Dr Robert Hess aims to maximize immunity levels in his clients for the event that they become infected with SARS-CoV-2. He also keeps his clientele informed about the latest developments in the pandemic and offers a personalized vaccination strategy on an ongoing basis.
Dr Robert Hess takes a look at new data on the protein-based inactivated vaccine.
Many people who are skeptical of mRNA technology have been waiting for a conventional vaccine against coronavirus to come along. “Classic” vaccines are traditionally based on proteins. However, the one formulated by Novavax has a major disadvantage, specifically its ability to provide long-term protection against virus variants.
On 10th October, scientists presented the results of a Phase 3 trial involving almost 30,000 adults resident in the USA and Mexico. In the preprint, they report an efficacy of 90.4 percent against symptomatic infection with SARS-CoV-2. In September, the New England Journal of Medicine published results from a trial involving 15,000 volunteers in the UK which came to the same conclusion. Both studies were conducted before the Delta variant became the dominant form of the virus. It was observed that the direct side-effects of vaccination in the Phase 3 study were less noticeable with the Novavax candidate than with the mRNA vaccines. Novavax is also injected in two doses.
Among the manufacturers of protein-based vaccines, the US pharmaceuticals giant is the furthest along in the approval process; its application has been running in the EU rolling review process since February of this year. The EU Commission has secured 200 million doses in anticipation of approval. Novavax plans to submit an application for approval of its vaccine in the USA this year. This was the state of play as of 15th October 2021. On closer inspection, however, the Novavax vaccine is somewhat less than conventional. The company itself makes reference to “innovative proprietary recombinant nanoparticle technology.” Although NVX-CoV2373 is a “killed” (i.e. inactivated) vaccine and is thus consistent with an established vaccination principle, it has also been given a new type of adjuvant to boost its effectiveness. This is based on a saponin extract obtained from the soap bark tree native to Chile. It is significant that the COVID-19 vaccines approved so far do not contain an active adjuvant.
The vaccine is produced in insect cell cultures, with up to 14 SARS-CoV-2 spike proteins being combined to form a nanoparticle which, for the immune system, resembles the virus itself. But the nanoparticle does not contain any genetic material – which is not only an advantage, but also a problem. This is because RNA or DNA content strengthens the immune response. This is part of the natural defense against infection, because regular pathogens also contain genetic material.
The adjuvant of the protein-based Novavax vaccine is apparently very effective, as indicated by the high efficacy in the studies. However, it cannot solve one problem of protein vaccines: they neither penetrate body cells nor do the multiply there. This means that the stimulation of the second arm of our immune system – the cellular immune defense – does not take place.
Vaccination can initiate a cellular immune defense response (T-killer cells, memory cells) as long as the vaccine enters body cells, something that Vector and mRNA vaccines are capable of. With protein-based vaccines, on the other hand, the cytotoxic T-cells are only marginally stimulated, with the main thrust coming in the form of antibody response. This makes it easier for the virus to become resistant to these vaccines because the immune response is not as broad.
This may also explain the results of a phase 3 trial in South Africa, where the efficacy of the Novavax vaccine NVX-CoV2373 against symptomatic SARS-CoV-2 infections was only around 50 per cent – possibly because of the local dominance of SARS-Cov-2 Beta which is the most efficient variant at evading neutralizing antibodies.
The Delta variant of coronavirus does not appear to lead to a more severe course of disease in children than earlier forms of the virus, such as the Alpha or Beta variants. This finding emerged from a prospective symptom study conducted in the UK, in which British school-aged children were compared for symptomatic COVID-19 courses over different time periods.
Study results coming in earlier this year had already indicated that the Alpha variant of the SARS-CoV-2 virus does not appear to make children more ill than the “wild” form of the virus which first appeared in China. The prospective COVID-19 symptom study, the results of which were published last week, compared two groups of school-aged children with confirmed SARS-CoV-2 infection: 694 children infected with the Alpha variant between late December 2020 and early May 2021, and 706 children infected with the Delta variant between late May and early July.
