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Moderna Therapeutics today reported a 94.5% efficacy for its COVID-19 vaccine, which doesn't need to be stored at the same ultra-cold temperatures as does a similar vaccine developed by Pfizer. It also said short-term safety concerns, such as headaches and injection site soreness, self-resolved within days, and that it could have 20 million doses available by year-end.
Axios Re:Cap speaks with Moderna chief medical officer Tal Zaks about the new data, distribution, politics, and how it was preparing for this moment even before COVID-19 was discovered.
Dan Primack: We're joined now by Tal Zaks, chief medical officer at Moderna Therapeutics. So Tal, your company had been working on coronavirus vaccines before COVID-19 was known about. You had even been doing some so-called “war gaming” on pandemics or viral pandemics with NIH. How much did those activities help give you maybe even a heads start on the COVID vaccine development?
Tal Zaks: Yes, I believe the answer is yes, and I think there are two elements here that underscore our ability to get to today. One is science and the other is collaboration and people working together. In terms of the science, we had always envisioned that one of the core capabilities of this platform would be to react quickly to a pandemic. And it's no, it's not by chance that our first two vaccines, started back in 2015, were against pandemic strains of influenza. So we always saw this as a potential.
Now, fast forward to the end of last year, we were down at the NIH, Stéphane [Bancel, CEO of Moderna,] and myself, talking to Tony Fauci and his team. They had been worried for many years that a pandemic could come. We've seen SARS, we've seen MERS, and we had been collaborating with them in preclinical models to demonstrate the utility of this platform to prevent such a pandemic. In fact, one of the discussions we had back at the end of last year was: Do we need to take a model vaccine, say a virus that most of us never heard of like Nipah virus, that is not a threat, but use it as a drill to kind of artificially start the clock and see how fast we can go?
And as we were talking about what could be a demonstration project, we started to hear in December about this pneumonia out of China. And in the beginning of January, we started talking to them and we said, okay, it looks like this is not a drill. This is live, live-action here. And so we got together very quickly. We had already a collaboration with them in the scientific realm and that's what enabled us and them, I think, to advance this vaccine so quickly.
DP: Moderna has a bunch of products that do get prescribed, they're in clinical trials, but you haven't had one commercially approved before. And so I'm not so much curious about that, but when you think about the manufacturing and the manufacturing at scale — not something that Moderna has experience with at this sort of scale — give me the explanation for why you're confident you guys can pull this off if the vaccine is approved by the FDA.
TZ: Two reasons. One we've been at it for a number of years and had envisioned and had put, if you will, the train tracks on where the train should roll because our lead vaccine, a different vaccine against cytomegalovirus is starting its phase three trials next year. And so we've invested a lot already at risk. We built our own manufacturing plant and opened it a couple of years ago. So we had pre-invested knowing the importance of manufacturing. Our head of manufacturing used to head all of manufacturing for Novartis, Juan Andres. So we have a very competent and experienced team. We had built the manufacturing infrastructure. We'd already worked very hard on the process to be able to scale up. And so when this hit, we were ready.
The second element is we have since then invested at-risk a quite significant effort, starting in the beginning of this year, both [in] our own infrastructure and leveraging that of other what are called contract manufacturing organizations, namely Lonza, which is a well-established company that knows what they're doing, have been added for a large number of years both in the U.S. and in Europe to expand our supply chain.
And so we've been investing in manufacturing significantly. We've been expanding that and we've been working with partners who know what they're doing. We've been sharing our data as we go along with the right government agencies. And all of that gives me. The confidence that indeed we'll be able to supply large amounts of this vaccine.
DP: Speaking of data, you guys did release — you talked a little bit about safety today, talked about how there were some mild side effects, some headaches, some fatigue, some site-soreness, nothing that didn't self-resolve. Is the expectation that Moderna in the next week or two will release more detailed safety data from the trials?
TZ: So first of all, let me say one last point on manufacturing and then I'll come back to data.
I think the proof is in the pudding. Today we've also announced that our supply chain in terms of cold-chain requirements is continuing to improve. In terms of our data, we can store this and ship it at minus-20 [°C] for up to six months, but it can be in the fridge at two to eight degrees for up to 30 days. And these all indirectly speak to the critical quality attributes on the manufacturing side. And they basically say that you can keep this vaccine at temperatures that we all have in our fridge at home. So no real infrastructure, special infrastructure required. And that is an important element in my confidence that we'll be able to indeed supply the market in the hundreds of millions of doses.
Now to come back to data and when data will be available. We've been very transparent with our data as it emerges and I'm very proud of our transparency. We've spoken to the point estimate. We've given the breakdown of the subjects, in terms of the minorities and old people in the trial and in the cases. And we've also described the safety profile, the preliminary safety profile and the reactors’ [unclear] profile today. And I think in the coming weeks, what I anticipate will happen is: As we have the final data in the coming weeks from all 151 cases and safety beyond the two months median follow-up that is per FDA guidance, that will form the basis of a very public discourse on a very detailed analysis of this trial that will be discussed at what's called VRBPAC, the FDA committee of experts, and the world at large will be able to see these data. [Note: This refers to study design, participation, and a median of two months of safety data.]
