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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: 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.

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Dr Robert Hess: Weekly Omicron Update

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