Tag Archives: COVID 19

Dr Robert Hess: Booster jabs are contributing

Dr Robert HEss

Dr Robert Hess – 10/08/2021

Dr Robert Hess: Booster jabs are contributing to the individualization of the vaccination concept: Weighing up the potential side-effects of the Covid-19 vaccines and deciding the “price” we are willing to pay.

As winter approaches in the northern hemisphere, booster vaccinations are being rolled out with the aim of giving maximum protection to the elderly, the immunocompromised and professionals exposed to the virus. The administration of booster jabs against Covid-19 is a new concept and one that is likely to be with us for the foreseeable future, as the efficacy of the vaccines against Covid-19 wears off over time. According to the manufacturer of the Pfizer/BioNTech vaccine, it loses approximately six percent of its effectiveness every two months, but our experience has shown that this is a conservative estimate.

This is a game changer, as we are no longer dealing with primary protection, but rather with the boosting of immune status which is composed of antibodies, T-cell reactions and much more besides. However, this attempt at maintenance also entails certain risks. Although the documentary evidence for short-term side-effects of booster vaccination does not give cause for concern so far, we cannot yet clearly assess what the cumulative effect of repeated vaccine doses on our bodies might be in the long term. Repetitive vaccination (and we are not just talking about SARS-CoV-2) puts everyone at increased risk of an adverse dose reaction, for example in the form of anaphylaxis. The bioaccumulation of LNPs (= lipid nanoparticles, an adjuvant of the mRNA vaccines, which enclose the RNA and transport it) could also trigger immune reactions, a potential outcome that is becoming ever more relevant with the booster shots.

All of these considerations have to be weighed up against the alternative: absolute renunciation of the booster vaccine could mean accepting the risk of infection with Covid-19 and possible long-term sequelae. There are, of course, no circumstances under which death from Covid-19 is an acceptable risk, but the long-term consequential damage from Long Covid may well be such. Along with permanent optimization of the immune system, vaccination is currently the most potent means of strengthening our immune status.

In summary, we wish to make you aware that, with every vaccine dose you receive, there is a certain “price” to be paid. This can range from minimal side-effects to hypersensitivity reactions, triggering of autoimmune diseases and symptoms of toxicity. How high this price ultimately goes and whether we should consider it reasonable is not always obvious and is a matter for each individual to decide. Depending on age, immune status and various other factors, the recommendation will vary. Our SARS-CoV-2 Task Force will continue to use your data analyses and our A.I. system to advise on the acceptable “price” (i.e. level of risk) for you.

Dr Robert Hess: Corona drug molnupiravir

Dr Robert HEss

Dr Robert Hess – 10/05/2021

Dr Robert Hess: Corona drug molnupiravir significantly reduces number of severe cases of disease and raises hopes, says manufacturer.

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.

Molnupiravir has not yet been fully approved, but an Emergency Use Authorization (EUA) from the FDA is expected. Could this antiviral pill bring the world a little closer to normal again?

What is molnupiravir and what are its origins? Molnupiravir was initially developed for the treatment of flu, but has not yet made it to the approval stage for this particular disease. The medication was developed at Emory University in Atlanta, Georgia, in the course of drug discovery research, and in late July 2020, Merck and Ridgeback Biotherapeutics announced plans to study the efficacy of molnupiravir against COVID-19 in trials that would begin in September 2020. On 19th October 2020, Merck then commenced the one-year Phase II/III study of hospitalized COVID-19 patients in the United States.

Molnupiravir itself is a prodrug of N4‑hydroxycytidine, a long-established virustatic agent. As early as the 1970s, scientists were studying the effectiveness of N4‑hydroxycytidine against smallpox viruses. N4‑hydroxycytidine is a ribonucleoside analogue that is inserted into the viral RNA as a “bad” building block, which leads to considerable errors in the copying process with the RNA polymerase (a protein complex that initiates the formation of RNA on the basis of an RNA or DNA template). The mechanism of action is similar to that of the nucleotide analogue remdesivir. However, the effects seem to be more pronounced. The researchers observed lethal viral mutagenesis with catastrophic consequences for the virus (RNA virus error catastrophe). N4‑hydroxycytidine is claimed to be effective against coronaviruses such as SARS-CoV, MERS-CoV and SARS-CoV-2.

What do the results of the trials tell us? The Phase 1 trial of molnupiravir was conducted by the Miami-based manufacturer Ridgeback Biotherapeutics, which had acquired the rights to molnupiravir from Emory University. Molnupiravir was tested on healthy volunteers at a center in the UK at a single ascending dose of 50 to 1,600 mg. No serious adverse events occurred.

Molnupiravir was then tested in a Phase 2 trial on 202 patients who had been infected with SARS-CoV-2 but had only mild COVID-19 symptoms. Patients were given 200 mg to 800 mg of either molnupiravir or a placebo twice daily for five days. At the end of this 5-day period, all patients who had taken tablets containing 400 mg or 800 mg of molnupiravir were virus-free, while the smear test in the placebo group was positive in 11% of patients. As in the Phase 1 trial, molnupiravir was well tolerated. The rate of treatment-induced or serious side-effects was not higher than in the placebo group.

Merck (MSD) has since acquired the license and is currently investigating molnupiravir in multiple international Phase 3 trials at 170 separate centers. The MOVe-OUT trial involved 775 patients displaying mild to moderate COVID-19 symptoms, whose infection had been confirmed no more than five days before. All patients had at least one risk factor for adverse disease progression such as obesity, old age, diabetes mellitus or heart disease. Patients were randomized to five days of treatment with either molnupiravir or a placebo.

An interim analysis in early August found that molnupiravir had reduced the risk of hospitalization or death by around 50%. According to the manufacturer’s press release, this primary endpoint occurred in 28 out of 385 patients (7.3%) in the molnupiravir group as compared with 53 out of 377 patients (14.1%) in the placebo group. There were no deaths in the molnupiravir group compared with eight deaths in the placebo group, so that continuation of the trial was suspended after consultation with the FDA.

