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Pandemic Journal

Dr Robert Hess: Long Covid After Vaccination

Dr Robert HEss

Dr Robert Hess – 03/23/2022

Dr Robert Hess: Long Covid After Vaccination

In rare cases, coronavirus vaccines may cause Long Covid–like symptoms.

As mentioned 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 Studies conducted by Nath on around 30 case reports have so far remained unpublished, but publication is expected soon.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 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.

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.

 

Pandemic Journal

Dr Robert Hess: Weekly Omicron Update

Dr Robert HEss

Dr Robert Hess – 12/11/2021

Dr Robert Hess: Weekly Omicron Update

Teams of researchers around the world are working hard to understand the new Omicron variant of the coronavirus. It is the most highly differentiated among the five variants that have so far qualified for the World Health Organization classification “variant of concern” since the pandemic began.

 

The number of cases in South Africa has risen rapidly to nearly 20,000 per day since the country first reported the discovery of Omicron two weeks ago. In the weeks leading up to that, the number of COVID-19 cases in the country had remained relatively low, even though only 26% of the population was fully vaccinated. With a vaccination rate of under 30% and many South Africans having most likely been infected naturally at some point, it will be interesting to see if the same rapid rise in cases occurs in countries with a high take-up of mRNA vaccines.


There are three important questions, the answers to which will indicate the likely impact of Omicron on countries around the world. How transmissible is this new variant of coronavirus?
How well is it able to evade the antibodies and T‑cells that make up the immune defenses of both the vaccinated and unvaccinated? And what is the probability that an infection with Omicron will be severe, resulting in the hospitalization and possibly death of an infected person?


How easily does Omicron spread?
The Omicron variant spreads more readily than the original “wild type” SARS CoV-2 virus first identified in Wuhan. This is already evident from the numbers coming in from all around the world. How easily Omicron spreads compared to Delta is not yet clear. According to a study by Professor Hiroshi Nishiura of the Health and Environmental Sciences Department at Kyoto University in Japan, who specializes in mathematical modeling of infectious diseases, the Omicron variant of COVID-19 is 4.2 times more transmissible in the early stages than Delta – a finding that is likely to confirm fears about the contagiousness of the new strain.
Furthermore, scientists believe that anyone infected with Omicron can transmit the virus to others, even if they are vaccinated or have no symptoms.


Will Omicron cause more severe disease progression?
More data is needed to assess whether Omicron infections – especially reinfections and breakthrough infections in individuals who are fully vaccinated – cause more severe disease or death than infections with other variants. There are fears that Omicron could cause more damage around the world than Delta, and the WHO has warned that outbreaks with “severe consequences” could occur. However, the surge in cases in South Africa following the emergence of the variant in the country has not yet led to hospital overload, so there is currently a degree of confidence that Omicron will not trigger more severe courses of the disease. However, it is important to note that the first reported cases involved university students – younger people whose lifestyle exposes them to greater risk of infection – so it will be days to weeks before the severity of the Omicron variant is fully known. There is no information as yet to suggest that the symptoms associated with Omicron are different from those of other variants.


Do vaccines work against Omicron?
The current crop of vaccines are expected to offer a certain percentage rate of protection against severe illness, hospitalization and death due to infection with the Omicron variant. Studies are being conducted around the world to establish the actual level of protection. Moderna and Pfizer/BioNTech are currently testing their existing vaccines against the Omicron variant with a view to modifying them if the results should prove disappointing.

To study the effectiveness of a vaccine against a particular variant of Sars-CoV-2, researchers typically carry out what are called “neutralization tests”. They look to see how many antibodies a vaccinated person has in his or her blood that can bind to the viral variant and thus eliminate it. However, the true protection status of vaccinated persons cannot be completely determined in this way; clinical studies involving several thousand volunteers are needed, or evaluations of the speed at which the disease is spreading.

Last Wednesday, Sandra Ciesek, a virologist at Frankfurt University Hospital, published initial results showing a significantly reduced antibody response to the new Omicron variant. According to Ciesek, the data lends weight to the suggestion that the development of a vaccine specially adapted to Omicron is the way ahead. On Tuesday, South African experts had already presented similar data showing a weaker antibody response to Omicron in vaccinated individuals. Researchers at the Africa Health Research Institute in South Africa released preliminary data on the effectiveness of the BioNTech/Pfizer vaccine against Omicron. The results suggest that the viral variant escapes the antibody response of twice-vaccinated individuals, whereas a third booster jab neutralizes the new variant. Antibody levels against the Omicron variant are as high after booster vaccination as they are against the wild type after two doses. In vaccinated individuals who had also been infected at some stage, a substantial antibody response was also measurable.

