COVID 19 Archive -

Dr Robert Hess: New, updated ingredients are now available.

Dr Robert Hess – 03/14/2022

Dr Robert Hess: We further review our supplements and adjusts them in response to the latest developments in the pandemic: New, updated ingredients are now available.

As I mentioned I undertook a major review of the current situation over the past few weeks. The latest guidelines, herbal medicines/supplements and other beneficial measures have been checked through, incorporated into our program, and individualized for our clients.

In addition to the recent increase in frequency of testing and the changes to diagnostic methods, we have now also revised the composition of our supplement-system so that these too can be optimally adjusted to the current pandemic-related circumstances and status of our clients.

The focus of our review was mainly on the sequelae of a COVID-19 infection and of mRNA or vector-based vaccines. The pandemic “aftermath” is something we are all likely to be faced with sooner or later, making this issue more relevant and universal than ever before.

Because of COVID-19 disease, the vaccines that have been developed against it and the spike protein damage that follows are relatively new phenomena, the current guidelines draw on established and emerging medical research as well as on the clinical experience of international physicians and teams operating in the field. The guidelines we issue are subject to ongoing review as our knowledge increases.

I already reported in detail on general prophylactic measures that our clients can take, such as building up the immune system, heat and cold therapies, improved diet, etc. In any case, these measures permeate our entire program, where they are individually incorporated and constantly updated.

We once again stress the indispensability of a daily intake of key multivitamins and minerals. In the modern world, it is hardly possible to absorb all the necessary vitamins and minerals from food alone, and this applies especially with regard to the systematic avoidance of COVID-19 sequelae. This is where our high-quality personalized supplements come in.

We have completed the process of updating the composition of our supplements, focusing on the spike protein, on the furin enzyme, on the ACE2 receptors and on interleukin-6, and we are therefore now in a position where we can supply our clients with their own personalized supply.

If you have any further questions, or if you feel we do not have all the information about your individual COVID-19-related circumstances, please feel free to contact your consultant at any time.

Dr Robert Hess: Managing the Covid-19 aftermath

Dr Robert Hess – 03/07/2022

Dr Robert Hess: Managing the Covid-19 aftermath: Detox of the spike-protein.

Two full years after the pandemic began, it is now time to consider our next moves. In order to maintain a clear overview, I placed great emphasis on accurate documentation and ongoing information exchange right from the start. This meticulous approach, together with insights from science and research findings, enabled us to make precisely tailored recommendations for our clients. In the last few weeks and months, we have been gathering up loose ends and shifting our focus to appropriate preventive measures as well as preparations for the aftermath of the Covid-19 pandemic. In addition to shortening test intervals and adapting diagnostic methods, we will now also review the composition of our supplements to ensure that they are likewise optimally adjusted to the individual pandemic-related circumstances of our clients.

The focus of our prophylactic supplement program and of the measures we are taking for the COVID-19 aftermath is primarily on the spike protein. The spike protein, which is not only a component of the SARS-CoV-2 virus but also produced in our bodies as a result of vaccination, can circulate in our bodies and damage cells, tissues and organs. It is our view that “detoxing” the body of spike proteins as soon as possible after infection or vaccination can protect against damage from residual or circulating spike proteins. Various international committees have been drawing up guidelines and collating information on how to remove viral and vaccine-induced spike proteins from the body. The lists of herbal medicines and dietary supplements together with the information on them were compiled in collaboration with international physicians, scientists and health practitioners.

COVID-19 infection, COVID-19 vaccines and spike protein damage are all relatively new phenomena, so the guidelines have been based on established and recent medical research as well as the clinical experience of international physicians. The respective guidelines will be updated on an ongoing basis as new knowledge and findings emerge. We will review the guidelines, herbal medicines and dietary supplements, as well as other measures and, as appropriate, incorporate them into our program and adapt them individually for our clients.

What exactly is the spike protein?
The SARS-CoV-2 virus first identified in Wuhan has spike protein on its surface. The spike protein is also found in all SARS-CoV-2 variants. In a natural infection, the spike protein is the component of the virus that allows it to enter the cells of your body. One region of the protein, called S2, binds the viral envelope to the cell membrane. The S2 region also has the effect of making the SARS-CoV-2 spike protein easily recognizable to the immune system, which then produces antibodies that attack and bind to the virus.
Spike proteins are also produced by the human body following vaccination against COVID-19 and function in a similar way, in that they can fuse with cell membranes. It is not yet entirely clear to what extent spike proteins formed by vaccination interact with our immune system, as they are produced in our own cells, but this does not necessarily mean that an immune response cannot also be triggered. Misdirected immune responses (i.e. the inability of our immune system to distinguish between virus-related and vaccine-produced spike protein) could have devastating consequences and damage healthy cells in our body.

