SOTT FOCUS: The Rocky And Potentially Costly Road To A SARS-CoV-2 Vaccine

vaccinate world

Since the start of the Covid-19 crisis, a lot of talk has centered around the development of a SARS-CoV-2 vaccine. Some countries, like New Zealand, have suggested, that they won’t open up their borders for international travel until a vaccine is available.

I would like to give a bit of background about a few things related to the coronavirus in general, about the development of a vaccine, and about the problems the development of such a vaccine might pose.

I am not going to talk about the problems associated with vaccination in general (although I might touch upon these in relation with the points mentioned above) – and there certainly are plenty of problems associated with vaccination, as it is commonly done today – but these have been discussed in detail elsewhere.

What Is SARS-CoV-2

SARS-CoV-2, as it is called, is the virus that is responsible for triggering Covid-19 – Coronavirus related infectious disease.

SARS-CoV-2 is part of the family of corona viruses (CV), which forms a group of related RNA viruses, that cause disease in mammals and birds. In humans they are mainly responsible for upper respiratory tract infections, which can range from mild to lethal. They are one of the many viruses that can cause ‘seasonal flu‘ – amongst others like influenza A and B, rhinoviruses and respiratory syncytial virus (RSV).

coronavirus family

(Source)

The SARS-CoV-2 virus has a positive-sense, single strand of RNA and is wrapped into a protein shell (as opposed to ‘naked viruses’). They typically show club-shaped spikes on their surface, forming an image that looks like a crown under the electron microsocpe, from which their name is derived.

Six species of CV are known that infect humans, with one species subdivided into two strains. Four of these are part of the ‘seasonal flu syndrome’ – the respiratory syndrome mentioned above – and can be found in the population every year:

Human coronavirus OC43 (HCoV-OC43)

Human coronavirus HKU1 (HCoV-HKU1)

Human coronavirus 229E (HCoV-229E)

Human coronavirus NL63 (HCoV-NL63)

A study from 2018 found the following numbers in Israel:

HCoVs were detected by real-time PCR analysis in 1910 respiratory samples, collected from influenza-like illness (ILI) patients during the winter sentinel influenza survey across Israel.

[…]

While no MERS-CoV infections were detected, 10.36% of patients in the survey were infected with HCoV-OC43 (43.43%), HCoV-NL63 (44.95%), and HCoV-229E (11.62%) viruses. The HCoVs were shown to co-circulate with respiratory syncytial virus (RSV) and to appear prior to influenza virus infections. HCoV clinical symptoms were more severe than those of RSV infections but milder than influenza symptoms. Hospitalized patients had similar HCoV types percentages. However, while it was absent from the public winter survey, 22.6% of the patients were HCoV-HKU1 positives, mainly during the spring-summer period.

Three human coronaviruses produce symptoms that are potentially severe or lethal:

Middle East respiratory syndrome-related coronavirus (MERS-CoV)

Severe acute respiratory syndrome coronavirus (SARS-CoV)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (2)

SARS, MERS and SARS-CoV-2

Severe acute respiratory syndrome (SARS), a viral respiratory disease first appeared in the early 2000s caused by the SARS-CoV, which was the first-identified strain of the SARS coronavirus species causing severe respiratory symptoms and was potentially lethal. The syndrome caused the 2002-2004 SARS outbreak. In late 2017, Chinese scientists traced the virus through the intermediary of civets to cave-dwelling horseshoe bats in Yunnan province. No cases of the first SARS-CoV have been reported worldwide since 2004.

Middle East respiratory syndrome (MERS), also known as camel flu, is a viral respiratory infection caused by the MERS-coronavirus (MERS-CoV). Symptoms may range from none, to mild, to severe. Like in the case of SARS-CoV-2 symptoms are generally more severe in patients with other health problems.

MERS-CoV is a coronavirus believed to be originally from bats, but humans are said to be typically infected from camels, either during direct contact or indirectly. Some suspect that MERS-CoV is an engineered virus which may have escaped from a lab. The first identified case occurred in 2012 in Saudi Arabia and most cases have occurred in the Arabian Peninsula. About 2,500 cases have been reported as of January 2020. About 35% of those who are diagnosed with the disease die from it (866 recorded deaths). Larger outbreaks have occurred in South Korea in 2015 and in Saudi Arabia in 2018.