What are current expectations? Based on the above results, the manufacturer Merck (MSD) hopes for an emergency approval (EUA) in the near future. Corresponding applications are also to be submitted to other regulatory authorities worldwide. If the medication is approved by the US Food and Drug Administration (FDA), the US government plans to purchase 1.7 million doses.

According to MSD, the company could produce ten million doses by the end of the year. MSD has already entered into licensing agreements with five Indian generic manufacturers, which means that the drug could be made available quickly in large quantities if it is successful.

The latest results from the Phase 3 trial look very promising. The fact that molnupiravir is a drug that is most effective in the early phase of the disease is also a great advantage. We are working on the assumption that the results of the trials will indeed lead to an EUA from the FDA. When this will come is not yet entirely foreseeable, especially since the data have not yet been published and subjected to peer review.

We will continue to keep an eye on what is happening and keep you informed about this. We will also find out when the drug would be available at the earliest and whether it might make sense to be able to have access to it in the event of an infection. Depending on your personal situation, we will contact you again individually as soon as this drug is approved.

Dr Robert Hess: FDA approves booster

Dr Robert HEss

Dr Robert Hess – 09/29/2021

Dr Robert Hess: FDA approves booster dose of Pfizer-BioNTech vaccine for the over-65s and for vulnerable categories but not yet for the wider population.

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.

On 22nd September 2021, the FDA issued Emergency Use Authorization (EUA) for the booster dose of Pfizer-BioNTech’s COVID-19 vaccine, but only for certain population groups. The FDA’s decision not to extend the scheme (at least for the moment) to the general population or to all persons aged 16 and older came as a direct rebuff to the announcement from the Biden administration in August that boosters would become available to all eligible Americans starting in late September. It remains to be seen whether this extension of coverage will now happen. At the beginning of last week, the Key Vaccine Advisory Committee voted by a majority of 16-2 against a third vaccination for younger groups of people because of uncertainty as to whether it could be justified in the absence of firm data.

The approval granted by the FDA to the booster vaccination is limited to the following groups of people:

– persons aged 65 years and older;
– persons aged 18 to 64 years for whom who a severe course of the COVID-19 disease poses a significant risk; and
– persons aged 18 to 64 years who are at high risk of severe COVID-19 complications due to occupational exposure to SARS-CoV-2, such as health care workers, teachers etc.

The CDC made known its own booster vaccination recommendation on 23rd September, which is broadly consistent with the terms of approval granted by the FDA. The CDC further recommends that people aged 50-64 years with an underlying health condition should also receive a booster shot of the Pfizer-BioNTech vaccine.

They also advise that, depending on the balance of individual benefit and risk, people aged 18- 49 with an underlying health condition should also receive a booster shot of the Pfizer-BioNTech vaccine. The roll-out of Pfizer-BioNTech booster vaccinations will now begin quite soon in the United States. The single booster jab is to be administered no earlier than six months after completion of the Pfizer-BioNTech primary series (i.e. the first two doses of COVID-19 vaccine). Moreover, the approval of the booster vaccination only applies to the Pfizer-BioNTech vaccine and does not cover the Moderna or J&J alternatives.

The FDA and CDC have thus laid down a guideline, which we will also follow as far as possible. While booster vaccination undoubtedly makes sense for individuals who have passed a certain age threshold or whose physical constitution warrants and/or allows it, different criteria apply to younger age groups. This is the precise reason why we operate on the individuality principle, answering this question on an individual basis for anyone who does not specifically find themselves in one of the above-mentioned groups. If you have any questions or comments, please do not hesitate to contact one of our SARS-CoV-2 Task Force consultants.

Dr Robert Hess: Current status and news of new concepts

Dr Robert HEss

Dr Robert Hess – 09/16/2021

Dr Robert Hess: Current status and news of new concepts such as antibody therapy and vaccination by inhalation against COVID-19 infection.

Dr Robert Hess has a special interest in this topic, because for some of our premium members the conventional vaccination against Covid-19 is not an option or even can be counterproductive. We see these new concepts as possible solutions for additional protection against coronavirus infection without the need for vaccination.

In certain cases, monoclonal antibodies (MAK) are considered to be a promising drug against severe disease progression in SARS-CoV-2 infection and have been used in the clinical setting for some time. In this context, we are particularly interested in the question of whether and, if so, when antibody therapy might also be used in the context of prophylaxis against a covid infection.

What exactly are monoclonal antibodies (MAK)?

Monoclonal antibodies (MAK) against the SARS-CoV-2 coronavirus are proteins of the immune system that have been biotechnologically engineered to dock to specific surface structures of the SARS-CoV-2 coronavirus. The engineered antibodies bind structures on the coronavirus or block receptors on human cells, preventing SARS-CoV-2 viruses from entering human cells. MAK-containing drugs may also contain combinations of multiple monoclonal antibodies. Monoclonal antibodies were previously only intended as drugs for early therapy in persons infected with SARS-CoV-2 at risk of a severe course, but in August of this year, the FDA approved the first monoclonal antibody therapy for post-exposure prophylaxis as part of the emergency use authorization (EUA).

The FDA revised the EUA for REGEN-COV, which consists of the monoclonal antibodies casirivimab and imdevimab administered together, authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and adolescents (12 years of age and older) who are at high risk of progression to severe COVID-19, including hospitalization or death. It remains the case that REGEN-COV has not been authorized for pre-exposure prophylaxis to prevent COVID-19 (i.e. before being exposed to the SARS-CoV-2 virus) – only after exposure to the virus. REGEN-COV was already approved earlier this year for the treatment of mild-to-moderate COVID-19 in adults and adolescents (12 years of age and older) who have tested positive for SARS-CoV-2 and are at high risk of progression to severe COVID-19, and it remains authorized for that.

The FDA emphasizes that prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. REGEN-COV may only be used as post-exposure prophylaxis for adults and adolescents who are:

– at high risk of progression to severe COVID-19, including hospitalization or death, and

– not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and

– have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria or

– who are at high risk of exposure to an individual infected with SARS-CoV-2 because of other individuals in the same institutional setting becoming infected with SARS‑CoV‑2.