Why should I consider a spike protein detox?
Recent research has linked viral spike protein to negative effects and consequences, such as blood clots, brain fog, pneumonia, and heart muscle inflammation. A Japanese-led biodistribution study examining the Pfizer/BioNTech vaccine also demonstrated that the vaccine particles had reached various tissues throughout the body within 48 hours of vaccination and did not remain at the injection site, with high concentrations found in the liver, bone marrow and ovaries. New evidence also shows that the spike protein may interfere with the ability of our cells to repair DNA. All of the above taken in the context of Long Covid prompted us to focus more on this issue. Taking preventive action in this area could be of tremendous benefit on multiple levels.

If you have had side-effects after being vaccinated or if you suffer from Long Covid or Long Covid-like symptoms, the “Spike Detox” is one of the best ways to tackle your symptoms. Even if you have not experienced any of the above phenomena and have ever been vaccinated or infected with COVID-19 (with or without symptoms), this is relevant to you. Spike protein induced by a natural infection or alternatively a COVID-19 vaccine has high potential to damage our cells, so it is important to take steps to detoxify the body as much as possible.

What is the purpose of the Spike Detox?
General measures such as heat therapies, sauna sessions and hot baths, are good ways to detoxify from spike protein. Intermittent fasting, a dietary measure that stimulates the body’s autophagy ability, can also be helpful in this context. This is essentially a recycling process that takes place in human cells, whereby cells break down and recycle components. By means of autophagy, the body eliminates damaged cell proteins and can destroy harmful viruses and bacteria resulting from an infection.

The right diet is, of course, also essential here, the consumption of pro-inflammatory foods should be avoided, and it also makes sense to aim for a low-histamine diet. The daily intake of important multivitamins and minerals is essential – we already cover this with our personalized supplements.

The targeted spike protein detox primarily refers to four different components, which we will discuss in more detail below:

– the spike protein
– ACE2 receptors
– interleukin 6 (IL-6)
– furin

“Protein-binding inhibitors” impede the binding of the spike protein to human cells, while others neutralize the spike protein, rendering it potentially incapable of causing damage to human cells.

Spike protein inhibitors: prunella vulgaris, pine needles, emodin, neem, dandelion leaf extract, ivermectin

Spike protein neutralizers: N-acetylcysteine (NAC), glutathione, fennel tea, star anise tea, pine needle tea, St. John’s wort, comfrey leaves, vitamin C

Ivermectin has been shown to bind to the spike protein, potentially preventing it from binding to the cell membrane. A number of naturally occurring plants – including pine needles, fennel, star anise, St. John’s wort, and comfrey leaves – contain a substance called shikimic acid that may help neutralize the spike protein. Shikimic acid is also believed to counteract the formation of blood clots. Pine needle tea has a strong antioxidant effect and contains high concentrations of vitamin C, which has a key role to play in neutralizing toxins.

What are ACE2 receptors?
ACE2 receptors are found in the cell wall, in the epithelial and endothelial lining of lungs and blood vessels, and in blood platelets (thrombocytes). Spike protein binds to ACE2 receptors, and it is thought that variable concentrations of spike protein can bind and adhere to our ACE2 receptors, blocking their regular function in various tissues. In addition, the “stickiness” of the spike protein at the ACE2 receptor could cause the immune system to attack healthy cells and possibly trigger autoimmune diseases.

Substances that can naturally protect ACE2 receptors: ivermectin, quercetin (with zinc), fisetin

There is evidence that, when ivermectin binds to an ACE2 receptor, this prevents the spike protein from binding to it.

Why attack IL-6?
Some natural substances support the detoxification process after infection by acting on interleukin- 6. It has been scientifically proven that cytokines such as IL-6 are present at much higher levels in individuals who have been infected with COVID-19 than in those who have not. IL-6 has also been used as a parameter for measuring the progression of COVID-19 cases. In 2021, a meta-analysis using worldwide datasets showed a correlation between IL-6 levels and the severity of COVID-19 disease and demonstrated that IL-6 levels were inversely related to the number of T cells in ICU patients.

IL-6 inhibitors (anti-inflammatories): Boswellia serrata (frankincense) and dandelion leaf extract

Other IL-6 inhibitors: black cumin (Nigella sativa), curcumin, fish oil and other fatty acids, cinnamon, fisetin (flavonoid), apigenin, quercetin (flavonoid), resveratrol, luteolin, vitamin D3 (with vitamin K), zinc, magnesium, jasmine tea, spices, bay leaves, black pepper, nutmeg, and sage

Several natural, plant substances are used in antiviral therapy. The plant pigment quercetin has been shown to have broad-spectrum anti-inflammatory and antiviral effects. Zinc acts as a powerful antioxidant that protects the body from oxidative stress, a process associated with DNA damage, excessive inflammation and other harmful effects.

What is furin?
Furin is an enzyme that cleaves proteins and makes them biologically active.
Furin has been shown to cleave the spike protein, allowing the virus to enter human cells. There is a furin cleavage site on the spike protein of COVID-19, which is thought to make the virus more infectious and transmissible. Furin inhibitors could therefore prevent cleavage and thus activation of the spike protein.

Furin inhibitors: rutin, limonene, baicalein, hesperidin

Many of these measures and detox options are already part of our program. All further suggestions and research results will be reviewed in the coming weeks for our clients and, if we consider them to be necessary, safe and prophylactic, they will be individually incorporated into the supplements. It is therefore of enormous benefit that we are up to date regarding the infection, recovery and vaccination situation of each client. If you have any further questions or if we do not have all the information about your individual situation, please do not hesitate to contact your consultant.

