November 30, 2021 • 35 mins
Two biotech companies, Germany’s BioNTech and the U.S.’s Moderna, decided in January 2020 to wager their futures on developing a messenger RNA shot to fight Covid-19. What ensued was a head-spinning race to bring a vaccine to market quicker than ever before.
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Speaker 1 (00:00):
It's a cloudy, freezing Friday night in January. In Minds,
(00:10):
a university town in central Germany, or Shine, a doctor
and cancer researcher, bikes home from his lab in the dark.
He makes a cup of tea and settles in to
read the week's medical journals and starts with leading papers.
Has spent more than twenty years of his life trying
(00:32):
to figure out how to use the body's immune system
to target and destroy tumors. But tonight, a different disease
catches his interest. An ominous new virus is spreading in China.
Medical journal The Lancet has just published the first case
descriptions for forty one people who'd gotten sick in the
(00:53):
city of Juhan. Uger notices one thing right away. A
new message in this paper was that one of the
family members had the disease was VIBUS positive, but did
not have fever or other symptoms. This was new. The
asymptomatic cases meant the virus could spread in secret. The
(01:15):
symptoms described in the article are serious pneumonia, heart injury,
six deaths. Uer looks up the population of Juhan, eleven
million people, bigger than central London. Then he checks flights
between the city and the rest of the world. There
are dozens of flights every day. It was extremely highly
(01:37):
likely that this is going to be a pandemic, and
we started to discuss what we can do. The next morning,
he turns to the person he trusts the most, his
wife and fellow researcher with them too, Ritchy. She's the
one who challenges his big ideas, forces him to hone
his hypotheses. He spends about an hour showing her what
(01:59):
hend on. They both know the best weapon to fight
what's coming will be a vaccine. They've been testing a
new technology using messenger RNA and experimental cancer therapy, and
had done a lot of lab work on a potential
flu vaccine, but neither they nor anybody else had ever
(02:19):
used the technology in an approved medicine for humans. After that,
it was not about discussing. It was about asking the question,
how can we make this happen? If we really want
to contribute and try to engineer a vaccine, how quick
this work. They had never even done a patient trial
(02:42):
in infectious diseases before, just lab experiments. Nobody knew whether
it would work, but they were about to embark on
an unprecedented race to find a vaccine against COVID nineteen.
We decided to start a program because it was clear
it was an obligation to do something. Welcome to the
(03:07):
seventh episode of our series. In our last episode, we
heard about how researchers Catalan Kariko and Drew Wiseman worked
for decades and relative anonymity to lay the groundwork for
getting m RNA into cells. With the pandemic, their work
has a chance to make its way to patients far
faster than what would have previously seemed possible. This time
(03:31):
we're looking at the remarkable race to speed up development
time of a COVID nineteen vaccine in the usual decade
or so to a head spinning ten tranzied months. This
is a story about the biggest scientific breakthrough with the
pandemic mRNA vaccines. Now Suddenly, vaccines are the world's number
(03:51):
one priority and the race to make them is on. Soon,
hospitals and morgues will be filling up. Hundreds of thousands
of people are about to die in cities around the globe.
Every hour of every day is crucial as scientists race
to do years of work and months. Whoever gets the
(04:11):
finish line first, will make a name for themselves as
science heroes, victors in a once in a century war
with the killer virus. So many lives on the line,
and for the drug companies billions of dollars in profits too.
My name is Naomi Kraski and I'm a health reporter
for Bloomberg News from the Prognosis podcast. This is Breakthrough,
(04:53):
the story of the COVID vaccine race starts with a
pair of young biotech companies. One is BioNTech, led by
Or Shah and it slam too duchy when we just met.
The other is Moderna, founded by Derrick Rossi, the stem
cell researcher we met in our last episode, and led
by a charismatic Frenchman. Needs to fund cell. Unlike BioNTech,
(05:18):
which had mostly been a cancer company prior to the pandemic,
Moderna was able to build on a lot of prior
work and infectious disease. Here's to fund the CEO. We've
been working on the mountain for ten years. We have
been working on infectious disease of vaccine for most of
those teneos. Moderna had started patient trials on nine other
(05:40):
potential vaccines against other infectious diseases before this pandemic vaccine,
so this was not new to us. We've been working
on it a lot. In Moderna had started working with
the US government to design vaccines. The project included mers
A coronavirus that it hits out of Arabia and other countries,
(06:02):
and the follows to fund. Briefed officials from the National
Institute of Allergy and Infectious Disease known as NAIAD on
a factory the company had built in Massachusetts. It could
produce new vaccines in just sixty days. Steffun invited the
government officials to tour the facility. Sensing some skepticism, he
(06:24):
offered to do a test run for a hypothetical pandemic.
The agency would send Moderna the genetic sequence for an
emerging viral disease. Moderna would see how fast it could
get a vaccine ready. The agency was about to pick
a virus to use when along came stars Covey two.
It was a perfect test case. So we were made
(06:47):
aware of the virus between Christmas and New Year of
We got the sequence from the Chinese government in our
January the tenth put online. By the fifteen of anyway,
we had the vaccine design lockdown on the computer, because
all in Silico we never touched a physical virus. Here,
(07:10):
it's helpful to step back for a minute and review
what distinguishes mRNA vaccines from conventional shots. In the old
way of doing things, vaccines introduced dead or weakened bits
of virus into the body primarily immune system to recognize
and destroy the real thing. Messenger RNA vaccines work differently.
(07:34):
They contain a template that cells will use to make
the bits of viral protein themselves, essentially turning the body's
own cells into vaccine making factories. The differences also extend
to manufacturing. Conventional vaccines are grown inside live cells. Some
even use chicken eggs. Messenger RNA vaccines don't need any
(07:59):
of that. Making them is a chemical process, a little
bit like cooking. Makes the ingredients together and you get
the vaccine. That may sound simple, but it isn't. Stefan
told us that going from the theory to actual drugmaker
seemed like a long shot when he quit his previous
job joined Moderna. But if he's going to work, you
(08:20):
would change medicine forever. Great pandemic. Bion tech had been
mostly focusing on cancer one thing it's scientists were able
to do in those early days was pull off the
method for developing rapid personalized versions of m RNA vaccines
based on cancer patients individual tumors. So we had the
(08:43):
technology that we could use a vaccine platform to come
up as a new vaccine was in a few weeks.
