can do nothing but proceed according to a tried and tested pattern. They are helpless in the face of the catastrophe, but they have caused it themselves. As the very first institution, they could and should have foreseen the avalanche-like outbreak of the pandemic. If they had immediately taken up my suggestion to immunize the population with such a banal antigen, the spread of the disease would have been stopped very quickly. Hundreds of thousands of people would not have become ill, tens of thousands would not have died.
It is unbelievable how the PEI is still being courted, like gods who are pleased to approve a vaccine under certain conditions and after long and careful examination of every single detail, whether every stamp is in the right place and every piece of paper is folded correctly, while social life and the economy are collapsing. For me, these slowing down authorities are just as bad as the disease itself and unworthy to bear the name of Paul-Ehrlich, whose achievements would not have come to us in the environment of increasing excessive bureaucracy. Entrepreneurial qualities would be more in demand here, not paralyzing dirigisme. And no impotent stammering on television. It would do our society good if the Paul Ehrlich Institute had a little competition, something like the Technical Inspection Agency or DEKRA.
In the current catastrophic situation, one does not need lengthy double-blind trials to precisely work out differences in efficacy. Vaccinate the first thousand test persons (preferably with the Lübeck method) and make them immune right away. If that goes well, ten thousand people get it, and then the rest. But some clinicians always have their eye on their third-party funding account and want to approach the matter scientifically in a way that is tried and tested for them, and first carefully find out whether a few percent more or less anti-covid antibodies develop in a vaccine candidate. After all, not every vaccine will be able to induce antibodies in very high concentrations that eliminate (neutralize) the coronavirus in 95% of patients, like the one from Lübeck.
Initially, it is not important to prove a long-term effect in a time-consuming manner. First of all, a herd immunity has to be established immediately, and in one or two years we will see if the pandemic has been largely contained. The main thing to check was whether the side effects were kept within limits, and this is precisely what takes too much time with RNA vaccination and the like; with the Lübeck variant, this could be answered within six weeks.
By the way, my suggestion of rapid immunization with the Corona S1 antigen was received with enthusiasm by several scientists. And by others it was dismissed and criticized without any sense: Who did not come up with this idea themselves, or who possibly get their research budget financed by (newly) established vaccine manufacturers. Perhaps some "scientists" receive so much in third-party funding that they talk down my simple approach to a solution so as not to go away empty-handed. Because the manufacturers will not allow a comparison, because they are afraid that my vaccine can compete with their newly patented substances, then the patents become worthless and the expected sales of hundreds of billions of dollars and euros are questioned. I do not rule out the possibility that our so admired god-like authority is not only hostile to innovation, but may even have acted on someone else's behalf by turning a blind eye to the simplest solution and suing them. And with so much money at stake, I am now putting my life in danger as well. "From you, you Corona victims up there, if no other voice speaks, then be my murder complaint raised!" Victims of short-sighted "scientists", cowardly paragraph servants and bureaucrats.
In the same context is to be seen certainly the demand of the Paul Ehrlich institute that one is to recognize a positive antibody result in the vaccination certificate only if it came by a certified vaccine. There even persons are to be inoculated again after survived Corona infection, who earned their antibody honestly. Apparently so that the minions do not miss anything. Will someone report the Paul Ehrlich Institute?
To avoid the stupid accusation of some of the said "scientists" that my "self-experiment" has no probative value, I gave in to the fervent wish of some of my colleagues and friends and legally immunized them according to my scheme - as I did with my family last April. As a physician, I am authorized to do so and do not require the approval of any authority. During our vaccination series from December 2020 to January 2021, we did not experience any relevant undesirable side effects, and we were able to detect very high titers of anti-spike IgG in 60 of 65 patients in our laboratory in Lübeck; five are still being revaccinated, and in 64 the antibodies were virus-neutralizing. No vaccinee became incapacitated. All positive patients are happy about their newfound freedom.
Winfried Stöcker
