Why I trust the COVID vaccine [PODCAST]

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“Many friends have asked for my perspective on the COVID vaccine. Answering this requires both an explanation of clinical trials and an understanding of what normally slows down pharmaceutical development.

Importantly, COVID vaccines are required to go through the same process as every other pharmaceutical.

Vaccination is a personal choice, but I 100 percent recommend it. Personally, I can’t wait to get vaccinated and am so grateful to the thousands of heroes who made this possible.”

Alexandra Fairchok is a medical student.

She shares her story and discusses her KevinMD article, “Why can I trust the COVID vaccine?”

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Hosted by Kevin Pho, MD, The Podcast by KevinMD shares the stories of the many who intersect with our health care system but are rarely heard from.

Transcript

Kevin Pho: Hi, and welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. My name is Kevin Pho, founder and editor of KevinMD. Today on the show, we have Alexandra Fairchok. She is a medical student, and she wrote the KevinMD article “Why can I trust the COVID vaccine?” Alexandra, welcome to the show.

Alexandra Fairchok: Hi, thanks for having me. I really appreciate the opportunity to speak to you about all of this.

Kevin Pho: So we’ll get into the article in a little bit, but first off, can you share your story and your journey to where you are today?

Alexandra Fairchok: Yeah. So I guess, where to start? My parents are actually both in the military. They met in Germany, so that’s where I was actually born, and we moved around quite a bit. So I feel like from a young age, I was really exposed to both different cultural perspectives and also kind of health care, because my mom is an infectious specialist.

I mainly grew up in Washington, and then I ended up going to Holy Cross for undergrad, and I majored in international relations and global health development. And then I decided, it was actually in undergrad, I hadn’t taken classes to apply to medical school, and I had done an internship at the Harvard School of Public Health, and I kind of realized that to be able to do what I was super interested in, I really needed an MD. So then I did a postbac at Mount Holyoke, and then I did some research for the Military HIV Research Program for a little while and worked in pain management, and now I’m at Tufts.

Kevin Pho: Wonderful. And how’s your medical education training going during the pandemic?

Alexandra Fairchok: Yeah, it’s good. It definitely was disrupted a little bit. I was supposed to be in my third-year clinical rotations this year, but early on in the pandemic, I became very sick and was hospitalized on a COVID ward. That happened right at my dedicated, so it’s pretty good, because it didn’t interrupt my pre-clinical years, but it certainly interrupted my progression. So I’m excited to get back into clinic soon.

But this year’s also been really nice for me, to be able to kind of have that break, because I picked up old research projects, and so I have some manuscripts coming out. And it’s been nice, too, because I’ve been able to do things like write the article for you, in terms of public education surrounding the pandemic.

Kevin Pho: Excellent. And just, I guess, from a public policy standpoint, I know that’s something that you’re interested in. What are you seeing as some of the challenges regarding the pandemic going forward?

Alexandra Fairchok: I think that, honestly, the biggest problem that we’ve had with the pandemic has been an issue in terms of information transparency, and making it understandable and intelligible to people not within the medical community. That was partially kind of why I had written this article in the first place, because I really noticed a theme during my medical education and just watching other providers talk to people, along with the news.

So I feel like, in general, clinicians tend to be pretty binary, where either they just tell patients, “Oh, just trust me,” and they diminish concerns, or they use such organized language, because, you know, as medical providers, the whole training, you really are learning a separate language, and it’s hard to kind of translate. So I think translational medicine is a huge issue, and we’ve really seen that when it comes to vaccine hesitancy and people being confused about kind of what we know.

And also, the other thing I think has been a big issue is a public understanding of the scientific method, and that we don’t always know something right away. So people will say, “Oh, the science changes.” It’s like, well, it’s not really changing. It’s just that we’re learning more, and so our hypothesis changes.

Kevin Pho: So that’s a good transition into your article, which is titled “Why can I trust the COVID vaccine?” And before we get into the article, I want to give my audience a background. In general, when it comes to vaccine development, can you just briefly outline what the normal process is?

Alexandra Fairchok: Yeah, absolutely. So basically, the big thing you want to think about when you’re having a clinical trial for vaccine production is you have phases one through four. But even before that, you have preclinical trials, which is where you’re really experimenting for safety and efficacy on animal models, because obviously, before we test anything in humans, we want to make sure, basically, that there’s a good chance it might work, based on what we’ve seen in other species, and also that in other species, it’s relatively safe.