Disease profiles (prevalence of symptoms, duration and severity), hospitalization and presence of prolonged (≥ 28 days) illness were assessed. In both groups, half of the children were ill for no longer than five days. Although the Delta variant displayed slightly more symptoms than the Alpha, especially in older children, this was offset by a similar duration of symptoms, whether these were considered individually or for the illness as a whole. Furthermore, very few children in either group required hospitalization, and long periods of illness were rare. The study was, however, limited by the lack of information on differences between the groups that might have influenced the results, such as whether lockdowns were in force and the impact of different seasons on the course taken by the disease.
However, the data suggests that the clinical symptoms of COVID-19 caused by the Delta variant in children are broadly comparable to those of the disease caused by other variants. This also appears to be consistent with data from the US Centers for Disease Control and Prevention (CDC). That is to say, although we are seeing more cases in children, the severity of the disease is not increasing. The reason why more children are contracting COVID-19 is mainly because there are more COVID-19 cases in the population as a whole.
The study contributes quantitative information to the debate on whether there are significant clinical differences in COVID-19 due to the Alpha and Delta variants, and to the discussion on whether it is appropriate or necessary to vaccinate children (especially those in the younger age bracket) against SARS-CoV-2. We will continue to monitor developments here, especially with regard to new approvals for the vaccination of children.
Merck Sharp and Dohme (MSD), the US pharmaceutical giant based in Kenilworth, New York, last week reported positive results from a Phase III trial of its new corona drug, molnupiravir. The manufacturer claim that it alleviates the course of the COVID-19 disease and halves the risk of hospitalization or death from a coronavirus infection. The potentially groundbreaking results promise a new way of treating COVID-19 and herald the first of hopefully many more antiviral drugs. Until now, COVID-19 has been treated with steroids such as dexamethasone and intravenous antibodies (MAB). Both are administered to patients who are already extremely ill. This is not the case with molnupiravir: according to the manufacturer, the medication helps most when it is taken within five days of the onset of symptoms, i.e. in the early phase of the disease.
The issue of booster vaccination has risen high on the agenda, and every country is taking a different approach to it. Israel, Austria and Russia are already offering booster jabs to the general population, whereas Belgium, the United Kingdom, Denmark, Finland, France, Ireland, Italy, Spain and Sweden are restricting them to the immunocompromised or elderly. Germany will reach its own national decision in early October, and in the United States, the FDA announced last week that it had approved boosters, albeit on a more restrictive basis than had been expected.
As experts in the field of human and molecular genetics and thus also on the topic of mutations, Dr Robert Hess provides regular updates and forecasts of where the pandemic might be heading. Recently, new discoveries have come into the frame, so we have summarized these findings for you and added our own assessment.
Several thousand COVID-19 variants exist around the world, but most of them do not change the way the virus acts. So far, only a few mutants have evolved from the original strain that have given the virus an advantage and accelerated the course of the pandemic. Experts are constantly working to figure out which variants we should focus on and how they change the way in which we combat COVID-19.
CureVac's first-generation vaccine candidate CVnCoV unfortunately fell by the wayside in mid-June after failing to meet the statistical criteria for success, but there is now news regarding a modified second-generation vaccine candidate, which CureVac has developed in collaboration with British pharmaceutical giant GSK.
Back in February of this year, CureVac and GSK announced a €150 million joint project with the primary objective of developing multivalent vaccine candidates against viral variants. The initial preclinical data for the second-generation vaccine candidate, CV2CoV, was published in May, with the prospect of clinical trials commencing in the third quarter of this year. However, this target was missed, and the data from the preclinical study in non-human primates did not become available until 16th August 2021.
This study compared the immune response and protective efficacy of the first- and second-generation vaccine candidates. The second-generation CV2CoV was found to activate the innate and adaptive immune response better than its first-generation predecessor at the same dose, resulting in a faster onset of immune response, higher antibody titers and stronger activation of memory B and T cells. In addition, CV2CoV achieves greater antibody neutralization of all selected virus variants, including Beta, Delta and Lambda.
