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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.