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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: Weekly Omicron Update

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.

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: Update on Booster jabs and vaccine breakthroughs.

Dr Robert Hess – 11/26/2021

Dr Robert Hess: Update on Booster jabs and vaccine breakthroughs.

Infection rates in Germany, Austria and the Netherlands have risen to a new and worrying high. Hospitals have had to postpone planned surgical procedures, and intensive care units are rapidly filling up. The situation in Germany is unfortunately a forerunner of what is likely to happen in the United States soon. The UK had the unwelcome distinction of being ahead of the curve in Western Europe, although the rate there now seems to be leveling off. We expect the current fourth wave will hit the USA in a few weeks. There are two main reasons for this: firstly, waning vaccine efficacy paired with vaccine breakthroughs, and secondly, the slow progress being made by the booster vaccination campaign. More and more studies are showing what we already concluded a few weeks ago, namely that the protection afforded by the vaccines is declining at a rapid rate and that antibody counts are also falling fast.

Eleven months ago, there was great jubilation at the test results from a study conducted by BioNTech which showed that their vaccine had a 95% success rate against infection with the SARS-CoV-2 virus. Not long after, Moderna reported a similar impressive result. This was all the more encouraging, because the FDA had set a modest efficacy threshold of only 50%. Since then, billions of people have been vaccinated against the coronavirus, and numerous studies have confirmed the high protective effect in practice.

Unfortunately, it is now clear that even a double dose of vaccine is not going to be enough to end the pandemic. There were indications of this relatively early on when the initially high antibody titers in the blood of vaccinated individuals dropped again just a few months after they had received their second dose. In Israel, which had vaccinated its population earlier and faster than any other country, the infection curve rose steeply again in the summer, but this has since been flattened out and brought under control by the booster vaccination roll-out.

In Germany, too, it is primarily unvaccinated Covid-19 patients who are occupying beds in intensive care units, but the number of breakthrough infections is also rising. This does not come as a complete surprise from an immunological perspective, as we know that vaccine protection gradually wears off after approximately six months.

Large-scale analyses from different countries now reveal the extent to which vaccine protection declines over time. Scientists in Israel recently published the results from their analysis of cases involving vaccinated adults who had contracted Covid-19 between 11th and 30th July. These showed that individuals who had been vaccinated seven months earlier were at twice the risk of infection as those who had been vaccinated only five months earlier. A study by Pfizer also reached the same conclusion.

An analysis from Sweden produced an even more unpleasant surprise. The research team there found that protection against infection was no longer detectable at all seven months after vaccination and that even protection against hospitalization was down to only 42 percent. Another study from the UK made a comparison using the case-control method. According to this observational study, protection against infection two months after vaccination was 96 percent compared to the placebo group. Five to seven months later, however, it had dropped to 84 percent. Data from the USA also show the diminishing effect.

The effectiveness fades particularly quickly in the elderly, whose immune system responds more weakly anyway. And people in this most at-risk group are precisely the ones whose protection depends on vaccination administered more than six months previously.

With a large proportion of its population now triple-vaccinated, Israel seems to have broken the fourth wave. A recently published analysis shows the effect of the booster campaign, with protection for recipients of the third dose now restored to a highly satisfactory 93-percent level.

The data we have gathered had already indicated the dwindling protection afforded by the vaccines, and what we already suspected has now been confirmed by the latest analyses and studies. The third jab is not “just” a booster per se, but rather complements the vaccination series. According to our data, a third dose of the vaccine finesses immunity and completes the vaccination protection. The antibodies after a third shot are usually in a range that cannot be achieved by just two. This means that, even if vaccine efficacy slowly declines again after a third dose (and it will), it does so from a higher baseline and thus probably more slowly. We are working on the assumption that “fully vaccinated” status will soon no longer apply to those who have had only two doses. How policymakers and governments react to this remains to be seen.
Vaccine breakthroughs are becoming an increasingly acute problem, and booster vaccination is currently the only way to tackle it. The more people, especially the elderly, receive booster vaccinations, the more we will be able to flatten out the wave. In our opinion, countries that have a vaccination rate below 70% and in which the population received their first and second vaccinations early are at a disadvantage in this scenario. The recommendations we make to our clients will continue to be on an individual and, above all, laboratory-dependent basis. This means that we look at the overall picture of antibody quantity and quality, T‑cell immunity and general immune system status. Our recommendations are therefore not country-dependent and may therefore not necessarily be in accordance with national rules and regulations.

