Moderna Co-Founder: “Supplies Are Ready To Go Out the Door”

CHRISTIANE AMANPOUR: Next, we turn to the high-speed race for a coronavirus vaccine. Pfizer and BioNTech today are asking the FDA for emergency use authorization with Moderna soon to follow. This will week Moderna had announced preliminary results that showed their vaccine to be nearly 95 percent effective at preventing COVID-19. And our next guest is the co-founder and chairman of Moderna, Noubar Afeyan, and here he is talking to our Walter Isaacson about the herculean task of producing and distributing the vaccine, and why he believes immigration equals innovation.

WALTER ISAACSON: Thank you, Christiane. And Dr. Afeyan, welcome to the show.

NOUBAR AFEYAN, CO-FOUNDER AND CHAIRMAN, MODERNA: I’m glad to be here, Walter.

ISAACSON: Congratulations on this new vaccine. It’s really exciting. Tell me how it works.

AFEYAN: Well, the vaccine is based on a brand-new technology called messenger RNA, and I said brand new and that obviously the molecule has been around since life has been around, but the use of it as a drug or a vaccine is actually unprecedented. Some 10 years ago the company Moderna that I co-founded and I now chair took on the challenge of taking early academic work and seeing if you could actually create a molecule, a new class of medicine based on messenger RNA that would allow the person who receives it to use their own body, their own cells to manufacture a protein of interest. That protein could be a drug, or that protein, in this case, could be a vaccine that will train the immune system. So, essentially, the way it works is that, in this case, the vaccine is a molecule that codes for the spike protein, that very kind a of decorative picture that people show about this coronavirus. The thing that enables it to get into human cells is what’s called a spike protein, and that spike protein, we’ve taken the sequence, the DNA sequence of, made the messenger RNA and then encapsulate it had into a particle such that when we administered it to a subject that gets into cells. They read the mRNA naturally and they make the spike protein. Now, of course, there’s no virus in that person but the spike protein informs the immune system that there’s something foreign. The immune system gets trained and then stands on guard for when the virus does show up. And now, the immune system is ready to attack virus, like the other vaccines, and prevent it from being able to infect or certainly infect in a serious way that person. That’s how the technology works this. This would be the first time that a messenger RNA vaccine is not only tested but at large scale and then approved by regulatory authorities when it happens.

ISAACSON: Yours does not quite need the same deep temperature refrigeration that the Pfizer vaccine needs. Why is that?

AFEYAN: Well, because we have been trying to develop this as a platform technology, so not just for one vaccine but for many, many different ones, we foresaw that if this could work it wouldn’t just work in one case. We’ve spent quite a few years and made significant investments actually developing the packaging technology, the particles and our processes such that we could make a product that’s stable for a long, long period of time at only minus 20 degrees Fahrenheit. It is those advancements that have given Moderna the ability to have a vaccine that can be stored at minus 20. Furthermore, we’ve continued to improve and test this product such that just this week we announced results that we now can certify, attest to the fact that our vaccines can be kept in refrigerated conditions, 38 degrees for a month, and moreover on a benchtop, on a table at room temperature for 12 hours. And what that means is that we can ship this vaccine to central storage repositories for very long-term storage. But then from there to a point of administration, for a month, it could be kept in our refrigerator and then, again — so this is ease of use, and it doesn’t require any different supply chain than what is available only in the U.S. but throughout the world.

ISAACSON: When do you hope to get FDA approval?

AFEYAN: Of course, that is a question that depends a lot on the comfort of the FDA with the data that we submit. So, we have said we’re going to submit data very shortly. They in turn will review the data. There’s a process, there’s an advisory group called VRPAC that will meet and give FDA advice. But we hope and expect that all of that can be done say by the middle of December perhaps such that we can get the first wave of vaccine, if emergency use authorization is granted already in December.

ISAACSON: What are you going to submit to the FDA?

AFEYAN: Our expectation is that we will submit to the FDA essentially the complete trial, that is exceeding 150, 160 cases that would be defined the full trial. What we announced earlier this week was a first interim look at the trial which ended up being 95 cases. As you know, Walter, the way a vaccine trial runs there’s a certain threshold of cases needed to be able to adjudicate whether the vaccine is working effectively and how effectively. In our case, that number was slated to be 53. But by the time we were able to get the data gathered, there was such a rise in cases as we’re experiencing, unfortunately, throughout the U.S., that we already had 95 cases. So, against the 95 cases, we reported that 90 in our experience were from the placebo group. They did not receive the vaccine and only five were from the vaccine group, and that creates a 94.5 percent effectiveness. Furthermore, all of the 95 cases, 11 were severe COVID cases, and all of those were in the placebo group, there wasn’t a single severe case yet in the vaccine group. We also looked at age groups over 65, which is a particularly vulnerable age groups, and, in fact what, we see there is highly consistent across all age groups so that we feel we have already preliminary evidence in the phase three that we should be effective at protecting folks at those age ranges.