Scientists emphasize that Omicron still relies on the same biological mechanism as the other corona variants to attack human cells. Consequently, T-cells and antibodies continue to have a protective effect. If it turns out that the efficacy of vaccines against Omicron falls below 50%, then this variant would come under our definition of a “super mutant”. We will present scenarios for this again as more data become available.

Breakthrough infections in people who are fully vaccinated can still be expected.


Will therapies and treatments work against Omicron?
Scientists are seeking to determine how well existing treatments work against COVID-19. Because of Omicron’s altered genetic profile, it is likely that some treatments will remain effective, while others may be less so.

 

What are the vaccine manufacturers saying?
On Wednesday, Moderna CEO Stephen Hog announced that his company could have a COVID-19 booster vaccine targeting the Omicron variant tested and ready for approval in the USA as early as March. Moderna said in a statement that booster vaccines with genes that specifically target mutations in the newly discovered Omicron variant would be the fastest way to address the reduction in vaccine efficacy which the variant is expected to cause. The company is also working on a multivalent vaccine that would target up to four different coronavirus variants, including Omicron.

Moderna, as well as Pfizer/BioNTech, have already started to work on the further development of their vaccines. How long it will take for these to be approved is as yet unknown. Given previous guidance from the U.S. Food and Drug Administration, which requires mid-stage clinical trials, the process could take three or four months. According to Stephen Hoge, the Omicron-specific boosters will not realistically be ready for rollout until March or possibly the second quarter – unless, of course, the FDA changes its guidance on the data needed for approval.

 

One dilemma we currently face is whether to recommend a booster jab with one of the existing vaccines or to wait. And how can we prevent the emergence of more virulent pathogens in the future?
The data on the risk posed by the Omicron variant is gradually building up and becoming clearer. Nevertheless, based on what we know so far, booster vaccinations provide relatively good protection, if not against an actual infection, then definitely against severe disease. Moreover, this is for the moment our only proven effective weapon in the fight against the virus. Scientific opinion is that an x-fold reduction in neutralizing activity does not necessarily mean that a vaccine is x times less protective. The actual loss of immunity is much less, and the triple vaccination is the best protection we have.
New vaccines are not expected until after the winter wave washes over the northern hemisphere, so politicians continue to push the booster programs. However, if the FDA and other regulatory agencies change their rules, the process of approving a new, more effective vaccine against Omicron could be significantly accelerated. We expect to have more information and data on this in the run-up to Christmas, so for now, we are adopting a wait-and-see approach, especially for our clients who are under no particular time pressure as regards boosting and are reasonably well placed in terms of antibody count and T-cell immunity.

Another matter that concerns us is how new mutations and vaccination regimes should be dealt with in the future. Some scientists believe that vaccines and the mass distribution of them in industrialized countries could lead to the emergence of even more virulent pathogens. Conventional wisdom holds that natural selection eliminates highly lethal pathogens, as the death of the host greatly reduces transmission to other persons. Vaccines that keep the host alive but still allow transmission could therefore enable highly virulent strains to circulate in a population. The data that we have accumulated so far shows that vaccines against diseases that do not prevent transmission can create conditions that favor the emergence of pathogen strains capable of causing more severe disease in unvaccinated hosts.

Importantly, most vaccine experts agree that current vaccines still protect against severe disease and death in the event of Omicron infection. Thus, we are not left completely defenseless. However, once again, timing is critical here in deciding whether to boost now with one of the vaccines already available or to wait and boost with a next-generation vaccine. We know from our private sources that vaccine adaptation will be on a far greater scale than previously assumed. In addition, the definition of “fully vaccinated” status will be expanded from double vaccination to triple vaccination. We will be weighing this carefully over the next few weeks and will keep you updated.

We wish to reiterate that my Premium clients can contact us at any time if they have any concerns regarding booster vaccination or vaccination status or if a change is pending. We only give out highly individual recommendations in this regard – a refinement in procedure that is currently gaining more and more relevance.

Pandemic Journal

Dr Robert Hess: What next for the SARS-CoV-2 pandemic?

Dr Robert HEss

Dr Robert Hess – 11/02/2021

What next for the SARS-CoV-2 pandemic?

The number of infections worldwide is on the increase, and with it, the number of vaccine breakthroughs. However, it is not only the rising rate of infection that is the root cause of this, but also the waning effect of the vaccines themselves. Nevertheless, individuals without any form of immunization are significantly less protected against COVID‑19 disease, and the mRNA booster jabs seem to be delivering on their promise of offering almost complete protection. There are multiple factors at play here that will continue to occupy our attention this winter. In the meantime, this is how we see the current situation. 

How prevalent are vaccine breakthroughs, and has their number increased? The number of vaccine breakthroughs worldwide is increasing. All manufacturers and vaccines are affected. A vaccine breakthrough occurs when a fully vaccinated person contracts a coronavirus infection with clinical symptoms.