Dr Robert Hess: In rare cases

Dr Robert Hess – 02/28/2022

Dr Robert Hess: In rare cases, coronavirus vaccines may cause Long Covid-like symptoms.

As mentioned on Long Covid and potential risk factors, the symptomatology of this condition can be very similar to the side-effects and possible long-term consequences of vaccination. While preliminary data suggests that getting yourself vaccinated significantly reduces your risk of succumbing to Long Covid, there have also been cases where vaccination has caused Long Covid-like symptoms – and for a lengthy period of time.

We always take a balanced view, so that our clients are optimally informed and can weigh up the available information accordingly. There are no official figures, nor have there been any large-scale studies on this phenomenon as yet, but the symptoms, the link to vaccination and the accounts given by those affected are currently being investigated by the National Institute of Health (NIH) and other researchers around the world.

Previous studies have been too limited in scope and have not allowed 100% conclusions to be drawn about whether any of the vaccines have caused some rare form of long-term health problem and, if so, by what mechanism.

Long Covid-like symptoms such as fatigue, brain fog, insomnia, headaches, blood pressure fluctuations and various others are currently being investigated for a possible link to the administration of a COVID-19 vaccine. A number of scientists and research institutes are looking into this matter, among them neuroimmunologist Avindra Nath, clinical director of the Neurological Diseases Institute of the U.S. National Institutes of Health (NIH). In the specialist journal Science, he posited “temporal associations” between vaccination and Long Covid symptoms, but he would not be drawn on whether there was an “etiological association” (i.e. a causative link). Studies conducted by Nath on around 30 case reports have so far remained unpublished, but publication is expected soon.

Much remains unclear about Long Covid, especially the cause of its non-specific symptoms. It is broadly assumed that there is an underlying persistent immune dysregulation, in other words a defective immune response. Some candidates for further research are beta-interferons, immunoglobulins, mini blood clots and autoantibodies.

The Science article also explores the role of autoantibodies – their importance is recognized not only in acute CoV-2 infection, but also in Long Covid. According to recent studies, autoantibodies can be detected up to six months after infection, and as Harald Prüss, a neurologist at the German Center for Neurodegenerative Diseases (DZNE) and at the Charité Hospital in Berlin, writes in an as yet unpublished paper, they are capable of damaging brain tissue. Experiments on animals have suggested that antibodies targeting the SARS-CoV-2 spike protein – the same protein that many vaccines use to trigger a protective immune response – could cause collateral damage. While searching for antibody therapies for COVID-19 in 2020, Harald Prüss and his colleagues discovered that, of the 18 antibodies they identified with strong efficacy against SARS-CoV-2, four also attacked healthy tissue in mice – an indication that they could trigger autoimmune problems.

Initial clinical data point in a similar direction. Last year, researchers testing people infected with SARS-CoV-2 found unusually high levels of autoantibodies, which can attack the body’s own cells and tissues. In the May 2021 issue of Nature magazine, immunologists Aaron Ring and Akiko Iwasaki and their colleagues at the Yale School of Medicine reported finding autoantibodies in acute COVID-19 patients that were targeting the immune system and brain. They are now investigating how long the autoantibodies persist and the extent to which they can damage tissues. In January of this year, Cedars-Sinai Medical Center cardiologist Susan Cheng and protein chemist Justyna Fert-Bober reported in the Journal of Translational Medicine that autoantibodies can still be present up to six months after infection, although the researchers did not link their persistence to long-term symptoms.

To find out whether such autoantibodies harm humans, scientists at the German Center for Neurodegenerative Diseases (DZNE) are testing cerebrospinal fluid from Long Covid patients for antibodies that react to brain tissue obtained from mice: if there is indeed a reaction, these antibodies could also attack human neural tissue. Prüss and his team have published a paper in which they describe finding autoantibodies in at least one third of these patients, which are capable of attacking mouse neurons and other brain cells.

In August 2021, a group at Northwestern University reported in an advance publication that, in patients with neurological complications after COVID-19, a subset of T cells is persistently activated, similar to how it would be in persistent SARS-CoV-2 infection, suggesting an aberrant immune response or a lingering virus.

Scientists investigating possible side-effects are faced with a dilemma: their work risks stoking opposition to vaccines that currently seem to be “safe and effective” (this statement cannot be made with 100% certainty. After all, we have only been vaccinating for about 2 years and we are therefore rather cautious with these statements). “You have to be very careful about associating COVID-19 vaccines with complications,” Nath cautions. “People can draw the wrong conclusions. The implications are enormous.” Complex and persistent symptoms like those experienced by most sufferers are even more difficult to study, because patients often don’t have a clear diagnosis.

