Developing a Vaccine to Protect Against Pandemic Influenza

Public Statement by GlaxoSmithKline

27 February 2007

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Challenges for a Pandemic Vaccine

The population is immunologically naïve to a pandemic virus

Reactive production of a pandemic vaccine, even with a large capacity increase, could leave most people unprotected

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GSK’s Position

Advance production and stockpiling are the foundation of pandemic preparedness

The ideal vaccine to support this approach:

Effective against drift variants

Antigen-sparing

Can be stockpiled (shelf-life)

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Effect of GSK’s Adjuvant System on Immune Response to H5N1 Vaccine

Since baseline HI titersare largely <10,rates of ‘seroprotection” and seroconversion are essentially equal

CHMP/CBER 70% criterion

0

10

20

30

40

50

60

70

80

90

100

No Adjuvant

With Adjuvant

3.8 ug 7.5 ug 15 ug 30 ug

% o

f Sub

ject

s (9

5% C

I)

No Adjuvant

With Adjuvant

No Adjuvant

With Adjuvant

No Adjuvant

With Adjuvant

ClinicalTrials.gov identifier: NCT00309634

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Regulations for Pre-Pandemic Vaccines

Europe’s CHMP has issued comprehensive guidanceEfficacy surrogate → HI antibody response to vaccineSupportive data for cross-protection:

Cross-reactive neutralizing antibody responsesProtection in ferret modelAbility of vaccination to support a booster-response upon vaccination with a drifted strain

GSK filed a EU license application for its pre-pandemic vaccine 29 Jan 07GSK is discussing with FDA what evidence will enable a U.S. license application

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GSK’s Pre-Pandemic Vaccine Development Plan

Conduct pivotal trials of our vaccine with adjuvant under an IND in 2007 and file a U.S. license application

While application under review, extend safety database, generate data for supplemental application:

Pediatric indication

General use prophylaxis of all ages