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This tiny creature
and the silent killer it carries
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is the target of one of
medical science's greatest quests.
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A battle to save millions of lives
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and end a scourge
that has shaped human history.
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Malaria.
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One child dies every single minute
from malaria.
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So you might ask yourself,
"Why are kids still dying?"
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For almost a century,
scientists have had one goal.
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We don't want to use the word
the Holy Grail,
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but if we got vaccines,
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then, of course,
that would be transformational.
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The chances of success
are really, really small,
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but the rewards if you do it
are enormous.
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This is the inside story,
across four continents,
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of a new vaccine against malaria.
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ls Slate 1 up on mine, or is it
on yours? No, but the folder's up...
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It's being made
by the same Oxford University team
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behind the UK's Covid vaccine.
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We have the head off.
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It's those little sacs
that have got the parasites in.
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But this time it's an even more
complex scientific challenge.
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It didn't work, it didn't work,
and it didn't work.
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I remember very openly
and straight telling
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that this is not going to work.
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And then,
after many tweaks and changes...
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...it did.
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Well, to me, it was unthinkable
before it happened.
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Another good news story
about British vaccines.
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It will probably have
the biggest impact
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on global public health
for generations.
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It will be up there
with clean water. It is that big.
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APPLAUSE
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This could be a game changer.
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You are touching human life.
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You are going to
save the human life.
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It's not one or two.
It's millions of lives.
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Amazing, isn't it?
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Throughout our history,
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the mosquito has been
the paramount killer of humanity.
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If we look at our Neverland
nightmares, we're taught to fear
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all these other creatures
because they kill so many humans.
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That's just simply not true.
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For example, wolves and sharks
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kill, I think,
about ten people per year.
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Whereas the mosquito,
this tiny little animal
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the size and weight of a grape seed,
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is responsible for
up to a million deaths a year.
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But it's not the mosquito itself,
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it's the pathogens
that hitch a free ride
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that cause so much suffering,
death and destruction.
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Of all the pathogens
that mosquitoes carry,
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by far the most lethal
and the biggest killer of humanity
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has been malaria.
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A highly effective vaccine
against malaria
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would be a historic breakthrough.
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And getting there
starts with knowing your enemy.
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London's Natural History Museum
is home
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to one of the world's
greatest collections of insects.
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Senior curator Erica McAlister
looks after 150,000 specimens,
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representing 2,900 species
of mosquito.
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We have maybe
350 drawers of mosquitoes,
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but only 20 of those drawers
are the species of mosquitoes
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that are important
for the transmission of malaria.
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The difference between the males
and the females is very important.
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The males are all vegetarian,
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but the female
has to generate the eggs.
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Therefore, she needs
a really, really high-protein meal.
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The blood.
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You've got the proboscis,
her fantastically long mouth part.
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It's composed of six stylets.
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She uses two of those to kind of,
like, penetrate the flesh,
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she uses two of them
to keep it open,
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and then her final two,
one is basically a tube
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which she will suck up
your blood with,
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but the other one,
through that she releases her saliva
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to prevent the blood clotting.
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Ancl it is in that process
that the malaria parasite
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is able to transfer into us.
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NEWSREEL: Public enemy number one -
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Anopheles, the malaria mosquito,
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wanted for bringing sickness
and misery to untold millions.
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Today, malaria is considered
a tropical disease,
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but until very recently
it affected people worldwide.
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And it's played a huge part
in our history.
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When we look at European history,
for example,
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Europeans actually called malaria
the Roman fever.
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The word malaria - malaria -
actually means bad air in Italian.
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So Rome was surrounded by
310 square miles of Pontine Marshes,
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which were a hotbed
of malarious mosquitoes.
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Now, interestingly, they acted
as a shield from foreign invasion.
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Invaders either
couldn't conquer Rome
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or had a very brief stay before
malaria started to sap the strength
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of their troops
and they would withdraw.
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So it safeguarded and shielded Rome,
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allowing for the expansion of Rome,
the city, and also the Roman Empire.
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For the next 2,000 years,
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malaria-carrying mosquitoes
continued to plague most of Europe.
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Modern science would not even begin
the fightback
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until barely a century ago.
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At the dawn of the 20th century,
a physician of tropical medicine
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remarked that the future of humanity
would be decided by one battle -
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man versus mosquito.
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All right, men,
now we can begin to fight.
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RALLYING BUGLE TUNE
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During World War ll, military
casualties from malaria were so high
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that the authorities declared
total war,
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even recruiting Walt Disney
for the fight.
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Attaboy, DOPEY-
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Kill her good and dead.
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The newly invented insecticide DDT
destroyed mosquito populations...
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...swamps were drained...
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...protection against bites
improved...
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...as did the availability
of malaria treatments and tests.
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In the Western world, malaria
was made extinct, essentially.
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As a result,
the malaria burden shifted
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to lower socioeconomic countries,
specifically in the Global South.
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Funding for malaria research
was drastically cut,
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and malaria was generally all but
forgotten in most wealthy nations.
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Nine out of ten people
in Tanzania, East Africa,
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live in the country's malaria zone.
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And it's the youngest children,
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naturally much less able
to fight off infections,
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who are most at risk.
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Farhiya Saturn is three years old.
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She lives in Kiwangwa village
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with her mother, Zohara Abasi,
a pineapple farmer and small trader,
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and her grandmother, Huba Mohamedi.
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Across Tanzania and much of Africa,
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malaria costs lives
and livelihoods,
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undermining the potential
of an entire continent.
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Dr Ally Olotu of
the lfakara Health Institute
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serves on the medical front line.
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I got malaria when I was young,
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and I also got malaria
when I went to the university.
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That's when I became aware
that this is...
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It's an awful disease.
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Globally, malaria causes
over 200 million cases
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and more than
600,000 deaths annually.
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About 80% of these deaths
are actually young children
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below the ages of five.
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Tawakar is three years old,
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and was in grave danger
of falling into a coma
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until he came to the hospital
just 24 hours ago.
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Seeing kids who are suffering
from malaria,
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emotionally it's always difficult.
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As a clinician, as a father,
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I have to develop interventions
to do everything possible
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to get rid of malaria.
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While Ally regularly treats children
who have been infected...
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...his colleague,
mosquito biologist Fredros Okumu,
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works on malaria prevention.
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Hey, how are you doing?
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How are the mosquitoes today?
Have you blood-fed the mosquitoes?
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Yeah. Uh-huh.
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To evaluate specific products
for protecting people,
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we have to rear the mosquitoes
in our labs.
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MOSQUITOES BUZZ
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We have to provide
water, sugar and blood.
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Today, it is lab technician
Stuart Ngala's turn
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to feed the mosquitoes.
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MOSQUITOES BUZZ
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The mosquitoes we have in the lab
are malaria-free.
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It's something
that we scientists do.
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So, I mean, I do it as well.
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Fredros uses these mosquitoes to
test insecticide-treated bed nets.
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It's estimated that,
over the last 20 years,
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tools like these
have prevented a staggering
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two billion cases of malaria
and nearly 12 million deaths.
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Yes, there's been
extensive progress.
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Is it sufficient progress?
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No. Because now we have this
challenge since around 2015
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where there are many countries
in Africa
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where malaria cases are going up.
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It's not much killing the mosquito.
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So that particular net
didn't kill enough mosquitoes. OK.
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The bed nets that we have
in the villages
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are starting to face
a lot of challenges.
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Mosquitoes are no longer
being killed as effectively
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because they have become resistant
to the insecticides
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that we put on the surface, and so
the bed net can lose that quality,
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the killing effect.
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You've got mosquitoes that are able
to lay hundreds of eggs.
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They have some really short
generation times.
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So some mosquitoes
can be, like, two weeks,
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and then suddenly
you've got a new generation.
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So any time they get
a new chemical thrown at them,
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if it's not clone correctly,
you can see gene resistance.
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Ancl it's like, "Poof!" -
game over for that insecticide.
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They're so adaptable.
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Despite concerns
about increasing resistance,
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bed nets treated with insecticide
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remain the world's number one weapon
against malaria.
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But research shows they reduce
child deaths by less than 20%.