According to the weekly report issued by the Robert Koch Institute (RKI), 95,487 fully vaccinated persons in Germany, have already been infected with the coronavirus since February. In the week of 27th September ‑ 24 October alone, almost 41,000 vaccine breakthroughs occurred among 18- to 59-year-olds. Measured across the entire period since the start of the vaccination campaign in Germany, the percentage of vaccine breakthroughs among symptomatic COVID‑19 cases in this age group has risen to 10.9. However, if we look only at the last four weeks, the ratio is significantly higher at 37.5 percent.
Increases can also be observed in the over‑60s age group, where the percentage of vaccine breakthroughs among symptomatic COVID‑19 cases is 16.1 for the period since the start of the vaccination campaign. And when we take the figures from only the last four weeks, this percentage increases to 58.9.
Other European health authorities are also reporting that, in some regions, half of the new infections are among the fully vaccinated, and the trend is unfortunately upwards. According to the UK government, four out of ten new hospital patients currently being admitted for coronavirus infection have been vaccinated.
In the USA, breakthrough infections were studied in six states – California, Colorado, Massachusetts, Oregon, Utah, Vermont and Virginia – as the authorities there collect the most detailed data on the disease. Whether their findings can be extrapolated to the entire USA is therefore unclear, but breakthrough infections in those six states accounted for 18 to 28 percent of registered cases during September. Among those who had been vaccinated, Johnson & Johnson recipients displayed slightly higher rates of vaccine breakthrough and of related deaths. Additionally, those vaccinated with Pfizer-BioNTech had slightly higher rates than recipients of Moderna, which can most likely be attributed to dosage differences.

Which age groups are affected?
Vaccination breakthroughs are occurring in all age groups. The proportion of breakthroughs is highest among individuals over 60 years of age. In both the EU and the USA, it appears that it is mainly older persons who are being hospitalized with the more acute infections, as well as individuals whose immune system is relatively weak or who have some sort of immunodeficiency. According to CDC data, 74 percent of vaccine breakthroughs occur in adults aged 65 and older.

Why are there so many vaccine breakthroughs?
The statistics show that vaccine breakthroughs tend to increase as more people are vaccinated against a particular pathogen. In the case of SARS-CoV-2, however, this is not the only reason, as multiple factors are involved here. Firstly, the virus now has renewed opportunities to spread, because most countries have relaxed their regulations on social distancing and face coverings, and because the northern hemisphere is entering the colder winter months. Secondly, the dominant form of the virus is still the Delta variant which is more contagious than the original “wild type” (i.e. Wuhan) or successor Alpha variant and also more successful in undermining vaccine efficacy.

In our opinion, the reason why vaccine breakthroughs have increased so rapidly, especially in recent weeks, is due to dwindling vaccine protection. Current studies even indicate that protection could be as low as 20 per cent only four months after the second dose of a COVID‑19 vaccine. Although a double dose is effective against the Delta variant, the protection it affords begins to diminish after only 30 days. A British study in August found that the effectiveness of the vaccine dropped to 90%, 85% and 78% after 30, 60 and 90 days, respectively. The data from such studies may vary, but the take-home message is that we too have observed the phenomenon of rapidly declining protection during the regular antibody level checks we perform on our clients. We therefore have to assume that the antibodies developed as a result of vaccination wane more quickly than was previously thought and generally published.

So, what are the causes of vaccine breakthrough?
Weakened immune system and age: An already weakened immune system will often be a decisive factor. This mostly affects cancer patients undergoing chemotherapy, patients with autoimmune diseases or the elderly. Especially in senior citizens, it is often the case that the immune system no longer responds adequately to immunization.

Mutations: Mutations also impair the effectiveness of the vaccine. The aggressive and significantly more contagious Delta variant reduces the efficacy of the vaccines. This is because this mutation is better adapted than its predecessors to evade the antibodies that are formed after vaccination. Although the current crop of vaccines are also effective against the Delta variant, more antibodies are needed to neutralize it.

Waning effect: As with almost all vaccines, the effect wears off after some time. This seems to be happening somewhat faster with the COVID‑19 vaccines than initially thought. Data from Israel gathered around mid-July 2021 was already indicating that the effectiveness of the BioNTech/Pfizer vaccine had begun to diminish. Israel was therefore one of the first countries to recognize the need for a follow-up booster jab. Their data showed that, after three months, antibody concentration was reduced by about half.

So, is vaccination pointless?
No, on the contrary. Vaccination protects against infection and, above all, staves off a severe course of the disease. Even if the protection against infection declines over time, protection against the potentially severe consequences remains. According to the CDC study, vaccinated people are eight times less likely to become infected and 25 times less likely to be hospitalized and/or die. A survey of intensive care units also confirms that most COVID‑19 patients admitted are unvaccinated. Data from the UK and Europe suggests that vaccination affords 90% protection against hospitalization. Among those aged 60 and older, protection against the risk of hospitalization is 86 percent. Corona vaccines protect against a fatal outcome by as much as 98 percent (87 percent in the over-60s). But in any case, the only sensible way to drive down the rising number of infections is to refresh vaccine protection with a booster jab.

