FDAs Role in Facilitating the Availability of Influenza Vaccine

1
FDAs Role in Facilitating the Availability of
Influenza Vaccine

• Norman W. Baylor, Ph.D.
• Director, Office of Vaccines Research and Review
  CBER/FDA

2
Current Progress

• FDA have been instrumental in increasing licensed
  influenza vaccine manufacturing diversity,
  capacity and quality.
• FDA has utilized an accelerated pathway for
  influenza vaccines resulting in the more rapid
  ability to develop, evaluate and approve new safe
  and effective influenza vaccines for US licensure.

3
Current Progress (continued)

• FDA is also providing technical input and
  regulatory guidance, as well as promoting global
  cooperation, to assist in the more rapid
  development, evaluation and deployment of new
  vaccine technologies, such as dose sparing,
  manufacturing using cell cultures and recombinant
  DNA technologies, and new vaccines that can
  protect against multiple flu strains.

4
Meeting the Pandemic Influenza Vaccine Challenge

• Developing needed evaluation and regulatory
  pathways to speed vaccine availability
• Facilitating vaccine manufacturing and
  availability
• Increasing manufacturing diversity and capacity
• Scientific and related technical needs
• Enabling both current and evolving technologies
• Assuring safety and public confidence
• Considering pathways to prevent a pandemic
• Thinking and working globally
• Research and scientific expertise critical
• in all these areas

5
Timelines for Vaccine Production
6
Time to First Trivalent Vaccine Lot after Strain
Change
7
Timing of Production and Distribution

• FDA is identifying methods to achieve earlier
  testing and release of vaccine
• Periodic reassessment of all aspects of
  testing/release/support to ensure timely release
  of vaccine and continued highest standards of
  product safety, efficacy, potency.
• Changes to monovalent testing procedure under
  consideration.
• Investigations into alternative methods to
  produce reagents a high priority.
• Investigations into improved test methods a high
  priority.
• Some aspects of timeline will be difficult to
  alter, e.g., strain selection process, virus
  growth characteristics.

8
Early Production of Monovalent Bulks at Risk

• FDA (CBER) will continue to test monovalent bulk
  lots immediately upon receipt when manufacturers
  produce lots at risk early in the season (e.g.,
  Jan/Feb),
• Early in the season competing demands for
  serology studies necessary for strain selection.
• In general, there has been no waiting period for
  monovalent testing, continuous from Feb-Nov
• Under consideration are changes to the current
  procedure for monovalent potency assignment.

9
Production of Potency Reagents

• Earlier availability of potency reagents could
  lead to earlier monovalent potency assignment and
  trivalent formulation, but will have minimal
  effect because of staggered monovalent
  production.
• Antisera production begins when antigen is
  available. Antigen is available when reference
  virus is available. High titer antisera requires
  multiple booster injections.
• Research priorities include investigations into
  new methods of antigen production and antisera
  production (e.g., new vectors, concurrent antigen
  preparation at CBER).

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Summary

• CBER is committed to working with manufacturers
  and our partners in global public health to
  ensure a safe, effective and adequate supply of
  vaccine for seasonal and pandemic influenza
• Changes to monovalent testing procedure under
  consideration.
• Investigations into alternative methods to
  produce reagents and improved test methods is a
  high priority.
• Timelines for vaccine production are relatively
  fixed, but CBER will explore all options to
  expedite without compromises to safety, efficacy,
  and potency.
• CBER is supportive of lengthening the season for
  which influenza vaccination is recommended in
  order to maximize vaccine coverage.
• CBER VRBPAC strain selection will continue to
  follow WHO meeting to eliminate delays.