I Volunteered for a Covid-19 Vaccine Trial—Here’s What I Learned
A family physician enrolls in a Covid-19 vaccine trial desperate to find a treatment for her patients. Over time, she's realizing there's still a ways to go.
Courtesy Ochsner Health
Tens of thousands of people around the world are receiving experimental Covid-19 vaccines as part of clinical trials. Victoria Smith, MD, a family practice physician at Ochsner Health in Kenner, Louisiana, is one of them. Ochsner Health is one of 120 trial sites worldwide, and they’re enrolling between 250 and 300 participants to test a vaccine called BNT162b2, developed by Pfizer and BioNTech SE. A smaller trial, published August 12 in Nature, found that BNT162b2 was safe and produced antibodies against SARS-CoV-2, the virus that causes Covid-19. Now it’s on to the next step: Finding out if it actually works. “A vaccine is probably the best prevention we will have for Covid-19,” says Julia Garcia-Diaz, MD, principal investigator for the Ochsner segment of the trial and Ochsner’s director of clinical infectious diseases research in New Orleans. “Everything is moving very, very fast.”
Dr. Smith spoke to us just one day before receiving her second injection of either the vaccine or a placebo. Neither she nor any other participants nor the investigators know who received the real thing and who received the placebo.
How do I keep my family and patients safe?
When all this started, there was so much confusion. At Ochsner, we immediately changed many of our visits from being physical visits to virtual visits and we were fortunate to have personal protective equipment. I’m also the mother of two sons. One was in his senior year of college in Miami and he came home because we didn’t know what was going on. Another son was starting college and he came home as well. I was asking myself, “How do I keep myself safe and take care of patients and keep my family safe?” We were social distancing and wearing masks. That was sometimes a challenge with my children because they’re 18 and 22 and they wanted to see their friends. I said, “Okay, you can see your friends but can you wear a mask? Can you maintain social distancing?”
My son got sick
My 18-year-old son contracted Covid-19 about a month ago. He had a very mild case with just a loss of taste and smell. We quarantined him in the house. I did not hug him or kiss him for the 10 days of his quarantine. It was hair raising because somebody was actually positive in my home and before he developed Covid-19 symptoms, I had normal contact with him. I was thinking, “Oh my gosh, do I have it?” At some point, I did develop some fatigue and chills and body aches and I was tested and it turned out to be negative.
Many of my patients are elderly and I have had some patients who have been hospitalized for Covid-19. Unfortunately, I’ve had three patients that I know of who passed from Covid-19 and I have many patients who are African American or Latino who have been disproportionately affected. I had one patient who lost her mother, husband, and brother to Covid-19 and patients who have lost multiple friends.
A vaccine trial opportunity
There had been talk about Ochsner being part of a Pfizer vaccine trial and I happened to be in an elevator with someone who was working on the trial. I said, “I would love to be part of the trial when we start it.” On July 29, I found out that Ochsner had been approved as a trial site for Pfizer. I enrolled in the trial on July 30. My son’s illness with Covid-19 played some role in my decision. A greater motivation was the devastation and suffering caused by Covid that I was seeing as a physician and my knowledge that the only real end to the pandemic would be the development and widespread distribution of a vaccine. I really wanted to be part of the solution to this problem—to be part of that effort. At some point in history, people had to go through clinical trials for the flu vaccine and I said, “Okay I want to be part of history.”
I had to go through a pretty long informed consent process. There was also a thorough review of my medical records. I got my first of two injections about three weeks ago, the same day I signed the informed consent. [The trial involves two vaccine shots given three weeks apart.] The whole process took about three hours. Then, for safety purposes, I was monitored for 30 minutes after receiving the vaccine to make sure I didn’t have an allergic reaction to the vaccine (or to the placebo—I could have got either one).
There’s still a ways to go
I will have six to seven visits over the two years of the study. The one thing that surprised me was learning that the trial would go for 24 to 26 months. That should not have shocked me as a vaccine trial is not only about whether it’s effective, but also how long it’s effective. After my second injection tomorrow, I have to monitor my temperature for any side effects of the vaccine for seven days. At any point during the trial, if I were to develop possible Covid-19 symptoms, I need to let the team know. I have my own Covid-19 swabbing test at home that I would need to do and bring in. I will be asked to complete a Covid-19 illness diary weekly or at any time that I have Covid-19 symptoms.
I still have to take the precautions I normally would: wear a mask, no Covid-19 parties. I’ll also get tested for antibodies. I’m still in the office most days of the week. One patient came in with symptoms she thought were allergies, but I thought she needed a test. I put on my full protective gear and went back in and did a swab and she was positive.
Did I get the real thing?
I don’t know if I got the vaccine or a placebo. But I think I did receive the actual vaccine because I had some soreness that day. I also felt a little flu-y. That made me feel great that maybe I’d gotten some early protection. I’m just glad to be part of the trial and advancing toward a vaccine by the end of the year. There’s still so much to be studied about Covid-19.
—As told to Amanda Gardner
- Victoria Smith, MD, family practice physician, Ochsner Health, Kenner, Louisiana
- Pfizer Inc: "Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program"
- Nature: "Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults"
- Julia Garcia-Diaz, MD, director of clinical infectious diseases research, Ochsner Health, New Orleans