FluMist

1
FluMist(Influenza Virus Vaccine Live,
Intranasal)Reception, Challenges and Product
Plans
2
FluMist? 2003-04 Launch

• First new influenza vaccine in 50 years
• Late launch (June 17, 2003 approval)
• 5M doses (25 of 20M capacity) produced at risk
• Vaccine availability in September
• Comprehensive promotional campaign
• Education via non-branded (disease awareness) ads
• Branded, direct-to-consumer advertising
• Storage devices made available to customers

3
2003-04 Influenza Season

• FluMist Utilization
• 5M doses made at risk
• Clinical data indicating protection against drift
  variant
• Slow up-take
• Initiated gt50 rebate
• Minimal usage through state and federal channels
• 4M (80) doses wasted

• Influenza Season
• Early epidemic
• Drift variant
• Pediatric mortality
• Demand for vaccine
• TIV shortage
• Heightened public awareness

4
Continued Commitment to Improving Access to
Influenza Vaccine

• Response
• Correct misperceptions
• ACIP recommendations
• Medical education
• Assess pricing options
• Develop refrigerator-stable formulation
• Studies to expand indication

• Challenge
• Misperceptions
• Live attenuated
• Transmission
• Price
• Reflects cost of innovation and manufacturing
• Storage
• Limited indication

5
Planned and Proposed Studies

• Phase 4 commitments
• Large (N60,000) safety surveillance trial over
  multiple seasons
• Shedding and immunogenicity trial (N300)
• Expanded age indications
• Children lt5 years of age and adults over 49 years
  of age
• Additional studies to address transmission
• Ongoing studies of virus recovery from vaccine
  recipients
• Further evaluation of HID50
• Proposed studies to address consequences of
  transmission to immunosuppressed persons
• Other
• School-based community intervention studies in
  progress
• Considering head-to-head comparison with TIV

6
Focus

• Education
• Safety and efficacy of FluMist
• Misperceptions (live vaccine, transmission)
• Influenza burden in healthy persons
• Importance of influenza prevention for everyone
• Improved Access
• Assess pricing options
• Improving product storage profile
• Proactive partnership with public health
  organizations