So once you’re cleared through the preclinical trials, then there are phases one through four. Phases one through three are really where we’re kind of figuring out, like, does it work and is it safe? And then phase four is actually once it’s hit the market, and we’re able to kind of see on a very broad scale, like, people are able to report any unanticipated adverse events that might occur.

So the mnemonic we usually use is SWIM. So for phase one, S would be, like, safety, and then phase two is “Will it work?” And then from there on, basically, with every phase, you include more and more people to make sure that we’re capturing just how efficacious it is. Phase one is a very, very small number of humans. Phase two would be, we’re trying to use hundreds of volunteers to make sure that it actually prevents the infection. And then phase three, you actually have, like, tens of thousands of people.

So when people are concerned that, “Oh, we skipped the line with the clinical trial,” that’s really not true, because we’ve followed all the different phases, essentially.

Kevin Pho: So talk a little bit more about your article, the phases, and how they specifically relate to the various COVID vaccines that have been approved.

Alexandra Fairchok: With the COVID vaccines, something that’s really important to understand is that both the Pfizer and the Moderna vaccines are mRNA-based vaccines, which a lot of people have concerns about, because they’re worried that, you know, we’ve never used mRNA before, how can we develop it this quickly? But the reality is that we’ve actually been experimenting with mRNA-based vaccines since the 1990s.

So the biggest thing that really slows down clinical trials normally is kind of background information and the bureaucracy of the approval process. So what has happened, really, with the COVID vaccine is we were able to skip, or not skip, but we already had the baseline information for mRNA vaccines, because we’ve been researching them for the past 30 years. So that was able to expedite the first part. So really, it was just about, are we able to formulate our vaccine appropriately to work for this specific virus?

So I guess for people who don’t have such a background in medicine or science, it’s important to understand what mRNA is. Basically, you can think about mRNA as the picture of what our immune cells need to look for. So an analogy I like to use is, there’s a baking show called Nailed It. I don’t know if you’ve seen it. Have you seen Nailed It?

Kevin Pho: I haven’t, no.

Alexandra Fairchok: OK, so basically, it’s very funny. But what it is, you know how normally on cooking shows, it’ll be professional chefs. OK, so picture an average person who has really, like, no baking experience, and then they’re trying to make the cake or whatever, right?

So what an mRNA vaccine does is, you can think of it as being like the picture of the idealized, like, “This is what the cake is supposed to look like,” or in this case, “This is what COVID is supposed to look like.” And then our chefs, or like the immune cells, you know, they’re the ones who are trying to identify that cake, and they know that that is COVID. And so then when something mutates, kind of like when our chefs are really bad at baking, so maybe they don’t decorate it quite right, you still can tell as the judge. You can still tell that that is what that’s supposed to be. And so you still know, like, OK, this is supposed to be, you know, like a smiley-face cake, and this smile doesn’t look quite right, but we still know that that’s, like, COVID.

Kevin Pho: So you talk about the Pfizer and Moderna mRNA vaccines being kind of the first of their kind, but they’ve been in research for, like, 30 years. Why has it taken so long to develop a viable mRNA vaccine?

Alexandra Fairchok: Yeah, I don’t want to speak for that, just because I feel like I’m not a virologist, and I don’t want to kind of speak above my level of training. But I do know that one of the reasons is, so for instance, with the SARS outbreak, they looked at that too. And so I think part of the reason why mRNA vaccines really haven’t gone to market is because traditional vaccines, which would be like live attenuated or killed or whatever, you know, those have worked pretty well. And with the SARS pandemic, we were able to get that under control fairly quickly.

The big concern with COVID is that we have a lot of asymptomatic spread, and so we can’t really just close down borders or limit the spread like we did with, you know, Ebola, for instance. So I think that there’s a lot of pressure to have different types of vaccines come out.

Another thing that’s important to know, too, is that, like any sort of scientific research, it takes a while to be able to get a product to market. And it’s not like Pfizer and Moderna were the only two vaccines that were being tested. I mean, there were hundreds of different vaccines that were being looked at, and they just happened to be the first two that came through. And I don’t believe, so for instance, the Johnson & Johnson vaccine just got approved, and I don’t think that that is an mRNA-based vaccine. So it’s not that we necessarily need to have that formulation.

But what is really good about it is, because mRNA is just a specific code, it’s easily tweaked. So that way, you know, if the virus mutates, like what we’re seeing now in South Africa, we’re able to pretty rapidly produce a different vaccine that should be able to work as well.

Kevin Pho: So you mentioned a couple of challenges in vaccine development being bureaucracy and funding. Can you go and speak in a little more detail about why that is?