The origin of SARS-CoV-2, the virus responsible for Covid-19, has again been described as transmitted from bats in the Chinese city of Wuhan. However, in general viruses don’t jump from bats to humans without an intermediary host. There seems to be good evidence, that SARS-CoV-2 escaped from a lab – either from Fort Detrick, the USAMRIID bioweapons research facility in Maryland, which was shut down in July 2019 due to ‘severe safety concerns’, or from a level 4 biosafety lab in Wuhan:

“And now we know that Dr. Tony Fauci and the NIH funded the Wuhan Institute of Virology in 2015.

Back in 2015 the NIH under the direction of Dr. Tony Fauci gave a $3.7 million grant to the Wuhan Institute of Virology.

The Wuhan Institute of Virology is now the main suspect in leaking the coronavirus that has killed more than 50,000 Americans and, thanks to Dr. Fauci again, destroyed the US economy.

[…]

US officials made several trips to the Wuhan laboratory.”

What Is A Vaccine?

Vaccines all work on the same basic principle: Scientists try to make something that resembles the disease-causing agent enough for the immune system to develop a strong memory of the infecting agent, so that with another exposure, the body will attack the virus before a clinical infection can develop. That’s the theory, anyway!

There are a few different methods for making vaccines:

– vaccines from ‘dead’ microorganisms

– live, but weakened microorganisms

– live, but fully virulent microorganisms

– vaccines made from parts of microorganisms or from proteins that mimic parts of it

Given that the SARS epidemic happened around 20 years ago, and the MERS epidemic about 10 years ago, we might expect there to be a vaccine available against those strains. But this is not the case.

In the case of SARS, the infection disappeared within just 4 months after it spread across the globe. Companies that were developing a vaccine had to give up their research because there was just no more demand for it, or patients to do the required studies with.

But there is another problem with the development of a vaccine against CV – a process called ‘immune enhancement’. This problem was discovered during the trials of another vaccine in the 1960s.

The Story Of The RSV Vaccine

The respiratory syncytial virus (RSV) – also known as human orthopneumovirus – is a virus that causes mainly lower respiratory tract infections and affects mostly children. After the infection, the body develops immunity, but that diminishes over time, so that people can be infected multiple times. Severe RSV infections are increasingly found among the elderly, for reasons that are not entirely clear.

1966 a vaccine with a formalin-inactivated RSV was first studied in ferrets. Ferrets are one of the preferred animals in vaccine research due to the portability of the results to humans. When the vaccine was injected into the animals, they developed a strong immune response. Next, the vaccine was studied in a group of children, who again developed a strong immune response. But it subsequently became clear that these children developed an severe over-reaction, when they were reinfected with the wild strain of the RSV, and 80% of the vaccinated toddlers became very ill, as opposed to only 5% in the control group. Two children in the vaccine group died. The trial of the vaccine had to be stopped.

Enhanced Respiratory Disease

What exactly happened has been the focus of intense research and much has been discoverd about this over-reaction of the vaccinated.

Two mysterious observations defied the understanding of this over-reaction for a long time, which has been termed ‘enhanced respiratory disease’ (ERD), and is characterized by an enhanced form of RSV symptoms: ERD never occured in children who had already contracted the disease before the vaccination, and no child has ever experienced ERD twice.

ERD has finally been defined as the result of an over-production of complement-fixing versus neutralizing antibodies, which leads to immune-complex deposition in the lungs of the reinfected recipients of the vaccine, which cause the severe symptoms of EDR, essentially a massive inflamation in the lungs.

Meanwhile it has been found, that numerous cell types, cytokines and other substances can either promote or mitigate ERD. The problem with vaccine development is that vaccine trials similar to those in 1966 will have to be done in animals exclusively, because ERD never occured in children who had already been exposed to the RSV, before they are given to unexposed subjects.

Even today, despite the very high disease burden by RSV during every flu season, no vaccine is currently on the market. A paper published in 2019 claimes that a RSV vaccine could be available within the next 10 years (sic!).

Viral Interference

Another issue with vaccines (any vaccine, not just a potential SARS-CoV-2 vaccine) is something called ‘viral interference’.

