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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: Best medication yet?

Dr Robert Hess – 01/20/2022

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr Robert Hess: 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: Antiviral drugs – One more strategic option in the fight against SARS-CoV-2.

Dr Robert Hess – 11/12/2021

Dr Robert Hess: Antiviral drugs – One more strategic option in the fight against SARS-CoV-2.

The development of effective drugs against COVID-19 has lagged behind that of vaccines. Recently, however, two major manufacturers have reported promising results from studies they have conducted. The UK has already granted approval to one of the new drugs. We assess the current state of play below.

On 4th November 2021, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) gave official approval to the world’s first tablet for treating persons infected with COVID-19. The antiviral drug molnupiravir, was developed by the pharmaceutical giant Merck Sharp & Dohme. This was followed one day later by an announcement from US-based competitor Pfizer that its paxlovid anti-corona pill had also shown high efficacy in interim clinical tests. Pfizer is now also trying to get its own offering approved quickly.

Just how effective are the new anti-corona drugs?

According to Pfizer, paxlovid, which is used in combination with an older antiviral drug called ritonavir, is very successful in preventing severe disease progression in high-risk patients. An interim analysis of test results showed that the drug reduced the risk of hospitalization and death by 89 percent in COVID-19 patients. This rate of success applied to cases where treatment was given within three days of the first COVID-19 symptoms manifesting themselves; similar encouraging results were observed for treatment within five days of the first symptoms appearing.

According to the preliminary results, paxlovid would appear to be more effective than Merck Sharp & Dohme’s molnupiravir. On the basis of a clinical study conducted by the manufacturer, this drug is claimed to reduce the risk of hospitalization and a fatal outcome by 50%, i.e. half of the rate for untreated patients. The drug has been approved in the UK for individuals who have at least one risk factor for succumbing to a severe course of the disease; these include a weakened or suppressed immune system, obesity, advanced age, diabetes and heart disease. The MHRA recommends that the medicament is administered within five days of the onset of symptoms.

How do the new antiviral drugs work?

Paxlovid belongs to the class of protease inhibitors. The active substance blocks an enzyme that SARS-CoV-2 needs to multiply. As a result, the virus cannot replicate itself in the cell and is therefore not able to infect any other cells. The viral load is thus very quickly reduced.

Molnupiravir from Merck has a different mechanism of action, which is designed to introduce errors into the gene code of the virus during replication. These mutations remove the virus’s ability to reproduce further. Because molnupiravir and paxlovid attack viral replication at different sites, it might even be possible to combine the two drugs. This is a conceivable scenario for exceptionally severe cases.

What are the advantages of antiviral drugs against COVID-19?

Molnupiravir and paxlovid are administered in pill form. This is a big advantage compared to previous therapy options – both remdesivir (the only drug approved in the EU for the treatment of COVID-19) and monoclonal antibodies have to be administered intravenously. Consequently, administration as a tablet is simpler, easier to manage and more manageable in an outpatient context.

What are the disadvantages of these two anti-corona pills?

Both paxlovid and molnupiravir must be taken in the first three to five days after the first COVID-19 symptoms appear. However, most infected people do not go to the doctor promptly, waiting until they feel really ill. By then, however, it may already be too late for treatment with antiviral tablets. According to Pfizer, paxlovid will not help save a patient who is already in intensive care.

Not much is known about possible side-effects of the tablets at the moment. The only information from Pfizer in this regard is that severe side-effects were less frequent in the treatment group than in the placebo group. This is a good sign for the time being. Before prescribing paxlovid, however, it is necessary to clarify the extent to which the protease inhibitors are compatible with other drugs, especially those that patients have to take because of pre-existing conditions.

When can approval be expected in the EU and the USA?

The European Medicines Agency (EMA) announced at the end of October that it would review the use of molnupiravir. After the drug was approved in the UK, the EMA stated that it now intended to speed up the review process. Molnupiravir is also pending approval in the USA.

In the case of paxlovid, Pfizer had already submitted an application for emergency approval to the US Food and Drug Administration (FDA) in October. The results of the clinical trials are now to be submitted to the FDA as speedily as possible using the fast-track procedure. Because of the impressive results, the trial involving around 1,200 volunteers has been brought to an early conclusion. Although approval is still pending, President Biden has announced that the USA has already placed an advance order for millions of units of the drug. The UK and Israel have also secured their first batches.

Will vaccinations become superfluous after the anti-Corona pills are approved?

The new COVID-19 drugs from Pfizer and Merck are so far no more than another weapon in our armory for combating the pandemic and, for the time being, should not be regarded as a substitute for vaccination. Declining the opportunity to get vaccinated at the moment is not a good option. However, we do not see the current vaccination regime as the ultimate solution.

The current crop of antiviral drugs are intended to treat those who actually contract the disease and do not yet offer any benefit in the area of prevention. The timing is also crucial: antiviral drugs cannot be used to treat patients in intensive care, because they have passed the point at which the medication might have worked. Furthermore, we cannot yet assess the extent to which the virus can be repressed by antiviral drugs or whether it could even form a resistance to their active substances. We know that individual treatments with inhibitors often lead to the development of resistance in viral diseases. For now, we have to wait and see how they complement the vaccines that are already available.

Whether the manufacturers’ claims will be substantiated in the long term remains to be seen. We see two main possibilities for the future, one of which is the familiar route of vaccination. However, provided we make further progress in the research area of antiviral medication, vaccination could recede somewhat into the background over time or become a bridging solution. Because, as we see it at the moment, vaccination is not the ultimate way out of the pandemic. The effect of vaccination does not last long enough to guarantee comprehensive protection, and it cannot be the goal to keep vaccinating the global population against coronavirus every 4-5 months. Vaccination compliance among the general public will decrease over time due to continued vaccine skepticism, vaccine breakthroughs and also undesirable side-effects. This situation could possibly be mitigated with effective antiviral drugs. Currently, antiviral pills are specific, but if it proves possible in the future to produce non-specific broad-spectrum antivirals, this could be a gamechanger.

We will continue to keep an eye on developments in this area and inform you about further research findings.

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: 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.

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

Dr Robert Hess – 07/20/2021

The skepticism of Dr Robert Hess regarding the efficacy of all previous vaccines against the Delta variant has been confirmed by the announcement from BioNTech/Pfizer that they are working on a vaccine that will specifically target this mutant.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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