short commentry

„LubecaVax“: The Individual Anti-Corona Vaccine from Lübeck. Primum Nihil Nocere! Version 2022-06-01

Author: Winfried Stöcker*

*Corresponding Author: Prof. Dr. Winfried Stöcker, Clinical-Immunological laboratory, Am Sonnenberg 9, D-23627 Groß Grönau, Germany

Clinical-Immunological laboratory, Am Sonnenberg 9, D-23627 Groß Grönau, Germany

Received Date: 03 June, 2022

Accepted Date: 28 June, 2022

Published Date: 01 July, 2022

Citation: Stöcker W (2022) „LubecaVax“: The individual anti-corona vaccine from Lübeck. Primum nihil nocere! Version 202206-01. J Vaccines Immunol 7: 175. DOI: https://doi.org/10.29011/2575-789X.000175

Short Commentry

Protection against corona virus infections can effectively and harmlessly be accomplished by vaccination with a tiny inconspicuous protein. Already in March of 2020 we used for the first time worldwide the recombinant Receptor Binding Domain (RBD) of the corona virus for immunisation in humans. The antigen was produced by genetic engineering in cell culture. The protein corresponds exactly to the structures of the virus that it uses in unvaccinated individuals to bind to the angiotensin-2 receptors of the capillary endothelium, the alveolar epithelium of the lungs and to many other cells. The antibodies induced block the receptor binding domain of the virus, so that the virus finds no footing to the cells and cannot infect them. The antigen of LubecaVax is not capable of replicating. In the scientific community, my idea of immunising safely with the receptor-binding domain of the corona virus is meanwhile considered as the best way forward. H. Kleanthous et al.: Scientific rationale for developing potent RBDbased vaccines targeting COVID-19. Nature, npj Vaccines 6, 128 (2021.10.28). The abstract is attached below. And the idea has been imitated already several times. For example, India just recently granted an emergency approval for a vaccine with wild type RBD, which is expressed in the yeast Pichia pastoris, using Alhydrogel as adjuvant (as is done in Lübeck). The vaccine is called Corbevax and will be produced by Biological E Ltd. in India. Currently, an application for WHO approval is underway. The vaccine can be easily produced and stored. Also in Cuba, recombinant RBD is used for immunisation against corona virus (Abdala). The antigen is produced in Pichia pastoris and purified, aluminum hydroxide is used as adjuvant. Similar to LubecaVax. In July 2021, an emergency admission was granted for this vaccination to bring a corona outbreak in Cuba under control. Abdala is applied also in Vietnam and several other countries. The antigen of the vaccine we invented in Lübeck (LubecaVax) is already synthesised when it is administered. The human organism is not misused to produce the antigen, as is the case with gene-based vaccines. Due to the simple, proven principle, the Lübeck antigen can hardly cause damage in the organism, and the potential for undesired side effects is close to zero. LubecaVax uses only 15% of the spike protein. Vaccines against the whole spike protein exhibit many more different viral epitopes, which induce correspondingly more (not necessarily required) antibody and T-lymphocyte specificities. In this respect, an extreme case of doing so are whole extracts of inactivated virus. In the event of infection, this multivalence can lead to intensification of clinical symptoms (antibody dependent enhancement), since many different antibodies and cytotoxic T cells are drawn to the infected tissue. Through formation of immune complexes and the release of cytokines, these promote the inflammatory processes. In addition, in the case of a new corona infection in a person with waning immunity, the number of specificities increases the risk of phagocytes being infected via internalisation of their Fc receptors together with antibodies and virus. LubecaVax is generally administered three times for basic immunisation: on day zero, around two weeks thereafter and again another four weeks later. The antibody concentration is then measured another two weeks later, since we do not have the officially decreed assurance that immune protection has actually built up after a standardised vaccination program in each single case. In the meantime, with a delay of more than one year, the fact that basic immunisation requires at least three injections has also been recognised by the German authorities responsible for vaccines. Only a complete basic immunisation evidently protects significantly from a severe course of a disease after infection. LubecaVax can be easily and promptly adapted to newly emerging dominant mutants. Already since August 2021, LubecaVax administering physicians have used the delta variant together with the wild type for immunisation. The LubecaVax Omicron variant is available already since middle of February 2022. With some gene-ferries, e. g. from Biontech and Moderna, encapsulated RNA is introduced into the body. The Mrna contains particular gene sequences coding for the SARS-CoV-2 spike glycoprotein or other components of the corona virus.