How is close contact to an individual infected with SARS-CoV-2 defined?

The CDC defines close contact as someone who has been within six feet of an infected person (laboratory-confirmed or a clinically compatible illness) for a cumulative total of 15 minutes or more over a 24-hour period.

What are the possible side effects of receiving a treatment with monoclonal antibodies, such as REGEN-COV?

The most common side-effects were injection site reactions. The signs and symptoms of injection site reactions which occurred in at least 1% of subjects in the REGEN-COV group were skin redness (erythema), pruritus, and ecchymosis (discoloration of the skin resulting from bleeding underneath, caused by bruising). There were no cases of severe hypersensitivity reactions, or potentially life-threatening allergic reactions such as anaphylaxis.

Vaccination by inhalation:

Inhaled vaccines aren’t unheard of — they exist for other viruses such as flu. But they are a relatively new technology, arriving on the market in the early 2000s. The Covid-19 pandemic, however, requires the largest mass-vaccination campaign in history, which means all options need to be on the table for first-round vaccines and any boosters that may be required. Inhaled vaccines should be easier to administer as well as being more accessible and are claimed to have fewer systemic side-effects.

There are currently several research facilities and drug companies testing and evaluating possible intranasal and inhaled COVID-19 vaccines. CanSino Biologics, a Chinese drug company; just finished their phase 1 clinical trial on the world’s first aerosolized adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) and announced its safety and effectiveness after administration of two doses. Phase 2 clinical studies of the vaccine are ongoing.

In the UK, scientists at the University of Oxford have begun phase 1 clinical trials on 54 healthy adults to investigate intranasal vaccination with Covishield following positive findings from studies done on hamsters, while Codagenix, a biotech startup, is currently evaluating a novel inhaled COVID-19 vaccine candidate called COVI-VAC in phase 1 clinical trials involving 48 participants. COVI-VAC is a single-dose, intranasal, live-attenuated vaccine against COVID-19. Unlike many other COVID-19 vaccines, COVI-VAC is designed to produce immunity against all SARS-CoV-2 proteins, not just the spike surface protein, positioning it to protect against a range of SARS-CoV-2 strains.

And in the US, the startups Phage Novo Bio and Precision Virologics have also shown through animal trials that their inhaled candidates for Covid-19 vaccines were safe and effective. In a new study assessing the potential of a single-dose intranasal COVID-19 vaccine, a team from the University of Iowa found that the vaccine fully protects mice against lethal COVID-19 infection. The vaccine also blocks animal-to-animal transmission of the virus.

So far, all of the inhaled Covid-19 vaccine candidates are either in the animal testing phase, or the first stages of clinical trials testing the safety and effectiveness of these sprays in a small group of healthy people. We can therefore only provide an overview of this topic but will continue to keep an eye on what is happening. The publications and findings to date seem promising. Ordinarily, it can take years for vaccines to go from early clinical trials to the market. At the moment, drug regulators have accelerated the authorization process by laying out the exact kinds of data companies need to generate to prove their products are safe and effective. The urgency of vaccinating the world may keep these high-speed processes in place to get the much-needed approvals.


Dr Robert Hess: Update on new mutations

Dr Robert HEss

Dr Robert Hess – 09/14/2021

Dr Robert Hess: Update on new mutations and what you need to know about COVID-19 variants.

As experts in the field of human and molecular genetics and thus also on the topic of mutations, we provide 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. At the moment, there are only a handful of COVID-19 variants that give us cause for concern. The current “variants of concern” (VOCs) all have mutations in the virus’s spike protein, which acts as a key to break into cells and infect them. This is a source of concern because the spike protein from the original version of the virus is what the scientists have used to design all three authorized vaccines. It is also what monoclonal antibody treatments latch on to so the virus is unable to get into your cells, effectively neutralizing the threat. So far, none of these mutations have changed the virus enough to undercut the vaccines. The current VOCs listed by the WHO are Alpha, Beta, Delta and Gamma SARS-Cov-2 variants.

The Delta variant is our biggest concern at the moment. Identified in India in October 2020, it gained dominance quickly after it was first reported in the U.S. in March 2021. In fact, Delta has now spread to such an extent that it has splintered into several subvariants, referred to as “Delta plus”. Delta plus variants have a mutation in the spike protein found in both the Beta and Gamma variants that may help to evade neutralizing antibodies. While around 13% of infections in the U.S. are from Delta plus variants (AY.1, AY.2, and AY.3), they still behave similarly to the Delta variant. The AY.3 subtype is one of the most recent descendants of Delta but among the most notable. Experts suspect that it is potentially better at escaping the immune system. The variant is most dominant in the US where it makes up roughly 9% of all cases. Along with AY.1 and AY.2, it is now also a variant of concern (VOC). Together, the Delta lineages make up 80-95% of sequenced infections in the U.S. Like other VOCs, Delta has multiple mutations in its spike protein. What makes Delta unique is that it is much more efficient at latching onto your cells and is much more contagious. As already stated, Delta is about twice as infectious as the original strain and estimated to be 60% more infectious than Alpha. People infected with the Delta variant have been reported to have viral loads 1,000 times higher than other variants. Besides the above, five variants of interest (VOI) are currently (as of 09/07/2021) listed and followed with special attention: Eta, Iota, Kappa, Lambda und Mu. While the first four have been under special observation for at least one and a half months, Mu was only classified as a variant of interest by the WHO towards the end of August 2021 due to outbreaks in Europe and increasing infections in Colombia and Ecuador, where the Mu variant is responsible for 39% and 13% of COVID-19 infections. Mu was first sequenced in Colombia in January 2021. So far, it has been documented in 39 countries, including the U.S. However, the percentage of COVID-19 cases triggered by the Mu variant in the U.S. has been falling since July, and the Mu variant caused only about 0.2% of COVID-19 infections in the country in the week of 20th ‑ 27th August. What worries scientists is that the Mu mutations could indicate possible resistance to vaccines. Early research from Italy shows Mu is susceptible to antibodies produced by the Pfizer-BioNTech vaccine, but they don’t work as well as they do against the original Wuhan strain or Alpha variant. In addition, the combinations these mutations indicate a risk of immune resistance. Early research from the U.K. found the specific mutations may help Mu escape the immune system. Further studies are needed for an accurate assessment.

