How Moderna And Pfizer-BioNTech Developed Vaccines In Record Time
Let's start with the tumble in the Chinese market as new fears of the Coronavirus grow. Meg Tirrell, has some breaking news from the CDC. Meg? Hey, Wilf, well the CDC has confirmed the first patient in the US diagnosed with this novel Coronavirus, a man in Washington state who recently returned from Wuhan, China where this outbreak has been going on since last month.
The piece that I think really worries me a lot is that he was already everywhere that that the death rate was going up, you know, very drastically very steeply in January in China Investors trying to figure out just how this virus will disrupt travel, to what extent and if it will also result in Chinese consumers pulling back from making purchases. I don't think any one of us knew what it would at the end do. We will begin in China the latest on the Coronavirus, where the total number of confirmed cases worldwide is now exceeding 60,000.
It was alarming to understand or to feel at least that we were in this alone for so long. Biotech company Moderna stock soaring this week on news that delivered the first batch of its potential vaccine, We say look, it's a good opportunity to try to help and try to see how fast we can grow Pfizer and Moderna were in this and they were both driving really hard toward a goal that had never been accomplished before. It's nice to have people following your footsteps. It's uncomfortable to have people following your footsteps You can't be concerned about what others are doing.
The US death toll now stands at 14. There's the circuit breaker 2549 48 and the bell. So we'll wait here. We calculated that we could come up within a few weeks with a number of vaccine candidates. Frankly, I didn't know that it would work until the last last moment until November 8 breaking news from Pfizer this morning about its vaccine and a 90%. efficacy What we're doing isn't playing in a sandbox trying to demonstrate our technology, we're developing the vaccine that's going to stop the pandemic When you are forced to do something because failure is not an option. You find solutions.
This is D-day. This is the turning point when we really fight back against Covid. As everybody's rooting both of these companies on, it's also this fascinating dynamic of a David versus Goliath trying to save the world.
So I was actually in France, it was just between Christmas 2019. And, and New Year. And I was reading the Journal like every morning, and I read about the new infectious disease agents pneumonia like symptom in China. And they didn't know what it was.
I remember waking up the first week of January, it was really cold. I get up really early, but it's dark in in New England. And I was sitting by our gas fireplace with a cup of coffee at like 430 in the morning. And Stefan had sent like four emails over the course of an hour. I received an email from our CEO, Stefan, who had been exchanging emails with Barney Graham at the vaccine research center part of nyad literally double click on my own button on my iPad. And I sent an
email to my team to say Hey, what is this in classics different way it was like one liner emails, it was like, we should pay attention to this. There's something happening here and then forwarding links or forwarding texts that he'd gotten from friends. I was in Los Angeles at the end of January, I didn't feel comfortable, to be honest. I mean, even traveling, you know,
they will then news that the virus was also appearing in other places. And shortly thereafter, I'm in my, my husband and I we really were like hermits in our apartment, we wouldn't go out anymore. No in stores or anything other than walking the dog.
The big aha moment was I was traveling in Europe. And I was in my home country to speak to global economic forum, the Delphi Economic Forum. That's a very big deal for Greece. And they arrived two days before the conference so that they can attend it in person, the prime minister was going to attend.
And then the day before I am receiving a note, it's canceled, the forum is cancelled. That has never happened before. It was in January on January 24. As well, I was just back from the United States. And it was a Friday evening. And I was reading a Lancet paper, which was the first publication describing this outbreak in China I only started to pay attention after, Uğur Şahin, my husband came up with a Lancet publication. I did a number of
calculations, fast calculations and realized that that this virus had already spread worldwide and it was clear that it is already too late to stop the disease and that we are most likely running into into a global outbreak and pandemic. The CDC now confirming one case of the coronavirus in the United States. And the Dow taking a hit intraday on that news. Meg Tirrell joins us now with more on this developing story. This is fascinating.
Developing and developing very quickly as of this morning, we were just hearing about mounting case numbers in China and other nearby countries more than 300 there and six confirmed deaths so far here Waiting any minute for word from the World Health Organization after it has convened an emergency committee meeting to determine whether to declare this a public health emergency of international concern. This would be just the sixth time they have declared such an international health emergency after declaring it about Ebola twice before h1n1 swine flu Zika. So CNBC started covering Covid, probably in late January. And by then the companies were already starting to work on vaccines and potential drugs for this. So by the time the world kind of woke
up to the thread of what was happening in China, these companies were already working. And so that was a lot of our early work was a just trying to decipher the news that was coming out of China, but be already trying to triangulate and figure out what the pharmaceutical industry was doing. And as it happened, it was pretty early, but they were already doing quite a lot. At the time, when we believe it's an outbreak, we say look, it's a good opportunity to try to help and try to see how fast we can go. As we've always believed the amount it could go
really fast. But we never had a test case to to do it. Moderna was not a small company. I mean, I had a multi billion dollar market value when it went into this, but it had never proved itself with a vaccine that had reached the market. It was this very sort of cheeky, bold biotech that made a lot of big statements about how this technology that most people knew nothing about and called mRNA was going to change medicine changed the world. We hadn't seen that proven out yet
Moderna Therapeutics, a biotech that uses your cells to develop treatments for previously incurable diseases, and to speed up the pharmaceutical development process. Moderna's technology gives patients cells instructions to create proteins and antibodies to fight diseases from diabetes to certain types of cancer. What we do is we basically make the messenger RNA injected into you and your own ribosome is gonna make your own protein, right. So you make your own drug. Even early on talking with Stefan, he always seemed to exude this certainty that they could do it, that if it could be done with mRNA, that they were going to be able to do it.