We expect that the future will bring more opportunities to recommend full protection against Covid-19. Although vaccination is currently our main pillar of defense, we expect that other methods such as approved antiviral drugs, more effective antibody therapies and differentiated vaccination regimens will be increasingly incorporated into the protection program in the near future.

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

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.

Dr Robert Hess: A first step in the right direction

Dr Robert Hess – 09/21/2021

Dr Robert Hess: A first step in the right direction: BioNTech introduces the “individualization” concept into vaccination strategy.

Where are we now, almost two years into the pandemic? Nine months after the first vaccines for the prevention of Covid-19 were approved, are there any conclusions that can be reliably drawn? Since December 2020, 2.39 billion people worldwide have been vaccinated against Covid-19, with a total of 5.82 billion doses having been administered. Just under 30% of the world’s population has thus been fully vaccinated, and in the United States that figure has now passed the 50% mark.

The raw data on how well the vaccines perform against infection with Covid-19 and on whether they provide sufficient protection are well known. Vaccinated individuals are less likely to become infected and, if they should nonetheless contract the virus, the course of the disease is generally much less severe. These statistics are enough to persuade most people, despite the acknowledged risk of vaccine side-effects. So, how are we to weigh up the advantages of vaccination in preventing a disease that can cause long-term harm and even death against the possible side-effects? This is the dilemma in which a large proportion of the population find themselves, depending on age, pre-existing conditions and personal conviction.

In the current circumstances, it is difficult to find the objective middle ground, as there are many different perspectives on the matter. On the one hand, we are currently witnessing a mass clinical trial, in which all those who line up for vaccination are effectively test subjects, and the scientific community is on standby to respond to any side-effects that manifest themselves. These side-effects range from minor local reactions and discomfort after injection to fever, pain, nausea, swelling of the lymph nodes, sensory disturbances, autoimmune disorders and blood clotting. One of the most recent findings was an increased incidence of myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the tissue that surrounds the heart) associated with a second dose of an mRNA vaccine, an occurrence more frequently observed in adolescent males. This again highlights the potential severity of such side-effects and also the importance of meticulously thorough monitoring.

On the other hand, we are approaching the point where the sheer number of vaccine doses and the thoroughness of monitoring make the detection of further rare diseases increasingly unlikely. Reliable data is available for the elderly who were vaccinated first in the USA, Europe and elsewhere. Nevertheless, there are always the “unknown unknowns”. In other words, vaccines against Covid-19 could theoretically set in motion internal processes that we could not have anticipated. For the moment, at least, the vaccines are safe and surprisingly effective, but what about three years further down the road? We cannot know today what the long-term results will be. The current crop of vaccines are based on an entirely new scientific principle which we are only just beginning to understand. So the question arises as to which groups of people should they be used on? It’s like this: if you are 60 years old, you won’t want to take the approximately one percent risk of dying from corona. In the case of children or unborn fetuses who still have their whole life ahead of them, however, the possibility of long-term complications is a major consideration.

Dr Robert Hess believes that this dilemma should be tackled by means of a specific strategy, with the key concept being “individualization”. The current aim of governments and of the World Health Organization is to vaccinate as many people as possible and thereby maximize protection against infection with SARS‑CoV‑2. Yet this is supposed to happen in a world where individuality counts for more than at any time in history. This issue, which is at the very least defined by differences in age, gender and ethnicity is largely ignored. A structured and finely-tuned individualization plan, such as the one Dr Robert Hess creates, would not only identify risk groups and thus avoid vaccination side-effects, but would also have a positive effect on vaccination success and help to reassure those elements of society who are vehemently opposed. Our individualization plan comprises analysis of age, sex, medical history, risk factors and exposure, vaccine dose and immune status, as well as T-cell immunity and antibody titers against SARS‑CoV‑2.

A strategy of individualization has not yet been introduced on a broad scale, as the focus of the vaccination campaign is currently on the total number of doses administered rather than on the welfare of the individual. Which is not surprising, as there are limitations on the extent to which a policy of individualization can be implemented.

We were therefore delighted to learn last week that the BioNTech team have taken the first step towards individualization in their vaccination concept, specifically in terms of dose adjustment. BioNTech plans to apply for approval of its corona vaccine for children between the ages of five and eleven in the coming weeks. The data for this should be available by the end of September. The dose for this age group will be ten micrograms, which is one third of that given to adults. The data for even younger children (aged 6 months to 4 years) should be available towards the end of the year. Here, too, they expect that the dose can be further lowered.