Subsequently, the synthesis of these corona virus antigens takes place in the human organism! The antigens then appear on the surface of the cells and in their vicinity – and stimulate the immune system. The principle was first designed for immunisation against particular tumour antigens in cancer treatment, but for the past without significant success. Another principle uses genetically modified viruses as vectors. The genetic information for the spike protein of SARS-CoV-2 is integrated into their DNA (AstraZeneca or Johnson & Johnson). It cannot be ruled out that over time the SARS-CoV-2 genes enter the genome of some host cells. Both variants –vaccination with RNA and with vector viruses – cause in some people severe side effects. According to a current study: M Ziemann, S Görg: Inability to work after corona vaccination in medical staff. Deutsches Ärzteblatt int. 2021; 118: 298-9, five% of persons vaccinated with Biontech had to take sick leave after the first vaccination and 20% after the second vaccination. With AstraZeneca it was even half of the individuals after the first vaccination. However, the second AstraZeneca vaccination was better tolerated than the first, as the immune system apparently already recognises the vector virus and removes part of it from circulation. With a Russian vaccine based on vector viruses, different viruses are therefore used for the first and second shots (Sputnik 1 and 2).

Many scientists consider immunisations using geneferries dangerous. Both, encapsulated RNA and vector virus, are introduced into endothelial cells and other cells of the blood vessels and various organs, where they induce the synthesis and expression of corona virus-specific antigens as intended. Since antibodies against these antigens emerge in the organism within a few days as intended, or are present as a result of a previous vaccination or COVID-19 infection, a type of autoimmune reaction takes place: On the membranes of the cells or in their vicinity, detrimental immune complexes of locally newly produced corona virus antigen and the pre-existing serum anti-corona virus antibodies arise. Complement is then bound to these immune complexes, which results in inflammation of differing intensity, as known from the autoimmune disease lupus erythematosus. Inflammatory mediators such as interferon and different interleukins are attracted and activated. Moreover, tissue thrombokinase released from the damaged endothelial cells stimulates blood coagulation, and millions of tiny fibrin clots develop, eventually forming larger thrombotic clots. Further, cytotoxic T lymphocytes also contribute significantly to this pathogenic process by destroying large numbers of previously healthy, now antigen-producing endogenous cells. Possibly, similar mechanisms as observed during a severe COVID-19 course also play a role (Berlin Institute of Health, Charité, Press Release: The fatal role of T cells in COVID-19. 29 December 2021): CD16-positive cells of the innate immune system recognise anti-corona virus antibodies on the surface of the infected cells and stimulate the immune cells to release cytolytic enzymes and destroy the infected cells.

Hyperreactions occur, which often cause a more severe disease course in COVID-19 patients with well-established anticorona virus immunity („antibody enhancement of the disease“) than in patients with a weaker immune response. The defence mechanisms of the organism cause these severe symptoms, not the virus itself. “Experts” are excited that the pronounced antigen presentation together with HLA class I molecules on the surface of the geneferry- infected cells, generates an excess of corona antigen specific T lymphocytes, an extreme powerful T-cell response compared to protein-based immunisations. But what “experts” claim to be an advantage of gene-ferries, a QUANTUM LEAP for vaccinations, can be the main cause of many unexpected deleterious side effects – different diseases and death. A disastrous misconception! Formerly perfectly healthy cells (now infected with foreign genes) fall victim to cytotoxic T-cells, they die, cause destruction and inflammation. Such superfluous specific cytotoxic T-cells are totally dispensable, as numerous protective immunisations against other viral infections with ready-synthesised, partly recombinant antigens indisputably have proven. This global anti-corona gene-ferry experiment is not justified, since harmless conventional vaccines with simple protein agents have been available since March 2020 for immunisation against corona virus, which in the case of the Lübeck vaccination lead to high neutralising antibody levels and have not shown any unfavourable side effects in the administration of 60,000 vaccine doses to date. Mankind has experience with many different genefree vaccinations. Such a large number of side effects as have been observed with gene-ferry-based vaccines against COVID-19 have never been experienced before with other mass immunizations and for the most part, they resemble the long covid syndrome. The fact that such side effects hardly ever occur with many protein-based vaccines should be an admonition to rely on proven methods and to test gene-ferries extensively in small populations before vaccinating the entire world’s population. Different signs of disease can arise due to the humoral as well as the cytotoxic general campaign against the organism of the vaccinee, depending on which organ is affected and to what extent. The “safety report” of the Paul Ehrlich Institute from July 2021 highlights some cases of adverse events, which definitely occur in connection with the currently favoured gene-ferry vaccinations. These include myocarditis and pericarditis (inflammation of the heart, often in very young men), and thrombotic events with coagulation disturbances, thrombocytopenia and bleeding tendency. Life threatening fatalities are thromboses in the sinus veins of the dura mater. There are also reports of nerve inflammation (Guillain- Barré syndrome) and anaphylactic reactions, possibly against the excipient polyethylene glycol, which coats the injected RNA (increased risk at second and further vaccinations). Once the blood-brain barrier is disrupted and the brain itself is attacked, various neurological manifestations including sight disorders or stroke may occur. And when foreign proteins are deposited in the brain over many years, dementia may be a possible outcome. It is not excludable that the immune system itself becomes victim of gene-ferries, and the immunocompetent cells become fewer in number or loose function after getting infected with the foreign genetic material – that can be deduced from reports that in some cases the anti-corona-immunity decreased with the number of RNA boosters.