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We need a transformational tool,
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and I do not think
there is any medical intervention
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that has clone better or more
than vaccines.
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When it comes to transforming
human health and saving lives,
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vaccination is up there
with clean water and sanitation.
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Smallpox, which killed up to 500
million in the 20th century alone,
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was eradicated in the 1970s
thanks to vaccination.
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And there's also been huge success
against polio, measles,
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and recently Covid-19.
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But a highly effective
malaria vaccine has never emerged.
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That's not for lack of trying.
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Ally himself has worked
on multiple vaccine candidates.
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So do you know
what Daddy's working on?
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What am I working on? Malaria.
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Malaria what?
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Malaria vaccine. OK.
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So that you can...you can
protect children, isn't it,
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from getting malaria?
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Because children below...
under five years who have malaria
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are in much bigger danger
than others.
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Ancl they die. Yes, they can die.
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But if you go to hospital first,
you will survive.
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I saw a child three years old
who had malaria in the hospital,
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but he was treated
and he will get better.
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But he was very lucky.
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As night falls,
this is the most vulnerable time.
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MOSQUITO BUZZES
That's when the mosquitoes come in.
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When the mosquito bites,
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it injects into that child
small parasites.
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We call them sporozoites.
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These spend a very few minutes
in the blood,
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and then quickly go and start
to multiply within the liver.
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And these kids
could be playing around,
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they can be playing football,
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they could be singing
with their parents.
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Nobody can suspect anything.
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But from the liver,
within a few clays,
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you could have thousands
and thousands of parasites
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released into the blood.
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They attack our red blood cells,
destroying them.
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Ancl this is what actually
gives rise to malaria symptoms.
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That child you saw playing
with his friends just a few clays ago
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can quickly become severely sick.
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And if not diagnosed
and treated very fast,
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that child might lose life.
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It's this process -
the way the body is overwhelmed
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before it has a chance
to fight back -
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that makes malaria so dangerous,
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and the development of a vaccine
so challenging.
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We have developed vaccines
for other diseases, of course,
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but most of these are viruses
and bacteria,
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which are much simpler pathogens
compared to malaria.
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It's a very complex parasite.
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So I was really excited to be part
of the consortium of scientists
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00:17:07,240 --> 00:17:09,615
put together
by the University of Oxford
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to work on a new malaria vaccine.
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The University of Oxford is home
to one of the world's largest
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academic vaccine
development programmes.
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In 2020, the university's
Jenner Institute
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created the Oxford AstraZeneca
Covid-19 vaccine.
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And, since then, 3 billion doses
have reached 170 countries.
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Adrian Hill and his colleagues
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have found malaria
much more difficult.
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We've known for over 100 years
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that it would be fantastic
to have a malaria vaccine.
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People have been trying
for about 120 years,
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ever since the parasite
was discovered.
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I did a count about six months ago
of how many vaccines had been made
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and gone into clinical trials for
malaria, how many different ones,
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and that number was 142.
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I'm not sure there's another disease
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where there have been that
many vaccines that didn't work.
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Katie Ewer is the lead immunologist
on the Oxford team.
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I think malaria is more personal
for me because it's children.
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I think you'd have to be
a very hard-hearted person
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not to be moved by a death toll of
400,000 kids a year dying in Africa,
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under the age of five, from malaria.
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It's a huge motivator
to work on something
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where the chances of success
are really, really small.
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But the rewards, if you do it,
are enormous.
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For the last 13 years, the Oxford
team has been working on a vaccine
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called R21.
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Its goal is to fire up
the body's immune defences,
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to be ready to attack the parasite
at its most vulnerable moment -
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just after it enters our blood.
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When an infected female mosquito
takes a bite
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and injects sporozoites -
malaria parasites -
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there's about
a half-hour to two-hour window
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before the parasites
invade the cells in your body
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and set up infection there.
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Ancl that's the window that we're
trying to target with our vaccine.
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What all vaccines must do
286
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is mobilise the immune system's
front line defence against invaders.
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An army of antibodies.
288
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Their goal is to quickly neutralise
any invading pathogens...
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...by tightly binding
to their surface,
290
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stopping them in their tracks,
291
00:19:55,120 --> 00:19:57,455
and marking them for destruction.
292
00:20:00,120 --> 00:20:02,535
The problem has been
to produce enough antibodies
293
00:20:02,560 --> 00:20:05,935
to clear all of those parasites
very quickly.
294
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Threatened by just
a few invading parasites,
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00:20:08,920 --> 00:20:12,535
our antibody response
is usually too little, too late.
296
00:20:13,800 --> 00:20:18,055
But luckily, the malaria sporozoite
has an Achilles' heel.
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00:20:19,680 --> 00:20:24,335
To invade the liver,
it relies on a coating called CSP -
298
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the circumsporozoite protein.
299
00:20:28,320 --> 00:20:31,895
What we need are large amounts
of very specific antibodies
300
00:20:31,920 --> 00:20:36,735
that bind as tightly as possible
to the circumsporozoite protein.
301
00:20:36,760 --> 00:20:38,975
Then we should be able
to stop the parasites
302
00:20:39,000 --> 00:20:40,735
before they can reach the liver.
303
00:20:43,120 --> 00:20:46,335
This is where the R21 vaccine
comes in.
304
00:20:47,360 --> 00:20:50,495
It is built from the CSP protein,
305
00:20:50,520 --> 00:20:55,135
and so induces the body to produce
antibodies tailor-made and ready
306
00:20:55,160 --> 00:20:57,135
to neutralise the parasite.
307
00:20:59,560 --> 00:21:01,695
But this is not a new idea.
308
00:21:03,360 --> 00:21:08,855
First designed in 1987, a vaccine
called RTS,S already does this.
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00:21:11,280 --> 00:21:14,895
I've had privilege to work
on RTS,S malaria vaccine,
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00:21:14,920 --> 00:21:19,695
and the overall efficacy
of RTS,S is about 40%
311
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against clinical disease.
312
00:21:22,040 --> 00:21:25,615
40% may sound as
not very good efficacy,
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00:21:25,640 --> 00:21:28,855
but you have to think about
the burden of malaria.
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00:21:28,880 --> 00:21:32,375
We have well over
600,000 deaths annually,
315
00:21:32,400 --> 00:21:37,055
so saving or reducing the burden
by 40% is better than nothing.
316
00:21:40,560 --> 00:21:42,615
After lengthy deliberations,
317
00:21:42,640 --> 00:21:47,535
in 2022, RTS,S became
the first malaria vaccine
318
00:21:47,560 --> 00:21:51,775
approved by the WHO -
the World Health Organization -
319
00:21:51,800 --> 00:21:55,135
35 years after
it was initially developed.
320
00:21:56,640 --> 00:22:01,775
But RTS,S is expensive to produce,
supply is currently limited,
321
00:22:01,800 --> 00:22:04,855
and it falls short
of the WHO's own target
322
00:22:04,880 --> 00:22:08,895
of having a 75% effective vaccine
by 2030.
323
00:22:11,360 --> 00:22:15,695
And so the Oxford team had long
set their sights on an upgrade.
324
00:22:16,760 --> 00:22:18,735
R21 was born out of the idea
325
00:22:18,760 --> 00:22:22,015
that perhaps we could make
a slightly better version of RTS,S.
326
00:22:22,040 --> 00:22:25,055
So it started with a PhD student
called Kat Collins
327
00:22:25,080 --> 00:22:27,055
taking this on as her project.
328
00:22:28,680 --> 00:22:33,135
The RTS,S vaccine is made
of billions of tiny particles.
329
00:22:34,600 --> 00:22:40,055
They're built from a virus protein
that forms a harmless, empty shell,
330
00:22:40,080 --> 00:22:45,695
and part of the same CSP protein
that coats the malaria parasite.
331
00:22:45,720 --> 00:22:49,815
Together, they trigger
the body's immune response.
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00:22:49,840 --> 00:22:52,415
But unlike the malaria parasite,
333
00:22:52,440 --> 00:22:56,135
less than a quarter
of each particle's surface is CSP.