The beauty of a technology is that we are able to develop a lot of drugs in parallel, which is very atypical from biotech companies. And I remember meeting with him maybe five years ago, or even longer at this business lunch in in New York City. And he brought their investor deck to me to show me the slides of what the possibilities of mRNA technology are. And he was just, you know,
scrolling through the pages showing me it'll treat this disease, it can treat this disease, it can do vaccines, it can do rare diseases, just showing me the scope of what was possible. At the time, I was kind of like, okay, you know, we'll see how this plays out. And that's how he is I mean, the CEO of a company like that, which raised so much money privately, he really had to prove to the world that they could do this. And the pandemic gave him this chance, If you know Stéphane, from the first email, things were starting to turn. And so from the very first week of January, through a series of emails that I'd received, but he sent them to Hamilton, he sent them to our research team, central manufacturing, even saying, hey, we've got to go get ready. And
he was also actually quickly interacting with the folks at NIH and Barney Graham and his team. And so by the time we got to the actual sequence of the virus, people had all been keyed up, to be ready to take that sequence, turned it into a vaccine and start manufacturing. If you think about it, that's really in just the first 10 days of January. We had previously worked on coronaviruses. We knew what this might look like. So when this happened, we said if we know
what this viral pneumonia is, so probably take us a couple days to figure out what that antigen looks like and we'll get it into phase one. And if we can move very quickly into phase one, best case the pandemic subsides, it turns out to be a seasonal coronavirus and it disappears. But we've got a product into phase one. We've demonstrated proof of concept. And we can put the product on the shelf and if it re-emerges in the fall, and it turns into a seasonal pathogen. We can pull it off the shelf and we can go conduct that larger clinical study.
The sequence was published on January 11. Up until then, nobody knew exactly what the virus was and certainly didn't know what part of the virus we'd want to make a vaccine to. We thought it was going to be a coronavirus. Everybody believed that it was a Coronavirus, a spike protein was the right thing to do. But we got that information and then NIH and Moderna independently went off said Okay, so we're going to design a vaccine. What would it be like? So they sent us a
sequence. I think it was probably that Tuesday after the sequence was published on the 14th, it was the same work that we had been looking at ourselves. It matched all of the conversations we've had. And we got that information and together said, well, let's go do this. Moderna get busy manufacturing and NIH get busy planning for the phase one study In our bubble. We were all focused on this. But when you
left work, and you went to see your friends, and you're talking with your family, who really weren't paying attention to it, and people seem to think, well, it's not in the US yet. So we'll deal with it later. I think it was really eye opening for a lot of people that our borders aren't going to keep out these The funny story is, we had agreed in November of 2019, with viruses.
Dr. Fauci team to do in the second quarter of 2020, pandemic mock up. Together, where they were going to send us the sequence of a virus by email, pretending they just sequence that new virus, and we're going to make the mRNA GMP, I mean to go to go into clinical testing. And then we're going to start the clock wash, see how fast we could go and send it back to them. And the reason in November, we decided not to do it in January, is because they were too busy in Q1. So they said can we do it in the spring. I'm like sure we'll do it in the
spring. And then of course we know the rest is history. We have it totally under control. It's one person coming in from China, and we have it under control. It's going to be just fine. Earlier today, I spoke with Stéphane Bancel. He's the CEO of
Moderna Therapeutics. This is a company that we listed as a CNBC Disruptor. I know Stéphane.
He told me that they are working with the NIH right now to try and develop a vaccine for this very issue. I go to Davos and in Davos, I meet several times a day two, in my opinion, amazing infectious disease doctors, Sir Jeremy James Farrar, who runs the Wellcome Trust, and Dr. Richard Hatchett, who runs CEPI. What was fascinating is they
refreshed my memory on biology of coronaviruses, like incubation time, and stuff like that. And then they start sharing with me, anecdotes that we are getting from infectious disease friends in China. And we start literally on the napkin, as we run into Davos, you know, to map our notes and Deaf writes, and we start to realize very early on that the R naught is very high. And I remember asking him a remind me coronavirus is you know, seven to 14 days incubation time, right? They're like, yes. So I get my iPad out. Google Maps.
