Influenza Vaccine Manufacturing Infrastructure
The National Strategy for Pandemic Influenza Implementation Plan (2006) (PDF - 404 MB) directed BARDA to expand domestic influenza manufacturing surge capacity for the production of pandemic vaccines for the entire domestic population within six (6) months from the onset of a pandemic. To accomplish this goal, BARDA's Influenza Vaccine Manufacturing Infrastructure maintained active public-private partnerships with U.S. licensed seasonal influenza vaccine manufacturers., as well as pandemic support for ancillary suppliers. These public-private partnership investments increased preparedness levels and response capabilities for influenza pandemic events.
The Influenza Vaccine Manufacturing Infrastructure has made significant achievements in recent years through cost-sharing public-private partnerships. In 2012, Medimmune's live-attenuated influenza vaccine manufacturing and filling capabilities in Santa Clara, CA and Philadelphia, PA were retrofitted to expand manufacturing at least two-fold. The 2014 retrofit of sanofi pasteur's influenza vaccine manufacturing facility in Swiftwater, PA increased its pandemic response capability to meet 25% of the Nation's pandemic influenza vaccine needs. BARDA and Novartis partnered to establish a new facility in Holly Springs, NC that utilized new cell-based vaccine and adjuvant technologies capable of making 33% of the Nation's pandemic influenza vaccine supply. This partnership resulted in the Novartis cell-based influenza vaccine (Flucelvax®) being licensed from this facility in 2014. BARDA support of Protein Sciences seasonal influenza vaccine at its commercial-scale manufacturing facility in West Point, NY, which received FDA-licensure of FluBlǾk® from this facility in 2015, increased further U.S.-based pandemic influenza vaccine manufacturing capacity. Lastly, BARDA's Centers for Innovation in Advanced Development and Manufacturing, which include the new Novartis facility and Fill Finish Manufacturing Network, were established as part of this infrastructure to expand domestic pandemic influenza vaccine manufacturing capacity.
BARDA and its Influenza Vaccine Manufacturing Infrastructure partners will strive to maintain pandemic preparedness capacity as Novartis Vaccines' influenza vaccine franchise transitions to BioCSL. Similarly BARDA will support the technology transfer associated with MF59 adjuvant manufacturing from Novartis to sanofi pasteur. These infrastructure programs, collectively, will continue to allow for rapid response to a pandemic through the use of public-private partnerships to maintain logistical capabilities, supply assurances, and domestic vaccine manufacturing capacities. BARDA's new National Medical Countermeasure Response Infrastructure incorporates many parts of the Influenza Vaccine Manufacturing Infrastructure to address not only pandemic influenza but also emerging infectious diseases.