AACN Past President Discusses Participation in COVID-19 Vaccine Trial

Dec 22, 2020

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As the COVID-19 pandemic surges across the nation, front-line healthcare workers are among the first to receive a COVID-19 vaccine. Some nurses, however, have questions about the safety and efficacy of the vaccine.

Dr. Marianne Chulay, a leading nurse researcher and past president of AACN, offers a unique perspective on the conversation, because she participated in the clinical trials for Pfizer’s vaccine. AACN Chief Clinical Officer Connie Barden spoke with Dr. Chulay about her experience. In this video, Dr. Chulay describes the side effects she experienced and explains how rapid development was achieved while still ensuring adequate testing of the vaccine.

Connie Barden: I'm Connie Barden, chief clinical officer at the American Association of Critical-Care Nurses. I'm thrilled today to get to have a conversation with Dr. Marianne Chulay on the very timely topic of vaccines and nurses and clinical trials. Many of you know Marianne as a past president of AACN several years back, or if you're ever at the NIH, you might have known her as a clinical nurse specialist in critical care for many years, or certainly you know her legacy there. And more recently, I think we all know her as a preeminent leader in nursing research and mentor for literally thousands of nurses and their units and their hospitals bringing the understanding of nursing research and doing it and getting it right to the bedside where it makes the most difference. So who better should we talk to about nurses and clinical trials then Dr. Chulay.

Marianne, thank you for joining us. You told me not long ago that this summer you participated in one of the clinical trials. There are things about, "Oh, we're going first." I've heard a lot of people using the term guinea pig lately, and all of that. Did any of that go through your mind? What was your thinking?

Marianne Chulay: Well, I can't say that it did. I mean, I can imagine that it would for a lot of people. My husband and I both have very strong science backgrounds, and we've been following the literature on at least the Pfizer, Moderna vaccines, this new messenger RNA vaccine, so we were intellectually understanding the science behind the technology.

I'm sure for anyone else, it would be an incredibly big conversation item, but for us, it had already occurred over probably two months. So it felt right when we were given the opportunity.

At the time we knew about some of the phase-two results from the Pfizer and the Moderna vaccine, so there were no real stumbling blocks or roadblocks in terms of side effects. They were very typical side effects that you'd expect with any vaccine, so we felt comfortable. But again, I can certainly understand why some people might have concerns. I recommend you've got to understand the science of whatever the vaccine is you're being offered, because that'll help you realize what the risks and the benefits might be to you.

Connie Barden: One of the specific concerns that I hear a lot of people talk about is the speed at which these vaccines are being brought to market. Why do you think the manufacturers have been able to do this when normally lead in time for vaccine is years, multiple years, and this has been under a year? What do you know about that?

Marianne Chulay: I think one of the sad things about the description of this “Operation Warp Speed” is that it's given people the idea that the science, the conducting of the trials has been speeded up, and that's not exactly what speeds it up. What's really been speeded up is the processing or the manufacturer of the vaccine, the behind the scenes stuff. But the actual clinical trials themselves have not been rushed through. They're going through the same time-span that would normally happen with any vaccine or drug therapeutic.

What's different is, in a normal process you would test the vaccine at phase one, you would pause, you would do all sorts of manufacturing changes and scale up for the next. There would be these interims in between phase one, two and three, where there'd be big lag times while the company took the next step in terms of development of the product. There are six vaccines that are in the process of being developed. The government provided money to the company in the early days to give them enough money to do all of the production of the vaccine assuming it would be good and not knowing. They were still in phase one trials at the time the money was allocated to those groups. So what's got speeded up is companies didn't have to stop after phase one and, if you will, produce enough vaccine for the next step of the trial.

Connie Barden: I think nurses really want to know how to make good decisions and they would be interested. Did you have some side effects from either injection one or injection two? What was that like?

