5. “With the exception of safe water, no
other modality, not even antibiotics, has
had such a major effect on mortality
reduction...”
Plotkin S et al,Vaccines, 20111
Vaccines
6. Every year up to 3 million
deaths are prevented and
750,000 children are saved
from disabilities through
vaccination2
7. What vaccination can achieve
• Globally:
• Approximately 700,000 deaths caused by
pneumococcal disease could be prevented
by 20158
• Cases of polio are down by over 99% - from
over 300,000 per year in 1988 to less than
2,000 in 20099
• Some countries have witnessed declines in
hospitalisations due to rotavirus infection of
up to 80%10
• Vaccination and screening can bring down the
burden of cervical cancer 11
• GlaxoSmithKline has vaccines in all these disease
areas
8. • For over 50 years we have supplied polio vaccines for
elimination and eradication efforts worldwide20
• Our pneumococcal conjugate vaccine (PCV) Synflorix™i
was the first PCV to receive WHO ‘prequalification’
for global use
• RotarixTM has been included in government vaccination
programmes for newborn babies in many countries..
Worldwide more than 100 million doses of RotarixTM
have been distributed globally, the vast majority to
Least Developed Countries20
i. SynflorixTM is a registered trade mark of the GlaxoSmithKline group of companies
ii. RotarixTM is a registered trade mark of the GlaxoSmithKline group of companies
GSK playing its part
9. Providing access to GSK vaccines
•In 2010, we delivered 1.4 billion vaccines doses
to 179 countries worldwide19
•Up to 70% of our volumes are distributed in low
and middle income countries19
•GSK has a tiered pricing policy to enable pricing
to be aligned to a country’s ability to pay19
•The price for UN’s Least Developed Countries list
should not exceed 25%* of the western European
average21
* In very isolated cases existing contractual agreements with supranational organisations such as PAHO or GAVI may mean a higher figure than 25%
11. Beyond The Antigen Support
Cold Chain Support Access & Advocacy
Patient information
Leaflets/Videos
Disease
Awareness
Materials
Vaccination Record
Cards
Capacity Building
House of Vaccines
12. GSK’s Support Beyond The Antigen
– Based on previous experience, GSK
provides support to facilitate an effective
vaccination experience:
– Cold chain management
– Social mobilization / Overcoming barriers to
vaccination
– Vaccinator training
– GSK’ vast implementation knowledge ensures
to make the most of a vaccine introduction
program
– Community
– Hospital
• Decades of experience in
vaccine introduction
• Localized & “bottom-up”:
Relying on local knowledge
• Learnings from other
countries and vaccines are
leveraged
• On-going implementation
monitoring and clinical
surveillance
Value of holistic
support
20. Cervical Cancer Vaccination Value Offer
Worldwide cervical
cancer kills one
woman every two
minutes1
Cervarix is dedicated to
prevent Cervical Cancer
Cervarix from GSK
offers values beyond
the antigen
Cervical cancer is the
second biggest cause of
female cancer mortality
worldwide2
References:
1. Ferlay J et al. Globocan 2002. IARC 2004
2. WHO initiative for vaccine research
3. TBC
Persistent HPV infection is
the necessary cause
of Cervical Cancer
• All Women are at
Risk of Oncogenic
HPV throughout
their Lives
21. Cervarix is dedicated to
prevent Cervical
Cancer
High efficacy:
~100% for 16/18 and
93% across all types
Lehtinen et al. Lancet Oncol 2012;13:89-99
Cervarix has a good
safety and tolerability
profile
Cervarix – the appropriate choice for Cervical
Cancer Protection
Cervarix has been
licensed with a 2 dose
schedule for girls 9-14
years
Cervarix from GSK offers
values beyond the antigen
22. Efficacy of HPV vaccines
Overall vaccine
efficacy
Efficacy against
HPV 16/18
Efficacy against
non-vaccine
oncogenic types
= +
23. Efficacy of HPV vaccines
Overall vaccine
efficacy
Efficacy against
HPV 16/18
Efficacy against
non-vaccine
oncogenic types
= +
24. PATRICIA: Efficacy results against high grade lesions
associated with HPV 16/18
1. Lehtinen M, et al. Lancet Oncol 2012; 13:89–99;
2. Paavonen J, et al. Lancet 2009; 374:301–314..
Endpoint Group N n
Vaccine efficacy, %
(95% CI)
CIN2+
Vaccine 5,466 1
99.0 (94.2–100.0)Control 5,452 97
CIN3+
Vaccine 5,466 0
100.0 (85.5–100.0)
Control 5,452 27
TVC-naïve cohort
End-of-study analysis1
Approximate
to young women before
sexual debut:
≥ 1 dose
26. Efficacy of HPV vaccines
Overall vaccine
efficacy
Efficacy against
HPV 16/18
Efficacy against
non-vaccine
oncogenic types
= +
27. – Estimated worldwide prevalence of HPV 16/18 in high-grade lesions (CIN2/3) is 51%2
TVC-naïve
1 Lehtinen M, et al. Lancet Oncol. 2012 Jan;13(1):89-99; 2. WHO/ICO Information Centre on Human papilloma Virus (HPV) and Cervical Cancer. Available at:
http:www..hpvcentre.net/dataquery (accessed Jan 2014) ;
Endpoint
Vaccine
cases
N = 5,466
Control
cases
N = 5,452
Efficacy,
%
95% CI
CIN2+ irrespective of DNA
in the lesion † 61 172 64.9 52.7–74.2
CIN3+ irrespective of DNA
in the lesion
3 44 93.2 78.9–98.7
End of study analysis1
Approximate
to young women before
sexual debut:
≥ 1 dose
PATRICIA: Efficacy results against high grade lesions
irrespective of HPV type
28. DOSAGE
– AGED 9 – 14 YEARS OLD
– If flexibility in schedule is necessary, the 2nd dose can be given between 5 and 12 months after the 1st
dose. If the 2nd dose is given before month 5, then a 3rd dose must be given.
– AGED15 YEARS AND OLDER
DOSE 1 DOSE 2
0 month 1 2 3 4 5 6 months
DOSE 1 DOSE 2 DOSE 3
0 month 1 month 2 3 4 5 6 months
If flexibility in schedule is necessary, the 2nd dose can be given between 1 and 2.5 months
after the 1st dose, and the 3rd dose between 5 and 12 months after the 1st dose.1
Cervarix. Summary of Product Characteristics. January 2014
AWA/CER/0003/14
29. AWA/CER/0003/14
Cervarix® Vaccine Pooled Studies: Safety Analysis
Descamps D, et al. Hum Vaccin 2009; 5:1–9.
SAE = severe adverse event.
Pooled clinical trial data analysis
(29,953 girls and women 10 to 72
years)
The most common adverse
reaction was injection site
pain: the majority were mild to
moderate severity and were
not long lasting
Fatigue, headache and
myalgia were the most
common solicited general
symptoms
No significant increase in
relative risk of potential
autoimmune events detected
in meta-analysis
Similar overall rates of
pregnancy outcomes
30. AWA/CER/0003/14
Further information
– Full Prescribing Information For Cervarix® Vaccine Is Available Upon
Request
– For Safety Information Or For Reporting Any Adverse Event
Associated With GSK Products,
Kindly Call GSK 24-hours Dedicated Toll Free Line
0800CALLGSK (08002255475 )