334
00:22:57,440 --> 00:23:00,855
Kat Collins and her Oxford
colleagues wondered,
335
00:23:00,880 --> 00:23:05,815
could increasing the amount of CSP
to better mimic the malaria parasite
336
00:23:05,840 --> 00:23:07,415
make a better vaccine?
337
00:23:09,240 --> 00:23:13,575
We kept on trying different ways
to get that to form into a particle,
338
00:23:13,600 --> 00:23:17,015
and it didn't work, it didn't work,
and it didn't work.
339
00:23:17,040 --> 00:23:20,935
Ancl eventually,
after many tweaks and changes...
340
00:23:20,960 --> 00:23:21,975
...it did.
341
00:23:23,040 --> 00:23:24,255
That was a big clay.
342
00:23:26,200 --> 00:23:28,015
You can literally
see these particles
343
00:23:28,040 --> 00:23:29,735
with an electron microscope.
344
00:23:29,760 --> 00:23:32,655
And, boy, those images
are memorable.
345
00:23:32,680 --> 00:23:34,735
We managed to cover
all of the surface
346
00:23:34,760 --> 00:23:39,095
of every R21 particle in CSP.
347
00:23:39,120 --> 00:23:42,095
We thought, "Fantastic!"
We immunised mice, and guess what?
348
00:23:42,120 --> 00:23:44,615
They were nearly all protected
very well.
349
00:23:44,640 --> 00:23:46,335
This was 2012.
350
00:23:46,360 --> 00:23:47,895
We were finally getting there.
351
00:23:47,920 --> 00:23:52,095
And, of course, getting there means
you're ready to try and manufacture
352
00:23:52,120 --> 00:23:53,895
and go into the clinic.
353
00:23:59,640 --> 00:24:04,335
Oxford University's R21
was doing exactly as they'd hoped,
354
00:24:04,360 --> 00:24:07,815
creating a strong protective
immune response.
355
00:24:07,840 --> 00:24:10,455
But that was just in mice.
356
00:24:10,480 --> 00:24:13,975
The big challenge now
would be testing it in humans.
357
00:24:16,200 --> 00:24:19,095
For this, they called on
Eleanor Berrie,
358
00:24:19,120 --> 00:24:22,615
a specialist in vaccine manufacture
for human trials.
359
00:24:24,000 --> 00:24:28,255
Vaccines are actually one
of the most complicated things
360
00:24:28,280 --> 00:24:29,815
you can manufacture.
361
00:24:29,840 --> 00:24:36,135
But Adrian and Kat were
so enthusiastic about R21,
362
00:24:36,160 --> 00:24:40,175
they had generated
some excellent preclinical data,
363
00:24:40,200 --> 00:24:43,055
and that enthusiasm rubs off on you.
364
00:24:43,080 --> 00:24:47,295
So, you know, you begin to feel,
"Yeah, we could do this."
365
00:24:47,320 --> 00:24:48,415
Yeah.
366
00:24:49,600 --> 00:24:53,495
Eleanor and her team
only needed to make enough R21
367
00:24:53,520 --> 00:24:56,495
to inject a small number
of healthy people,
368
00:24:56,520 --> 00:24:59,135
less than half a cup's worth,
369
00:24:59,160 --> 00:25:02,695
but thousands of times more
than Adrian's team had created
370
00:25:02,720 --> 00:25:04,895
in the lab for their mouse tests.
371
00:25:05,960 --> 00:25:08,855
And this time
with human safety on the line.
372
00:25:11,440 --> 00:25:16,775
I've always had the ethos,
the feeling that...
373
00:25:18,240 --> 00:25:21,975
.."Am I happy for this product
to go into somebody?"
374
00:25:22,000 --> 00:25:24,215
Ancl the best analogy I can use is,
375
00:25:24,240 --> 00:25:26,535
"Would I inject it
into one of my two children?"
376
00:25:26,560 --> 00:25:30,975
Ancl if I can categorically say yes,
then I feel reassured
377
00:25:31,000 --> 00:25:34,375
in the knowledge that we've clone
everything we possibly can
378
00:25:34,400 --> 00:25:37,695
to produce a safe product.
379
00:25:40,680 --> 00:25:46,495
We started the project in 2012,
and took us three and a half years.
380
00:25:47,560 --> 00:25:50,215
If we had been
in a commercial situation,
381
00:25:50,240 --> 00:25:52,695
I would think
that they would have just...
382
00:25:53,880 --> 00:25:56,495
...stopped the project
on many occasions.
383
00:25:56,520 --> 00:26:00,895
We kept going and kept spending
and finding and spending more money
384
00:26:00,920 --> 00:26:02,975
to get it manufactured.
385
00:26:03,000 --> 00:26:07,775
The major feeling was just a sense
of relief that we had got there.
386
00:26:09,640 --> 00:26:14,895
The 10th of November 2015,
85 vials certified.
387
00:26:15,960 --> 00:26:17,655
Three closes per person.
388
00:26:17,680 --> 00:26:20,015
20 to 30 people, that would cover.
389
00:26:20,040 --> 00:26:22,455
Not exactly vaccinating the world,
is it?
390
00:26:22,480 --> 00:26:23,975
But it's where we started.
391
00:26:25,760 --> 00:26:29,135
With these precious few doses
of R21,
392
00:26:29,160 --> 00:26:32,855
the Oxford team
began small-scale human trials.
393
00:26:32,880 --> 00:26:37,775
First, they mixed the vaccine
with a substance called Matrix-M,
394
00:26:37,800 --> 00:26:40,815
which helps strengthen
the immune response.
395
00:26:40,840 --> 00:26:43,255
They injected 28 healthy adults
396
00:26:43,280 --> 00:26:47,935
and reported it induced an antibody
response comparable to RTS,S
397
00:26:47,960 --> 00:26:50,175
at a much lower vaccine dose.
398
00:26:51,240 --> 00:26:54,455
Next, they purposely exposed
a few vaccinated people
399
00:26:54,480 --> 00:26:59,415
to infectious mosquitos in what's
known as a malaria challenge trial
400
00:26:59,440 --> 00:27:02,335
and found that
they were protected from malaria.
401
00:27:03,840 --> 00:27:08,855
Such exciting early results
drew attention beyond Oxford.
402
00:27:08,880 --> 00:27:11,815
Word had got around.
We academics talk at meetings,
403
00:27:11,840 --> 00:27:13,615
and you never know
who's in the room,
404
00:27:13,640 --> 00:27:16,575
but my guess is there was somebody
from the Serum Institute of India,
405
00:27:16,600 --> 00:27:19,935
and the next month,
Umesh Shaligram turned up here
406
00:27:19,960 --> 00:27:21,655
wanting to talk about malaria.
407
00:27:23,120 --> 00:27:26,615
Certainly, Oxford data
was very convincing, early data,
408
00:27:26,640 --> 00:27:30,615
so that certainly made
a big difference in our conviction.
409
00:27:30,640 --> 00:27:33,575
They'd heard about
the initial challenge results.
410
00:27:33,600 --> 00:27:35,495
They came to us.
411
00:27:35,520 --> 00:27:37,535
Normally,
we go begging to companies,
412
00:27:37,560 --> 00:27:39,015
asking them to work with us.
413
00:27:39,040 --> 00:27:42,015
We made a kind of a handshake deal
414
00:27:42,040 --> 00:27:45,135
that we could manufacture
the product.
415
00:27:45,160 --> 00:27:46,975
That's how the whole thing started.
416
00:27:53,640 --> 00:27:57,895
The Serum Institute of India
is the largest vaccine manufacturer
417
00:27:57,920 --> 00:27:59,215
in the world.
418
00:28:01,120 --> 00:28:04,175
Two thirds of
all babies born globally
419
00:28:04,200 --> 00:28:07,215
get at least one of
Serum's childhood vaccines,
420
00:28:07,240 --> 00:28:08,695
made here in Pune.
421
00:28:10,480 --> 00:28:14,695
It's made this family-run company
a global life-saver
422
00:28:14,720 --> 00:28:18,735
and CEO Adar Poonawalla
a multi-billionaire.