A peer-reviewed paper highlights a dramatically increased risk of heart disease after mRNA vaccination: Omer Ahmed Shaikh, Priyanka Mohan Lal, Anmol Mohan, Um-Ul- Wara, Ana Carla dos Santos Costa, Shoaib Ahmad and Mohammad Yasir Essar: Corona virus disease 2019 (COVID-19) mRNA vaccine and the risk of myocarditis: An increasing concern. Journal of the American Heart Association, published online by Cambridge University Press: November 26, 2021. It is not without reason that the German ministry of health explicitly warns against doing any sport for up to three weeks after vaccination with gene-ferries. We suggest having the activity of the enzyme cardiac specific creatine kinase (CK-MB) or troponin levels measured every other day during this period in order to detect the risk of developing myocarditis as early as possible. Many of these cases end in a heart attack, and sudden cardiac death often occurs as a result of cardiac arrhythmias, when the entire heart muscle is interspersed with foci of inflammation and the conduction tissue is also affected.

Sangjoon Choi, SangHan Lee, Jeong-Wook Seo, Min- Ju Kim, Yo Han Jeon, Ji Hyun Park, Jong Kyu Lee, Nam Seok Yeo: Myocarditis-induced Sudden Death after BNT162b2 mRNA COVID-19 Vaccination in Korea: Case Report Focusing on Histopathological Findings. J Korean Med Sci 2021 Oct 18;36(40):e286. The abstract is attached below. Further information on this subject is provided by an interview of the cardiologist PD Dr. Henning Steen by Dr. med. Dirk Wiechert dated 26. 3. 2022, which is available on the Internet: “Cardiac myocarditis due to corona infection AND vaccination - What does magnetic resonance imaging reveal?” In this interview it becomes clear that cardiac (and also other) symptoms of a corona infection are similar to those of a vaccination with a gene-ferry. The explanation is quite simple: corona-infected cardiomyocytes are eliminated by cytotoxic T lymphocytes, so that viruses are no longer replicated - a reasonable mechanism, but one that is accompanied by inflammatory reactions. Cells infected with RNA or vector virus are destroyed in the same way, but without necessity, and caused by the fact that our organism is insanely forced to synthesize the antigens needed for the vaccination itself in its own cells. However, these antigens can easily be produced recombinantly and supplied from the outside by vaccination! The safety committee of the European Medicines Agency (EMA) concluded in July 2021 that inflammatory heart diseases can occur in very rare cases after vaccination with Comirnaty (Biontech/ Pfizer) or Spikevax, and more frequently in younger men after the second dose. However, the benefits of vaccination based on the mRNA technology used by both Moderna and Biontech/ Pfizer continue to outweigh the risks, according to regulatory authorities in the U.S. and EU and the World Health Organization.

Further references: Bozkurt B et al. (2021): Myocarditis With COVID-19 mRNA Vaccines. US Review Circulation. DOI: 10.1161/CIRCULATIONAHA. 121.056135.

Witberg G et al. (2021): Myocarditis after Covid-19 Vaccination in a Large Health Care Organization. NEJM. DOI: 10.1056/ NEJMoa2110737

Diaz GA et al. (2021): Myocarditis and Pericarditis After Vaccination for COVID-19. JAMA. DOI: 10.1001/jama.2021.13443.

