As vaccine distribution ramps up across the U.S., and globally, skepticism remains. Many cite the speed at which vaccines have rolled out as one of their main concerns. In this episode we explore how we got here, how the biopharmaceutical industry readied for this very moment that allowed them to move at warp speed.
The vice president for science and regulatory advocacy at PhRMA, Jim Mayne, PhD, joins us to explain how the science-based, public-private partnerships aided in the momentum, how the R&D ecosystem has evolved and why he believes the bio-pharmaceutical industry was not caught off guard by the pandemic.
The following is a transcript of his interviews with "Track the Vax" host Serena Marshall:
Serena Marshall: Dr. Mayne, thank you so much for joining us here at Track the Vax.
James Mayne, PhD: It's a pleasure to be here. Thanks for the opportunity to speak with you.
Marshall: So I want to talk and start out with Operation Warp Speed. We've heard so much about how fast that has happened; less than a year from virus identification to research, production. And now distribution. Has it been that fast, when we look at the history of where we've come with vaccines and scientific development?
Mayne: I think it's been tremendously fast and really focused on the urgency of the moment. Operation Warp Speed, most important aspect of that effort is that it brought together the ecosystem. And we always like to think about Pharmaceutical research and development as being an ecosystem.
Vaccine research and development has its own ecosystem within that. And Operation Warp Speed really helped to bring together the ecosystem of researchers, manufacturers, clinical trialists, distribution networks, and so on. That would be necessary to take a new vaccine all the way from the laboratory, to the bedside or from shots on goal to two shots in arms.
Marshall: But that ecosystem hasn't lost any of the rigor that we've seen in past trials.
Mayne: No, people ask the question all the time, "how were we able to go so quickly?" And I think the answer is that: We were able to go so quickly because of big changes on the frontend and on the backend, but the important part in the middle, the important part of getting clinical trials done right, making sure they're large enough, making sure you have enough evidence, making sure you have enough safety data. All of that was done dull-normal.
And then on the backend, being able to say, all of the things that we usually do after we discover if a vaccine works or not, we're going to front load, we're going to front load manufacturing, or we're going to front load all the planning about providing finished goods distribution and managing the special supply chains that might be required.
The compression really happened on the frontend and the backend, but those large clinical trials, that's the way large clinical trials with vaccines are conducted.
Marshall: And I want to get into some of that frontend and backend stuff in just a moment. But first, how has past research led us to this moment? I mean, experimentation goes back millennia. When we look at, just for example, the MRNA technology, that wasn't necessarily a compression on the frontend either though. Was it?
Mayne: No, it wasn't. And it's a great question to ask. I have a favorite quote. I think I have a different favorite quote every week, but this week, my favorite quote is that a global political infrastructure was caught off guard by the pandemic, but the bio-pharmaceutical industry was not.
And I think that's very true. The bio-pharmaceutical industry has been dealing with pandemics, has been responding to viral outbreaks for, literally for decades. We'll don't have to look back too far to remember SARS in 2002, H1N1 in 2009, 2010. And the swine flu, the MERS outbreak, Ebola and each one of those provided a learning opportunity.
In addition to the need to develop treatments and medicines in a short period of time. That created platforms, created experienced scientists, created experienced manufacturing techniques to make us ready for this moment. So way back in January, before we even had the genetic code in hand, I was speaking with the heads of research and development from pharmaceutical companies.
They were all revved up and devoting resources to this. This is something that the industry moved on very quickly and had the experience, the expertise and the capacity to move on very quickly.
Marshall: I want to look back a little bit further in history to the polio vaccine program is among the largest in the nation. I believe, possibly, before what we're now experiencing, perhaps the largest. Many Americans probably don't even remember it, but what have we learned about implementing such a wide scale program over the past half century?
Mayne: I think, what we've learned is that we can actually eradicate disease with an effective vaccine, but it takes partnerships. It takes collaboration and cooperation. And I think what we've learned with this pandemic is: one of the important partnerships that is, has changed. The dynamic has changed, as the partnership between industry government and the public.
When the polio vaccine was coming out there was quite a bit of willingness and interest in taking the vaccine. There were systems created, with schools and with other institutions to distribute the vaccine. We're not seeing that approach now because there's a different level of question and a different level of scrutiny that's being placed on these products.
So I think there's a different energy and a different cultural response this time around that has to be taken into account as part of this distribution plan and as part of the communication and education plan as well.
