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COVID Vaccines and the Early Approvals: An Interview With Site Expert Maria Chester

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The FDA has already granted several emergency approvals to COVID-19 vaccines, and the UK is just beginning its first round of vaccinations. Is approval of these new vaccines premature? Join Darshan Kulkarni as he talks with guest Maria Chester about how the COVID vaccines may perform as they’re being deployed. Plus, we’ll discuss the importance of durability in vaccines.

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have Maria Chester with us again. Welcome again, Maria, could you reintroduce yourself?

Maria: Thank you. Maria Chester, vice president of operations at GuideStar here. Happy-

Darshan: Go ahead. I'm sorry, please.

Maria: No, happy to be here.

Darshan: Maria, remind everyone, what does GuideStar do?

Maria: We are a third party vendor that assist hospitals and health systems nationwide with clinical trial processing and research consulting.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast with host, Darshan Kulkarni. You can find the show on Twitter @darshantalks. Or the show's website at darshantalks.com.

Darshan: You are the better version of site [inaudible 00:00:48] networks, and that type of product? The updated version that doesn't have many of the old problems, is that fair or is that unfair?

Maria: That's very fair. Basically we are the physician and research staff advocate to get their trials up and running efficiently A, and B, in the best interest of the physicians and patients.

Darshan: Exactly. Now, we had a very brief conversation just before we got onto the recording on COVID. And that, I like to think that it was, shall we say, illuminating? Let's start with the news. The news was that the UK just approved its COVID vaccine. My first question to you, Maria, as someone who is on the ground floor doing research, and I'm not going to say whether or not you're doing the research on COVID. That may or may not be confidential, but doing research, what is your opinion on you UK's approval, the first in the world? What is your take on that?

Maria: It is, and I do think my gut says it's a bit premature. Again, I know that we've been in quarantine for many months, and we've suffered losses of all kinds worldwide. We need to move to a treatment. I've just, from a research background we need to really do due diligence in knowing that the benefit outweighs the risk number one. Number two, with the issue of durability post vaccine, is it really there? When we don't really have any sort of long-term data whatsoever to kind of go from.

Darshan: You used the word, "Durability." Could you explain what you mean by that?

Maria: Meaning that the effect to remain impervious to COVID at least 90 days out from the second vaccine injection.

Darshan: Moderna, I believe Moderna said theirs works for 90 days at least. Is that right?

Maria: Exactly. That was the newest kind of thing in the last few days.

Darshan: My question to you is, is this basically where we're going? Where we start having to pay COVID vaccinations every 90 days or so. Therefore, every quarter we all go in, we get a new vaccine. Or do you think that this is just a temporary glitch? And we'll get back to normal if you will.

Maria: It is. I think the reaction would be, "Well, at least we can vaccinate everyone to have a 90 day durability," but then of course the question is, like other medications, if we continue to dose, do we see increased toxicities with cumulative dosing? And all those other questions that come into it. Cost obviously, is insurance going to pay for all of us worldwide? You can't go get every day, every 90 days the vaccine. It kind of leads to 1,000,001 questions, all of which definitely need to be answered. I just, I hate to kind of jump into this prematurely and then see any sort of long-term toxicity, especially giving the vaccine to healthy patients that wouldn't otherwise have these things.

Darshan: What I think about is, I don't know if you've heard, I'm sure you heard about this already, the CDC came out with initial recommendations on who should get the vaccine.

Maria: Sure.

Darshan: My question is, if you've got these initial recommendations, you're barely going to start scratching the surface in 90 days. To then say, "Now, go back and give the same people the vaccine again because it doesn't work past 90 days." What happens then?

Maria: Yeah. It's a double edged sword, right? Because you want to give it to the elderly, the young. But then those are the people where if there are any toxicities we don't know about yet or what have you, they're really going to have issues. But then again, you don't want to give it to a healthy person either, and really have the risk outweigh the benefits. [inaudible 00:04:54]

Darshan: Let's flip that around. Can you imagine giving this to all your healthcare providers and they're going, "I'm sick now."

Maria: Yes.

Darshan: There's no one left to help-

Maria: To take care. Yeah.

Darshan: Yeah.

Maria: Who's going to be the workforce because as you know, I mean, we already have burnout as an RN-

Darshan: Yeah, precisely.

Maria: So many of my colleagues still at the bedside are just exhausted mentally and physically.

Darshan: Here's my next question. Let's assume that we have a vaccine that is potentially going to work. What is your take on the UK actually saying, "We're a single country, but we know that this is going to work for us." You described it as premature. What made you think, what makes you think of the data itself would be premature? Again, we don't know. We haven't looked at the data, so we're really just going off of what our gut tells us. Let's put that disclaimer out there.

Maria: Exactly. I mean, obviously I'm not to privy to direct knowledge about this. I'm just kind of like you who does a lot of reading and kind of looking into this. I, to my knowledge, the full data analysis has not yet been done for those studies. I think one of them had 14,500 research participants. Kind of what I want to know out of those is when were they first vaccinated? What's the longest followup that we do have? Let's just say that kind of post March when we flew into all of this. If they started in April, it doesn't leave us too much followup data even if they kind of got up and running very quickly.