This is another really important point about mr anda of vaccines.
The technology itself took decades to refine, but within that framework,
designing a vaccine to target a particular pathogen is actually
(09:04):
really quick. Before mr and A vaccines came along, the
fastest vaccine project ever was the n and Drug Company
American co licensed to Shop for Moms. That took four years.
The scientists who led the project, Maurice Hillman, swabbed his
six five year old daughter's throat in order to get
the lab specimen he needed to make the shot. With
(09:28):
m r and A vaccines, you don't have to do
anything like that. You don't need swab samples. All you
need is the genetic code of the virus cattle and
carry co. The pioneering researcher who left academia to work
at BioNTech, says this and the event of the Internet
gives researchers a leg up. You know you you are
(09:50):
very young, so you don't remember, but how long it
took like for HIV to set up the test to
recognize this infected recognizing the I mean it took so
long because the technology was not advanced in minds. We
were an earths them get a slightly later start than
their US rival. They have their kitchen table conversation about
(10:14):
committing to a COVID vaccine a few weeks after MODERNA
is already working on the vaccine design, but they start
moving quickly. To the day after their decision to start
work on a vaccine, we were calls a series of
meetings with his manufacturing team, pre clinical testing team, and
business development team. The crowd into his office in Mines.
(10:37):
It's a simple room with the desk, conference table, some
family pictures tacked onto a bulletin board. It's on the
same hallway as the labs. He asks everyone to start
planning how they can divert resources away from their other
projects to a new full court press COVID vaccine push.
On this Monday, I had five or six meetings with
(10:59):
different and we had to day thereafter a board meeting
to discuss how this can be supported by other board members.
The same day, the first COVID case is confirmed in Germany.
It's a thirty three year old man living near Munich.
He works at an auto parts company. We had just
(11:21):
been in a meeting led by a colleague who was
visiting from China. We were assigned twenty five people to
work on a potential vaccine, setting up shifts that run
through evenings and weekends. It's basically seven operation. We had
to reduce the timelines. We tried to figure out how
to do that, and in principle we came up as
(11:45):
a number of really innovative strategies. One was doing things
in parallel instead of doing it sequentially. It's a risky
of a time saving decision. Usually companies don't prepare for
a pay Asian trial until they have a potential drug
to test. But Uger's teams start working on getting trials
(12:06):
ready to go already. They figure they can add the
details about the vaccine that's going to be used once
they have it, they start making multiple candidates. You need
to do a lot of detailed paperwork before you can
test any kind of drug on people. So Uger also
gets in touch with German clinical trial authorities. He knows
(12:27):
them well because of bion texts work with cancer vaccines.
He asked them for a meeting. Usually it takes three
months to get a meeting date. So I called them
and asked if we could come up just just data
day and and they said, first of all, prepare a
briefing book and if you've managed that, you can come
(12:50):
next week. So Uger's team works night and day to
write an ad page document describing there would be COVID
vaccine project. They agreed to our plan. The only only
challenge for us. They wanted to see a toxicology try.
It usually takes six months, and we wanted to start
(13:12):
in April. Yeah, so will be the beginning fable Abby
and they they quested to have a talk study and
they had to figure out how to do the talk
in in less than less than three months. And the
teams you get that out. Moderna is also doing things
in parallel, setting up the next steps for bigger trials
(13:35):
before the early ones are done. By February forty two
days after it started, the company ships the first batch
of vaccine to NAIAD. Remember that's the National Institute of
allergy and infectious disease. Like BioNTech, they are relying on
close partnership with regulators. Unlike BioNTech, they have a direct
(13:57):
government partnership. The National Institutes of Health is the co
developer of the vaccine. The Food and Drug Administration is
taking their calls at all hours of the night into
the weekend. Stefan says, I think one of the hero
of this remarkable SENSEFIC achievement of twenty is vf D
(14:19):
because you know, usually through the process is set up
by the agency. You know it would sometimes take months
to get an answer to a question. Well, here we
had answers on questions seven with the NIH to help them. Well,
Darrena moves forward without a big farm a partner for
(14:42):
BioNTech in Germany, that's not the case we're in Aslam. No,
they can't run the huge clinical trials needed for approval
on their own. Neither do they have the kind of
global distribution you need the ship of vaccine all around
the world to succeed. They need a sponsor with deep
pockets who picks up the phone and calls his contact advisor.
(15:06):
The drugs behemoth based in New York. The companies had
already made a deal in to work together on an
m R and a flu vaccine. Phil Dormantzer, chief scientific
officer for Viral Vaccines Advisor, remembers that call who are
wanted to transfer people who are working on flu to
the new virus really just swapping out the influenza and
(15:29):
engine coding sequences and swapping in the stars COVID to
ANDREW coding sequences, because we like to be really out
in front of this new disease that's broken out in Wuhan, China.
Remember when I said vaccine makers no longer needed live
cells or swabbed samples to build vaccines, but that all
(15:52):
you need is the genetic code of the virus. That's
what Phil is talking about here, and this is a
big deal. Ion Tech might not have had ongoing human
trials with infectious disease vaccines, but they were already working
in the area. Paddlan explains how far along the flu
work already was. We were advancing those studies. Animals studies,
(16:14):
monkey studies were finished, and we were just there to
request the authorities work for the permission all of the sudden.
Instead of influence, so we switched over to to Corona.
By March two, they have twenty vaccine candidates that could
spur a strong immune response against the virus, and lab
animals and cell culture experiments. That day, Uber calls Katrin Jansen,
(16:39):
visors had a vaccine research and development and Phil spots
it doesn't take long to convince her. I remember there
was a call on which Uger and Katherine Jansen, who
who leads vaccine research and development advisor UM and I
spoke about this and they said, well the work plan.
So I'll literally get him overnight typed up a work plan.
