WHO press conference on Malaria vaccine recommendations - 6 October 2021
00:00:41
CD Hello,
everyone, and welcome to this World Health Organization Virtual Press
Conference on October 6th 2021. My name is Carla Drysdale, and I’m a
Communications Officer at WHO, headquartered in Geneva. Today’s press
conference focuses on the Global Advisory Body’s review of evidence for the RTS,S
malaria vaccine. The two bodies are the WHO Strategic Advisory Group of Experts
on Immunization, or SAGE, and the WHO Malaria Policy Advisory Committee or MPAG.
Their review of the full package of RTS,S
evidence informs a potential WHO recommendation for the wider use of this
vaccine. Joining Dr Tedros Adhanom Ghebreyesus, WHO’s Director-General, today,
are Dr Shidi Moeti, WHO Regional Director for Africa; Dr Alejandro Cravioto,
Chair of WHO’s SAGE; Professor Dyann Wirth, Chair of WHO’s MPAG, and online,
actually, in the room, I think we have Dr Soumya Swaminathan, WHO Chief
Scientist.
00:01:56
Also joining today, and available to respond to
any technical questions during the Q&A session for journalists, are Dr
Pedro Alonso, Director WHO Global Malaria Programme, Dr Kate O’Brien, Director
of the WHO Immunization Vaccines and Biologicals department, as well as Dr Mary
Hammel, Senior Technical Officer, Malaria Vaccine Implementation Programme, and
Dr David Schellenberg, Scientific Advisor for the Global Malaria Programme.
Speakers will first give their remarks, and then
we’ll begin the Q&A with journalists. When we open the floor to the media
Q&A, please enter your name and media outlet, and to ask a question, please
click Raise Hand. And when you’re called upon, of course, don’t forget to
unmute. And, please, only one question per journalist. And a reminder that, as this
is a press conference related to RTS,S, please keep your questions related to
malaria and the RTS,S vaccine.
If you have questions about COVID-19, you can
ask them in our presser tomorrow. So, with that, I will now give the floor to
Dr Tedros. The floor is yours, Dr Tedros.
TAG Thank
you, Carla. Dear colleagues and friends, as some of you may know, I started my
career as a malaria researcher, and I longed for the day that we would have an
effective vaccine against this ancient and terrible disease.
00:03:36
And today is that day, an historic day. Today,
WHO is recommending the broad use of the world’s first malaria vaccine. This
recommendation is based on results from an ongoing pilot programme in Ghana,
Kenya and Malawi that has reached more than 800,000 children since 2019. This
long-awaited malaria vaccine is a breakthrough for science, child health and
malaria control.
Using this vaccine in addition to existing tools
to prevent malaria could save tens of thousands of young lives each year. We
have made incredible progress in the fight against malaria in the past two
decades. Since 2000, malaria deaths have fallen by more than half, and we have
succeeded in eliminating malaria from many parts of the world.
But globally, progress has stalled at an unacceptably
high level, with more than 200 million cases and 400,000 deaths every year. Two
thirds of those deaths are children under five in Africa. WHO has said
consistently that we need new tools to get malaria control back on track. Two
years ago, WHO and our partners began a pilot programme to roll out this
vaccine in Ghana, Kenya and Malawi. Here is what we have learned.
This vaccine can be delivered through child
health clinics by ministries of health and readily reach children at
high-coverage levels. Community demand for the vaccine is strong. It has broad
reach to children, including the most vulnerable, who may not use a bed net,
thereby expanding access to preventive measures to children at risk. It is
safe.
00:05:59
It significantly reduces life-threatening severe
malaria, and we estimate it to be highly cost-effective. This is a powerful new
tool, but like COVID-19 vaccines, it’s not the only tool. Vaccination against
malaria does not replace or reduce the need for other measures, including bed
nets or seeking care for fever. Of course, the key to any public health
handover of this size and scope is partnership.
I thank the children, families and communities
who have participated in this historic pilot programme. I thank the ministries
of health of Ghana, Kenya and Malawi for their leadership in embarking on these
pilot programmes, which have continued despite COVID-19.
I thank the researchers in Africa who generated
the data and insights that informed this decision. This is a vaccine developed
in Africa by African scientists, and we’re very proud. I thank GlaxoSmithKline
and many research partners for creating the vaccine and [unclear] for bringing
it from discovery through development with support from the Bill & Melinda
Gates Foundation.
And I thank Gavi, the Global Fund and Unitaid
who funded the pilot programmes and the evaluations. Malaria has been with us
for millennia, and the dream of a malaria vaccine has been a long-held, but
unattainable, dream.