Ryan Ruiyang Ling et al. Lancet Respir Med. 2022: Myopericarditis following COVID-19 vaccination and non- COVID-19 vaccination: a systematic review and meta-analysis. Interpretation: The overall risk of myopericarditis after receiving a COVID-19 vaccine is low. However, younger males have an increased incidence of myopericarditis, particularly after receiving mRNA vaccines. Nevertheless, the risks of such rare adverse events should be balanced against the risks of COVID-19 infection (including myopericarditis). Severe side effects of geneferry vaccines can affect organs or organ systems other than the heart, including the central nervous system, skin, lungs, and so on. Attenuated post-Covid symptoms are found, and the risk of this increases with each booster if vaccinated with RNS or vector virus. The mRNA-containing lipid nanoparticles alone already caused immediate toxic, proinflammatory, and in some cases lethal effects in animal studies: Sonia Ndeupen, Zhen Qin, Sonya Jacobsen, Aurélie Bouteau, Henri Estanbouli, Botond Z Igyártó: The mRNA-LNP platform’s lipid nanoparticle component used in preclinical vaccine studies is highly inflammatory. iScience 2021 Dec 17;24(12):103479. doi: 10.1016. The abstract can be found at the end of this article.

In a statement to the U.S. Securities and Exchange Commission (SEC), Biontech writes that serious undesirable events could occur in its clinical trials or even after receiving regulatory approval. In addition, the durability of the immune response has not yet been proven in clinical trials. BioNTech also does not guarantee that newly discovered or developed safety issues will not occur. Biontech’s conclusion is therefore cautious: “Subsequent discovery of previously undetected problems could negatively impact commercial sales of the product, lead to limitations of the product, or result in the product being withdrawn from the market.” Also, a large study by the Charité Berlin (40,000 follow-ups over more than 1 year) reveals for the first time that the number of severe side effects with the “gene-ferry vaccinations” in Germany is not 0.02%, as claimed by the Paul Ehrlich Institute. In reality, it is 0.80%! The results of this study are only based on an Internet survey and are therefore doubted by critics. They try to dispute that the initiator of the survey, Harald Matthes, endowed professor for integrative and anthroposophic medicine, has the required objectivity due to his professional specialization. Among other things, the researchers are accused of deficiencies in statistics, but in this case of only counting is necessary. A largescale survey of all physicians who participate in health care should be conducted: I assume that most of them would agree with the information provided by Prof. Matthes. It is scandalous that most of the serious side effects of the currently approved anti-Covid 19 vaccines are neither consistently reported nor adequately treated. Many people believe that the authorities want to hide the severe incidents so that they can ruthlessly continue their vaccination program.

However, free citizens expect that every case of significant health disruption temporally related to anti-Covid 19 vaccination will be meticulously investigated. Otherwise, the authorities should not expect free people to be forced or coerced into such vaccinations. In a liberal society, it must be self-evident that such topics are discussed openly and that scientists with views and proposals that deviate from the official position are not isolated and defamed. And that no vaccine manufacturers influence renowned scientific journals and cover up the dangers of vaccinations, for example in the New England Journal of Medicine, as Nicola von Lutterotti complains in the Frankfurter Allgemeine Zeitung (Wednesday, May 25, 2022, page N1). The study authors of a vaccine manufacturer immunized 5,000 individuals and found no myocarditis in any of them. Apparently, they wanted to create the impression that this known side effect was not of relevance: Obviously an intentional misinformation, as this vaccination damage is so rare that it would be pure coincidence to have found it in the examined cohort. “These adverse events affect about one to ten out of every 100,000 individuals who were vaccinated and, what’s more, it primarily affects teenagers and young adults – a cohort that barely appeared in the present study.” Overall, however, the number of fatal myocarditis cases alone is so large that genetic anti-COVID vaccines should immediately be withdrawn from circulation, especially since safe alternative vaccines are available, such as LubecaVax. Dermatologists also frequently see manifestations of anti-corona vaccinations with gene-ferries. The skin reveals the effects of the worldwide experiment. The pity picture of the other organs in some cases of gene-ferry impact, is not visible at first glance. Majenka P, Naoum C., Hartmann M.: Multiform erythema after COVID-19 mRNA vaccination. Dtsch Arztebl int 2021; 118: 690. DOI: 103238/ arztebl.m2021.0289.

