This tiny creature and the silent killer it carries
is the target of one of medical science's greatest quests.
A battle to save millions of lives
and end a scourge that has shaped human history.
Malaria.
One child dies every single minute from malaria.
So you might ask yourself, "Why are kids still dying?"
For almost a century, scientists have had one goal.
We don't want to use the word the Holy Grail,
but if we got vaccines,
then, of course, that would be transformational.
The chances of success are really, really small,
but the rewards if you do it are enormous.
This is the inside story, across four continents,
of a new vaccine against malaria.
ls Slate 1 up on mine, or is it on yours? No, but the folder's up...
It's being made by the same Oxford University team
behind the UK's Covid vaccine.
We have the head off.
It's those little sacs that have got the parasites in.
But this time it's an even more complex scientific challenge.
It didn't work, it didn't work, and it didn't work.
I remember very openly and straight telling
that this is not going to work.
And then, after many tweaks and changes...
...it did.
Well, to me, it was unthinkable before it happened.
Another good news story about British vaccines.
It will probably have the biggest impact
on global public health for generations.
It will be up there with clean water. It is that big.
APPLAUSE
This could be a game changer.
You are touching human life.
You are going to save the human life.
It's not one or two. It's millions of lives.
Amazing, isn't it?
Throughout our history,
the mosquito has been the paramount killer of humanity.
If we look at our Neverland nightmares, we're taught to fear
all these other creatures because they kill so many humans.
That's just simply not true.
For example, wolves and sharks
kill, I think, about ten people per year.
Whereas the mosquito, this tiny little animal
the size and weight of a grape seed,
is responsible for up to a million deaths a year.
But it's not the mosquito itself,
it's the pathogens that hitch a free ride
that cause so much suffering, death and destruction.
Of all the pathogens that mosquitoes carry,
by far the most lethal and the biggest killer of humanity
has been malaria.
A highly effective vaccine against malaria
would be a historic breakthrough.
And getting there starts with knowing your enemy.
London's Natural History Museum is home
to one of the world's greatest collections of insects.
Senior curator Erica McAlister looks after 150,000 specimens,
representing 2,900 species of mosquito.
We have maybe 350 drawers of mosquitoes,
but only 20 of those drawers are the species of mosquitoes
that are important for the transmission of malaria.
The difference between the males and the females is very important.
The males are all vegetarian,
but the female has to generate the eggs.
Therefore, she needs a really, really high-protein meal.
The blood.
You've got the proboscis, her fantastically long mouth part.
It's composed of six stylets.
She uses two of those to kind of, like, penetrate the flesh,
she uses two of them to keep it open,
and then her final two, one is basically a tube
which she will suck up your blood with,
but the other one, through that she releases her saliva
to prevent the blood clotting.
Ancl it is in that process that the malaria parasite
is able to transfer into us.
NEWSREEL: Public enemy number one -
Anopheles, the malaria mosquito,
wanted for bringing sickness and misery to untold millions.
Today, malaria is considered a tropical disease,
but until very recently it affected people worldwide.
And it's played a huge part in our history.
When we look at European history, for example,
Europeans actually called malaria the Roman fever.
The word malaria - malaria - actually means bad air in Italian.
So Rome was surrounded by 310 square miles of Pontine Marshes,
which were a hotbed of malarious mosquitoes.
Now, interestingly, they acted as a shield from foreign invasion.
Invaders either couldn't conquer Rome
or had a very brief stay before malaria started to sap the strength
of their troops and they would withdraw.
So it safeguarded and shielded Rome,
allowing for the expansion of Rome, the city, and also the Roman Empire.
For the next 2,000 years,
malaria-carrying mosquitoes continued to plague most of Europe.
Modern science would not even begin the fightback
until barely a century ago.
At the dawn of the 20th century, a physician of tropical medicine
remarked that the future of humanity would be decided by one battle -
man versus mosquito.
All right, men, now we can begin to fight.
RALLYING BUGLE TUNE
During World War ll, military casualties from malaria were so high
that the authorities declared total war,
even recruiting Walt Disney for the fight.
Attaboy, DOPEY-
Kill her good and dead.
The newly invented insecticide DDT destroyed mosquito populations...