423
00:28:21,480 --> 00:28:23,535
Every time we look at a vaccine,
424
00:28:23,560 --> 00:28:25,815
the way we look at it is that,
unless we can make
425
00:28:25,840 --> 00:28:28,295
hundreds of millions of doses
for the whole world,
426
00:28:28,320 --> 00:28:32,375
and unless it has that need
and demand, we don't get into it.
427
00:28:32,400 --> 00:28:34,935
Ah, Beto, what's happening?
428
00:28:34,960 --> 00:28:38,775
These are very large populations,
so they need a lot of vaccines.
429
00:28:38,800 --> 00:28:42,735
It would be unimaginable if they
had to pay $10, $20 for a vaccine.
430
00:28:42,760 --> 00:28:44,935
They wouldn't be able to afford it.
431
00:28:44,960 --> 00:28:47,695
We charge pennies on the dollar
for the vaccine,
432
00:28:47,720 --> 00:28:50,655
but the economies of scale
that we operate at
433
00:28:50,680 --> 00:28:53,735
enable us to do that
and still make a modest profit.
434
00:28:53,760 --> 00:28:55,455
You can go ahead with that.
435
00:28:58,520 --> 00:29:03,095
In 2017,
Serum took over manufacturing R21
436
00:29:03,120 --> 00:29:07,095
and spent two years
developing a new, reliable method
437
00:29:07,120 --> 00:29:08,815
to produce it at scale.
438
00:29:11,600 --> 00:29:15,255
The team chose the West African
country Burkina Faso,
439
00:29:15,280 --> 00:29:18,655
where around half the population
gets malaria each year,
440
00:29:18,680 --> 00:29:21,375
for the vaccine's
first real-world test.
441
00:29:24,080 --> 00:29:28,295
In 2019, 450 very young children,
442
00:29:28,320 --> 00:29:30,615
the group most in need
of protection,
443
00:29:30,640 --> 00:29:33,175
were vaccinated
in a phase 2 trial.
444
00:29:34,280 --> 00:29:37,455
For success, these babies
would have to experience
445
00:29:37,480 --> 00:29:39,895
no unexpected side effects,
446
00:29:39,920 --> 00:29:43,095
and they would need to be
a significant reduction
447
00:29:43,120 --> 00:29:46,535
in malaria cases
in those who received R21.
448
00:29:50,440 --> 00:29:53,015
The UK team waited for news.
449
00:29:54,400 --> 00:29:57,055
It was actually my colleague,
Mehreen, who said,
450
00:29:57,080 --> 00:29:59,455
"Look at your email,
we've got the results."
451
00:29:59,480 --> 00:30:03,655
77% efficacy, as good as
we could possibly have hoped.
452
00:30:03,680 --> 00:30:06,535
I wasn't even sure that I could
quite believe what I was reading.
453
00:30:06,560 --> 00:30:08,815
You know, we showed
that the vaccine,
454
00:30:08,840 --> 00:30:14,455
albeit just over six months,
had worked in the target population
455
00:30:14,480 --> 00:30:16,455
in the target age group.
456
00:30:16,480 --> 00:30:20,375
But if you've seen really good
results, you know what's coming.
457
00:30:20,400 --> 00:30:23,055
Large-scale phase 3 trials.
458
00:30:23,080 --> 00:30:25,535
Definitely a very daunting prospect.
459
00:30:28,720 --> 00:30:32,415
Phase 3 is the largest
clinical trial.
460
00:30:32,440 --> 00:30:34,775
It'll need to be
big enough to determine
461
00:30:34,800 --> 00:30:40,655
if R21 can safely prevent malaria
in thousands of children.
462
00:30:40,680 --> 00:30:44,295
And this will cost
around $20 million.
463
00:30:45,560 --> 00:30:49,695
Me and Adrian went
almost every door-to-door
464
00:30:49,720 --> 00:30:52,095
and tried to search
for the funding.
465
00:30:52,120 --> 00:30:56,615
Somebody should support us,
and we had a really tough time.
466
00:30:56,640 --> 00:30:58,175
We were fighting for funding
467
00:30:58,200 --> 00:31:02,095
against people dealing with other
very important medical diseases.
468
00:31:02,120 --> 00:31:06,655
People are more likely to try and
invest in something that sounds new
469
00:31:06,680 --> 00:31:09,535
than the old idea
of making a vaccine against malaria,
470
00:31:09,560 --> 00:31:12,135
which has failed and failed
and failed over decades.
471
00:31:13,440 --> 00:31:18,295
After a year's try, I remember
I said, "Mr Poonawalla, sir,
472
00:31:18,320 --> 00:31:19,935
"|'m having a big challenge
473
00:31:19,960 --> 00:31:22,895
"of getting the funding
for the phase 3."
474
00:31:22,920 --> 00:31:26,535
Ancl he said, "No, no, don't worry.
Malaria is very close to my heart,
475
00:31:26,560 --> 00:31:29,895
"and I want to support the phase 3."
476
00:31:29,920 --> 00:31:34,615
The Serum Institute's CEO
agrees to fund the trial.
477
00:31:34,640 --> 00:31:36,895
The results have demonstrated
that the vaccine
478
00:31:36,920 --> 00:31:38,975
is giving you protection.
479
00:31:39,000 --> 00:31:40,855
So, instead of wasting time,
480
00:31:40,880 --> 00:31:43,215
we just wanted to
get on with the work.
481
00:31:46,920 --> 00:31:51,055
In April 2021,
phase 3 trial preparations begin
482
00:31:51,080 --> 00:31:56,015
in Burkina Faso, Mali, Kenya,
and here in Tanzania.
483
00:31:59,520 --> 00:32:03,215
Mehreen Datoo is a British
infectious diseases doctor...
484
00:32:04,560 --> 00:32:09,975
...but her key role on the R21 team
is to oversee its ultimate test.
485
00:32:11,400 --> 00:32:13,735
What we wanted to
propose today to do
486
00:32:13,760 --> 00:32:16,975
is a mock-up
vaccine preparation for us,
487
00:32:17,000 --> 00:32:19,575
just to check
it's all running smoothly.
488
00:32:19,600 --> 00:32:23,815
Nearly 5,000 very young children
are set to receive shots
489
00:32:23,840 --> 00:32:27,655
in the phase 3 trial-
hundreds of them in Tanzania.
490
00:32:30,760 --> 00:32:34,095
For every two children
that receive R21,
491
00:32:34,120 --> 00:32:36,935
one child will receive
a control vaccine.
492
00:32:38,000 --> 00:32:40,735
In this case,
a vaccine against rabies.
493
00:32:42,040 --> 00:32:44,415
This should look just like R21
494
00:32:44,440 --> 00:32:47,255
but offer no protection
at all from malaria.
495
00:32:48,640 --> 00:32:51,855
The rabies vaccine is a good option
because it's not a vaccine
496
00:32:51,880 --> 00:32:55,215
that children would normally receive
in that part of the world,
497
00:32:55,240 --> 00:32:57,655
so it does provide some benefit.
498
00:32:59,240 --> 00:33:02,895
Crucially, Mehreen
and almost everyone involved
499
00:33:02,920 --> 00:33:06,095
is blind to which vaccine
each child receives...
500
00:33:07,240 --> 00:33:10,935
...so they must monitor cases
of malaria across the whole trial
501
00:33:10,960 --> 00:33:16,135
and only learn much later if those
cases were in the R21 vaccine group
502
00:33:16,160 --> 00:33:18,655
or the control group.
503
00:33:18,680 --> 00:33:21,695
The only people that are unblinded
are the pharmacy team,
504
00:33:21,720 --> 00:33:24,055
who prepare the vaccine.
505
00:33:24,080 --> 00:33:26,495
You want to make sure
the whole volume is covered.
506
00:33:26,520 --> 00:33:28,895
The whole idea of this
is to not know which vaccine
507
00:33:28,920 --> 00:33:31,175
the child has received,
to ensure there's no bias.
508
00:33:31,200 --> 00:33:33,895
It means that, you know,
we will get the most accurate data.
509
00:33:33,920 --> 00:33:36,015
That's why
there's two of you to do it.
510
00:33:36,040 --> 00:33:39,495
There's always
a spare pair of hands.
511
00:33:39,520 --> 00:33:42,095
CHATTER
512
00:33:46,200 --> 00:33:48,975
My family are actually
from East Africa.