I expect that the administration of gene-ferries has deleterious effects on pregnancy, gene-ferries will not stop at the placental barrier. I would not trust the official recommendations to vaccinate pregnant women using gene-ferries. They want to make us believe that we don’t have to be afraid of this vaccination – in my eyes against all reasons. Other vaccines containing components not capable of reproduction as against influenza, tetanus and whooping cough are officially recommended with every right to be applied also during pregnancy, but never infective attenuated viruses. Immunization using a safe small protein as the RBD of the corona virus is obviously harmless, and provides protection from Covid-19 for mother and child. In the “safety report” the many severe and sometimes fatal events are justified by the enormous threat of the COVID pandemic: The number of deaths from vaccination is only a fraction of the deaths that would occur with an uncontrolled infection wave. Disease and death of people who were completely healthy before the vaccination is predictable on the grounds of the mechanisms described above, but are deemed acceptable! In the opinion of many reputable scientists, they are on the accounts of regulatory authorities, which fight against safe alternative vaccine techniques, always wanting to be right and, like the motorist driving against the traffic, unswervingly stick to their disastrous course. It appears that the authorities responsible did not want to investigate the serious complications immediately after coronavirus vaccination observed by thousand doctors, ignoring the side effects and playing down the number of vaccine induced deaths, since authorities fear that the failure of the rush approval of a complete novel vaccine, which is already suspected of being unsafe, would become obvious. And a further reduction of the willingness to become vaccinated with a gene-ferry had to be avoided. The pathologist Peter Schirmacher from Heidelberg, for example, was criticised because he demanded that all deaths that occurred in timely connection with an anti-corona virus vaccine be thoroughly pathologically investigated. The pathologist Arne Burkhardt from Reutlingen has carried out such pathohistochemical studies and reported on them in Lahnstein at a physicians’ symposium on 24. 4. 2022, the video recording can be seen at https://youtu.be/ QNhflLpDyg4. He has shown what severe lethal consequences anti-corona vaccinations with gene-ferries can have, largely due to inflammation of the arterial walls, for example of the coronary arteries. He reports postvaccinal vascular lesions with aneurysms and hemorrhages, including in the brain (encephalitis, meningitis, hypophysitis, strokes). And the “safety report” did not mention the mild adverse effects, such as headache, joint aches, fever, chills and indisposition, which were experienced million-fold and lasted just a few days, keeping many from working. Such adverse effects hardly ever occur with protein-based vaccinations. According to many physicians the “Lübeck vaccine” is safe and effective. It is likely the most suitable for immunising children or pregnant women, as the antigen is already produced when it is injected and the organism of the vaccinated person is not misused for synthesis of the antigen and damaged. In addition, the vaccine does not contain any components capable of replication or any genetic information (RNA or viral DNA). With the gene-ferry vaccines there is still substantial uncertainty about possible integration into the genome of the vaccinated individuals. We learn more every week about the manifold and in part serious side effects of gene-ferry vaccines. Why should children be exposed to this risk when they almost never or only mildly get COVID-19? How dare you! To put a vaccine on the market, that is to give it to third persons or make it available to third parties, requires an official approval from the authorities. They take their responsibilities very seriously, require complete exclusivity and stick to rigid rules. But in the corona virus pandemic it has become clear that bureaucrats are overburdened with such a difficult, indeed life-threatening situation and cannot react reasonably. Along with many German politicians and advisors. Narrow-minded thinking and sticking to ingrained procedures have made thousands of people sick or killed them. Their handling was characterised by helplessness and serious misjudgements (for example, that until recently it was supposed to be sufficient for basic immunisation to vaccinate only twice, that people do not care about antibody levels at access controls, but are only interested in whether someone has been vaccinated or recovered). Our social life has come to an almost complete halt and our economy is paralysed, because, due to excessive approval requirements, a nationwide immunisation could not be undertaken in good time and a promising vaccine was blocked in its tracks. Instead of supporting the evidently safe Lübeck vaccine by all means, the President of the Paul Ehrlich Institute (PEI) initially started legal proceedings and brought a charge against the initiator for vaccinating his own family with a non-approved method! “I am regent in Kaiser’s place in the land of vaccines, be quiet and obey.” In this particular matter I only used my constitutional right as a physician. With all his might and full ambition the President of the PEI positioned himself, guided by formalistic (or other?) motivation, arguing against a long-established vaccine principle, whose innocence and at the same time high immunogenicity would regrettably only be recognised by real experts. He also spread the falsehood, including to our Parliament, that his institute approached me with an offer for discussion in September of 2020.