Where is Wuhan? Big city. And then we realize it's a big autoparts industrial center. And then I get to Google and start to look at Google flights. And I start to realize that there are flights coming out of Wuhan to all the big capitals in Asia, or big capitals in Europe, and the big cities in the West Coast of the U.S. And so I look back to them and say, "It's everywhere, right?" And they tell me, "Yeah, by now it's everywhere." And
then that night, China locked down Wuhan. And I'm like, when is the last time I know city has been locked down because of infectious disease. And what goes through my mind is whether the Chinese know that we don't know. It took me I think another night or two. And I remember waking up Saturday morning sweating at four in the morning, saying geez, it's going to be a pandemic like 1918? There was a lot of debating, at that time at Moderna—back and forth and in the way that we sometimes do. We take different
positions, and I was definitely in the camp of this is this is going to peter out we're going to get it under control. It's not going to explode. It's divine. And others were definitely in the other camp of saying no, this is a really big deal. The moment that clicked for me was actually watching
China build a hospital in six days. We could probably all remember it. Those cranes in that field and all that digging. And I just remember thinking like, what causes a government like that to act like that? We were still in this country, seeing maybe our first case maybe our first death, but it seemed like a very far away problem. I do remember that that morning watching that video on being, "Oh my god, this is going to explode." And as we've seen those case numbers tick higher. We're also hearing from more pharmaceutical companies responding to the outbreak. Some are developing potential vaccines, including
Moderna Therapeutics, which is working with the NIH, others are exploring development of new drugs like Regeneron and Vir Biotechnology. And another approach is testing whether existing drugs might work against this novel Coronavirus. So BioNTech is run by two scientists who happen to be married to one another. And they recognize the threat of this
virus early on and pivoted their company to start working on it. But it was sort of this small, little known German company that was known to be working in cancer drugs using messenger RNA to try to fight cancer and this really cutting edge way. Suddenly, we have two major companies talking about using messenger RNA. And what that is, is it actually delivers the genetic instructions to make a specific protein from the coronavirus to your body. Your body then makes that protein and your immune system learns how to recognize it. That's how mRNA
vaccines work, but because they've never been developed before, for any product. There were a lot of people questioning if this was really the prudent way to go in a pandemic, but one of the beauties of it is it can be done so quickly. We knew that we have a technology, our personalized mRNA vaccine technology, where we can design very fast vaccines, genetically engineered vaccines. And we calculated that we could come up within a few weeks with with a number of vaccine candidates. And we realized that we could be among
the first companies. We informed our supervisory board, we discussed was all management part that we need to start a project and shift resources from from the cancer research to the vaccine development pivot. The company decided to call the project Project Lightspeed having the goal to develop a vaccine in the shortest possible time.
I know him very well, for a long time, and I know that he doesn't cry wolf. Without a clear rationale and reason to do so it was about a stepwise process, in which we would also observe how the environment would develop and how real the danger would get. We had, at the time point already a collaboration with two colleagues from Pfizer about developing vaccines against influenza, flu, we had the first contact with Pfizer a few days, after starting the project. At that time Pfizer was not yet
interested. Not many believed, at that point, when we reached out that this would really become a pandemic. One of the biggest things people worried about at the beginning of this was that the drug supply would be interrupted, because so much of the active ingredients that go into a lot of really critical drugs come from China. And so Pfizer was a key player in that. And what we heard from them at the beginning was just what they were doing to ensure that there was a continuous supply of critical medicines For me generally, I was not focusing at all on Covid. I was
only focusing on China. In late February, I started thinking that we need to do something, and this is when I decided not only treatment, but also vaccine. And then I asked our team, I want to have a vaccine, what is the best approach, you think? We were thinking about a protein based vaccine, we were thinking about a vectored vaccine. And they all had too few pros and too many cons and not understanding what this virus virus really needed in terms of how you protect against it. It was not given that we will go for mRNA. Actually, mRNA was the most counterintuitive decision because of all the choices, because there was never a vaccine made with mRNA. So I
wrestled a little bit with with a decision. We had another meeting. And they convinced me and I said yeah, let's let's take the risk we go for mRNA. Clearly, for me, it was very counterintuitive, but we said, let's go. Uğur, while we were
doing all of that, called Katherine Jansen Uğur, called me and said, you know, we have those constructs, who has been working on this for a while Five weeks later. Yeah. I did a second call, called Katherine Jansen, and told her that that we are that we are now candidates, and that we are developing a vaccine. And at that time, the outbreak was already in New York. Yeah. So it was very clear now, five weeks past, that this is not only selected cases somewhere in Wuhan, but this is already an outbreak which had reached the United States and Europe. And I
asked Katherine, do you think that Pfizer would like to work with us? And I said, absolutely. Let's talk about this. We started working together before we even had an agreement in place. That was the beginning of I believe a great friendship also, in addition to partnership that I developed with with Uğur. We went on the phone since that first phone call. Twice a week, maybe, and we were discussing everything. This is what the
relation was built in this atmosphere of trust and mutual respect. Pfizer comes in and it's this massive company, one of the biggest pharmaceutical companies in the world. If people know Pfizer, they probably know it for drugs like Lipitor, and Viagra not for cutting edge vaccines developed in a public health crisis. And yet, it's massive. It operates all around the world that has tremendous manufacturing capacity. It has tons of amazing scientists and they've got billions of dollars to work with. They jump into the pond and we're off to the races.
The Dow was now down more than 1100 points as moments ago. The WHO has formally declared the Coronavirus a global pandemic Breaking news a global sell off underway as the 11 year bull market comes to an end. Stock futures pointing to heavy selling at the open, this as President Trump takes unprecedented action to help stem the spread of the coronavirus in the US. By late spring, early summer, it was clear that Pfizer and Moderna were in this and they were both driving really hard toward a goal that had never been accomplished before developing this vaccine in record time, hopefully by the end of the year, and you had this situation where you had this brash, biotech and Moderna kind of the David to Pfizer's gargantuan Goliath, one of the biggest pharmaceutical companies in the world. And so as everybody's rooting both of these companies on it's also this fascinating dynamic of a David versus Goliath, trying to save the world.