Viral interference is a well-known phenomenon where infection of an organism, whether plant, animal, or bacterium, with a virus can prevent, or partially inhibit infection with another virus in the same host. The first case of viral interference was reported in 1804, when Jenner reported that herpetic infections could prevent the development of vaccinia lesions (which was the organism derived from cow pox that was used as vaccine agianst smallpox).

What initially sounds like a good thing however turns out to be a problem, because while viral interference decreases the risk of infection for some viruses, at the same time it increases the risk for others.

This has recently been shown in a study published in the journal Vaccine, where the influenza vaccine increased the risk of an infection with corona virus by 36%.

Problems On The Road To A SARS-CoV-2 Vaccine

Apart from the possibility, that a SARS-CoV-2 vaccine might trigger ERD, there are several other issues that make it unlikely that a safe and effective vaccine will be available within the next 12 – 18 months.

The development of vaccines happens in 3 phases. Note, that this is the absolute minimum time. This leaves out longer-term safety studies – these are generally relegated to ‘post-marketing surveillance’, which is patchy at best, not least because adverse reactions are not mandatory to report.

Phase 1 involves just a few dozen healthy volunteers, and is meant to evaluate whether the vaccine is safe. That takes about three months. If the healthy volunteers don’t suffer any adverse effects, it’s on to Phase 2. This time, several hundred people will get the shot, ideally in an area experiencing a Covid-19 outbreak, so scientists can gather data on how well it spurs the production of antibodies and fends off the disease for these trial subjects. That’s another six to eight months. If everything still looks good, Phase 3 is to recruit a few thousand people in an outbreak zone and repeat the experiment. That’s another six to eight months — if you don’t have any problems recruiting patients or with your vaccine supply. Then a regulatory agency, like the US Food and Drug Administration, has to review all the data before making a decision about whether to approve the vaccine. That can take months to a year.

Now, if you have done the math, this process alone takes at least 18 months to go though, unless the vaccine is ‘fast-tracked’, which is an euphemism for ‘cutting corners’. Given that longer-term safety studies are virtually never done for any new vaccine, this cutting of corners massively increases the risk that a vaccine that appears new on the market may show undesirable or potentially catastrophic side-effects. Even more so for the fact, that there are a myriad of companies and research teams that are working on this vaccine, many of them using novel and totally untested techniques.

One of the issues that is currently being investigated is the question whether or not long-lasting immunity is achieved after an infection with the SARS-CoV-2.

In the case of the four seasonal CVs which mostly produce mild symptoms, an immune response is generated in response to an infection with these viruses, but immunity wanes quickly and is lost within months to one or two years. That is one of the reasons why people get sick with the flu again and again. The more severe CV diseases (SARS, MERS) seem to produce an immunity that lasts longer, but the data is very limited (again, because these epidemics affected a relatively small number of people).

Why is this important in regards to a potential SARS-CoV-2 vaccine? If the natural infection doesn’t produce a strong and long lasting immunity, how is a vaccine going to fare, given that the immune response of a vaccine is always weaker than the natural infection (a measles infection gives life-long immunity, but the vaccine does not)?

In addition it has been found that a person can get infected with the seasonal corona virus even if that person has preexisting antibodies to the virus. The fact that there is an antibody response to an agent doesn’t automatically mean that this person will be immune to a reinfection. The reason is that there are further immune mechanisms that need to activate (like the cellular arm of the immune response) to fend off an infectious agent.

SARS-CoV-2 is different to any other virus in the group of human CVs. While all the other CVs mainly cause upper respiratory tract infections, SARS-CoV-2 can invade all the cells – this is the reason why Covid-19 comprise neurological, cardiac, gastrointestinal and renal symptoms. So maybe it is not possible to really make inferences about the nature of its disease progression by comparing it to the other CVs.

Further, it is unclear at the moment if SARS-CoV-2 is going to mutate quickly and behave like the influenza viruses. Remember, influenza viruses shift and/or drift their genome every year, so immunity for last year’s viruses may not confer any protection to this year’s batch. The seasonal CVs seem to be very stable – samples from 30 years ago are not appreciably different. In the case of SARS and MERS, again, there is insufficient data to evaluate this point.

In short, all of these issues make a vaccine for SARS-CoV-2 difficult to develop and ineffective at best, if not completely worthless.

But is a vaccine really the only feasible way?

To answer this question we first need to look at the potential scenarios how this ‘pandemic’ might unfold.