Induction of innate immunity was studied on the basis of specific cytokine markers. Adaptive immune responses were assessed according to specific antibodies for the receptor-binding domain and neutralizing antibodies, as well as memory B and T cells. The current preclinical testing of CV2CoV is to be followed by a phase 1 clinical trial commencing in the fourth quarter of 2021.
What exactly is the difference between the first-generation vaccine candidate (CVnCoV) and the second-generation version (CV2Cov)? CV2CoV is currently in the preclinical development stage and, like CVnCoV, consists of non-chemically modified mRNA which has been encoded for the prefusion-stabilized full-spike protein of the SARS-CoV-2 virus and formulated in lipid nanoparticles (LNPs).
However, CV2CoV is based on a newly developed mRNA “backbone” with specifically optimized non-coding regions to allow improved mRNA translation for enhanced and prolonged protein expression in comparison to that of the first-generation mRNA. The dosage of both vaccine candidates has not changed and remains at 12 µg per vaccine vial.
The data on the new CV2CoV vaccine looks promising so far, and if it carries on in this same positive direction, we expect the vaccine to be available sometime in 2022. We will continue to follow developments closely and provide you with any further information as soon as it becomes available.
Doctor Robert Hess comments about recent studies that have established a strong link between the presence of autoantibodies against interferon-I and a severe progression of disease after infection with SARS-CoV-2.
As we have explained in previous Keynotes, our body’s own interferon system plays an important role in the activation and modulation of the immune defenses. In this update, we will focus on what happens when there is a failure to activate the type I interferons (IFN-I) and on the risks that this poses. IFN-I is of immense importance in relation to the body’s own virus defense and thus highly relevant in the context of the SARS-CoV-2 pandemic.
Current thinking is that the functionality of interferon-I can be inactivated and/or neutralized by two mechanisms in particular: Firstly, a functional restriction can result from a genetic mutation, i.e. depending on the gene sequences in which the changes are located, it can distort the signaling pathway of interferon-I activation and thus weaken resistance to the virus. Studies conducted in 2020 were already able to establish a relationship between gene mutations of the interferon-I pathway and severe courses of the Covid-19 disease. The second potential factor behind restricted IFN-I functionality are the so-called “autoantibodies”, which have been the focus of research for some time. Originally, it was assumed that autoantibodies were the result of a severe Covid-19 infection, but it is now looking more likely that they are in fact the cause. This realization is based on two independent studies that investigated the prevalence of autoantibodies against IFN-I in the healthy population and the presence of autoantibodies against IFN-I in severely ill Covid-19 patients. It was found that 0.18% of healthy 18- to 69-year-olds had autoantibodies against interferon-I and that this proportion increased with age: autoantibodies were present in approximately 1.1% of 70- to 79-year-olds and in 3.4% of those over 80.
In the most recent study conducted in August of this year, scientists tested nearly 4,000 critically ill Covid-19 patients for autoantibodies to IFN-I. Overall, 13.6% of these patients had autoantibodies, ranging from 9.6% in those under 40 to 21% in those over 80. Autoantibodies were also present in 18% of those who died from the disease. Autoantibodies against IFN-I are therefore present to a certain percentage in the entire population, and their number increases with age. Taken in conjunction with other factors, it was therefore to be expected that there would be a connection between older age and a severe course of infection with SARS-CoV-2. Experts therefore recommend that patients suffering from Covid-19 be tested in hospital for potential autoantibodies against IFN-I and IFN-I mutations in order to better assess and predict the course of the infection.
The role of autoantibodies – also in relation to other infectious diseases – has not yet been fully explored. We expect that further insightful findings on this topic will emerge from research in the future.
As part of the Salvagene C-19 immunization program, the interferon receptors and their activity level are regularly tested. This allows us to ensure the optimization of interferon receptors and thus improve immune response through therapy suggestions.
For the first time since the Salvagene SARS-CoV-2 Task Force was established 18 months ago, a difference of opinion has arisen, specifically with regard to the Lambda variant. What everyone agrees on is that the Lambda or C.37 variant is clearly more contagious than the original Wuhan strain. In addition, it is much more resistant to antibodies, and the existing vaccines therefore have a reduced efficacy against it. The reason for this is three mutations in the spike protein, which render it less susceptible to neutralization by antibodies. Added to which there are two mutations that make the variant itself more infectious.