At the same time, understanding these problems could help those who currently suffer from them and, if a link is found, help in the development of the next generation of vaccines, perhaps identifying the ones that pose a high risk of serious adverse events. “We shouldn’t be averse to adverse events,” is how William Murphy, an immunologist at the University of California, sums it up. In November 2021, he suggested in The New England Journal of Medicine that an autoimmune mechanism triggered by the SARS-CoV-2 spike protein could explain not only the Long Covid symptoms but also some rare vaccine side-effects, and he called for more basic research to investigate possible links. He also maintains that it is more important to reassure the public that everything is being done in research to understand vaccines than to just say everything is safe, an assertion that we also endorse.

In the meantime, many affected people feel they have been let down by the health care system. The issue is sadly neglected, poorly defined and also politically sensitive, so family doctors and hospitals have not yet taken any initiatives. Many would like to see a network of specialist outpatient clinics for people with Long Covid and Long Covid-like symptoms, sharing their knowledge and experience.

Long Covid symptomatology after vaccination seems to be rare so far. Nevertheless, this is a topic that needs to remain in focus and be subjected to greater in-depth investigation. Overall, there are still too many unknowns and therefore there are currently no approved and effective therapies on the market. Nevertheless, we are able to take preventive action. We have already adapted our prophylactic measures in this regard, and we will also revise our supplements. We are one step ahead in this regard and we have put together effective options exclusively for our clients. Next we will report on how to best protect yourself from long-term effects and just how useful a “detox” of the spike protein can be.

If you have any questions about Long Covid or specific symptoms, please do not hesitate to contact your Consultant. We will continue to monitor this issue closely and to update our knowledge.

Dr Robert Hess: Long Covid risk factors

Dr Robert Hess – 02/15/2022

Dr Robert Hess: Long Covid risk factors now identified.

According to the latest figures, between 10 and 30 percent of all persons who test positive for SARS-CoV-2 go on to develop long-term symptoms that can last for weeks, months or potentially even years. These can vary greatly depending on the severity of the disease, the age of the patient and his or her medical history. When – or indeed whether – those who suffer so‑called “Long Covid” can expect their symptoms to clear up is unclear, and there is as is as yet no treatment for the condition that does more than just alleviate symptoms. A U.S.-based research group has now identified four factors that significantly increase the risk of Long Covid.

In order to derive a more complete picture of Long Covid and to better define the term, an international team of researchers has analyzed data from a large-scale survey of covid-specific symptoms, involving 16 studies conducted in different countries around the world. The researchers found that there were no fewer than 55 long-term effects associated with COVID-19. Most of these effects are classic clinical symptoms such as fatigue, headaches, joint pain, anosmia (olfactory disturbance), ageusia (lost sense of taste), muscle weakness, depression and cognitive impairment (i.e. concentration and memory problems). However, long-term effects such as respiratory problems and hair loss, as well as diseases such as myocarditis, the onset of diabetes mellitus and thromboembolism, have also been observed.
In some cases, these long-term effects also overlap with vaccination side-effects. It is therefore is important to take into account the point in time when the symptoms first manifested themselves. Some patients infected with SARS CoV 2 are at greater risk of developing Long Covid than others. Triggers for the syndrome have previously included advanced age, severe obesity and underlying pulmonary/coronary conditions. Gender also appears to play a role: the research concludes that women are disproportionately affected by fatigue syndrome as a long-term consequence of infection.

Recent studies suggest that people who have been hospitalized for COVID-19 are significantly more likely to suffer from long-term sequelae. In this group, no fewer than 76 percent of patients were still suffering from Long Covid symptoms six months after discharge.

A team of researchers led by Yapeng Su at the Institute for Systems Biology in Seattle has now identified four additional risk factors for Long Covid. For the purposes of their research, the team followed almost 300 patients from their initial COVID-19 diagnosis through convalescence (two to three months after diagnosis) in an in-depth multimicroscopic longitudinal study. The subjects, whose age ranged from 18 to 89 years, had contracted COVID-19 in 2020 and early 2021. Consequently, the results cannot be extrapolated to the Omicron variant.

The patients were quizzed about more than 20 symptoms considered typical of Long Covid, such as persistent fatigue, shortness of breath or cognitive impairment (see above). Of those who reported three or more symptoms, 95 percent had one or more of the four risk factors identified in the study:

1) a high viral load in the blood at the onset of infection, as evidenced by high levels of viral RNA;

2) the presence of certain autoantibodies which are directed against the patient’s own immune system, have the capacity to aggravate an infection and also occur in rheumatoid arthritis or other autoimmune diseases (COVID-19 sufferers can form a large quantity of such antibodies, which are detectable up to six months after the acute illness and are evidently involved in the development of Long Covid syndrome);

3) reactivation of the Epstein-Barr virus (EBV) which is responsible for triggering glandular fever, a disease that many people become infected with at a young age (EBV can lie dormant in the body for very many years and become active again during systemic illness, in much the same way as the herpes virus);

4) the presence of diabetes mellitus (Type 2).

More than 60 percent of those examined in the study exhibited two or more of the typical symptoms. Autoantibodies were found in two-thirds of them, and no other factor played such a significant role. Diabetes, high viral load and EBV were each identified in one third of the sample. Typically, however, more than one factor was present at the same time, and the combined effect therefore proved decisive. These findings could now open up new approaches to the treatment of Long Covid.

