Aviron FluMist
Executive Summary
FDA does not accept June 30 PLA/ELA submission, stating that it requires additional information on manufacturing processes and facilities. Evans Medical will conduct bulk manufacturing and PCI will do secondary manufacturing of the influenza vaccine. Aviron said the additional information requested "is on-track and was already planned for submission in October." However, FDA may require another trial bridging the manufacturing process used for the Phase III trial to the process planned for marketing. Such a trial could delay the planned commercialization for the 1999-2000 flu season, the company said. Aviron has requested a meeting with FDA