(17:02):
What are the things that we would do. The plan
goes to Albert Berla, visor CEO. Albert basically said we
are going all in on this, that this is clearly
an emergency. Albert said, in this circumstance, we need to
divert resources and do whatever is needed to bring the
(17:22):
vaccine forward. So his expectations of timelines were far faster
than anything that that that we would have imagine before. Meanwhile,
the FDA signs off on Moderna's plans for a trial
in humans. Stefan's team injects its first volunteers on March sixteen.
(17:42):
About a month later, on April Bion second Fiser start
their human trial in Germany. Less than two weeks after that,
a US trial begins. I think we were the only
company which really started was all ever having ever tested
their their platform in infectas disease. And we've also the
(18:06):
only company which tested multiple candidates in pavalum Ugar is
talking about shoehorning in one more science experiment, he wants
to test four different potential vaccines in the first human
study to see which one is the best. It's risky
because it could delay development. Well, Darren has already picked
(18:28):
the full spike for its vaccine, but UGO wants to
try to optimize their shot as much as possible before
they give it to thousands of people. The question is
whether to make a vaccine based on only a piece
of the virus is spike or the whole thing. Picking
the right bit of the protein for the vaccine could
potentially make a big difference in how well it works.
(18:51):
And you could find in the literature arguments for both
and against both. And so we said, let's test both
and get the clinical data, get the preclinical data, and
then get the answers. In July, both Moderna and the
Fiser BioNTech team announced early data showing their vaccines can
(19:13):
produce antibodies in people. Biontechs first data is for the
version of the vaccine that made only one part of
the spike protein, something called the RBD domain. It's good data.
The clock is ticking. Some people want to move forward
with that version of the shot right away. We had
a lot of pressure from the clinical teams just to
(19:36):
go ahead domain it teams to insist on waiting for
the data from the full spike to see whether it
might wind up making a safer or more effective vaccine.
They have to move fast. While the pandemic has ebbed
in some places like Germany, the US is in the
middle of a summer surge about to hit a hundred
and fifty COVID deaths. Experts warned that another wave will
(19:59):
probably come in the fall. They rush blood samples from
volunteers to labs in Germany and the US. The safety
data shows that the full spike vaccine is even better
than the partial spike. It might cause fewer side effects,
gives a better immune response to so on July they
decide to go with that one. Remarkably, three days later,
(20:22):
on July, both Moderna and Fizer BioNTech start the huge
clinical trials necessary to win regulatory approval. There are tens
of thousands of volunteers. Their real life experience will show
whether the vaccines can work outside the confines of a lab,
(20:42):
whether they can make a dent against the virus in
real life. That summer, Moderna also get one billion dollars
in funding from Operation Warp Speed, the Trump Administration's effort
(21:05):
to hurry along vaccine development. The money is allocated via BARDA,
the Biochemical Advanced Research and Development Authority. I think this
is one story that is not talked about enough, is
what Balda and then Operation vout Speed did by you know,
sponsoring six companies, giving us the financial resources to take
(21:30):
a lot of business risk. Eiser doesn't take US government funding,
although the partners signed a one nine billion dollar contract
to sell one hundred million doses to the US government
if the show works, that's its own form of security.
Moderna has its own deal for one hundred million doses
(21:50):
for about one point five billion, and BioNTech takes German
government funds. They need the money to build a factory.
They've never had to new factor for millions of people before.
They searched Germany and find an old novartist vaccine factory
in Marburg, close to Frankfurt. They close on the site
in the fall and work on retrofitting it for m
(22:12):
R and A manufacturing. But there's a problem with making
a key part of vaccine. Or and Katherine Jansen talked
about this earlier this year at a conference hosted by
healthy website stat Yes that that was indeed the low points,
so we had an effect the vaccine. We wanted to
(22:32):
to produce one hundred million doses and then it turned
out that's one off the components did not work as
as expected. The problem was with lipid nanoparticles. These are
tiny bubbles of that that worked like a protective coating
for the vaccine. They keep the body's enzymes from destroying
(22:54):
it before it can make its way to a cell.
The lipid issue that we faced at one time, that's
through a real monkey wench, and it's so not only
did we have to keep the program on track, we
had to have a significant number of our colleagues, you know,
working through it and trying to understand it. It originally
said that if the vaccine worked, it could make a
(23:16):
hundred million doses. Because of the manufacturing issues, they had
to scale that back to fifty million doses. Well, we
faced enormous challenges like in in every in every development
program and vaccine development program, you have enormous challenges and
the difference why we usually those challenges of COVID ten years, Yeah,
(23:38):
the same challenges a nine months. By this point, they're
working NonStop to solve the manufacturing problems. But the biggest
question is still open, just how well does the vaccine work.
The answer will come in the huge study that Fiser
is running. They've expanded. It's more than forty patient people
(24:01):
all around the world who have volunteered to get two
shots in the arm without knowing whether what's in the
syringe is a vaccine or just a placebo. Then they'll
go out and live their lives and see whether they
catch COVID. If they get symptoms, the test will show
whether it's the virus. The researchers themselves also don't know
who got the vaccine and who didn't. It's just a
(24:24):
matter of time waiting to see how many people get sick.
And all around the COVID pandemic is getting worse. The
second wave is happening Europe heads back into lockdown. In
the US, the death toll hits two thousand people in September.
In only two months, another fifty people die. How we're
(24:48):
not in a good place for a couple of reasons.
Cases surging in nearly every state, more than two new
cases in just twenty four hours in this country, alas
as a cruel much of Europe, the virus is spreading
even faster than the reasonable worst case scenario of our
(25:08):
scientific advisors. It's Sunday in November eight, almost ten months
after the Sunday morning when it's them and UGO had
talked about whether to tear up their company plan and
chase after a COVID vaccine. They're waiting in their apartment
(25:29):
for five or CEO Albert Burla to call. They're on edge.
