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