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What It Was Like to Participate in a Covid-19 Vaccine Trial
Friday: We spoke with one Los Angeles nurse about why she volunteered for the Pfizer-BioNTech clinical trial.
- Dec. 18, 2020, 9:02 a.m. ET
Good morning.
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 percent 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.
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, Dr. 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 Dr. 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.
Covid-19 Vaccines ›
Answers to Your Vaccine Questions
With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:
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- If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
- When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
- If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
- Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.
[Track coronavirus cases and hospitalizations across the state.]
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 is part of the California Today newsletter. Sign up to get it delivered to your inbox.)
Here’s what else to know today
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The virus is spreading unabated in California despite strict stay-at-home orders. More than 60,000 new cases and 398 deaths were reported on Wednesday. [The New York Times]
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A judge in San Diego ruled that two strip clubs could remain open, a decision that extends to restaurants and will allow them to reopen to some extent. [The San Diego Union-Tribune]
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Covid-19 rampaged through one family, leading to four hospitalizations and two funerals. None of the family members had the luxury of working from home. [Los Angeles Times]
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Lake Tahoe is cracking down on short-term rentals, but officials can’t stop visitors from coming. [SFGATE]
Read more about California’s latest travel restrictions.
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Valerie Louie rescued thousands of dogs from shelters in the Bay Area over the past two decades. She died of Covid-19 in November after two weeks in an intensive care unit. [The New York Times]
A quick note: A Gmail outage caused a large number of emails to go undelivered, so you may not have received this newsletter over several days this week. We apologize for the inconvenience. You can read any editions that you didn’t get by email online here.
California Today goes live at 6:30 a.m. Pacific time weekdays. Tell us what you want to see: [email protected]. Were you forwarded this email? Sign up for California Today here and read every edition online here.
Jill Cowan grew up in Orange County, graduated from U.C. Berkeley and has reported all over the state, including the Bay Area, Bakersfield and Los Angeles — but she always wants to see more. Follow along here or on Twitter.
California Today is edited by Julie Bloom, who grew up in Los Angeles and graduated from U.C. Berkeley.
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