...swamps were drained...
...protection against bites improved...
...as did the availability of malaria treatments and tests.
In the Western world, malaria was made extinct, essentially.
As a result, the malaria burden shifted
to lower socioeconomic countries, specifically in the Global South.
Funding for malaria research was drastically cut,
and malaria was generally all but forgotten in most wealthy nations.
Nine out of ten people in Tanzania, East Africa,
live in the country's malaria zone.
And it's the youngest children,
naturally much less able to fight off infections,
who are most at risk.
Farhiya Saturn is three years old.
She lives in Kiwangwa village
with her mother, Zohara Abasi, a pineapple farmer and small trader,
and her grandmother, Huba Mohamedi.
Across Tanzania and much of Africa,
malaria costs lives and livelihoods,
undermining the potential of an entire continent.
Dr Ally Olotu of the lfakara Health Institute
serves on the medical front line.
I got malaria when I was young,
and I also got malaria when I went to the university.
That's when I became aware that this is...
It's an awful disease.
Globally, malaria causes over 200 million cases
and more than 600,000 deaths annually.
About 80% of these deaths are actually young children
below the ages of five.
Tawakar is three years old,
and was in grave danger of falling into a coma
until he came to the hospital just 24 hours ago.
Seeing kids who are suffering from malaria,
emotionally it's always difficult.
As a clinician, as a father,
I have to develop interventions to do everything possible
to get rid of malaria.
While Ally regularly treats children who have been infected...
...his colleague, mosquito biologist Fredros Okumu,
works on malaria prevention.
Hey, how are you doing?
How are the mosquitoes today? Have you blood-fed the mosquitoes?
Yeah. Uh-huh.
To evaluate specific products for protecting people,
we have to rear the mosquitoes in our labs.
MOSQUITOES BUZZ
We have to provide water, sugar and blood.
Today, it is lab technician Stuart Ngala's turn
to feed the mosquitoes.
MOSQUITOES BUZZ
The mosquitoes we have in the lab are malaria-free.
It's something that we scientists do.
So, I mean, I do it as well.
Fredros uses these mosquitoes to test insecticide-treated bed nets.
It's estimated that, over the last 20 years,
tools like these have prevented a staggering
two billion cases of malaria and nearly 12 million deaths.
Yes, there's been extensive progress.
Is it sufficient progress?
No. Because now we have this challenge since around 2015
where there are many countries in Africa
where malaria cases are going up.
It's not much killing the mosquito.
So that particular net didn't kill enough mosquitoes. OK.
The bed nets that we have in the villages
are starting to face a lot of challenges.
Mosquitoes are no longer being killed as effectively
because they have become resistant to the insecticides
that we put on the surface, and so the bed net can lose that quality,
the killing effect.
You've got mosquitoes that are able to lay hundreds of eggs.
They have some really short generation times.
So some mosquitoes can be, like, two weeks,
and then suddenly you've got a new generation.
So any time they get a new chemical thrown at them,
if it's not clone correctly, you can see gene resistance.
Ancl it's like, "Poof!" - game over for that insecticide.
They're so adaptable.
Despite concerns about increasing resistance,
bed nets treated with insecticide
remain the world's number one weapon against malaria.
But research shows they reduce child deaths by less than 20%.
We need a transformational tool,
and I do not think there is any medical intervention
that has clone better or more than vaccines.
When it comes to transforming human health and saving lives,
vaccination is up there with clean water and sanitation.
Smallpox, which killed up to 500 million in the 20th century alone,
was eradicated in the 1970s thanks to vaccination.
And there's also been huge success against polio, measles,
and recently Covid-19.
But a highly effective malaria vaccine has never emerged.
That's not for lack of trying.
Ally himself has worked on multiple vaccine candidates.
So do you know what Daddy's working on?
What am I working on? Malaria.
Malaria what?
Malaria vaccine. OK.
So that you can...you can protect children, isn't it,
from getting malaria?
Because children below... under five years who have malaria
are in much bigger danger than others.
Ancl they die. Yes, they can die.
But if you go to hospital first, you will survive.
I saw a child three years old who had malaria in the hospital,
but he was treated and he will get better.
But he was very lucky.