Marshall: What would you like to see as part of that communication and education plan?
Mayne: Well, a couple of things. I, I particularly liked to see all of our institutional leaders, political leaders, religious leaders, educational leaders, scientists, etc. speaking out and speaking up about the importance of vaccines in general and the value of that. These vaccines bring in particular.
It's not a difficult argument to make that vaccines have been one of the most beneficial innovations to mankind in history. And, I think we need to remind people of all the luxuries that we enjoy, because of the availability of high quality healthcare and vaccines are up near the top of that list.
So understanding the value proposition and the sort of risk-benefit proposition of vaccines is one part of the communication. But I think another very important part of the communication that we need to focus more on is bringing that information into communities that don't necessarily have the same access or the same reliance on traditional communication methods.
And here, I'm talking about some of the underserved communities where health inequity exists and where we've seen the spotlight of COVID shine on some of these health inequities. So being able to provide high quality information at the right time and coming from the right trusted sources into these communities, I think is going to be critically important this time around.
Marshall: Communication's so important. And can this moment be an opportunity for reconciliation for historically underserved and marginalized communities?
Mayne: I think it's part of the process. There's a lot of work to do. It's not going to be fixed overnight or this year or next year, but I do think it's part of the process of, both engaging and involving, these communities in the process of creating new medicines and also, making sure that they derive the full benefit of new medicines.
The problem with health inequity is dramatic in this country. I think there are active solutions being put into place and, and being pursued. But it's not a quick fix. It's going to take time and it's going to take a lot of work and effort.
Marshall: Have there been issues though, in bringing them into the process? In some of those clinical trials, we've heard a lot about the need for more diversity, that those underserved populations, minority populations weren't represented to the same degree that the pandemic has really hit them. So does there need to be a better way to bring them into that process?
Mayne: I will say that there was a tremendous amount of effort and progress made on that front. Particularly for the vaccine programs, I wouldn't call them, full successes because as you say, the representation from communities of color in those programs, while it reached levels as high as 40% in those very large vaccine programs, it still wasn't necessarily across the board representative of the populations most affected by the pandemic.
There's more work to be done. And it is a step in the right direction. I think there has been an effort to improve and increase communications into those communities. And from those communities. It all starts with listening, what do you need to hear? What information is most important and valuable to you?
And then getting those messages out and bringing those messages out from the right messengers. So a lot to do with communication, as you said, but I think good progress has been made. And I think the industry should be rightfully proud of the commitment that they made to having representation in the clinical trials and then their ability to demonstrate that they accomplish that.
Marshall: It's been hard though for the industry to overcome previous conceptions, like the Tuskegee experiment.
Mayne: Absolutely. Absolutely. And a lot of that comes with overcoming industry's posture on that. We need to collectively as an industry acknowledge and accept and describe our responsibility for those types of things happening. Most companies would say individually, 'well, you know, we weren't involved in the Tuskegee experiment; that was a government run experiment,' but I think collectively as an industry and as an ecosystem, going back to that term, I think we do have to be sure to own it, to acknowledge past wrongs and then to say, what is going to change and how it's changing as we go forward.
Marshall: I want to move on to some of the regulations and the questions around regulations. So we've seen Pfizer's FDA recommendation in some ways, set a precedent as getting emergency use authorization. Moderna, it seemed much more streamlined. Do diligence and the ones to come in the future have an ability to move just as quickly, even though there are different type of technology?
What have we learned from this process?
Mayne: I think future programs have the potential to move as quickly. As we get vaccines into the marketplace and out into distribution, it's going to become more difficult to do vaccine clinical trials for COVID, logically. And so those future trials will change in their nature. But, I want to make sure that people also understand that we don't need a vaccine or two vaccines.
We need a whole library of vaccines to manage this disease. So, we're not done yet. There will be more vaccines. They will be different types of vaccines and they will be vaccines that, maybe are easier to transport, maybe are more effective in different, specific types of population.
But we need those to really have the full solution to the pandemic along with of course, effective treatments and therapies.
Marshall: You used the term library of vaccines. That's not something we've seen for many other illnesses, viruses or pandemics.
Mayne: We haven't seen a whole lot of other pandemics like this one either. In many ways, unprecedented.
So, it's a challenge to our healthcare system, and it requires an extraordinary response. Extraordinary times require extraordinary measures. And so, the ability to get not just one or not just two vaccines across the goal line, but multiple vaccines across the goal line has always been the objective of industry to respond to this.
