What It Was Like to Participate in a COVID-19 Vaccine Trial

A health care worker at UCI Medical Center displays a vial of the Pfizer-BioNTech COVID-19 vaccine in Orange, Calif., Wednesday, Dec. 16, 2020. (Jenna Schoenefeld/The New York Times)
A health care worker at UCI Medical Center displays a vial of the Pfizer-BioNTech COVID-19 vaccine in Orange, Calif., Wednesday, Dec. 16, 2020. (Jenna Schoenefeld/The New York Times)

This week, as the state grappled with skyrocketing COVID-19 infections, overwhelmed hospitals and increasing deaths, the first parcels containing lifesaving vaccines began to arrive. The vaccine, developed by Pfizer and the German company BioNTech, has been shown to be 95% effective.

Kristen Choi, a researcher, nurse and professor at the University of California, Los Angeles, signed up for a clinical trial of the vaccine after a recruitment advertisement popped up in her Instagram feed in August. She did not know whether she would receive an active vaccine or a placebo.

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She wrote about the experience in JAMA Internal Medicine. The article caused mild alarm in some after she described experiencing adverse side effects that mimicked symptoms of COVID-19. However, far from discouraging people to take the vaccine, Choi said that she wanted to increase awareness about the potential for side effects and why they are actually a sign that things are working.

I asked Choi over email about what it was like to take part in the trial. The following conversation has been edited for length and clarity.

Can you talk a little about how your interest in an ad for the trial turned into full-fledged participation?

I hadn’t considered participating in the COVID-19 vaccine trials personally until fairly late in 2020. I am a health services researcher who primarily studies child mental health services. I was also fairly busy clinically. Then, in August, I got an Instagram ad for the Pfizer-BioNTech phase 3 trial. I clicked on the ad because I wanted to look at their recruitment website from a research methodology perspective. I guess the recruitment strategy worked, because I signed up to participate myself. As I read about the study and considered it for myself for the first time, it seemed very important to me to contribute in this small way to vaccine science.

Were you nervous about potentially receiving the vaccine, called BNT162b2?

No, I really didn’t feel nervous. When I told my family and friends that I was participating in the study, their reaction ranged from concern to saying, “Wow, you are brave!” But I think I felt confident about participating because I know how high the bar is for safe and ethical treatment, autonomy and informed consent for research participants. There is very strict ethical scrutiny and oversight of clinical trials like this one.

I was surprised to learn that you were called for a screening and later that day, injected with your first dose of the drug or placebo. Given the urgent need for a vaccine and the history-setting pace it was developed, were you surprised by the timeline?

Yes, the timeline felt fast to me. I didn’t know if I would get called at all. At the time when I signed up there had already been overwhelming demand to participate in the Pfizer trial. I knew the study slots were close to full.

What was it like for you, a researcher, to take part in a randomized trial?

The feeling of being randomized took me by surprise. I should note that the study staff were absolutely wonderful to me. They answered all my questions and treated me with the utmost kindness, dignity and respect. But even so, randomization was unsettling. Despite knowing full well what I signed up for, it even felt unfair for a moment. As a practicing nurse, I had already had a number of potential coronavirus exposures, though fortunately, I never actually contracted the virus. It would have meant a lot to me to get the active vaccine and I really, really did not want to be in the placebo group.

A month later, you received a second injection but it was a very different experience. You had soreness at the injection site, nausea, chills, dizziness and a fever that spiked to 104.9 degrees the next day. Although you later found out that these side effects are common, do you think it will be a barrier to some people getting the vaccine? And, are the side effects you experienced anything to worry about?

I have received many vaccines in my life and have never had a strong reaction like I did with this injection, if indeed I got the active vaccine. Side effects could be a barrier if people are not prepared for them. It is critical that we as health care providers explain potential side effects patients might experience so that they come back for the second dose and do not worry that the side effects are dangerous. In almost all cases, side effects are transient and minor. My experience of having multiple side effects is very rare.

The side effects you experienced are also similar to the symptoms associated with COVID-19. How can health care providers reassure people about its safety?

First, I would urge all health care workers to get the vaccine if and when it is offered. It can go a long way with patients to say, “I trust this vaccine enough to have gotten it myself.” Second, I would urge health care providers to plan enough time to have a meaningful conversation with patients about their questions and concerns around these vaccines. We must be very clear that it is impossible for mRNA vaccines to cause COVID-19 and that these vaccines do not contain coronavirus. Finally, I think health care providers should be sure to explain why side effects are happening. Vaccines work by activating the body’s immune system, and it is this activation that both teaches the body how to protect itself from the virus and causes side effects like fever, chills, muscle pain, etc. Health care providers should explain that side effects are, in a way, a positive sign that the vaccine is working.

This article originally appeared in The New York Times.

© 2020 The New York Times Company

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