While much of the world’s focus has been on the Delta variant of coronavirus, a new variant was identified in South Africa in May 2021. Currently referred to as the C.1.2 variant, it is yet to be called a VOI or VOC by the WHO, but is drawing the attention of scientists due to the number and types of mutations it contains and the speed at which the mutations have occurred. With 59 detected mutations, C.1.2 is reported to be the variant carrying the most mutations since the original “wild” variant emerged in China. The variant has emerged from the C.1 lineage which was one of the coronavirus lineages that dominated during the first wave of infections in South Africa in mid-May 2020. Although levels of the C.1.2 variant are still low among the South African population, it remains a concern to local public health experts and scientists across the world. Currently, Delta remains the dominant variant in Europe, the U.S. and much of the world. For a variant to become dominant it will have to outcompete Delta. That will mean increased transmissibility, being able to bind to human host cells and infect people quicker than Delta currently does. Time will tell whether any of the variants mentioned here will prevail against Delta and, if so, to what extent. The WHO, public health experts and scientists will continue to closely monitor the course of events. We will also continue to keep you informed about any news on this front.

Dr Robert Hess: Recent studies have established a strong link

Dr Robert HEss

Dr Robert Hess – 09/03/2021

Dr Robert Hess: Recent studies 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 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.

Differing opinions about the Lambda variant

Dr Robert HEss

Dr Robert Hess – 07/29/2021

Differing opinions about the Lambda variant: Super mutant, successor to Delta or damp squib?

For the first time since the 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.

The WHO still has Lambda marked out as a “variant of interest”, as does the CDC, but there are other authorities, such as in Japan, that have classified it as a “variant of concern”. Some scientists argue that the Lambda variant could also have the potential to become a super mutant. At the moment, it is particularly widespread in Latin America. In vitro laboratory experiments show that this variant is clearly more contagious than the wild-type (Wuhan) variant, but at the same time less contagious than the Delta variant. The logical conclusion from the in vitro laboratory tests is that it cannot out-compete the Delta. The long-term prospects for the Lambda variant are thus unclear, and we will report on further developments on an ongoing basis.

The reduced efficacy of vaccines is a hugely important topic of discussion at the moment. More and more data is being published all the time, and in the EU alone, over 150,000 fully vaccinated people have nonetheless contracted Covid-19. The figures emerging from Israel on so-called “breakthrough infections” where the virus manages to breach vaccine defense show that not only low responders and non-responders are affected, but also fully vaccinated, healthy individuals. The reduced effectiveness of the vaccines has the consequence that, even in countries with high vaccination rates, intensive care units are slowly beginning to fill up again. Because increased numbers of younger people and even children are being taken to ICUs, especially in the USA, the question arises as to whether the Delta variant is especially dangerous for children. There is a lot of evidence pointing in this direction. The trigger is possibly the viral load, which is considerably higher with Delta than with the wild type or the Alpha variant and therefore increases the risk of hospitalization. More data is required if we are to reach any meaningful conclusion, however, and the SARS-CoV-2 Task Force will be focusing this in the next few days and weeks.

For our Premium clients who belong to either the non-responder or low-responder category due to a pre-existing health condition, we have developed further criteria. We monitor the development of antibody formation after the second vaccination and set other benchmarks specifically for low- or non-responders, because approximately 20% of our Premium clients come under this heading. Even fully vaccinated individuals who become infected and do not fall into the low-responder or non-responder categories can, of course, also have symptoms, although these may be much less severe, more resembling a flu-like infection, with headaches and a runny nose, sometimes even a cough. It must nevertheless be borne in mind that even fully vaccinated persons who become infected can go on to develop and suffer from Long Covid. A high temperature is reported relatively infrequently. This is because the adaptive (i.e. acquired) immune system, is able to keep the infection under control after vaccination has taught it the specific structures of the virus. A high temperature tends to occur when the innate immune system is called into action to fight an unknown pathogen with a much more non-specific reaction.

This is precisely where the problem arises with the forthcoming season of coughs and sneezes: if a relatively low rate of coronavirus coincides with a wave of common colds and rhinovirus, it is vital that people displaying symptoms stay at home and take a rapid test to clarify which of the viruses they have contracted. The problem is that they might otherwise pass on coronavirus to someone who has not yet been vaccinated and who might therefore be susceptible to a severe bout of Covid-19. Strict self-isolation should therefore be observed if even the slightest symptoms manifest themselves. A rapid test should then provide the necessary clarification. It is also important to remember that symptom-free vaccinated persons are also able to pass on the virus.

For the past one and a half years, we have been wearing face coverings, have kept a minimum distance from each other and no longer shake hands. With rhinoviruses, we know that post-infection immunity does not last long, which is why most people inevitably get repeat infections. Because we have not been exposed to these viruses for a long time, the likelihood increases of getting infected when exposed. Significantly more viruses are shed when an individual has contracted the Delta variant. Moreover, a much smaller volume of virus particles seems to be sufficient to infect another person. The upper respiratory tract is particularly affected. That is why sufferers often report nasal and throat symptoms as well as headaches. For the coming wave of influenza, it will be very important to quickly establish which virus is involved.

In the next two months, we will be making recommendations to our Premium clients on booster or next-generation vaccines against the coronavirus as well as other vaccinations that are appropriate for the autumn season and can help stave off a severe bout of flu, pneumococcus, whooping cough and shingles. With the exception of shingles, these are all diseases of the lungs. We work out the optimal protection against a flu epidemic for each of our Premium clients on an individual basis. And there is one further point to consider: if you have not yet been fully vaccinated with both doses of a coronavirus vaccine, please note that there should be a minimum two-week interval between a corona jab and a flu jab.