But this was provably only on January 6th, 2021. And long before this date, the President had already brought a charge against me. Exceptional events like the corona virus pandemic require an exceptional course of action appropriate for the situation. It was an illegal action of emergency Helmut Schmidt justified his procedure ordering military troops to stem against a century flood in Hamburg in 1962, in contradiction to the constitution. The former German Federal Minister of the Interior Hermann Höcherl (1965-1969) once caused headlines with his request that, when fast action is necessary, public officials should not always walk around with the code-of-law book under their arms. And in my case the law was even on my side! Among other things, given the availability of a harmless but highly effective vaccine, the authorities and their numerous advisors should not insist on lengthy double-blind trials as a prerequisite for the approval of a vaccine that is necessitated so urgently. It must suffice to vaccinate several thousand people in a defined environment and measure the vaccination success by determining the antibody titre. Everything could have been established more than one year ago! We then would have seen that after full basic immunisation with the Lübeck corona virus vaccine the corona virus incidence is very likely to decrease dramatically compared to non-vaccinated persons and that the vaccination, however, does not cause any serious side effects (as gene-ferrybased anti-corona virus vaccines do). The large-scale trials as a prerequisite for approval are unnecessarily inflated and for some placebo subjects even fatal, as for example happened in Brazil. They provide external funds for the conducting physicians and also keep the circle of vaccine producers small. And not forgetting, they maintain the flow of money in the direction of the European Medicines Agency (EMA) and the Paul Ehrlich Institute. The EMA is financed to 86% by fees that they raise from examinations and approvals of medicaments and vaccines. Last year this amounted to 330 million Euros, which must be justified by services in return! In Germany as in many other countries, licensed physicians are granted the freedom to treat, which is guaranteed by the constitution. Without special permission they are allowed, to personally produce an agent themselves and individually administer it to their patients. The legitimacy of this procedure stems from a fundamental decision of the Federal Constitutional Court (resolution from 18.03.1997 – 1 BvR 420/97-). Therefore, any physician in Germany can mix an antigen with an adjuvant (and only then it is called a vaccine) and legally inject or apply it individually to a patient. The adjuvant captures the antigen and presents it to the immune system. Without the adjuvant the antigen would be distributed in the whole organism and diluted and thus rendered ineffective. Both components must be kept separately as a functional agent and mixed freshly each time. However, physicians are not allowed to give their “homemade” vaccine to third parties (bring it onto the market). This medical freedom enabled open-minded physicians in Germany who truthfully wanted to “follow the science”, to exercise their right and apply the Lübeck method. They have so far administered around 50,000 such vaccinations. I myself oversee a fair number of 2,000 patients and have not observed any serious side effects: No thrombosis, no heart muscle inflammation or pericarditis, no heart attack, no nerve inflammation, no deaths have been reported to me. No one has become sick from the Lübeck vaccine.

During the months of June and July 2021, for example, 376 persons in the vicinity of Görlitz were legally vaccinated by physicians with the Lübeck method. These persons sought protection from COVID-19 in the context of an individual treatment. Not one of the treated persons suffered a health problem from the vaccination. Aside from minor local reactions, all of them were well and able to work following the vaccination appointment. Everybody was happy to have gained acquired protection from the virus. A few people did not show full immune response and received a fourth vaccination with a double dose – such individuals can only be identified when their serum antibodies are measured. And in approximately 50% of the boostered patients the 4th shot yielded a satisfactory result. After basic immunisation, over 97% of the vaccinated persons developed high concentrations of class IgG antibodies against the corona virus spike protein. The antibodies were capable of neutralising (inactivating) corona virus in almost all cases, and in three quarters of cases T-cell immunity developed (see table in attachment). The authorities, however, do not want to be patronized by the constitution of the Federal Republic of Germany. They operate with scare tactics and use every means to try and restrict doctors’ freedom to treat. Through a defamatory campaign they try to place our method in a bad light. They want to annul the law using regulations at their discretion and they put pressure on physicians who apply it. In our case, among other things, they demand evidence of GMP-compliant manufacturing (Good Manufacturing Practice).