The early parts of January, there were a lot of companies that were talking about this and even in February. And even going into March, there were voices that said vaccines were false hope. There were other voices that were more optimistic. But it did feel for a period of time that we needed to defend even the idea of trying and that it wasn't false hope and that we really felt we could scale and develop highly effective vaccines within a year, When we were thinking about, how do we get into phase one? What does it look like to prepare for a pandemic? The eyes of the world felt as though they were looking at Moderna as this biotech of what are they doing over there? What are they trying to do, and it was only when we transitioned in that March notification from the WHO that this is a global pandemic, it's an emergency, that I think people started to realize what we're doing isn't playing in a sandbox trying to demonstrate our technology, we're developing the vaccine that's going to stop the pandemic. It was until May, when we decided after we'd seen the first data from the phase one study, and we'd seen what's happening from a public health perspective that not only do we need to make this the almost singular focus of the company, from here on out, we got to go all in. But actually, we need to go back to investors and ask for their support. And that's where
we were able to raise a substantial amount of money, $1.3 billion in May, that we put 100% in to solving this problem in scaling manufacturing. We always play the long game, focus on the science put the guides down, sweated over people for hours didn't really change how we felt about it. We just had to do a job which is trying
to make this science work, because if we could, he was gonna change medicine forever. Previously, the world record for developing a vaccine was four years. Most vaccines take longer than that develop even a decade or longer. So while we saw these companies doubling
down and working at speeds we'd never seen before, we also saw the government do similar things, in terms of providing billions of dollars in funding to some of these companies. Through a historic series of funding bills, my administration is providing roughly $10 billion to support a medical research effort without parallel. Today, I want to update you on the next stage of this momentous medical initiative. It's called Operation Warp Speed. But also changing the regulatory structure. So that things that
were previously done sequentially, phase one, phase two, phase three, manufacturing, were suddenly started to stack on top of each other. So while the phase one study was happening to test the initial safety and immune reaction of the vaccines, they were planning phase two, while they were planning phase two, they were already starting to get things in place for phase three. And as all of this was happening, they were also starting to ramp up manufacturing, to ensure before they even knew if we were going to have a vaccine, that if they were successful, we would actually have vaccine doses ready to give to people In the Spanish flu, there was a first wave that was lethal. But the second one that came in the fall was the one that really killed a lot of people. I had a strong belief that this thing will not go and in fall, we're gonna have a huge problem. So I
said, we need to have one by fall. And I said this when I said that the date, by end of October. Put in really stringent rules, masking social distancing, and made sure that the people who had to come in were safe. And it actually worked very, very well.
We were able to start our first phase one study in just over 60 days, which is a month faster than we had initially planned. So there were three of us that we call the troika of this, though, is myself the head of infectious disease research and the head of technical development. You get the three of us in a room, we can do anything. And so that was it every morning at 8:30, two of us would be in the office, the other would be walking into the office and we would have a call.
What's our priority today? How did everything go yesterday? Can we pull in those timelines? And what do we need to do to get the clinical study up and going as we got closer to phase one, as we started to think about continued development beyond that, our troika just started to grow a little bit. We would pull in, you see members here or there, and Steven would join us or Stéphane would join us. And then Juan, our head of manufacturing was gung ho—'Alright, you're going to need capacity, I'm going to go find capacity for you.' I truly believe that people, they don't know what they can and what they cannot do. And in most of the cases, they have the
tendency to severely underestimate their capability until they are tested. And the ultimate test is to give someone a goal that it is very important to achieve, for example, in this case, because human lives are at stake, and that force you to think completely different. All your focus,all your energy, and everything goes on. What do we have to do, solving the problems as we go, it was just like non-stop. And I think was this focus, you almost block out reality because you just have no capacity to worry about, at this point, just about anything, but to make it happen.
Moderna saying and in its phase one trial, it observed that after two doses, all patients in the trial developed antibodies to the virus. They observed what they call a dose dependent response, meaning the higher the dose, the more the immune reaction that the vaccine elicited. Moderna, that's a Massachusetts biotech company says preliminary data indicates eight out of 45 patients that they tested developed antibodies that neutralize the virus. So it was May when we first saw data from a few patients from Moderna's Phase One study, and it was tremendously exciting, because we didn't know if these mRNA vaccines were going to work, if they were going to do anything. I t was the first glimmer that these vaccines were doing something and that they might be the solution.
I remember waiting on pins and needles for that phase one data in the middle of May, I remember the night that it actually came over email to us, in the middle was about 9pm at night, was sent in from the folks at NIH who had access to the data first. And you know, ripping through the the figures and try to get a sense of what happened, what happened, what happened pretty raw data. And realizing with some elation that this actually worked. I mean, it really worked, we generated strong immune titers in everybody that got the vaccine, Everything's a little bit muted when you're isolated at home when these when these big events occur. But I remember sitting at my computer late at night, with an immunogenicity report coming in and everything is sent with a password protected, so you get the report. And then a couple minutes later, you get the the password that comes through and it's just staring at your inbox waiting for it to refresh.
I'm not the type of guy who cries. But I dried a couple tears, I think, more out of relief. Because I know there's so much relying on that data being positive. And then being able to share that with the rest of the organization was great, because I it's there's a team of people that are working on this and the manufacturing colleagues, their research colleagues that are a little bit more removed from the phase one at that point, but have been investing in this for six weeks. So it's really nice to be able to take that and
share it back with the team and say, all of this hard work that you did for the six weeks in January and February, is paying off About an hour after that there were these phone calls and texts flying around and everybody are congratulating each other, some some quite tearfully, because it felt like we really had hope now. And I didn't realize it. But up until that moment, up until the middle of May, everything was just sort of without hope. And we had this belief in the science. But we didn't have anything in our hands that suggested we were going to be able to help and from the middle of May 4, we really believed mRNA 1273 was going to have an impact. And it was up to us to deliver it. Pfizer and BioNTech's Covid-19 vaccine phase one two results, they just posted online on a preprint server meaning they've submitted it to a journal, they haven't yet been peer reviewed. But these results show in this early stage trial looking at 24 patients on to lower doses of this vaccine, all 24 generated neutralizing antibodies, those are the important ones that stop the virus from being able to infect cells and they saw that at levels 1.8 to 2.8 times what you'd see in patients who've
recovered from COVID-19 That was a relief to see that we indeed get a strong antigen specific directed against the virus, immune response. And I think Uğur at that time even said we have in terms of immune responses, we have a near ideal profile. We had an expectation of what good would look like and we always used the the immune response that we saw from individuals that got infected with SARS-CoV-2 kind of as our guide post, and then when the data came in the antibody data, the neutralizing antibody data and also the T cell data. We said, well, that's great. So we are doing actually better than what the virus does. So I think we have a good chance.