...which makes it all the more difficult to make any firm predictions for the autumn. In focus: Vaccine side-effects versus post-acute sequelae (“Long Covid”).
Dr Robert Hess skepticism regarding the efficacy of all previous vaccines against the Delta variant has been confirmed by the announcement from BioNTech/Pfizer that they are working on a vaccine that will specifically target this mutant.
So far, we have been testing only one of the two immunity pillars, namely antibody production. In addition to checking the full range of antibodies, we at Salvagene go far beyond the generally applied classification to differentiate between the neutralizing antibodies and identify efficacy classes – low, medium and high – plus ADE antibodies which may even have the undesired effect of amplifying an infection. From now on, we will also be measuring the second Covid-19 immune pillar – namely T cell immunity – in great detail. For this purpose, we have upgraded our Covid-19 Immunization Program with the inclusion of the new SARS-CoV-2 T-Cell immunity analysis.
The SARS-CoV-2 T-Cell immunity analysis is to be integrated into the Covid-19 Immunization Program for Salvagene Premium clients with immediate effect. So far, we have been testing only one of the two immunity pillars, namely antibody production. In addition to checking the full range of antibodies, we at Salvagene go far beyond the generally applied classification to differentiate between the neutralizing antibodies and identify efficacy classes – low, medium and high – plus ADE antibodies which may even have the undesired effect of amplifying an infection. From now on, we will also be measuring the second Covid-19 immune pillar – namely T cell immunity – in great detail. For this purpose, we have upgraded our Covid-19 Immunization Program with the inclusion of the new SARS-CoV-2 T-Cell immunity analysis.
Though the news was not entirely unexpected, we regret to report that the breakthrough vaccine promised by CureVac will now not be forthcoming. There are a number of reasons for this, but the main factor was the high demands that CureVac itself placed on the product. The aim was to develop a vaccine that was as natural as possible – ideally the most natural vaccine to date. In the end, it was the much-debated issue of vaccine-induced side-effects and long-term effects that thwarted their endeavor.
This is a vital question that can only be answered when enough time has elapsed for results to come in.
There is one thing we can be certain of, however, namely that the protection afforded by vaccines does not live up to the claims made by their manufacturers. We strongly disagree with the assertion that “vaccine protection will remain at the same high level for approximately one year, so that we can get into an annual vaccination cycle like the one we have for influenza.” This is the reason why we set up our SARS-CoV-2 Antibody Profile Monitoring for Premium clients at the start of this year, measuring levels of SARS-CoV-2 antibodies as well as T-helper cells specific to SARS-CoV-2 and thereby covering both pillars of the immune response.
In India, the Delta variant has been responsible for a sharp increase in the number of infections, illnesses and fatalities. The health system there is at breaking point. In the meantime, the Delta variant has also been discovered in other parts of the world, especially in the UK, which is a country where virus variants are monitored with exemplary thoroughness. It is expected that the Delta variant will supplant Alpha (B.1.1.7), which has been the most widespread variant so far. According to official data, Delta is currently present in nine out of ten samples sent for analysis.
... SARS-CoV-2 antibody and immunization testing that the track record of the vaccines is very disappointing, with more side-effects than originally expected. We therefore intend to have a personalized vaccine combination in place for 2022. In contrast to the phase 3 data published by the various vaccine manufacturers, some of which claim headline rates of more than 90% efficacy, the test results that have come back from our clients indicate none of the vaccines has achieved this sort of success. Based on the clinical data and biochemical evaluations that we carry out at regular three-monthly intervals, we conclude that the levels actually attained are considerably lower. Antibody production and quality in particular reveal a significantly lower immunization status. This applies to all vaccines.
...to the effect that a laboratory accident as the cause of the pandemic was “extremely unlikely”. The skepticism we expressed at the time about their findings is now being vindicated.
