When it came time to evaluate the safety of COVID-19 vaccines, the FDA tapped into Optum Scientific Consulting's 25 year history of conducting drug and vaccine safety. Optum Chief Scientific Officer John Seeger discusses the companies role in evaluating vaccines for kids ages 5 to 11 and the broader impact data has on drug and vaccine safety.
As the FDA went about the critical work of evaluating the safety of COVID-19 vaccines, the agency tapped Optum Scientific Consulting, with a 25-year history of evaluating drugs and vaccines. In this episode, Optum's Chief Scientific Officer John Seeger explains:
Ira Apfel
Hello, and welcome to UnitedHealth Groups the Weekly Dose podcast, where we'll get you up to speed on the latest trends, shaping the future of health care. I'm your host Ira Apfel.
The COVID-19 pandemic is now entering its third year, with seemingly no end in sight. But researchers have learned a lot about the corona virus and its many variants. Perhaps most important, researchers have developed vaccines that help prevent people from contracting the Coronavirus. Ensuring that vaccines are safe to administer is no easy task though. The Food and Drug Administration has worked tirelessly to achieve this goal.
To help the FDA develop safe COVID-19 vaccines. The agency has collaborated with private organizations leveraging their skills and knowledge. In this episode of the Weekly Dose, we'll talk to the leader of one of those organizations helping the FDA develop safe COVID vaccines. Dr. John Seeger is the head of Optum Life Sciences epidemiology team, and he's the person leading outcomes COVID-19 vaccine consultant work with the FDA. A professor at the Harvard Chan School of Public Health, Dr. Seeger is going to explain how Optum scientific consultant team provided critical data and analysis to help the FDA evaluate the risks and benefits of authorizing the Pfizer vaccine for kids ages five to 11, as well as the FDA helping it the set up its vaccine safety monitoring system.
Dr. John Seeger, welcome to the podcast.
John Seeger
Thank you for having me. It's good to be here.
Ira Apfel
So first question, what is the Optum Life Sciences epidemiology team?
John Seeger
So our life sciences epidemiology team is a group of people, epidemiologist, but also analysts and support staff who conduct drug safety and effectiveness as well as vaccine safety and effectiveness studies that are done for regulatory purposes.
Ira Apfel
And broadly speaking, what does the team do? How does it do its testing?
John Seeger
Well, have you ever thought about how the FDA tracks the safety of drugs or vaccines after they've been approved?
Ira Apfel
I have not. But I'm sure napus has become more Top of Mind with the pandemic, so fire away.
John Seeger
Okay, well, you know, the FDA doesn't rely on any single source of information to do this. Instead, what they do is, is they use multiple streams of information that then can integrate into sort of decisions that they have to make about the safety or effectiveness of drugs or vaccines that they've approved. And so we at Optum epidemiology serve as one of the streams of information we use the combination of our expertise and epidemiology. And briefly what that does, what epidemiologists do is it goes beyond what you might see about infectious disease epidemiology. And in the context of the COVID pandemic. We learn a lot about epidemiologist, but that's what just one branch of epidemiology, more broadly speaking, what epidemiology is, it's about drawing causal inferences from observational data. And so we had a Optum use the real world data that we have access to through Optum to draw inferences about safety or effectiveness of drugs or vaccines.
Ira Apfel
So can you give me an example of an inference that you have drawn or your team has drawn, let's say from the data?
John Seeger
Sure. So Optum, epidemiology has been doing this for many years, 25 years, and more. And so we've been involved in many fairly high profile, drug safety questions of the day. So for example, we were involved in in some of the work related to Vioxx, and its association with myocardial infarctions. And so that's one of the inferences that we were able to draw from the data was about, you know, how much does Vioxx increase your risk of myocardial infarction?
Ira Apfel
Got it. So you and your team will be looking for something, some kind of clue or some kind of signal, if you will, and then you'll dive deeper on that and explore and make sure that is not adversely affecting the safety of vaccines or a drug?
John Seeger
Yes, that's right. It's kind of a quantification of this sort of, you know, a purely qualitative assessment of you know, does the drug or vaccines increase the risk of, of this adverse event? So we move it from that purely qualitative statement to Okay, how much so quiet To find, how much does it increase the risk of the adverse effect that you're observing.
Ira Apfel
Got it. So the Optum Life Sciences epidemiologist has been around for 25 years, as you said, Tell me about some of the other projects or successes outside its work with the FDA.