513
00:33:49,000 --> 00:33:51,535
Unfortunately, when I was doing
some research there previously,
514
00:33:51,560 --> 00:33:54,575
I got malaria,
and I was very, very sick.
515
00:33:55,600 --> 00:33:57,535
I basically fainted and collapsed
516
00:33:57,560 --> 00:34:00,015
and then was diagnosed
with severe malaria.
517
00:34:00,040 --> 00:34:03,255
I don't remember a lot of it because
I was just very, very unwell.
518
00:34:04,640 --> 00:34:06,895
I was in my early 20s,
519
00:34:06,920 --> 00:34:10,655
so I can't even imagine
how it affects very young children.
520
00:34:16,920 --> 00:34:18,575
Here in Tanzania,
521
00:34:18,600 --> 00:34:21,375
Dr Ally Olotu
is managing the vaccination
522
00:34:21,400 --> 00:34:24,335
and monitoring of 600 children.
523
00:34:36,960 --> 00:34:38,095
OK.
524
00:34:51,480 --> 00:34:54,575
In late 2022,
a precious cargo arrives
525
00:34:54,600 --> 00:34:57,775
at the Kiwangwa Clinic from India.
526
00:35:00,400 --> 00:35:04,055
After an initial three doses
of either R21
527
00:35:04,080 --> 00:35:06,295
or the rabies control vaccine,
528
00:35:06,320 --> 00:35:09,495
a one-year booster shot
is now being prepared
529
00:35:09,520 --> 00:35:12,415
for Farhiya
and the other trial participants.
530
00:35:39,440 --> 00:35:42,575
For Zuhura Abbasi,
vaccination is about much more
531
00:35:42,600 --> 00:35:46,335
than simply preventing
her daughter from falling ill.
532
00:36:02,600 --> 00:36:03,975
SIZZLING
533
00:36:39,040 --> 00:36:40,855
CHATTER
534
00:36:42,640 --> 00:36:45,175
For families and scientists alike,
535
00:36:45,200 --> 00:36:48,015
Vaccination Day is special.
536
00:36:48,040 --> 00:36:50,935
They all look relatively happy.
No-one's crying.
537
00:36:50,960 --> 00:36:52,655
Yeah, yeah, absolutely.
538
00:36:54,120 --> 00:36:56,375
Really nice to see
the relationships the trial team
539
00:36:56,400 --> 00:36:58,735
have with the participants
and the caregivers,
540
00:36:58,760 --> 00:37:01,935
because I think that makes it, you
know, almost a bit more like family.
541
00:37:21,200 --> 00:37:23,855
TEAM EXCLAIMS AND APPLAUDS
542
00:37:23,880 --> 00:37:27,815
After vaccination, Farhiya
and the other children in the trial
543
00:37:27,840 --> 00:37:31,095
are closely monitored
for signs of malaria.
544
00:37:31,120 --> 00:37:33,855
The vaccine's success or failure
545
00:37:33,880 --> 00:37:37,535
will depend on how many
malaria cases occur in children
546
00:37:37,560 --> 00:37:41,255
who received R21
versus the control vaccine.
547
00:37:43,760 --> 00:37:47,295
While they wait for this result,
the team is also investigating
548
00:37:47,320 --> 00:37:50,095
what the vaccine
is doing inside the body.
549
00:37:53,360 --> 00:37:56,695
For that, they have to study
the children's blood.
550
00:37:59,560 --> 00:38:04,095
We can now measure the amount
of antibodies that are in the blood.
551
00:38:06,000 --> 00:38:09,695
Some of this will be shipped
into a reference lab in Oxford,
552
00:38:09,720 --> 00:38:12,095
where samples from other sites
553
00:38:12,120 --> 00:38:15,375
which are participating
will be analysed.
554
00:38:22,240 --> 00:38:25,775
As phase 3
booster vaccinations proceed,
555
00:38:25,800 --> 00:38:28,375
immunologist Katie Ewer and her team
556
00:38:28,400 --> 00:38:31,775
are deluged
with these blood samples.
557
00:38:31,800 --> 00:38:33,695
There's absolutely loads
still to do.
558
00:38:33,720 --> 00:38:36,735
I have a freezer full of thousands
of samples from the phase 3
559
00:38:36,760 --> 00:38:39,295
that we haven't had a chance
to start looking at yet.
560
00:38:43,080 --> 00:38:45,495
Having had, very recently,
the experience
561
00:38:45,520 --> 00:38:47,895
of taking a vaccine through
to phase 3 for Covid,
562
00:38:47,920 --> 00:38:49,735
where we had
an enormous team of people
563
00:38:49,760 --> 00:38:51,375
and AstraZeneca working on it,
564
00:38:51,400 --> 00:38:53,735
the contrast to the team
working on malaria,
565
00:38:53,760 --> 00:38:57,295
where there are seven of us,
it's a very different experience.
566
00:38:58,560 --> 00:39:01,015
BEEPING
You've got the timer? Great.
567
00:39:02,080 --> 00:39:05,615
We're under pressure
to start churning out some data,
568
00:39:05,640 --> 00:39:07,415
so it's full speed ahead.
569
00:39:07,440 --> 00:39:09,775
ls plate one up on mine
or is it on yours?
570
00:39:09,800 --> 00:39:11,295
No, but the folder's up... OK.
571
00:39:11,320 --> 00:39:14,455
The team needs to analyse
the children's antibody responses
572
00:39:14,480 --> 00:39:18,255
to R21 and the control vaccine.
573
00:39:18,280 --> 00:39:22,775
immunologist Lisa Stockdale
is running a test called an ELISA.
574
00:39:22,800 --> 00:39:24,615
We've got quite a big variation.
575
00:39:24,640 --> 00:39:27,215
Some of the samples
have quite a lot of antibody,
576
00:39:27,240 --> 00:39:29,135
whereas some of them don't.
577
00:39:29,160 --> 00:39:31,335
We're blinded to which group
people are in,
578
00:39:31,360 --> 00:39:34,975
but in general, it looks like
the plate's developing well.
579
00:39:35,000 --> 00:39:37,415
I've been doing hundreds
of these ELISA plates.
580
00:39:37,440 --> 00:39:39,775
Hundreds and hundreds.
SHE CHUCKLES
581
00:39:41,280 --> 00:39:44,575
To be effective,
R21 must prime the blood
582
00:39:44,600 --> 00:39:48,855
with antibodies
that target the malaria CSP protein.
583
00:39:48,880 --> 00:39:51,055
But the team also needs to know
584
00:39:51,080 --> 00:39:56,175
if those antibodies can actually
neutralise REAL malaria parasites.
585
00:39:56,200 --> 00:39:59,815
We take the parasites out
by dissecting a mosquito.
586
00:39:59,840 --> 00:40:02,295
Ancl so, I'm just going to hold it
with one hand.
587
00:40:03,600 --> 00:40:06,215
Pull the head away...gently.
588
00:40:07,840 --> 00:40:11,015
OK, so we have the head off.
589
00:40:12,200 --> 00:40:15,135
You end up with two pairs
of salivary glands.
590
00:40:15,160 --> 00:40:17,735
They look like little, fat sausages.
591
00:40:17,760 --> 00:40:20,615
It's those little sacs
that have got the parasites in.
592
00:40:24,800 --> 00:40:26,415
Aha! Got them.
593
00:40:27,680 --> 00:40:30,815
The parasites are added
to lab-grown liver cells,
594
00:40:30,840 --> 00:40:33,175
along with blood
from vaccinated children.
595
00:40:35,120 --> 00:40:38,215
If the liver cells
do not become infected,
596
00:40:38,240 --> 00:40:41,895
it suggests the antibodies
should protect the children, too.
597
00:40:44,720 --> 00:40:46,895
There's just a lot of pressure
to get through all these samples
598
00:40:46,920 --> 00:40:48,895
to get the antibody data together.
599
00:40:48,920 --> 00:40:51,695
Should we do both of them
together now?
600
00:40:51,720 --> 00:40:53,255
Could do.
601
00:40:53,280 --> 00:40:56,055
I am getting emails
at two or three in the morning.