Marianne Chulay: We anticipated that if we got the vaccine with the first injection, we should have some local inflammation. That would be a pretty typical response to the vaccine. Within an hour after getting the vaccine, my husband says, "Oh, my arm hurts." I'm like, "Mine doesn't hurt." So I'm like thinking, "Oh man, I got the placebo. Darn.” In the evening I developed it and I'm like, "Oh guess what? I got pain in my arm."

It was very minor pain with the first injection. Probably similar to what you get with a flu shot, where you get a little heat, a little bit of pain. After the second injection, a very similar scenario, I had a little bit of discomfort at the injection site, so did my husband. Then about 12 hours after receiving the vaccine, I developed a little bit of a low grade fever. I was kind of achy all over, sort of like you feel with the flu. I had what I call a generalized malaise. I didn't want to do anything. I mean, I didn't have any energy, but I wasn't really sick, sick, sick, but I just felt punky. And then it was as though somebody flipped a switch 12 hours later. I went from that to feeling perfectly fine. So for me, there was a little bit of what they call mild post-vaccine symptoms.

Connie Barden: That's very helpful. As we wrap up I heard as recently as this morning about a survey that showed that about a third of nurses are saying, "Yep, can't wait. Going to get that vaccine." About a third are on the fence, not sure. And about a third are saying, "Heck no, I'm not interested." Given your experience as a nurse scientist, what advice do you have for nurses as they consider the decision around the vaccine?

Marianne Chulay: Well I think that no matter whether they think they've already made up their mind or not, I think as they're presented with the opportunity to take the vaccine, I think everybody needs to step back and reassess.

The first step for anyone is to really understand the science and the evidence that we have with the vaccine. In order to do that, I think it's really important right now to go to trusted sources for information about the vaccine and what we know about it in terms of side effects and efficacy. There are a lot of myths or disinformation going around, particularly in social media, that are incredibly wrong based on the science and the evidence we have. So I think as people make their decision, they need to be very cautious about getting proper information through places like the FDA and the CDC, AACN, you've got links to all sorts of things. These trusted sources for information are not serving the wrong agenda. That's number one is to really know what the science, what the evidence shows us about the vaccines.

I think the other thing you've got to do is weigh the risks and the benefit for you personally. All of us are different. All of us have different family situations. We all have different health situations. I think you'd have to look at it from a very personal standpoint and say, "If I get this vaccine, what might be the risk? If I don't get the vaccine, what might be the risk?"

Because if less than 70% of us get the vaccine, we're going to be very unlikely to push down this virus and get control of it. People talk about it as herd immunity, but with 70% of the people having either been infected before with the virus or having had a vaccine, there's a really good chance we can push this thing down and really kind of squelch it. But without that, we're going to be living with this for a long time. That's kind of the way I would encourage people to think.

Connie Barden: That's very helpful and very much a scientific and a human approach, so thank you for that. Those are my questions. Are there any other comments or questions that you have to wrap up today?

Marianne Chulay: Well let me turn the tables on you, Connie. What about you? What have you been thinking about whether or not you're going to get vaccinated and if not, what are your concerns or issues?

Connie Barden: Oh, I'm in. I want to know how I can get one tomorrow, if I can get my hands on it. I just kind of have been that way. I am one of those people that comes from absolutely understanding the data. I know FDA is not done with their analysis. Of course, I'll wait on that. I trust that completely. I've already done the other part; my risk and benefits personally. I am one of those that does feel like I have a part to play in the profession and in society. It's bolstered by talking to people who I respect like you and your husband and knowing that folks like you have stepped up, and I'm right behind you. As soon as I can get my arm near a vaccine center, I'll be there as well just like you.

Marianne Chulay: Good.

Connie Barden: Yeah. Marianne, I can't thank you enough. It's an honor always to have you come and talk to us and share your knowledge and wisdom. I know you had to carve it out of a busy schedule, so thank you again for sharing your time and expertise with us.

Marianne Chulay: You're welcome, and I was glad to do it.