PRESS RELEASE

Malaria vaccine candidate hasdemonstratedefficacy over 3-4 years of follow-up

Final results from Phase III trialsuggest substantial public health benefitscould be provided by the RTS,S
malaria vaccine candidate in endemic regions in sub-Saharan Africa
Vaccine efficacy enhanced by administration of a booster dose
Final results from a large-scale Phase III trial of the RTS,Smalaria vaccine candidate, including the
impact of a booster dose,published today in The Lancet,show that the vaccine candidate helped protect
children and infants from clinical malaria for at least three years after first vaccination.

malaria has yet to be eliminated or even fully controlled in many parts of the world;these data suggest
that malaria vaccines can help us take some critical steps along that path.
Next steps

The latest results demonstrated that vaccination with RTS,S, followed by a booster dose of RTS,S
administered 18 months after the primary schedule, reduced the number of cases of clinical malaria
in children (aged 5-17 months at first vaccination) by 36%to the end of the study1 (over an average
follow-up of 48 months across trial sites) and in infants (aged 6-12 weeks at first vaccination) by 26%
to the end of the study (over an average follow-up of 38 months across trial sites). Efficacy decreased
over time in both age groups. Without the booster dose, the 3-dose primary schedule reduced clinical
malaria cases by 28% in children and 18% in infants to the study end.The efficacy of RTS,S was evaluated
in the context of existing malaria control measures, such as insecticide treated bed nets, which were
used by approximately 80% of the children and infants in the trial.

The European Medicines Agency (EMA) is currently reviewing the regulatory application for RTS,S
through the Art. 58 procedure initiated in July 2014.
A positive opinion from the EMAs Committee for Medicinal Products for Human Use, together with
a potential policy recommendation from the World Health Organisation (anticipated by the end of
2015), would be the basis for licensure applications to National Regulatory Authorities in sub-Saharan
African countries. If positive, these regulatory decisions would help pave the way for the introduction
of RTS,S through African national immunisation programmes. If RTS,S is approved, GSK has committed
to making the vaccine available at a not-for-profit price.

For children in the 5-17 month age category who received a booster dose 18 months after the primary
schedule, an average of 1,774 cases of clinical malaria were prevented for every 1,000 children
vaccinated across the trial sites, over an average of 48 months of follow-up. For infants aged 6-12 weeks
at first vaccination with RTS,S, who received a booster dose, 983 cases of clinical malaria, on average,
were prevented for every 1,000 infants vaccinated across trial sites over an average of 38 months of
follow-up. More cases were averted in areas of higher malaria transmission. In the absence of a booster
dose, 1,363 cases of clinical malaria were prevented, on average, for every 1,000 children aged 5-17
months at first vaccination and 558 cases for every 1,000 infants aged 6-12 weeks at first vaccination
to the end of the study.

UNC Project Lilongwe- is a collaboration between the University of North Carolina at Chapel Hill and
Ministry of Health. It started doing research in Malawi in the early 1990s. Its mission is to identify
innovative, culturally acceptable and relatively inexpensive methods for reducing the risk of HIV,
Sexually Transmitted Infections (STI), Tuberculosis (TB), Malaria transmission and cancer through
research;strengthenlocal research capacity through training and technology transfers andimprove
patient care capacity and delivery. It mainly operates from Kamuzu Central Hospital, Bwaila Hospital,
Area 18, 25 and Kawale Health Centres. Over the years, its operations have expanded to cover health
facilities in the Central West Zone including Lilongwe, Dedza, Kasungu, Ntcheu, Dowa, Mchinji and
Salima. Find us for more information at www.id.unc.edu/malawi

Statistically significant efficacy against severe malaria to the end of the study period was observed only
in children who received the booster dose.There was indication of increased risk for severe malaria in
children who did not receive the booster dose, compared to those in the control group.

GSK one of the worlds leading research-based pharmaceutical and healthcare companies is
committed to improving the quality of human life by enabling people to do more, feel better and live
longer. For further information please visit www.gsk.com.

Eleven research centres in seven African countries2 conducted the efficacy and safety trial, in partnership
with GSK and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda
Gates Foundation to MVI. The trial, started in March 2009 and concluded in January 2014, enrolled
15,459 participants, in two age categories: children (aged 5-17 months at first vaccination) and infants
(aged 6-12 weeks at first vaccination).

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and uncertainties that may cause actual results
to differ materially from those projected. Such factors include, but are not limited to, those described
under Item 3.D Risk factors in the companys Annual Report on Form 20-F for 2014.

Safety
RTS,S continued to display an acceptable safety and tolerability profile during the entire study period.
The incidence of fever in the week after vaccination was higher in children who received RTS,S than
in those receiving control vaccine. In some children who experienced fever, thefebrile reaction was
accompanied by generalized convulsions, but all those affected fully recovered within seven days.