602
00:40:56,080 --> 00:40:59,215
So a lot of people
are working super hard.
603
00:40:59,240 --> 00:41:03,255
I'm a little bit anxious that maybe
we've had to push them too hard
604
00:41:03,280 --> 00:41:05,735
or were too ambitious
in our timeline.
605
00:41:08,720 --> 00:41:09,815
I'm exhausted.
606
00:41:11,080 --> 00:41:14,415
I'm tired. I'm stressed.
I'm not sleeping.
607
00:41:14,440 --> 00:41:17,815
Er, yeah, I'm probably not a great
person to be around at the moment,
608
00:41:17,840 --> 00:41:19,255
if I'm honest.
609
00:41:20,600 --> 00:41:25,615
All this lab effort is crucial
to understanding how R21 works.
610
00:41:27,280 --> 00:41:29,615
But, above all, they need to know
611
00:41:29,640 --> 00:41:33,255
if the vaccine protects enough
children in the real world.
612
00:41:36,120 --> 00:41:39,215
After around a year
of closely monitoring the health
613
00:41:39,240 --> 00:41:43,135
of all 4,800 phase 3 children,
614
00:41:43,160 --> 00:41:45,215
the wait is nearly over.
615
00:41:53,280 --> 00:41:58,295
The key phase 3 trial
is coming to the end point.
616
00:41:58,320 --> 00:42:00,375
The statisticians have the data
617
00:42:00,400 --> 00:42:04,095
and they are analysing it
as we speak.
618
00:42:06,240 --> 00:42:08,575
You know, this is something
that we've all worked on for years.
619
00:42:08,600 --> 00:42:10,415
So to be this close,
620
00:42:10,440 --> 00:42:13,935
it's kind of nauseatingly,
sickeningly
621
00:42:13,960 --> 00:42:15,735
anxiety-inducing, really.
622
00:42:17,320 --> 00:42:19,215
You know, we just don't know
what we're going to see.
623
00:42:19,240 --> 00:42:23,455
Um, and I think we'll be all
really relieved to get that result.
624
00:42:23,480 --> 00:42:28,215
11 years after R21 was first made
here in the lab,
625
00:42:28,240 --> 00:42:33,055
after seven years of trials,
over 20,000 vaccinations,
626
00:42:33,080 --> 00:42:36,015
and hundreds of thousands
of samples analysed...
627
00:42:37,280 --> 00:42:38,495
...an GHSWGI'.
628
00:42:40,640 --> 00:42:42,815
Even got significance
on severe malaria.
629
00:42:42,840 --> 00:42:44,135
73%". Bloody hell!
630
00:42:44,160 --> 00:42:46,415
With wide confidence intervals,
but bloody hell, that's...
631
00:42:46,440 --> 00:42:48,415
I mean, that... Yeah, absolutely.
632
00:42:49,760 --> 00:42:50,775
Great.
633
00:42:51,880 --> 00:42:54,215
Oh, God, get me a drink!
634
00:42:54,240 --> 00:42:55,615
Oh!
635
00:42:56,760 --> 00:42:58,975
SHE SIGHS
Yeah.
636
00:42:59,000 --> 00:43:01,335
So we have the result
of the phase 3.
637
00:43:01,360 --> 00:43:03,615
Um, so a big moment. Um...
638
00:43:05,560 --> 00:43:07,975
As expected from the phase 2,
639
00:43:08,000 --> 00:43:10,135
so really interesting results
in there,
640
00:43:10,160 --> 00:43:13,375
but, yeah, really good
and really reassuring, and...
641
00:43:13,400 --> 00:43:15,295
Yeah, just very happy.
642
00:43:15,320 --> 00:43:17,295
SHE LAUGHS TEARFULLY
643
00:43:20,920 --> 00:43:23,655
SHE SOBS
644
00:43:35,200 --> 00:43:36,855
Yeah, we're very happy.
645
00:43:36,880 --> 00:43:38,695
Although it probably
doesn't look like it!
646
00:43:38,720 --> 00:43:42,495
But, yeah, it's just a moment
I've been waiting for for so long.
647
00:43:44,320 --> 00:43:48,095
But, yeah, what we wanted and
what we hoped for, so really good.
648
00:43:49,320 --> 00:43:50,455
Yeah.
649
00:43:56,560 --> 00:43:58,335
Barely a month later,
650
00:43:58,360 --> 00:44:01,175
there's a global medical conference
in Seattle.
651
00:44:03,120 --> 00:44:06,375
The promise of the initial
phase 3 trial results
652
00:44:06,400 --> 00:44:07,935
is now sinking in.
653
00:44:09,960 --> 00:44:13,895
Across the different ages and
locations of children in the trial,
654
00:44:13,920 --> 00:44:16,895
around a year after
they were first vaccinated,
655
00:44:16,920 --> 00:44:20,575
R21 has reduced cases
of clinical malaria
656
00:44:20,600 --> 00:44:23,375
by about 70% to 80%.
657
00:44:23,400 --> 00:44:25,215
Hey! Good morning!
658
00:44:25,240 --> 00:44:26,335
Wow! How are you?
659
00:44:26,360 --> 00:44:31,695
So the teams from Oxford, Tanzania,
Kenya, Mali and Burkina Faso
660
00:44:31,720 --> 00:44:36,055
gather to prepare to present their
data publicly for the first time.
661
00:44:37,280 --> 00:44:40,215
These people are just extraordinary.
They are leaders in their field.
662
00:44:40,240 --> 00:44:41,815
Hello.
663
00:44:41,840 --> 00:44:43,615
How are you?
664
00:44:43,640 --> 00:44:48,175
The results that have come in
show safety looks absolutely fine
665
00:44:48,200 --> 00:44:50,575
in literally thousands of children,
666
00:44:50,600 --> 00:44:53,495
and even more excitingly,
the efficacy.
667
00:44:53,520 --> 00:44:55,495
The reaction was they cheered.
668
00:44:57,680 --> 00:45:01,935
You know, seeing the numbers,
that was a moment of excitement.
669
00:45:01,960 --> 00:45:04,535
Everybody was taken aback and said,
670
00:45:04,560 --> 00:45:07,695
"You know what?
Wow, this is...this is real.
671
00:45:07,720 --> 00:45:09,175
"This is something."
672
00:45:10,600 --> 00:45:12,695
When this result came out,
673
00:45:12,720 --> 00:45:18,335
I was like, "Ahh, 00f, this is
what I was waiting for long."
674
00:45:19,800 --> 00:45:22,215
So here we are on Sunday.
On Wednesday,
675
00:45:22,240 --> 00:45:25,135
we're going to try and tell
the world about what we found.
676
00:45:28,240 --> 00:45:30,255
If you'd asked me this morning,
I would have said,
677
00:45:30,280 --> 00:45:32,055
"|'m filled with anxiety.
678
00:45:32,080 --> 00:45:35,495
"I have no idea how the rest
of the scientific community
679
00:45:35,520 --> 00:45:37,295
"are going to take it."
680
00:45:37,320 --> 00:45:39,935
You know, people are going
to critically analyse the results,
681
00:45:39,960 --> 00:45:43,415
that...that's what science is
and that's what should be clone.
682
00:45:43,440 --> 00:45:45,095
But having had the meeting today
683
00:45:45,120 --> 00:45:47,255
and, you know,
the most important people
684
00:45:47,280 --> 00:45:49,015
who are part of the trial
being there,
685
00:45:49,040 --> 00:45:53,255
the Pls of every site and just how
excited they are, now I'm excited.
686
00:45:58,120 --> 00:46:01,975
We know our vaccine works.
We know we have good data.
687
00:46:02,000 --> 00:46:04,335
I hope everyone
is as excited as we are.
688
00:46:10,880 --> 00:46:14,735
I'm very pleased today to be able
to share with you the first data
689
00:46:14,760 --> 00:46:18,535
on the safety and efficacy
of R21/Matrix-M,
690
00:46:18,560 --> 00:46:20,255
a new malaria vaccine.