Now this is just the latest of the Operation Warp Speed deals that the government has made earlier in July. $1.6 billion to Novavax, another big deal $1.2 billion to AstraZeneca. Those are a little bit different, because they do support development and manufacturing of the vaccines as they are going through the process. Whereas the Pfizer deal is only if it gets through regulatory approval guys and gets on to the market. It's great to have you this is a big day, the first phase three trial in the United States of a COVID-19 vaccine kicking off. So tell us about the timelines we should expect here. This is a
30,000 participant trial, how quickly do you think you can enroll that many participants? And when will we see the data? Yes, good morning Meg. Thank you for having us back. So indeed, it's a big day. It's a first phase three of a Covid vaccine in the US. It's a first phase three for an mRNA vaccine ever. And it's the company's first phase three as well. So a big day.
I looked at Moderna as another company with a similar technology. And I was very clear that one company cannot solve that problem. By that time, it became very clear. It didn't really occur to me that they were going to go after this particular pandemic. And I think it was even more
surprising that Pfizer jumped in in the way that they did in April, because they didn't have that experience. We did it based on our confidence, decade of work and the fact that we've done it many times before, whereas those two companies had had really never done it before. It was definitely a little looking over your shoulder a little, you know, it's nice to have people following your footsteps. It's uncomfortable to have people following your footsteps. You can't be concerned about what others are doing. It's like
you need to focus on what you need to do. Right? It doesn't matter what somebody else announces says or does, because it doesn't help you. We started to adopt a mindset that it's going to take six, maybe seven different companies, each able to manufacture enough doses for a billion people to end the pandemic. And we need to root for all of them to get in this fight because otherwise it was going to be really lonely and really difficult. Pfizer saying that they plan on potentially starting a phase three as soon as later this month. That puts them really neck and neck with Moderna and getting to that 30,000 participant late stage efficacy trial. Moderna also has Fast
Track designation Moderna CEO Stéphane Bancel telling me last week they have actually slowed down enrollment slightly in order to ensure diversity in the clinical trial population, particularly from the Black community. Good morning, Dom, rising numbers are certainly raising the already high stakes for a vaccine, Pfizer and BioNTech, in All of these clinical trials were going to be at least 30,000 fact, are proposing expanding their phase three coronavirus vaccine trials to about 44,000 participants to help increase the diversity of the trial population. That's up from the current 30,000 volunteers. people and these are massive clinical trials done under an incredibly tight timeframe. But Pfizer a certain way through, lowered the age in their clinical trial and expanded the number of people participating. There were also a few
differences in the designs of how the vaccines were given, and how they measured the response. For Pfizer, the doses are given three weeks apart, and then they started measuring efficacy one week after the second dose for Moderna, they were given four weeks apart and efficacy was measured two weeks after the second dose, in some ways that enabled Pfizer to start looking at whether the vaccine worked earlier than Moderna. In other ways it was a risk. Because the farther apart the doses in, you
know, vaccinology typically the better the immune response. Also, the longer time you give to start counting, the more an immune response has time to build up. I think the decision to slow down for diversity was one of the more difficult ones we made. But we really felt like it was
the right thing to do to build confidence in the vaccine. When we talked about it with a team and the board about slowing down the study, which was one of the hardest decision I took last year. It was, look if we'd worked so hard for so long, and there are a lot of communities of color. We don't feel confident that the vaccine is efficacious for that community, is safe for that community. Then there'll be a part of us where we will have felt we have failed. We'd rather have more
people taking the vaccine because I think confidence and being fair. And so as we thought about those two things will likely look the best outcome if you take a year or two year view isn't getting products used by as many people as you can, so let's do the right thing. We might not be first, but that's gonna be fine.
It wasn't difficult, though, because of Pfizer. It was important to know that never in those conversations was at about relative to, to Pfizer at the time, but it was actually it was entirely about there's a pandemic and people are dying. And are we sure we want to slow down to focus on diversity in the study? And the answer was, yes, now more than ever, because the people that are dying, and that are higher risks, highest risk, need to have confidence in this study. And unfortunately, that was disproportionately from communities of color.
