In recent months, a large number of dangerous side effects of RNA- and virus-based (genetic) vaccinations have been observed. In contrast, immunization with the protein-based LubecaVax is almost free of side effects, and it results in high levels of neutralizing antibodies against corona viruses in 97% of vaccinated individuals. Due to its well-proven concept over many decades, this vaccination does not pose the innate risks which genetic vaccines reveal more and more.

In the meantime, experience with the protein-based LubecaVax has been gained with about 60,000 vaccinations. They were started in March 2020, based on the receptor-binding domain (RBD) of the corona virus. Initially RBD of wild-type was used, since August 2021 RBD of the Delta virus, and since February 2022 RBD of Omicron plus wild-type. The vaccines do not contain any foreign genetic material – neither RNA nor the DNA of weakened viruses, and are by far better accepted by the public, since many people regard vaccinations with gene-ferries dangerous. LubecaVax hardly triggers allergic reactions, is low-priced and easy to be produced and to handle. Any physician can prepare it in his practice and administer it legally on an individual basis at the request of his patients. The components of the vaccine do not need to be transported deep-frozen and can be stored in the refrigerator (the few well-meant donations of provisionally approved vaccines in many cases fail due to logistics and the requirement of a cold chain).

The German Paul Ehrlich Institute either did not realize the potential of the Lübeck vaccine or eagerly wanted to leverage a new vaccination principle, which many scientists consider dangerous, and therefore blocked the way for an approval of the Lübeck vaccination. Having used the Lübeck anti-corona virus vaccine developed in March 2020 in the correct manner, the whole of Germany would presumably be free of the corona virus epidemic by now – if self-important authorities would not have prohibited the development and application of this vaccination.

In the warm season, in Germany the risk of infection with corona viruses is again very low. Also, the official vaccinations that have already been given (even though they are dangerous), may have contributed to herd immunity. But it is foreseeable that by the upcoming fall, the pandemic will have us firmly in its grip again. Vaccinated people should not be deceived into a false sense of security: Serum antibody levels for corona virus have been found to drop very rapidly, often to half or less within six months, so that people can soon become infected again after complete basic immunization (as we have experienced with the Delta-virus). However, even high levels do not protect against infection with more mutated variants (example Omicron), but the disease is usually very mild after immunization against wild type and Delta.

For the moment, it is therefore highly recommended to boost twice a year, in any case with an up-to-date recombinant antigen construct. A six-month break can be taken if the antibody concentration in the blood is sufficiently high, but this must be measured. Since RNA- and vector virus-based vaccinations can cause more and more damage with each further booster, only non-dangerous recombinant corona-RBD antigens should be used in the future, such as LubecaVax.

And here is my recommendation to the authorities in Germany: Let physicians exercise their right to treat their patients individually, if that is the patients’ intense desire. Stop depriving them of their basic constitutional right to produce and administer a vaccine in line with the freedom of choice of treatment. If the expectations come true that we will again have to immunize extensively against COVID-19 next fall, 10 million people will want to get a vaccine as LubecaVax. And they will not have to be forced by authorities to do so­ – what an opportunity! They are justly afraid of the state-ordered mass experiment with genetic vaccinations! They don’t want to be patronized and they don’t want a uniform press – we had that behind us long ago.

And another piece of advice to all the health authorities in our world: Don’t wait again several months before vaccinating when a new dangerous pathogen is spreading. As was shown with COVID-19, the genetic code of the virus and the epitopes suitable for vaccination were decoded within a few weeks of its first appearance. Let an institution have cell cultures on standby that can be used to produce harmless protein based vaccines (as in LubecaVax) in large quantities on short notice! The institution must already possess all approvals for such production.

 

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

 

Further information can be found in the articles

“LubecaVax: The individual anti-corona vaccination from Lübeck”, version May 9, 2022 and

“Gene-based anti-corona vaccines are dangerous! The pseudo-COVID syndrome”, version May 3, 2022.

 

The Lübeck corona antigen is a genetically engineered copy of the receptor-binding domain of the corona virus (Fig. 1). Already since the 26th of March 2020, it has been successfully used in Lübeck for vaccination against Covid-19. Some public authorities have criticized the fact that GMP-compliant production cannot be demonstrated for the corona protein used in the Lübeck vaccination. In terms of urgency, this is the wrong approach, as it takes at least two years to establish GMP-compliant production. But the world needs effective vaccines today, not in two years, and with a non-hazardous product. This is not the time for a large-scale global experiment with a new vaccination principle that has not yet been sufficiently tested. Instead, methods must be used that have been tried and tested a hundred million times: An antigen is applied that has been synthesized and that the body does not have to produce itself first, whereby it would itself become the target of the emerging immunity.