DP: On the safety side, just by virtue of what's happening here, this incredibly fast vaccine development — not just by you guys, but by Pfizer and others — much faster than typical vaccine development: How do you answer people who are concerned that if this vaccine is, say, available to them in January or February, just by virtue of the fact that COVID-19 is so new, there won't be long-term safety data on these vaccines?
TZ: I think that is true. But I think what also is true is that when you launch a vaccine or a medicine, what's important is the benefit-risk. What is the benefit and what is the risk? Now in the risk, there always is: What don't I know I don't know. And that's in the bucket of, well, what are the unknown risks that we don't know yet that we may see years from now?
DP: But those could be serious when you're talking about vaccinating the entire population, correct? I mean, it could be everything from neurological to cardiovascular. We just don't know, correct?
TZ: So that is true, but we do have a scientific basis to predict two things. One, if it is serious, It will be very rare because we've had a very large trial. And there is a scientific basis of understanding, well, what does this vaccine do? And this vaccine, this technology really focuses the attention of the immune system only on this one protein. Right? And so it's a very precise vaccine in the effect that it has. And I believe personally that that precision should translate into a good safety and tolerability profile.
Now, it will take time to demonstrate that. I think what is salient in the coming months is: We are all living in an era of very high transmission rates. We know what the consequences are, we're learning what the severe consequences of infection with COVID-19 are, and I think the benefit is becoming quite clear.
DP: You guys — obviously part of the development of this, and we talked about this at the beginning, came from the U.S. government, particularly a relationship with BARDA. What strings, if any, does the BARDA money mean for Moderna when it comes to distribution? You guys, for example, talk about 20 million doses by the end of the year. How much of that goes to folks in the U.S. or is allocated to people in the U.S. and how much of that is tied to the U.S. taxpayer money?
TZ: So all of this is going to the U.S. All of this should cost the individual vaccinated at the end of the day nothing, as per what the U.S. government has committed. And this is, the distribution here will be handled by the U.S. So I think the real work of distribution will begin once we have regulatory approval and we can start distributing this per the U.S. government, and to CDC, and then to states.
DP: Does that complicate — because you guys are part of COVAX or this vaccine is part of the COVAX project, which is for emerging countries — how do those two things square that all this initial vaccine goes to the folks in the U.S. but that you are a part of this other consortium?
TZ: There is a dialogue ongoing with COVAX. I don't think we have quite aligned with them on how many doses and when those doses would be available for the COVAX collaboration.
DP: A political question for you. When Pfizer came out with its data last week, the president and those tied to the president seemed fairly upset about the timing. They seem to be fairly upset about your timing today. Can you explain when you, as chief medical officer, had the efficacy data in your hands or when the company had it in its hands, and why you decided to release today as opposed to, say, a few days ago, or a few weeks ago?
TZ: I had it in my hands less than 24 hours ago.
DP: As you know, there are critics who are going to say that is extremely convenient. Can you speak to that at all? Because again, there is a political component here.
TZ: Oh, there is nothing convenient about this. Let me be clear. My mother is over 80 years old. I want these data out as soon as I humanely can possibly get them. We have been working days, nights, 24/7. And it's not just us. It's our collaborators who are actually running this. It's the volunteers who've signed up. It takes time to see the cases and have the cases accrue. And once the cases accrue, we very quickly analyze them and — or I should say the data safety monitoring board, the independent group of experts analyze them.
I don't think this was humanely possible to do any sooner. And to be fair, we have always guided, as we looked back in July and August and we saw the cases emerge, we've always been clear on two things. One is that this is a case-driven design. So we don't control when cases occur. And I personally hope they never occur and it takes us forever. But the paradox of vaccine development is that the worse the pandemic is out there, the faster cases accrue. And we were always committed that as soon as we have results for the interim, we will look at them and we will try to ascertain what is the efficacy here. And as the second wave started to swell in the United States, we continued to refine those predictions. But I think we were always clear that we expected this data to, to occur by, you know, Thanksgiving, if we're fortunate from a vaccine development. And so I think our predictions have been born out and we've stayed true to that.
DP: Final thing, just a quick timing thing: you mentioned Thanksgiving. Should we expect that the emergency use authorization request comes before or after Thanksgiving from Moderna?
TZ: It'll be in the coming weeks.
DP: Tal Zaks, thank you so much for joining us.
TZ: A pleasure. All the best. Thanks.
Editor's note: An earlier version of this episode mistakenly referenced Jerome Powell instead of Jay Clayton as chairman of the Securities & Exchange Commission. This has been corrected.