They've heard that the independent panel of experts that's monitoring
the trial is reviewing the results. They're expecting the panel's
predict at any moment. We both are very tense. The
entire day. There was still the scenario that would be
(25:50):
oh THEO at all. Yeah, and remember that that understood
that I I was worried, and he said, you know,
it does not matter what we hear later today, it
might well be that does not look good, but anyway,
it was worth it and it was of a moral
(26:11):
obligation to at least try it. Finally, at eight p m.
The phone rings. Albert is on the line. They put
him on speaker. He said, do you want to know
the Lisa, and I said no. I realized already from
his voice that there would be a positive a message,
(26:32):
but neither of them were prepared for just how good
the results would be. Ure told me he was expecting
efficacy in the range of against the virus. They have
to hit at least fifty for the vaccine to be
considered viable for the market. What they get is well
above nine. This was incredible. Yeah, this was just wave
(26:57):
taking and that in this moment he understood, Hey, days,
a vaccine for mankind and corna is is a problem
that can be solved. Across the Atlantic, Phil Dormantzer is
sitting in his apartment close to find SoRs office when
he gets a similar call. He's sitting in the small
(27:19):
room where he does his work. Zoom calls and because
there's an embargo on this information, nobody can know because
nobody is supposed to trade on the announcement. His lips
are sealed. Once I found out, I couldn't tell anyone.
I mean, this was this was highly confidential material information
until it was announced publicly. I couldn't tell my wife,
(27:40):
I couldn't tell anybody. So so it was. It was
actually a quiet moment. He has to keep quiet for
less than a day. On Monday, November nine, at six
am in New York, Visor and BioNTech send out their
press releases and break the news to the world. Trials
carried out by the U s pharmaceutical John Fisa and
(28:02):
the German manufacturer bio in Tech suggest they have created
a coronavirus vaccine which is more than nine effective. It
is a great day for science. It is a great
day for humanity, sort of like a bright ray of
sun pushing all the clouds away. The good news is
that science that has given us the vaccines that we
(28:26):
have have been a spectacular success story. We probably all
remember the moment we learned a vaccine is coming and
it's almost certainly going to work. Since this is Bloomberg,
(28:49):
I'll put it into financial terms, that Monday the vaccine news.
Since stocks around the world soaring by more than one
point eight trillion dollars after months of uncertainty, people see
a way out of the pandemic. There are also some
skeptical voices that first press release doesn't have all the details,
(29:10):
the results of preliminary but it looks really, really good.
The researcher who helped start it all, Cattle and Kerrycho
gets the news in Pennsylvania. She'd been stuck in the
US while the vaccine was being developed, running her lab
in Germany. Via video chat after being in Pennsylvania and
a visit with her husband when countries closed their borders,
(29:34):
she tells CNNs Chris Cuomo she was confident the shot
would work. I heard you celebrated with an entire bag
of chocolate covered peanuts. Yeah it was Google. Yeah that's
my favorite. But you know, I am not a kind
of exuberant person who yeah, this is nice. In Philadelphia, JW.
(29:57):
Wiseman breathes a huge sigh of really, he'd been nervous
that great results and animals wouldn't translate. Remember how he said,
my sly and monkeys exaggerate. I got it in the
press release with everybody else. Um, so I was very nervous.
I was nervous because we've worked on probably twenty different
(30:20):
RNA vaccines or influenza, neuro virus, how HIV, a bunch
of different diseases, and just about every one of them
we had protection in our animal models. So I was
nervous because I was worried that the that the human
(30:42):
vaccine might be effective and we wouldn't know why and
we wouldn't understand why. So when I heard they were effective,
I was happy because that meant we saw in humans
what we had seen and everything from ice, the pigs,
the chickens and my cates to every animal we tried.
(31:06):
A week later, on November six, Moderna announces its vaccine
had been ninety four point five percent effective in a
similar huge trial. After more analysis, Visor bumps up its
trial results to From there, you know the story. The
FDA and other regulators around the world clear the vaccines
(31:28):
for sale. That jump starts a global race to get
enough shots. The vaccines will almost certainly be this year's
best selling drugs. The fiser BioNTech shot is on track
for thirty six billion dollars in sales. Moderna had to
scale back its targets because of problems getting all the
vaccines it made into files and out to customers, but
(31:50):
still it's seeming for up to eighteen billion dollars in sales.
The vaccines can't end the pandemic all by themselves. Another
wave is rolling across the Northern Hemisphere and a new
highly mutated variant called Omicron has just emerged. Our ability
to deal with both will be hampered by significant pockets
(32:13):
of unvaccinated people who don't trust a shot that was
developed so fast people still need masks. Countries with enough
doses to go around are rolling out booster shots the
top of community that seems to fade slightly around the
six month mark. The vaccines are also increasingly being approved
(32:34):
for kids. Lower income countries are in an even tighter
spot as wealthier places gobble up the available doses. But
as you were said, the shots have shown us the
light at the end of the tunnel, and if they
need to be altered to deal with the Omicron variant,
that should be possible within a matter of months. In
(33:00):
December eighteen, Catle and Curry Coo Andrew Wiseman go together
to get vaccinated. Pennsylvania hospital had started giving shots two
days before and we are collaborating ever since, you know
we met at the xerox machine. They had come full circle.
We're waiting the hashcare workers into in line there to
(33:23):
get their vaccine, and you know, they collapsed and then
then I dried. It was exactly what she had wanted
why she left academia to take the job at BioNTech,
the chance to see her research help people. M Next
(34:00):
we come Breakthrough, We'll talk about what researchers like Catalan
and Derek were originally hoping to do with m R
and A your diseases. We'll look at whether success against
COVID is just the first step towards helping people with
everything from cancer to multiple sclerosis and malaria. Wherever protein
is needed, it can be applied. That could be six
(34:23):
thousand genetic diseases, oncology, cancer, mutated jeans. This episode of
Prognosis Breakthrough was written and reported by me Naomi Krasky
So for Foreheads as our senior producer. Carl Kevan Robinson Jr.
Is our associate producer. Our theme music was composed and
performed by Hannas Brown, Ema Court and Bob Langreth contributed reporting.
(34:47):
Rick Shine is our editor Francesco Levi is the head
of Bloomberg Podcasts. Be sure to subscribe if you haven't already,
and if you liked this episode, please leave us a review.