The preferred regimen against influenza is currently a high-dose quadruple vaccine. At least, that is the plan in Europe. In the USA, the decision has still to be made as to whether to go with triple vaccine as before or to upgrade to quadruple, which is looking increasingly likely. With the social distancing measures in place last season, the influenza wave was virtually absent, which means that much higher numbers are to be expected this autumn-winter season. It is important to reduce the risk of bacterial superinfection in case of SARS-CoV-2 infection.

Among the secondary diseases that are associated with Covid-19, special mention should be made of mucormycosis, also known as “Black Fungus”. It is spreads easily, many patients have died from it, and it is cropping up in countries all around the world. In New Delhi (India), for example, a separate hospital ward had to be set up because of the rampant fungal infection. We have to assume that secondary diseases associated with corona infection will increase along with the arrival of new mutations. Even the otherwise sensible wearing of masks unfortunately causes side-effects, especially in the case of children. One example is respiratory syncytial virus (RSV), a common cold virus that is harmless for most people but potentially deadly for infants, as instances throughout this summer have shown. The reason is that children have built up an “immune deficit” – the compulsory wearing of masks has meant that their immune protection has not been sufficiently trained and collateral damage has occurred. Against this background, we ask all Premium clients who have children under one year of age to contact their consultant to discuss a possible passive vaccination against RSV.

In one of our forthcoming Keynotes, we will be looking at the issue of vaccine-induced mortality in greater detail. On our Task Force, we have a pathologist who is researching this very issue. A year ago, we were already stressing the importance of conducting post-mortem examinations of individuals who have died from Covid-19 to gain a better understanding of the disease. On the other hand, we also think it is necessary to conduct post-mortem examinations of individuals who have died not long after being vaccinated, although this is a much more controversial matter. In previous Keynotes, we have reported in detail on cerebral venous sinus thrombosis (CVST) cases associated with vector-based vaccines. There remains a large gap in our knowledge here. Pathologists are generally not even aware that a deceased person may have recently been vaccinated. There are several university clinics and research institutions conducting studies into this whole issue. Previously, the sole focus of their attention had been on patients who died from Covid-19. More recently, they have also been looking at the rare but severe side-effects of vaccination. These include not only CVST and myocarditis but also autoimmune diseases.

The problem arises because vaccinated individuals, unlike Covid-19 patients, do not usually die while under clinical observation. The medical examiner then fails to make a connection with the vaccine and certifies the cause of death as natural or unknown, so that the authorities see no suspicion of foul play and release the body for burial or cremation. This procedure is standard in all OECD countries. We therefore have to assume that the number of people who have actually died due to vaccination is higher than officially reported. This conclusion is politically explosive, especially at a time when the vaccination campaign is running out of steam, when the Delta variant is spreading exponentially and politicians are considering the introduction of vaccine passports. The medical reasons for vaccination have to be weighed up on an individual basis, and as we see it, considerations of individual protection are being subordinated to the social policy objective of getting the whole population vaccinated as quickly as possible. Carrying out more autopsies of deceased patients who have been vaccinated would help to clarify matters, so that any causal link can be definitively ruled out or in.

This area of research could also significantly improve the further development of vaccines while boosting public confidence in vaccination in both the medium and long term. At this point, we have to remind our readers that, after more than a year now, no vaccine has yet been finally approved. BioNTech/Pfizer do, however expect their vaccine to receive approval from the FDA in the autumn.

In our previous Keynote, we had indicated that we expect the situation to become much more complex in the coming weeks, with the next step being the introduction of booster and next-generation vaccines. We are working hard to develop the best possible individual strategy for our Premium clients. The CDC has also begun to develop a concept for booster vaccinations for the coming winter.

In the political arena, too, a lot has happened, and the next move on the vaccine front is being mapped out as a priority by governments around the world. The EU has already ordered 1.8 billion doses from BioNTech for a possible third vaccination. Many countries are developing strategies for a third round of vaccination. While Sweden is looking to a possible start in 2022, Israel has already embarked on its third round of vaccination, and President Isaak Herzog has set an example by receiving his third jab.

As first world countries discuss booster vaccinations, the shortage of vaccines in the third world is inevitably going to lead to political tensions. The current dispute between the WHO and the German government is just a foretaste of what lies around the corner.

We discussed booster vaccinations and next-generation vaccines at great length in our last Keynote, setting out clear criteria for our Premium clients. As already indicated, we expect the WHO to adopt the same criteria. We are of the opinion that the mutation rate will most likely increase. Consequently, we would advise against booster or next-generation vaccines being administered too soon, because society cannot carry on vaccinating ad infinitum – every new vaccination is bound to trigger an autoimmune reaction. In most cases this is harmless, of course, but we have to assume that many autoimmune diseases will be further aggravated by the vaccines. So there is a natural limit to how often you should be inoculated. Consequently, one has to be very careful about deciding if and when to get a booster vaccination. The accelerated policy discussions on booster vaccination are being driven by the skyrocketing numbers, a prime example being Israel where significantly more people are having to be hospitalized despite its high vaccination uptake. Based on the first available figures from Israel, the side-effects of vaccination, at least with the mRNA vaccine, are similar to those of the second vaccination. The Israeli Ministry of Health has announced that the efficacy of the current vaccine has dropped from the original 39% estimated two weeks ago to a more realistic 29%. With figures in this range, it is unlikely that regular approval would be granted.

In the USA, too, some states are registering a new peak in infections, with more than 100,000 cases per day nationally. Florida alone has seen an increase of 50%. As a result, mask wearing has been reintroduced in some states, even for the fully vaccinated.

Israel has reverted to imposing restrictions and protective measures. In this regard, they are adopting a completely different approach than the UK where restrictions have been lifted entirely and the government is relying on the population to exercise common sense. In Britain, the number of deaths attributable to the coronavirus has risen to a daily high last seen in March. There is a strong push for certain groups to be vaccinated, for example pregnant women. We are in favor of this in principle, but only after due consideration on an individual basis. If you, as a Premium client, have any questions in this regard, please contact your consultant.