00:08:02
Today, the RTS,S malaria vaccine, more than 30
years in the making, changes the course of public health history. We still have
a very long road to travel, but this is a long stride down that road. This
vaccine is a gift to the world, but its value will be felt most in Africa
because that’s where the burden of malaria is greatest.
It’s now my pleasure to welcome my sister and
colleague, Dr Shidi Moeti, WHO’s regional Director for Africa, to talk about
the difference this vaccine will make on the continent. Dr Moeti, you have the
floor.
SM Thank
you, very much, Dr Tedros. I’d like, in my turn, to warmly greet my fellow
speakers and also to say hello to our colleagues in the media and at WHO. I,
and my colleagues at WHO in Africa, are beyond delighted that after decades of
action on malaria, there’s finally a vaccine that can reduce cases,
particularly of life-threatening severe malaria among young children. For
centuries, malaria has stalked Sub-Saharan Africa, causing immense personal
suffering.
As it stands today, the African region, as the Director-General
has already said, accounts for 94% of the global malaria burden. Every year,
hundreds of millions of people fall ill, and hundreds of thousands die, sadly,
due to this preventable and treatable disease. Every two minutes, a child under
five dies of malaria. This indirectly impacts on African families, societies
and economies. And the indirect impacts are enormous.
00:10:13
We’ve long hoped for ineffective malaria
vaccine, and now, for the first time ever, we have such a vaccine recommended
for widespread use. Today’s recommendation therefore offers a glimmer of hope
for the continent. We expect many more African children will be protected from
malaria and grow into healthy and productive adults. I’d like, in my turn, to
commend Ghana, Kenya and Malawi for leading the pilot programme for the RTS,S
vaccine.
I’d like to give a shoutout, too, to the
caregivers who brought children to be vaccinated, recognising the ever-present
threat of malaria, even as societies battled the COVID-19 pandemic. To take
forward this recommendation, the African Vaccine Regulatory Forum, convened by
WHO, will support national authorities to fast-track the regulatory approvals
to introduce this vaccine in the countries where it is needed. This is an
excellent opportunity too, to explore production on the continent, of a vaccine
that will benefit generations of Africans.
The RTS,S vaccine is a game changer, and it’s
arriving at the right time. Progress in reducing the malaria burden in Africa
has stalled in recent years, and innovative tools and approaches are urgently
needed to get the global malaria control effort back on track. In the African
region, we’ve already started a consultative process of rethinking malaria to
look at the barriers to progress and how to overcome them.
With the RTS,S vaccine and other anticipated
changes in the malaria business model, we expect to see greater impacts on the
malaria burden in Africa in the very near future.
00:12:08
It’s clear that more investment is needed in
strengthening service delivery platforms to make sure that malaria tools reach
at-risk groups. Children are among the vulnerable groups being missed by key
interventions, and so, equity-focused investments are crucial.
The same kind of political leadership,
multisectoral action and community engagement that we’ve seen in response to
COVID-19 will be vital to drive action to save lives and prevent ill health
from malaria. Together, we should accelerate action towards a future free from
malaria, and the RTS,S vaccine, as part of a comprehensive set of actions, can
help us to get there. Thank you.
TAG Thank
you, Shidi. WHO’s recommendation is based on the advice of two advisory groups,
the Strategic Advisory Group of Experts on Immunisation, or SAGE, and the WHO
Malaria Policy Advisory Group, or MPAG. Their advice was formulated, based on a
detailed review of the evidence carried out by the SAGE-MPAG Working Group,
chaired by Dr Peter Smith. First, I’m pleased to welcome Dr Alejandro Cravioto,
Chair of SAGE. Dr Cravioto, you have the floor.
AC Dr
Tedros, thank you very much, and happy to be here with you. As was said, the
Advisory Group of Experts on Immunisation that the WHO convenes is a group of
15 members from around the world, who review and assess evidence regarding
vaccines, immunisations, and especially the delivery of these products and the
linkages with other health interventions. So, in that sense, the work that we
have been doing over the past months to see how the evidence gathered from these
three studies in Africa, in the second phase of the testing of the RTS,S/AS01
vaccine, have been extremely important for us in our ability, then, to be able
to come today and have a final discussion and be able to make recommendations
about issues.
00:15:04
I would like to stress two things, which are
different in the case of this vaccine. One, that before these pilot studies in
Africa were started, we worked together with the Global Malaria Programme to be
able to have a framework for policy decision that allowed us to have all the
information that we needed for the group to gather before the end of the
studies, and for us to be able, then, to have the capacity to be able to review
that information and be able to make recommendations.
This was based on previous experience, in which
we didn’t have this information and that made our task more difficult, in the
sense of coming to decisions.
