FARGO — It seems the world as we knew it has completely stopped. With the onset of the coronavirus pandemic, people all over the world are facing troubles they probably only had ever seen in their worst dreams.
Typically when I am feeling the stress of the world, I like to whip out my handy-dandy card for some retail therapy. But times are tight, and of course, COVID is a thing. Fortunately, I'm usually up for a good part-time job. I've waitressed, tended bars, took Sunday morning shifts at my hometown radio station and babysat — along with a lot more. When it comes to living my life the way I want to, I work hard and do what I have to do to be able to make that happen.
Enter Helmut Schmidt's Aug. 7 article on Lillestol Research's newest study.
In a July press release, Pfizer and BioNTech SE announced "a global phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2."
Soo what does that mean?
Basically, the biotech companies Pfizer and BioNTech SE have created a vaccine against the novel coronavirus and are ready to start testing it in human participants. These trials come only after extensive research and reviews of many variations of the RNA sequence to create this new type of vaccine to provide acquired immunity. Just like conventional vaccines, which oftentimes contain "dead" or "weakened" versions of a virus combined with a protein, the mRNA vaccine uses small parts of the virus's genetic code that's injected into the muscle where cells use protein to get the body's immune system to recognize the foreign particles and create antibodies to destroy them.
The immune system works like a computer with a giant hard drive. Once it encounters a new pathogen (bacteria, fungus, virus, etc.) it will "remember" it — which, in turn, makes it easier for the body to fight off any infection it encounters. The immune system, like the internet, never forgets. (Unless, of course, you contract measles. This infection can wipe out the immune system's memory of other illnesses. That's why it's important to stay up-to-date with vaccines.)
Before these vaccines can be approved for human testing, they must undergo a series of pre-trial tests to help figure out the safety, tolerability and the ability to provoke an immune response in subjects. These are known as "Phase 1" trials. In the case of the Pfizer-BioNTech SE's vaccine, the Phase 1 trial was a randomized, placebo-controlled, observer-blinded study, according to an early July press release. The initial part of the study included 45 healthy adults between the ages of 18 and 55.
Phase 2/3 trial (the one currently being held around the world) is a randomized, observer-blinded study that has subjects in a 1:1 ratio of vaccine to placebo. This study is specifically held to gather data on safety, immune response and efficacy.
By the end of the Phase 2/3 trial, this study is expected to be active at roughly 120 clinical research sites around the world — including Argentina, Brazil and Germany, as well as 39 states across the U.S.
One of those sites in the U.S. is right here in Fargo.
Lillestol Research, a Fargo-based company that conducts clinical research trials to determine the safety and effectiveness of new and existing therapeutic drugs, is one of the sites involved in "Operation Warp Speed." A call-out for participants went out in early August, seeking healthy adults between the ages of 18-85, who are at average risk for contracting the virus — meaning, they are out in the community either working, visiting stores or other activities that take them away from home.
As I said before, I'm in need of some of that sweet, sweet... direct deposit slip. So when I saw Helmut's article about the trial I was very intrigued.
I've tried to apply for studies in college through another research facility, but unfortunately my short, stocky figure puts me in the "obese" category of the BMI chart, which automatically disqualifies me for most trials.
Once I was accepted and scheduled, the waiting game began. I'm usually pretty confident in decisions I make about myself and my body, but to be honest I hmm'ed and haw'ed over this one. In fact, I almost dropped out a few times in the week or two leading up to my initial appointment. Because of the medicine she takes, my mother is extremely immunocompromised and I really don't think I would do well not seeing her for two years. Beyond that, the thought of potentially infecting any one of my loved ones makes me sick to my stomach. But with a bit more research, and quite a few calls to my mamma, I decided it would be a good thing to participate in what could be a huge part of the world's medical history. Also, you know, the compensation made it easy too.
My appointment was scheduled for 7 a.m., Thursday Aug. 27. I woke up bright and early, got myself together and drove the couple miles from my North Moorhead house to the facility at 4450 31st Ave. S., Fargo.
After getting checked in, I was led back to a medical room and was given time to read and understand the consent forms — something I did carefully so I knew exactly what I was getting myself into.
Once I was informed and consented to the trial, a nurse and I went over my medical history and I was brought to another room to do a blood draw.
Next came my most dreaded part of this whole experience: the COVID test.
Now, I suppose I should have figured that I would be getting a brain-swab when I signed up to do a COVID study. But for some reason I was really shocked when they told me about it. In fact, I almost dropped out as soon as I found out. But I was reassured that the stick doesn't actually touch your brain when it goes in your nose, and was reminded by my mother that small rock that made its home in my sinus when I was 3 or 4 years old was probably far worse than a swab gathering a couple cells and I decided to go for it.
The test isn't the most glamorous — all I could think about was violently sneezing and giving myself an accidental lobotomy — but it was only a few seconds of discomfort and it was over as soon as it began.
A nurse and I went over next steps and I was given the "all clear" to get the vaccine (or placebo, I have no idea which one). I hung out for a half hour in case of any immediate reactions and I was sent on my merry little way.
But this time, with an arm full of substance and a bag full of instructions and information.
It's been a week since my first appointment at Lillestol Research.
The only side effect I experienced was a sore arm from the injection — which makes sense, considering a foreign object was plunged into my shoulder muscle.
With this study, participants are to go back five times after their initial appointment — for a total of six office visits over a period of 24 months. In between appointments, participants are asked to carefully monitor themselves for any side effects or signs of COVID.
I've always been a fan of research. In high school I had the thoughts of going into the biology field once I got to college. Unfortunately my inability to do any sort of math had me choose the mass communications/journalism lifestyle instead, but I am grateful to those who are putting in time and effort to help find a cure or prevention to the coronavirus pandemic.
Scientists need a way to test their vaccine that has the potential to save millions, if not billions of lives around the world, and I'm thankful I'm able to play a small part in this piece of history.