It helps others find out about the show. Thanks for listening.
(35:20):
M
It's a cloudy, freezing Friday night in January. In Minds,
(00:10):
a university town in central Germany, or Shine, a doctor
and cancer researcher, bikes home from his lab in the dark.
He makes a cup of tea and settles in to
read the week's medical journals and starts with leading papers.
Has spent more than twenty years of his life trying
(00:32):
to figure out how to use the body's immune system
to target and destroy tumors. But tonight, a different disease
catches his interest. An ominous new virus is spreading in China.
Medical journal The Lancet has just published the first case
descriptions for forty one people who'd gotten sick in the
(00:53):
city of Juhan. Uger notices one thing right away. A
new message in this paper was that one of the
family members had the disease was VIBUS positive, but did
not have fever or other symptoms. This was new. The
asymptomatic cases meant the virus could spread in secret. The
(01:15):
symptoms described in the article are serious pneumonia, heart injury,
six deaths. Uer looks up the population of Juhan, eleven
million people, bigger than central London. Then he checks flights
between the city and the rest of the world. There
are dozens of flights every day. It was extremely highly
(01:37):
likely that this is going to be a pandemic, and
we started to discuss what we can do. The next morning,
he turns to the person he trusts the most, his
wife and fellow researcher with them too, Ritchy. She's the
one who challenges his big ideas, forces him to hone
his hypotheses. He spends about an hour showing her what
(01:59):
hend on. They both know the best weapon to fight
what's coming will be a vaccine. They've been testing a
new technology using messenger RNA and experimental cancer therapy, and
had done a lot of lab work on a potential
flu vaccine, but neither they nor anybody else had ever
(02:19):
used the technology in an approved medicine for humans. After that,
it was not about discussing. It was about asking the question,
how can we make this happen? If we really want
to contribute and try to engineer a vaccine, how quick
this work. They had never even done a patient trial
(02:42):
in infectious diseases before, just lab experiments. Nobody knew whether
it would work, but they were about to embark on
an unprecedented race to find a vaccine against COVID nineteen.
We decided to start a program because it was clear
it was an obligation to do something. Welcome to the
(03:07):
seventh episode of our series. In our last episode, we
heard about how researchers Catalan Kariko and Drew Wiseman worked
for decades and relative anonymity to lay the groundwork for
getting m RNA into cells. With the pandemic, their work
has a chance to make its way to patients far
faster than what would have previously seemed possible. This time
(03:31):
we're looking at the remarkable race to speed up development
time of a COVID nineteen vaccine in the usual decade
or so to a head spinning ten tranzied months. This
is a story about the biggest scientific breakthrough with the
pandemic mRNA vaccines. Now Suddenly, vaccines are the world's number
(03:51):
one priority and the race to make them is on. Soon,
hospitals and morgues will be filling up. Hundreds of thousands
of people are about to die in cities around the globe.
Every hour of every day is crucial as scientists race
to do years of work and months. Whoever gets the
(04:11):
finish line first, will make a name for themselves as
science heroes, victors in a once in a century war
with the killer virus. So many lives on the line,
and for the drug companies billions of dollars in profits too.
My name is Naomi Kraski and I'm a health reporter
for Bloomberg News from the Prognosis podcast. This is Breakthrough,
(04:53):
the story of the COVID vaccine race starts with a
pair of young biotech companies. One is BioNTech, led by
Or Shah and it slam too duchy when we just met.
The other is Moderna, founded by Derrick Rossi, the stem
cell researcher we met in our last episode, and led
by a charismatic Frenchman. Needs to fund cell. Unlike BioNTech,
(05:18):
which had mostly been a cancer company prior to the pandemic,
Moderna was able to build on a lot of prior
work and infectious disease. Here's to fund the CEO. We've
been working on the mountain for ten years. We have
been working on infectious disease of vaccine for most of
those teneos. Moderna had started patient trials on nine other
(05:40):
potential vaccines against other infectious diseases before this pandemic vaccine,
so this was not new to us. We've been working
on it a lot. In Moderna had started working with
the US government to design vaccines. The project included mers
A coronavirus that it hits out of Arabia and other countries,
(06:02):
and the follows to fund. Briefed officials from the National
Institute of Allergy and Infectious Disease known as NAIAD on
a factory the company had built in Massachusetts. It could
produce new vaccines in just sixty days. Steffun invited the
government officials to tour the facility. Sensing some skepticism, he
(06:24):
offered to do a test run for a hypothetical pandemic.
The agency would send Moderna the genetic sequence for an
emerging viral disease. Moderna would see how fast it could
get a vaccine ready. The agency was about to pick
a virus to use when along came stars Covey two.
It was a perfect test case. So we were made
(06:47):
aware of the virus between Christmas and New Year of
We got the sequence from the Chinese government in our
January the tenth put online. By the fifteen of anyway,
we had the vaccine design lockdown on the computer, because
all in Silico we never touched a physical virus. Here,
(07:10):
it's helpful to step back for a minute and review
what distinguishes mRNA vaccines from conventional shots. In the old
way of doing things, vaccines introduced dead or weakened bits
of virus into the body primarily immune system to recognize
and destroy the real thing. Messenger RNA vaccines work differently.
(07:34):
They contain a template that cells will use to make
the bits of viral protein themselves, essentially turning the body's
own cells into vaccine making factories. The differences also extend
to manufacturing. Conventional vaccines are grown inside live cells. Some
even use chicken eggs. Messenger RNA vaccines don't need any
(07:59):
of that. Making them is a chemical process, a little
bit like cooking. Makes the ingredients together and you get
the vaccine. That may sound simple, but it isn't. Stefan
told us that going from the theory to actual drugmaker
seemed like a long shot when he quit his previous
job joined Moderna. But if he's going to work, you
(08:20):
would change medicine forever. Great pandemic. Bion tech had been
mostly focusing on cancer one thing it's scientists were able
to do in those early days was pull off the
method for developing rapid personalized versions of m RNA vaccines
based on cancer patients individual tumors. So we had the
(08:43):
technology that we could use a vaccine platform to come
up as a new vaccine was in a few weeks.