At the time, we came in for considerable criticism for our assessment that the probability of a laboratory accident having released the virus was around 60%, and we were even accused of stirring up a conspiracy theory.
In our series on smart solutions for managing the coronavirus crisis, Dr Robert Hess has frequently reported on C19 rapid antigen testing, and he has explained how this technology has the potential to be a real game changer in the context of the Covid-19 pandemic.
With the onset of the flu season, it is vital to correctly diagnose symptoms to establish what kind of infection they indicate. We explain below why this is so important. During the flu season, we are exposed to a whole range of different viruses, of which SARS-CoV-2 is currently the greatest cause for concern. The four most important virus types in this flu season also include the coronaviruses responsible for triggering the common cold, the influenza viruses which cause flu and the noroviruses responsible for gastrointestinal infections.
It is very important to distinguish and diagnose which disease you may be suffering from. As we have already reported, in the event of multiple infections, the order in which they have been caught will determine the severity of the course of the disease.
In the first part of this Keynote thread, we discussed the role and functionality of interferons in relation to the pandemic. Their importance is apparent from the very many projects in this field taking place around the world.
The current pandemic can be viewed from three distinct perspectives:
The warnings are growing louder about a winter in which we not only have to contend with the risks posed by SARS-CoV-2 but also by influenza viruses. It is still not clear whether the viruses are mutually reinforcing.
As we have already reported in our WhatsApp broadcast, an examination of the genetic mutations in the various types of SARS-CoV-2 virus currently circulating in the world reveals two trends. On the one hand, the viral load is in some cases significantly higher than before because of these mutations, and as a result the viruses are easier to catch, as can be seen from the sharp increase in the number of cases being reported. On the other hand, the multiplicity of mutations observed suggests that the number of very severe Covid-19 cases is decreasing and that the mortality rate is slowly falling. Yet overall mortality remains high due to the sharp increase in the number of infections. However, there are also several mutations that lead to more complex and complicated courses of the disease.
The one place in the body where the virus cannot be shaken off. Fatigue, headaches, strokes – SARS-CoV-2 also causes serious damage in the brain. It has now been proven that the virus can cross the blood-brain barrier and even infect unborn babies. How can it be stopped?
An incorrectly formulated vaccine can significantly exacerbate the harm done by the virus.
We have previously reported on the long-term damage that results from Covid-19, and examinations conducted by pathologists are providing an especially rich source of information confirming this. Some time ago, we wrote about a study at UKE in Hamburg, which is looking at the effect on various organs. In this Keynote, we will address the issue of long-term cardiovascular damage.
Gam-Covid-Vac is a joint project between the Russian Ministry of Defense and the internationally little-known Gamaleya Research Institute of Epidemiology and Microbiology. Starting on 20th August, the world’s first vaccine against Covid-19 will be widely distributed for use on the general public. The first large-scale trials began some time ago on thousands of military personnel as well as doctors and teachers. The decision has now been taken to extend it to the entire population.
Many people who catch the coronavirus manage to avoid infecting anyone else. The disease is mainly spread by just a few individuals. In this podcast, we explain what makes these individuals so infectious and the significance of the k factor.
In our first podcast, we present some of the new technologies behind potential Covid-19 therapies to complement the solutions already outlined in our Keynote series. We see them as, at best, a bridging solution while we wait for a future vaccine to become globally available.
Unfortunately, it is still too soon for us to be making individual recommendations on vaccination. This is mainly because we do not recommend that our clients volunteer to be among the first 1-2 million recipients of any particular vaccine, as experience has shown that this is the stage at which adjustments to dosage take place and any unwanted side-effects generally manifest themselves.
Medical associations such as DEGAM (Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin) in Germany have been adopting the same recommendations we have been making to our Premium clients since May as part of our Covid-19 Immunization Program and have developed their own individual measures based on this strategy.
The wider interests of society in combating the pandemic and the interests of the individual have not yet converged. What is best for society in its efforts to control the pandemic may not necessarily coincide with what is best for the individual.