Under my supervision, the quality of the Lübeck vaccine is closely controlled. It has the required quality, but for formal reasons it does not yet have a corresponding official certificate. Even without such a certificate, the safety of the Lübeck vaccine has long been proven in 50,000 vaccinations. It is effective and does not make anyone ill, and according to the German Basic Law, such proof should be dispensable as long as the vaccine is produced by the doctors themselves and administered individually at the request of each patient after appropriate information. However, it may not be marketed, i.e. sold to doctors who do not produce it themselves., According to surveys, 10 million people in Germany would immediately be voluntarily vaccinated with the Lübeck method, and no sanctions would be required to achieve complete herd immunity against Corona virus.

For the production of the recombinant SARS-CoV2 spike RBD2 protein (Fig. 1), the CHOEBNALT-85 system is used (Table 1). Cell culture of this CHO-based cell line (chinese hamster ovary) is performed in serum-free culture medium. The CHO cell line was stated by the manufacturer to be free of retroviruses. The protein is isolated by metal affinity chromatography followed by size exclusion chromatography and passed through a 0.2-µm sterile filter. Protein identity was confirmed by mass spectroscopy (Table 2, Figure 2). It shows high purity (>95%, based on SDS-PAGE, Figure 3), high monodispersity (analytical size exclusion chromatography, Figure 4 top) and high stability (analytical size exclusion chromatography after 3 freeze-thaw cycles, Figure 4 bottom). The functionality of the SARS-CoV2 spike RBD2 was validated by determining the binding affinity to the ACE2 receptor using Octet measurements (Figure 5).

In addition, the neutralizing effect of the antigen on anti-Covid-19 positive patient sera is also measured (Figure 6).

Due to the preparation methods used, particles larger than the respective RBD protein (hydrodynamic diameter: approx. 2.5nm) are separated. Thus, a possible contamination of retroviruses or parvoviruses (hydrodynamic diameter: approx. 100nm and 25nm, respectively) is excluded in the final product.

The measured endotoxin concentration according to the Limulus amebocyte lysate test (LAL test) of the SARS-CoV2 spike RBD2 is below 0.1EU/mg (see Figure 1, manufacturer’s specifications).

No microbiological growth was detected in the sterility test (bacteriological) of the protein (see figure 7).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 1: Structure of the recombinant SARS-CoV2 spike RBD2 protein

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Table 1: Manufacturer’s specifications for SARS-CoV-2 S1 RBD2

 

 

 

 

 

In the protein analysis, the score was calculated by the software Mascot with -10*log(P), where P is the probability that the hit found is a random event. A score above the cut-off is considered significant (p<0.05). If the target antigen was found during the evaluation, it is indicated in the table. In addition, all unrelated proteins above the cut-off are indicated, taking into account origin (e.g. organism, production) and size. If there were no hits above the cut-off, the band was labelled “not identified”. Database: combined sub-database of the NCBInr database (mammalia + viruses combined).

 

 

 

 

 

 

Table 2: Mass spectrometric protein analysis of the SARS-CoV-2 S1 RBD2

 

 

 

 

 

After reduction and alkylation, SARS-CoV-2 S1 RBD2 was denatured using lithium dodecyl sulfate followed by electrophoretic separation in Bis-Tris gel (MES buffer system). Staining was performed using Blue Silver. The labelled bands (41-44) were cut out of the gel, proteolysed in the gel using trypsin and then analysed by MALDI-TOF.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The mass spectrometric analysis of the tryptic peptides was performed on an Autoflex III (MALDI-TOF, Bruker Daltonik) using the positive reflector mode. A peptide mass fingerprint (PMF) spectrum was acquired from the peptide mixture of each gel band. Automated MS/MS analyses were performed on a maximum of four peptides from each PMF spectrum. The PMF and MS/MS data were aligned with a house-created sub-database of NCBInr (mammalia + viruses combined) using Mascot software (Matrix Science).

 

Figure 2: Identity determination of the SARS-CoV2 spike RBD.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 3: SDS-PAGE of the SARS-CoV-2 S1 RBD2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 4: Analytical size exclusion chromatography of SARS-CoV-2 S1 RBD2. Top: initial sample, bottom: after three freeze-thaw cycles.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 5: Determination of the binding affinity of SARS-CoV-2 S1 RBD2 to the ACE2 receptor using Octet measurements

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The addition of RBD-delta antigen to an antibody-positive serum causes the neutralization of RBD-specific antibodies and thus leads to a decrease in signal in the anti-SARS-CoV-2 QuantiVac ELISA (IgG) (Euroimmun). Neutralization with wild-type antigen leads to analogous results.

 

Figure 6: Neutralization

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 7: Sterility testing of the SARS-CoV-2 RBD2