Marshall: I want to explore the cost of clinical trials and the cost of doing these trials for a COVID vaccine. Many of these companies have said they're going to do it at no cost, but these are for-profit companies in the end.
Mayne: They absolutely are. And been, perhaps that's the reason that they were able to mainframe, maintain the infrastructure and the expertise to pull this off in the first place. But, I really applaud the companies that are engaged in this effort, in creating these vaccines, for standing up very early in the process before they even knew if they had effective vaccines and saying, 'look, we're going to make these available. We're going to make them affordable.'
And both of those are important, both affordability and availability. That commitment is, really, a great example of how the industry as a whole is approaching this pandemic. The challenge with the manufacturer of vaccines, is that by pharmaceutical standards, vaccines are a relatively large volume, a low margin type of business.
And it's one reason that there are not a lot of companies that are manufacturing vaccines anymore. If you look across the landscape of industry. So we want to preserve that capability. We want to make sure that we have cutting edge science going towards the development of new vaccines.
And one way to do that is to make sure that the vaccines that are manufactured and brought to the marketplace continue to be affordable. And I think if we look back over history as well, vaccines have a great track record of affordability. That we also recognize that there needs to be a return on investment or a, an incentive for companies to continue to work in that field.
Marshall: Earlier, you mentioned how the big change that allowed us to move so fast was changes to the backend and the frontend. Manufacturing the vaccines in parallel with the research that was being conducted. Now, obviously that's a big cost.
So is that a model though, we can see in the future, even though it works against their, as you said, return on investment, perhaps?
Mayne: In many ways the pharmaceutical industry is a risk-benefit type of industry. And that's how decisions are made on whether drugs or provable, but it's also how decisions are made in terms of which drug programs companies are going to pursue. So when you think about companies making the commitment to a vaccine for a pandemic like this, that's a very singular event.
Fortunately, we don't have to deal with this every year. It's not a regular part of companies' business models. So I would not expect the type of approaches that have been taken in this space to replicate out into chronic disease products or other parts of the ecosystem.
But what I do hope is that we can take learnings from this experience and say, we learned from the vaccine programs, how to do recruiting for large scale clinical trials, way ahead of the start of the trial and even have patients consented and screened before we even started the trial.
And could we do that more routinely? Is that a way to get trials up and running, and reduce the white space between the different stages of drug development? I think that's a very valid question and it's something that maybe we'll see more of as we go forward and not just in vaccine programs.
Marshall: But pharmaceutical companies, the pharmaceutical industry is a trillion dollar industry. There's trillions of dollars in profits, according to a JAMA article that these companies have. Why can't they take this approach for other kinds of illnesses like cancer, for example?
Mayne: There's a lot of money in the pharmaceutical industry, but I always remind people that it it's the profits that you see in the industry are those made by the companies that are successful. There's a long list of companies that have ceased to exist because they didn't have the good fortune of identifying a strong performing or blockbuster product.
And so if you factor in that part of the story, it actually is not an unusually profitable or successful industry. And again, it's all about risk and reward, as is most, most types of companies. I don't think that we would expect, for example, to see in the pharmaceutical industry or in any industry, manufacturers eager to manufacture hundreds of millions of doses of something before they understand whether or not it's effective or safe.
Marshall: But much of the backend research has come from crossover or collaboration with the government. Not... we've definitely seen that happen in the COVID space, but it also happens in a lot of other research and development spaces. So in some ways isn't a lot of this backend research government funded?
Mayne: I think the backend basic research is government funded. So if there is a, a new learning about how the capsule of the coronaviruses is designed to support the presentation of S-proteins to human cells, that type of basic research, more often than not is done either through a research grant, extramural funding as they would call it at NIH, or in one of the institutes of NIH.
But that type of basic research is a long way away from a drug. It's not a piece of information that you can use to treat a patient. So, what the pharmaceutical industry does and does uniquely, I want to emphasize, is take that basic science information and not just basic science information generated in the U.S., but generated anywhere in the world and translate it into real druggable targets and real drug products.
And there isn't any other part of the ecosystem that is built to do those two steps. I think even Dr. Fauci has recently commented that without the pharmaceutical industry, there would be no drug products or very few. And if you, sort of scratch your head and try to count the number of new drugs that have come from say NIH or from private laboratories, it's a very small number.
Marshall: So what can this moment teach us about collaboration between agencies to propel research during an outbreak like we're seeing now?