But before we do that, I’d like to make a comment about ‘flattening the curve’ – a concept that is often misunderstood. Not one of the health services that has been espousing the concept of ‘flattening the curve’ has ever gone on record saying that this would lead to fewer deaths. In fact, the ‘area under the curve’ – the number of deaths – is the same for the peaked and for the flattened curve, even on the governments own graphics and those of the newspapers.

flatten the curve

Source

So ‘flattening the curve’ only served – by the governments own admissions – to not overwhelm the medical system, not to reduce the total amount of deaths. In fact, the lockdown measures potentially might even increase the death rate, not only from Covid-19, but for a host of other reasons: increase in suicides, increase in domestic and child abuse, increase in substance abuse, untreated medical issues (because patients were discouraged/afraid to seek medical attention other than Covid-19) etc.

So what are the different scenarios of how this ‘pandemic’ might play out?

The first possible scenario is what happened to SARS in 2004. The disease burned itself out within a few months, and no new case has been diagnosed since 2004.

The second possible scenario is that SARS-CoV-2 is going to be just another ‘seasonal flu virus’, something that will reoccur every year, but nobody will pay much attention to it anymore. It is little different to the normal flu.

In the third possible scenario SARS-CoV-2 returns repeatedly like a bad flu, it is ‘seasonal’, which reflects the fact that many viruses don’t tolerate heat and humidity (like the flu virus and the four CVs). If SARS-CoV-2 follows suit, containment efforts plus the arrival of summer should drive infections down to near zero.

In the first case we don’t need any vaccine at all. In the second case a vaccine is not going to help a lot either, and in the the third case a vaccine might have benefits to the people within risk groups, if it is safe and effective.

But there seem to be other avenues, that in my mind haven’t been explored enough, and if successful, would render a vaccine absolutely superfluous.

Pharmaceutical Therapy

A lot of controversy has gathered around different pharmaceutical treatments.

Recently the FDA approved remdesivir as a first-line antiviral drug, but again, this is couched in controversy. After the National Institute of Health (NIH) started a large-scale study, it was suddenly terminated (allegedly after an ‘interim analysis’) and it was decided to stop the placebo arm and give the active compound to all patients. That essentially limits the researchers ability to determine whether the new drug really saves lives. This is generally done if the results of the study are so overwhelmingly positive (or negative), that it is deemed unethical to continue the study and statistical significance has already been reached. However in the case of remdesivir, before this decision was made, the mortality in the active arm was 8%, compared to 11.6% in the placeb group, and the result was NOT statistically significant.

This is a pretty astonishing thing to do and smacks of obfuscation. From the outset, we only see a trend in increased patient survival (remember, the difference was not statistically significant).

What about other pharmaceutical therapies – like azithromycin (AZT) and chloroquine (HCQ)?

Again the story is thin on science and thick on politics. One of the first to mention chloroquine was Professor Raoult, a French researcher at the Research Unit in Infectious and Tropical Emergent Diseases (URMITE) in Marseille. Then it was picked up by President Trump, at which stage the anti-Trumpian troll-army mobilized to destroy any credibility of Trump, and by extension the reputation of its proponents and CHQ itself. Since then a number of further studies have been published, but no definitive consensus has been reached within the medical community in regards to its safety and efficacy yet.

However, other non-mainstream reports have noted HCQ and AZT are highly effective in the treatment of Covid-19. The most famous is Dr. Zelenko from NYC, who has claimed to have treated hundreds of patients with virtually zero side effects. According to him it is crucial to initiate the treatment at the onset of symptoms – if you wait until the patient is severely ill, CHQ is unlikely to change the outcome.

In many of the protocols using HCQ and AZT, zinc has been added. Zinc has long been known to have antiviral activity via numerous mechanisms and might increase the overall efficacy of the protocol.

At this point in time there is no definitive answer to the effectiveness of HCQ and AZT in the treatment of Covid-19, but given that the treatment is safe (if certain measures are taken) and there are many stories of good success, I would not hesitate to take it myself. It is unlikely that studies will come out in the near future that will provide a bulletproof case for the treatment of Covid-19 with AZT/HCQ, for the simple fact that both drugs are out of patent, and there is virtually no money to be made from them. Which ties in to the remdesivir, discussed further up.

