Pioneering Phase 3

Molly PereiraFeatured News

By Chris Macri, D.D.S.
From the Winter 2021 Journal of the Colorado Dental Association 

On Friday, July 17, 2020, I was the third person in Colorado to receive the Moderna COVID-19 vaccine. This is my story.

The serenity prayer asks for the serenity to accept the things I cannot change, the courage to change the things I can, and the wisdom to know the difference. I’ve never been good at items one and three. As such, the feeling of helplessness with the pandemic has been tough for me to accept. When I found out about the vaccine trial coming to Colorado last year, it wasn’t a difficult decision for me. I know there are risks with participating in any drug trial, but I felt it was my small way of exerting control in an out-of-control situation.

I remember sitting at home reading an article about the Moderna trial. They were looking for people to enroll in phase 3 trials for the vaccine. This was the first trial in Colorado, and they would be holding it at the University of Colorado Anschutz Medical Campus. I Googled phase 3 trials to see what that meant. In phase 1 they test to see if the vaccine is safe (i.e., will it kill you?). In phase 2 they figure out the appropriate dosage. Phase 3 is proof of concept (is it effective?). Since they must have passed the “will it kill you” part, I felt okay with phase 3.

I had previously been a patient at CU for a mountain bike related ankle injury. At some point I had downloaded the CU health app on my phone. For whatever reason, the app gave me a notification asking if I’d like to participate. I signed the online form and within a few days, I received a phone call. They asked a few generic health-related questions and while filling in the required answers on her computer, the researcher casually asked what I did for a living. When I told her I was a dentist, she perked up and excitedly said, “Oh, we want you! You’re high risk!” That was something that I both did and did not want to hear. I was happy they wanted me, but the risks of my profession were now officially confirmed by science. Regardless, I was in. I scheduled for their first available slot that fit my schedule. As it turns out, I was the third participant in the study. Since they were the first study in Colorado, that means I was the third person in Colorado to potentially get the vaccine. The first and second were in just before me. It was not my intention to be such an early adopter, but had I known I was so close, I would have scheduled earlier in the day just for bragging rights. Nevertheless, third isn’t bad.

When I arrived, I sat down with the researcher to discuss what I was signing up for. They went through risks, allergies and a thorough physical with one of their doctors. They performed a COVID-19 test and blood draw. I asked a few questions. “How long would the vaccine potentially last?” They didn’t know. “For sure, there was no live or attenuated virus in the vaccine, right?” The answer was no. They used no virus in the vaccine. They explained the process of mRNA injected into muscle tissue. The muscle cells begin producing the protein that is the spike on the Coronavirus shell. My body sees those proteins and makes the antibodies. I felt comfortable that I understood. Having demystified the nebulous term “vaccine,” I felt comfortable being the guinea pig.

I had one final thought at this point, and it wasn’t until I asked the question that I received my most memorable answer. “Do you feel that the creators and researchers of the vaccine skipped any steps?” The news, social media feeds, my friends and family felt there was no way to safely create a vaccine in this short amount of time without skipping something, so I felt the need to ask that question. They grabbed one of the molecular biologists who was there to see the first day of phase 3 testing. When I asked her the same question, she beamed with pride. She told me not only had they not skipped steps, this was the first time the entire planet had come together for a single purpose. Countries that normally didn’t speak were freely sharing information with each other. Yes, each company had its own secret sauce to create its own version of a vaccine, but the level of cooperation and communication was unprecedented. She said the genome for the vaccine was freely shared from China—something that could have held things up for months was readily available online. She did say that years of grant writing and searching for funding had been bypassed. So yes, that part was skipped. But the constant communication and multi-country and multi-corporation cooperation had produced something the world had never seen before. We had achieved scientific success for a global problem through a collaborative global effort. This is what made the vaccine possible—not shorting steps in search of profit. Mind you this was not a Moderna employee nor a politician. She was a grad student—a science-type personality I remember from my undergraduate years. Someone whose interest was in science. And, unlike me when I was a bored research intern animating drosophila larvae SEMs, this was someone who was extremely proud to be part of something important.

Curiosity satisfied; I got my first injection. I followed up with them every day that week and then with weekly phone interviews. I had a little injection site soreness, slight soreness of the axillary lymph node on the ipsilateral side and very mild generalized joint soreness. That was about it. It was double blind, so I had no idea if I had the actual vaccine or the placebo. The liquid had a yellowish color, so I was hopeful it wasn’t just colored saline. Surely, they wouldn’t bother to color the saline, but who knew.

About a month later, I returned for injection number two at 8 a.m. Again, the side effects were nothing of significance that day. The excitement, however, started around midnight. I woke up in a cold sweat. My muscles and joints ached. I felt like I had the worst flu I’d ever had. My temperature was 102 and I was freezing despite being under all the covers. If this is what full-blown COVID-19 felt like, it was absolutely awful.  Around 9 a.m. the next morning I called the research group. I asked if they would tell me if I had COVID-19. They said, of course they would. The person I spoke with paused for a moment and then added, “Give it some time, we’ve seen this before and it will resolve.” “So other people have reported this reaction?” I asked. “Yes. We’ve had a few,” she said. “Give it some time and it will get better.” She was right. At 3 p.m. that afternoon I was laying on the couch really regretting my decision to do this trial. And then at 4 p.m., I’d had a miraculous recovery and was outside working on the yard. The difference was night and day. I never had any breathing troubles.

After that, there really wasn’t much to report. I filled out my online diary, as required, and did the check-in calls weekly. Then, just before Thanksgiving, my daughter tested positive for COVID-19. She was mostly asymptomatic after being exposed at school. Then my wife tested, and the result was inconclusive. According to the powers that be, it meant she was exposed to the virus. It was either too late or too early to make a positive diagnosis. My results were all negative, but since I was pretty sure I was in the test group that had received the actual vaccine, I asked the nurse to run an antibody test in addition to the COVID-19 PCR test. I let her know about the vaccine study. She called me back in about 90 minutes and her first words were, “You have a ton of antibodies. You’re really immune!” I guess the blood darkens a circle on the test strip if you have antibodies and my test turned darker than anyone else she’d seen. It was confirmed, I was vaccinated.

During my time quarantining with my family, I did have the same soreness in my axillary lymph node that I had after that first shot, for about two days. I’d like to think that’s my COVID-19 detector. Kind of like my sore ankle that tells me if the weather is going to be bad, my armpit will tell me if you’ve got COVID-19. OK, maybe not.

That’s the whole story. I’m still wearing my mask everywhere. I’m still social distancing and treating every patient with the enhanced universal precautions we all know. Either I’m really brave or really dumb, but I feel comfortable with my choices.  Maybe you think getting the vaccine without long-term studies is foolish. Maybe you feel the virus, itself, is rubbish. My goal in writing this is not to change your mind. But if having one positive story to share for 2020 is my big contribution to the year, I’m comfortable with that too. 2020 has been a year filled with negative things and like I said, I just can’t accept things I can’t change.

Dr. Chris Macri is a general dentist in Greenwood Village, CO. He graduated from Indiana School of Dentistry. He is a KIND volunteer, as well as a volunteer at Inner City Health Center. Since 2006, Dr. Macri has worked outside the office as an examiner for CRDTS.