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  • 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 Modernaback 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

  • ur, 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 withur. 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

  • thinkur 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, founderur 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 emergenciesEbola 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

Let's start with the tumble in the Chinese market as new fears

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B1 中級 美國腔

輝瑞(How Moderna And Pfizer-BioNTech Developed Vaccines In Record Time)

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    joey joey 發佈於 2021 年 08 月 29 日
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