We were doing our part to help facilitate making the vaccine available to the public.
I was feeling confined and socially distanced due to COVID-19, as many of us are – and anxious for a vaccine so I could get back to a more normal life. I had heard about vaccine trials on the national news, so I did some research on the Internet about them. The closest clinical trials were 70 miles from where I live. My husband encouraged me to get more information, so I called the clinical trial phone number, and they sent us paperwork to complete.
We felt that enrolling in a trial would help facilitate the process of making a vaccine available to the public. We knew participants for clinical trials were needed. I also was hoping to get a vaccine as soon as possible. We began this process in September, when Moderna and Pfizer were in third-phase clinical trials. We were both eligible, and it was determined by the research center in Jacksonville, Florida that we would be in the Pfizer trial, as we were adhering to the Centers for Disease Control and Prevention (CDC) recommendations for social distancing and wearing masks.
We had an initial phone interview and were sent forms via email. We completed a medical history form and current medication list, and signed a consent. We had a phone interview during which I asked several questions, including “what happens if we get placebo?”, “when can we get the actual vaccines?”, “if the Pfizer vaccine is not approved, can we get an approved vaccine when one becomes available?”, and “how long will the trial last?” We were given information about our commitment, which is two years, and were accepted into the Pfizer clinical trial.
In early October, I drove to Jacksonville, where I met with the staff at the clinical research center. I was interviewed by a staff member, had vital signs taken, and received a brief physical by a physician. I signed a lengthy consent form, had a COVID test, and received my first injection in the beginning of October. My husband received his a week later. We were given a kit with a thermometer, a COVID test, instructions for an app to keep a weekly diary, and contact information in case we developed COVID symptoms..
I received the second injection three weeks later, and had at least two subsequent appointments for follow-up physicals, additional COVID tests, labs, and interviews. My husband had similar visits, and one additional visit after he had one possible vague COVID symptom, which he reported. When this happened, he called the research center, and he was instructed to do a COVID test. I was positive he didn’t have COVID, but we followed protocol.
When I received the two injections, I did not have any symptoms, while my husband had dizziness for a few days, which was worse after the second injection. This led me to believe that I likely had received the placebo, and he had received the actual vaccine. This study was blinded, and we were unable to verify this. The staff thought we might be a priority for the vaccine if we received the placebo when I inquired, but we did not have this in writing, as it was not confirmed.
When the vaccine was approved for emergency use and nurses were able to be vaccinated in Georgia, I called the research center to inquire if I received the vaccine or placebo. The vaccine was available where I worked, and I was anxious to have this information. About two weeks later and after several calls, my case was unblinded, I determined I had not received the vaccine, and then I was given an appointment to receive one on Dec. 22. It was a great Christmas present!
My husband’s study was to be blinded until his next appointment, but that later changed. We recently learned that he did get the Pfizer vaccine in October!
Most of our follow-up at this point will be via phone, and we continue to complete our weekly diaries. When we have spoken to friends, some people are interested in our experience and appreciative for our efforts, and others joke about us being guinea pigs. We feel we were only trying to do our part to help facilitate making the vaccine available to the public.
Programming Note: Listen to Carol Lester report this story live today during Talk Ten Tuesdays, 10 a.m. Eastern.
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