PATH is the leader in global health innovation. An international non-profit organization, we save lives
and improve health, especially among women and children. We accelerate innovation across five
platformsvaccines, drugs, diagnostics, devices, and system and service innovationsthat harness
our entrepreneurial insight, scientific and public health expertise, and passion for health equity.
By mobilizing partners around the world, we take innovation to scale, working alongside countries
primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable
results that disrupt the cycle of poor health. Learn more at www.path.org.

The meningitis signal previously reported remains in the older age category, including two cases
reported after the booster dose of RTS,S.Thiscould be a chance finding, as comparisons were made
across groups for many different diseases, and because some of these cases happened years after
vaccination without any obvious relationship to vaccination. The occurrence of meningitis will be
followed closely during Phase IV studies, if RTS,S is licensed.
Prof Francis Martinson, a principal investigator in the trial in Malawi said Malawi has tried for a long
time to reduce the burden of Malaria in children. The efforts have paid off in the last couple of years as
the prevalence has reduced. However Malaria still continues to be a huge burden on the health sector
with children being the most affected. So we need to continue to look for other tools to add to the
existing prevention measures to further protect our children from getting Malaria. Today we report the
success of a vaccine that have shown to be effective in preventing acquisition of Malaria in children.We
salute the children of Malawi and their parents who through their participation have contributed to
this successful story. We look forward to the day when children will go to the clinic and be vaccinated
to be protected against Malaria.
Dr KwakuPoku Asante, a principal investigator in the trial and chairperson of the RTS,S Clinical Trials
Partnership Committee said We finally have in our sights a candidate vaccine that could have a real
impact on this terrible disease that affects many children during their first years of life. The large
number of children affected by malaria, sometimes several times per year, means that this vaccine
candidate, if deployed correctly, has the potential to prevent millions of cases of malaria.
On behalf of the African scientists and research centres that worked on the RTS,S trial, we give thanks
to our national health authorities, and to the trial participants, for enabling us to reach this important
milestone.
Dr MoncefSlaoui, Chairman Global Vaccinesat GSK, said: We are extremely encouraged that the
results point to continued and significant public health benefit for those children whose lives are
so disrupted by this awful disease.We might reasonably now expect that the impact of this vaccine
candidate when used with existing interventions will allow more children to survive the early years
which we know is the most dangerous time to be infected with malaria. We are working hard to submit
the necessary evidence to regulatory authorities and the World Health Organisationso that they can
take an informed decision on whether theRTS,S vaccine candidateshould be made available as an
additional tool for malariaprevention.
Dr David C. Kaslow, Vice President of Product Development at PATH, said: Credit for reaching this
scientific milestone goes to the thousands of African families and hundreds of scientists, clinicians, and
health professionals who have made a commitment for many years to this vaccine trial. The publicprivate partnership behind RTS,Shas successfully collected pivotal human efficacy and safety data that
regulators and policymakers can now use to decide on its use. While eradication is the ultimate goal,

The PATH Malaria Vaccine Initiative (MVI) is a global program established at PATH through an initial
grant from the Bill & Melinda Gates Foundation. MVIs mission is to accelerate the development of
malaria vaccines and catalyze timely access in endemic countries. MVIs vision is a world free from
malaria. For more information, please visitwww.malariavaccine.org.
1
2

Intention to Treat (ITT) analysis, for this statistical reference and those that follow
Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania

CONTACT INFO FOR MEDIA CONTACTS

Malawi Media enquiries:
Tapiwa Tembo
+265 (0) 881589725

Portia Kamthunzi
+265 (0) 999553034

Francis Martinson
+265 (0) 888838388

Nelecy Chome
+265 (0) 888338631
GSK enquiries:
UK Media enquiries:
David Mawdsley
+44 (0) 20 8047 5502

Simon Steel
+44 (0) 20 8047 5502

David Daley
+44 (0) 20 8047 5502

Catherine Hartley
+44 (0) 20 8047 5502

Sarah Spencer
+44 (0) 20 8047 5502

Claire Brough
+44 (0) 20 8047 5502

US Media enquiries:
Sarah Alspach
+1 202 715 1048

Mary Anne Rhyne
+1 919 483 0492

Melinda Stubbee
+1 919 483 2510

JenniLigday
+1 202 715 1049

Karen Hagens
+1 919 483 2863

Analyst/Investor enquiries: ZibaShamsi
+44 (0) 20 8047 5543

Tom Curry
+ 1 215 751 5419

Gary Davies
+44 (0) 20 8047 5503

James Dodwell
+44 (0) 20 8047 2406

Jeff McLaughlin
+1 215 751 7002

(Malawi)
(Malawi)
(Malawi)
(Malawi)
(London)
(London)
(London)
(London)
(London)
(London)
(Washington, DC)
(North Carolina)
(North Carolina)
(Washington, DC)
(North Carolina)
(London)
(Philadelphia)
(London)
(London)
(Philadelphia)

All PATH Malaria Vaccine Initiative (MVI) media enquiries: Ellen Wilson at +1 301 280 5723 or ewilson@
burness.com