AJMC®: Hello, I’m Matthew Gavidia. Today on MJH Life Sciences’ Medical World News, The American Journal of Managed Care® is pleased to welcome Dr Victoria Smith, a board-certified family physician and member of the Ochsner Health Board of Directors. Can you just introduce yourself and tell us a little bit about your work?
Dr Smith: Well, my name is Victoria Smith. As you mentioned, I’m a family physician at Ochsner Health in the New Orleans area, and I’m very happy to be able to talk to you today.
AJMC®: Can you give a brief overview of the phase 2/3 clinical trial by Pfizer assessing their investigational vaccine against COVID-19?
Dr Smith: So, it is going to be a study over, or my participation will be over, the next 24 to 26 months. It started with my first initial visit. First of all, I was screened for being in good health to be able to be part of the trial. There was a review of my health conditions, any medications that I was taking. Then it is a randomized, double-blind, controlled trial, so I was then put in either the placebo or the vaccine arm.
So, the first visit, I received an injection. Then 3 weeks later, I went back to receive another injection, and then I’ll be followed 1 month after the injection, 6 months, 12 months, and then 24 months. After each injection, that evening for 7 days, I was asked to monitor any symptoms that I might have using an app, which was pretty easy. I got a nice thermometer, as well. Then every week, over the next 2 years, I’m just asked to report on any symptoms of COVID-19 that I might have.
AJMC®: Why did you decide to participate in the trial, and what was the vaccine candidate’s administration?
Dr Smith: The injection, I didn’t know what I was being injected with, whether it was the placebo or actually the investigational vaccine, but it was the same process as receiving any other vaccine–receiving a flu vaccine or tetanus. So, nothing scary or really out of the ordinary.
I wanted to participate in the trial for a lot of reasons. One, as a family physician I’ve definitely treated patients who thought they had COVID-19, had COVID-19. I did have at least 3 of my patients who did succumb to this illness and died of COVID-19 in the hospital.
So, in studying more, learning more, I recognized that because this was a novel virus, there was not going to be any treatment soon, and so the real answer was going to be a vaccine in terms of preventing and protecting people against developing the illness. So, as a physician, I very much wanted to be a part of history and of trying to improve the situation for myself, my patients, and society.
Also, as an African American female, I was very aware that this had a disproportionate impact on black and brown peoples. So, I wanted to be part of anything that could help to decrease this burden. I also know that for many African Americans, Latinos, we’ve had a sordid history when it comes to medical research, and many times research has been done upon black and brown bodies and not together with.
So, I really wanted to be part of a trial that I thought would do this safely, ethically, and in a way that I could have an impact on creating a solution as opposed to just worrying. As I think for everybody, it’s still kind of nerve-wracking, and so I wanted to be part of a solution.
AJMC®: As you just alluded to, an issue that has been spotlighted amid the pandemic is the disproportionate effect of COVID-19 on minority communities, particularly Black Americans. Can you speak about how the current trial will account for different racial and socioeconomic backgrounds in their findings?
Dr Smith: Well, I think that one of the goals of the trial is to enroll as many African Americans, Latinos in the trial as possible to be able to assess, are there any differences in vaccine efficacy or safety that might be due to racial or ethnic differences. Hopefully there are not, but you don’t really know until you actually study that.
So, that was also, once again, knowing the kind of mistrust many times African American communities and people can have. I also wanted to be a role model of participation in this trial. Many of the patients that I care for are African American and Latino, and they have been, I think, impressed to see that I’ve been part of it. And I’ve been able to encourage patients to think about them or their family members taking part in this trial.
AJMC®: Why did Ochsner decide to participate in the trial, and how many health care workers besides yourself are participating?
Dr Smith: Well, I think Ochsner has a long history of being involved in research and innovation. We took care of a lot of patients with COVID-19. So, I think that Ochsner’s participation in this trial and clinical research, in general, just really falls in line with our mission to heal, serve, educate, and innovate. So, it totally follows along with what we do.
I can’t speak to the exact number of other health care providers who are enrolled in the study, but I can say I’ve had colleagues reach out to me as a result of seeing that I was participating and also patients who found out that I was participating–asking me more about participating themselves.
AJMC®: Going back to a topic we kind of alluded to before, after being administered either the vaccine candidate or placebo, how did you feel?
Dr Smith: I felt okay. I mean, the evening after both injections, I did have a little soreness in my arm. The next day after both injections, I felt a little flu-y, nothing major. I really hope that I did actually get the vaccine candidate, but I don’t know.
AJMC®: What should the general public understand about the COVID-19 vaccine trials?
Dr Smith: Well, I think that they should understand that there are many vaccine trials going on, because COVID-19 is affecting the world in a way that I think a virus has not affected the world since 1918, the flu pandemic, at that point.
There are lots of companies that are working to develop a safe and effective vaccine. I would also want the general public to know that the processes to protect participants are very strenuous and stringent. So, there’s constant monitoring, first of all, from the beginning to make sure that this is going to be a safe trial for patients. There’s an extremely long informed consent process that is 19 pages, which is great.
So, no one’s being enrolled in this without really understanding the pros and cons of their participation, being able to drop out of the trial at any point. I think it’s one of the things I would just really encourage and hope that many people in the general public would consider being part of a COVID-19 vaccine trial, and especially people of color.
AJMC®: Lastly, do you have any other concluding thoughts?
Dr Smith: I think that this is really historic, important research. I really hope that all of your listeners will consider being part of part of these trials. When I reflect on the fact that I get a flu vaccine every year, I know that there were people who, at some point in history, were part of trials to test to make sure that flu vaccine was safe and effective.
Now, every year, we all take a flu vaccine without thinking about it. So, I would just really encourage people to think about being part of making history and protecting not only people now, but into the future.
AJMC®: To learn more, visit our website at ajmc.com. I’m Matthew Gavidia. Thanks for joining us!