The study results are already available and must now be finalized for submission to the regulatory authorities. The European Medicines Agency (EMA) has stated that it cannot yet give a timeframe for possible approval. However, BioNTech is already preparing the production of the vaccine doses, so that the vaccination of children between five and eleven years of age could start as early as mid-October. Clinical trials are underway in the USA for both the Pfizer/BioNTech and Moderna vaccines. Previously, there had been delays because the FDA had required a greater number of child participants in the clinical trials being conducted by both BioNTech and Moderna.

According to immunologist Anthony Fauci, the vaccination of children in the States could begin in late autumn or early winter. For younger children, it may take a little longer, as the age groups six months to two years and two to five years are being tested separately. In late July, Israel became the first and so far only country to give the green light for BioNTech/Pfizer to be administered to children in the five to 11 age range who are at risk of serious health complications such as brain, heart or lung problems.

The Pfizer/BioNTech vaccine has been licensed for administration to children aged 12 and upwards since the end of May 2021, and the Moderna vaccine for the same age group since July 2021, but to date there is no vaccine specifically for children, particularly those in the 0-12 age group, which is why the dose adjustment announced now and further clinical research in the field is so important. Possible late complications of vaccination and undesirable side-effects in children can thus be counteracted.

In summary, we can say that we are looking forward to this development and will continue to follow it with great interest. It makes us all the more convinced of the importance and benefits of the individualization program, and we will continue to use this as the basis for our analyses and recommendations of Dr Robert Hess. If you have any further questions about our strategy and our individualization program, please do not hesitate to contact one of Dr Robert Hess consultants.

Dr Robert Hess: FDA grants full approval to the Pfizer

Dr Robert Hess – 08/25/2021

Dr Robert Hess: FDA grants full approval to the Pfizer/BioNTech COVID-19 vaccine – What exactly does full FDA approval of a vaccine mean?

The Pfizer/BioNTech COVID-19 vaccine first received Emergency Use Authorization (EUA) from the U.S. authorities in mid-December 2020 for administration to persons aged 16 and older. On Monday, the FDA announced that it has now granted full approval. The vaccine has thus become the first to receive FDA approval for use against coronavirus. More are expected to follow in the coming weeks and months. Emergency Use Authorization continues to apply for use on adolescents aged 12 to 15 years and for administration as a third booster dose to immunocompromised individuals. Further monitoring of the vaccine’s safety and efficacy remains mandatory, even after approval, and will be carried out assiduously.

How does full authorization differ from the previous EUA (Emergency Use Authorization)?

For both emergency and full approval of COVID-19 vaccines, the FDA first requires data from Phase 1 trials to determine their safety, as well as possible side-effects and the most effective dosing regimen. Once this is successfully completed, the vaccine is tested for efficacy in a more extensive Phase 2 clinical trial conducted in a controlled setting. It should be mentioned that the number of volunteers in the first COVID-19 safety trials was similar to the number participating in trials for other commonly used vaccines, such as tetanus, diphtheria, whooping cough and meningitis. The difference in the approval procedures lies primarily in the length of time the volunteers remain under surveillance. For emergency approval to be granted, the FDA requires that at least half of the participants in the original trials be followed for at least two months after vaccination, whereas for full FDA approval, participants in the original trials must be followed for at least six months. The vaccine manufacturer is also required to submit more detailed production plans and procedures and to commit to a higher level of monitoring and inspections.

How do vaccine approval procedures in the USA differ from those that apply in Europe?

Unlike the FDA, the European Medicines Agency (EMA) has approved the current crop of coronavirus vaccines within the framework of a conditional EU marketing authorization. This has the advantage over emergency marketing authorization that pharmacovigilance (i.e. drug safety), manufacturer controls and other post-authorization obligations are legally binding and subject to ongoing assessment by the EMA’s scientific committees. At the same time, it allows vaccine developers to submit additional data, even after the marketing authorization has been granted (in contrast to a normal marketing authorization, where all data are submitted before the marketing authorization is granted). In addition, the marketing authorization holder is responsible for the product and its safe use. This is in contrast to the emergency marketing authorization under EU law, whereby the marketing authorization holder is exempt from administrative and civil liability. The vaccine developers Pfizer/BioNTech are therefore fully liable.

