The E(N)d of COVID-19
…but first, a resounding Happy Birthday to the most narcissistic, nefarious organism to enter our lives and make 2020 a year we will never forget (but will sincerely hope to, someday).
I use “narcissistic” because of the constant attention this thing has begged for, and will continue to demand years after this post… and I use “nefarious” due to the ramifications COVID-19 has on the human body, on society, on science, and on trust.
This title has been a deliberate choice. Many people who are concerned about the COVID-19 vaccine are missing a simple explanation as to why many things can’t be answered. The honest answer deals with N, a variable used in statistics to represent total samples — which are low within COVID-19, because it has never been studied before. In even easier terms, scientists can’t answer these things because they don’t know. This isn’t due to laziness, or lack of work motivation. This shortcoming only deals with time, and despite how agonizingly long it has felt to all of us in a lockdown, the amount of time science has had to work with COVID-19 is incredibly small.
Wait — who are you? Where am I? How did I get here? What is this about?
You’re probably here because you clicked on a link that someone (maybe me?) posted somewhere. In a nutshell: I am a recent graduate from the University of Toronto (Canada) with a double major in English and Earth & Environmental Systems, who recognizes and sympathizes with misunderstandings and mistrust around science. Once upon a time, I too refused a vaccine because of mistrust and overall dislike for the government (the vaccine was for the H1N1 flu in 2008). See? I’m on your side — you are someone who has clicked my click-baiting title (sorry — its just business) and found yourself on my blog.
A blog? So you’re not a reputable source? You don’t have a medical degree? This is crap!
Yep, 100% not a medical student with no medical knowledge except that which has been imparted on me by my registered-nurse mother, and that which I have the privilege of accessing. What this allows is an unbiased, unaffiliated opinion that I am publishing completely for free based upon research I have explored on my own time. By my not being involved with the medical community, it means I offer an outsider perspective to pour over articles already published and serve as your unofficial science translator. If all of this sits well with you, I encourage you to read on about…
The E(N)d of COVID-19
By now, you should be aware that a company called Pfizer-BioNTech (or just Pfizer) has developed an mRNA vaccine against COVID-19 in a fairly speedy way. I mean, the health professionals on national television were all warning us that the earliest a vaccine can be developed would be 2021 — if we were lucky. But Pfizer-BioNTech has successfully created a vaccine in just 8 months, and there are primarily 2 reasons this happened:
1. Never before has a vaccine been more heavily funded, something to the tune of $10-$18 billion USD. That is $10 000 000 000. If you have trouble understanding the exponential relationship of ‘billions’ please click this.
2. Prior to January 2020, decades of research have been conducted examining the potential of mRNA vaccines to treat diseases like SARS, HIV and even cancer. One woman, Dr. Katalin Karikó, has dedicated the last 4 decades to this research. She’s pictured below, as a PhD student in 1980 at the Hungarian Academy of Sciences.
Most vaccines take anywhere from decades to centuries to finalize; from the dawn of any given virus to the final product of ensuring that virus cannot infect anyone further. While COVID-19 only reared its ugly head one year ago today, you can thank the efforts of Dr. Karikó for looking into mRNA as a viable form to treat respiratory diseases (like COVID-19 and SARS) and, potentially, other illnesses.
mRNA is a new technology that teaches your body how to create, attack, and eliminate cells that look like the coronavirus. Once these instructions are read by your body, they disintegrate and exit your body, leaving nothing behind except the knowledge of how to fight anything that looks like the coronavirus cell. A full explanation is found here
Potentially? So there has never been an mRNA vaccine until now? Are we all guinea pigs?
