I am enrolled in a Covid-19 vaccine trial

333

 “You’re gonna let them just shoot you up with that?” “What do they do, just expose you to Covid after that?” “You’re crazy. There’s no way I would do that.” I get a lot of these kind of reactions when I tell people I signed up for a Covid-19 vaccine trial. Admittedly, I wondered some of these same thoughts in late August as I awaited my appointment for September 2nd.

I had found a link for the Phase 3 Moderna Covid-19 vaccine trial one night when I was scrolling through the NextDoor app and I signed up. I had read and heard a little about mRNA vaccines and I was fascinated. Afterwards I figured, “Whatever, they’ll probably never call me anyway. I’m a 40-year-old-out-of-shape-smoker, I’m probably gonna be a hard pass.”

So, they called me a couple of days later (never said I always guess right). I scheduled my appointment and printed the email they sent that had me fill out my medical history and current medications. I was both excited and nervous. Sometimes it was “what the hell am I doing?” “What am I getting into?” and other times “I am going to help end a pandemic! I am going to be a (very) minute part of history!” I wondered if people who had signed up for the polio vaccine trials had felt this way too. In the days leading up to my first appointment, that was my rationale, “I don’t have polio because someone did this for me.”

I went to the clinic for my first appointment. The people who worked there were so friendly and welcoming. I wasn’t sure if they were going to put 10 of us in a room and walk us through it or what. I guess I was sort of hoping they would because I wanted to meet other people who maybe had the same thoughts that I did. But, (I’m guessing) because of the pandemic and the nature of the study, I was shown into an exam room by myself. I read the informed consent packet which told me all about the study, risks, and benefits and what I could expect at each visit.

A very nice nurse came in and asked if I had any questions, “Just one. Will I ever be unblinded?” This was a double-blind study. Meaning, out of the 30,000 of us who are participating in this, only half will get the vaccination. The other half will get a shot of normal saline and we won’t know which one we received. She answered with, “No, they’ll never tell you unless it will have an effect on your health.” She then mentioned that if Moderna ever decided to unblind us, the clinic would contact me.

This was my first moment of hesitation. “What? I work in healthcare; I can’t just not know. I have an elderly father; I can’t just not know. What if my job requires that I get one? What if my dad gets sick? What if, what if, what if…” Within the span of 60 seconds (which felt much longer), I decided to just take the leap and do it. How else can we end this? If everyone decides it’s not worth it, how will we get through this? I silently wondered how many others asked the same question. Did they walk out when they got this answer? The nurse left the room with my signed paperwork. This was it. I was in.

 We then went over what answers I had filled out on the email printout about my medical history and current medications. She then asked me some behavioral questions such as “Do you go out frequently?” “Do you wear a mask at all times?” She assured me that there were no right or wrong answers and that these were just for study purposes. As she was leaving the room, she instructed me to undress to my bra and underwear and put on one of those crappy paper gowns. A couple of minutes later (they move quick here), a doctor entered the room. He was a very nice man, a thick accent (which sorry, I couldn’t quite place), and very direct. He gave me a brief physical and left the room.

After the physical, I had to take a pregnancy test and get the nasal swab COVID-19 test. I want to tell you that those aren’t bad, but I won’t lie to you here. That was very uncomfortable (I won’t say painful), the good news is, it’s very quick.

I didn’t have much time to pat myself on the back for saving the world because the same nurse returned soon with “my shot.” We had agreed earlier that we would do it in my right arm (I’m left-handed), she sat down and was ready to stick me. I stared at the syringe as she shot it into my arm. Was this the real deal? Were there any clues that would tell me what it was? No, it looked like anything else, just a cloudy colorless liquid in a syringe. It was almost totally painless, just a quick stick. I had no idea what she just injected me with.

They wanted me to stay for 30 minutes after my shot to see if I had any reactions. In that time, they taught me how to use the online reporting app. A very helpful and understanding lady walked me through the online app process (full disclosure: I am not good with technology). I wasn’t feeling anything; I was sure I had received the placebo. I thought, “surely, if this was the real thing, I’d feel something, right? After it was determined that I hadn’t had an immediate reaction, I was free to go.

I went home that night and had dinner uneventfully. I took my temperature later on as instructed and it was normal. I felt nothing. I woke up the next morning and my right arm was slightly sore. Not enough to do anything about, I didn’t take anything for it.  I took my temperature and it was normal. I filled out the online health app questionnaire. I was sure that I had gotten the placebo. For the next 13 days, I would log into the app, take my temperature, and report my (nonexistent) symptoms.