...antibody medication from Eli Lilly. Numerous active substances have so far been tried out against the virus. Once they have been officially approved for use, we look at their pharmacogenetic profile to decide whether they offer individual efficacy for our Salvagene Premium clients over and above the standard range of efficacy that is determined in the course of the official approval process. It has to be said that, apart from the cortisone preparation dexamethasone, there is no really convincing treatment for patients suffering from the effects of Covid-19. As we have been reporting for some months now, our best hopes lie in so-called “monoclonal antibodies”.
With the announcement by the FDA last Friday evening (11th December) that they had given emergency approval for the vaccine developed by the Mainz-based BioNTech company and manufactured by its commercial partner Pfizer, we are now able to make initial and preliminary recommendations to Dr Robert Hess Premium clients in the USA.
The first Covid-19 vaccine in the Western world, which was developed by BioNTech in Germany, was granted emergency approval in the UK, USA, Canada and other countries several days ago. It is therefore no surprise that political pressure has been growing in Europe in response to the obvious question why a vaccine developed in Germany is not also available in the member states of the European Union.
We at Salvagene have been specializing in the field of genetics for more than 20 years, and it now constitutes our core competence. We are therefore looking at the coronavirus pandemic and the Covid-19 disease from a genetics-based perspective, and we regard it as a matter of utmost priority.
Genetic information that instructs human cells to produce a fragment of the virus. Despite the fact that research in the field of mRNA has been going on for 30 years now, not a single medication based on this technology had succeeded in getting past the approval stage until the EMA authorized its use a few days ago.
will be determined by the genetics of the SARS-CoV-2 virus itself. The prospects for success in defeating the pandemic in 2021 are therefore uncertain. SARS CoV-2 Task Force: As we have long maintained, the direction taken by the pandemic will be determined by the genetics of the SARS CoV-2 virus itself. The prospects for success in defeating the pandemic in 2021 are therefore uncertain.
Dramatic development in long-term effects from Covid-19 – Individual recommendations on vaccination for Dr. Hess premium clients. We have been predicting for some time now that SARS CoV-2 would mutate and evolve. From the variants that have since emerged – in particular B.1.1.7. and 501Y.V2 – it is clear that central monitoring of new variants as they arise, similar to that for influenza viruses, has a vital role to play in ensuring better management of the pandemic. It is also important for us in the work we do advising our clients on vaccination.
... following further mutations in the SARS-CoV-2 virus – Dr. Hess reserves judgment on vaccination. The eyes of the entire scientific world are currently fixed on two countries: on the one hand, Israel, which has achieved the highest per capita vaccination rates and could therefore provide valuable lessons in terms of vaccine rollout, effectiveness, infectivity and herd immunity; and on the other, Brazil, specifically because of the SARS CoV-2 gene variants discovered there, which have led the British government to impose entry bans from the South American continent and from Portugal.
Doctor Hess introduces infection and vaccination log for Premium Clients. This last year has gone by surprisingly fast for us, and it seems like only yesterday that we were putting our team together. Almost six weeks before the World Health Organization declared the pandemic, the data we had already received from Asia prompted us to react at a relatively early stage. It was a very busy time for us, during which we learned a lot. Looking back at all of our communications with you during these past 12 months, we have published around 100 Keynotes and at least as many podcasts. They are still all available online as well as on our app. Somewhat to our surprise, none of these communications has turned out to be wrong in terms of content. We have no regrets as to the information we have published here, because we pride ourselves on taking a very clear approach and see ourselves as a filter to minimize the spread of “fake news”.
Right from the start, SARS CoV-2 has measured up to the two main criteria of a model pandemic virus: it spreads easily and kills only a small percentage of those infected. However, new mutant forms have produced a new twist in the plot. It comes as no surprise to us that the goalposts have been moved in favor of the virus.
We have been monitoring tocilizumab for some time now and have already reported on its potential in previous Keynotes. We are of the opinion that it could, under certain circumstances, be used in the treatment of Covid patients.