Meanwhile in Japan, the brakes are being slammed on because of the Delta virus. Hospital capacity is being stretched, not least because of the Olympic Games. Only the most serious cases are admitted to hospital, and the majority of those who fall ill have to stay at home and receive treatment from their family. In Texas, too, many hospitals have had to postpone elective surgical procedures. Our assessment that the Delta variant is extremely contagious is becoming more and more self-evident. The CDC also confirms that the Delta variant is at least as contagious as chickenpox. It is more rapidly transmissible than MERS (Middle East respiratory syndrome), SARS, Ebola or seasonal flu. Added to this is the fact that even vaccinated people with breakthrough infections of the Delta variant carry just as many viruses in their nose and throat as the unvaccinated and can thus spread the disease just as prolifically.

To date, there have been more than 200 million coronavirus infections and the official death rate stands at 4.25 million. By our own calculations, however, the number of deaths is closer to 12 million, a figure that the WHO has recently confirmed as being more realistic. We arrived at this total by subtracting the collateral damage caused by hospital occupancy from excess mortality over the relevant period. This is the same approach that is now being taken by the statisticians at the WHO. Calculated over 18 months, this number is far higher than that for influenza deaths in recent years.

The EU is also buying 200 million doses of Novavax from the USA, a vaccine that still has to be approved. We have our reservations about Novavax. However, due to the delay in approval, its Phase 3 testing has coincided with the current variants. This vaccine could potentially play a supplementary role. We are, of course, continuing to monitor developments here.

In the case of a booster vaccine, the correct timing depends on a combined score derived from the reference values for the three defining pillars, namely antibodies, T-cell immunity and general immune response. This score is calculated by means of an AI algorithm, taking into account the effectiveness of the current vaccines against the prevalent Delta variant. And of course, each calculation of the best and most sensible time for booster vaccination is made on an individual basis. We have further raised the reference values for the antibodies, in particular Class 1 antibodies (i.e. those with a low effect) of which much greater numbers are required to counter the significantly higher resistance of the Delta variant. We have also introduced a four-level classification of high responder, medium responder, low responder and non-responder for all Premium clients as a further parameter for the AI system. The calculation additionally takes into account any side-effects that manifested themselves after the first two vaccine doses were administered. On this basis, we are able to calculate the optimum interval before a third vaccination takes place. To date, there have been very few studies on this topic. We have at our disposal almost all the data that has been published so far, in particular from the USA. This clearly indicates that the interval between a second and a third vaccination should be around the six to eight months mark. Of course, the decision must also take into account whether it might not be more sensible to wait for a next-generation vaccination, for example the BioNTech version that has been formulated to target the Delta variant. Another option is to induce a heterogeneous immune response by means of a heterogeneous (mix-and-match) vaccination strategy.

The skepticism of Dr Robert Hess regarding the efficacy of all previous vaccines against the Delta variant has been confirmed

Dr Robert HEss

Dr Robert Hess – 07/20/2021

The skepticism of Dr Robert Hess 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.

The Delta variant of the novel coronavirus, which is causing concern across the whole of Europe, is now starting to show up in America. BioNTech and its manufacturing partner Pfizer announced last Friday that they are developing an updated version of the Pfizer/BioNTech Covid-19 vaccine that will target the complete spike protein of this latest variant. They also stated that the first batch of this vaccine consisting of approximately 20,000 doses has already been produced at the Mainz plant in Germany. The clinical trials are due to start in August this year.

It was seven and a half months before the original vaccine received official approval, but for the adapted version, the procedure could be accelerated. The urgency is even Dr Robert Hess because scientists have detected new mutations in the meantime that are significantly more complex. This confirms that we were right to express our reservations about the effectiveness of the current crop of vaccines against the Delta variant.

We have always taken with a pinch of salt the headline figures, which tend to be empirical, have so far not been backed up by any clinical study and are primarily intended to shape public opinion. The Pfizer vaccine is the best to have emerged to date, so with the decision by the clear world market leader to go down this route, we see our assessment as being vindicated. Based on information from unofficial sources, we have reason to believe that nearly all vaccine manufacturers are now engaged in developing new vaccines against the spike protein of the Delta variant. So the question now arises as to what happens next with booster vaccines. The Pfizer/BioNTech team are already planning far ahead, having notified FDA, the EMA and other regulatory authorities of their intention to submit an application for a third dose booster jab. We interpret this as confirmation of our assessment that the protection afforded is significantly reduced due to the relatively low antibody production of the vector-based vaccines, and the insufficient T-lymphocyte-based immunization provided by the mRNA vaccines. This is precisely what our Covid-19 antibody and T-cell monitoring has been confirming for some time. The protection conferred by vaccination persists for a much shorter duration than expected, and the purpose of the third jab is to boost immunity sooner than was originally envisaged.

A conservative estimate is that a third dose is needed six months after the first course of vaccination to maintain the highest possible protection. While the FDA has not yet made any response, the EMA is already signaling that it would be premature to issue any statement either way, because there is not yet enough data from the vaccination campaigns and ongoing studies to draw any conclusion. In this matter too, we disagree with the EMA, because there are clear indications that vaccine immunity is significantly lower and lasts for a shorter period than expected. For this reason, we cannot understand the hesitancy on the part of the EMA.

The crucial point is that full vaccination against the Delta variant has to be the priority. With regard to the first round of vaccination, there is an excellent paper from the Pasteur Institute in Paris, which was published in Nature magazine. Here, AstraZeneca and BioNTech/Pfizer vaccines were tested for efficacy against the Delta variant. Only 10% of recipients were protected after a single shot, but the figure rose to about 95% after the second dose. However, we consider these estimates to be wishful thinking. The findings suggest that the first vaccination offers virtually no protection against the Delta variant but that the success rate is significantly enhanced by the second dose. However, all of our Premium clients have already been double jabbed, so they have already jumped over this particular hurdle. There are many millions of people in Europe who have not yet followed up a first dose of AstraZeneca with a second. These people are virtually unprotected against the Delta variant.

The same paper from the Pasteur Institute addresses the question as to whether individuals who have recovered from a first bout of Covid-19 are resistant to the Delta variant, and the answer is an emphatic NO. Survivors must have at least one dose of vaccine to come close to adequate protection against the Delta variant. Unlike the EMA, which recommends that this booster vaccination should not be given until six months later, we believe that the AstraZeneca follow-up jab should be administered 8 to 12 weeks after recovery.

