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U.S. Department of Health and Human Services

About FDA

Vaccine Roundtable Meeting

Description: Hold Vaccine Roundtable Meeting with manufacturers of Influenza Virus Vaccine to review the 2009 H1N1 campaign and exchange information on regulatory considerations for facility changes and manufacturing supplements. The meeting will focus on best practices and lessons learned with the goal of streamlining and improving the process for the future.

Accomplishment: On June 4, 2010, CBER held a roundtable meeting with manufacturers of Influenza Virus Vaccine. During the meeting, CBER and the manufacturers discussed the results of the 2009 Monovalent H1N1 Influenza Virus Vaccine campaign, in the effort to identify best practices and areas of future process improvement. In general, the campaign was viewed to be a success, with over 460 lots of H1N1 Monovalent Influenza Virus Vaccine released by CBER, constituting more than 145 million doses of product, according to CDC. One improvement area identified concerned the quality of information submitted to CBER in manufacturing supplements for contract facilities. The Office of Compliance and Biologics Quality (OCBQ) will consider the development of instructions to assist manufacturers in the content of such submissions in the event of another emergency. In addition, CBER will continue to work closely with DHHS’s Biomedical Advanced Research and Development Authority (BARDA) to further preparedness efforts for future supply.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Identify FDA planning committee and select OCBQ members

1/15/2010

Completed 11/20/2009

B. Contact manufacturers and identify meeting date, time, location

2/1/2010

Completed 2/1-3/5/2010

C. Draft meeting agenda

2/15/2010

Completed 3/5/2010

D. Hold planning meeting with vaccine manufacturers

3/1/2010

Completed 3/5/2010

E. Confirm speakers

4/15/2010

Completed 5/5/2010 (1)

F. Finalize meeting agenda and distribute to FDA and manufacturers

5/1/2010

Completed 5/26/2010 (1)

G. Finalize FDA presentations

6/1/2010

Completed 6/4/2010

H. Hold Vaccine Roundtable Meeting

6/30/2010

Completed 6/4/2010

Footnotes

  • (1) Previously noted logistical issues resulted in delay in meeting this milestone. However, project was completed ahead of original schedule.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.