John Seeger
Sure, a lot of the work that we do flies under the radar. Most of our work produces no headlines, it's not even associated with headlines. Often there's a suspicion that a drug or vaccine is associated with some particular adverse event. And we do our due diligence, we conduct a study well designed study with good data source good analysis. And it shows that the drug or vaccine is not associated with the adverse event that had been suspected of and that's the majority of our work finds that and that is a really useful function, because it gives the FDA confidence that you know, that the drug or vaccine can stay on the market, and that it's not causing this this risk that might have been suspected for one reason or another.
Ira Apfel
When is your team typically called in? Or you typically called in when there is some kind of inference or someone suspect something's going wrong? Or are you partnering with the development alongside the development of the vaccine or at the truck?
John Seeger
Yeah, it's I think, mostly the former that is there's a, there's a suspicion that the drug or vaccine is associated with a particular adverse event, and they call us in or usually, the manufacturer contacts us to say, you know, can we do a study to to address that particular question. And those suspicions arise often, you know, through one of sort of three mechanisms, one mechanism is it's something that was observed in a in the randomized trials that the drug or vaccine went through to get on the market. But typically, in those trials, there aren't enough patients that get the drug or the vaccine for that adverse event to become statistically significant. That is it, it could be just a chance finding. And so what we are brought in is, okay, now, once it's on the market is given to lots of people, we'll be able to develop larger numbers, so that we can provide greater precision about, you know, how much does it increase the risk? Or maybe it doesn't increase it at all? And that will address the question. So that's one ways that it's based on these pre marketing studies. A second way is when an adverse event case report occurs through spontaneous reporting, and it may occur, a few cases may occur, there may be enough cases to occur to lead the regulators or the other manufacturers to be suspicious. And then we might be called in to do a study to address that. And then the third is if there's a sort of an extension of the pharmacology of the product, so it's, like, you know, this, this particular drug increases blood pressure or heart rate, then there might be a suspicion that that drug might cause, you know, cardiovascular outcomes that you don't want, like heart attacks. And so then we would be potentially called in to conduct the study and say, Does this drug increase the risk of heart attacks? We know it increases the risk of or blood or increases blood pressure, but does that translate into increased occurrence of heart attacks? And then that's, that's one of the studies that we've actually done.
Ira Apfel
Your team was called in to help the FDA evaluate the risks and benefits of authorizing the Pfizer vaccine for kids, ages five to 11. I'm wondering when did what were you contacted by the FDA, and why did they reach out to your team? And what needs did they have that a private company like Optum epidemiology could help fulfill?
John Seeger
Sure, a lot of it goes back to this what I mentioned the 25 year history of conducting these types of studies. So the FDA was aware of us that is our research team sitting within Optum conducting these drug safety or vaccine safety studies. And so they knew of our capabilities and through the FDA best initiative, they were looking for research groups that set within data sources that could conduct doing help them with their, their evaluations of drugs or vaccines. And, and they reached out to us in in 2020 to become part of Have the best initiative and we work through a process to become a part of it. You know, for the particular question around the, you know, the analysis of myocarditis pericarditis and in kids, that was a specific study that we did within the context of this best initiative. And we what it is, is it was a, you know, at the time we provided this analysis, you know, the vaccine was not approved for use in in kids. So we had no data on, on kids getting the vaccine, but what we did have was data on kids aged five to 11. Before in the time before the vaccines were on the market, so that we could say, Okay, here's the general background occurrence of myocarditis and pericarditis in children of this age. And then the FDA was able to use that information along with information about the effect of the vaccine that they got from the clinical trials to, to conduct a risk benefit analysis that showed you know, the benefits of vaccinating children ages five to 12, or five to 11. Was sort of outweighed the risks that would be associated with vaccinating children in that age range. And the FDA Advisory Committee used that information as a part of their fact basis in making the recommendation to allow vaccination for children's in this age range.
Ira Apfel
How does the partnership specifically for research into the Pfizer vaccine for kids ages five to 11, had that partnership between Optum epidemiology and the FDA work, walk listeners through the kind of steps that the two work organizations, Optum, private company, and FDA, large, regular took to kind of make it all work?
John Seeger
Sure, this FDA best initiative is it has a number of different stakeholders. And you know, certainly the FDA is part of it, but then Optum and then a whole number of other partners as well. And really, what happens is the FDA provides guidance, they say, here's the research questions that we're interested in, and then they then they work on, you know, within this really consortium of that is FDA best to, you know, they have sort of coordinators within that partnership into there's a couple of coordinating sites. And then we are really kind of one of the doer sites, we have the research team and the and the data. And, you know, the coordinating site, sort of helps the FDA convert their question their guidance on what they're interested in, into action. And then they the coordinating sites work with us to, to actually move that action forward to conduct the study within the data sources, and then, you know, use the scientific expertise to help interpret that data and feed it back to FDA in a way that the FDA can act on it.