The second thing I would like to stress is that,
although it is very sad to see children dying of any disease, malaria included,
the ones that survive are the ones that should worry us the most. Anything that
we can do to curb the amount of infection in a growing child means that that
child is going to have a higher altitude, be taller, and also be smarter. And I
think those are things that we tend to forget sometimes when we decide and on
interventions, and especially on the cost of these interventions.
00:16:29
I think that the experience we have had before
with other infections showed us clearly that a child that is repeatedly sick is
maimed for life. And that means that he or she is not capable of developing the
capacities that he or she is born with, in the sense of achieving an adulthood
that will be meaningful for him or her and their community. So, in that sense,
having anything that protects them or helps them to be less sick during this
growth phase, is essential for us, as a community, in the sense of having a
much better group of people that can really help us change the coming world.
When we talk about climate change, when we talk
about other issues, it is without thinking that the main factor, which are
human wills involved in that, need also to be protected with any and everything
that we have available. Therefore, the decision that we came on today, which is
based on the evidence gathered in these three pilot studies, is essential for
us to do three things.
One, we can declare that the vaccine is safe and
that the safety issues that came out of the initial trial have been resolved
satisfactorily, and thoroughly, to be able to say that we don’t have any
worries about that. And, second, that the vaccine does protect people against a
severe disease, such as malaria and especially the more severe types of malaria
in that sense.
Furthermore, I think we have the capacity to be
able to increase the use of this vaccine, now that it has been reached at this
level. And, in that sense, I think we should all be congratulated, in the sense
of having been able to do the work, and now to come back and saying that we can
follow and have a new phase of these things. I would like to join Dr Tedros, Dr
Moeti, and my co-chair, Dr Wirth, in celebrating the achievements today, and
especially in thanking everybody that has been involved, both in the
development and the testing of this vaccine.
00:18:58
And I would also like to thank all the group
that helped SAGE within the Department of Immunization, Vaccines and
Biologicals, especially Dr Joachim Hombach and his team, who would lead the
Secretariat for SAGE, who are the ones that enable us to be able to do these
type of things that we hope are for the benefit of everybody. Thank you very
much.
TAG Thank
you very much, Dr Cravioto, and I fully endorse the people you have
appreciated. And thank you also to all SAGE members for your work and advice.
It’s now my pleasure to welcome Dr Dyann Wirth, the Chair of MPAG. Dr Wirth,
you have the floor.
DW Thank
you very much. It’s a pleasure to be here. We all know that progress toward
malarial elimination in Africa has stalled, and the RTS,S vaccine recommended
today gives us a new tool in our fight against malaria. It will be used with
existing tools to enhance the impact on disease burden. Important is that a
vaccine is a completely different mode of action than the existing tools for
vector control, diagnosis and treatment.
A vaccine recruits the human immune system to
fight the parasites as soon as they enter the body. A vaccinated person is
poised to fight off the infection at its earliest stage. This is the first ever
vaccine for a human parasite and demonstrates that a vaccine is possible for
this challenging infection.
00:20:42
While ongoing threats to our existing tools,
drug-resistant parasites, insecticide-resistant mosquitos, innovation is
needed, not only to create new tools, but to better tailor our current tools to
achieve maximum impact. The malaria parasite is a formidable foe, and while we
are excited by this recent development, major battles remain.
I join with Dr Tedros and Dr Moeti in thanking
those who took the bold decision to introduce the vaccine in their communities,
with the hope of changing, not only their lives, but the lives of their fellow
humans afflicted with this disease.
This vaccine, as we’ve heard, has now been given
to over 800,000 children in Africa. This is the largest evaluation of any
intervention for malaria, and probably one of the largest undertakings for any
disease. Our hats are off to WHO for their leadership. I would also like to
recognise the nearly 50 years of research that led us to this achievement.
We stand on the shoulders of giants, like Dr
Ruth Nussenzweig, who discovered the vaccine and the cadre of scientists from
around the world, with an emphasis of scientists in Africa, in academia,
government, industry, NGOs and communities who carried this vaccine through its
various phases of development. We can already see the next phase. New uses for
the RTS,S vaccine are already being discovered. Improved versions are in the
pipeline, and new innovation in vaccine is on the horizon.
00:22:33
Today is an inspiration, a major scientific
achievement with huge implications for improving human health. Thank you.
TAG
Thank you, Professor Wirth, and thank you to all members of MPAG for your
efforts. The recommendation for wide use of this vaccine is a triumph for
public health, but it’s also a triumph for science. My deep thanks and
congratulations, once again, to everyone who has made this possible. Carla,
back to you.