This is another really important point about mr anda of vaccines.
The technology itself took decades to refine, but within that framework,
designing a vaccine to target a particular pathogen is actually
(09:04):
really quick. Before mr and A vaccines came along, the
fastest vaccine project ever was the n and Drug Company
American co licensed to Shop for Moms. That took four years.
The scientists who led the project, Maurice Hillman, swabbed his
six five year old daughter's throat in order to get
the lab specimen he needed to make the shot. With
(09:28):
m r and A vaccines, you don't have to do
anything like that. You don't need swab samples. All you
need is the genetic code of the virus cattle and
carry co. The pioneering researcher who left academia to work
at BioNTech, says this and the event of the Internet
gives researchers a leg up. You know you you are
(09:50):
very young, so you don't remember, but how long it
took like for HIV to set up the test to
recognize this infected recognizing the I mean it took so
long because the technology was not advanced in minds. We
were an earths them get a slightly later start than
their US rival. They have their kitchen table conversation about
(10:14):
committing to a COVID vaccine a few weeks after MODERNA
is already working on the vaccine design, but they start
moving quickly. To the day after their decision to start
work on a vaccine, we were calls a series of
meetings with his manufacturing team, pre clinical testing team, and
business development team. The crowd into his office in Mines.
(10:37):
It's a simple room with the desk, conference table, some
family pictures tacked onto a bulletin board. It's on the
same hallway as the labs. He asks everyone to start
planning how they can divert resources away from their other
projects to a new full court press COVID vaccine push.
On this Monday, I had five or six meetings with
(10:59):
different and we had to day thereafter a board meeting
to discuss how this can be supported by other board members.
The same day, the first COVID case is confirmed in Germany.
It's a thirty three year old man living near Munich.
He works at an auto parts company. We had just
(11:21):
been in a meeting led by a colleague who was
visiting from China. We were assigned twenty five people to
work on a potential vaccine, setting up shifts that run
through evenings and weekends. It's basically seven operation. We had
to reduce the timelines. We tried to figure out how
to do that, and in principle we came up as
(11:45):
a number of really innovative strategies. One was doing things
in parallel instead of doing it sequentially. It's a risky
of a time saving decision. Usually companies don't prepare for
a pay Asian trial until they have a potential drug
to test. But Uger's teams start working on getting trials
(12:06):
ready to go already. They figure they can add the
details about the vaccine that's going to be used once
they have it, they start making multiple candidates. You need
to do a lot of detailed paperwork before you can
test any kind of drug on people. So Uger also
gets in touch with German clinical trial authorities. He knows
(12:27):
them well because of bion texts work with cancer vaccines.
He asked them for a meeting. Usually it takes three
months to get a meeting date. So I called them
and asked if we could come up just just data
day and and they said, first of all, prepare a
briefing book and if you've managed that, you can come
(12:50):
next week. So Uger's team works night and day to
write an ad page document describing there would be COVID
vaccine project. They agreed to our plan. The only only
challenge for us. They wanted to see a toxicology try.
It usually takes six months, and we wanted to start
(13:12):
in April. Yeah, so will be the beginning fable Abby
and they they quested to have a talk study and
they had to figure out how to do the talk
in in less than less than three months. And the
teams you get that out. Moderna is also doing things
in parallel, setting up the next steps for bigger trials
(13:35):
before the early ones are done. By February forty two
days after it started, the company ships the first batch
of vaccine to NAIAD. Remember that's the National Institute of
allergy and infectious disease. Like BioNTech, they are relying on
close partnership with regulators. Unlike BioNTech, they have a direct
(13:57):
government partnership. The National Institutes of Health is the co
developer of the vaccine. The Food and Drug Administration is
taking their calls at all hours of the night into
the weekend. Stefan says, I think one of the hero
of this remarkable SENSEFIC achievement of twenty is vf D
(14:19):
because you know, usually through the process is set up
by the agency. You know it would sometimes take months
to get an answer to a question. Well, here we
had answers on questions seven with the NIH to help them. Well,
Darrena moves forward without a big farm a partner for
(14:42):
BioNTech in Germany, that's not the case we're in Aslam. No,
they can't run the huge clinical trials needed for approval
on their own. Neither do they have the kind of
global distribution you need the ship of vaccine all around
the world to succeed. They need a sponsor with deep
pockets who picks up the phone and calls his contact advisor.
(15:06):
The drugs behemoth based in New York. The companies had
already made a deal in to work together on an
m R and a flu vaccine. Phil Dormantzer, chief scientific
officer for Viral Vaccines Advisor, remembers that call who are
wanted to transfer people who are working on flu to
the new virus really just swapping out the influenza and
(15:29):
engine coding sequences and swapping in the stars COVID to
ANDREW coding sequences, because we like to be really out
in front of this new disease that's broken out in Wuhan, China.
Remember when I said vaccine makers no longer needed live
cells or swabbed samples to build vaccines, but that all
(15:52):
you need is the genetic code of the virus. That's
what Phil is talking about here, and this is a
big deal. Ion Tech might not have had ongoing human
trials with infectious disease vaccines, but they were already working
in the area. Paddlan explains how far along the flu
work already was. We were advancing those studies. Animals studies,
(16:14):
monkey studies were finished, and we were just there to
request the authorities work for the permission all of the sudden.
Instead of influence, so we switched over to to Corona.
By March two, they have twenty vaccine candidates that could
spur a strong immune response against the virus, and lab
animals and cell culture experiments. That day, Uber calls Katrin Jansen,
(16:39):
visors had a vaccine research and development and Phil spots
it doesn't take long to convince her. I remember there
was a call on which Uger and Katherine Jansen, who
who leads vaccine research and development advisor UM and I
spoke about this and they said, well the work plan.
So I'll literally get him overnight typed up a work plan.
