10/26/2021
As a clinical data expert working in outcomes research for over 15 years, my perspective is simple, and not influenced by the government, industry, or media of any type. The views expressed are my own, not the university I am employed.
I’m not a doctor. I am a university professor who has a director role for overseeing clinical data termed ‘informatics’ for research. The reason I am writing this is to try and clarify a lot of misunderstanding about COVID-19 and the mRNA vaccines. Over the past 10-12 months, I have explained in simple terms what is going on, to countless friends, connections and random people who simply have not had a clear, unbiased and concise explanation of the virus and the vaccine. I have no financial, political, or theoretical interest in this, I just understand science and have access to data. In nearly every example of my explanations, people reply, “Why don’t they just say that?”
As of this writing, about 60% of eligible Americans are vaccinated – this varies wildly by state. This is not a script to encourage vaccination for those who are hesitant, rather a perspective for anyone, so more informed decisions can be made. First, COVID is real. Enough said. As we learn more about the pathogen, downstream effects can cause other illnesses months later, called sequelae; the common term is long-hauler. This virus will continue to wreak havoc until we have reached 'herd immunity'; the point where the pathogen cannot reproduce effectively. Let's address common questions...
How was the mRNA vaccine developed so quickly?
In a 1905, the philosopher George Santayana said, “Those who cannot remember the past are condemned to repeat it.” We can put this statement in context regarding Smallpox, the infamous ‘speckled monster’. Smallpox is one of the most devastating and deadly diseases that has wound its way into humanity. This contagious disease has ravaged humankind for over 3,000 years. The total death toll is incalculable due to ancient and nonexistent record keeping. However, it is known that it killed 10 million people just in the 20th century alone. The earliest inoculations date way back to 1500 AD, but never proved viable. But in 1896, Dr. Edward Jenner in Britain developed a vaccine proven effective. The vaccine was produced from cow cells, related to Cowpox that affected only cattle. There was major resistance; in the following decades, people railed against the vaccine because it was simply misunderstood. There was a general mistrust of medicine, and religious views implied that injecting any such remedy derived from a lesser species was “un-Christian”. The unnerving fact, is that while an effective vaccine was developed in 1896, the Smallpox virus was not eradicated until 1980. It took 84 years to win that battle. How not to win the Human Race.
Historically, it takes 4-5 years to develop a vaccine, but this is based on older technology. Until COVID, all vaccines developed used either mammal cells or chicken eggs to cultivate and transport a disabled version of a virus to teach our system to create immunity; the same basic principle as in 1896. Whether polio, mumps, measles, rubella, or the seasonal flu, all these vaccines had to be grown in the lab in large quantities for vaccine manufacture. Let’s define ‘large quantities’; the United States has population of about 330 million people. Vaccines have been traditionally delivered at certain ages, time periods or variables such as risk factors. This means the U.S. does not need 330 million doses of a vaccine all at once, let’s say 25 million are needed at any given time. This is possible using chicken eggs. Now let’s consider a pandemic. Instead of millions of doses, we need billions. It is simply not possible to grow billions of vaccines with this technology. Until COVID came into existence, there were no real reasons (technically called ‘use cases’) that required massive scale to deliver a solution. The only way to create billions of doses of a vaccine, is to do it without animal byproducts, that is, derived synthetically. Pharmaceutical companies were supplied the DNA sequence of the virus and employed similar approaches to vaccine development. The concept was to allow the human body itself to generate an immune response through natural cellular processes. Enter mRNA.
It is important to understand that mRNA technology is NOT new, it has been in development for nearly 30 years. This provided the platform where the biggest challenge was creating the specific sequence that would tell your body what to do. This was followed by comprehensive, global clinical trials that yielded extremely positive results that is scientifically measured as efficacy, broadly meaning effectiveness. It is further proven by what we call ‘real world evidence’ from population-based health outcomes. This is the data referred to earlier.
How does mRNA work and how do I know it’s safe?
COVID has another name, Coronavirus. It is casually called this because it has spike proteins on the outside of the virus structure that resemble a king’s crown (that is how the virus grabs healthy cells), hence the name coronavirus. The mRNA vaccine (“m” stands for ‘messenger’) is a small amount of synthetic, single-stranded RNA molecule that is an instruction set for your immune system. The payload is packaged in tiny, fragile jelly packets which is why it needs to be stored at very cold temperatures. Once injected into your arm, the muscle cells ingest the tiny mRNA molecule that has the instructions for cells to create only the protein spikes that look exactly like the spikes of the actual virus, based on the virus' DNA sequence. The spikes are harmless but do one critical thing; they cause the body to immediately recognize them as an outside invader. This is not the virus at all, just its unique protein shape - Brilliant. Your body launches the natural response system and creates antibodies and white blood cells that are the ‘special teams’ of the immune system which create a defensive line. These teams use past behaviors and cellular processes to recognize specific threats and destroy them when they reappear. In this specific example, the recognition are those protein spikes. Immunity has begun.