Given the urgency, the wrong standard, by which the in our opinion best corona virus vaccine gets taken out of the way, in order to protect the manufacturers of already established and approved vaccines and to underscore the high relevance of the regulatory authorities. Because it is common knowledge that at least two years are needed to establish a GMP-compliant production. The current Lübeck agent possesses the required and exactly controlled outstanding quality (see attachment), but for formal reasons has not yet received a certificate with a nice stamp. Even without an already available GMP certificate, the safety of the Lübeck vaccine has been proven. It is effective and does not make anybody sick, and according to our constitution, such proof is not required. The authorities should convince themselves of LubecaVax and support this vaccine. They could initially grant emergency use authorization in Germany, and any resistance against corona immunisation falls apart. Million people would drive across Germany to get immunized with LubecaVax. “Fully vaccinated” – so far the authorities considered a person having received two immunisations against SARS-Cov-2 as sufficiently protected and “non-infectious”. This was, however, a fatal mistake, which substantially contributed to cases skyrocketing at the end of 2021. In the meantime, they have followed us in demanding a third vaccine for a basic immunisation. Currently vaccinated and recovered persons pose a greater risk of infection than the unvaccinated, as they have a false sense of security, do not test themselves and sometimes abstain from wearing a mask. Today we have a “pandemic of the vaccinated”! The “2 G strategy” (vaccinated and recovered considered as immune) is dangerous nonsense. We now have learned that immunity against corona virus in recovered persons as well as in the vaccinated does not last for several years, as is the case with vaccinations against many other infectious diseases, for example hepatitis A and B. The initially high levels of anti-corona virus antibodies often drop to a nadir within half a year. The protection is no longer sufficient and people can become infected and infectious. This occurs with the already officially approved vaccines as well as with the Lübeck vaccine. Maybe a booster will be required every half year until the pandemic ends. Access to a public event during this time should only be allowed for persons who can demonstrate an actually sufficiently high antibody titre or, in situations with increased risk, additionally a recent negative PCR or corona virus antigen test. That against all evidence the public health authorities only rely on a vaccine stamp or proof of a past infection, can only be interpreted as extortionary behaviour to force the public and especially the nursing staff to accept a vaccination with only provisionally approved substances. Thus, the previous Federal Health Minister demanded a proof of a past corona virus infection by a positive PCR from the time of illness, to authorize a positive antibody result. If not available, the person should then be vaccinated with an approved vaccine (Dr. Thomas Gebhart Mai 2021, job number 5/098). But many people have a corona virus infection without realising it or having it identified. How should they obtain a positive PCR test months later! The subsequent vaccination in the case of a clearly antibody positive result is not only superfluous, but also not medically justified and even dangerous. This coercion should be resisted. We doubt, the new Federal Health Minister, although a specialist, is ready to implement the necessary changes in Germany. Most infections in the second half year of 2021 were caused by the delta variant. Delta replicates many times faster than the wild type and also affects persons whose originally high anti-corona wild- type antibody titre dropped to a low level after more than six months. These individuals who are no longer fully protected only suffer minor symptoms and often confuse them with a normal cold, relying on the official stamp in their vaccination passport and, unknowingly infect many others within a short time. In contrast to non-immunized individuals, they mostly recover from their illness within a few days due to their preformed immunity and long-term immunological memory. Their antigen test or PCR is usually negative again the following week. LubecaVax contains additional delta antigens since August 2021. New on the plan and quickly dominant is Omicron. Several cases have shown that even a strong immunological barrier against wild type and delta – obtained by complete immunisation or past infection – does not provide sufficient protection against Omicron. The reason for this is the large number of mutations in Omicron; the receptorbinding domain of Omicron alone differs from the wild type by 15 mutations (the delta variant by only 2 mutations). Individuals who are sufficiently vaccinated with wild-type antigens and who then become infected with Omicron frequently show a positive PCR but almost no signs of disease, in contrast to Omicron patients without a previous anti-corona immunisation who often suffer from a more severe course of disease. As from the middle of February 2022, LubecaVax also contains additional Omicron antigens. Since the concentration of antibodies after corona virus vaccination falls quickly, many booster vaccinations will be required in the future. In my opinion, when gene-ferries (RNA, vector viruses) are used with repetitive doses, there is a substantial risk that thousands of people will become sick and some of them even die from the vaccination: As already described above, the human body has to produce the antigen itself and may be the target of auto-aggression caused by the already established immunity. From our perspective only booster vaccinations with a protein vaccine should be used.