My second appointment was October 2nd. Since nothing eventful (as far as my health is concerned) happened in that last month, this was a much shorter visit. They took blood from me and I had to do another nasal swab and they gave me my second shot. I had to stay 30 minutes again to see if I had any reactions. There was nothing. I felt fine. I left the clinic and went on about my daily business.

 The following is not the smartest move that I’ve ever made. In the interest of honesty and fair reporting, I am continuing with sharing my experience.

By dinner time that night, I’d almost completely forgotten about my second shot earlier that day. I wasn’t feeling anything and my temperature was normal. After dinner, I poured drinks in the living room bar. To be honest, I had probably three (heavy handed) drinks. I went to bed with a buzz and slept in the next day. I woke up feeling hung over. I took my temperature and it was normal but I felt sluggish. I reported all of my symptoms on the online app and that’s when I realized what I had done. Was I hung over or was I feeling the effects of the second shot? How will I know if I got it? I wondered if it felt like a hangover because that’s what I was feeling.  I was off work that day but I could have gone to work if I had to. My arm was slightly sore but again, not enough to take anything.

The next two months consisted of one visit to the clinic in late October, phone calls from the clinic and weekly check-ins on the app. I continued to wear a mask everywhere I went, continued social distancing, and carrying around hand sanitizer. I often wondered, “what if I got the real thing though?” “Am I avoiding everybody for no reason?” “If I got the real vaccine, how quick does it wear off?”

On December 4th, I received an email from the clinic, they were going to unblind us. Moderna decided that when they were granted FDA approval, they would unblind us. The FDA would make their decision about the Moderna vaccine on December 18th. Pfizer had already received approval on December 11th, so those vaccines were already headed out to hospitals and other healthcare facilities.

I work in a local hospital. Everyone in the hospital got an email about signing up for the vaccine. I thought, “what do I do now? I can get what is definitely the real vaccine right now.” I decided it was best to wait and hear from the clinic.

I got another email from the clinic on December 16th. They promised that I would be unblinded shortly but in the meantime, if I demanded to be unblinded and I had received the vaccine, I would still be in the study. If I demanded to be unblinded and I had not received the vaccine, I would be eliminated from the study. If I didn’t demand to be unblinded and had received the placebo, they would give me the real vaccine (soon) and allow me to stay in the study. Or, (and I’m not kidding) I could choose to stay blinded for the next two years. “Ok, so what do I do? I can get the vaccine through my job; do I just demand to be unblinded?” I chose to wait for them to tell me if I had received it or not. I felt the research was important as far as long-term effects.  My coworkers all rushed to go get their first shot, everyone would ask if I had gotten mine yet, I would just shrug and say I don’t know. I would explain why I didn’t know and they would just shrug back, I think they thought I was crazy.

The clinic called me sometime in late December and I scheduled an appointment to be unblinded on January 7th. This was it. I would find out. I’ll admit, as weird as it sounds, by this time I was kind of indifferent as to whether I had received the real vaccine or not. What difference would it have made? I still wouldn’t have felt comfortable going out as my small circle of two others who hadn’t been vaccinated and I still would’ve had to wear a mask everywhere I went. Not really considering that I may have had that extra layer of protection against this virus, I was indifferent.

On the 7th, I went to the clinic. This was my moment of truth. I was immediately shown into an exam room and I was given a new informed consent agreement that told me what I could expect now that I was being unblinded and I signed it. A nurse came in and asked me a few general health questions, took my temperature and blood pressure and then excused herself out of the room. She came back in with my vaccine card and told me I had received the real vaccine. I had been vaccinated for months. It felt anti-climactic, I’m not sure what I expected but no balloons fell out of the ceiling, there was no parade, it was just a card with dates on it. They took another blood sample from me and I was free to go. My next appointment is in mid-March and I’m guessing it will be basic health questions and another blood draw. This study will continue for about a year and a half after that.

I hope this offers some insight on getting the vaccine. As I mentioned before, many of my coworkers have also received the vaccine. The majority of them have reported feeling nothing from the first shot and being “a little groggy” after the second shot. Please be aware that science is still determining whether this will prevent a person from contracting the virus or just help the body to better fight the virus. I still wear a mask everywhere, I still stay (what I’m guessing is) six feet away from other people. But I have hope, and that’s really what I signed up for.

To learn more about mRNA vaccines visit:

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

Here is a link with all the available places to sign up for a covid-19 vaccine (when available):

https://news.stlpublicradio.org/coronavirus/2021-01-20/heres-where-to-pre-register-for-the-covid-19-vaccine-in-the-st-louis-area