How does full FDA vaccine approval differ from other earlier vaccine approvals?

To speed up the process of full vaccine approval, the FDA has adopted a number of different approaches. These include the Priority Review and Fast Track processes, both of which were used in the case of the approval granted to the Pfizer/BioNTech COVID-19 vaccine. The Priority Review designation signifies that the FDA aims to make a decision on an application within six months, compared to the ten-month period that applies with the Standard Review. However, the scientific/medical standards for approval and for the quality of the evidence required remain unchanged. The Fast Track process is intended to speed up the development and testing of medicines and/or vaccines and to make them available to patients sooner. Fast Track status allows companies to submit parts of their authorization application to the FDA for review as soon as these are completed. There is a further expectation that communication between vaccine manufacturers and the FDA will be intensified and a continuous exchange of information will take place.

According to the FDA, the differences between the approval of a COVID-19 vaccine and earlier vaccines lie in the speed of the process and the number of staff deployed. It cannot be ruled out, however, that this acceleration of the process will leave the quality uncompromised, especially with regard to the shortened observation period and the consequent lack of data. We will therefore continue to closely observe the current procedure and any further developments and to keep our Premium clients informed.

Dr Robert Hess: Any decision on whether to receive a booster jab

Dr Robert Hess – 08/17/2021

Dr Robert Hess: Any decision on whether to receive a booster jab (and which one to choose) or to wait for a next-generation vaccine should be based on the following criteria.

1 – Which is preferable – a booster jab or a next-generation vaccine? This depends on a number of factors, primarily which next-generation vaccine becomes available and when. It should be noted that the latest vaccine under development at BioNTech has been formulated exclusively to counter the threat of the Delta variant. We therefore need to carefully monitor how the virus continues to mutate, because the successor to Delta is already on the way. It may even turn out that, by the time the next-generation vaccine is ready for rollout, the current Delta variant is no longer relevant. At this point in time, BioNTech is the only manufacturer to have not only developed a next-generation vaccine but also to have produced an initial batch. However, it has not yet received official approval. Whether and when this is granted by the FDA will not be based on medical criteria, but on political considerations, namely how to persuade the public to receive the 700 million or so doses of the current vaccine if it became common knowledge that the BioNTech next-generation vaccine had already been approved.

2 – When is the moment to act? Before any action is taken, the individual status of each client has to be considered carefully. The three decisive criteria here are the most recent antibody count, the level of T-cell immunity and the general immune response. These reference values are then run through an algorithm by our AI system to determine the optimal timing of any further vaccination. The decisive factor is, of course, the general immune response and whether it is strong enough and operates with pinpoint accuracy in the event of an infection. This is precisely the purpose of our ongoing monitoring. And it is a good reason to keep taking the recommended supplements very regularly, even into the autumn.

3 – What would a sensible vaccination strategy look like? All three of the above criteria should be considered. For example, if T-cell immunity is weak and the first vaccination was with an mRNA-based vaccine, it would make sense to adopt a mix-and-match approach and switch to one of the vector-based vaccines, because these are better at improving T-cell immunity. The problem for our clients in the USA is that the only vector-based vaccine currently approved there is the Johnson & Johnson, and unfortunately, we are not convinced by the version currently available.

4– What else needs to be considered in deciding on further vaccination? A further criterion in taking the next step is the natural limit on the number of doses the human body can cope with in a given period. The underlying problem is that every vaccine, especially those developed to combat SARS-CoV-2, overstimulates the immune response, thereby triggering autoimmune reactions. We are of the opinion that no-one should receive more than 2-3 doses per year of the vaccines so far developed. Assuming that the pandemic will continue for a very long time, it is important to consider exactly when to vaccinate and which vaccine to choose in order to derive the greatest possible benefit. This way, the risk can be avoided of vaccinating too many times in a limited period of time, thereby putting a strain on autoimmune capacity and prompting autoimmune diseases in the future. After a finite number of vaccinations in a set period of time, of course, the autoimmune capacity has increased to such an extent that, at some point, the benefit has to be weighed against the cost. In other words, the harm done is greater than the risk of damage from Long Covid. That is why we have to be cautious about the number of vaccinations we subject ourselves to within a certain period of time.