Preliminary data from Israel indicates that vaccination against SARS-CoV-2 inhibits the development of Long Covid syndrome. In the specific case of Israel, the vaccine administered was exclusively of the mRNA variety. This was found to not only reduce the risk of severe disease but also to make long-term sequelae following vaccine breakthrough less likely. Data from individuals who contracted SARS-CoV-2 relatively early in the pandemic suggests that vaccination could also reduce the risk of Long Covid: persons who became infected after previously receiving the BioNTech/Pfizer vaccine were significantly less likely to report typical long-term symptoms (e.g. fatigue and persistent exhaustion) than those who were unvaccinated at the time of infection. In fact, vaccinated people were no more likely to complain of certain symptoms than people who had never contracted SARS-CoV-2. The results of the study are preliminary, however, and the peer review process has yet to be carried out.

As mentioned in our last Keynote, we will now be incorporating these risk factors into our prophylactic program and updating it with regard to Long Covid symptomatology in addition to vaccination side-effects. Thanks to our C-19 saliva testing and antibody monitoring last year, we have already managed to collect all specific data in this regard for our Premium clients, which puts us one step ahead. We will be shortening the intervals between tests for clients with a higher risk profile and introducing even more targeted diagnostic methods.

Dr Robert Hess: Updates and Revises

Dr Robert Hess – 02/04/2022

Dr Robert Hess: Updates and Revises Section 4 of its Prophylactic concept.

In the current circumstances, it is more important than ever to maintain a clear overview. The number of vaccinations and infections, the virus variants in circulation and the available vaccines, the course taken by an infection, possible side-effects and the administration of various drugs against severe COVID-19 – these are all factors that make our efforts to provide comprehensive protection more complex, requiring close attention and detailed documentation. Protection of the organism as a whole remains our priority, which is why we are now broadening the scope of our prophylactic concept and scheduled check-ups.

In the last two years, our immune system has been through a lot – it has had to adapt and evolve, to adjust and play a supportive role in meeting the new challenges of either infection with COVID-19 or injection with an mRNA vaccine. To complicate matters, a pandemic is a fast-moving and generally unpredictable state of affairs that may drag on over months and years. Right at the start of the COVID-19 pandemic, I placed great emphasis on accurate documentation of the vaccination and infection status of my clients in order to ensure that data is systematically processed and that possible sequelae are spotted. The information we have gathered will now be evaluated and incorporated into our amended prophylactic program.

With this specific focus on prevention, we aim to identify and monitor potential long-term effects of SARS-CoV-2 infection. Long covid and post-covid are both sequelae of the disease, but they describe a very broad and elusive picture of diverse symptoms. As the pandemic has progressed, it has become increasingly clear that infection with SARS-CoV-2 can have long-term health consequences, even if the course of the disease itself is mild or is asymptomatic and therefore goes unnoticed. For this reason, I pay special attention to the sequelae of COVID-19 with the aim of defining these terms more precisely for our clients in the future.

At the same time, we also have to consider the possibility that certain symptom manifestations might instead be associated with vaccine damage and the long-term consequences of repeated vaccinations. More and more studies are producing information about the effects of the spike protein and about endothelial damage. However, we are surprised that there are no large-scale studies on possible carcinogenic effects or immunomodulatory changes so far. We will continue to keep this on our radar.

This specific focus on prevention in relation to the COVID-19 pandemic also shifts attention to the internal organs, where we are primarily looking at the kidney, liver, coronary arteries and the bronchial and neurological systems. Likewise, our prophylactic recommendations will also cover the relevant techniques and diagnostic methods. For example, we consider echocardiography (ultrasound examination) in cardiac and coronary artery diagnostics as no longer sufficient for our requirements and would therefore favor diagnostics based on a cardiac MRI scan.

In conclusion, I would like to inform my clients that we now intend to shorten the intervals for preventive care planning. This has the advantage that continuous monitoring of our clients and the availability of individualized data allows us to intervene at an early stage and thereby prevent damage in the long term.

Dr Robert Hess: Weekly Omicron Update

Dr Robert Hess – 01/27/2022

Dr Robert Hess: Weekly Omicron Update

An end to the Omicron wave is in sight

All regulations and restrictions in England have now been removed (though not in Scotland, Wales or Northern Ireland where such decisions are devolved to regional parliaments). According to UK Health Minister Sajid Javid, England will be the most open country in Europe. Omicron cases also appear to be peaking in the United States, although the number of deaths has not yet shown any sign of falling away. On Tuesday, Pfizer/BioNtech announced the start of clinical trials for their new Omicron vaccine. Meanwhile, a new Omicron subvariant is coming under global scrutiny.

Restrictions put in place to stem the Omicron wave will be ditched in England on Thursday. Mandatory mask-wearing, COVID-19 vaccination passports and Home Office guidelines – known as Plan B – will no longer apply. According to Health Minister Sajid Javid, this will make England “the most open country in Europe”.
But are the restrictions being lifted too soon? Infection numbers may be down, but they are still well above the levels seen at the height of last winter.