As night falls, this is the most vulnerable time.
MOSQUITO BUZZES That's when the mosquitoes come in.
When the mosquito bites,
it injects into that child small parasites.
We call them sporozoites.
These spend a very few minutes in the blood,
and then quickly go and start to multiply within the liver.
And these kids could be playing around,
they can be playing football,
they could be singing with their parents.
Nobody can suspect anything.
But from the liver, within a few clays,
you could have thousands and thousands of parasites
released into the blood.
They attack our red blood cells, destroying them.
Ancl this is what actually gives rise to malaria symptoms.
That child you saw playing with his friends just a few clays ago
can quickly become severely sick.
And if not diagnosed and treated very fast,
that child might lose life.
It's this process - the way the body is overwhelmed
before it has a chance to fight back -
that makes malaria so dangerous,
and the development of a vaccine so challenging.
We have developed vaccines for other diseases, of course,
but most of these are viruses and bacteria,
which are much simpler pathogens compared to malaria.
It's a very complex parasite.
So I was really excited to be part of the consortium of scientists
put together by the University of Oxford
to work on a new malaria vaccine.
The University of Oxford is home to one of the world's largest
academic vaccine development programmes.
In 2020, the university's Jenner Institute
created the Oxford AstraZeneca Covid-19 vaccine.
And, since then, 3 billion doses have reached 170 countries.
Adrian Hill and his colleagues
have found malaria much more difficult.
We've known for over 100 years
that it would be fantastic to have a malaria vaccine.
People have been trying for about 120 years,
ever since the parasite was discovered.
I did a count about six months ago of how many vaccines had been made
and gone into clinical trials for malaria, how many different ones,
and that number was 142.
I'm not sure there's another disease
where there have been that many vaccines that didn't work.
Katie Ewer is the lead immunologist on the Oxford team.
I think malaria is more personal for me because it's children.
I think you'd have to be a very hard-hearted person
not to be moved by a death toll of 400,000 kids a year dying in Africa,
under the age of five, from malaria.
It's a huge motivator to work on something
where the chances of success are really, really small.
But the rewards, if you do it, are enormous.
For the last 13 years, the Oxford team has been working on a vaccine
called R21.
Its goal is to fire up the body's immune defences,
to be ready to attack the parasite at its most vulnerable moment -
just after it enters our blood.
When an infected female mosquito takes a bite
and injects sporozoites - malaria parasites -
there's about a half-hour to two-hour window
before the parasites invade the cells in your body
and set up infection there.
Ancl that's the window that we're trying to target with our vaccine.
What all vaccines must do
is mobilise the immune system's front line defence against invaders.
An army of antibodies.
Their goal is to quickly neutralise any invading pathogens...
...by tightly binding to their surface,
stopping them in their tracks,
and marking them for destruction.
The problem has been to produce enough antibodies
to clear all of those parasites very quickly.
Threatened by just a few invading parasites,
our antibody response is usually too little, too late.
But luckily, the malaria sporozoite has an Achilles' heel.
To invade the liver, it relies on a coating called CSP -
the circumsporozoite protein.
What we need are large amounts of very specific antibodies
that bind as tightly as possible to the circumsporozoite protein.
Then we should be able to stop the parasites
before they can reach the liver.
This is where the R21 vaccine comes in.
It is built from the CSP protein,
and so induces the body to produce antibodies tailor-made and ready
to neutralise the parasite.
But this is not a new idea.
First designed in 1987, a vaccine called RTS,S already does this.
I've had privilege to work on RTS,S malaria vaccine,
and the overall efficacy of RTS,S is about 40%
against clinical disease.
40% may sound as not very good efficacy,
but you have to think about the burden of malaria.
We have well over 600,000 deaths annually,
so saving or reducing the burden by 40% is better than nothing.
After lengthy deliberations,
in 2022, RTS,S became the first malaria vaccine
approved by the WHO - the World Health Organization -
35 years after it was initially developed.
But RTS,S is expensive to produce, supply is currently limited,
and it falls short of the WHO's own target
of having a 75% effective vaccine by 2030.
And so the Oxford team had long set their sights on an upgrade.
R21 was born out of the idea
that perhaps we could make a slightly better version of RTS,S.