691
00:46:21,840 --> 00:46:23,535
This is a vaccine that works,
692
00:46:23,560 --> 00:46:27,335
that's going to be widely available
at a reasonable price,
693
00:46:27,360 --> 00:46:30,335
and it could really, really make
a big difference.
694
00:46:30,360 --> 00:46:33,335
It's trite to say game-changer,
but I really think it is.
695
00:46:33,360 --> 00:46:36,335
It's very encouraging news that they
have the Serum Institute in Pune
696
00:46:36,360 --> 00:46:38,615
who's going to be able
to really scale up
697
00:46:38,640 --> 00:46:41,015
the production of the vaccine.
698
00:46:41,040 --> 00:46:44,575
For reducing the burden of disease
and death in children,
699
00:46:44,600 --> 00:46:47,015
I mean, it's a wonderful result.
700
00:46:49,080 --> 00:46:50,135
For the team,
701
00:46:50,160 --> 00:46:52,815
sharing their results
is a moment to savour.
702
00:46:54,120 --> 00:46:57,695
R21 can't be directly
compared with RTS,S -
703
00:46:57,720 --> 00:46:59,455
their trials were different -
704
00:46:59,480 --> 00:47:03,535
but there's now no doubt
about this new vaccine's potential.
705
00:47:07,960 --> 00:47:12,935
Yet, for R21 to have any impact
on the lives of children in Africa,
706
00:47:12,960 --> 00:47:16,535
all the data must be handed over
for independent scrutiny
707
00:47:16,560 --> 00:47:18,655
by the World Health Organization.
708
00:47:28,440 --> 00:47:32,015
There's never any time to sit back
and enjoy the moment particularly.
709
00:47:32,040 --> 00:47:35,655
It's a relief,
but back to the grindstone, really.
710
00:47:35,680 --> 00:47:38,775
The end of this week
is submission to WHO,
711
00:47:38,800 --> 00:47:43,175
and so it's a massive dossier
0f safety and efficacy data
712
00:47:43,200 --> 00:47:48,135
that WHO will look at and decide
whether that's enough data for them
713
00:47:48,160 --> 00:47:50,535
to approve the vaccine
for widespread use.
714
00:47:51,600 --> 00:47:53,655
The key people at
the Serum Institute are working
715
00:47:53,680 --> 00:47:57,575
on the submission package with us,
so there's a lot going on.
716
00:47:59,920 --> 00:48:03,855
The reason WHO assessment
matters so much is stark.
717
00:48:05,320 --> 00:48:06,815
To purchase vaccines,
718
00:48:06,840 --> 00:48:10,495
African countries
rely heavily on donated funds,
719
00:48:10,520 --> 00:48:14,735
and these won't be released
without a WHO seal of approval.
720
00:48:16,040 --> 00:48:17,735
If there's no money to distribute
this vaccine,
721
00:48:17,760 --> 00:48:19,495
I mean, we can make
the best vaccines in the world,
722
00:48:19,520 --> 00:48:21,935
but if nobody's going to buy it,
nobody's going to distribute it,
723
00:48:21,960 --> 00:48:23,415
then it's all a waste of time.
724
00:48:23,440 --> 00:48:27,375
So, this is the next stage
of the vaccine process.
725
00:48:29,280 --> 00:48:33,775
But ahead of any WHO decision,
in April 2023,
726
00:48:33,800 --> 00:48:35,695
there's surprise breaking news.
727
00:48:35,720 --> 00:48:41,175
A clay of pure elation for Ghana,
for science and for all of humanity,
728
00:48:41,200 --> 00:48:44,175
as the FDA has granted approval
to a new vaccine.
729
00:48:44,200 --> 00:48:46,775
NEWSREADER: Ghana's government
has become the first in the world
730
00:48:46,800 --> 00:48:50,895
to clear the roll-out
of malaria vaccine R21.
731
00:48:50,920 --> 00:48:54,415
Ghana's drug regulator
has reviewed the data on R21
732
00:48:54,440 --> 00:48:56,255
and approved it for use,
733
00:48:56,280 --> 00:49:00,095
signalling a clear and urgent demand
for this new vaccine.
734
00:49:01,560 --> 00:49:06,375
Days later, Nigeria follows suit
and Angola looks to place an order.
735
00:49:09,040 --> 00:49:13,255
But there's still no certainty that
the WHO will approve the vaccine,
736
00:49:13,280 --> 00:49:15,975
and so unlock the necessary funds.
737
00:49:16,000 --> 00:49:20,135
Let's get into the manufacturing
details of how to scale up
738
00:49:20,160 --> 00:49:23,575
as soon as possible, because now
I think there's a lot of excitement.
739
00:49:23,600 --> 00:49:28,615
In Pune, Serum's CEO has
a very big decision to make.
740
00:49:28,640 --> 00:49:31,775
How many doses
should we then make at risk?
741
00:49:31,800 --> 00:49:34,495
I was thinking around
20 million to 25 million doses.
742
00:49:34,520 --> 00:49:36,055
Do you think that would be OK?
743
00:49:36,080 --> 00:49:38,615
That is...
So 5 million, Angola wants,
744
00:49:38,640 --> 00:49:41,095
and Nigeria also want
around 5 million, 10 million
745
00:49:41,120 --> 00:49:42,575
and Ghana
around 5 million, 10 million.
746
00:49:42,600 --> 00:49:44,175
So 20 million, 25 million
is good enough.
747
00:49:44,200 --> 00:49:46,455
Well, should we make
around 30 million to be safe?
748
00:49:46,480 --> 00:49:47,935
I think so. We should try.
749
00:49:47,960 --> 00:49:49,415
Fine. Go ahead, do it.
750
00:49:49,440 --> 00:49:53,375
Let me know what the costing and
the risk we're taking in that is,
751
00:49:53,400 --> 00:49:55,015
but let's just go ahead.
752
00:49:55,040 --> 00:49:56,735
What's the expiry on that?
753
00:49:56,760 --> 00:49:58,695
The expiry is about 18 months.
754
00:49:58,720 --> 00:50:00,575
Yeah, that's a matter of concern.
755
00:50:02,200 --> 00:50:06,695
Adar Poonawalla has just risked
over $100 million
756
00:50:06,720 --> 00:50:10,775
to start production
of 30 million doses of R21.
757
00:50:14,640 --> 00:50:18,735
They'll be offered at the very
low price of under $4 a dose.
758
00:50:21,360 --> 00:50:25,015
The gamble is whether WHO approval
and sales
759
00:50:25,040 --> 00:50:28,175
will come before
the vaccine stockpile expires.
760
00:50:32,760 --> 00:50:35,175
We've taken all the risk, you know,
for the trials,
761
00:50:35,200 --> 00:50:37,775
for manufacturing
the 30 million doses.
762
00:50:37,800 --> 00:50:40,815
We just hope that it's all worth it.
763
00:50:40,840 --> 00:50:42,535
I wouldn't have the freedom
764
00:50:42,560 --> 00:50:45,615
to make these sort of
risky decisions and bets
765
00:50:45,640 --> 00:50:48,695
had I been accountable
to multiple stakeholders,
766
00:50:48,720 --> 00:50:50,535
shareholders, banks, etc.
767
00:50:50,560 --> 00:50:53,255
Here, it's just a few people
coming together
768
00:50:53,280 --> 00:50:56,215
and quickly deciding
to go ahead on something.
769
00:50:56,240 --> 00:50:59,655
Everything is now on WHO
to approve the vaccine.
770
00:50:59,680 --> 00:51:02,455
That's all we're waiting for,
and then we can roll it out.
771
00:51:03,680 --> 00:51:08,935
In Serum's cold storage, the shelves
rapidly begin to fill with R21.
772
00:51:08,960 --> 00:51:10,535
This is our R21 storage vault.
773
00:51:12,240 --> 00:51:15,335
This is a place
where your heart fills with a joy
774
00:51:15,360 --> 00:51:20,375
because finally, the product which
will get into the humans is ready.
775
00:51:20,400 --> 00:51:24,095
This entire cold room
can accommodate 40 million closes,
776
00:51:24,120 --> 00:51:26,935
which means 10 million
children's vaccination.
777
00:51:28,080 --> 00:51:29,215
Amazing feeling.
