“You really have to test a vaccine carefully and not just roll it out because people are clamoring for it with an epidemic underway.”(1)
This doesn't seem to be a controversial statement, does it? In an ideal world, or even in this world, a traditional vaccine would be tested for 5-10 years to understand any long term issues and, as will be explained, any genetic modification possibilities. I know we've all be assured that our DNA cannot be altered by this new technology, but I'd like to make sure.
We've also been assured that the vaccines are safe, that side effects are a healthy sign as it means our immune system is responding and that the reward outweighs the risk. We've been told that last one a lot. I'm not convinced that those that have experienced serious adverse events would agree and it's always struck me as a purely subjective judgement, cloaked in mystery.
Who has decided? What criteria are they applying? Separate individuals may consider the same set of variables (although they may not), but they will, inevitably, assign different weight to each of them. It's a natural consequence of being a discrete, sentient being; each of us accords our own measure of importance to the different factors and even to what we consider a desirable outcome and those judgements won't all be the same.
And what happens if the ground shifts from under us, if the situation changes as more knowledge is accrued? Do we have the flexibility, the confidence to amend our judgement or do we find ourselves boxed into a corner by our prior vehemence and lacking the courage to change course? In any event, as a blanket statement, without qualification, it means nothing and reeks of arrogance and we know best-ism.
The second part of the quote is equally important, although the point has rather slipped under the radar. Is it a good idea to administer a vaccine in the middle of an epidemic? What are the possible consequences?
Still, let's not prejudge anything. Maybe what we're being told is true. Maybe the messaging is completely trustworthy and the authorities have resisted the temptation to gild the lily, even though they seem very keen to persuade us all to take a vaccine. Maybe everything is fine and politics and science have remained separate, with no pressure brought to bear and no outcomes preordained. Maybe the media has engaged in reporting, rather than cheerleading. But this is a human story; it's not just about the cold logic of science. It's also about expectations, mistakes, pressure, greed and more besides.
Some useful definitions
mRNA: essentially, a single strand of the double stranded DNA which is the messenger, enabling DNA to do its job. In the normal course of events, DNA converts into RNA, but reverse transcription can also takes place.
Reverse transcription: where RNA converts into DNA.
Adjuvants: other vaccine ingredients that assist in its take-up by the body.
Spike protein; a part of the virus that sticks out, making it the favored site to bind to the body's cells.
What are these vaccines?
What they are not is traditional vaccines. Traditional vaccines use all or part of the virus to stimulate an immune response which then targets all or part of the live virus. There are four main types, none of which have been shown to be effective in treating coronaviruses. These vaccines are a different breed and they are not all precisely the same, a fact that has been lost in the noise.
The Moderna and Pfizer/Biotech vaccines are mRNA vaccines. These vaccines do not contain the whole virus. A traditional vaccine contains inactivated particles of the virus, which cannot replicate. The immune system will nonetheless recognize these particles as foreign bodies and respond with antibodies.
This is a B cell response, which is directed by T cells which have their own defensive methods, based around an ability to recognize viral particles on the surface of infected cells; cells which they then destroy. This can be seen to a higher risk strategy, as the destruction of too many cells would not be a good thing for the host, us. Nonetheless, the combination of B and T cells is usually an effective immune response.
mRNA vaccines, on the other hand, seek to trick our immune system into producing a protein that is present on the surface of the virus – the spike protein. The vaccine comprises billions of particles of artificially engineered mRNA code, each protected by a lipid coating. Without the coating, the immune system would recognize the particles as foreign invaders and seek to destroy them. But with the coating, the particles penetrate our cells.
The mRNA then tells the cells to produce thousands of copies of just one part of the virus; the spike protein that the immune system would naturally target, anyway. The theory is that some of these spike proteins end up in the blood, where B cell antibodies (neutralising antibodies) destroy them and some attach to cells where T cells destroy them. Then the mRNA degrades, the body stops producing spike proteins and the immune system is primed if a live virus comes along. There can be no actual viral infection from the vaccination itself, because only part of the genetic code of the virus has been implanted. So far, so good.
If that was all she wrote, we'd be moving right along; nothing to see here. But (and there is often a but, especially when we've decided to improve on nature), there is a little more to it, which I will come to shortly.