We have identified relevant cases among our Premium clients. Here, the situation is much more transparent, because our immunity testing allows us to give a clear diagnosis of the effects of an infection, based on T-cell immunity and antibody formation. From these results, we make a personalized and individual recommendation as to when a booster vaccination should be carried out and with which vaccine. Because the WHO still does not give a reference value for immunity for both pillars, we are using our own findings as reference values to decide if and when a booster should be administered, or whether it makes more sense to wait for a complete solution based on the next-generation vaccines. Because the picture could change again in the autumn as new variants come along and, depending on the level of immune protection provided by vaccination in each individual, it will be necessary either to start completely “from scratch” with the administration of a next-generation vaccine, or to reinforce existing protection with a booster jab.

 protection with a booster jab.As things stand, we have to assume that a booster is necessary when antibodies, measured as BAU/ml, fall below 2,000. And of these, at least 70% must be neutralizing antibodies, of which again at least 30% fall into the highly effective category. In T-cell immunity, which is ultimately at cellular level, the interferon-Gamma release in the index should not be higher than 5.0, and the interleukin-2 release should not be greater than 2.0. Based on our clients’ own monitoring results, these are the reference values that we currently see as the benchmark for maintaining perfect immune status. They must, of course, be combined with all the other values that signify immunological response. For SARS-CoV-2 in particular, these are our reference values.

The fact that the vaccination campaigns in general are not really getting anywhere near tackling the Delta variant with the existing vaccines is a phenomenon that we have observed for some time in Israel and also in the UK. But in Israel, the trend is particularly noticeable. The country has had by far the speediest vaccination campaign in the world, yet now the daily incidence rate has risen to 450 per 100,000 population. That is one of the highest figures that Israel has had to date, and most alarmingly, 7% of those who have been completely vaccinated fall seriously ill and have to be treated in intensive care units. This is a very high rate, considering that Israel administered mainly mRNA vaccines. In the meantime, face coverings have again been made compulsory in indoor spaces. So here, too, we see the progress made going into reverse. Ignoring the EMA’s hesitant attitude towards approval, the Israeli government has started to administer booster vaccines to certain groups.

For this reason, we are again dubious about the recent statement issued by Johnson & Johnson that its own vaccine is 85% effective against the new mutant and that the immunity it confers will last at least eight months. Frankly, we are astonished by J&J’s assertion that protection lasts eight months when the Delta variant has only been in circulation outside India for the past ten weeks.

The consequences of the Delta variant are enormous. Many countries are initially ignoring the spread of infection, the UK being a notable example. Ultimately, it all comes down to political expediency. And in this context, we think we are heading in a direction where each person, individually and for themselves, devises their own strategy for coping with the pandemic in the coming years, because governments will increasingly withdraw from medical approaches and economic-political factors will instead guide their decision making. One such decision may, of course, be to adopt a policy of so-called “herd immunity” which assumes a 90-95% vaccination rate. This is a prospect that is looking increasingly difficult to achieve. We have had our reservations about the feasibility of herd immunity from the outset and see it as an unattainable goal at this stage.

Some countries remain very cautious, for example Norway, which has postponed its proposed step-by-step reopening. Other governments, such as the French, have gone even further and cancelled arrangements. There are countries where the Delta variant is beginning to circulate which have a very high vaccination rate, such as Chile. High infection rates are already being registered here, with severe cases being treated in intensive care units. This is not exclusively due to the Delta variant, but also to the fact that in these countries inoculation was mainly carried out with Chinese vaccines, most of which are protein-based and achieve efficacy rates of less than 50%. We are convinced that the protein-based vaccines will prove to be even less effective against the more dangerous mutations that lie ahead. And it has to be remembered that the Chinese vaccine products have not passed the rigorous standards of the major regulatory authorities in the western world, not least because data from the critical third phases of testing were never published in reputable peer-reviewed medical journals. There have been no estimates of efficacy in vulnerable, elderly people because too few subjects from this group were included in large-scale trials. Therefore, at least for the time being, the Asian vaccines are playing a negligible part in the fight against the pandemic.

In a recent Keynote, we made our forecast for this autumn in the northern hemisphere. We cannot share the optimistic predictions of a less harsh fourth wave next winter, not least because the mutations already observed are showing another clear change of direction with the Delta variant.

This is where the excellent work being done by the Com-Cov research team in the UK comes into its own. A study on vaccination and cross-vaccination regimens has also begun in Germany. As we reported in a previous Keynote, AstraZeneca and BioNTech (or indeed Moderna) have different strengths that complement each other well. AstraZeneca is particularly good at triggering a T-cell response, whereas BioNTech mainly activates antibody formation. Both vaccines provide the immune system with minimally modified learning material, which is crucial, as was clearly demonstrated in the Com-Cov study. The second BioNTech vaccination is therefore ideal for retraining immune cells already boosted by a first dose of AstraZeneca.

In this scenario, the second vaccination with BioNTech helps the body to remove unsuitable antibodies and T-cells from the body, of which there is an abundance after the AstraZeneca vaccination, thereby enabling the immune system to respond even more efficiently to the pathogen. These additional, unsuitable antibodies are precisely those which, in our view, could constitute the so-called “infection-enhancing” antibodies. We have seen data from the Charité in Berlin that also point in this direction. Should the merits of “mix-and-match” vaccination be confirmed, it will of course be included as an option in the individual strategies we devise for our Premium clients.

The SARS-CoV-2 T-Cell immunity analysis

Dr Robert HEss

Dr Robert Hess – 07/09/2021

The SARS-CoV-2 T-Cell immunity analysis is to be integrated into the Covid-19 Immunization Program for Dr Robert Hess 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 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.

This supplementary CE-certified blood test facilitates the cellular immunological detection of a SARS-CoV-2 infection. Protection against Covid-19 afforded by vaccination is also shown in detail. It works by testing specific cellular immunity after a SARS-CoV-2 infection, as well as detecting immune reactivity against endemic coronaviruses, also referred to as background immunity.