You noted that to try to avoid any distraction, as you're pursuing this mission for COVID-19 vaccine, everybody has agreed not to enter into new 10b5-1 trading plans, add new shares to these plans or engage in additional unscheduled sales of Moderna stock in the open market. Tell us why you made that decision. And also, you know, as these criticisms mount, Do people really make a differentiation between these scheduled sales and ones that were already part of these plans? I understand as recently as a few days ago, you and others on the executive team have had these scheduled stock sales. So people keep seeing these mount up, why not just stop them completely? Yeah, so there's a lot of considerations to be taken in stopping the plan. As you know, this is highly regulated by the SEC. What we've decided to do with the team and the board in
terms of not starting new plan is because the phase three is ongoing, even though we have access to no data, because again, the safety committee, which is independent from the company has access to the data. I don't even know if we have had cases so far, Meg, and how many we have, I have seen nothing since we started those subjects as it should be. As these companies were racing toward developing a vaccine, you also saw tremendous volatility in their stock prices, you know, results on a few patients could drive up Moderna share price, 10, 20, even more percent. And that meant that the executives who owned a lot of that stock got really, really wealthy, at least on paper, and many of them also had stock sales set up.
They were timed sales that were not tied to them knowing what was going to be happening, but just regular stock sales where they would sell some of their shares. And this garnered a lot of attention and a lot of criticism that these executives, even though it was through a perfectly legal mechanism, were profiting as they were working on these vaccines to solve a public health emergency. Much of the focus this week has been of course, on the election. We have also been watching a huge spike in coronavirus cases. 120,000 new cases reported yesterday according to Johns Hopkins, that's another daily record.
So leading up to the phase three results. There were a lot of hints that these vaccines may work. Nobody knew. And nobody knew if they weren't how well they were going to work. It was
also a time when we were heading into the colder season here in the US. Cases had picked up again, it was starting to look really really scary again. Maybe scarier than we'd even seen before. We had discussed that the something in the seventies would be a great, great, great success for us. The FDA had set the bar
at 50. And ourselves internally we set it a little bit higher at 60%. The day of truth was was a Sunday. And we woke up and we tried to focus on other things, I was expecting that it would be great if we could have 80%. But 70% would also be nice, we were of course afraid that we could get negative data.
We have what's called a data monitoring committee. So this is a group of independent external physicians, highly experienced. And their job was to say, this works. You need to know go ahead and file. This doesn't work, you need to know, stop the study. Or
we don't know yet. Continue the study And it was reams and reams and reams of narratives and for each of the participants and all of this of course needed to be checked that it's it's accurate. They deliberated didn't take very long and then they called some senior folks including myself, they said you know you made it. We strongly recommend you to start preparing filing.
But they didn't tell us how well it was met. Well, we were happy anyway because said okay, well. There we go. Then, at the second call, it was only me and lega, the general counsel of Pfizer, and then a group of two statisticians call to give us the numbers. They told me 95.6%. I still remember.
And that was for me, unbelievable, a moment of joy. I knew that the vaccine worked. And then of course, you know, Albert disclosed to us that it was over 90%. And that was great.
Albert called me and asked me to just sit and then he said, the results are great. They are really great. There a lot of jumping up and down and hugging and relief. And so it was a great feeling. And then we came to the decision, but we need to tell the world not only what it is successful, because until now the plan was to say we have successful study, you will see the results when you file but also to give them sign that this is a very effective vaccine. And to avoid getting a number we said over 90% the efficacy. That's why you remember in the
beginning, everybody was saying is over 90 over 90. It was 95.6. That weekend, November 8, I got the information on embargo. This often happens with reporters covering something you agree to not put out the news until a certain time and I learned Sunday night that the vaccine worked with 90% advocacy. I have never been more excited to get to go on television and tell the world something.
Hi, Andrew. Well, 90% efficacy in this trial. This was a trial that enrolled almost 44,000 participants, and they saw 94 infections as of this first interim look. Now the way they get to 90% effectiveness is basically breaking down how many infections were on people on the vaccine and how many were in people on placebo. And they saw just such a dramatic imbalance. That's how you see that this protects with 90% efficacy against COVID-19. I was so worried somebody else was gonna do it before me. But I just knew that this was the news everyone had been waiting for.
It changed my life. It changed your life. It changed everybody's life who was watching. It was the first sign that this pandemic was going to end and we knew how it was going to end.
Meg Tirrell has a very special guest this morning. Meg, this is Becky, thank you, that guest i Albert Bourla, the CEO of Pfize the news of the morning, the news of the week. And much more , Albert, thanks for being her . What a morning. I can on than that, go ahead and take this away. We are all ears. y imagine what you all at Pfiz r are feeling today. What was It was exactly what you can imagine. It is a great day for
t like when you saw the resul s 90% efficacy for your vacci e for Covi science. It is a great day for humanity, when you realize that your vaccine has a 90% effectiveness. That's overwhelming. You understand that the hopes of billions of people and millions and businesses and hundreds of governments that were felt on our shoulders. Now we can
credibly tell them, I think we can see the light at the end of the tunnel. I feel blessed. I feel that very few people are in a position to be able to say that something that they did had a positive impact in so many people. And that is true for me and for all
the team actually, even more for them. So I feel blessed. It's interesting. I was a bit bipolar about it. There's a side of me that was upset about falling a week behind. Nobody likes to fall behind. But there was a side of me, which was a
week is not going to change how many million lives we're going to be able to protect. To start after Moderna and finish before Moderna, no one would expect because they would expect Moderna to and they were great company and they will move very, very fast. No one would expect it from a big company like Pfizer. And we did. And for me that was the best confirmation that yes, look, this is a very different Pfizer. It just feels good that despite all of this and the difficulties, you end up with your nose above the finish line. The first. I mean, that's, of course that makes you feel makes
you feel good. We felt grateful to be in this position because as a scientist, you always want to do something good. This is a privilege to be in the position to be able to do that. It was a relief. Okay, so seeing that another mRNA technology had demonstrated efficacy meant that that last little piece of doubt of are those immune responses that we saw going to translate, fell away. And so we knew at that point that our results were going to come in a week or so and then we knew that they're probably going to be comparable. That almost felt as though it
was our results. We were able to put things in motion that maybe we would have been a little bit more reluctant. This is Plan A. We know that it works. We know that our results are going to come in in a week. And now the question is, how quickly can we get to our filing first in the US and then around the world? Good morning, Andrew. That's right. So remember, of course,
Pfizer reported that 90% efficacy number on his vaccine trial for Covid on Monday. It's stock went up quite a bit. We are now learning that Pfizer CEO Albert Bourla sold $5.6 million worth of stock, 132,500 shares on November 9. Now that was pursuant to one of these 10b5-1 plans, sort of a pre planned sale.