In broad terms, AstraZeneca's vaccine starts one step behind, as a cold virus DNA (as in common cold) is injected, the cells break the DNA down into RNA and the RNA produces the spike protein...you know the rest. The same goes for Johnson and Johnson's vaccine. These are known as viral vector vaccines. In any event, all four vaccines seek to trick the body into performing in ways that it wouldn't do naturally.
You might reasonably ask why there is a need for new technology; why won't a traditional vaccine do the job? It's not for lack of trying, but coronavirus vaccines have always been problematic – SARS ones, in particular. I have covered the history of vaccine attempts in some detail in a previous article ('A potted history') but, in short, traditional vaccines have never progressed beyond animal trials due to two separate processes, or a combination of both.
One is known as pathogenic priming (or ADE), whereby the immune system turns on itself and actually exacerbates the effect of the virus if it is encountered and the other is a variety of severe inflammation which causes permanent organ damage, especially to the lungs. The vaccines that produced these effects were also targeting the spike protein.
In an effort to circumvent these problems, mRNA vaccines had been researched for many years. Moderna was founded in 2009, specifically as an mRNA company, with designs on using the technology to advance cures for diseases. Other major companies were also in the hunt, but gradually dropped out.
Nobody could find a way to use them without inducing serious, short term side effects, which increased in line with the number of shots required. It was believed that the polyethylene glycol (PEG) element of the vaccine, the coating on the nano particles, was responsible. As a report from an executive at Moderna itself stated,
“Currently, no mRNA therapeutic is approved for use in humans, and a beneficial safety profile in patients still has to be demonstrated. A first clinical application will likely not be a prophylactic vaccine, because the tolerance for side effects is very low for a drug that is injected into healthy individuals.”(2)
Additionally, it was found that a majority of people have anti PEG antibodies in their immune systems and that approximately 10% of vaccinated people may have an adverse effect. For that reason, it was recommended that all patients should be screened prior to the administration of a PEGylated drug.(3)
It's worth noting that long term effects were never studied as coronavirus vaccine testing never got that far. In the light of these findings, Moderna delved into the less lucrative field of vaccines, as one or two shots (rather than multiple) would reduce the severity of side effects. Still, by the beginning of 2020, none of their products had reached stage III clinical trials.
Pfizer, the other front-runner, are paired with BioNTech, a small German research company who had been working on similar mRNA technology. None of their work had made it to stage III, either. And neither AstraZeneca nor Johnson and Johnson (J&J) had managed to bring their products to market.
That was the state of play in early 2020. And then, as we all know, the sudden appearance of a 'novel' coronavirus and dire warnings of tens of millions of deaths worldwide. For the grown-ups, the balance of risk and reward had just tilted in favor of pretty much anything that might be more good than bad. The vaccine equivalent of the Hail Mary pass. And so, starting in mid March 2020, with Moderna the torch bearer, Phase I clinical trials were, improbably, under way.
Trials
Clinical trials for new drugs take place in three phases, gradually expanding the number of enrollees and the demographic. Before that stage is reached, there are several years of pre-clinical trials. By Phase III, the vaccine is administered to broad demographic groups, the population intended to be the recipients of the vaccine. The process takes from 5-10 years, to allow for proper evaluation and follow up. This time-frame enables a comprehensive evaluation of short and long term effects. After all, we do not understand all the body's processes; the possible consequences of the law of unintended consequences will need to be investigated.
However, pre clinical, Phase I and Phase II passed in the blink of an eye. By July, Moderna was embarking upon the crucial Phase III trials with Pfizer about a month behind. Soon afterwards, the results were in (90%+ effectiveness for both) and, by December, authorizations started being granted by the UK, by the Federal Drug Agency (FDA) in the US, which authorized Pfizer, Moderna and J&J and the European Medicines Agency (EMA) in the EU. In the end, it had turned into a vaccine arms race, with the UK winning the pennant.
Still, it was a miracle nonetheless, wasn't it? Now we could save all those lives we keep hearing about. Well, opinion is divided. And informed opinion cries foul, because all is not what it seems. For beginners, that word 'authorization'. What does it actually mean, in this case? It doesn't mean it's been approved, not by the FDA or the EMA. They have slightly different wording, but the meaning is the same. The FDA calls it an Emergency Use Authorization, the EMA uses the term Conditional Marketing Authorization.
These two terms translate to much the same thing; when there is a 'public health emergency', normal standards are suspended. Because it's a balance of risk versus benefit, and the risk is perceived to be so great, a drug that can show that it's more good than bad will be temporarily approved. Proving that it's more good than bad is left largely to the vaccine makers, as you do. And a process that should take five years minimum, is completed in nine months.
