Developing a Vaccine to Protect Against Pandemic Influenza

1
Developing a Vaccine to Protect Against Pandemic
Influenza

• Public Statement by GlaxoSmithKline
• 27 February 2007

2
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

3
GSKs 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)

4
Effect of GSKs Adjuvant System on Immune
Response to H5N1 Vaccine
100
90
80
CHMP/CBER 70 criterion
70
60
of Subjects (95 CI)
50
40
30
Since baseline HI titers are largely lt10, rates
of seroprotection and seroconversion are
essentially equal
20
10
0
No Adjuvant
With Adjuvant
No Adjuvant
With Adjuvant
No Adjuvant
With Adjuvant
No Adjuvant
With Adjuvant
3.8 ug
7.5 ug
15 ug
30 ug
ClinicalTrials.gov identifier NCT00309634
5
Regulations for Pre-Pandemic Vaccines

• Europes CHMP has issued comprehensive guidance
• Efficacy surrogate ? HI antibody response to
  vaccine
• Supportive data for cross-protection
• Cross-reactive neutralizing antibody responses
• Protection in ferret model
• Ability 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 07
• GSK is discussing with FDA what evidence will
  enable a U.S. license application

6
GSKs 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