VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE Topic 1: Discussion of BLA for Sanofi Pa

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VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY
COMMITTEETopic 1 Discussion of BLA for Sanofi
Pasteurs H5N1 Vaccine

• Norman W. Baylor, Ph.D.
• Director, Office of Vaccines Research and Review
• FDA/CBER
• 27-28 February 2007

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INTRODUCTION

• Today we will be presenting data in support of
  the first biologics license application for a
  vaccine against H5N1 influenza virus.
• This vaccine was manufactured by Sanofi Pasteur
  in Swiftwater, PA. using the same process as used
  for their licensed seasonal vaccine.
• The safety and immunogencity data for the H5N1
  strain were derived from a clinical trial
  completed by 3 NIH Vaccine Treatment and
  Evaluation Units.

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INTRODUCTION (cont)

• There are currently no human vaccines licensed in
  the U.S. for avian influenza viruses such as
  H5N1.
• FDA is working with other government partners,
  e.g., the National Institutes of Health (NIH),
  the Centers for Disease Control (CDC) and the
  Department of Health and Human Services (DHHS)
  and the vaccine industry to facilitate the
  licensure of safe and effective vaccines for use
  against potential pandemic influenza strains.
• FDA is also facilitating the evaluation of
  vaccines for potential use in the period prior to
  a pandemic, including potential uses for priming
  and cross protection against evolving strains.
• to be discussed in session 2 of todays VRBPAC

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The Risk of Pandemic Influenza

• The risk of pandemic influenza is serious
• H5N1 is present in large parts of Asia
• There is increased risk that more human cases
  will occur
• The continuing presence and spread of the virus
  to new areas in poultry and wild birds increases
  the opportunities for human cases to occur.
• Each additional human case provides the virus an
  opportunity to improve its transmissibility in
  humans, and thus develop into a pandemic strain.
• The timing and severity of the next pandemic
  cannot be predicted however, the probability
  that a pandemic will occur has increased.
• Vaccines will be an important intervention
  against pandemic influenza
• Modeling studies suggest that even a single dose
  of a vaccine of limited effectiveness may have
  significant effects early in a pandemic in
  reducing illness and spread of the virus.

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Cumulative Number of Confirmed Human Cases of
Avian Influenza A/(H5N1) Reported to WHO 19
February 2007
Total number of cases includes number of
deaths.WHO reports only laboratory-confirmed
cases. All dates refer to onset of illness.
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BACKGROUND

• Sanofi Pasteurs A/Vietnam/1203/2004 H5N1 Vaccine
• Uses the same manufacturing process as the
  licensed seasonal influenza vaccine.
• For U.S. licensed seasonal influenza vaccines no
  additional clinical data are required to
  substitute new vaccine strains into the vaccine.
• The clinical trial for SPs H5N1 vaccine was
  designed primarily as a dose ranging study, and
  as a result, the data are limited.
• immunogencity was evaluated in the clinical study
• Proposed Indication 18-64 years of age for use
  during a pandemic or for those at high risk of
  exposure to H5N1
• This vaccine will not be marketed commercially
  but is intended for the U.S. stockpile.

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SUMMARY

• The threat of an influenza pandemic is real and
  likely to continue.
• This vaccine is intended to be an initial step to
  support pandemic preparedness, and to facilitate
  a rapid, early vaccine response.
• If licensed, this vaccine will become the first
  licensed vaccine available in the U.S. against an
  H5N1 strain.
• The vaccine industry in partnership with the US
  DHHS is pursuing other approaches intended to
  elicit enhanced immune responses, and require
  less antigen (e.g., formulations with novel
  adjuvants).
• If and when such vaccines are found to be safe
  and effective, they are likely to supplant use of
  this vaccine formulation.
• The benefit of having a licensed vaccine
  available now against a potential pandemic
  influenza virus strain must be weighed against
  the potential risk of having no vaccine at the
  time of a pandemic.

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BACKGROUND

• Sanofi Pasteurs A/Vietnam/1203/2004 H5N1 Vaccine
• Uses the same manufacturing process as the
  LICENSED seasonal influenza vaccine WHICH HAS A
  LONG RECORD OF S and E USE AGAINST ANNUAL FLU??
• For U.S. licensed seasonal influenza vaccines no
  additional clinical data are required to
  substitute new vaccine strains into the vaccine.
• The clinical trial for SPs H5N1 vaccine was
  designed PRIMARILY as a dose ranging study, and
  as a result, the data are limited.
• effectiveness was evaluated based on
  immunogenicity
• FLU VACCINE INDUCED IMMUNOGENICITY AND PROTECTION
  IS A CONTINUUM NO WELL DEFINED CUTOFFS
• PRELIMINARY RESULTS OF STUDIES OF ELDERLY AND
  PEDIATRICS SHOW SIMILAR IMMUNOGENICITY
  Indication 18-64 years of age for use during a
  pandemic or for those at high risk of exposure to
  H5N1
• This vaccine will not be marketed commercially
  but is intended for the U.S. stockpile