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VRBPAC 25 February 2011

Industry Agency Shared Responsibility is necessary for Successful Influenza Vaccine Production & Supply

Communication

Continued timely sharing of surveillance and candidate virus information

Strain selection

Timely review and selection of the appropriate viral strains

Balanced consideration of strain surveillance, selection timing, and impact to vaccine availability

Virus availability:  rapid availability of wild-type viruses and reassortants

Access to wild-type viruses to reassortant labs (NYMC, NIBSC, CSL, MedImmune, etc) is rate-limiting step

Opportunity for manufacturers to evaluate growth characteristics of potential strain candidates

Availability of potency test reagents for new strains by June

Vaccine approval and release

Timely approval of Annual License Supplement

In-Season Lot review and release process

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