How important are booster jabs?
Due to the rising numbers of vaccine breakthroughs, booster vaccination has taken on a new urgency. Some countries fear they will be entering a fourth wave around Christmas time, and governments are appealing to their citizens to get their booster without delay. But the vaccination program is faltering in many places, and the approach taken by individual countries also varies greatly. In Germany, the booster vaccine is so far only recommended for the over-70s and the immunocompromised. On Friday, however, the German health minister spoke out in favor of offering booster vaccination to all citizens. Sweden and the USA currently offer a booster jab to everyone over the age of 65 and the UK to everyone over 50 (as well as the immunocompromised, health workers, the occupationally exposed, etc.). Israel has already completed the majority of its booster vaccinations. The country was already battling a fourth coronavirus wave in the summer but now seems to have survived the immediate crisis. According to the Israeli health authorities, this is mainly due to the widely administered third vaccination against the virus.

Until now, all booster vaccinations have been given at least six months after the second dose of Pfizer/BioNTech or Moderna. The length of this interval is now up for debate, especially in view of rapidly declining antibody levels. Thanks to our capacity for monitoring the individual antibody levels of our clients, we have been able to ascertain that some would benefit from a booster jab as early as four months after the second dose. If the vaccine administered was J&J, a booster is already appropriate after only four weeks. This is an option that we also recommend, as we have found that the antibody gain from vaccination with J&J is insufficient.

With governments adopting so many different approaches and also national graphs peaking at different times, it will be interesting to see what stage the pandemic has reached in different countries two or three months further along the line.

What do initial data on the effectiveness of the Pfizer/BioNTech booster tell us?
The first full study has shown that a third dose of the Pfizer vaccine provides an “excellent” level of immunity. On 21st October, Pfizer/BioNTech shared results from their Phase 3 study involving more than 10,000 volunteers. These showed that the booster jab conferred 95.6 percent efficacy. In the half cohort who did not receive booster vaccination, 109 persons later became symptomatically infected. In the half who had received booster vaccination, this number was only five. It also showed that those who received a third dose of the Pfizer vaccine almost a year after their first two had higher protection against symptomatic infections than those who had received only two doses. An earlier study based on real-world population data from Israel found a similar increase in protection against serious illness.

Scientists believe that a decrease in the protection afforded by the first two doses is more than compensated for by the third. However, this refers only to a complete and exclusive series of Pfizer/BioNTech vaccination; there are no comparable data yet on the effectiveness of a third dose of Pfizer/BioNTech to top up a course of AstraZeneca or J&J. Two further studies on booster vaccines were also published in the October edition of New England Journal of Medicine. One found that antibody levels to the Delta variant increased almost tenfold after a booster shot of the Pfizer vaccine. We too have observed this antibody increase in our clients who had already received a booster vaccination.

The long-term prospects may at first seem somewhat daunting, but the data speak for themselves. SARS-CoV-2 will remain with us for the foreseeable future, and we will therefore have to learn how best to live with it. Although we may have hoped for even more ways to combat the coronavirus at this point, science never sleeps and we expect that there will be more to come in the future, including not only new vaccines but also drugs to treat a COVID‑19 infection. Apart from having a well-armed immune system, our defenses against a SARS-CoV-2 infection are “limited” to the best available vaccines. But this weapon seems to be effective enough when applied correctly and affords satisfactory protection for the time being. The realization that antibody levels decrease more rapidly than expected after a second dose of vaccine came as a surprise to many, but the phenomenon of diminishing protection over time is nothing new and can also be observed with many other vaccines.

Vaccines and subsequent responses by the immune system are under permanent review and subject to reinterpretation. While constant chopping and changing of rules and regulations may not always be entirely understandable and can at times be unsettling and demoralizing, it is the only realistic way to tackle the pandemic. We learn something new every day. The biggest advantage we see for our clients in this context is that we are not only privy to the latest research findings but can also incorporate them directly into our individual client concept. The specific data on each individual enables us to make precisely tailored recommendations regarding optimal protection against COVID‑19 and to use our own A.I. data sets in the process. Especially against the background of faster than expected decline in antibody levels and T-cell immunity, this puts us at an enormous advantage.

As we cannot yet predict how severe the coming winter will be, we would urge you to continue to maintain your immunity by following our general recommendations and taking your individually formulated supplements regularly. We will keep you informed and continue to advise you individually on booster vaccinations. If you have any questions, do not hesitate to contact our team of consultants.

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Pandemic Journal

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.

Pandemic Journal

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.