(17:02):
What are the things that we would do. The plan
goes to Albert Berla, visor CEO. Albert basically said we
are going all in on this, that this is clearly
an emergency. Albert said, in this circumstance, we need to
divert resources and do whatever is needed to bring the
(17:22):
vaccine forward. So his expectations of timelines were far faster
than anything that that that we would have imagine before. Meanwhile,
the FDA signs off on Moderna's plans for a trial
in humans. Stefan's team injects its first volunteers on March sixteen.
(17:42):
About a month later, on April Bion second Fiser start
their human trial in Germany. Less than two weeks after that,
a US trial begins. I think we were the only
company which really started was all ever having ever tested
their their platform in infectas disease. And we've also the
(18:06):
only company which tested multiple candidates in pavalum Ugar is
talking about shoehorning in one more science experiment, he wants
to test four different potential vaccines in the first human
study to see which one is the best. It's risky
because it could delay development. Well, Darren has already picked
(18:28):
the full spike for its vaccine, but UGO wants to
try to optimize their shot as much as possible before
they give it to thousands of people. The question is
whether to make a vaccine based on only a piece
of the virus is spike or the whole thing. Picking
the right bit of the protein for the vaccine could
potentially make a big difference in how well it works.
(18:51):
And you could find in the literature arguments for both
and against both. And so we said, let's test both
and get the clinical data, get the preclinical data, and
then get the answers. In July, both Moderna and the
Fiser BioNTech team announced early data showing their vaccines can
(19:13):
produce antibodies in people. Biontechs first data is for the
version of the vaccine that made only one part of
the spike protein, something called the RBD domain. It's good data.
The clock is ticking. Some people want to move forward
with that version of the shot right away. We had
a lot of pressure from the clinical teams just to
(19:36):
go ahead domain it teams to insist on waiting for
the data from the full spike to see whether it
might wind up making a safer or more effective vaccine.
They have to move fast. While the pandemic has ebbed
in some places like Germany, the US is in the
middle of a summer surge about to hit a hundred
and fifty COVID deaths. Experts warned that another wave will
(19:59):
probably come in the fall. They rush blood samples from
volunteers to labs in Germany and the US. The safety
data shows that the full spike vaccine is even better
than the partial spike. It might cause fewer side effects,
gives a better immune response to so on July they
decide to go with that one. Remarkably, three days later,
(20:22):
on July, both Moderna and Fizer BioNTech start the huge
clinical trials necessary to win regulatory approval. There are tens
of thousands of volunteers. Their real life experience will show
whether the vaccines can work outside the confines of a lab,
(20:42):
whether they can make a dent against the virus in
real life. That summer, Moderna also get one billion dollars
in funding from Operation Warp Speed, the Trump Administration's effort
(21:05):
to hurry along vaccine development. The money is allocated via BARDA,
the Biochemical Advanced Research and Development Authority. I think this
is one story that is not talked about enough, is
what Balda and then Operation vout Speed did by you know,
sponsoring six companies, giving us the financial resources to take
(21:30):
a lot of business risk. Eiser doesn't take US government funding,
although the partners signed a one nine billion dollar contract
to sell one hundred million doses to the US government
if the show works, that's its own form of security.
Moderna has its own deal for one hundred million doses
(21:50):
for about one point five billion, and BioNTech takes German
government funds. They need the money to build a factory.
They've never had to new factor for millions of people before.
They searched Germany and find an old novartist vaccine factory
in Marburg, close to Frankfurt. They close on the site
in the fall and work on retrofitting it for m
(22:12):
R and A manufacturing. But there's a problem with making
a key part of vaccine. Or and Katherine Jansen talked
about this earlier this year at a conference hosted by
healthy website stat Yes that that was indeed the low points,
so we had an effect the vaccine. We wanted to
(22:32):
to produce one hundred million doses and then it turned
out that's one off the components did not work as
as expected. The problem was with lipid nanoparticles. These are
tiny bubbles of that that worked like a protective coating
for the vaccine. They keep the body's enzymes from destroying
(22:54):
it before it can make its way to a cell.
The lipid issue that we faced at one time, that's
through a real monkey wench, and it's so not only
did we have to keep the program on track, we
had to have a significant number of our colleagues, you know,
working through it and trying to understand it. It originally
said that if the vaccine worked, it could make a
(23:16):
hundred million doses. Because of the manufacturing issues, they had
to scale that back to fifty million doses. Well, we
faced enormous challenges like in in every in every development
program and vaccine development program, you have enormous challenges and
the difference why we usually those challenges of COVID ten years, Yeah,
(23:38):
the same challenges a nine months. By this point, they're
working NonStop to solve the manufacturing problems. But the biggest
question is still open, just how well does the vaccine work.
The answer will come in the huge study that Fiser
is running. They've expanded. It's more than forty patient people
(24:01):
all around the world who have volunteered to get two
shots in the arm without knowing whether what's in the
syringe is a vaccine or just a placebo. Then they'll
go out and live their lives and see whether they
catch COVID. If they get symptoms, the test will show
whether it's the virus. The researchers themselves also don't know
who got the vaccine and who didn't. It's just a
(24:24):
matter of time waiting to see how many people get sick.
And all around the COVID pandemic is getting worse. The
second wave is happening Europe heads back into lockdown. In
the US, the death toll hits two thousand people in September.
In only two months, another fifty people die. How we're
(24:48):
not in a good place for a couple of reasons.
Cases surging in nearly every state, more than two new
cases in just twenty four hours in this country, alas
as a cruel much of Europe, the virus is spreading
even faster than the reasonable worst case scenario of our
(25:08):
scientific advisors. It's Sunday in November eight, almost ten months
after the Sunday morning when it's them and UGO had
talked about whether to tear up their company plan and
chase after a COVID vaccine. They're waiting in their apartment
(25:29):
for five or CEO Albert Burla to call. They're on edge.
They've heard that the independent panel of experts that's monitoring
the trial is reviewing the results. They're expecting the panel's
predict at any moment. We both are very tense. The
entire day. There was still the scenario that would be
(25:50):
oh THEO at all. Yeah, and remember that that understood
that I I was worried, and he said, you know,
it does not matter what we hear later today, it
might well be that does not look good, but anyway,
it was worth it and it was of a moral
(26:11):
obligation to at least try it. Finally, at eight p m.