So I should ask to sell that before. In January. That was before Covid. So there is a third party that is monitoring the conditions. And once the price goes up, they will say,
this is what happened. And the shares were sold. Actually I didn't even see that they were sold. Frankly, I was very sad, very devastated. I mean, I was in, in a situation that I was worried about how to make sure that we have a vaccine, and then all of that derailed the discussion and reflected bad on me and on Pfizer. But, you know, that comes with the territory. And I knew that I'm perfectly fine. And then that disappeared
after a couple of days of gossips. The Pfizer results were incredible relief for everybody. But it was also just a fact that one company could not do this by itself. And so the pressure was on for Moderna to deliver as
well. We knew at the end of the week before we saw Moderna's results that the results were coming, they had a hint that the data set was blocked, they had enough cases to be able to start counting and ti deliver the efficacy figure Our results are reviewed by an independent data safety monitoring board, a DSMB. And we went into the open part of that session, which is Moderna and a lot of our collaborators across the portfolio of products from Operation Warp Speed, and then they go into a closed session. And they kick most of us out of the room. And there are a few people that are on the line that get to hear the efficacy results. I was one of the people that was dropped from the line. I was kicked off the call. But
we had an open room waiting to hear the results when our team returned. And I just got this text message. Our clinical operations lead. He was saying jump back on the line. We're hearing the results. So I came on and Steven Hoge, our president had been invited to the closed session of the DSMB to hear the results. He put it on speaker so that those of us that were in the room could hear it, and then, this muffled voice came through and said, "You guys did a great job. Now get to
work." And that muffled voice was Dr. Fauci. And he was so happy, we were so happy. He lasted 10 minutes. He just told me the top line results and I said we're gonna send you the data. And so I left my office I went see my wife and
this time I cried a lot. Alright, listen up, everybody, some breaking news from Moderna. Meg Tirrell, joins us right now with the headlines and a special guest. Meg, take it away. Hi, Becky. Well we're getting Moderna is phase three interim
results. 94.5% efficacy for their COVID-19 vaccine in this phase three trial. T hey found 95 cases of COVID-19 among these 30,000 participants to talk about all of this, we're going to bring in Stéphane Bancel, the CEO of Moderna right now. Stéphane, thanks for being with us this morning. Another historic day. 94.5% efficacy for your vaccine. Help us understand
what this means. The second vaccine to show such high efficacy for getting us through this pandemic I think it's great news. We're were excited last week when we heard the good news about the Pfizer vaccine. And I think with the data that we're presenting this morning, it's just hope that we should be able to get those vaccines soon into the marketplace to help vaccinate people at high risk to stop the pandemic. We opened a nice bottle of wine from the wine cellear that night when all the press releases and everything was done, and the slides and so on because we're doing a conference call and so on when all the work was done. And we've
had prepared a nice dinner and we open a very nice bottle of wine. And we enjoyed it and I kept the bottle. It was just such incredibly good news, not just because it meant we had a second tremendously successful, effective vaccine to deliver us out of this pandemic. But because in science, there's almost nothing more important than replicating an experiment to prove that the first result wasn't a fluke. Now you have two vaccines that use the same technology that delivered extremely similar and amazing efficacy one week after the other. If that's not a miracle, I don't know what is.
Do you look at the rising shares of Moderna biontech, Novavax, Pfizer, McKesson all creating billions of new shareholder wealth, including at least four new billionaires. Now, topping the list is BioNTech, which of course is partnering with Pfizer, founder Uğur Şahin gaining $4 billion in wealth just this year, he just became the 463rd richest person in the world with a total of $5.4 billion I am as a founder of the of the company, of course, I have shares. And since the company has increased its value, I am now on the paper, a billionaire. But I didn't sell any of my shares. It's not in our interest. We didn't start the company to become rich. We really started the company to
make a difference. And that's what we focus on? How is it different for all the teams that made vaccines our products? There's just teams that made Zoom or any other product that was used in a pandemic. It just happened to be there. I mean, the way I think about it, this was going to
happen over time, because the technology we know now was going to work for over vaccines down the road. So it was an accelerator. And that's the piece that that's just what it is. I think it's part of what makes this country special, which is people are rewarded for taking a risk. You know, half the stock I have is stock I got as CEO. But a lot of time people
forget halva stock I have, it's because I bought it. And the only investor in the world, we bought stock in all the private tranches, from A to G. There's no other investor who has done that. My wife thought I was a bit crazy when I was taking our
retirement savings from my previous jobs at Eli Lilly and bioMérieux and investing it into our stock. She would see me and tell me, "It's going to work, it's not going work, it's going to work" for many years. So there's been a long journey. But then there's a bigger question now about how much money these companies are making from these vaccines. Not every
company did this in a for profit way. Others went the nonprofit route. But they were the ones that won the race, Moderna, and Pfizer and BioNTech won the race. And they did this on a for-profit basis. And they're going to reap billions of
dollars in sales every year. These vaccines are going to be some of the biggest drugs of all time. They help save the world, or at least the world that has access to vaccines, in a record time, performed a miracle. But they're getting criticized for
how much money they're making. It's a historic day today. This is the moment that the fight against Covid begins in earnest after months of research and clinical trials, the Pfizer biotech vaccine delivery underway. And that's probably why you see the Dow futures indicated up by about 200 points this morning. That is the Moderna vaccine, unlike the Pfizer vaccine does not need to be kept at negative 80 degrees Celsius, we could see that is moving out and we'll go to distribution warehouses and hospitals today and all this week.
