1. FDA’s 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).

10. 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.