LubecaVax with its small, trivial vaccination protein produced outside of the body, as well as different RBD-based vaccines are best choice for boosters and already available. Novavax also contains a ready synthesized immunogen, consisting of whole spike proteins S1 + S2 (possibly unnecessary big). The adjuvant consists of saponins and phospholipids. We do not have experience with this vaccine. A basic Novavax immunization is told to consist of only two doses, which seems to be not sufficient. The antibody titers should be analyzed anyway and, if necessary, a booster vaccination should be given.

Prof. Prof. h.c. (RCH) Dr. med. Winfried Stöcker

Three abstracts attached:

H. Kleanthous et al.: Scientific rationale for developing potent RBD-based vaccines targeting COVID-19, Nature, npj Vaccines 6, 128 (2021.10.28). Vaccination of the global population against COVID-19 is a great scientific, logistical, and moral challenge. Despite the rapid development and authorization of several full-length Spike (S) protein vaccines, the global demand outweighs the current supply and there is a need for safe, potent, high-volume, affordable vaccines that can fill this gap, especially in low- and middleincome countries. Whether SARS-CoV-2 S-protein receptor binding domain (RBD)-based vaccines could fill this gap has been debated, especially with regards to its suitability to protect against emerging viral variants of concern. Given a predominance for elicitation of neutralizing antibodies (nAbs) that target RBD following natural infection or vaccination, a key biomarker of protection, there is merit for selection of RBD as a sole vaccine immunogen. With its high-yielding production and manufacturing potential, RBD-based vaccines offer an abundance of temperaturestable doses at an affordable cost. In addition, as the RBD preferentially focuses the immune response to potent and recently recognized cross-protective determinants, this domain may be central to the development of future pansarbecovirus vaccines. In this study, we review the data supporting the non-inferiority of RBD as a vaccine immunogen compared to full-length S-protein vaccines with respect to humoral and cellular immune responses against both the prototype pandemic SARSCoV- 2 isolate and emerging variants of concern.

Sangjoon Choi, SangHan Lee, Jeong-Wook Seo, Min- Ju Kim, Yo Han Jeon, Ji Hyun Park, Jong Kyu Lee, Nam Seok Yeo: Myocarditis-induced Sudden Death after BNT162b2 mRNA COVID-19 Vaccination in Korea: Case Report Focusing on Histopathological Findings. J Korean Med Sci 2021 Oct 18;36(40):e286. We present autopsy findings of a 22-year-old man who developed chest pain 5 days after the first dose of the BNT162b2 mRNA vaccine and died 7 hours later. Histological examination of the heart revealed isolated atrial myocarditis, with neutrophil and histiocyte predominance. Immunohistochemical C4d staining revealed scattered single-cell necrosis of myocytes which was not accompanied by inflammatory infiltrates. Extensive contraction band necrosis was observed in the atria and ventricles. There was no evidence of microthrombosis or infection in the heart and other organs. The primary cause of death was determined to be myocarditis, causally-associated with the BNT162b2 vaccine.

Sonia Ndeupen, Zhen Qin, Sonya Jacobsen, Aurélie Bouteau, Henri Estanbouli, Botond Z Igyártó: The mRNA-LNP platform’s lipid nanoparticle component used in preclinical vaccine studies is highly inflammatory. iScience 2021 Dec 17;24(12):103479. doi: 10.1016. Vaccines based on mRNAcontaining lipid nanoparticles (LNPs) are a promising new platform used by two leading vaccines against COVID-19. Clinical trials and ongoing vaccinations present with varying degrees of protection levels and side effects. However, the drivers of the reported side effects remain poorly defined. Here we present evidence that Acuitas’ LNPs used in preclinical nucleosidemodified mRNA vaccine studies are highly inflammatory in mice. Intradermal and intramuscular injection of these LNPs led to rapid and robust inflammatory responses, characterized by massive neutrophil infiltration, activation of diverse inflammatory pathways, and production of various inflammatory cytokines and chemokines. The same dose of LNP delivered intranasally led to similar inflammatory responses in the lung and resulted in a high mortality rate, with mechanism unresolved. Thus, the mRNA-LNP platforms’ potency in supporting the induction of adaptive immune responses and the observed side effects may stem from the LNPs’ highly inflammatory nature.

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Journal of Vaccines, Immunology and Immunopathology

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