5 – What are the potential advantages of a booster jab? If your next vaccination is to be a booster jab rather than a next-generation vaccine, then it must be taken into account that the current vaccines from Moderna and BioNTech are both approximately 30‑35% effective in preventing infection by the Delta variant, i.e. a relatively low rate of efficacy. On the other hand, our internal research and our contacts with BioNTech suggest that a third dose of their vaccine boosts antibody levels by a factor of four. In these circumstances, even a 30% success rate is a strong argument in favor.

Over the next few weeks, we will be checking these criteria as they apply to each of our Premium clients, using all available data. At the same time, we will set our A.I. system to calculate the optimum choice and timing on an individual basis. We will then contact you directly. If you have any questions in the meantime, please contact your consultant.

As Dr Robert Hess expected, the pandemic is becoming more complex

Dr Robert Hess – 29/07/2021

As Dr Robert Hess expected, the pandemic is becoming more complex and problematic in nature, which makes it all the more difficult to make any firm predictions for the autumn.

In focus: Vaccine side-effects versus post-acute sequelae (“Long Covid”).

The forecast of Dr Robert Hess in the spring of 2021 that the pandemic would take off in a more complex and problematic direction ran contrary to general opinion. It is now being vindicated even earlier than we expected.

It is definitely not the case that the end of the pandemic is in sight, as claimed by various colleagues as well as some government leaders in May and June of this year. The reduced efficacy of the first-generation vaccines against the recently arrived and now prevalent Delta variant has introduced an element of considerable uncertainty that is also impacting on forecasts for the global economy.

As indicated in the previous Keynote, our current focus in the research we perform on behalf of our clients is on deciding whether their needs are best met by receiving a booster jab or by waiting for a next-generation vaccine to become available and, in either case, what the optimum timing might be.

We have already established reference values in our retesting procedures for antibody development and T-cell immunity, and we are confident that the WHO will adopt similar or even identical values by the end of the year. These are now the clear reference values for all our clients in deciding whether there is a need for action to ensure immunity against the SARS-CoV-2 virus and its mutants. This gives rise to a number of questions that we will clarify individually for each of our clients. The two key questions concern the timing and the choice of vaccine, specifically whether this should be a booster shot of the same vaccine. A third dose of the BioNTech vaccine can have the effect of increasing antibody counts by as much as fivefold. This is an attractive option for those clients who have antibody levels of less than 1,000 BAU/ml and thus far below our reference value.

The alternative is to wait for the next generation of vaccines to become available. As also reported in the previous Keynote, BioNTech has developed a proprietary vaccine to specifically target the Delta variant spike protein. This vaccine has already gone into production and is awaiting emergency approval from the FDA and EMA. Here, too, a fundamental decision must be made – booster or next-generation vaccine? What are the advantages and disadvantages?

The disadvantage of a next-generation vaccination could be that the next virus variant – and we have to assume that this already exists in the form of the Lambda or similar – could produce a change in the spike protein, thereby reducing the effectiveness of the newly developed vaccine, though not as much as that of its predecessors. This is the very race we wrote about several months ago and which is now well and truly underway. Unfortunately, the vaccine manufacturers are still in reaction mode at the moment, having to firefight the variants as and when they crop up. This consumes huge amounts of time and effort.

As to whether we are already on the home straight or only the opening lap of the race against new variants and whether the pace of mutation will pick up even further, Dr Robert Hess shares the general opinion that the odds are currently 50-50. In other words, there is a very real risk that the changes on the spike protein will become even more prominent. This issue carries over into the debate on super mutants.

On the assumption that the rate of mutation will continue to accelerate, this is a race that is going to be difficult to win. We still have the potential offered by artificial intelligence to make predictions about future mutations and thus stay one step ahead of the virus. But the probability of a super mutant has also increased significantly. The definition of a super mutant is that the virus has undergone a genetic change of such magnitude that the current vaccines become less than 20% effective.

The main argument against a third booster jab with the current generation of vaccines is that they are clearly less effective against Delta than against the Alpha variant, even if there are efficacy studies that seem to indicate the opposite. However, the number of people who are being hospitalized despite having been double-vaccinated is rising sharply in virtually all countries. In this matter, we have to disagree with our colleague Anthony Fauci in the USA, who attributes the problem of rising new infections to large numbers of non-vaccinated people becoming infected. This is certainly a major factor, but at the same time, the significantly reduced effectiveness of the vaccines currently in use is also a reason why the infection and hospitalization curves on the graph are heading upwards. In addition, there has been an increase in mortality in countries that have had the Delta variant for some time. The studies from Canada on the link between mortality and Delta as well as the latest data from the UK confirm that the new variant causes the death rate to rise. The scenarios differ slightly, in that the rise in number of cases in England is probably due to a relaxation of social distancing during the recent Euro 2021 Football Championship. But all in all, this is an indeterminate development that is very difficult to interpret.