The phone rings. Albert is on the line. They put
him on speaker. He said, do you want to know
the Lisa, and I said no. I realized already from
his voice that there would be a positive a message,
(26:32):
but neither of them were prepared for just how good
the results would be. Ure told me he was expecting
efficacy in the range of against the virus. They have
to hit at least fifty for the vaccine to be
considered viable for the market. What they get is well
above nine. This was incredible. Yeah, this was just wave
(26:57):
taking and that in this moment he understood, Hey, days,
a vaccine for mankind and corna is is a problem
that can be solved. Across the Atlantic, Phil Dormantzer is
sitting in his apartment close to find SoRs office when
he gets a similar call. He's sitting in the small
(27:19):
room where he does his work. Zoom calls and because
there's an embargo on this information, nobody can know because
nobody is supposed to trade on the announcement. His lips
are sealed. Once I found out, I couldn't tell anyone.
I mean, this was this was highly confidential material information
until it was announced publicly. I couldn't tell my wife,
(27:40):
I couldn't tell anybody. So so it was. It was
actually a quiet moment. He has to keep quiet for
less than a day. On Monday, November nine, at six
am in New York, Visor and BioNTech send out their
press releases and break the news to the world. Trials
carried out by the U s pharmaceutical John Fisa and
(28:02):
the German manufacturer bio in Tech suggest they have created
a coronavirus vaccine which is more than nine effective. It
is a great day for science. It is a great
day for humanity, sort of like a bright ray of
sun pushing all the clouds away. The good news is
that science that has given us the vaccines that we
(28:26):
have have been a spectacular success story. We probably all
remember the moment we learned a vaccine is coming and
it's almost certainly going to work. Since this is Bloomberg,
(28:49):
I'll put it into financial terms, that Monday the vaccine news.
Since stocks around the world soaring by more than one
point eight trillion dollars after months of uncertainty, people see
a way out of the pandemic. There are also some
skeptical voices that first press release doesn't have all the details,
(29:10):
the results of preliminary but it looks really, really good.
The researcher who helped start it all, Cattle and Kerrycho
gets the news in Pennsylvania. She'd been stuck in the
US while the vaccine was being developed, running her lab
in Germany. Via video chat after being in Pennsylvania and
a visit with her husband when countries closed their borders,
(29:34):
she tells CNNs Chris Cuomo she was confident the shot
would work. I heard you celebrated with an entire bag
of chocolate covered peanuts. Yeah it was Google. Yeah that's
my favorite. But you know, I am not a kind
of exuberant person who yeah, this is nice. In Philadelphia, JW.
(29:57):
Wiseman breathes a huge sigh of really, he'd been nervous
that great results and animals wouldn't translate. Remember how he said,
my sly and monkeys exaggerate. I got it in the
press release with everybody else. Um, so I was very nervous.
I was nervous because we've worked on probably twenty different
(30:20):
RNA vaccines or influenza, neuro virus, how HIV, a bunch
of different diseases, and just about every one of them
we had protection in our animal models. So I was
nervous because I was worried that the that the human
(30:42):
vaccine might be effective and we wouldn't know why and
we wouldn't understand why. So when I heard they were effective,
I was happy because that meant we saw in humans
what we had seen and everything from ice, the pigs,
the chickens and my cates to every animal we tried.
(31:06):
A week later, on November six, Moderna announces its vaccine
had been ninety four point five percent effective in a
similar huge trial. After more analysis, Visor bumps up its
trial results to From there, you know the story. The
FDA and other regulators around the world clear the vaccines
(31:28):
for sale. That jump starts a global race to get
enough shots. The vaccines will almost certainly be this year's
best selling drugs. The fiser BioNTech shot is on track
for thirty six billion dollars in sales. Moderna had to
scale back its targets because of problems getting all the
vaccines it made into files and out to customers, but
(31:50):
still it's seeming for up to eighteen billion dollars in sales.
The vaccines can't end the pandemic all by themselves. Another
wave is rolling across the Northern Hemisphere and a new
highly mutated variant called Omicron has just emerged. Our ability
to deal with both will be hampered by significant pockets
(32:13):
of unvaccinated people who don't trust a shot that was
developed so fast people still need masks. Countries with enough
doses to go around are rolling out booster shots the
top of community that seems to fade slightly around the
six month mark. The vaccines are also increasingly being approved
(32:34):
for kids. Lower income countries are in an even tighter
spot as wealthier places gobble up the available doses. But
as you were said, the shots have shown us the
light at the end of the tunnel, and if they
need to be altered to deal with the Omicron variant,
that should be possible within a matter of months. In
(33:00):
December eighteen, Catle and Curry Coo Andrew Wiseman go together
to get vaccinated. Pennsylvania hospital had started giving shots two
days before and we are collaborating ever since, you know
we met at the xerox machine. They had come full circle.
We're waiting the hashcare workers into in line there to
(33:23):
get their vaccine, and you know, they collapsed and then
then I dried. It was exactly what she had wanted
why she left academia to take the job at BioNTech,
the chance to see her research help people. M Next
(34:00):
we come Breakthrough, We'll talk about what researchers like Catalan
and Derek were originally hoping to do with m R
and A your diseases. We'll look at whether success against
COVID is just the first step towards helping people with
everything from cancer to multiple sclerosis and malaria. Wherever protein
is needed, it can be applied. That could be six
(34:23):
thousand genetic diseases, oncology, cancer, mutated jeans. This episode of
Prognosis Breakthrough was written and reported by me Naomi Krasky
So for Foreheads as our senior producer. Carl Kevan Robinson Jr.
Is our associate producer. Our theme music was composed and
performed by Hannas Brown, Ema Court and Bob Langreth contributed reporting.
(34:47):
Rick Shine is our editor Francesco Levi is the head
of Bloomberg Podcasts. Be sure to subscribe if you haven't already,
and if you liked this episode, please leave us a review.
It helps others find out about the show. Thanks for listening.
(35:20):
M
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