So it started with a PhD student called Kat Collins
taking this on as her project.
The RTS,S vaccine is made of billions of tiny particles.
They're built from a virus protein that forms a harmless, empty shell,
and part of the same CSP protein that coats the malaria parasite.
Together, they trigger the body's immune response.
But unlike the malaria parasite,
less than a quarter of each particle's surface is CSP.
Kat Collins and her Oxford colleagues wondered,
could increasing the amount of CSP to better mimic the malaria parasite
make a better vaccine?
We kept on trying different ways to get that to form into a particle,
and it didn't work, it didn't work, and it didn't work.
Ancl eventually, after many tweaks and changes...
...it did.
That was a big clay.
You can literally see these particles
with an electron microscope.
And, boy, those images are memorable.
We managed to cover all of the surface
of every R21 particle in CSP.
We thought, "Fantastic!" We immunised mice, and guess what?
They were nearly all protected very well.
This was 2012.
We were finally getting there.
And, of course, getting there means you're ready to try and manufacture
and go into the clinic.
Oxford University's R21 was doing exactly as they'd hoped,
creating a strong protective immune response.
But that was just in mice.
The big challenge now would be testing it in humans.
For this, they called on Eleanor Berrie,
a specialist in vaccine manufacture for human trials.
Vaccines are actually one of the most complicated things
you can manufacture.
But Adrian and Kat were so enthusiastic about R21,
they had generated some excellent preclinical data,
and that enthusiasm rubs off on you.
So, you know, you begin to feel, "Yeah, we could do this."
Yeah.
Eleanor and her team only needed to make enough R21
to inject a small number of healthy people,
less than half a cup's worth,
but thousands of times more than Adrian's team had created
in the lab for their mouse tests.
And this time with human safety on the line.
I've always had the ethos, the feeling that...
.."Am I happy for this product to go into somebody?"
Ancl the best analogy I can use is,
"Would I inject it into one of my two children?"
Ancl if I can categorically say yes, then I feel reassured
in the knowledge that we've clone everything we possibly can
to produce a safe product.
We started the project in 2012, and took us three and a half years.
If we had been in a commercial situation,
I would think that they would have just...
...stopped the project on many occasions.
We kept going and kept spending and finding and spending more money
to get it manufactured.
The major feeling was just a sense of relief that we had got there.
The 10th of November 2015, 85 vials certified.
Three closes per person.
20 to 30 people, that would cover.
Not exactly vaccinating the world, is it?
But it's where we started.
With these precious few doses of R21,
the Oxford team began small-scale human trials.
First, they mixed the vaccine with a substance called Matrix-M,
which helps strengthen the immune response.
They injected 28 healthy adults
and reported it induced an antibody response comparable to RTS,S
at a much lower vaccine dose.
Next, they purposely exposed a few vaccinated people
to infectious mosquitos in what's known as a malaria challenge trial
and found that they were protected from malaria.
Such exciting early results drew attention beyond Oxford.
Word had got around. We academics talk at meetings,
and you never know who's in the room,
but my guess is there was somebody from the Serum Institute of India,
and the next month, Umesh Shaligram turned up here
wanting to talk about malaria.
Certainly, Oxford data was very convincing, early data,
so that certainly made a big difference in our conviction.
They'd heard about the initial challenge results.
They came to us.
Normally, we go begging to companies,
asking them to work with us.
We made a kind of a handshake deal
that we could manufacture the product.
That's how the whole thing started.
The Serum Institute of India is the largest vaccine manufacturer
in the world.
Two thirds of all babies born globally
get at least one of Serum's childhood vaccines,
made here in Pune.
It's made this family-run company a global life-saver
and CEO Adar Poonawalla a multi-billionaire.
Every time we look at a vaccine,
the way we look at it is that, unless we can make
hundreds of millions of doses for the whole world,
and unless it has that need and demand, we don't get into it.
Ah, Beto, what's happening?
These are very large populations, so they need a lot of vaccines.
It would be unimaginable if they had to pay $10, $20 for a vaccine.
They wouldn't be able to afford it.
We charge pennies on the dollar for the vaccine,
but the economies of scale that we operate at
enable us to do that and still make a modest profit.