Darshan: Right.

Maria: Again, it just has a tendency on my part for the safety. And even if it's efficacious for the 90 days.

Darshan: I'm going to pivot a little bit because it raises these questions of obviously there was over the last, well, nine months or so, this giant push to get something out there.

Maria: Yes.

Darshan: Have you seen other protocols where there have been giant pushes in the US? Is there sort of a spill over effect from the research being done on COVID to research being done outside COVID?

Maria: I've not seen in my career where something was this expedited. Obviously, even in some of our really positive oncology studies, and there's kind of, we kind of push through because we see how efficacious it is. It's still obviously always we'll err on the side of caution, and that's kind of where I just want to make sure that that's not being missed in pushing through COVID. But again, I know the other thing is, if we could prevent one person out of the 100,000 dying, then it's kind of worth it. But again, are we causing harm to some others as well? We seem to be pretty good at managing it, fortunately, at least in the US where unfortunately we still have deaths obviously. But I think physicians, in their brilliance and kind of clinical experience, are being better at treating them and kind of getting on [inaudible 00:08:25] I think as patients become more knowledgeable we all have to deal with this and live through it. Maybe they're being treated sooner than initially then. Maybe that's helping with the overall morbidity, et cetera.

Darshan: But I guess I'm referring more to the actual processes. I know that NIH has come out and they've talked about a process where they're expediting the research. There are other organizations, other groups, that are doing the same thing. Do you think there are lessons that are being translated on how to do research faster and potentially cheaper? I don't know if it'd be cheaper or not, but I'd be curious.

Maria: I don't think from a cost perspective that kind of changes doing it in a more accelerated manner, or starting the trial in a more accelerated manner. I think perhaps that piece is slightly improved, but as far as going through the FDA approval process, that's what certainly from my perspective is different. Like I said, even from other positive studies, I think, much more so expedited. Again, I understand the rationale for that. I've just not experienced that before. I guess we'll kind of have to see with the UK kind of moving forward first. Although, we are ensued to kind of start by the end of December, it seems.

Darshan: Are we really? I missed that part. Interesting.

Maria: Yeah. I know a lot of hospitals even locally here in the New Orleans area are kind of anticipating by the end of December having at least doses for healthcare employees.

Darshan: I can just imagine people walking around and healthcare employees being comfortable walking out and everyone else being really jealous. You think that there might be some social follow through because healthcare employees got pushed ahead of the line?

Maria: I don't think so much for healthcare employees, but I do think since we're on a global scale here, I do think that, and I know I already see this kind of on social media. It's like, "Why is UK starting first? Should be the US." I feel like it's going to be like that. "Why is India being dosed?" It's kind of pointing fingers. Everybody wants to be the first.

Darshan: Do they? Until they don't.

Maria: Yeah exactly, until they don't. You have the new shiny toy and I don't.

Darshan: Yeah, until you find out the shiny toy contains arsenic. Well, hopefully that's not the problem here or there's no problem at all. I'm wishing the best of the UK quite honestly. I'm sure you are as well. It's just-

Maria: Absolutely. I hope I'm wrong about kind of not wanting to rush into this so much, and that it's an absolute blockbuster and everyone does exceedingly well-

Darshan: Right.

Maria: And has long-term immunity.

Darshan: Let's sort of take that next step and ask that next question that goes along with it. Did you follow what happened with the Oxford AstraZeneca vaccine?

Maria: No.

Darshan: What was an interesting piece, what happened was that they put out some, so as I'm sure you noticed a few weeks ago, there was lit, I'm making up dates here. But on Monday, Moderna goes, "We have a vaccine that's 90% effective." I think Pfizer came out and said, "We have a vaccine that's 95% effective."

Maria: Correct.

Darshan: On Thursday, AstraZeneca comes on and goes, "We have a vaccine that's 96% effective." We're like, "Okay, this is getting ridiculous." Until someone looked at the data and said, "Are you sure AstraZeneca? Because these numbers don't line up." It turns out that they made some mistakes in their data and in the data collection. They said, "Well, our point still stands, but maybe it wasn't, we may have rushed through the analysis a little bit." The question for you is what is the impact you think on the public, as someone who does clinical research, do you think that these mistakes happen? Or is this everyone was trying to push their numbers, and their values, to the roof and AstraZeneca just caught up in it. Or as someone who works in clinical research, "This is just normal and you know what? We learn and we move on."

Maria: I don't think it's normal. And that's exactly what I'm speaking to where it's kind of the pacemaker [inaudible 00:13:05] wave in trying to push through so much that you're not double and triple checking. Which is so vital obviously in this space. That's exactly what I worry about it. We do usually err on the side of precaution, all of us. The sites double and triple check. Pharma, double and triple check, then the FDA does the same thing. I think there is a little, a very little error margin if you will. Whereas when you're really expediting to this level on this huge scale, obviously, you're just more apt to make an error when everyone's not being able to triple check. And kind of have the time to work through all the data.