CD Thank
you, Dr Tedros, and thanks to all of our speakers for your inspiring remarks on
this historic day with this historic announcement. I’d like to now start the
Q&A section of this briefing, and if I could just remind you, journalists
online, to unmute yourself, I’d like to first call on Simon Ateba, Today News,
Africa. Could you, please, unmute and go ahead?
SA Thank
you for taking my question. This is Simon Ateba with Today News Africa in Washington
DC. For those of us who grew up in Africa, we never knew that there could be a
malaria vaccine, so this is almost, like, the biggest news for Africans this
year. I guess, my question is, how long will it take for everyone in Africa to
get access to the malaria vaccine? How long does it last? So, how long does it
protect against infection? How much money is needed for everyone to have access
to it in Africa, and whether you are getting any support from the Biden
Administration? Thank you.
00:24:16
CD Thanks
for that question, Simon, and I will hand over to Dr Pedro Alonso, Director of
GMP, to answer.
PA Well,
thank you for the question, and in normal circumstances, I would probably take
half an hour or 45 minutes to answer this one, but the brief answer to all the
very good questions is, the vaccine’s duration of protection is sufficient to
cover the most at-risk period for children, of getting severe disease and
dying. How long will it take to scale it up? Well, recalling what Dr Tedros, Director-General,
said, already, 800,000 children have received it, and a lot more are on the way
to receiving it.
However, the next few months will be critical,
in terms of defining the financing mechanisms to ensure that, with the current
production capacity, all the children that can benefit, do benefit from this
vaccine. The financial resources will be required, and it is a great
opportunity to show that success in having a new malaria vaccine is also a
great opportunity for global solidarity, generating further resources to ensure
that all African children that can and should benefit from this vaccine do get
this vaccine in the, hopefully, not-too-distant future.
CD Thanks
very much, Dr Alonso, and Dr Katherine O’Brien would like to add. Go ahead,
Kate.
KO I
just want to add a couple of things. I think the issues that you’re really
driving at, Simon, are issues of equity. And, what I think we’ve seen is that
there will be decisions made through the Gavi Board, coming up by the end of
the year, and there’s already a great partnership between GSK, who is the
manufacturer of the vaccine, then tech transfer, along with investors from
other sectors, med access in particular.
00:26:28
And so, these questions of exactly how it will
be financed, what the cost per dose is, these are still issues that are out in
front of us. But as we’ve seen from the COVID-19 vaccine, where there is
political will, there is funding available to assure that vaccines are scaled
to the degree that they’re needed. Thanks.
CD Thank
you. I’d like to turn to Damien Coulomb from Le Quotidien du Medicin. If you’re
online, Damien, could you, please, unmute? Okay, I’m going to read Damien’s
question. I’ll read it out, and speakers can answer. Sooner this year, we had
some interesting results concerning the circumsporozoite protein-based R21
vaccine. Is the SAGE already working on the integration of this vaccine into
the WHO Guideline? Perhaps, Dr Alejandro Cravioto, you could address this?
AC SAGE,
normally looks at vaccines once they are in the final stage of testing, and
sometimes in parallel to their whole regulatory process for approval, as we
have done with the COVID vaccines in a very accelerated way. So, we are aware
of the other vaccines, but that is through the Product Development Advisory
Group that the department also has, that looks at the pipeline. And then they
are the ones who follow the development of these vaccines and when SAGE should
be made aware of them, so that we can work together, in the sense of knowing
what the date is, coming up, and when we can make recommendations.
00:28:16
But, for us to make a formal recommendation, we
would really need to look at what is the evidence coming up from the phase 3
trials mostly, and then going back to the phase 1 and 2 to look at the whole
evidence, and then be able to make a recommendation for use.
CD Thanks
very much for that explanation on procedure. Let’s go to Professor Dyann Wirth
to add to that, please.
DW Great,
thank you. Yes, just to say that we hope that, in fact, this recommendation
today actually enhances the development of other vaccines. The R21 vaccine you
refer to is the same antigen that is in the same molecule that’s in RTS,S, but
in a new formulation. And so, it’s a second generation of the same vaccine, but
we also hope there will be more vaccines targeting more parts of the parasite
lifecycle. This is a complex disease, and we’re going to need more work on it.
CD Thanks
very much to both of you. I’d like to now go to Carmen Paun at POLITICO.
Carmen, could you, please, unmute and ask your question?
CP Yes,
thank you for giving me the floor. I wanted to get a bit more details on the
side effects. We heard that the ones that came up in the clinical trials have
been resolved, and they don’t seem to pose any reason for concern, but can we
get more details on that? What are the side effects that you found after
vaccinating 800,000 children? And can you give us a bit more details about how
many doses the vaccine is in and at what intervals they are given? Thank you.