You can go ahead with that.
In 2017, Serum took over manufacturing R21
and spent two years developing a new, reliable method
to produce it at scale.
The team chose the West African country Burkina Faso,
where around half the population gets malaria each year,
for the vaccine's first real-world test.
In 2019, 450 very young children,
the group most in need of protection,
were vaccinated in a phase 2 trial.
For success, these babies would have to experience
no unexpected side effects,
and they would need to be a significant reduction
in malaria cases in those who received R21.
The UK team waited for news.
It was actually my colleague, Mehreen, who said,
"Look at your email, we've got the results."
77% efficacy, as good as we could possibly have hoped.
I wasn't even sure that I could quite believe what I was reading.
You know, we showed that the vaccine,
albeit just over six months, had worked in the target population
in the target age group.
But if you've seen really good results, you know what's coming.
Large-scale phase 3 trials.
Definitely a very daunting prospect.
Phase 3 is the largest clinical trial.
It'll need to be big enough to determine
if R21 can safely prevent malaria in thousands of children.
And this will cost around $20 million.
Me and Adrian went almost every door-to-door
and tried to search for the funding.
Somebody should support us, and we had a really tough time.
We were fighting for funding
against people dealing with other very important medical diseases.
People are more likely to try and invest in something that sounds new
than the old idea of making a vaccine against malaria,
which has failed and failed and failed over decades.
After a year's try, I remember I said, "Mr Poonawalla, sir,
"|'m having a big challenge
"of getting the funding for the phase 3."
Ancl he said, "No, no, don't worry. Malaria is very close to my heart,
"and I want to support the phase 3."
The Serum Institute's CEO agrees to fund the trial.
The results have demonstrated that the vaccine
is giving you protection.
So, instead of wasting time,
we just wanted to get on with the work.
In April 2021, phase 3 trial preparations begin
in Burkina Faso, Mali, Kenya, and here in Tanzania.
Mehreen Datoo is a British infectious diseases doctor...
...but her key role on the R21 team is to oversee its ultimate test.
What we wanted to propose today to do
is a mock-up vaccine preparation for us,
just to check it's all running smoothly.
Nearly 5,000 very young children are set to receive shots
in the phase 3 trial- hundreds of them in Tanzania.
For every two children that receive R21,
one child will receive a control vaccine.
In this case, a vaccine against rabies.
This should look just like R21
but offer no protection at all from malaria.
The rabies vaccine is a good option because it's not a vaccine
that children would normally receive in that part of the world,
so it does provide some benefit.
Crucially, Mehreen and almost everyone involved
is blind to which vaccine each child receives...
...so they must monitor cases of malaria across the whole trial
and only learn much later if those cases were in the R21 vaccine group
or the control group.
The only people that are unblinded are the pharmacy team,
who prepare the vaccine.
You want to make sure the whole volume is covered.
The whole idea of this is to not know which vaccine
the child has received, to ensure there's no bias.
It means that, you know, we will get the most accurate data.
That's why there's two of you to do it.
There's always a spare pair of hands.
CHATTER
My family are actually from East Africa.
Unfortunately, when I was doing some research there previously,
I got malaria, and I was very, very sick.
I basically fainted and collapsed
and then was diagnosed with severe malaria.
I don't remember a lot of it because I was just very, very unwell.
I was in my early 20s,
so I can't even imagine how it affects very young children.
Here in Tanzania,
Dr Ally Olotu is managing the vaccination
and monitoring of 600 children.
OK.
In late 2022, a precious cargo arrives
at the Kiwangwa Clinic from India.
After an initial three doses of either R21
or the rabies control vaccine,
a one-year booster shot is now being prepared
for Farhiya and the other trial participants.
For Zuhura Abbasi, vaccination is about much more
than simply preventing her daughter from falling ill.
SIZZLING
CHATTER
For families and scientists alike,
Vaccination Day is special.
They all look relatively happy. No-one's crying.
Yeah, yeah, absolutely.
Really nice to see the relationships the trial team
have with the participants and the caregivers,
because I think that makes it, you know, almost a bit more like family.
TEAM EXCLAIMS AND APPLAUDS
After vaccination, Farhiya and the other children in the trial
are closely monitored for signs of malaria.