The deliberations about the Delta variant, which have been going on in Europe for some time, have now also reached the USA. Delta was ignored there for too long, and in the meantime, there are districts in California where masks are once again being made compulsory in enclosed public spaces, even for vaccinated persons. The complexity of the situation is also global in the sense that political decision-makers are reluctant to issue any clear guidance on whether booster jabs or next-generation vaccines are the way ahead. For pandemic management and to achieve herd immunity, it is essential to have clarity on vaccination of children under 12 and teenagers. Because of the exaggerated immune response to vaccination, especially in younger age groups, the appropriate dosage should be based on the same categories that apply with any medicine, namely “Babies”, “Children”, “Adolescents” and “Adults”. These should be introduced as soon as possible as a crucial success factor in pandemic response. This is a move Dr Robert Hess was already calling for a year ago.

The politicians and licensing authorities are showing some reticence in regard to next-generation vaccines, for example the one from BioNTech which is already being developed and produced in Mainz (Germany), because of a fear that the prospect of their arrival in the near future might further reduce take-up of the current generation of vaccines. In almost all countries of the western world, vaccine hesitancy is already high, and the availability of an upgraded Delta vaccine would reduce vaccination acceptance even further. It is therefore a topic of discussion that is not wanted either politically or by the WHO, which is a rather unfortunate state of affairs.

The booster jab is also a politically sensitive topic because the majority of the world’s population does not yet have access to any vaccine at all. Meanwhile, first-world countries such as Israel have already embarked on their third round of vaccination. This imbalance is an added complication to the whole situation, with disturbing consequences such as were witnessed last weekend when vaccine poverty provoked anti-government demonstrations in the emerging countries of Tunisia and Brazil as well as in several Third World countries.

At the same time, the precise opposite phenomenon is manifesting itself in western countries where supplies of vaccines are more than adequate. In France and Italy, for example, there were also mass demonstrations at the weekend, albeit in opposition to mass vaccination. Against this background, it is wholly understandable that the WHO currently opposes booster jabs on principle.

All in all, the issue of booster vaccination has been taken up too late by the political decision-makers. We have been pursuing our retest strategy to continuously monitor the SARS-CoV-2 immunity of our clients since June, which has flagged up a disappointing decrease in antibodies and in T-cell immunity. This came as a surprise even for us, and so we were obliged to consider the issue of booster vaccination sooner than expected. We have therefore decided to make recommendations to our clients regarding booster jab or next-generation vaccine on an individual basis. We aim to be in a position where we can issue appropriate recommendations to our clients by mid-August.

Around the world, governments of all political complexions are steadily moving away from the imposition of mandatory social measures towards the individual taking responsibility for protecting his or her own health and safety and that of others. We intend to provide our clients with an even more focused basis for decision-making. The UK has adopted something of a pioneering role here. We have been very pleasantly surprised that the majority of the population there is behaving prudently and only using their restored freedoms in moderation. We think this is the right approach. Each individual must be allowed to map his or her own route through the pandemic.

It is not surprising that there are still people who do not want to be vaccinated. The main reason for reluctance is the side-effects of vaccination that have been observed so far. Of course, this is only a cautious analysis, because we have to assume that there will be a considerable increase in vaccine-induced autoimmune diseases in the coming years. The relevant data will begin to emerge only gradually. On the other hand, we already know for certain that Long Covid sequelae are more severe and more enduring than the side-effects of the vaccines. In this context, there are more and more warning signs, especially from the FDA and EMA, of capillary leak syndromes associated with the Johnson & Johnson vaccine. This can lead to acute episodes of oedema, mainly in the body extremities and when blood pressure is low. Another alert issued in connection with the Johnson & Johnson vaccine concerns Guillain-Barré syndrome, a rare inflammatory neural disease that may occur around the six-week mark after vaccination. There are also the myocarditis syndromes associated with mRNA vaccinations. Pericarditis, an inflammation of the heart muscle or the pericardium, is more often triggered after the second dose of the vaccine. The first instances of autoimmune disease have now appeared with the Moderna vaccine, specifically immune thrombocytopenia. These cases are being closely studied by both the FDA and the EMA. We see a clear link here with the vaccine. Another side-effect of mRNA vaccination is the occurrence of dermatological problems, namely delayed reactions in the form of skin eczema and hives that are usually associated with urticaria. These are triggered by so-called lipid nanoparticles that serve as a sort of protective packaging for the mRNA. These nanoparticles have the ability to activate the immune defense cells directly, so that large amounts of histamines (i.e. inflammatory messengers) are released. Where urticaria-like reactions occur, this is generally after the second shot of vaccine, and they can lead to severe complications such as asthma.