00:30:06
CD Thanks,
Carmen. First, we’ll go to Dr Kate O’Brien and then to Professor Dyann Wirth.
Go ahead, please.
KO So,
one of the reasons that the Implementation Programme was initiated was that,
during the clinical trials that were conducted, the safety surveillance
identified that there were three signals, is what we referred to. And the
signals were a concern around children getting meningitis, cerebral malaria and
the balance of possible increase in deaths among girls. This was assessed by
the Safety Committee, during the clinical trials, to be a chance finding, but
they were serious enough that they needed to be evaluated before really rolling
out the vaccine in a routine way across a large number of countries.
And what the implementation evaluation has shown
in a very rigorous way is that none of these signals were seen in the
evaluation now of 800,000 children who have been vaccinated. So, this really
brings to a close any concern around those three signals. But this is a vaccine
that, like all vaccines, does have some level of mild side effects. In addition
to the mild side effects, children do develop some fever associated with the
vaccine, some children do.
And so, there is a low risk of having a short
period, a short event of convulsions associated with fever.
00:31:51
So, children who have high fevers, some of them
will develop self-resolving convulsions. You asked, also, about the interval
and the dosing for this vaccine. So, we’ve seen, just to summarise, then, on
the safety profile, a very good safety profile, I think we’ve resolved any of
the concerns or the signals from the clinical trial.
This is a vaccine that is a four-dose vaccine.
However, the need for that fourth dose is still under full evaluation, and we
will continue to watch the data to assess the degree, to which that fourth dose
is providing a degree of impact that would demand continuing to get the fourth
dose. And it is in a three-dose schedule that is separated one month apart.
There is some flexibility around how those doses can be given.
And so, country programmes have a lot of
flexibility around exactly what ages, at which they want to incorporate the
vaccine, starting at five months of age. And the fourth dose would be around 18
months of age, so a five, six, seven schedule or something in that range.
CD Okay,
let’s go to the next question from John Zarocostas for France 24. Go ahead,
John, and unmute yourself.
JZ Yes,
good afternoon. Can you hear me there?
CD Absolutely.
Go ahead, please.
JZ Yes,
I was wondering if you could elaborate what is the efficacy of the vaccine?
00:33:29
A few years ago, I think they were mentioning
40%. Is it more than 50% now? What is the level of efficacy? Thank you.
CD Okay,
we’ll call on Dr Pedro Alonso to answer. Go ahead, Sir.
PA John,
thanks very much for your question. The results you probably recall are from
the phase 3 trial. That’s a rigorous phase 3 clinical trial, and what we are
looking at right now is what we call effectiveness. That is the impact of the
vaccine, when deployed through routine immunisation services. What the
committees have seen is that, consistent with the phase 3 trials, areas where
the vaccine has been deployed have reduced the admission to hospital of
children with severe malaria.
And when we talk of severe malaria, we’re
talking of a very severe condition that is associated with a high risk of
dying. So, in this case, a 30% reduction of admission with severe malaria is a
very significant impact, given the magnitude of the burden associated with
malaria.
CD Thanks
very much, Dr Alonso. Next, we have Helen Branswell online. Helen, could you
unmute and ask your question, please?
HB Hi.
Thanks very much for taking my question. I wanted to follow up on Dr O’Brien’s
comment about the fourth dose.
00:35:07
I know that the pilot programme hasn’t been
underway that long, but are you starting to see anything that would signal
that, perhaps, a fourth dose is not needed? Thank you.
KO You
know, Helen, we really do need to wait for a continued observation period, to
really fully assess this. The results from the phase 3 trial initially
indicated that the fourth dose was an important dose to receive, and further
evidence that has come from that phase 3 trial and re-analysis gives us some
expectation that the major part of the effect is in the first three doses. And
so, just like with other vaccines that we’ve been talking about, we always want
to be sure that we’re advising on the number of doses that will achieve the
best impact and no more than that.
So, really, we need to wait for the remainder of
the evidence to come through, so that we can provide adjustments to the current
recommendations as we get more certainty and clarity on some of those
uncertainties. At this point, the recommendation is for a four-dose regimen, as
was evidenced through the clinical trial. And again, the implementation
programme will be continuing, to address, in part, this specific question.
Thank you.
CD Thanks
very much, Kate. Next, we have Anne Gulland from The Telegraph. Anne, please
unmute and go ahead.
AG Oh,
hi there. Thanks very much for taking my question. I wondered what the WHO’s
initial goal was for the effectiveness of a vaccine. I know, with COVID, I
think you wanted to 50% effectiveness.
00:36:59
Was it the same for malaria, or was it lower?
And if this vaccine is lower than your initial goal, why are you wanting to
approve it? Thank you.