The vaccine's success or failure
will depend on how many malaria cases occur in children
who received R21 versus the control vaccine.
While they wait for this result, the team is also investigating
what the vaccine is doing inside the body.
For that, they have to study the children's blood.
We can now measure the amount of antibodies that are in the blood.
Some of this will be shipped into a reference lab in Oxford,
where samples from other sites
which are participating will be analysed.
As phase 3 booster vaccinations proceed,
immunologist Katie Ewer and her team
are deluged with these blood samples.
There's absolutely loads still to do.
I have a freezer full of thousands of samples from the phase 3
that we haven't had a chance to start looking at yet.
Having had, very recently, the experience
of taking a vaccine through to phase 3 for Covid,
where we had an enormous team of people
and AstraZeneca working on it,
the contrast to the team working on malaria,
where there are seven of us, it's a very different experience.
BEEPING You've got the timer? Great.
We're under pressure to start churning out some data,
so it's full speed ahead.
ls plate one up on mine or is it on yours?
No, but the folder's up... OK.
The team needs to analyse the children's antibody responses
to R21 and the control vaccine.
immunologist Lisa Stockdale is running a test called an ELISA.
We've got quite a big variation.
Some of the samples have quite a lot of antibody,
whereas some of them don't.
We're blinded to which group people are in,
but in general, it looks like the plate's developing well.
I've been doing hundreds of these ELISA plates.
Hundreds and hundreds. SHE CHUCKLES
To be effective, R21 must prime the blood
with antibodies that target the malaria CSP protein.
But the team also needs to know
if those antibodies can actually neutralise REAL malaria parasites.
We take the parasites out by dissecting a mosquito.
Ancl so, I'm just going to hold it with one hand.
Pull the head away...gently.
OK, so we have the head off.
You end up with two pairs of salivary glands.
They look like little, fat sausages.
It's those little sacs that have got the parasites in.
Aha! Got them.
The parasites are added to lab-grown liver cells,
along with blood from vaccinated children.
If the liver cells do not become infected,
it suggests the antibodies should protect the children, too.
There's just a lot of pressure to get through all these samples
to get the antibody data together.
Should we do both of them together now?
Could do.
I am getting emails at two or three in the morning.
So a lot of people are working super hard.
I'm a little bit anxious that maybe we've had to push them too hard
or were too ambitious in our timeline.
I'm exhausted.
I'm tired. I'm stressed. I'm not sleeping.
Er, yeah, I'm probably not a great person to be around at the moment,
if I'm honest.
All this lab effort is crucial to understanding how R21 works.
But, above all, they need to know
if the vaccine protects enough children in the real world.
After around a year of closely monitoring the health
of all 4,800 phase 3 children,
the wait is nearly over.
The key phase 3 trial is coming to the end point.
The statisticians have the data
and they are analysing it as we speak.
You know, this is something that we've all worked on for years.
So to be this close,
it's kind of nauseatingly, sickeningly
anxiety-inducing, really.
You know, we just don't know what we're going to see.
Um, and I think we'll be all really relieved to get that result.
11 years after R21 was first made here in the lab,
after seven years of trials, over 20,000 vaccinations,
and hundreds of thousands of samples analysed...
...an GHSWGI'.
Even got significance on severe malaria.
73%". Bloody hell!
With wide confidence intervals, but bloody hell, that's...
I mean, that... Yeah, absolutely.
Great.
Oh, God, get me a drink!
Oh!
SHE SIGHS Yeah.
So we have the result of the phase 3.
Um, so a big moment. Um...
As expected from the phase 2,
so really interesting results in there,
but, yeah, really good and really reassuring, and...
Yeah, just very happy.
SHE LAUGHS TEARFULLY
SHE SOBS
Yeah, we're very happy.
Although it probably doesn't look like it!
But, yeah, it's just a moment I've been waiting for for so long.
But, yeah, what we wanted and what we hoped for, so really good.
Yeah.
Barely a month later,
there's a global medical conference in Seattle.
The promise of the initial phase 3 trial results
is now sinking in.
Across the different ages and locations of children in the trial,
around a year after they were first vaccinated,
R21 has reduced cases of clinical malaria
by about 70% to 80%.