Darshan: That raises the other question which is, if you're not double and triple checking, the impact is that you're potentially going to have multiple vaccines on the market. All which are, and again, these are just three companies. I know they're several more working through their own vaccines.

Maria: Sure.

Darshan: The big issue that's also popped up is the idea that these vaccines for the most part need to be refrigerated, and they need to be controlled. The entire distribution process needs to be controlled. From an ethical perspective the impact of this is going to be that several countries literally are going, "We can't have this vaccine because we don't have a cold supply chain. We don't have the ability to transport this vaccine the way it needs to be transported."

Maria: Sure.

Darshan: How do you, you're both a clinician and also a person who works in clinical research, but in both those roles from an ethical perspective, do you think it's dis-concerning? What is your sort of take on that, if you will?

Maria: Oh, it is concerning. I mean, operationalizing everyone getting the one or two doses would be a huge feat globally. But then again, especially with kind of the seeds being planted of this 90 day duration, if we would have to be dosed kind of on a consistent basis, or even an annual basis. Kind of like the flu vaccine is now. How we would all do that globally? I mean, that's a good question. Obviously there will be several countries as a whole that probably have a hard time participating. Even within that, only the privileged who have healthcare can get there. I mean, that brings in the whole ethical thing, but then if you don't vaccinate everyone, are you really helping the whole? It's a conundrum, no doubt. It'll be interesting how we can kind of move through this. Like I said, even if we do find out that there is more durability than we think now, and we do only need that kind of initial dosing.

Darshan: That sort of raises the question of, and I'm going to sort of pivot a little bit. I don't usually get on these topics, so feel free to educate me if you know more about this than I do, but there's a concept out there on social determinants of health. Have you heard about this before?

Maria: No.

Darshan: Okay. The idea is that where you are born and where you grow up has a major impact on how healthy you will be through your life.

Maria: Sure.

Darshan: That if you grow up in a rural poor town, you'll have less access to health that has its own impact on whether you get the appropriate kind of healthcare within you [inaudible 00:16:44]. Usually social determinants of health is usually, as a new concept, that's sort of popping up that people's still trying to understand this properly, but the impact of that is in the US there are large swats of people.

I don't know if you can call people, "Swats," but large groups of people, if you will, who don't have appropriate access, if you will, to healthcare. But what happens when you start talking about this globally, and you're talking entire countries being, having lack of access to healthcare. In those situations do you end up in this scenario where the US is open, the UK is open, Germany's open, but Thailand isn't, Vietnam isn't, and India isn't. Does that create a list of haves and have nots? Therefore increase not only health inequality, but wealth inequality. What is the impact of that as we continue? I'd love to sort of get your perspective.

Maria: I absolutely think that that's a potential. As I was mentioning with whole countries not being able to operationalize something so intense as this. And then within that country, you're exactly right. Do only the elite kind of get it, or the educated ones who have established healthcare in general? What about your rural farmers in Thailand, and Southern India and those kinds of places, what happens?

It'll be interesting to see even restrictions as we kind of hopefully increase movement and travel and those things. If those kinds of countries we still have to maintain. If you visit there, you still have to quarantine there, and when you return, and all those other pieces. But minority based healthcare and the have nots as you mentioned, it's always a challenge. Even in our regular indications that, trying to diagnose hypertension and diabetes kind of early on. When you don't have the access to healthcare, you also don't have that kind of rapport and trust factor. That's the other piece that I worry about kind of moving too quickly is you want to make sure that no one kind of loses that fundamental faith of, "You are doing the double and triple checking, so when I'm sending my daughter to be vaccinated, I can feel confident that it's going to do more benefit than harm." That's the other piece to that is.

Darshan: Have you ever watched this movie, I think it was Elysium from Matt Damon. Did you ever watch that?

Maria: No.

Darshan: Okay. It was this movie with this basis that there's a floating satellite in the sky, and everyone who lives in the satellite is super rich, super powerful, has loads of money. Then there's Earth, and Earth is just a, excuse my language, but they're the **** show. The idea's that they have no access to health or anything like that. Every so often people from Elysium would come down and they would sort of walk around the Earth at that point. The idea would be that people would kind of not like them because of the fact that they had more access, more stuff, than they did.

Maria: Sure.

Darshan: My question is, does this, as we continue into a COVID world with countries not getting access, can you imagine the wealthy tourists going, "You know what? I want to go to Bali right now." I can. What is the implication of that? As we continue where these wealthy tourists are able to travel to Bali, and the people in Bali are serving them, but they can't leave their own houses. I find that to be fascinating as we continue.

Maria: It is fascinating. It's kind of heartbreaking to think about, but God, I wish I had the answer.

Darshan: Maria, this was really good. Thank you for coming on. I'd love to do more with you, but I know you have a little bit of a time restriction, but any closing thoughts?

Maria: Not really. I will be looking at the data. I would love to come back and discuss this further as we kind of see things at least regarding COVID. But certainly any clinical research topic, pick my brain anytime. Thank you so much again for having me.

Darshan: Thank you again.

Maria: All right. Take care.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks. Or the show's website at darshantalks.com.

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