Dr Winfried Stöcker has created and produced, in a fast and targeted manner, a recombinant antigen construct for reliable detection of antibodies against SARS-CoV-2. And a formula for a vaccine is "now available to everyone, free of charge," Stöcker's spokeswoman confirmed to FWM. But instead of being hailed as a true trailblazer, the doctor says he now fears for his life.
The accomplished scientist from Lübeck had already spoken out about the gradual loss of civil liberties well before the Covid-19 pandemic. Currently this is one of the major concerns for many ordinary citizens with demonstrations against lockdowns increasing in many countries.
The vaccine that Stöcker proposes has not been patented and neither does he hope to profit from it. And it is essentially engineered in the same way as the safe and tested vaccines for Hepatitis A and B.
But despite this huge breakthrough, the Paul Ehrlich Institute in Germany has sued Stöcker essentially not for any criminal enterprise. It is not clear how they hope to advance with their effort when he has clearly not broken any laws.
“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, causes 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,” he remarked.
“The first vaccination was rather trivial than heroic. There was no vector, no RNA, no inactivated coronavirus, but only a tiny peptide.”
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 the infection,” Stöcker explained.
The company that Winfried Stöcker built up, Euroimmun has always been involved in the diagnostics of infectious diseases. Scientists from the company 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. Thus Crimean Congo, West Nile, Japanese encephalitis, Usutu, Dengue, Chikungunya, Mayaro, MERS Corona, Zika, SARS 1 and Ebola were identified thanks to his extensive experience in the development of reagents used for the diagnostics of viral infections. This places him in a unique position to understand the current health crisis which has also become a global economic burden.
“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.”
Stöcker has vaccinated thousands of his employees with these kind of vaccines. He pointed out that with these vaccines, a relatively uncomplicated vaccination scheme is required, which has proven itself over decades and uses a readily available trivial antigen. It evidently should have been rolled out to combat Covid-19. The new vaccines pose a danger, he believes.
“To adopt completely new approaches, for instance, of introducing virus RNA into the body of those vaccinated 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 to 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.”
He added that Corona viruses produced in culture and inactivated thereafter were outdated as vaccination antigens. “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 has become ill or had to take sick leave.”
He had asked the Paul-Ehrlich Institute (PEI), which is the German Federal Institute for Vaccines and Biomedicines, for permission to carry out this simple vaccination programme as soon as possible with a larger number of volunteers. But instead of agreeing to his suggestion, the PEI sued him even though he broke no laws.
“Maybe this was because they felt left out in their divine role – I had already done a trial on five [sic] persons which I am entitled to do as a doctor, being allowed to mix together for therapy whatever I deem right. Anyone who is so knowledgeable 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.”
This emergency has justified his unconventional means, he said. “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. Some 95 percent of the those vaccinated developed high concentrations of protective antibodies within six weeks.
He said the regulatory authorities were unable to cope but despite that, they continue to try to follow rules rather than find solutions. “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 of thousands would not have died.”
About the charges against him, Stöcker said it was unbelievable how the PEI acted as if they were gods who liked 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 was in the right place and every document was folded correctly, while the lives of ordinary citizens are threatened, also by an economic collapse.
“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.”
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 people (ideally with the Lübeck method), thus making them immune straight away, Stöcker underscored.
“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 percent 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.,” the scientist continued. He added that with the Lübeck solution this crisis could be resolved 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 much third-party funding 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.
Those who succumb to the disease, are victims of “short-sighted ‘scientists’, cowardly sticklers for the letter of law and bureaucrats” he concluded.
And in order to counter the silly accusation of some of these “scientists” that his self-test has no evidential value, Stöcker has yielded to the entreaties of some of his colleagues and friends and vaccinated them in a fully legal way, as he did with his family in April last year.
“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 of the recipients 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, he said.
Manufacturing the vaccine: 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.
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