ISAACSON: President Trump and some of his supporters have seemed to charge that both you and Pfizer and maybe in conspiracy with the FDA held off reporting all of this until right after the election. Any truth to that?

AFEYAN: No. In our case, if you follow the set of disclosures we made, we were the first to enter the clinic, I would say, and give a lot of credit to our colleagues at NIAID and NIH for being poised to help us through the partnership we had already for several years to very rapidly identify the sequence, make the mRNA and get it into humans. This was already done a few weeks after starting in March. Since that time, we’ve been quite transparent about what our plans are. And among them, this summer, was a decision we made to actually increase the diversity in our trial from the initial numbers we were getting to ensure adequate representation of people of color, in different segments, age segments we wanted to cover. To do that, back in July already, we indicated that we would, if needed, even slow down the trial in order to achieve that objective. I’m pleased to say that 37 percent of our trial participants were in fact people of color, and that was a design goal in terms of ensuring that. Other than that, which was disclosed quite a long time ago and in fact chosen in concert with NIH and all of our collaborators, I can tell you that the timing was such that we were not going to get data before November in any event. I can’t speak to our colleagues in Pfizer, but I find it hard to believe that they would engage in that either because, look, the end of the day, this activity has a lot of downside, less upside for the companies engaged in it, and the notion that we would expose further downside to any slowing down when people’s lives are at stake, I don’t see that happening.

ISAACSON: Have you talked to the Trump administration about the plans there might be for a rollout?

AFEYAN: Of course. All of this work is being done in very close coordination by — with Operation Warp Speed, which is part of HHS, in turn part of the current administration’s overall group dealing with this. And indeed, there’s been an incredibly close collaboration such that the rollout plans are in place. Supplies are ready to go out the door. We have already manufactured quite a bit of the vaccine, and it’s now down to day- to-day planning pending the FDA’s green light to make sure that we don’t waste hours, forget about days, in getting the vaccine out because, again, it’s going to be a long slog to get as many people vaccinated as we can, but we cannot delay it any more than that’s needed to ensure proper review, safety, efficacy. That has to be looked at by the FDA. But, yes, there’s been a very good coordination with Operation Warp Speed, and my hat’s off to them and the work they have done, not just for Moderna but with multiple folks, fair, transparent and very much putting the goal in mind of getting the vaccines out as soon as possible.

ISAACSON: Are you concerned that if there’s no cooperation between the outgoing Trump administration and the incoming Biden administration that could lead to some delays, might even cost some lives?

AFEYAN: Look, I would hope that that possibility has already been largely preempted by the establishment of the processes and the entities that will conduct this, and I really would not like to see anything get in the way of that. But I have confidence that in the end, especially with this effective a vaccine or a couple of this effectiveness of these vaccines, that we are not going to be subjected to that. Look, there was a possibility that these vaccines were only 50 percent effective, 60 percent effective, that the experts who had already been weighing in for months saying, don’t you dare approve a vaccine that’s barely effective and how do you know whether we can believe, all that have should be, over time, counteracted by facts and by reasoning. And so, I think under these circumstances we have a solution. Look, I consider this, Walter, a form of — you know how people have been saying that a mask may be the best vaccine. I think a vaccine is the best molecular mask. So, messing with getting this right has downstream consequences that I really expect and hope will not be caught up in politics.

ISAACSON: You’ve said that you hoped to get authorization sometime in December, that the rollout plan seems to be ready. What will an average person be able to walk somewhere and get a vaccine?

AFEYAN: Hopefully, by the second part of the second quarter, by kind of spring, late spring, we’ll begin to see a broader coverage. And then, hopefully, people will make themselves kind of available to receive the vaccine so that we get the maximum protection we can.

ISAACSON: How much will the government involvement in Warp Speed and funding this and pre-buying certain doses, how will that affect the cost?