Why is mRNA way more effective than the annual flu vaccine?
Another very good question asked is how can the COVID vaccine be 95% effective compared to the annual flu vaccine that never seems to get past 70? The influenza virus is always with us and conveniently moves around the globe on modern transportation systems. The flu thrives best in colder climates where people hold up in dwellings where warm air is circulated and germs spread. Remember, when it is summer in the U.S., it is winter in southern hemisphere. The flu keeps going around and around and mutating. Pharmaceutical companies (still) use chicken eggs to create and transport a weakened virus into your arm that must be re-administered each year. Because of the ongoing process, they take their best guess at creating a version early in the flu season. Because the flu virus continues to mutate during the cold months, the vaccine created in August is often less effective by the time January rolls around. But the protein spike of COVID is unique, specific, and identifiable, there is no mistaking it at the biological level.
Does mRNA change my DNA?
Your DNA, or genetic code, is not part of this process. Although the mRNA molecule enters a cell’s wall, it does not enter the nucleus where your DNA is stored. It only kick starts the process that generates the spike proteins that awakens the immune system. After that occurs, your cells destroy the mRNA molecule, similar what your liver does to alcohol. Cheers to that.
What about variants?
So long as there are unvaccinated people who act as hosts to for the virus to reproduce, the virus will continue to thrive. COVID-19, like any other living cell, will multiply and seek to reproduce, and like other living cells, its reproduction/cell duplication sometimes does not do it perfectly. These natural errors create variants. There are over a dozen documented COVID variants so far. Until we reach herd immunity, more variants will arrive.
I don’t know who to believe…
Since the beginning, it has been very difficult to comprehend not only COVID, but the vaccines. Here is part of it, enter the untamed world of social media. All these platforms share a common theme – ‘anything goes’. Countless people strive to make money by becoming popular, attracting followers, generating ‘likes’ and building an audience. YouTube calls these people “Influencers”. With hundreds of thousands of eyeballs on their wavelength – and always seeking the elusive “gone viral” status – these people create content that sell advertising, and generate revenue. This quest for this status encourages any behavior leading from misleading facts to outright untruths. Social media is about getting attention. Just one example is a video of someone holding some sort of numerical scanner on “the unvaccinated arm where it reads 00000, then the vaccinated arm where it reads 53821”, suggesting the vaccine is implanting some kind of tracking system in our bodies. Indeed, absurd but gets Likes and Shares. For these people, I'd like to say that the word "gullible" has been removed from the dictionary. And if you are worried about being tracked, don’t, just accept it because if you use a smartphone, you already are.
People have every right to deny vaccines, or other medical attention. It may be that society will repeat the history of smallpox, pay the price in terms of illness, suffering and mortality. Furthermore, we will live with a different set of rules and get used to boosters when the virus mutates beyond what previous mRNA messages had in its instructions. As I write this, I am on a plane between Cincinnati and Atlanta… Wearing a mask. I really hope this is not a permanent social convention as well as other unwelcome inconveniences such as quarantines and suffocating lock downs for the next decade. This is not a modern approach.
The Spanish Flu of 1918 was our previous global battle and 675,000 Americans died. These Americans wish they had a vaccine. There wasn’t one. Although the population was about a third of what it is today, we have now surpassed that same death count that continues to climb. Yet we have a vaccine.
A fifth of the way through the 21st century - we have the technology that created a new generation of vaccine to defend against a new generation of virus. It is based on the essence of all living things, Deoxyribonucleic acid, or the DNA of the virus. We decoded the virus structure. For years, there has been research and hope that this new generation of medicine called “Smart Medicine” can perform far beyond archaic methods. The success of the mRNA vaccines is only the beginning of what can be done. These targeted, genetic interventions, also known as precision medicine, allow for other therapeutic advantages.
With all the negatives of the pandemic, one good thing is emerging… We now have proof that this technology works and instructs our body to create defenses based on the natural mechanics of our own immune system based on genome sequencing. For other illnesses such as Cancer, immunotherapy treatments are already in play, the possibilities are endless; imagine using this mRNA to cure Type 2 Diabetes, obesity, heart disease, or Alzheimer’s. We have hope. Let us all embrace.
Professor Harnett