Sure, though this is not at the fault of Dr. Karikó. Numerous times she has been demoted, denied, and put down by her colleagues when her research hasn’t attracted enough money for the academy. Luckily, she persisted and BioNTech (who has partnered with Pfizer) utilized her 2005 paper to develop the coronavirus vaccine. (If you dare, you can read that here: Suppression of RNA Recognition by Toll-like Receptors: The Impact of Nucleoside Modification and the Evolutionary Origin of RNA). This paper is evidence of breakthrough research — up until then, one severe side effect of receiving an mRNA vaccine was inflammation (swelling and heat to an area) but thanks to the Dr. Karikó, and changing one nucleoside (a chemical chain, in the simplest terms) this side effect was no more.
How can you say that? The Pfizer vaccine has several side effects that happen to more than 1 in 10 people!
While looking through the product monograph (which is a detailed document that every distributable vaccine has written about it — completely open to the public) I noticed interesting things. Before distribution of any vaccine, the vaccine must go through rigorous testing to ensure it is not damaging to the human body. Like other vaccines that are given out (like the flu vaccine, smallpox, typhoid, among others) Pfizer’s passed these tests. The side effects that many people are concerned with are the same side effects that come with any other vaccination — fatigue, chills, headaches, pain at the injection site, and so on. What many mainstream news outlets fail to acknowledge is that the placebo also replicated these side effects. The following table was taken directly from the Pfizer-BioNTech COVID-19 Product Monograph:
What this means is that 47.4% of people who received the first dose of the vaccine (because two doses are recommended for full immunization) were fatigued, as well as 33.4% of people who didn’t even receive the Pfizer vaccine. Similarly (and mildly hilariously), 11.1% of people who received the Pfizer vaccine reported having diarrhea — and more people (11.7%) reported diarrhea after getting the placebo.
This means there are side effects in people who successfully received the vaccine, as well as those who received nothing.
Well, who’s to say these are reflective of the entire population? I still don’t trust it!
If you are still skeptical at this point, I applaud you. It is crucial that there are skeptics in science — but there is a fine line between healthy, informed skepticism and downright cynicism. To be an informed skeptic is to do actual research — not take heresy from facebook, twitter, or other faulty unaccredited websites, but information from people who belong in the fields where this work comes from, like Dr. Karikó.
There is nothing inherently sinister about science. All science has done for humans is advance our means of living; before regularly administered vaccines, life expectancy sat at an average of 35 years in 1750, and it is thanks to vaccines (and more hygienic practices) that the average life expectancy is now 80 years and over.
Part of being a healthy skeptic is acknowledging that results will never return a 100% efficacy. It can be rounded to 100%, in the event of a 99.9999% — but even that is not 100%. A common example given in beginner statistics classes introduces a box of Smarties as being potentially poisonous. You eat one Smartie — and it is not poisonous! Is it probable that the rest of the box is harmless? Yes, there is a probability — but by only sampling one Smartie, you cannot lawfully say “100% of the box is completely harmless”. It would set you up as a liability. The next person to take a box of Smarties and contract food poisoning could sue you for declaring the Smarties are harmless. In essence, the only way to achieve 100% is to test all the Smarties, and only then can you say (with 100% confidence) that “these Smarties are harmless!” … But that is only your box of Smarties. What about the next one? Or the one after that? Will you taste all the Smarties in the entire world to ensure they are all not harmful? Who else will get to enjoy the Smarties then?
In statistics, this is where a ‘confidence interval’ is introduced. In science, you may have seen someone refer to their ‘p-value’ as being ‘less than 0.05’ or maybe seen “p-value < 0.05”. What this means is that that scientist has analyzed their data, fit it to a pattern, and can declare with “95% confidence” that their results are true, real, and valid. In other words, if you have a p-value of 0.05, you have significant results that are publishable; your experiment was not done in vain, and you have unlocked another key piece in the science puzzle! A large factor in getting good results is replication — or an N value. By consuming several dozen boxes of Smarties and having no adverse side effects, you could quite confidently say, “Smarties are not poisonous nor harmful.” But if you only consume one box of Smarties, you could not confidently say the same. Sure, you can announce that “Smarties are not harmful! I’m fine!” but your p-value would not be significant, only because you have not repeated the experiment several times to ensure your results are real.