CD Okay,
we’ll go to Dr Alonso to answer.
PA Our
goal, as WHO, and I believe, as the broader immunisation and malaria community,
is to have a 95% efficacious vaccine, a tool that would actually allow us to
foresee a world free of malaria. However, as Professor Dyann Wirth mentioned
earlier in the call, we’re confronted with an extraordinary complex organism.
It’s an [unclear]. It’s a parasitic disease, and this is orders of magnitude
more complex, in terms of the biology of the causative organism.
And so, I don't think we are within reach of a
highly efficacious vaccine yet, but what we have right now is a vaccine that
can be deployed, that is accepted that it’s safe, and that can have a massive
impact, in terms of lives saved and episodes of malaria averted, even if it is
only, in inverted commas, 30%.
Now, that 30%, given the magnitude of what
malaria represents, is probably one of the most impactful vaccines that one
could actually use in Africa right now. So, we aimed for much higher, but what
we have right now can already make a huge difference for children in Africa.
CD Thanks
very much, Dr Alonso. Professor Wirth, please go ahead. You’d like to add
something?
00:38:45
DW Yes,
I want to reinforce what Pedro said, and I think we’d all like a magic bullet
that completely cured the disease and was given once in your lifetime, but this
is a very complex disease that has evolved mechanisms to evade the normal
immune system, which controls infectious organisms. And so, I think that we
should recognise the challenge and the relative success.
Depending on how you give this vaccine, if you
look through the phase 2 trials, you can get much higher efficacy by actually
targeting when you give the vaccine, relative to transmission, but is that
actually implementable in a worldwide large-scale way?
And so, I think this is one of those situations
where we have a tool, it’s demonstrated through, both the clinical trial, and
now through the inflammation trials, to have a measurable and significant
impact. And that’s the reason we’re approving it. We’re not saying this is the
end, and in fact, I’m hoping this is the beginning, a renaissance, of vaccine
development in the malaria field.
I think the fact that now we have an approved
vaccine, means it may actually spur the field to use some of the great new
innovations in vaccines that have occurred since this vaccine was first
developed over 30 years ago.
CD Thanks
very much, Professor Wirth. Dr Kate O’Brien would like to supplement.
KO I’d
just like to draw the analogy to other life-saving vaccines that have been authorised
and recommended for use. When you have… First of all, we do hear the term of a
modestly efficacious vaccine, and, frankly, there are no vaccines that we have
that are completely efficacious.
00:40:49
So, every vaccine we have has some degree of
modest efficacy. But I think the most important point is that a per cent
reduction in a very common and severe outcome is a very significant reduction
in the rate of that outcome. And what it also means is that there’s still work
to be done to improve on the vaccine, and for layering of the interventions.
Such an important point here is that this is not
about a vaccine replacing the tools that are already out there. It’s about
supplementing what’s already out there because there’s no intervention for malaria
that is highly efficacious in its use across all settings. For the malaria
situation, it’s really about layering on tools to get as high impact as is
possible to protect the lives of children. Thank you.
CD Thanks
very much, Dr O’Brien. And since we’re talking about the R&D aspects of
vaccine development, wondered if Dr Soumya Swaminathan would like to
supplement, WHO’s Chief Scientist. Please, go ahead.
SS Thank
you, and again, I would like to congratulate all the partners who’ve been
involved in this very long journey, GSK, who did a lot of the work and
continued to work with the WHO and the other partners, Gavi, Unitaid, Global
Fund, Gates Foundation. I think it just shows that you need partnerships, you
need public and private sector, philanthropy sometimes, but then you also need
the researchers in the countries.
00:42:29
You need the trial participants or the research
participants. So, research, especially on complex things like vaccines, is not
simple, and you heard, it’s taken 30 years to get here. What we do have now is
a couple things. One is we have new technologies like the mRNA platform that
clearly has proved that it can work. It’s safe and efficacious, as we have seen
with COVID. And we’re already working with companies to develop, to start the
process of development of mRNA vaccines for TB and malaria and other diseases.
So, it gives us hope that we can use new
platforms, but building on the experience that we have about diseases like
malaria and the antigens that we know now work, can take it forward. And again,
it’s a process where we’ve started this development programme, which involves
experts, involves private sector and academics, to develop a roadmap or a
pathway for development of a new vaccine for TB, for example, using a new platform.
What would the development process look like? We
don’t want to take 30 years. We want it to be done much faster, but that can
only be done if you lay out in advance, the benchmarks, the target product
profiles, what clinical trial, what endpoints we should be looking at, what
regulatory agencies should be looking for, and at the same time, also planning
for scale-up of vaccines, looking for manufacturers, trying to build capacity,
as we’re doing now in South Africa with the first mRNA technology transfer hub.
