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I Am a Moderna Trial Volunteer

In a couple of weeks, Moderna’s application for Emergency Use Authorization will be heard by the FDA. If all things go well, the FDA will most likely approve Moderna to distribute its mRNA vaccine, mRNA-1273, to the US. It would follow Pfizer’s vaccine based on the same technology. These vaccines will be the game changers for curbing the COVID-19 pandemic in the US. I was one of those who answered the call to participate in Moderna’s Phase 3 vaccine trial. For months, I shared this information with only a select group of people to avoid any misinformation being spread about the vaccine until it reached this point. Now, with some people spreading misinformation about the vaccines, I feel it’s important to share what led me to volunteer and how I’m doing now.

Vaccine 101

To start with, I think it’s important to understand the COVID-19 vaccines and more specifically, the mRNA vaccine I volunteered for. Vaccines are designed to elicit an antibody response from our bodies to target a virus and neutralize it, eventually killing it. In the case of SARS-CoV-2, the antibody response targets the spike protein that forms the “corona” around the virus. By creating antibodies to attached to those spike proteins, our body cuts off the ability for the virus to attach to the ACE2 receptors on some of our cells, particularly lung cells, and then attack the virus itself to kill it and prevent replication.

The traditional way was to culture active viruses, sometimes in chicken egg cells, then either weaken or inactivate them. That way they can be introduced into the body, trigger an immune response, and train the body to recognize the virus in the future. That process takes months, often years, to develop adequate vaccines for our bodies. The best approach following this process is to weaken the virus so it can sometimes replicate which allows only a dose or two to get the immune response we need.

The downside of that approach is that sometimes a vaccine will contain a virus that isn’t weakened enough. In those cases, you end up getting a mild case of whatever disease the virus causes. That’s why people sometimes actually get the flu from the flu vaccine. Also, sometimes the weakened viruses are weakened too much and don’t produce the level of immune response needed to protect you in the future. That’s why the flu vaccine isn’t 100% effective.

Another way is to re-engineer another virus, like an adenovirus, that isn’t as dangerous and embed the antigen into it. That way the body’s immune system responds with the appropriate measures to attack the virus should it enter the body. The adenovirus replicates enough to get the response with only one or two doses. That’s what the AstraZeneca and Johnson & Johnson vaccines are made of. Both are in Stage 3 trials now.

mRNA Vaccines

Finally, let’s look at the technology used by the two candidates who have applied to the FDA for EUA, Pfizer/BioNTech and Moderna. These use a relatively new approach to deliver antigens into the body to elicit an immune response, mRNA. mRNA is not a weakened/inactivated virus or an adenovirus. In fact, it’s not even a virus in any shape or form. It’s an RNA strand designed to coax our cells to create spike proteins in the cytoplasm of the cell.

Encapsulated in a lipid nanoparticle to help it survive the trip into our body, it enters cells and uses cellular biology to generate spike proteins that enter the body and cause the immune system to ramp up to deal with the foreign particle in the body. Large numbers of antibodies are created, some of which attach to the spike protein, but the majority just hang around in the body waiting for more spike proteins to attach to. If a person gets infected with a SARS-CoV-2 virus, they are there waiting to attack.

Furthermore, the body’s immune memory, the T-cells, know what to look for in the future. So, if we get infected months down the road, they are there ready to kick the defenses in gear quickly and generate more antibodies to attack the virus. Based on current data, T-cell response was visible in not only younger adults, but older adults as well. Another study showed that antibodies were still present at strong levels 3 months after the second dose. That means that the body can react extremely fast at neutralizing the virus should you get infected, not having to wait on T-cell response.

If that doesn’t explain it well enough, this video from Zubin Damania (ak ZDoggMD) explains mRNA and how it works in much easier terms to understand than I can.

My Research On mRNA-1273

But, enough about Vaccine 101. Let’s talk about my reason to join the trial and what I experienced. When I heard that Arkansas would be one of the trial sites for the Moderna vaccine, I started researching the technology and experiences of early stage trial volunteers. I’ve already talked about mRNA and why I feel it’s safe and effective. I wanted to see what those first volunteers experienced, particularly in terms of side effects. There were reports of severe reactions to the vaccine, but it turns out those volunteers received a much higher dose than what is being given now.

In the first stage, Moderna was testing three different dose levels to see which would be the best to use going forward; 50μg, 100μg, and 250μg. Volunteers in the third group saw robust immune response, but also adverse side effects. However, the response was not much greater than the second group. Moderna ended up settling on 100μg as the right dose for their vaccine, mRNA-1273. Stage 2 volunteers saw side effects no different than a seasonal flu vaccine, with some experiencing a little more adverse reactions, but nothing off the charts.

I also wanted to help provide some protection for my mother who I live with and help take care of. I’m in the workplace daily and out and about running errands. That was a risk I didn’t like taking, but knew I had to take in today’s environment. Taking a chance at getting the vaccine or a placebo seemed worth it, even if I just got the placebo. Getting the vaccine would be icing on the cake.

The Experience

After I got the call that I had been selected as a volunteer, I went for my first visit at the Baptist Health Center for Clinical Research. Upon arrival, I had to completely read an extensive document that explained the trial to me, what services I would have access to should I become ill, and legal waivers. After that, an interview, health check, and a pretty hefty blood draw of about 8 or 9 vials of blood. After all of that, I went to the injection room where the shot was given in the left arm. With regards to shots, it was pretty painless.

That afternoon, I started to feel some fatigue, but thought it might be from the blood draw. Then the soreness in the left arm started and some mild aches. The soreness lasted three days and was gone. A month later came the second injection. Same routine sans the interview and then another injection. Still no pain. But that day, the arm really got sore, so much that when I rolled over in bed that night, it woke me up. It felt like I had been punched pretty hard in the arm.

No elevated temp even though you check it daily during the week following the injections. I did wake up the next day feeling like the onset of a mild flu. I was debating whether to go to work that day or not and decided to head on in. Taking some ibuprofen helped, but I definitely wasn’t at full steam. I had redness at the injection site and a little swelling. Everything but the sore arm went away after two days and the sore arm was gone after three days.

I haven’t had any problems since and feel fine. I’ve been back once for a checkup and will go back again in March. I’ve talked to a few who could tell they either had the vaccine or believe they got the placebo. Quite honestly, I hope they unblind the trial to allow those who received the placebo to get the vaccine as soon as possible. It is those who got the placebo who helped get this to EUA and they deserve to get the vaccine as soon as possible.

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