A deeper look at trial results
There are some big holes in the information you are being provided. We already know that trialing was expeditious, to say the least, but at least Phase III was completed. Wasn't it? By any objective measure, no. Phase III is to be conducted among a wide demographic of the target audience.
That would include the elderly and infirm who are most at risk, the young who need to go to school, those who are seriously ill, possibly pregnant women. No. It must be trialing how effective the vaccine is at preventing serious illness and death, surely? No. How about how effective it is at preventing transmission? No. Well, at least there weren't many short term side effects. No harm, no foul. No.
The trials weren't designed to measure transmissibility; the cohort of volunteers chosen did not represent a cross section of the population, much less a meaningful number of people most at risk. No pregnant or breastfeeding women, no-one under 16 years old. What the trials proved was that, perhaps, there was a measurable short term improvement in healthy people with moderate Covid. That's it.
Not only that, but serious adverse side effects were plentiful. In the Pfizer trial, 80% of the enrollees had pain or swelling as against 10% in the control group; 30% had moderate to severe pain, as opposed to 1% who took the placebo. In the Moderna trial, 18% suffered from fever, nausea or similar, symptoms that were quite possibly worse than if they'd contracted the virus itself.
There has been, to date, no disclosure from vaccine companies about how old people produced antibodies in the trials. This information would seem to be important as it is known that, in general, immune response in the elderly is more sluggish.(4)
Reverse transcription.
Do you remember every network and media outlet under the sun telling you that your genes cannot be altered by these vaccines? That it was all a conspiracy theory? Well, no.
“The researchers were puzzled by the fact that there is a respectable number of people who are testing positive for COVID-19 by PCR long after the infection was gone. It was also shown that these people were not reinfected. The authors sought to answer how a PCR test is able to detect segments of viral RNA when the virus is presumably absent from a person’s body. They hypothesized that somehow segments of the viral RNA were being copied into DNA and then integrated permanently into the DNA of somatic cells. This would allow these cells to continuously churn out pieces of viral RNA that would be detected in a PCR test, even though no active infection existed. Through their experiments, they did not find full-length viral RNA integrated into genomic DNA; rather, they found smaller segments of the viral DNA, mostly representing the nucleocapsid (N) protein of the virus, although other viral segments were found integrated into human DNA at a lower frequency.”(5)
A long quote, but illuminating. There is, obviously, a viable cellular pathway which can assimilate segments of RNA from Covid itself into our DNA. Given that an mRNA vaccine also consists of snippets of viral RNA, who's to say the same pathway can't be used? Especially as the synthetic RNA in the vaccine is more durable than natural RNA. Anybody with a sound knowledge of micro biology knows about these pathways. Reverse transcription (RNA to DNA) has occurred in over 40% of mammalian genomes.(6)
As previously noted, RNA in the vaccine is synthetic and, as such, much more stable than natural RNA. It is more efficient at being translated into protein, it's more likely to stick around and therefore have more time to be incorporated into our DNA and it is likely to be more active. No-one knows how long, but normal RNA degrades fairly quickly. This won't. The argument that has thusfar been presented is that RNA is a temporary molecule that will decay in your cell, because it is fundamentally different from DNA. This is misleading, at best.
There is a big difference between people (unwittingly) having their DNA changed by the virus and a scenario where we vaccinate billions whilst telling them it can’t happen as a result of a vaccine.
Pathogenic priming
The problem of pathogenic priming was never solved by traditional vaccine trials. In that context, the most important part of the whole game is non neutralising antibodies. These are antibodies that the immune system has created specifically to do a job that they are subsequently, for whatever reason, unable to do. But, rather than just hanging around being singularly useless, they have a tendency to join the other side and amplify the problem because they still have the trust of their original team. This allows access to parts of the organism (us) that the virus would not otherwise be able to access. You can see how this might be a problem.
If the vaccine is targeting the spike protein and the spike protein mutates, we also have a problem. It is already known that at least two strains have extensive mutations in the vital part of the spike protein, which will likely render that variant resistant to existing vaccines.
So, as previously explained, neutralising antibodies that have been created in response either to the live virus or to the vaccines, may not neutralize the virus effectively, if the virus spike protein has mutated sufficiently. It's not just a case of a vaccine that doesn't work properly and may not protect us. We know that it is very far from ideal to have non neutralising antibodies floating about for undetermined periods of time, primed to wreak havoc.