South Africa is also, the company Biovac is also
working with bioNTech to develop the mRNA vaccines, and we really look forward
to developing those manufacturing capacities, R&D capacities and the whole
ecosystem in Africa so that vaccines for diseases for Africa are manufactured
and made and developed from scratch in Africa in the future.
00:44:44
And we hope to continue these very productive
partnerships that we have had so far. Thanks.
CD Thank
you so much, Dr Swaminathan. I think we will wrap up fairly soon, but we do
have a question from Jason Beaubien from NPR. If you could unmute yourself,
Jason, and ask your question, please go ahead.
JB Yes,
I’m just wondering if you could just be more specific on what number you guys
are using for the efficacy of this vaccine. Dr Alonso said 30%, in terms of
preventing severe cases and hospitalisations. I’m seeing 40%, in terms of
stopping malaria infections. What is the number you guys are working with, in
terms of the efficacy that you are seeing with this vaccine?
CD Thanks
so much for that question, Jason, and I’ll turn to Dr Mary Hamel for an answer.
Go ahead, please.
MH Hi.
Thanks for that question. So, in the large phase 3 trials that were completed
in 2014, the efficacy was 40%, so a 40% reduction in clinical malaria, and a
30% reduction in severe malaria. And, as Dr O’Brien stated, because children
have malaria cases many, many times in a year, and every time that they have a
case of malaria, they’re at risk of severe malaria and death, at this level of
efficacy, the impact could be quite high.
00:46:15
And in fact, even in the phase 3 trial, we saw
that among children who were followed for four years, there were thousands of
cases of malaria prevented per thousand children vaccinated.
CD Thanks
very much, Dr Hamel. We have a question that was written in the chat, quite
interesting, about the economic impact of this breakthrough recommendation. It’s
from Marina Zapf from German Business Magazine. So, she asks, is anybody in the
room able to comment on the economic impact of this breakthrough
recommendation? Pedro Alonso, would you like to…?
PA We
don’t have a figure. What we can tell you is what malaria represents in the
continent, and the estimated cost, and this is probably a slightly outdated
figure, but the estimated cost of malaria in Sub-Saharan Africa is over $12
billion per year, and a substantial loss in growth. So, tools that help us tackle
malaria, improve the way we can control the disease, have a massive impact on
economic development and on health.
So, an exact figure of this vaccine and the
impact, we haven’t worked that out, but the impact of malaria in the continent
is massive.
CD Thanks
very much, Dr Alonso, for that answer. Aaron Ross from Thomson Reuters, could
you unmute yourself and ask your question, please?
AR Yes,
thank you very much. In 2015, GSK had said that there must be a separate
determination by the WHO, in addition to the recommendation for widespread use
that would guide African nations’ procurement deals. When will this
determination be announced, and how many steps are there before that’s made?
00:48:31
CD I’m
not sure we totally understand your question. Could you just rephrase it/repeat
it so that we can direct it to the right expert in the room? Thanks.
AR Sure.
Our understanding is that in 2015, GSK had said that after WHO makes a
recommendation for widespread use, there would be a separate determination that
would be used to make determinations about procurements for with a vaccine. Do
you have any idea when any such determination would be made?
CD I’ll
turn over to Dr Kate O’Brien.
KO So,
thank you for that question, and I think what you’re referring to is that in
2015, when WHO made a recommendation for the implementation programme, this was
a vaccine that was authorised for use by the European Medicine Agency, and
there was no broad recommendation for use at that time, as we’re all clear. The
implementation programme needed to go forward. What was also understood at that
time is that having a recommendation for policy would not itself be the
mechanism, through which funding for the vaccine would take place.
That would require a funding position,
presumably by Gavi, to assure that there were the resources available to
procure the vaccine.
00:50:01
And so, as I mentioned, that decision will go to
the Gavi Board at the beginning of December for a deliberation about investment
in this vaccine, having now achieved a policy recommendation from WHO. So, that
step of investment is still a step that we’re looking forward to.
CD Thanks
very much, Dr O’Brien. This is going to be our last question, and then I’ll
turn to a couple of our experts to see if they have any final comments. So, I’d
like to turn to Sarah Jerving from Devex. Sarah, please unmute and go ahead.
SG Sorry
about that. Thank you so much. So, you spoke about the potential for local
production. Do you have certain countries in mind for production? And are there
currently any production constraints that could prevent a widespread scaleup in
the coming months/year? And what challenges do you foresee in country rollouts?
CD Turning
to Dr Kate O’Brien, go ahead.