Alexandra Fairchok: I think that the biggest thing that people need to understand, and I think folks who have ever been in, like, the military or worked in the government, really, or even a big organization really get this, is that there’s a lot of red tape when it comes to different kinds of processes you might be pursuing.

So when it comes to funding, pharmaceutical companies are only going to develop a product that they know there is a market for. So for instance, if we look at a lot of different diseases, maybe, like, for instance, osteogenesis imperfecta, that’s a very rare disease. There’s not a lot of very good therapies for it, because it takes a lot of money to be able to produce a therapy, and then there’s not going to be very many people who can actually buy it. So there’s not a lot of economic incentive.

In this case, something that’s been really good, I think, about the COVID vaccine is that federal governments have given a lot of money in terms of funding, because it’s a public health issue and it’s a priority. So the funding really was taken out of it in terms of a concern for these pharmaceutical companies, because they knew that if they produced the vaccine and their clinical trials didn’t work, they wouldn’t be on the hook for the bill, essentially.

And then in terms of the bureaucracy, kind of going back to the different phases, you know, phases one through four, between each different phase of the clinical trial, you have to stop, and you have to give your data to the FDA, and they have to review it and approve it to go to the next phase. And it’s not something where the only thing we’re looking at right now is COVID vaccines. We’re also looking at, you know, chemotherapy or a myriad of other pharmaceuticals that are going in the pipeline. And because we were given emergency, you know, this is an emergency, basically, it’s almost like when you’re in Disneyland, you get the FastPass. You don’t have to wait in the whole long line. So the COVID vaccine has definitely benefited from that.

Kevin Pho: So some of the biggest concerns that I see in the exam room are patients concerned about the speed of the process and whether the vaccines are safe. Now, let me just ask you point-blank: Are the vaccines safe, and were any safety corners cut?

Alexandra Fairchok: No, no safety corners were cut. The thing that really, I think, you can point your patients to is, look, if corners were cut, then why would it be that all these pharmaceutical companies have been so transparent with their information, in terms of publishing their protocols online and showing all their data? They wouldn’t do that if corners were cut. Also, it would be a huge liability for the federal government, because what you really need for a country to function is trust within your government institutions. So definitely nothing was cut.

And then in terms of safety, there have been hundreds of thousands of people who have now received their vaccine, and, you know, it’s been shown to be safe. I mean, you’ve had everyone from physicians down to at-risk patients.

And I know another thing that a lot of people have been getting confused and afraid about is the idea of, like, someone gets a COVID vaccine and they die. I’ve seen a lot of clickbait like that. So for instance, I recently saw an article that said, you know, “Surgeon receives COVID vaccine and dies two weeks later,” which, really, I think I would encourage people to actually read the articles, because a lot of times it’s clickbait. So in this case, it wasn’t that he died because of the COVID vaccine. He died because he previously had been infected with COVID, and he had MIS, which is a late-term complication. You know, I mean, I’m sure that the man also drank water, but that didn’t mean that drinking water killed him. You know, unfortunately, people still die of other things regardless of whether or not they receive a vaccine.

Kevin Pho: We’re talking to Alexandra Fairchok. She is a medical student, and she wrote the KevinMD article “Why can I trust the COVID vaccine?” Alexandra, has anything surprised you during the development of these recent COVID vaccines?

Alexandra Fairchok: I think what surprised me has been just how efficacious they actually have been, because, you know, both Pfizer and Moderna are over 95 percent, and the FDA said they would have considered approving anything over 50 percent. So I think it’s really been a modern-day miracle, frankly, how effective they have been. So that’s been the biggest surprise for me, and I think that’s really encouraging in terms of battling the pandemic.

Kevin Pho: And my final question: What’s your take-home message that you want to leave with the KevinMD audience?

Alexandra Fairchok: I would say my take-home message is, even if you feel confident and you feel safe and healthy, and, you know, honestly, a lot of people, if they did get sick with this, they would be fine, I would encourage you to imagine that everyone around you is your grandparent, because certain age groups really aren’t fine. And even though you’re in a grocery store with people you don’t know, there’s someone to someone, you know, like, that’s someone’s grandma or someone’s grandpa or someone’s mom who has, like, a heart condition. And I think that if people really were able to conceptualize the harm and the destruction that has happened because of it, and make it personal, I think we’d all make better choices.

Kevin Pho: Well, thank you so much for sharing your time and insight, and thanks again for being on the show.

Alexandra Fairchok: Thank you.

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