Hey! Good morning!
Wow! How are you?
So the teams from Oxford, Tanzania, Kenya, Mali and Burkina Faso
gather to prepare to present their data publicly for the first time.
These people are just extraordinary. They are leaders in their field.
Hello.
How are you?
The results that have come in show safety looks absolutely fine
in literally thousands of children,
and even more excitingly, the efficacy.
The reaction was they cheered.
You know, seeing the numbers, that was a moment of excitement.
Everybody was taken aback and said,
"You know what? Wow, this is...this is real.
"This is something."
When this result came out,
I was like, "Ahh, 00f, this is what I was waiting for long."
So here we are on Sunday. On Wednesday,
we're going to try and tell the world about what we found.
If you'd asked me this morning, I would have said,
"|'m filled with anxiety.
"I have no idea how the rest of the scientific community
"are going to take it."
You know, people are going to critically analyse the results,
that...that's what science is and that's what should be clone.
But having had the meeting today
and, you know, the most important people
who are part of the trial being there,
the Pls of every site and just how excited they are, now I'm excited.
We know our vaccine works. We know we have good data.
I hope everyone is as excited as we are.
I'm very pleased today to be able to share with you the first data
on the safety and efficacy of R21/Matrix-M,
a new malaria vaccine.
This is a vaccine that works,
that's going to be widely available at a reasonable price,
and it could really, really make a big difference.
It's trite to say game-changer, but I really think it is.
It's very encouraging news that they have the Serum Institute in Pune
who's going to be able to really scale up
the production of the vaccine.
For reducing the burden of disease and death in children,
I mean, it's a wonderful result.
For the team,
sharing their results is a moment to savour.
R21 can't be directly compared with RTS,S -
their trials were different -
but there's now no doubt about this new vaccine's potential.
Yet, for R21 to have any impact on the lives of children in Africa,
all the data must be handed over for independent scrutiny
by the World Health Organization.
There's never any time to sit back and enjoy the moment particularly.
It's a relief, but back to the grindstone, really.
The end of this week is submission to WHO,
and so it's a massive dossier 0f safety and efficacy data
that WHO will look at and decide whether that's enough data for them
to approve the vaccine for widespread use.
The key people at the Serum Institute are working
on the submission package with us, so there's a lot going on.
The reason WHO assessment matters so much is stark.
To purchase vaccines,
African countries rely heavily on donated funds,
and these won't be released without a WHO seal of approval.
If there's no money to distribute this vaccine,
I mean, we can make the best vaccines in the world,
but if nobody's going to buy it, nobody's going to distribute it,
then it's all a waste of time.
So, this is the next stage of the vaccine process.
But ahead of any WHO decision, in April 2023,
there's surprise breaking news.
A clay of pure elation for Ghana, for science and for all of humanity,
as the FDA has granted approval to a new vaccine.
NEWSREADER: Ghana's government has become the first in the world
to clear the roll-out of malaria vaccine R21.
Ghana's drug regulator has reviewed the data on R21
and approved it for use,
signalling a clear and urgent demand for this new vaccine.
Days later, Nigeria follows suit and Angola looks to place an order.
But there's still no certainty that the WHO will approve the vaccine,
and so unlock the necessary funds.
Let's get into the manufacturing details of how to scale up
as soon as possible, because now I think there's a lot of excitement.
In Pune, Serum's CEO has a very big decision to make.
How many doses should we then make at risk?
I was thinking around 20 million to 25 million doses.
Do you think that would be OK?
That is... So 5 million, Angola wants,
and Nigeria also want around 5 million, 10 million
and Ghana around 5 million, 10 million.
So 20 million, 25 million is good enough.
Well, should we make around 30 million to be safe?
I think so. We should try.
Fine. Go ahead, do it.
Let me know what the costing and the risk we're taking in that is,
but let's just go ahead.
What's the expiry on that?
The expiry is about 18 months.
Yeah, that's a matter of concern.
Adar Poonawalla has just risked over $100 million
to start production of 30 million doses of R21.
They'll be offered at the very low price of under $4 a dose.
The gamble is whether WHO approval and sales
will come before the vaccine stockpile expires.