We applied to the Health Depart ent asking for permission to giv to it to essential Pfizer orkers. People that are going o manufacturing site. And peop e that are going to resear h centers, that without them bei g physically located and operat . And they gave us this and e started vaccinating them. A d then we started extending it. o the first one was non essentia
. And that was not essential. 5 and above that was the fir t group. So we opened in Monda , Tuesday, I went and I d d together with members of y team. I felt really liberate I got the vaccine, we my wife at the same time, and I held our hand, because within 10 years of sweating bullets, and a lot of ups and downs that it was kind of a super special moment. It also made me think about all the families that were going to come around the world, and that we're going to have a chance to protect them. So that was a super special feeling.
It was a huge relief because my husband was very worried. Yes, um, underlying conditions and he wasn't very, very concerned. Actually, he got his before I got mine in New York State and he came home after getting his first shot. And you could just see there was relief on his face to finally after all of this time. He knew, OK this is kind of pressure and anxiety seem to have lifted. I mean, he was another person. And then I got mine a few days later.
I being the nerd that I am signed up to get my first dose on the anniversary of the sequence release. So on January 10. I got my first dose and it just happened that a few days before I was due to show up at the clinic to get vaccinated they had opened up our employee vaccination to family so I was able to bring my husband with me to get vaccinated. So being able to share that experience with him, somebody who has been taking care of me for the last year and making sure that I'm fed and hydrated and the rest of the world around us is still running and my family knows that I'm alive. That was a really big moment. The CDC is updating its mask guidance given new information about how transmissible the Delta variant, is now recommending that in areas of high transmission, that people even who are fully vaccinated wear masks in public settings indoors So the immediate future is potential booster shots against Covid. We know this virus is mutating, the companies are
already working on updating the vaccines to cover new variants. And they've shown they can do this in tremendously short periods of time. Then they're looking at other viruses. Flu, that'll be something on the near term horizon, potentially other respiratory diseases as well. Maybe they'll all be packaged together in one mRNA vaccine that you get against a bunch of respiratory infections, every year. And then beyond that, scientists are working on even harder to reach viruses like HIV, because mRNA is something you can use to develop so quickly. And so powerfully, they think it might unlock new areas
where science has been unsuccessful so far. We are having a surveillance system that is tracking every single variant that is emergent. And we try to see if any of them escapes the protection of our vaccine, in the beginning or over time. So right now we have very high confience level with
within 90 days, from the day that we will identify a variant of concern, we will be able to have massive production of one. So I feel optimistic, I really think is the beginning of the decade of information based medicines. And this is what we're most excited about here is that we didn't build the company to solve the pandemic, we actually built the company to change the way medicines are made, that we're using mRNA as a molecule to send instructions to your body. The instructions can be anything you want. That can be how do you protect yourself against Covid. It can be how you protect yourself against flu. And it can also be as you said, how does your immune system attack your cancer in a personalized cancer treatment. And we're doing all those things
and people literally right now. And that's a much longer journey. That's the journey that we're on for the next 10 years as a company and the place that we're excited to invest our innovation, our time or blood, sweat and tears together. I've covered a lot of public health emergencies—Ebola Zika, swine flu. Didn't turn out to be as bad as we thought it was going to be, but back in 2009, we were really worried. Science has never been able to move fast enough to catch a virus. And
this time it did. And what a tremendous time for science to be so successful. We're just so lucky. I didn't expect that to happen.
Most people can spend their entire lives trying to work in therapeutics and vaccines and never have a product get even through clinical testing, let alone authorized. So to do that in a year was was remarkable. Nothing is granted, you have to do everything right. And we did
20 years of research, benefited from many years of research of others who bought in also their technologies and their know-how. So this is an accomplishment of, of more or less, human, science, mankind. There was a lot of pressure to make sure that I delivered clear information that people knew that they could trust. There was
a lot of misinformation through this pandemic, things got very political. And it wasn't that one side was always right. You had to cut through that. And in a sense, also, it was really strange covering this huge story from my house for 16 months. But it was also the kind of story where a reporter who covers the drug industry and who follows data, epidemiology, clinical trial results. In some ways, the most effective reporting I could do was sitting at my desk with a highlighter. And that's what I did. I made sure I understood the data. I made sure I could
talk to these experts from the CEOs of the companies, to the vaccine scientists with inside and outside the companies to make sure that we were really explaining both to the market which was swinging wildly for the last year, but also to all of our viewers who are also regular people worried about their health, worried about their families, what was going on and when we could expect to really get out of this. And that's why it was so amazing seeing these results because as a globe, we finally saw that this was going to end
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