This time, however, the starting point is different. A combination of immunity built up through vaccination and previous infections makes England – and indeed the rest of the UK – one of the best protected countries in the world. According to the latest data from the Office for National Statistics, more than 97% of the population has antibodies. At the start of the pandemic, of course, that percentage was zero. This does not necessarily mean that the population is immune to infection, but their immune system is at least better equipped to fight the virus. The result is that COVID-19 now causes milder illness and the mortality rate has dropped significantly. However, this is also partly due to the fact that Omicron is inherently less severe.
This combination has helped to keep the number of deaths in recent weeks much lower than in previous waves and at a level comparable to a severe flu season. Objectively, this is pretty much the best-case scenario compared to what was predicted when Omicron first arrived on the scene.

Hospital admissions in England appear to have peaked at just over 2,000 per day – only a third or a quarter of the figure predicted by modeling for a worst-case scenario; even the Scientific Advisory Group for Emergencies (SAGE) which officially advises the government expected it to be at least 3,000.

Omicron cases also appear to be slowly but surely peaking in the USA. However, the number of deaths continues to rise. As many as 700,000 new cases are reported daily in the United States. This is fewer than earlier in January, but still far more than any previous increase. We expect a similar trend here to the one seen in Europe.

Pfizer/BioNTech announced on Tuesday that they have begun clinical trials for the new version of their vaccine that specifically targets the COVID-19 Omicron variant. They plan to test the immune response elicited by the Omicron vaccine on 1,400 volunteers in the United States. It will be administered both as a triple shot to unvaccinated persons and as a booster shot for individuals who have already received two doses of the manufacturer’s original vaccine. They are also testing a fourth dose of the current vaccine against a fourth dose of the Omicron-based vaccine in people who received a third dose of the original vaccine three to six months earlier.
Pfizer/BioNTech further announced that, depending on the amount of clinical trial data required by regulatory agencies (FDA, EMA, etc.), it is quite possible that the original plan to launch the Omicron vaccine by the end of March may not be realized.

Some countries have already begun offering additional booster doses. However, a recent study from Israel has already shown that, while a fourth dose of mRNA vaccine increases antibodies, this is not sufficient to prevent infection with Omicron.

Just when some countries are experiencing a decline in cases and restrictions are being relaxed, scientists are now observing another sub-lineage of the Omicron variant which has been designated BA.2. Is this the beginning of another worst possible timing scenario? The subvariant has spread rapidly in Denmark and the United Kingdom, with BA.2 accounting for nearly half of the recent cases in Denmark. BA.2 has been circulating in the United Kingdom for some time, but at a lower level than BA.1, the Omicron type that predominates there. In parts of India and the Philippines, BA.2 is the main version of Omicron.
In previous waves, there were large regional differences as to which sub-lineage of a particular variant would succeed in asserting its dominance.

While BA.2 is definitely something to keep an eye on, from what we know so far, it does not present any great cause for concern. It could be that it has a slightly higher transmission rate compared to BA.1, but from the data currently available, it does not appear to cause more severe symptoms or to manifest special abilities to bypass the immune system. However, we await further developments.

Dr Robert Hess: Best medication yet?

Dr Robert Hess – 01/20/2022

Dr Robert Hess: Best medication yet? Paxlovid a potential gamechanger

Paxlovid received emergency approval in the USA just before Christmas, and it got the all-clear for use in Europe as early as January. This new medication could help reduce the number of people who fall severely ill with COVID-19, but supply shortages and manufacturing problems are so far hindering widespread distribution.

Taken early enough after a diagnosis of COVID-19, paxlovid could dramatically reduce the risk of severe illness. Its manufacturer, Pfizer, claims that the likelihood of hospitalization or death for high-risk patients following an infection is reduced by almost 90 percent. Many in the medical profession are now hoping for its rapid and widespread deployment. Indeed, Germany and other European countries will probably begin using paxlovid before it is officially approved by the European Medicines Agency (EMA). However, it will not be clinicians who administer paxlovid to their patients. Ideally, the drug will avert the situation where infected patients have to go to hospital in the first place. It will therefore be prescribed primarily by family doctors. In our opinion, the great advantage of Paxlovid is its convenience and ease of use, i.e. as a tablet that infected individuals can take at home.

Paxlovid is an antiviral medication against COVID-19 consisting of two substances. The actual active ingredient, newly developed by Pfizer, is called nirmatrelvir. This inhibits 3CL protease, a molecule that Sars-CoV-2 needs to replicate in body cells. This mechanism of action has a major advantage: the gene segment that codes for this protease is only changed at one site in Omicron compared with Delta. We therefore have reason to believe that paxlovid is also effective against the new variant. And according to Pfizer, its effectiveness has also been indicated by initial laboratory tests. The other active ingredient contained in paxlovid is ritonavir, a substance that is also used in the treatment of HIV. Ritonavir ensures that nirmatrelvir is broken down more slowly and can therefore act for longer. The two elements are dispensed as separate tablets in the package of paxlovid. Infected patients who are deemed eligible for the drug must take two doses of nirmatrelvir and one of ritonavir twice a day for five days.