We've taken all the risk, you know, for the trials,
for manufacturing the 30 million doses.
We just hope that it's all worth it.
I wouldn't have the freedom
to make these sort of risky decisions and bets
had I been accountable to multiple stakeholders,
shareholders, banks, etc.
Here, it's just a few people coming together
and quickly deciding to go ahead on something.
Everything is now on WHO to approve the vaccine.
That's all we're waiting for, and then we can roll it out.
In Serum's cold storage, the shelves rapidly begin to fill with R21.
This is our R21 storage vault.
This is a place where your heart fills with a joy
because finally, the product which will get into the humans is ready.
This entire cold room can accommodate 40 million closes,
which means 10 million children's vaccination.
Amazing feeling.
As R21 sits in storage, all the team can do now is wait.
Even in Ghana and Nigeria, where the vaccine is already approved,
no-one's come forward to pay.
So across Africa, everything rests on the WHO decision.
There's a lot of anticipation.
And, you know, it's the difference between thinking that, you know,
maybe this vaccine will get rolled out next year.
And, you know, those kids will start getting the benefit of the vaccine,
or we might have another four years of clinical trials.
It's the first part, I think, in this whole process
where I felt really sort of out of control of what's happening,
and it's quite an odd sensation
when, you know, you've created something
and then you just have to kind of release it out there
into the wider world and see what everybody else makes of it.
Due process has to be followed.
What's happening is that there's a balance being struck
between having long enough follow-up in thousands of children
to be really sure that there's no safety issue,
ancl balancing that against the fact that a thousand children are dying
from malaria every clay, who could be vaccinated
with a vaccine that is sitting in India waiting to be supplied.
Ancl that's tricky.
We would like it right now.
I mean, we would like it yesterday, if I may say so.
I mean, I would love to have vaccines available
for every single child in Africa who is at risk of getting malaria.
This is my, er... This is my hope and my dream, really.
We need to act fast, with urgency, because we know what is at stake.
It would be a tragedy if we allow this vaccine
to just be on the shelves.
Ancl therefore, my message to, you know, stakeholders
and people making decisions about access to vaccine,
I think they should remember that,
you know, we don't have time to wait.
With just my scientist head on, I think there's no reason
why this vaccine couldn't be approved for use.
Do I think it will be approved for use? I don't know.
It's now a year since the Seattle conference.
All that time, the team has been sharing continually updated evidence
with the WHO that the vaccine is safe and cost-effective.
And although R21's efficacy does decrease a little over time,
a booster dose bumps it back up.
But now...
Hello!
...they've been told to expect an announcement.
Good morning, good afternoon and good evening.
Today is a great day for health.
A great day for vaccines.
Almost exactly two years ago,
WHO recommended the broad use
of the world's first malaria vaccine called RTS,S.
Today, it gives me great pleasure to announce
that WHO is recommending a second vaccine called R21/Matrix-M,
to prevent malaria in children at risk of the disease.
The WHO has approved R21 for use
in any African child at risk of malaria...
...a decision that should trigger the release of critical donor funds,
paving the way for vaccine roll-out in 2024.
Congratulations! What a great clay!
Congratulations to you, too.
This is an historic day for Africa, I think.
We're not talking about hundreds or thousands
but, over time, well over a million lives saved
is just staggering- _ and hugely, hugely grat|fy|ng.
Ancl you just feel...
Wow.
Really happy. Really relieved and, you know,
proud that we've got here.
You know, this opens the door for the next stage for the vaccine,
which is to get out there into the real world.
Ancl that's the bit that I'm sort of most excited about, really.
I'm dreaming for that clay to come,
and I hope it will come sooner than later.
And, er...
Yeah, it's, er...
Yeah, this is what... This is what I want to see,
this is what every parent wants to see.
From 2024 onwards, the battle to beat malaria will be transformed.
If funds are sustained to get R21 to all who need it,
along with new, even better vaccines which may follow,
this will indeed be game-changing.
Beyond which the complete eradication of malaria
may no longer simply be a hope, but become a reality.
That will truly transform the lives and prospects
of hundreds of millions of people across Africa.
People like Zuhura Abbasi and her daughter, Farhiya.
THEY SING TOGETHER