Mayne: In some ways, the best posture that the public agencies, the government agencies can have, is "what can we do to help?" Maintaining some sort of a central or government infrastructure to try and replicate the response that was mounted by the industry. I don't think is a viable alternative.
It really requires the type of investment and the type of continual management of these capacities and capabilities that really only exists within the pharmaceutical industry. So, the really effective partnerships that we had with NIH and with FDA and with CDC, those partnerships and collaborations were around, "what can we do to help? How can we anticipate the needs of industry? How can we provide really focused and clear guidance on what will be needed and when it will be needed?" So the pathway itself was smoothed.
Marshall: Now speaking of anticipating the needs of industry, many companies and the U.S., local governments have promised Americans widespread distribution. Do you worry about supply chain capabilities and what is considered the largest vaccination program in American history?
Mayne: So yes and no. Yes, I worry about it because as you say, it is a huge scale, it is a challenging distribution. Some of these products have very specific needs in terms of their supply chain conditions and it's being done through a network of public and private partnerships that haven't been long standing necessarily. On the other hand, I'm not worried at all because this is what the industry does. Making, developing, manufacturing and distributing medical products is the bread and butter for these bio-pharmaceutical companies.
And I think as you've seen, they've been able to move literally hundreds of billions of doses, with relative ease, and had prepared well in advance to be able to do so.
Marshall: But we have seen some supply chain issues, for example, Pfizer cutting in half, essentially what they had anticipated producing just this year.
Mayne: Yeah. I'm not in a position to comment on individual company experiences or challenges, but I can say that as an industry, the ability to mount a production campaign and manufacturing campaign that is producing product in the numbers of hundreds of millions, is pretty impressive.
And I'm not sure there's a lot of other industries that could do that in the timeframe that has been done here.
So again, I'm on the side of looking at this and saying it's going amazingly well. Will there be hiccups? Anything that's that size, and anything that has that level of complexity, will have some rough spots, but has it been problematic or has there, is there some risk of failure to deliver? Not that I'm aware of.
Marshall: Now you said earlier that you believe the pharmaceutical companies are better poised than most industries to do that. Why do you believe leave that?
Mayne: Simply because it's what they do every day.
Marshall: To this scale though?
Mayne: In a way, if you think across the portfolio of products that a company like Pfizer or Merck or AstraZeneca produce, they have literally hundreds of products in the marketplace. And so they're moving hundreds of millions of doses on a regular basis across the planet. And it's not a single product, but it's multiple products and it's multiple supply chains. So yeah, they do this. They're familiar with the challenges. They have the business infrastructure and the business partners to pull it off.
Marshall: So what's the future look like? How has this information sharing kind of changed the game?
Mayne: I think information sharing is central to moving fast. There's been tremendous collaboration and data sharing between different companies that are under normal circumstances competitors. But, certainly, under these circumstances have learned how to share information very rapidly.
How are they approaching a given manufacturing challenge? How are they designing their clinical trial? What data are they collecting and how do those data look at an interim portion of the study? That type of information has been shared at high speed, between companies and between companies and public institutes, NIH and, and other researchers, and between all of those and regulators.
And as one of the reasons that the FDA, for example, was able to pick up applications from these companies, once they completed their clinical research and move through those very rapidly, because it wasn't the first time they were seeing the information.
They had been seeing and discussing and interacting with those companies all along the process so that they were able to jump in when it became their turn to carry the ball and also move very rapidly.
Marshall: Will we see these companies that continue to share their data on other illnesses?
Mayne: I think that we will. I actually do. There's been a big realization that there's tremendous value in this. But there has always been a sort of entropy curve or a barrier to data sharing, simply because of interoperability challenges. The ability to, literally the electronic ability to move data from one system to another.
And as those capabilities have improved in recent years. I think it's brought the attention back around to companies acknowledging that we really need to do more of this. And there's entire initiatives and public private partnerships and the like that have been formed to do just that.
Marshall: One of our last questions we always like to ask our guests, have you taken the vaccine and will you?
Mayne: I will take the vaccine as soon as it is available in my demographic. I will roll up my sleeve and, and sit down and receive it with confidence. And with a little bit of pride. I'll share that I'm a proud alumni of Pfizer and I'm really proud of the job that my former colleagues did to bring this product out and I can't wait to take it.
https://www.medpagetoday.com/podcasts/trackthevax/90529