AFEYAN: First, let me say that the very first investments that were made in this regard were made by BARDA and by our own shareholders. In our case, we reached out to the public markets and secured initially half a billion and then $1 billion to deploy towards this task. As the year has passed, 2020, there’s been larger financial commitments made by Operation Warp Speed, the U.S. government, such that we have said publicly that we have received some — $1 billion funding to support the clinical and pre- clinical development of our vaccine. And then in addition to that, we have received $100 million dose ordered from the U.S. government. That’s all public information. So, in aggregate, that’s about $2.5 million that will go into supporting the development of, manufacture of and the supply of 100 million doses with the ability to upscale the 100 million if the demand by the government is there. And, of course, that’s been a significant contribution because it’s allowed us to move at risk in parallel with the development, something that we would not under normal economic circumstances do because it would be difficult to justify to our shareholders that we assume the entire risk and that at the end, we would find out that the vaccine doesn’t work and we have nothing to show for it.

ISAACSON: How much is it going to cost me?

AFEYAN: I believe the U.S. government has said that it will be free to the individuals receiving it and that’s something that I would expect to be the case in most if not all countries.

ISAACSON: How — you’ve never produced 100 million doses. Are you worried about the supply chain? Are you worried about the ability to produce that many?

AFEYAN: Of course. Of course I’m worried in the sense that, you know, we – – given that this is at heart a startup, a 10-year-old startup, a (INAUDIBLE) startup, you know, we are in the business of foreseeing threats and difficulties in trying to get over them and prepared for alternatives if they, in fact, affect us, and this is no different. So, I could say that we have an excellent team in place with extremely competent leadership coming out of very experiences pharma companies that have joined Moderna already a couple of years ago, and we’ve put in place a manufacturing process that I believe is the most advanced in this field because this is a new technology. So, all the existing plans in the world, all the existing know-how isn’t going to help you make mRNA. mRNA is a completely new molecule. So, that, I think we are probably in a leadership positioning. But then, getting hundreds of millions of vials, getting it filled into the mouth (ph), this we are doing through a network of partnerships that we’ve announced. There’s several folks in particular. We have a manufacturing relationship with Lonza, which is, I believe, the largest independent contract manufacturing company of its sort in the world, and they — we were very, very pleased they partnered with us early on to help support our manufacturing scale-up, and they themselves have dedicated their own facilities to learn how our process works and make hundreds of millions of additional doses. So, Moderna and its all facilities that have been wrapped will make hundreds of millions, they, Lonza, will make hundreds of millions. And together, we have said publicly, we expect to have (INAUDIBLE) doses. And yes, there’s always risk along the way, but we’re doing everything we can through experts, investments and support from the OWS logistics folks, by the way, who have helped us a lot to ensure that we can come through.

ISAACSON: You’re born of Armenian parents in the beautiful and troubled city of Beirut and became a refugee and then an immigrant. Tell me about your life story and how that ties in with your theory of innovation.

AFEYAN: Well, indeed I was born and raised in Beirut before the civil war there, and we ended up being taken in as political refugees in Canada. They were generous enough to take us, and that displacement, that uprooting definitely had an effect, and adapting and then trying to figure out how to do the best I could do, kind of followed by coming to the U.S., in that case more to obtain a world-class education. That kind of uprooting, re- rooting, kind of, I think, is very much at the core of what innovation is about. I’ve come to think over the last few years that innovation is a form of intellectual immigration, and that is those subset of people that are comfortable leaving comfort behind and that are willing to take on a risk for a hope for a better life become more humble, more unassuming, more demanding of what the state owns them, kind of more defensive as it relates to protecting what they have as opposed to taking it for granted. All of those things in innovation lead to daring to leap, daring to go to places where experts who espouse dogma (ph) tell you is impossible. Moderna, mRNA as well as many other projects that — through my firm flagship pioneering, we’ve had the honor to be involved with, have — tell the same story, and that you have to kind of escape, if I can call it the intellectual gravity, of expertise and be able to dare to look on the other side and say, could there be a different reality, and then almost work backwards to make that reality attached to the current reality. So, you foresee, you envision a reality and then you come back. And I think immigration is that because the people who immigrate think of a better life, imagine a better life. It’s always not as good as they had imagined, but through hard work, it looks better than they imagined because it was partly their doing, not just what awaited them in an oasis. And so, I do find — you know, I’ve done this for 33 years professionally, and I do find that those two streams, the adversity, the survivalism you hear about in startups, boy, is that something that you get exposed to when you physically get displaced. I really do think the immigrant mindset and immigrants together are what make this country great, and I think we just have to keep building on that.

ISAACSON: Dr. Afeyan, thank you so much for being with us.

AFEYAN: Thank you.