Ira Apfel
How did your team help with establishing the vaccine safety monitoring program?
John Seeger
Sure, because when we were contacted with FDA in 2020, we this was all new to us. And so what we had to do was set up a, a series of data streams and monitoring programs to accomplish what they were after the parameters of what they were outlining for us. And that's it took a number of months actually, to get that up and running. But now that it is up and running, we every two weeks, we adopt and provide an update of cumulative cumulatively, what have you seen with respect to the adverse events that might happen after the vaccines and incrementally what you know, within the last two weeks, how many new cases were there of each of the different adverse events that we're monitoring? So it's a it's a sequential monitoring program that accumulates the data as well as providing the increments so that there's this ongoing record of the safety of these vaccines that can identify new things as well as becoming more and more precise about all the things that have already been tabulated.
Ira Apfel
I'm curious, what did you and your team learn while working with the FDA?
John Seeger
Yeah, it's it's really been a fascinating combination of sort of the science that really seems to be driving everything. But of course, there's a range of considerations that go beyond just the science and the public health. There's a range of political considerations, as well as, you know, things that you read about in the news about what's a hot topic. But it's no, and these, all of this considerations have, you know, sort of extended the range of what we typically deal with, when, you know, studying safety of a drug that's on the market.
Ira Apfel
I'm curious, based on your experience working with Optum epidemiology, was this the most complex or complicated project you worked on? Yeah,
John Seeger
it is. It is complicated. And when you say new, it's sort of, it's pushing the boundaries of our comfort zone. We're scientists, we work with the science, but this is me sort of helping move us into areas of policy that we haven't typically been involved in. But also, you know, as I described earlier, the complexity of the the best program, the FDA best program is it's, it requires coordination across a whole range of stakeholders and not, you know, our typical situation, we're dealing with a, a single manufacturer, for example of a drug. And, as you say, it's really complicated. A metric for this is that within Optum, epidemiology team, this is actually the largest project that we've ever worked on, we have the largest study team involved in it than we have, historically, over this 25 years.
Ira Apfel
How else are you? Is the FDA but also Optum, Epidemiology, applying what you've learned beyond COVID-19 vaccines for, say, a new drug, a new vaccine or the next pandemic?
John Seeger
Yeah, it's a great question, there's always going to be gaps in our knowledge. And you know, whether it be the clinical trials are, you know, certain size or even drugs that have been on the market for a fair amount of time, there's still gaps in the in the knowledge base, and so new adverse events might come up. And we, we apply our capabilities to, to addressing these gaps. And any of the aim is to fill in the knowledge so that, that patients and physicians can make more informed decisions regarding treatment choice, you know, selecting one drug or another, or whether to select a drug at all for a vaccine at all, in a particular situation. And that's, it's really filling in those gaps in in not just COVID-19 Vaccine Information, but essentially the information on any drug or vaccine on the market.
Ira Apfel
As you said before, this was the largest project that Optum epidemiology has worked on. And at the same time, you literally the whole world is watching, this is getting reported almost in real time. So I imagine for you and your team, it must have been very fraught, but also incredibly rewarding. How did you balance that? How did you deal with the pressures of all that?
John Seeger
Yeah, absolutely. It's, it really has been gratifying to see, you know, this, to be involved in the work and see on the front lines, what's going on with large numbers of patients, you know, taking getting the vaccine, and then what happens to them, and then being able to not just observe it, but able to synthesize it, and in a way that involves, you know, all of our training and expertise as epidemiologists to, to say, well, it looks like this vaccine is not increasing the risk of myocarditis or parotitis, or, you know, any of the other adverse events that we're looking at. And so, yes, it's been really very gratifying. And I think it's it the way the way we handle it is just keep, you know, sort of falling back on our, our process and our training as epidemiologist.
Ira Apfel
I mean, I guess this is really what gets you excited out of bed in the morning. This is what makes you tick projects like this, right?
John Seeger
Absolutely. This is the you know, I like to think of it as the thrill of discovery that, as scientists, that's one of the things that drives us is is the thrill of discovery. And you temper that thrill of discovery with all of your training all of the rigor and expertise that you bring to the table but that at the same time, you, you have sort of a almost childlike wonder at the at being able to see something that nobody else has ever seen before.
Ira Apfel
Dr. John Seeger, thanks so much for being on the podcast today.
John Seeger
All right, thank you for having me.
Ira Apfel
That's it for this episode of UnitedHealth group's Weekly Dose podcast. If you haven't done so already, please subscribe to the weekly dose podcast and Apple podcasts or Spotify. Thanks for listening and have a great rest of your week.