N’s and p’s and Smarties… What does this have to do with COVID-19? Couldn’t too much Smarties consumption lead to diabetes or high blood pressure? Why should I care?
Listen, the Smarties example might have been too simple. I introduce these concepts to bring you to the scary statistics that scientists will be throwing around, and what those statistics mean. P-value is a measurement of confidence. It enables scientists to announce their results as a piece of reality. N is a measurement of repetition — a higher N, a higher p-value (generally speaking. There’s a bit more to statistics than that, like Type A and Type B errors, but those don’t matter right now). In the tables I presented above, the N value for every administered test (be it placebo or real) were all over 2000 for years 18–22 (and above 1500 for ages 55+). This means over 3500 people participated in a given dose of the Pfizer vaccine, and around 3500 more were given the placebo, and the resulting side effects are posted in the product monograph. You should care about this because the vaccine has now rolled out to millions of people, and limited side effects are being reported. I would hazard a guess that updating the clinical trials would be a mute point — the percentages may shift by a fraction, but largely remain at the same level. 11.1% of people will report diarrhea; around half of the vaccine receivers will be fatigued, but these are normal with other regulatory vaccines that are administered.
But what about the pregnant women? Or children under 16? Or people with allergies?
The main reason the vaccine is discouraged from these people is simply because no targeted testing has been administered. That’s it! How many pregnant women will readily sign up to receive a vaccine that reports a side-effect of fevers? Fevers are terrible for fetus development. A statistic would surely roll out shortly after this trial that links the vaccine to miscarriages — only because of the fevers they could induce. As for children — how many parents are blindly willing to sign their child up for a clinical trial when the risks of receiving a vaccine were unknown? Adults (or rather, adult bodies) have a better chance at handling adverse side effects and fully recovering from a small bout of fatigue or diarrhea. Adults can also legally consent their own bodies to participate in studies like these ones. The discouragement around receiving the vaccine due to allergies is another liability statement, like the above example with the Smarties. The science is saying, “Talk to your doctor! Your doctor will know your past health record and any allergies, because those allergies may play into reactions from this vaccine.” Will they? 9/10 times, probably not. Your dust allergy and runny nose won’t suddenly combust into a severe illness. This allergy statement is put in place as a liability, and hasn’t been properly studied due to an absence of targeted studies looking at people with allergies who received the COVID-19 vaccine.
Update published Jan 18 2021: “MHRA revised its position on 30 December after careful consideration based on enhanced surveillance of over one million doses of the vaccine in the UK and North America — including in jurisdictions where people with serious allergies were never barred from receiving the vaccine. It found no evidence of an increased risk of anaphylaxis to the Pfizer-BioNTech vaccine among people with serious but unrelated allergy histories and advised that only people who had an allergic reaction to the first dose of this vaccine, or who previously had reactions to any of its components, should not receive it.” Source.
Science has been a complex part of human evolution and discovery. Without science, we would not have technology; literacy; glasses; light… the list goes on. Science works! There are rigorous testing and strict rules that science adheres to before anything is published into the world. Every research paper is subject to peer-reviewing, wherein several other scientists read over the paper you’re hoping to publish, and they question everything you have written about, from the methods, to the summary, to the results, to how your data is presented, to the references you cited in preliminary knowledge, to the grammar used, and more. They are there to protect people like you from faulty, fraudulent science! If there’s nothing else to trust, trust in those processes.
1. The Pfizer-BioNTech vaccine happened as fast as it did thanks to the decades of previous research on mRNA vaccines.
2. While mRNA vaccines are new and a little scary, they show no adverse side effects and leave no residue in the body. They provide your body with a set of instructions and a ‘Wanted’ poster of the cell your body should be targeting. This poster disintegrates and exits your body, but the knowledge of the perpetrator is left behind.
3. By understanding science, it makes a lot of these things less scary. Science is not sinister!