Paxlovid has been dubbed a potential gamechanger the basis of interim study results published by Pfizer at the beginning of November 2021. In mid-December, the company then issued a further announcement confirming these initial good results. According to the report, the drug is highly efficient in averting the need for emergency treatment and/or in preventing death among COVID-19 patients with mild or moderate symptoms who have not yet been hospitalized. In high-risk patients, paxlovid reduced the relative risk of hospitalization or death by almost 90 percent.

While only five of 697 people in the paxlovid test group required emergency treatment within four weeks (equivalent to 0.7 percent), among those who received a placebo, 44 out of 682 (equivalent to 6.5 percent) had to be admitted to hospital. Nine test subjects from the placebo group died from COVID-19, while there were no coronavirus deaths in the paxlovid group. These results apply to subjects who took paxlovid within three days of symptom onset, according to the news release. However – and this is very good news – Pfizer reports that efficacy is just as good when the first tablet is taken within five days of symptom onset. This considerably extends the window of opportunity.

Unlike molnupiravir, another antiviral drug we reported on a few weeks ago, estimates of paxlovid’s efficacy have not been downgraded. Merck & Co, the company that manufactures molnupiravir, had initially claimed that its product reduced the relative risk of severe COVID-19 by approximately 50 percent, but a subsequent review of the study results showed only a 30 percent reduction.

Based on everything we know so far, paxlovid looks the best of the available options. However, we must remember that there are still no published trial data. Pfizer has submitted its results to a medical journal for publication, but they are not yet open to public scrutiny. In order to better assess paxlovid, we require far more data, for example identifying the type of patients who most strongly benefit from treatment with the drug. The over-65s, who are automatically at greater risk due to their age, accounted for only 11.4 percent of the test subjects in an interim evaluation, and people over 75 made up only 2.9 percent of the sample. Furthermore, only unvaccinated individuals participated in the study. Since most of my clients are vaccinated, it is also important to see how effective paxlovid is among this population.

In terms of side-effects, paxlovid performed relatively well in the study. Apart from the more or less “usual” side-effects of drugs, such as diarrhea or vomiting, there were no unforeseen adverse reactions. The bigger problem with paxlovid is likely to be from another source, namely drug-drug interactions (DDIs).

The ritonavir component of paxlovid ensures that the actual active ingredient nirmatrelvir is broken down more slowly and can therefore take effect over a longer period. This happens because ritonavir inhibits an enzyme complex in the liver that is used to metabolize and break down many drugs in the body. And this, in turn, can cause these drugs to remain in the body in excessive concentrations. Other mechanisms associated with paxlovid consumption can also cause certain drugs to be broken down more quickly than normal, so that they work either inadequately or not at all. These interactions affect a wide variety of medications, but especially those prescribed for cardiac arrhythmias, antidepressants, cholesterol-lowering drugs, anticoagulants and certain antibiotics. We would therefore ask our clients to inform us in advance in the event of infection and a proposed course of paxlovid. We will then check and reconcile possible interactions with other medications.

And what about vaccination status?
The Pfizer study initially included only high-risk unvaccinated volunteers. Another study is currently analyzing the effectiveness of paxlovid in low-risk unvaccinated individuals and in vaccinated people with breakthrough infections. Nevertheless, vaccinated people will also be eligible to receive the medication.

The bigger problem in this context is availability and the inevitable triage scenarios, especially in the United States where doctors are already complaining about supply bottlenecks.

The U.S. government procures paxlovid centrally and allocates supplies to federal states where local health officials decide on distribution and on the guidelines to be issued to doctors. However, supplies have already been exhausted. The city of New York, for example, received about 1,300 paxlovid treatments at the end of December, but according to a spokesperson for Alto Pharmacy, which distributes the city’s supplies, these were used up within a week. We are reliably informed that New York City currently has no paxlovid in stock. Last Tuesday, the U.S. government doubled its paxlovid order, though we don’t expect supplies to last until April.

So while it is relatively easy to get a vaccine, there is likely nowhere near enough paxlovid to treat every at-risk individual who becomes infected. Manufacturing the drug also takes time, because producing the nirmatrelvir component is a complex multi-step process that takes months. Pfizer plans to produce up to 120 million units of paxlovid by the end of 2022. This sounds like a lot at first, but given the global demand, it is a drop in the ocean.

And it is not only paxlovid that is suffering from supply shortages. There are also problems with the procurement of proven monoclonal antibody therapy. Throughout most of the pandemic, monoclonal antibodies – a treatment generally administered intravenously in hospitals or clinics – have been the primary intervention for recently infected patients. The two most common types of monoclonal antibodies (casirivimab/imdevimab and etesevimab/bamlanivimab) do not work well enough against the Omicron variant. There is a third antibody treatment, sotrovimab, manufactured by GSK and Vir Biotechnology, that is effective against Omicron. However, the U.S. government had ordered only about 450,000 treatment units to date, many of which have now been used or have not yet been distributed to the state governments. On 12th January, the U.S. government announced in a press release that it had ordered an additional 600,000 units of sotrovimab.