The importance of the cellular immune response is as follows: an infection with or a vaccination against the SARS-CoV-2 virus should result in an activation of the adaptive immune system. Alongside the production by B lymphocytes of virus-specific antibodies, the stimulation and multiplication (clonal expansion) of virus-specific T lymphocytes is a central feature of this immune response. In the course of the acute immune response, the T lymphocytes first differentiate into effector T cells, which are actively involved in the elimination of virus-infected cells (CD8 killer T cells) and in controlling the function of other immune cells (CD4 T helper cells). The effector T cells are detectable as early as 10 to 14 days after infection or vaccination or after the onset of symptoms.

In the later stage of infection and after an individual has survived Covid 19 or alternatively been vaccinated against the disease, memory T cells should form and persist in the body, theoretically ensuring the maintenance of immune protection in the case of reinfection. If an individual is then exposed to the virus, the memory T cells can instantly trigger efficiently organized immune responses. In a coordinated response with neutralizing antibodies also present in the blood, the virus should then be rapidly repelled. Consequently, the detection of SARS-CoV-2-specific T cells is of particular importance with regard to the further spread of the virus and potential infection or reinfection.

Immunological diagnostics is a highly specialized field. The analysis of virus-specific T-cells in the context of routine laboratory diagnostics is no trivial matter due to the complex activation modality of these cells. Because T-cells are present in the blood only in low frequency or numbers, highly sensitive procedures are required for their detection.

The ELISPOT method, on which our SARS-CoV-2 T-Cell immunity test is based, provides a sensitive and specific analysis of T cells in the blood samples submitted by our clients. This cell culture test is based on the release of messenger substances from the immune system (cytokines) by single cells after stimulation of lymphocytes with virus fragments (peptides).

The fluorescence-based version of the ELISPOT method used for this test allows for the simultaneous detection of two different cytokines – interferon-y (IFN-y) and interleukin-2 (IL-2). While the production of IFN-y is characteristic of effector T cells, IL-2 is primarily secreted by activated memory T cells.

The ratio of T cells detected – active (IFN-y producing effector T cells) compared with residual (IL-2 producing memory T cells) – indicates the status of the T cell response and thus the current status of potential SARS-CoV-2 T cell immunity:

The confirmation by this cell function test of prior Covid-19 immunization succeeds significantly more often than with the serological determination of antibodies, as SARS-CoV-2-specific antibodies are not always detectable even with a PCR test following an infection. This is equally true in the case of an asymptomatic SARS-CoV-2 infection.

Two different peptide pools are used to stimulate the lymphocytes in this test. A positive T-cell indication after culture with the SARS-CoV-2 specific peptide mix is not only to be regarded as proof of a previous viral contact; with our current state of scientific knowledge, it can also be assumed that there is an existing cellular immunity, which gives the affected individual at least temporary immune protection. This is especially applicable in cases where IL-2-producing memory T cells are found in this test.

In addition, several studies have demonstrated the existence of cross-reactive memory T cells in Covid-19 patients and non-exported individuals which are derived from the immune response following infection with one of the endemic coronaviruses (HCoV-NL63, -229E, -OC43, -HKU1) related to the SARS-CoV-2 virus. Current thinking is that the presence of these T lymphocytes, which can be activated upon either infection with or vaccination against SARS-CoV-2, confers background immunity. This results in affected individuals becoming only mildly ill or not at all after infection or vaccination against SARS-CoV-2. To estimate the extent of such a putative cellular basic immunity, which is carried by the above-mentioned cross-reactive T cells, our test includes a stimulation of the lymphocytes with a PAN-corona peptide mix specific to the endemic coronaviruses.

Within the framework of our laboratory diagnostics for the Covid-19 Immunization Program, this new test is now available as an innovative cell function test that usefully supplements acute diagnostics by means of SARS-CoV-2 PCR (direct virus detection) as well as serological diagnostics with the detection of SARS-CoV-2-specific antibodies (IgG, IgM).

This analysis is to be introduced as standard in the Covid-19 Immunization Program for Dr Robert Hess clients with immediate effect.

CureVac were our great hope

Dr Robert HEss

Dr Robert Hess – 06/23/2021

CureVac was the great hope of Dr Robert Hess. They reached for the stars – and came back down with a bump.

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.

CureVac planned to optimize the “cell packaging” required for transport; this was to avoid having to make chemical changes to the product, as has been the case with vaccines from other manufacturers, in order to increase its tolerability. To fulfill this requirement, CureVac developed a highly natural mRNA-based vaccine. It was a risky strategy and one that ultimately failed, because the chemical-free packaging resulted in greater side-effects. This meant they had to limit the injection dose to 12 micrograms, which reduced the efficacy to just below 50%. By comparison, BioNTech sets its injection dose at 30 micrograms, while the Moderna is more than three times higher at 100.

CureVac also had the ambition to not only produce the most natural vaccine, but also to create one that would be effective against the mutations currently in circulation. With this objective in mind, the clinical phase 3 was delayed in order to include mutation events in the development stage of the product. In comparison to the three market leaders – Moderna, BioNTech and AstraZeneca – who tested only the original Wuhan wild type in their phase 3 trials, CureVac included all subsequent known mutations.

Unfortunately, this set the bar too high. CureVac even attempted to incorporate A.I. (artificial intelligence) into the prediction and detection of future mutations early on and to adapt their product to its findings. Essentially, the project failed because of the as yet insurmountable challenge of developing a natural vaccine that also covers current and even future mutations.

All in all, this is very disappointing news in the context of the pandemic, as governments and health bodies are counting on these next-generation vaccines to deal with future mutations by means of A.I. modeling. In this way, scientists would be able to get ahead of the game and anticipate viral mutations before they manifest themselves. As we have stated in previous Keynotes, we see technology as our only hope of bringing the pandemic under control.

There are other projects going down the same route as CureVac, for example the one at the University of Austin in Texas, but this announcement is still bad news for pandemic management.