In an interview by Dr. Mercola of world-renowned molecular biologist Dr. Judy Mikovits, Mikovits said that type-1 interferon alpha could be a valuable treatment alternative against COVID-19. Aside from interferons, other treatment strategies discussed in the interview include hyperbaric oxygen therapy, cannabinoids (CBD), peptide T and antioxidant support. However, again, the stumbling block here is the inability to get these compounds scientifically tested, as there is no money in them for the pharmaceutical industry, hence no incentive to perform the required studies.

The Fascinating Case Of The BCG Vaccine

A recently pre-published study seems to point to an interesting correlation between countries where BCG vaccination is still being offered, or has been performed in the past, and the severity of Covid-19.

BCG vaccine

“There has been a long history of reports from BCG producing a series of beneficial immune responses,” says Dr. Gonzalo Otazu from New York Institute of Technology. “For instance, a study in Guinea-Bissau found that children vaccinated with BCG were observed to have a 50 percent reduction in overall mortality, which was attributed to the vaccine’s effect on reducing respiratory infections and sepsis.” It is also being investigated as a therapy for type 1 diabetes.

There are now a series of trials underway that are testing the BCG vaccine to see, if it can give a boost to the immune system to help it fight off the novel CV causing Covid-19. For instance the Murdoch Children’s Research Institute (MCRI) in Melbourne is currently working to enroll 4,000 healthcare workers from hospitals around Australia in one study.

One of the questions is whether the BCG vaccine needs to be given to children to be effective, or if the vaccination of adults is protective as well.

Tuberculosis is still responsible for 2 million deaths every year, despite being a treatable airborne infectious disease (and contrast that to the official number of Covid-19 deaths, that stand at the time of writing at slightly over 280’000 – more so given that some countries are known to over-inflate the numbers, by not seperating the deaths of patients WITH SARS-CoV-2 from the patients dying FROM this virus). Recently new multi-resistant strains have appeared that make drug treatment difficult, and in some cases impossible, which complicates the picture.

Although the efficacy of the BCG vaccine continues to be controversial (the WHO doesn’t recommend it anymore), it is the only vaccine in use for the prevention of TB in humans. It is effective against the severe forms of TB and its prevents a large number of deaths worldwide. The BCG vaccine is not a uniform vaccine, because it is manufactured in different labs in different countries and seems to have diverging genomics and thus different immunogenicity.

Why the TB vaccine may help prevent Covid-19 is not entirely clear at the moment. A study published in 2018 discovered that BCG, which can remain alive in the human skin for up to several months, triggers not only Mycobacterium-specific memory B and T cells, but also stimulates the innate blood cells for a prolonged period of time, which can reduce infection rate up to 30% for any other pathogen.

Conclusions

It is unlikely that a safe and effective SARS-CoV-2 will be available for broad vaccination in the next 12 to 18 months, despite a few dozen teams and corporations frantically searching for such a vaccine and the first phase-1 trials coming online.

But the temptation will be immense to fast-track any vaccine, given the potential 7 billion ‘customers’ available. This means that thorough efficacy and safety testing may be sacrificed on the altar of Mammon.

But as we have discussed above, there are a number of alternatives to vaccines that seem tried and tested, just not within our ‘scientific-medical’ paradigm, where monetary interests rule over safety and the individual’s right to health and bodily integrity. Even more so given the fact that in the US it is impossible to prosecute a vaccine manufacturer in case of severe side effects or even death. That is handled by the government’s vaccine court, and the damages are paid by the state, aka the tax payer. Profits go the the manufacturer, the cost is picked up by the tax payer – a neat little scheme.

Given that mortality from/with Covid-19 is very low in the healthy population, and given that there seem to be safe and effective treatment modalities available even for the elderly and those with concurrent diseases, the development of a SARS-CoV-2 vaccine should be undertaken with great care and not rushed for monetary gains.

I for one would, at this stage, not be prepared to be injected with a vaccine, that may not be much more than experimental, even if some lessons may have been learned by the disaster of the RSV-vaccine from the 1960s.

And Jacinda Ardern, the Prime Minister of New Zealand, may well have to reconsider reopening the country, even in the abscence of a viable SARS-CoV-2 vaccine – lest all New Zealanders end up imprisoned in their own country for the forseeable future.

Then again, whatever the case, it will all, no doubt, be “for our own good”.