The AstraZeneca vaccine also contains a substance known as polysorbate 80, which is used as an excipient in some cosmetic medicines and also has considerable allergic potential. For this reason, we recommend heterologous vaccination (i.e. cross-vaccination) as standard, with a first dose of AstraZeneca followed by an mRNA vaccine as the second. Here, too, the vaccine side-effects can be considerable, and much stronger than with a homogeneous vaccination regimen. That is why we only recommend cross-vaccination in older people where immunosenescence (i.e. the gradual deterioration of the immune system brought on by aging) has set in.

The harm caused by Long Covid is much more difficult to assess, and we will discuss it in more detail in the next Keynote. From the data that is now beginning to accumulate, it is apparent that 80% of those who had symptomatic infections continue to feel worse after three months than they did before the onset of the disease. This is an alarmingly high percentage. A variety of check-ups and monitoring activities show that around 20% have sustained clearly detectable organ damage. The age group most affected by organ damage is between 40 – 50 years old, individuals who were previously relatively healthy and had no pre-existing chronic illnesses. Organ damage can even be found among the youngest cohort of 20-year-olds. There is an above-average number of athletes, which is probably down to the fact that the body feels completely different and that the perception of performance loss is therefore naturally felt more keenly. There are also neurological consequences ranging from disorders such as loss of taste, nerve pain and deafness to aphasia, significantly reduced cognitive and cardiological performance, shortness of breath, etc.

Understandably, the main focus of the check-up recommendations we make to our clients is on heart disease. This is because the endothelium in individuals who have survived Covid-19 has undergone massive changes and has essentially aged by many years. This manifests itself in cardiac insufficiency, cardiac arrhythmias and changes in the pulmonary interstitium that inhibit gas exchange and lead to respiratory distress. We will give an update on the consequences of Long Covid in the next Keynote.

As inoculation is a highly complex area, other scientific avenues are being explored involving different techniques. We have looked at three of them in some detail. Two come from a single country, namely Israel. We suspect that, should there ever be a solution that avoids inoculation, for example by means of a virus static, then the Israeli manufacturers will be at the forefront.

First, we looked at the oral Covid-19 vaccines produced by Oravax Medical, a company that specializes in this field. Clinical trials are already underway in Israel. We will monitor this development in detail and report back at a later stage.

The second solution comes from SaNOtize, another Israeli company. It is a so-called “anti-corona nasal spray” containing antibodies obtained from bovine colostrum which has already successfully negotiated clinical phase 2. Here, too, there is hope for success.

The third solution we will be pursuing from a poll of almost 20 companies drawn up by our research team comes from Australia, where CRISPR (clustered regularly interspaced short palindromic repeats) “gene scissors” have been deployed to inactivate the coronavirus. Here, too, the success rate does not look at all bad – it proved relatively easy to stop the SARS-CoV-2 from replicating in an infected cell. The results of the project have been published in Nature Communications magazine. It is an exceptionally interesting project for us because it concerns our own field of expertise, namely genetic engineering. Once the virus is identified, the CRISPR enzyme is activated, which then proceeds to dissect the virus. We will, of course, keep you updated on this development.

Differing opinions about the Lambda variant

Dr Robert Hess – 07/29/2021

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

For the first time since the SARS-CoV-2 Task Force was established 18 months ago, a difference of opinion has arisen, specifically with regard to the Lambda variant. What everyone agrees on is that the Lambda or C.37 variant is clearly more contagious than the original Wuhan strain. In addition, it is much more resistant to antibodies, and the existing vaccines therefore have a reduced efficacy against it. The reason for this is three mutations in the spike protein, which render it less susceptible to neutralization by antibodies. Added to which there are two mutations that make the variant itself more infectious.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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