778
00:51:34,800 --> 00:51:39,895
As R21 sits in storage,
all the team can do now is wait.
779
00:51:42,680 --> 00:51:46,695
Even in Ghana and Nigeria, where
the vaccine is already approved,
780
00:51:46,720 --> 00:51:49,015
no-one's come forward to pay.
781
00:51:49,040 --> 00:51:53,055
So across Africa, everything
rests on the WHO decision.
782
00:51:54,760 --> 00:51:56,175
There's a lot of anticipation.
783
00:51:56,200 --> 00:51:59,415
And, you know, it's the difference
between thinking that, you know,
784
00:51:59,440 --> 00:52:01,215
maybe this vaccine
will get rolled out next year.
785
00:52:01,240 --> 00:52:03,895
And, you know, those kids will start
getting the benefit of the vaccine,
786
00:52:03,920 --> 00:52:06,695
or we might have another
four years of clinical trials.
787
00:52:09,280 --> 00:52:11,815
It's the first part, I think,
in this whole process
788
00:52:11,840 --> 00:52:14,175
where I felt really sort of
out of control of what's happening,
789
00:52:14,200 --> 00:52:15,655
and it's quite an odd sensation
790
00:52:15,680 --> 00:52:17,535
when, you know,
you've created something
791
00:52:17,560 --> 00:52:20,215
and then you just
have to kind of release it out there
792
00:52:20,240 --> 00:52:24,135
into the wider world and see
what everybody else makes of it.
793
00:52:28,960 --> 00:52:31,655
Due process has to be followed.
794
00:52:31,680 --> 00:52:34,535
What's happening is that
there's a balance being struck
795
00:52:34,560 --> 00:52:38,135
between having long enough follow-up
in thousands of children
796
00:52:38,160 --> 00:52:42,015
to be really sure
that there's no safety issue,
797
00:52:42,040 --> 00:52:45,775
ancl balancing that against the fact
that a thousand children are dying
798
00:52:45,800 --> 00:52:49,775
from malaria every clay,
who could be vaccinated
799
00:52:49,800 --> 00:52:54,975
with a vaccine that is sitting
in India waiting to be supplied.
800
00:52:55,000 --> 00:52:56,375
Ancl that's tricky.
801
00:53:00,040 --> 00:53:01,295
We would like it right now.
802
00:53:01,320 --> 00:53:04,175
I mean, we would like it
yesterday, if I may say so.
803
00:53:04,200 --> 00:53:07,015
I mean, I would love
to have vaccines available
804
00:53:07,040 --> 00:53:11,135
for every single child in Africa
who is at risk of getting malaria.
805
00:53:11,160 --> 00:53:15,615
This is my, er... This is my hope
and my dream, really.
806
00:53:18,920 --> 00:53:23,495
We need to act fast, with urgency,
because we know what is at stake.
807
00:53:24,840 --> 00:53:27,935
It would be a tragedy
if we allow this vaccine
808
00:53:27,960 --> 00:53:30,135
to just be on the shelves.
809
00:53:30,160 --> 00:53:33,815
Ancl therefore, my message to,
you know, stakeholders
810
00:53:33,840 --> 00:53:38,175
and people making decisions about
access to vaccine,
811
00:53:38,200 --> 00:53:39,895
I think they should remember that,
812
00:53:39,920 --> 00:53:41,815
you know,
we don't have time to wait.
813
00:53:45,680 --> 00:53:49,735
With just my scientist head on,
I think there's no reason
814
00:53:49,760 --> 00:53:52,295
why this vaccine
couldn't be approved for use.
815
00:53:53,360 --> 00:53:56,455
Do I think it will be approved
for use? I don't know.
816
00:53:59,760 --> 00:54:02,935
It's now a year
since the Seattle conference.
817
00:54:04,600 --> 00:54:08,855
All that time, the team has been
sharing continually updated evidence
818
00:54:08,880 --> 00:54:13,055
with the WHO that the vaccine
is safe and cost-effective.
819
00:54:14,640 --> 00:54:19,055
And although R21's efficacy
does decrease a little over time,
820
00:54:19,080 --> 00:54:21,455
a booster dose bumps it back up.
821
00:54:23,120 --> 00:54:24,135
But now...
822
00:54:24,160 --> 00:54:25,215
Hello!
823
00:54:25,240 --> 00:54:27,615
...they've been told
to expect an announcement.
824
00:54:29,360 --> 00:54:32,815
Good morning, good afternoon
and good evening.
825
00:54:32,840 --> 00:54:35,895
Today is a great day for health.
826
00:54:35,920 --> 00:54:38,215
A great day for vaccines.
827
00:54:38,240 --> 00:54:40,655
Almost exactly two years ago,
828
00:54:40,680 --> 00:54:43,495
WHO recommended the broad use
829
00:54:43,520 --> 00:54:48,695
of the world's first
malaria vaccine called RTS,S.
830
00:54:48,720 --> 00:54:52,175
Today, it gives me great pleasure
to announce
831
00:54:52,200 --> 00:54:58,135
that WHO is recommending a second
vaccine called R21/Matrix-M,
832
00:54:58,160 --> 00:55:02,415
to prevent malaria
in children at risk of the disease.
833
00:55:05,080 --> 00:55:08,295
The WHO has approved R21 for use
834
00:55:08,320 --> 00:55:11,615
in any African child
at risk of malaria...
835
00:55:13,240 --> 00:55:17,535
...a decision that should trigger
the release of critical donor funds,
836
00:55:17,560 --> 00:55:20,895
paving the way
for vaccine roll-out in 2024.
837
00:55:22,800 --> 00:55:25,015
Congratulations!
What a great clay!
838
00:55:25,040 --> 00:55:27,375
Congratulations to you, too.
839
00:55:27,400 --> 00:55:31,255
This is an historic day for Africa,
I think.
840
00:55:31,280 --> 00:55:33,575
We're not talking
about hundreds or thousands
841
00:55:33,600 --> 00:55:37,495
but, over time,
well over a million lives saved
842
00:55:37,520 --> 00:55:42,775
is just staggering- _
and hugely, hugely grat|fy|ng.
843
00:55:42,800 --> 00:55:45,535
Ancl you just feel...
844
00:55:45,560 --> 00:55:46,575
Wow.
845
00:55:47,760 --> 00:55:51,495
Really happy.
Really relieved and, you know,
846
00:55:51,520 --> 00:55:53,495
proud that we've got here.
847
00:55:54,640 --> 00:55:57,735
You know, this opens the door
for the next stage for the vaccine,
848
00:55:57,760 --> 00:56:00,055
which is to get out there
into the real world.
849
00:56:00,080 --> 00:56:03,615
Ancl that's the bit that I'm sort
of most excited about, really.
850
00:56:06,440 --> 00:56:08,255
I'm dreaming for that clay to come,
851
00:56:08,280 --> 00:56:11,495
and I hope it will come
sooner than later.
852
00:56:11,520 --> 00:56:13,015
And, er...
853
00:56:15,200 --> 00:56:16,655
Yeah, it's, er...
854
00:56:18,040 --> 00:56:20,535
Yeah, this is what...
This is what I want to see,
855
00:56:20,560 --> 00:56:23,015
this is what every parent
wants to see.
856
00:56:26,480 --> 00:56:31,895
From 2024 onwards, the battle
to beat malaria will be transformed.
857
00:56:33,360 --> 00:56:37,375
If funds are sustained to get R21
to all who need it,
858
00:56:37,400 --> 00:56:40,895
along with new, even better vaccines
which may follow,
859
00:56:40,920 --> 00:56:43,295
this will indeed be game-changing.
860
00:56:45,080 --> 00:56:47,895
Beyond which the complete
eradication of malaria
861
00:56:47,920 --> 00:56:51,815
may no longer simply be a hope,
but become a reality.
862
00:56:53,040 --> 00:56:56,735
That will truly transform
the lives and prospects
863
00:56:56,760 --> 00:57:00,255
of hundreds of millions
of people across Africa.
864
00:57:00,280 --> 00:57:04,935
People like Zuhura Abbasi
and her daughter, Farhiya.
865
00:57:24,680 --> 00:57:26,535
THEY SING TOGETHER