There are three Covid-19 vaccines authorized by the US Food and Drug Administration, and they all required that each vaccine manufacturer conduct clinical trials with tens of thousands of volunteers to ensure that the vaccines are safe and effective.
CNN Medical Analyst Dr. Leana Wen participated in a clinical trial for the Johnson & Johnson vaccine, and she found out earlier this morning that she got the placebo.
"After nearly four months of being in the study, I was really excited to find out the result," said Wen. "As it turns out, I was in the 'control' group and received the placebo. Those of us who got the placebo had the opportunity to receive the vaccine today, which I took. It feels great to finally be vaccinated -- and since this is the one-dose vaccine, I'm glad to be done"
Wen is an emergency physician and visiting professor of health policy and management at the George Washington University Milken Institute School of Public Health. She's also the author of the forthcoming book, "Lifelines: A Doctor's Journey in the Fight for Public Health." Here she shares her experience as a clinical trial volunteer.
CNN: Why did you decide to participate in a clinical trial?
Dr. Leana Wen: It has a lot to do with CNN! I was part of the global town halls that (CNN Anchor) Anderson Cooper and (CNN Chief Medical correspondent) Dr. Sanjay Gupta held on coronavirus throughout last spring and summer. Anderson and Sanjay interviewed several guests who talked about why they were taking part in vaccine clinical trials. They spoke about how, during this pandemic, they wanted to do everything they could to help end it sooner. I was particularly moved by people who were part of minority communities, who wanted to join the trials to help inspire others in their communities to take the vaccines once authorized.
Initially, I wasn't eligible to join the trials, as I'd just had a baby and was nursing, and the trials weren't enrolling pregnant or breastfeeding people at the time. As soon as I stopped breastfeeding, in late fall, I enrolled in a clinical trial.
CNN: Why did you choose the Johnson & Johnson clinical trial? Was it because it's just one dose?
Wen: By the time I was eligible to participate, Pfizer and Moderna had finished their enrollment. There was a center near me that was enrolling for the Johnson & Johnson study, so that's what I went with.
I do like the public health potential of the one-dose Johnson & Johnson vaccine. We say in public health that the easier the logistics, the more likely to be successful. It's easier to be "one and done," in the case of this vaccine. For patients who are really scared of needles, a one-shot vaccine also helps.
I should mention that the Johnson & Johnson trial actually has two parts. The one part of the study that already has results—and is authorized by the FDA—is the one-dose trial. I was actually in the two-dose arm of the trial. The goal of that arm is to see if two doses provide better and longer protection than one-dose. Those results haven't come out yet -- they're expected later this spring.
CNN: What was it like to participate in the trial?
Wen: The first visit was a lengthy appointment about 90 minutes, where I answered questions including my medical history and what kind of activities I normally engage in. I got blood drawn to measures antibodies for prior infection and also had a nasal swab to see if I had coronavirus at that time. And they did a urine test to make sure I wasn't pregnant. Then, I received the first injection. This was a randomized and double-blinded study, which meant that neither I nor the person doing the injection knew what I got.
Twice a week, I filled out -- and still fill out -- a symptom checklist. I also received a thermometer and a pulse oximeter, and I had a telehealth visit a couple of times to document my vital signs. Then, 60 days after the first appointment, I went in for another appointment, when I got another injection. Again, neither I nor the person doing the injection knew what I got. Two weeks after that, I had another appointment where I had my blood drawn to measure antibody response.
CNN: Did you have any reactions to the injections?
Wen: Only a little soreness in my arm that went away within minutes. I made sure to stay at the study center for 30 minutes after the injection each time, since I do have a history of severe allergies to peanuts and penicillin. These are not components of the Covid-19 vaccines, but given my history of allergies, I did take extra care to stay for 30 minutes.
CNN: Some people want to know what happens to trial participants. Do they have to expose themselves to coronavirus or anything like that?
Wen: No, not at all. In fact, we are told to go about our daily activities, but of course to try to stay safe. That means wearing a mask in public places, avoiding risky behaviors like crowded indoor gatherings, and so forth. Remember there are tens of thousands of people in the trial. People are going to have different levels of exposures. The study is double-blinded for this reason, too, so that people don't behave differently once they got a shot. You can imagine someone who thinks they got a vaccine might let down their guard more than if they knew they got a placebo.
CNN: When you got your earlier shots, did you think you got the vaccine or placebo?
Wen: I was actually pretty convinced that I got the vaccine. That's because I had a high-risk exposure, where people around me all tested positive, but I continued to test negative—three times, in fact.
CNN: What happened this morning?
Wen: When I went in for my appointment, I found out got the placebo. Then I received the one-dose Johnson & Johnson vaccine. I am now very glad to be among the Americans who are now fully vaccinated.
Of course, I'll keep masking in public and practicing good public health prevention practices, but it's a big relief to know that I will soon be well-protected and am helping our country move towards a time when we can finally end the pandemic.
CNN: Does that mean you're done with the study?
Wen: No, we participants are in the study for two years. Now, I'm in the arm of the trial that received one vaccine dose, and will be compared with those who received two doses. We are followed to monitor any side effects, infection rates and so forth. I'm very glad to continue to participate in this clinical trial and to contribute to the science that's saving lives and helping the world to emerge from this pandemic.