KO So,
GSK was clear at the time, as we’ve proceeded with this vaccine, that, having
provided a large degree of development funding and producing the vaccine for
the implementation programme and a commitment to continue producing the vaccine
for a period of time, was nevertheless seeking a tech transfer partner for the
long-term production of this vaccine. There was a programme opened up to
initiate interest from vaccine manufacturers, and the partner who will be with
GSK for this tech transfer is Bharat Biotech in India.
00:52:11
So, this will be, at the outset, the site of
manufacturing. Over a period of years, this transfer of the technology will
take place, and as Professor Wirth mentioned, what we’re really looking for is
a healthy market for malaria vaccines. This is a breakthrough. It is historic.
It is the first, but we don’t expect that this will be the only vaccine. And
really, what the interest is, is in having a market that provides vaccines with
supply security.
And we will certainly be looking for additional
vaccines and additional manufacturing of the vaccines to assure that there are
sufficient doses for all of the sites and countries and children who require
the vaccine. Whether that’s this vaccine or next-generation vaccines, and where
that manufacturing will take place, really, the focus is on advancing the
manufacturing on the African continent.
And we’ve seen that with COVID vaccine, and, in
fact, a sightline for many more vaccines to be manufactured on the continent
for the populations in Africa.
CD Thanks
very much, Dr O’Brien. We have a couple of experts in the room. I’d just like
to ask them if they have any final comments before turning back to Dr Tedros.
We have Dr Suzanne Jacob in the room and Dr David Schellenberg, so, Dr? Okay,
David Schellenberg?
DS Thank
you. Just, maybe, to say, David Schellenberg from the Global Malaria Programme.
I’m the Science Advisor there.
00:53:56
And we’ve already heard that this is a historic
moment, a milestone for malaria control, about the long time that it’s taken to
get to this point. I’d just like to emphasise that a cornerstone of malaria
control is vector control, development of insecticides and new
insecticide-treated mosquito nets to prevent malaria.
And we celebrate every time there’s a
development in vector control that’s great. Likewise with drugs for prevention
of malaria, drugs for treatment of malaria. Innovations in the development of
drugs for malaria are really important. Likewise for diagnostics, but this
opens up a whole new avenue for malaria control. The availability of a vaccine
now recommended by WHO, that we heard about R21 and other malaria vaccines that
are in development, and we are very supportive of the continued development and
investment to develop new vaccines.
But we have to temper our optimism and
enthusiasm for the next generation of vaccines by recognising that there are
all sorts of pitfalls along the development path, and it falls to us to really
make the best use of the tools that we’ve got available in our hands now. And I
think today’s recommendation paves the way for such impact. Thank you.
CD Thanks
very much, Dr Schellenberg, and thanks to all the journalists online for your
really interesting questions today. We will wrap up this press conference now.
And a big thanks to all of our speakers today, and also to our interpreters who
helped with this press conference, with different languages. And just a
reminder that we have sent, already, the press release related to this news.
00:55:41
Journalists should have received that, and you
will also receive any post-presser links that we have. And always, if you have
further questions or might want to arrange one-on-one interviews, please get in
touch with mediainquiries, with an I, @who.int. So, with that, I’ll hand the
floor, now, back to Dr Tedros for his final remarks. Go ahead.
TAG Yes,
thank you, Carla. I think, as we have said earlier, today is a very historic
day, and because it’s not only this vaccine is just for malaria. This is not
first vaccine, just for malaria, but it’s also the first vaccine for any
parasitic diseases. So, it will open up opportunities for other diseases as
well, in the control of other diseases as well. So, that’s what I would like to
underline, and the second is, in terms of next steps.
I think many were interested on how we would
scale up intervention and make use of this new tool. And, as you may guess, we
will move into massive mobilisation because we will need resources. And if
we’re going to increase access to this new tool, then we will need increased
production of the vaccine. And that means we will need resources. And as Soumya
said, I hope the partnership and cooperation with continue to avail the
resources, so that children in Africa and in other parts of the world can have
access to this vaccine.
00:57:42
Having a vaccine is an important milestone, but
the key is having that vaccine in use and creating access to as many children
as possible. So, that will be the major challenge now, as you have already
guessed, and we will do everything to make sure that we have resources to
deliver this vaccine to those who need it.
So, once again, I would like to thank our
co-chairs, Professor Dyann Wirth. By the way, she is my mentor, and I’m glad to
be, today, on her side. Both from malaria, and also my good friend and brother,
Dr Alejandro Cravioto, and also all who have been involved within this work,
all our partners, all our colleagues from WHO and other institutions.
And also to the media, thank you so much for
joining us today, and look forward to having you tomorrow, when we launch the
COVID vaccine strategy with Secretary-General, Antonio Gutteres. Thank you.
00:58:59