Other strains, in other parts of the world, are showing the same spike protein mutation, suggesting that the virus is outsmarting the very specific vaccine and, in the process, they are becoming more transmissible (if milder), giving more opportunities for mutation.(7)
Retroviruses
Another risk. What if the cell is infected with another virus, or retrovirus, while the vaccine is active in the cell? This other virus could, randomly, gain a functional spike protein, leading to this new virus having an ability to infect a much wider range of tissues, such as respiratory organs, making them more pathogenic. This is theoretically possible if the synthetic mRNA is still active at the time of a secondary infection with a separate disease.
Vaccinations in a pandemic
It is textbook science – if you are vaccinated in the middle of an ongoing epidemic, the resultant antibodies are not fully mature in the immediate aftermath. If you are then 'challenged' by the live virus, when your immune system is sub-optimal, you are at risk of immune escape, meaning the virus can escape the immune response. And both Pfizer and Moderna reported that the drugs caused lymphocytes (white blood cells which fight disease) to drop in the days after vaccination – meaning that people were more susceptible to infection during that period of time, which was up to two weeks.(8)
Predictably, 'health experts' have been telling us that care home residents should be at the front of the queue for vaccinations, despite the fact that it hasn't been designed with them in mind and a compromised immune response is much more likely in the elderly.
Marek's Disease
Another hypothetical, which has not been ruled out and which applies as a general, evolutionary rule in the mutation of viruses. When a vaccine is widely administered, which protects the vaccinated individual but does not prevent transmission to others, a virus can transform from a slow moving, relatively mild disease into one that is fast evolving and much more deadly.
This has happened in chickens with Marek's Disease. This concept makes sense. Previously, a virulent strain would have died out and milder strains would have proliferated. But if you keep the host alive, there is no need for the virus to attenuate.(9)
Long Term Effects
Completely unknown.
Conclusions
Leaving aside the commonsensical, foundational question of why we think it's a good idea to monkey around with our immune system, especially to counter a virus that was swiftly found to be mild…. you may think that speculative. However, by December it was readily apparent that a virus with a 0.26% case fatality rate (at worst), did not warrant a worldwide vaccination campaign with an experimental vaccine.
Governments paid for vaccine development, vaccine companies have been granted immunity from prosecution, they get to keep the profits and any payouts for vaccine injury or death will come from us, our tax dollars at work.
There are other unaddressed questions, such as what are the dangers of being vaccinated if you've already had the virus?
I'm not saying that all of these scenarios will play out. I'm not even saying that one of them will. But the point is, we don't know and we should. That's what clinical trials are supposed to tell us; that and more. And we don't know because somebody decided that the risk of Covid outweighed all these possibilities. They are still holding that line, even now.
But what we have are vaccines that are not approved, for a type of virus that has never been successfully vaccinated, that have not been adequately tested, the long term effects of which are unknown but potentially seriously problematic and of a type (mRNA) that have never been used in humans before.
These vaccines are only allowed in this instance because the claim is of a dire emergency. But without the data to show that this is a public health emergency, the emergency authorizations would have to be withdrawn. That data doesn't exist and probably never did. And yet, here we are, with a Covid jab on the verge of being a de facto mandatory requirement.
Did governments find themselves in a difficult position? Perhaps, having overreacted initially, they feel that they must keep up the charade even now. Does that extend to inflicting these vaccinations upon us? Is our future health of less consequence than their pride? Or is there some other motivation? Interesting, isn't it?
Citations
Mark Lipsitch, https://doi.org/10.1101/2020.12.12.422516; MIT and Harvard study
Berenson, Alex. Unreported Truths About Covid-19 and Lockdowns: Part 4: Vaccines (p. 13). Blue Deep, Inc.. Kindle Edition.
Https://jacionline.org/article/S0091-6749(15)01667-X/fulltext
https://doi.org/10.1101/2020.12.12.422516; MIT and Harvard study.
Dixie L Mager & Jonathan P Stoye, Mammalian Endogenous Retroviruses, 2015
Weisblum et al, Escape from neutralising antibodies by SARS-COV-2 spike protein variants, 28/1/20.
https://journals.plos.org/plosbiology/article/info:doi/10.1371/journal.pbio.1002198