Paxlovid can only become a gamechanger and GSK’s MAB therapy can continue in a supportive role if these treatments are made as widely and easily accessible as possible. Currently, the system only favors those who have the time, energy and knowledge to seek out treatments.

We will continue to share our assessment of the situation with you. If you find yourself in the situation of needing paxlovid or MAK therapy, please contact us beforehand so that we can talk through all the options and tailor them to your individual circumstances.

Dr Robert Hess: Heavily mutated Covid variant has been identified.

Dr Robert Hess – 11/28/2021

Dr Robert Hess: Heavily mutated Covid variant has been identified, rapidly labelled a “variant of concern” and named Omicron.

Infection Omicron was first detected in South Africa last week, leading countries around the globe, including the United States, to impose travel restrictions on the southern African nation and at least seven others in the region. The new Omicron coronavirus variant kept spreading around the world on Sunday, with 13 cases found in the Netherlands and two each in Denmark and Australia, even as more countries tried to seal themselves off by imposing travel restrictions. The variant has now been detected in Britain, Germany, Italy, the Netherlands, Denmark, Belgium, Botswana, Israel, Australia and Hong Kong.

Omicron was first detected in South Africa last week, leading countries around the globe, including the United States, to impose travel restrictions on the southern African nation and at least seven others in the region. The new Omicron coronavirus variant kept spreading around the world on Sunday, with 13 cases found in the Netherlands and two each in Denmark and Australia, even as more countries tried to seal themselves off by imposing travel restrictions. The variant has now been detected in Britain, Germany, Italy, the Netherlands, Denmark, Belgium, Botswana, Israel, Australia and Hong Kong.

The discovery of Omicron, dubbed a “variant of concern” last week by the World Health Organization, has sparked worries around the world that it could resist vaccinations and prolong the nearly two-year COVID-19 pandemic. Omicron is potentially more contagious than previous variants, although experts do not know yet if it will cause more or less severe COVID-19 compared to other strains.

There have been many examples of variants that have seemed scary on paper, but came to nothing. The Beta variant was at the top of people’s concerns at the beginning of the year because it was the best at escaping the immune system. But in the end it was the faster-spreading Delta that took over the world. Beta was all immune escape and nothing else, Delta had infectivity and modest immune escape – Omicron potentially has both to high degrees.

What is this variant?
There are thousands of different types, or variants, of Covid circulating across the world. That’s to be expected because viruses mutate all the time. But this new variant, called B.1.1.529 or Omicron, has experts particularly worried because it is very different to the original Covid, which current vaccines were designed to fight. It has a long list of genetic changes – 50 in all. Of these, 32 are in the spike protein of the virus – the part which is the target of vaccines.

It is a rapidly evolving situation and we will keep you up to date with important findings. Omicron’s genetic profile has raised concerns, but there’s a shortage of real-world data that means nobody has the complete picture of what it can do.

Several vaccine manufacturers have announced measures against the new variant Omicron:
BioNTech and Pfizer are testing in the lab until about Dec. 10 how well their own already-approved vaccine protects against Omicron. If necessary, they will develop a vaccine adapted to the variant. Moderna is testing how well its licensed and the new variant-adapted vaccine candidates under development protect against Omicron. It is also directly initiating development of a vaccine adapted to Omicron. AstraZeneca is also evaluating how well its licensed vaccine protects against Omicron, according to the media report, and believes it can quickly develop an adapted vaccine if necessary. Janssen is also evaluating whether its own vaccine is protective, according to the media report. Novavax has started developing a variant of its own vaccine adapted to Omicron, according to the media report.

For now, this is just an update on the current situation and an initial assessment. In the course of the week, we will gain further insights and go into more detail on this topic. We will put current booster recommendations for our customers to the test again. Depending on how the situation develops, we may deviate from the original plan in some cases.

Dr Robert Hess: Could the Novavax vaccine candidate be a viable

Dr Robert Hess – 10/22/2021

Dr Robert Hess: Could the Novavax vaccine candidate be a viable alternative for skeptics wary of mRNA technology? We take 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.

There are still some gaps in our knowledge about the various Covid-19 protein-based vaccines on the horizon. Furthermore, Novavax currently seems to be having problems with its manufacturing process. It is not yet clear if and when approval will be granted, but we will continue to monitor developments. We expect more news on this front in early 2022. Also on our radar is the vaccine from the French-Austrian company Valneva. They too have recently published the results of a Phase 3 trial of their inactivated vaccine VLA2001 and are likely to submit an application for marketing authorization soon.

By contrast, we already have extensive knowledge about mRNA vaccines. They are safe and have the best efficacy rate. In our opinion, there is no good reason to wait for future marketing authorizations before getting vaccinated.

Dr Robert Hess: Evidence that Delta does not make children more ill

Dr Robert Hess – 10/20/2021

Dr Robert Hess: Evidence that Delta does not make children more ill than other variants of the coronavirus.

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 sevon the course taken by the disease. erity), 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.

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