... of vaccination are minimal to zero. This internal study involved Dr Robert Hess Premium clients who have subscribed to our Covid-19 Immunization Program since April 2020, who have a Covid-19 Risk Factor of <0.7 and a Cytokine Risk Factor of <0.6, and who have been fully vaccinated with both a first and a second dose. In this internal study, which covered an observation period of approximately eight weeks after vaccination, retests were performed within the scope of our Covid-19 Immunization Program, in which zero to minimal improvement in immune response was detected. The benefits that were noted were in the area of antibodies. In some cases, however, we actually observed deterioration of the interferon system during the study period.
... vaccines and optimization of the immune system is becoming an increasingly uphill challenge. Dr Robert Hess SARS-CoV-2 Task Force was set up in January 2020 with the aim of providing his Premium clients with the best possible service during the current pandemic by critically evaluating information on SARS-CoV-2, filtering out the irrelevant and/or misleading and communicating the results. It is a job that has become increasingly difficult.
The alpha version of this monitoring program will be applied immediately to all retests for Premium clients at no extra charge.
New strategy emphasis for Dr. Hess clients group in 2022. Dr Robert Hess considers that the likelihood of a major vaccine campaign bringing the pandemic to an end this summer is diminishing. With this long-term scenario in prospect, we at the Salvagene Group have had a strategic rethink, not least because we have been allocating so much of our resources to SARS-CoV-2 research over the past twelve months. We now intend to significantly expand capacity in our core expertise, namely cancer prevention, to avoid a situation where this priority is repeatedly pushed to one side. We have to work on the assumption that the SARS-CoV-2 virus will keep us occupied for a long time to come. To meet the challenge, we will be reorganizing and significantly expanding our research capacities.
We are not surprised by the latest developments surrounding the current crop of vaccines and the problems that have arisen, especially with regard to AstraZeneca. Since April 2020, we have repeatedly pointed out shortcomings in the design of the pivotal study, the results of the efficacy study and even fundamental design flaws in the vaccine.
Since posting our previous podcast in which we detailed our concerns about vector-based vaccines – more specifically AstraZeneca – as the possible cause of thrombosis, more material has come to hand explaining why there are significant though rare side-effects, including death. These concerns have led to many countries restricting the use of the AstraZeneca vaccine, at least for certain age groups. They have taken this decision despite the European agency, EMA, standing by its continued unrestricted approval. The relevant materials include records of thrombosis cases, including the incidences of sinus vein thrombosis that are of special interest for us.
... the rollout to their age group has been halted? Are vector-based vaccines really on the way out? As Dr Robert Hess mentioned, hundreds of thousands of young men and women have already received their first shot of the AstraZeneca vaccine. How to proceed next is a question that is preoccupying health authorities throughout the EU as well as in other first-world countries such as Australia and Canada.
Dr Robert Hess thinks that the lobbying power of the various pharmaceutical manufacturers – especially in Washington, Brussels and Amsterdam – will prove strong enough to ensure the continued deployment of vector-based vaccines. The industry is able to make a convincing case that these vaccines are needed, especially in Third World countries. Firstly, because AstraZeneca is a very cheap vaccine to store and secondly because only a single dose of Johnson & Johnson has to be administered. These vaccines are therefore a good solution for countries with poor infrastructure.
We view with concern policy statements emanating from various health authorities around the world regarding national testing strategies and whether these are to be applied to the vaccinated population. It has been suggested by both the Centers for Disease Control and Prevention (CDC) in the USA and the Robert Koch Institute (RKI) in Germany that vaccinated persons might be exempted from testing arrangements. We are very much opposed to any such policy because of the consequences it would have for the behavior of those who are vaccinated and for our Premium clients.
Biotech SMEs win hands down against big pharma in the race to develop vaccines. A word of caution to our Premium clients: Anyone in recovery from Covid or suffering from Long Covid needs to take precautions against aspergillus spores.
Dr. Robert Hess unveils strategy for transition to the next generation of SARS-CoV-2 vaccines. – Also for Premium clients, a new system for monitoring epigenetic changes triggered by vaccines.
Dr Robert Hess aims to maximize immunity levels in his clients for the event that they become infected with SARS-CoV-2. He also keeps his clientele informed about the latest developments in the pandemic and offers a personalized vaccination strategy on an ongoing basis.